1. Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

    The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency…

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy.

    The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status and were durable (median 9.5 months). Treatment-related adverse events ≥Grade 3 occurred in 11.7% of patients. Immune-related adverse events ≥Grade 3 occurred in 6.4% of patients. The most common adverse reactions (incidence ≥ 20%) were fatigue and diarrhea.

    "Patients with SCAC who have progressed after first-line chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDA's acceptance of this BLA for Priority Review brings us one step closer to addressing this historically neglected, yet important, tumor," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "Despite SCAC being a rare disease, its incidence is increasing and its impact is profound. We look forward to working with the FDA to potentially fill an unmet need and advance progress in SCAC for patients."

    Retifanlimab has been granted Orphan Drug Designation by the FDA for the treatment of anal cancer, along with Priority Review. The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the review period by four months as compared to Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for retifanlimab is July 25, 2021.

    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival, and there are no FDA-approved treatments for patients who have progressed after first-line chemotherapy.2

    POD1UM-303/InterAACT 2 (NCT04472429), a Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC, is now open and recruiting patients.

    About POD1UM-202

    POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

    The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

    About POD1UM

    The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 and several other Phase 1, 2 and 3 studies for patients with solid tumors including squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, among others.

    About Retifanlimab

    Retifanlimab (formerly INCMGA0012), an investigational intravenous anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

    Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

    In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about whether or when the FDA may approve retifanlimab for the treatment of patients with squamous cell carcinoma of the anal canal (SCAC), the potential of retifanlimab to provide a meaningful treatment for patients with SCAC, the retifanlimab development program, and the safety and efficacy of retifanlimab in patients with SCAC, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    _________________________

    1 Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol 2015;21:2294-2302.

    2 Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget 2014;5:11133-11142.

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  2. Incyte (NASDAQ:INCY) announced today that it has scheduled its fourth quarter and year-end 2020 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 9, 2021.

    The schedule for the press release and conference call/webcast is as follows:

    • Q4 & YE 2020 Press Release:

    February 9, 2021 at 7:00 a.m. ET

    • Q4 & YE 2020 Conference Call:

    February 9, 2021 at 8:00 a.m. ET

    • Domestic Dial-In Number:

    877-407-3042

    • International Dial-In Number:

    201-389-0864

    • Conference ID Number:

    13715042

    If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number…

    Incyte (NASDAQ:INCY) announced today that it has scheduled its fourth quarter and year-end 2020 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, February 9, 2021.

    The schedule for the press release and conference call/webcast is as follows:

    • Q4 & YE 2020 Press Release:

    February 9, 2021 at 7:00 a.m. ET

    • Q4 & YE 2020 Conference Call:

    February 9, 2021 at 8:00 a.m. ET

    • Domestic Dial-In Number:

    877-407-3042

    • International Dial-In Number:

    201-389-0864

    • Conference ID Number:

    13715042

    If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13715042.

    The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  3. PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).

    "With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path…

    PLANEGG/MUNICH, GERMANY and MONTREAL, QC / ACCESSWIRE / January 12, 2021 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).

    "With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist."

    "This important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys.

    The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL.

    Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

    About Diffuse Large B-cell Lymphoma (DLBCL)
    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter2, leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

    About L-MIND
    The L-MIND trial is a single arm, open-label, multicenter Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant. The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

    For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

    About RE-MIND
    RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

    For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

    About Tafasitamab
    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    XmAb(R) is a registered trademark of Xencor, Inc.

    The safety and efficacy of tafasitamab is under review and the market authorization in Canada has not yet been obtained.

    About MorphoSys
    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya(R), developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma. Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi(R) is a registered trademark of MorphoSys AG.

    Tremfya(R) is a registered trademark of Janssen Biotech, Inc.

    About Incyte
    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    MorphoSys Forward-looking Statements
    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    Incyte Forward-looking Statements
    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Canada for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    Contacts:

    MorphoSys

    Media Contacts:
    Thomas Biegi
    Vice President
    Tel.: +49 (0)89 / 89927 26079


    Investor Contacts:
    Dr. Julia Neugebauer
    Senior Director
    Tel: +49 (0)89 / 899 27 179

    Jeanette Bressi
    Director, US Communications
    Tel: +1 617-404-7816

    Myles Clouston
    Senior Director
    Tel: +1-857-772-0240

    Incyte

    Media Contacts:
    Catalina Loveman
    Executive Director, Public Affairs
    Tel: +1 302 498 6171

    Investor Contact:
    Dr. Michael Booth
    Division VP, IR & Global Responsibility
    Tel: +1 302 498 5914

    Ela Zawislak
    Director, Public Affairs
    Tel: + 41 21 581 5200

    Christine Chiou
    Senior Director, Investor Relations
    Tel: +1 302 274 4773

    References
    1Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209-16. doi.org/10.1016/j.beha.2018.07.014.
    2 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.
    3 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253-265. doi.org/10.3747/co.26.5421.

    SOURCE: MorphoSys AG



    View source version on accesswire.com:
    https://www.accesswire.com/624050/MorphoSys-and-Incyte-Announce-Acceptance-by-Health-Canada-of-the-New-Drug-Submission-for-Tafasitamab

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  4. MONTREAL and PLANEGG/MUNICH, Germany, Jan. 12, 2021 /CNW/ - Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from low grade lymphoma, who are not eligible for, or refuse, autologous stem cell transplant (ASCT).

    "With the acceptance of the NDS by Health Canada, review of the data can begin, an important step on the path to making tafasitamab available in Canada for use in combination with lenalidomide in eligible patients with relapsed or refractory DLBCL," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapeutic option to the clinical community and to appropriate patients for whom few treatment options exist."

    "This important milestone moves tafasitamab in combination with lenalidomide into the regulatory review process in Canada, with the potential to significantly advance patient care in the treatment of relapsed or refractory DLBCL," said Nuwan Kurukulasuriya, Ph.D., Senior Vice President Global Medical Affairs, MorphoSys.

    The NDS, submitted by Incyte, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL not eligible for autologous stem cell transplant, and is supported by the RE-MIND study, an observational retrospective study in relapsed or refractory DLBCL. 

    Incyte has exclusive commercialization rights for tafasitamab outside of the United States and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada. This NDS marks the second marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

    About Diffuse Large B-cell Lymphoma (DLBCL)

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide1, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about 40% of patients not responding to initial therapy or relapsing thereafter2,  leading to a high medical need for new, effective therapies3, especially for patients who are not eligible for an autologous stem cell transplant in this setting.

    About L-MIND

    The L-MIND trial is a single arm, open-label, multicentre Phase 2 study (NCT02399085) investigating the combination of tafasitamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who have had at least one, but no more than three prior lines of therapy, including an anti-CD20 targeting therapy (e.g. rituximab), who are not eligible for high-dose chemotherapy or refuse subsequent autologous stem cell transplant The study's primary endpoint is Overall Response Rate (ORR). Secondary outcome measures include Duration of Response (DoR), Progression-Free Survival (PFS) and Overall Survival (OS). In May 2019, the study reached its primary completion.

    For more information about L-MIND, visit https://clinicaltrials.gov/ct2/show/NCT02399085

    About RE-MIND

    RE-MIND, an observational retrospective study (NCT04150328), was designed to isolate the contribution of tafasitamab in combination with lenalidomide and to prove the combinatorial effect. The study compares real-world response data of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who received lenalidomide monotherapy with the efficacy outcomes of the tafasitamab-lenalidomide combination, as investigated in MorphoSys' L-MIND trial. RE-MIND collected the efficacy data from 490 relapsed or refractory DLBCL patients in the U.S. and EU. Qualification criteria for matching patients of both studies were pre-specified. As a result, 76 eligible RE-MIND patients were identified and matched 1:1 to 76 of 80 L-MIND patients based on important baseline characteristics. Objective Response Rates (ORR) were validated based on this subset of 76 patients in RE-MIND and L-MIND, respectively. The primary endpoint of RE-MIND was met and shows a statistically significant superior best ORR of the tafasitamab-lenalidomide combination compared to lenalidomide monotherapy.

    For more information about RE-MIND, visit https://clinicaltrials.gov/ct2/show/NCT04150328.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Following approval by the U.S. Food and Drug Administration in July 2020, tafasitamab is being co-commercialized by MorphoSys and Incyte in the United States. Incyte has exclusive commercialization rights outside the United States.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    XmAb® is a registered trademark of Xencor, Inc.



    The safety and efficacy of tafasitamab is under review and the market authorization in Canada has not yet been obtained.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

    Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether or when tafasitamab might be approved in Canada for the treatment of, and whether or when tafasitamab might provide a successful treatment option for, in combination with lenalidomide, certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and the L-MIND and RE-MIND clinical trial programs. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by Canadian regulatory authorities or other regulatory authorities, including the U.S. FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    MorphoSys Forward-looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.









    1 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209–16. doi.org/10.1016/j.beha.2018.07.014.

    2 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.

    3 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.

     

    SOURCE Incyte Biosciences Canada

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/January2021/12/c0137.html

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  5. - Incyte and Cellenkos will evaluate the combination of ruxolitinib (Jakafi®) and CK0804, cord blood-derived T-regulatory cells, in patients with myelofibrosis

    - Incyte has an exclusive option to acquire sole rights to CK0804

    Incyte (NASDAQ:INCY) and Cellenkos, Inc., a privately held, clinical stage biotech company, today announced a development collaboration to investigate the combination of ruxolitinib (Jakafi®) and CK0804, Cellenkos' cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis (MF). In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology…

    - Incyte and Cellenkos will evaluate the combination of ruxolitinib (Jakafi®) and CK0804, cord blood-derived T-regulatory cells, in patients with myelofibrosis

    - Incyte has an exclusive option to acquire sole rights to CK0804

    Incyte (NASDAQ:INCY) and Cellenkos, Inc., a privately held, clinical stage biotech company, today announced a development collaboration to investigate the combination of ruxolitinib (Jakafi®) and CK0804, Cellenkos' cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis (MF). In addition, Incyte has an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201230005038/en/

    "This collaboration supports our continued commitment to developing new therapeutic options that may improve and expand treatment options for patients with MF, part of a group of rare blood cancers known as myeloproliferative neoplasms (MPNs)," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are excited to partner with Cellenkos to initiate this study as part of our LIMBER clinical development program, designed to evaluate new monotherapy and combination strategies for patients with MPNs."

    "We are delighted to partner with Incyte, a global biopharmaceutical company, to further study and develop CK0804. Incyte's investment in strong science and R&D excellence makes them an ideal partner to evaluate CK0804 in combination with ruxolitinib as a potential treatment for the many patients living with myelofibrosis, especially those who are transfusion dependent," said Tara Sadeghi, Vice President, Clinical Operations, Cellenkos, Inc. "Our innovative strategy of exploiting the CXCR4/CXCL12 axis to redirect the immune modulatory T-regulatory cells specifically to the diseased bone marrow holds the promise of resolving inflammation to allow for normal hematopoeisis resulting in clinical improvement. This collaboration is in line with our corporate strategy to partner with world-leading major pharma companies in order to maximize access to our innovative cellular medicines."

    Per the terms of the agreement, the companies plan to initiate a Phase 1b single arm, open-label study evaluating ruxolitinib in combination with CK0804 in patients with MF. Incyte will fund the study, which will be operationalized by Cellenkos.

    In addition, per the agreement, Incyte will have an option to acquire an exclusive global license to develop and commercialize the program. Upon exercising the global licensing option, Incyte would be responsible for all activities and costs associated with research, development and commercialization of the program. Cellenkos would be eligible to receive a $20 million licensing fee and, for each distinct product under the agreement, development, regulatory and sales milestones totaling up to $294.5 million as well as tiered royalties ranging from mid-single digit to low-double digits, if approved.

    The collaboration is effective immediately.

    About Myelofibrosis (MF)

    MF is a rare, chronic blood cancer that is part of a group of diseases known as MPNs. In MF, scar tissue forms in the bone marrow and impairs its ability to produce normal blood cells. This can result in an enlarged spleen, and symptoms such as fatigue, itching and night sweats, which can impact a patient's quality of life. About 16,000 to 18,500 people in the United States are living with MF.

    About LIMBER

    Incyte is a leader in the discovery and development of therapies for patients with myeloproliferative neoplasms (MPNs). The Leadership In MPNs BEyond Ruxolitinib (LIMBER) program is designed to evaluate multiple monotherapy and combination strategies to improve and expand treatments for patients with myeloproliferative neoplasms (MPNs). The program currently has three key areas of focus: development of a new, once-daily formulation of ruxolitinib; ruxolitinib-based combinations with new targets such as PI3Kδ, BET and ALK2; and new therapeutic options.

    About Ruxolitinib (Jakafi®)

    Ruxolitinib (Jakafi) is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    About CK0804

    CK0804 is a novel allogenic cell therapy product consisting of T-regulatory cells that exploit the CXCR4/CXCL12 axis and are derived from clinical-grade umbilical cord blood units and manufactured using Cellenkos' proprietary process. The product is cryopreserved and readily available off-the-shelf, without any requirement for HLA matching, and is infused intravenously. One manufacturing campaign can result in multiple doses of cryopreserved product that can be shipped to the clinical site, where it can be stored for an extended period or made available for immediate treatment, as needed.

    Important Safety Information for Jakafi® (ruxolitinib)

    Jakafi can cause serious side effects, including:

    Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

    Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

    Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

    Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

    The most common side effects of Jakafi include: for certain types of MF and PV - low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

    These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

    Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

    Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

    Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About Cellenkos®, Inc.

    Cellenkos is a clinical-stage biotechnology company located in Houston, Texas, USA, founded in 2016 with the licensing of a proprietary umbilical cord blood T-Regulatory cell therapy platform arising from the laboratory investigations of Simrit Parmar, MD, MSCI, Associate Professor in the Department of Lymphoma and Myeloma at the University of Texas at MD Anderson Cancer Center.

    Being derived from umbilical cord blood, Cellenkos' T-Regulatory cells are naïve, bonafide suppressor cells that resolve inflammation through multiple direct and indirect interactions. Cellenkos is dedicated to the development and commercialization of the allogeneic, off-the-shelf cell based products for the treatment of rare inflammatory diseases and autoimmune disorders. For more information, please visit www.cellenkosinc.com.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding expectations regarding the combination of ruxolitinib and CK0804, the timing, design and potential results of the planned combination study, the potential benefits of the combination or of CK0804 for patients, the planned development, funding, commercialization and payments under this collaboration, and the LIMBER program, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by regulatory authorities; the efficacy or safety of Incyte's or its collaborators' products; the acceptance of Incyte's products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

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    • Initial data show that treatment with ruxolitinib plus standard-of-care (SoC) did not prevent complications in patients with COVID-19 associated cytokine storm

    Incyte (NASDAQ:INCY) today announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi®), a JAK1/JAK2 inhibitor, plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared…

    • Initial data show that treatment with ruxolitinib plus standard-of-care (SoC) did not prevent complications in patients with COVID-19 associated cytokine storm

    Incyte (NASDAQ:INCY) today announced that the Phase 3 RUXCOVID study evaluating the safety and efficacy of ruxolitinib (Jakafi®), a JAK1/JAK2 inhibitor, plus standard-of-care (SoC) as a treatment for patients 12 years and older with COVID-19 associated cytokine storm did not meet its primary endpoint. Initial data show that there was no reduction in the proportion of patients receiving ruxolitinib plus SoC who experienced severe complications including death, respiratory failure requiring mechanical ventilation or admission to the intensive care unit (ICU) care by Day 29, compared to SoC treatment alone (12.0% vs. 11.8% [OR: 0.91 [95% CI: 0.48-1.73], P=0.769, respectively)1.

    In addition, there was no clinically relevant benefit observed among secondary and exploratory endpoints, including mortality rate by Day 29 and time to recovery, defined as the first day a patient met the criteria for category 0 (Uninfected – No clinical or virological evidence of infection), 1 (Ambulatory – No limitation of activities), or 2 (Ambulatory – Limitation of activities) on the 9-point ordinal scale1. Ruxolitinib was generally well tolerated and no significant safety concerns were identified1. A comprehensive analysis including safety data is ongoing. The results of this study do not affect other ongoing non-COVID-19 related ruxolitinib clinical trials or approved uses of ruxolitinib.

    "Given the urgent nature of the COVID-19 pandemic and the need for treatments for patients hospitalized with severe COVID-19 associated cytokine storm, the results of the RUXCOVID study are disappointing," said Steven Stein, M.D., Chief Medical Officer, Incyte. "However, we hope that these findings will contribute to the scientific understanding of this complex disease and to the collective efforts of the biopharma industry to find solutions that improve outcomes for patients with COVID-19."

    The RUXCOVID study is complete. The data will be further analyzed to determine any potential impact on other studies of ruxolitinib in patients with COVID-19, and will be submitted for publication.

    Ruxolitinib (Jakafi®) is approved by the U.S. Food and Drug Administration for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. It is marketed by Incyte in the United States; ruxolitinib (Jakavi®) is licensed to Novartis ex-U.S.

    About COVID-19 Associated Cytokine Storm

    Cytokine storm is a severe immune overreaction that can be triggered by a viral infection and can lead to serious complications, including pneumonia and acute respiratory distress syndrome (ARDS). Patients with COVID-19 associated cytokine storm who experience these complications often require intensive care, including intubation and the use of mechanical ventilation, and are at an increased risk of mortality. RUXCOVID study patients were selected based on having pulmonary infiltrates, elevated respiratory rate or hypoxemia.

    About RUXCOVID

    RUXCOVID (NCT04362137) was a global, randomized, double-blind, placebo-controlled, 29-day, multi-center Phase 3 study evaluating the efficacy and safety of ruxolitinib plus standard of care (SoC) therapy in patients aged ≥12 years with COVID-19 associated cytokine storm compared to placebo plus SoC therapy. The study enrolled 432 patients globally, and randomization was stratified by geographic region2.

    The primary endpoint was the proportion of patients who died, or developed respiratory failure and required mechanical ventilation or required intensive care unit (ICU) care by Day 29. Secondary endpoints were various efficacy assessments including evaluation of clinical status using a 9-point ordinal scale; in-hospital outcomes (mortality rate; proportion of patients requiring mechanical ventilation; duration of hospitalization, ICU stay, supplemental oxygen, invasive mechanical ventilation); change in the National Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion of patients with no oxygen therapy (oxygen saturation of ≥94% on room air); and safety2.

    Eligible patients were randomized 2:1 to receive oral ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a total of 14 days. Study treatment was given in combination with SoC therapy according to the investigator's clinical judgement. After 14 days of therapy, if clinical signs or symptoms did not improve or worsen, and the potential benefit outweighed the potential risks, patients could receive an additional 14 days of study therapy. In total, patients were followed on study for 29 days post-randomization2.

    The RUXCOVID study was sponsored by Incyte in the United States and Novartis outside of the United States. For more information, please visit: https://clinicaltrials.gov/ct2/show/NCT04362137.

    To learn more about Incyte's response to COVID-19, including information on the 369-DEVENT study, please visit Incyte.com/COVID-19.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    Important Safety Information

    Jakafi can cause serious side effects, including:

    Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

    Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

    Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

    Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

    The most common side effects of Jakafi include: for certain types of MF and PV - low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

    These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

    Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

    Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

    Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding analysis and publication of the RUXCOVID results contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, which risks are detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.


    1 Data on file.

    2 "A Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID)." ClinicalTrials.gov. 2020. https://clinicaltrials.gov/ct2/show/NCT04362137.

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  6. INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen.

    "These published data from a rigorous, double-blind…

    INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that The New England Journal of Medicine has published peer-reviewed results from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Phase 3 study included 1,033 patients from 67 trial sites in eight countries. These results support the emergency use authorization (EUA) issued by the U.S. Food and Drug Administration (FDA) on Nov. 19 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen.

    "These published data from a rigorous, double-blind, placebo-controlled trial are critical in helping the scientific community make better-informed treatment decisions to improve clinical outcomes for patients," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center, a principal investigator of the ACTT studies and lead study author of the ACTT-2 New England Journal of Medicine manuscript. "Results of this study demonstrated baricitinib in combination with remdesivir provided a faster median recovery time and reduced progression to ventilation or death compared to remdesivir alone in hospitalized COVID-19 patients on oxygen."

    "Presently, there are limited published placebo-controlled data assessing treatment options to manage the symptoms and progression of COVID-19," said Anabela Cardoso, M.D., an author of the New England Journal of Medicine paper and Lilly global brand development lead, immunology. "We need high-quality research such as the ACTT-2 study to evaluate therapies to fight this pandemic and are pleased that this medicine is now available for patients under EUA."

    Read the full NIAID press release on ACTT-2 results here.

    Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. Please see below for important warnings and information about the authorized use of baricitinib in the U.S. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. 

    For information on the authorized use of baricitinib and mandatory requirements under the EUA, please review the FDA Letter of AuthorizationFact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (EnglishSpanish). 

    Authorized Use Under the EUA and Important Safety Information for baricitinib (in the United States) for COVID-19 

    Baricitinib is authorized for use under an Emergency Use Authorization (EUA) in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 

    Baricitinib has not been approved for the treatment of COVID-19, but has been authorized for emergency use by the FDA. Baricitinib is authorized under an EUA only for the duration of the declaration that circumstances exist justifying the authorization of the EUA of baricitinib under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.  

    Important Safety Information about baricitinib for COVID-19 

    The following provides essential safety information on the unapproved use of baricitinib under the Emergency Use Authorization. 

    Warnings 

    Serious Infections: Serious infections have occurred in patients receiving baricitinib. Avoid the use of baricitinib with known active tuberculosis. Consider if the potential benefits outweigh the potential risks of baricitinib treatment in patients with active serious infections other than COVID-19 or chronic/recurrent infections. 

    Thrombosis: In hospitalized patients with COVID-19, prophylaxis for venous thromboembolism is recommended unless contraindicated. If clinical features of deep vein thrombosis or pulmonary embolism occur, patients should be evaluated promptly and treated appropriately. 

    Abnormal Laboratory Values: Evaluate at baseline and thereafter according to local patient management practice. Monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Follow dose adjustments as recommended in the Fact Sheet for Healthcare Providers for patients with abnormal renal, hematological and hepatic laboratory values. Manage patients according to routine clinical guidelines. 

    Hypersensitivity:If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction. 

    See Warnings and Precautions in the FDA-approved full Prescribing Information for additional information on risks associated with longer-term treatment with baricitinib. 

    Serious Side Effects: Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib and are known adverse drug reactions of baricitinib. 

    There are limited clinical data available for baricitinib use in coronavirus 2019 (COVID-19). Additional information regarding baricitinib for its FDA-approved indication, including safety information, may be found in the full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide

    Use in Specific Populations 

    Pregnancy: Baricitinib should be used during pregnancy only if the potential benefit justifies the potential risk for the mother and the fetus. 

    Renal Impairment: There are limited data for baricitinib in patients with severe renal impairment. Baricitinib is not recommended for patients who are on dialysis, have end-stage renal disease, or have acute kidney injury. 

    Hepatic Impairment: Baricitinib has not been studied in patients with severe hepatic impairment. Baricitinib should only be used in patients with severe hepatic impairment if the potential benefit outweighs the potential risk. 

    BC HCP EUA ISI 19NOV2020

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click here for resources related to Lilly's COVID-19 efforts and here for baricitinib's EUA.

    About baciritinib (OLUMIANT ®)

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. The U.S. FDA-approved labeling for Olumiant includes a Boxed Warning for Serious Infections, Malignancy, and Thrombosis. See the full Prescribing Information here.

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.  P-LLY

    About Incyte 

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis and other conditions, as well as its supply, and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any such undertaking there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or authorizations or be commercially successful, that we can provide an adequate supply of OLUMIANT in all circumstances, or that OLUMIANT will be safe and effective as a treatment for COVID-19. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    Refer to:

    Kristen Basu; ; +1-317-447-2199 (Lilly media)



    Kevin Hern; ; +1-317-277-1838 (Lilly investors)



    Catalina Loveman; ; +1-302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

     

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/data-from-actt-2-trial-of-baricitinib-in-hospitalized-covid-19-patients-supportive-of-the-eua-published-in-new-england-journal-of-medicine-301191422.html

    SOURCE Eli Lilly and Company

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  7. Incyte (NASDAQ:INCY) announced today that it will present at the 39th Annual J. P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 7:30 a.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Incyte (NASDAQ:INCY) announced today that it will present at the 39th Annual J. P. Morgan Virtual Healthcare Conference on Monday, January 11, 2021 at 7:30 a.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  8. - Data from the CITADEL program of parsaclisib in patients with follicular, marginal zone and mantle cell lymphomas were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020)

    - Investor conference call and webcast scheduled for today, December 7, at 10:00 a.m. ET (7:00 a.m. PT)

    Incyte (NASDAQ:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas. These data were accepted for presentation at the 62nd…

    - Data from the CITADEL program of parsaclisib in patients with follicular, marginal zone and mantle cell lymphomas were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020)

    - Investor conference call and webcast scheduled for today, December 7, at 10:00 a.m. ET (7:00 a.m. PT)

    Incyte (NASDAQ:INCY) today announced data from three ongoing Phase 2 studies evaluating parsaclisib, a potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas. These data were accepted for presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually from December 5–8, 2020.

    The primary endpoint for the CITADEL-203, -204 and -205 studies is objective response rate (ORR); duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability are among the secondary endpoints. All radiology-based endpoints are based on independent review committee (IRC) assessment.

    Eligible patients received parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and patients initially enrolled in the WG were allowed to switch to DG. Data are presented for the DG and all patients.

    Key results from the CITADEL studies include:

     

    ORR (95% CI), %

    mDOR (95% CI),

    months

    mPFS (95% CI),

    months

    mOS (95% CI),

    months

    CITADEL-203: R/R Follicular Lymphoma

    DG (N=95)

    75 (65-83)

    14.7 (12.0-17.5)

    15.8 (13.8-19.1)

    -

    All (N=118)

    73 (64-81)

    15.9 (12.0-NE)

    15.8 (13.2-19.3)

    -

    CITADEL-204: R/R Marginal Zone Lymphoma

    DG (N=72)

    56.9 (44.7-68.6)

    NR (8.1-NE)

    NR (11.0-NE)

    -

    All (N=100)

    57.0 (46.7-66.9)

    12.0 (9.3-NE)

    19.4 (13.7-NE)

    -

    CITADEL-205: R/R Mantle Cell Lymphoma (BTK Inhibitor Treatment Naive)

    DG (N=77)

    71 (60-81)

    9.0 (6.7-14.7)

    11.1 (8.3-NE)

    NR (NE-NE)

    All (N=108)

    70 (61-79)

    14.7 (7.7-NE)

    11.1 (8.3-19.2)

    NR (NE-NE)

    CITADEL-205: R/R Mantle Cell Lymphoma (Previously Treated with Ibrutinib)

    DG (N=41)

    29 (16-46)

    3.7 (1.9-NE)

    3.7 (1.8-4.1)

    11.2 (7.9-NE)

    All (N=53)

    25 (14-38)

    3.7 (1.9-NE)

    3.7 (1.8-3.9)

    11.2 (7.9-17.1)

    R/R: relapsed or refractory; ORR: objective response rate; mDOR: median duration of response (reported for responders); mPFS: median progression-free survival; mOS: median overall survival; DG: daily dosing group; BTK: Bruton's tyrosine kinase.

    Parsaclisib was generally well tolerated in all studies with a manageable safety profile.

    "Data from the CITADEL studies presented at ASH 2020 are very promising and they highlight the potential of parsaclisib to become a meaningful treatment for patients with relapsed or refractory follicular, marginal zone or mantle cell lymphomas," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "We look forward to continuing our work as we seek to bring this medicine to patients."

    Presentations are available on the ASH website at https://www.hematology.org/meetings/annual-meeting; #338 (Oral presentation, CITADEL-204), #2935 (Poster, CITADEL-203), #1121 (Poster, CITADEL-205), #2044 (Poster, CITADEL-205).

    About Follicular, Marginal Zone and Mantle Cell Lymphomas

    Non-Hodgkin lymphoma (NHL) is a type of cancer that starts in the lymphocytes, a type of white blood cell. Follicular lymphoma (FL), marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) are forms of B-Cell NHLs. FL and MZL are indolent or slow growing lymphomas; MCL is an aggressive or rapidly developing form. There is an unmet medical need for treatment options for patients who are relapsed or refractory to initial therapies.

    About CITADEL

    The CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) clinical trial program is evaluating parsaclisib in several ongoing studies as a treatment for adult patients with lymphomas, including:

    • CITADEL-203 (NCT03126019) is evaluating patients with relapsed or refractory follicular lymphoma (FL) Grade 1, 2 or 3a who received at least two prior systemic therapies, had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2, and were ineligible for hematopoietic stem cell transplantation (HSCT).
    • CITADEL-204 (NCT03144674) is evaluating patients with relapsed or refractory marginal zone lymphoma (MZL) who received at least one prior systemic therapy and were Bruton's tyrosine kinase (BTK) inhibitor treatment naive. Patients with prior ibrutinib treatment were initially allowed to enroll; however, the cohort was terminated due to slow enrollment. Eligible patients had radiologically measurable lymphadenopathy or extranodal lymphoid malignancy (or histologically confirmed bone marrow infiltration in cases of splenic MZL), and an ECOG PS ≤2.
    • CITADEL-205 (NCT03235544) is evaluating patients with relapsed or refractory mantle cell lymphoma (MCL), who received one to three prior systemic therapies and were either naive to or were previously treated with a BTK inhibitor. Eligible patients had an ECOG PS ≤2, and radiologically measurable lymphadenopathy or extranodal lymphoid malignancy.

    Patients eligible for each trial were allocated to receive parsaclisib 20 mg once daily for eight weeks followed by either 20 mg once weekly (weekly-dosing group [WG]) or 2.5 mg once daily (daily-dosing group [DG]). Subsequently, daily dosing was selected as the preferred regimen and the WG patients were allowed to switch to DG. Prophylaxis for Pneumocystis jirovecii pneumonia (PJP) was required.

    About Parsaclisib

    Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway; and there are plans to initiate a trial to evaluate parsaclisib in combination with tafasitamab for B-cell malignancies.

    In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib. Under the terms of the agreement, Innovent has received the rights to develop and commercialize parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.

    Conference Call Information

    Incyte will host an investor conference call and webcast at 10:00 a.m. ET (7:00 a.m. PT) today, December 7, 2020—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.

    To access the conference call, please dial 877-407-3042 for domestic callers or +1 201-389-0864 for international callers. When prompted, provide the conference identification number, 13713399.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of parsaclisib to provide a meaningful treatment for patients with non-Hodgkin lymphomas, including follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, the CITADEL clinical program and other development plans for parsaclisib, including in combination with tafasitamab and with ruxolitinib, and the safety and efficacy of parsaclisib in patients with non-Hodgkin lymphomas contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the efficacy or safety of the Company's products; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

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  9. Preliminary safety and efficacy data from Phase 1b firstMIND trial in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) presented today

    - Also presented today: Long-term subgroup analyses from L-MIND study evaluating tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) announce that preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of tafasitamab or tafasitamab plus lenalidomide in addition to R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were presented today during the 62nd American Society…

    Preliminary safety and efficacy data from Phase 1b firstMIND trial in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) presented today

    - Also presented today: Long-term subgroup analyses from L-MIND study evaluating tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL

    Incyte (NASDAQ:INCY) and MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) announce that preliminary data from firstMIND, the ongoing Phase 1b, open-label, randomized study on the safety and efficacy of tafasitamab or tafasitamab plus lenalidomide in addition to R-CHOP for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) were presented today during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Additionally, a long-term subgroup analysis of the L-MIND study investigating tafasitamab combined with lenalidomide in patients with relapsed or refractory DLBCL was also presented at ASH.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201207005244/en/

    The preliminary results of firstMIND indicate that tafasitamab plus lenalidomide in addition to R-CHOP shows an acceptable tolerability profile. Toxicities appear to be similar to what is expected with R-CHOP alone or in combination with lenalidomide. Serious or severe neutropenia and thrombocytopenia events (grade 3 or higher) were more frequent in the tafasitamab plus lenalidomide arm. The incidence of febrile neutropenia was comparable between both arms and the average relative dose intensity of R-CHOP was maintained in both arms. Interim response assessments after three cycles were available for 45 patients. In both arms combined, 41/45 (91.1%) of patients had an objective response as per Lugano 20141.

    The preliminary data from this ongoing study in first-line DLBCL warrant further investigation. To that end, MorphoSys and Incyte plan to initiate frontMIND, a Phase 3 trial evaluating tafasitamab plus lenalidomide in combination with R-CHOP compared to R-CHOP alone as first-line treatment for patients with newly diagnosed DLBCL.

    "The initial results of the firstMIND study, shared today at ASH, as well as the long-term analyses from L-MIND, underscore the potential of tafasitamab as a combination therapeutic for patients with DLBCL, where there remains a significant unmet need. Along with our partners at MorphoSys, we are pleased to be moving forward with the initiation of a Phase 3 study in 2021," said Steven Stein, M.D., Chief Medical Officer at Incyte.

    "The preliminary firstMIND study results mark another important step as we explore the potential of tafasitamab as a backbone therapy," said Dr. Malte Peters, Chief Research and Development Officer at MorphoSys. "Given the data available to date, including data from the L-MIND study, we believe that the mechanism of action, efficacy and safety profile of tafasitamab have the potential to make it a preferred combination partner as we seek to transform the standard of care in DLBCL. We are committed to developing innovative therapies to battle this aggressive disease for the benefit of patients with DLBCL, and look forward to beginning the planned frontMIND in the first half of 2021."

    In addition to the firstMIND data presented today, the long-term L-MIND analyses showed that treatment with tafasitamab plus lenalidomide resulted in durable responses after ≥2 years of follow-up. At the time of analysis, patients with complete responses (CR) continued to experience durable treatment responses, including long duration of response (DoR) and overall survival (OS). The data also showed that tafasitamab plus lenalidomide taken for 12 cycles, followed by tafasitamab until progression, did not result in any unexpected safety signals2.

    In July 2020, the FDA approved Monjuvi® (tafasitamab-cxix), a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)3.

    The FDA decision represented the first approval of a second-line treatment for adult patients with DLBCL who progressed during or after first-line therapy.

    About Diffuse Large B-cell Lymphoma (DLBCL)

    DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide4, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter5. In the United States each year, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT)6,7,8.

    About firstMIND

    The firstMIND (NCT04134936) trial is a Phase 1b, randomized study of tafasitamab + R-CHOP (Arm A) or tafasitamab + lenalidomide + R-CHOP (Arm B) in patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). The study includes a safety run-in phase and a main phase. In the safety run-in phase, 24 patients were enrolled. The primary objective is to assess safety; secondary objectives include objective response rate, PET negative complete response (PET-CR) rate at end of treatment, progression-free survival, event-free survival, long-term safety, pharmacokinetics and immunogenicity of tafasitamab.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi® is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    Important Safety Information

    What are the possible side effects of MONJUVI?

    MONJUVI may cause serious side effects, including:

    • Infusion reactions. Your healthcare provider will monitor you for infusion reactions during your infusion of MONJUVI. Tell your healthcare provider right away if you get chills, flushing, headache, or shortness of breath during an infusion of MONJUVI.
    • Low blood cell counts (platelets, red blood cells, and white blood cells). Low blood cell counts are common with MONJUVI, but can also be serious or severe. Your healthcare provider will monitor your blood counts during treatment with MONJUVI. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or any bruising or bleeding.
    • Infections. Serious infections, including infections that can cause death, have happened in people during treatments with MONJUVI and after the last dose. Tell your healthcare provider right away if you get a fever of 100.4°F (38°C) or above, or develop any signs and symptoms of an infection.

    The most common side effects of MONJUVI include:

    • Feeling tired or weak
    • Diarrhea
    • Cough
    • Fever
    • Swelling of lower legs or hands
    • Respiratory tract infection
    • Decreased appetite

    These are not all the possible side effects of MONJUVI.

    Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before you receive MONJUVI, tell your healthcare provider about all your medical conditions, including if you:

    • Have an active infection or have had one recently.
    • Are pregnant or plan to become pregnant. MONJUVI may harm your unborn baby. You should not become pregnant during treatment with MONJUVI. Do not receive treatment with MONJUVI in combination with lenalidomide if you are pregnant because lenalidomide can cause birth defects and death of your unborn baby.
    • You should use an effective method of birth control (contraception) during treatment and for at least 3 months after your final dose of MONJUVI.
    • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MONJUVI.
    • Are breastfeeding or plan to breastfeed. It is not known if MONJUVI passes into your breastmilk. Do not breastfeed during treatment for at least 3 months after your last dose of MONJUVI.

    You should also read the lenalidomide Medication Guide for important information about pregnancy, contraception, and blood and sperm donation.

    Tell your healthcare provider about all the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    Please see the full Prescribing Information for Monjuvi, including Patient Information, for additional Important Safety Information.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

    Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    Incyte Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release - including statements about: plans to initiate frontMIND, a Phase 3 trial evaluating tafasitamab plus lenalidomide in combination with R-CHOP compared to R-CHOP alone as first-line treatment for patients with newly diagnosed DLBC; whether the mechanism of action, efficacy and safety profile of tafasitamab have the potential to make it a preferred or ideal combination partner in the treatment of DLBCL and, whether it will change or become the standard of care for the treatment of DLBCL; whether and when, if ever, confirmatory trials of tafasitamab will result in the conditional FDA approval of tafasitamab in the conditionally approved indication described above becoming a final approval; whether and when, if ever, the EMA will approve the filed MAA for tafasitamab; and additional development of tafasitamab, including in B-cell malignancies - contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA or the EMA; clinical and commercial supply of products in development or being commercialized; Incyte's dependence on its relationships with its collaboration partners; the efficacy or safety of Incyte's products and the products of its collaboration partners; the acceptance of Incyte's products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in Incyte's reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

    MorphoSys Forward-Looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.


    1 Belada D, M.D., Ph.D., et al. A Phase 1b, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In Phase. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3028.

    2 Maddocks KJ, M.D., et al. Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #3021.

    3 Monjuvi® (tafasitamab-cxix) Prescribing Information. Boston, MA, MorphoSys.

    4 Sarkozy C, et al. Management of relapsed/refractory DLBCL. Best Practice Research & Clinical Haematology. 2018 31:209–16. doi.org/10.1016/j.beha.2018.07.014.

    5 Skrabek P, et al. Emerging therapies for the treatment of relapsed or refractory diffuse large B cell lymphoma. Current Oncology. 2019 26(4): 253–265. doi.org/10.3747/co.26.5421.

    6 DRG Epidemiology data.

    7 Kantar Market Research (TPP testing 2018).

    8 Friedberg, Jonathan W. Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Hematology Am Soc Hematol Educ Program 2011; 2011:498-505. doi: 10.1182/asheducation-2011.1.498.

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  10. - Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1

    - Findings from the study are being presented at ASH 2020, and complement previously-reported positive results for Jakafi in steroid-refractory acute graft-versus-host disease (GVHD)2

    - Chronic GVHD is a life-threatening complication of stem cell transplants and half of patients become steroid refractory/dependent3,4

    - Investor conference call and webcast scheduled for Monday, December 7, 2020 at 10:00 a.m. ET (7:00 a.m. PT)

    Incyte (NASDAQ:INCY) today announced that detailed results from the pivotal Phase 3 REACH3 study demonstrate Jakafi® (ruxolitinib) significantly improved outcomes across a range of efficacy…

    - Results of REACH3 trial also demonstrate significant improvements in failure-free survival (FFS) and patient-reported symptoms1

    - Findings from the study are being presented at ASH 2020, and complement previously-reported positive results for Jakafi in steroid-refractory acute graft-versus-host disease (GVHD)2

    - Chronic GVHD is a life-threatening complication of stem cell transplants and half of patients become steroid refractory/dependent3,4

    - Investor conference call and webcast scheduled for Monday, December 7, 2020 at 10:00 a.m. ET (7:00 a.m. PT)

    Incyte (NASDAQ:INCY) today announced that detailed results from the pivotal Phase 3 REACH3 study demonstrate Jakafi® (ruxolitinib) significantly improved outcomes across a range of efficacy measures in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT)1. The results of REACH3, the first successful, randomized Phase 3 trial in chronic GVHD, were highlighted in a press briefing today and will be presented during the 62nd American Society of Hematology Annual Meeting & Exposition (ASH 2020). REACH3 is jointly sponsored by Incyte and Novartis.

    "The results from this large, randomized study further emphasize the role Jakafi can play as a meaningful option for patients with chronic GVHD, for whom new treatments are urgently needed," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "These data are important for patients living with GVHD and their physicians as they represent the continued success of Jakafi in the chronic form of the disease, a historically difficult-to-treat condition."

    In REACH3, patients treated with Jakafi achieved significantly greater overall response rate (ORR) compared to BAT (49.7% vs. 25.6%; p<0.00015) at Week 24, the primary endpoint of the study6. Jakafi also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints:

    • Patients receiving Jakafi had a significant improvement in failure-free survival (FFS; defined as time to the earliest recurrence of the underlying disease, the start of new systemic treatment for chronic GVHD, or death) versus patients receiving BAT (median FFS not yet reached vs. 5.7 months; hazard ratio, 0.37, 95% CI, 0.27-0.51; p<0.0001)1.
    • Patients treated with Jakafi also had greater improvements in patient-reported symptoms than those treated with BAT (24.2% vs. 11.0%; p=0.0011), as measured by the rate of responders who achieved a reduction of ≥ 7 points of total symptom score (TSS) from baseline of the modified Lee Symptom Score (mLSS)1.
    • Additionally, best overall response (BOR) rate, defined as any response up to week 24, was achieved in 76.4% of patients in the Jakafi arm compared to 60.4% in the BAT arm (odds ratio [OR], 2.17; 95% CI, 1.34-3.52). The median duration of response was 6.2 months in the BAT arm, but was not yet reached in the Jakafi arm1.

    No new safety signals were observed in REACH3, and adverse events (AEs) attributable to treatment were consistent with the known safety profile of Jakafi. The most common AEs in the Jakafi vs. BAT arms were anemia (29.1% vs. 12.7%), hypertension (15.8% vs. 12.7%) and pyrexia (15.8% vs. 9.5%). While 37.6% and 16.5% of patients required Jakafi and BAT dose modifications, respectively, the number of patients who discontinued treatment due to AEs was low (16.4% and 7%, respectively). Mortality rates were similar across treatment arms (19% vs. 16% BAT)1. Deaths reported as primarily due to chronic GVHD were slightly higher for Jakafi.

    "The damaging and sometimes deadly effects of chronic GVHD following stem cell transplant present significant treatment challenges, particularly for the nearly half of patients who do not adequately respond to steroid treatment," said Dr. Robert Zeiser, University Hospital Freiburg, Department of Haematology, Oncology and Stem Cell Transplantation, Freiburg, Germany. "Based on the compelling REACH3 results, we now have a potential new standard of care for these patients."

    GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) where the donated cells initiate an immune response and attack the transplant recipient's organs, leading to significant morbidity and mortality. There are two major forms of GVHD: acute, which occurs within 100 days of transplant, and chronic, which occurs after 100 days of transplant3. GVHD can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.

    In 2019, Jakafi® (ruxolitinib) was approved by the U.S. Food and Drug Administration for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older, based on the positive results of the Phase 2 REACH1 trial6. Jakafi is marketed by Incyte in the U.S.; ruxolitinib (Jakavi®) is licensed to Novartis ex-U.S.

    About REACH3

    REACH3 (NCT03112603), a randomized, open-label, multicenter Phase 3 study sponsored by Novartis and conducted in collaboration with and co-funded by Incyte, is evaluating the safety and efficacy of ruxolitinib compared with best available therapy in patients with steroid-refractory chronic GVHD.

    The primary endpoint is overall response rate (ORR) at Day 1 of the Cycle 7 (Day 168) visit, defined as the percentage of participants demonstrating a complete or partial response. Secondary endpoints include change in the modified Lee chronic GVHD symptom scale score at Day 1 of Cycle 7, rate of failure-free survival (FFS) up to 36 months, best overall response (BOR), duration of response (DoR), overall survival (OS), among others. For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03112603.

    About REACH

    The REACH clinical trial program evaluating ruxolitinib in patients with steroid-refractory GVHD includes the randomized pivotal Phase 3 REACH2 and REACH3 trials, conducted in collaboration with Novartis.

    The REACH program was initiated with the Incyte-sponsored REACH1 trial, a prospective, open-label, single-cohort, multicenter, pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination with corticosteroids in patients with steroid-refractory grade II-IV acute GVHD. For more information about the study, including trial results, please visit https://clinicaltrials.gov/show/NCT02953678.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    Important Safety Information

    Jakafi can cause serious side effects, including:

    Low blood counts: Jakafi® (ruxolitinib) may cause your platelet, red blood cell, or white blood cell counts to be lowered. If you develop bleeding, stop taking Jakafi and call your healthcare provider. Your healthcare provider will perform blood tests to check your blood counts before you start Jakafi and regularly during your treatment. Your healthcare provider may change your dose of Jakafi or stop your treatment based on the results of your blood tests. Tell your healthcare provider right away if you develop or have worsening symptoms such as unusual bleeding, bruising, tiredness, shortness of breath, or a fever.

    Infection: You may be at risk for developing a serious infection during treatment with Jakafi. Tell your healthcare provider if you develop any of the following symptoms of infection: chills, nausea, vomiting, aches, weakness, fever, painful skin rash or blisters.

    Skin cancers: Some people who take Jakafi have developed certain types of non-melanoma skin cancers. Tell your healthcare provider if you develop any new or changing skin lesions.

    Increases in cholesterol: You may have changes in your blood cholesterol levels. Your healthcare provider will do blood tests to check your cholesterol levels during your treatment with Jakafi.

    The most common side effects of Jakafi include: for certain types of MF and PV - low platelet or low red blood cell counts, bruising, dizziness, headache, and diarrhea; and for acute GVHD – low platelet, red or white blood cell counts, infections, and fluid retention.

    These are not all the possible side effects of Jakafi. Ask your pharmacist or healthcare provider for more information. Tell your healthcare provider about any side effect that bothers you or that does not go away.

    Before taking Jakafi, tell your healthcare provider about: all the medications, vitamins, and herbal supplements you are taking and all your medical conditions, including if you have an infection, have or had tuberculosis (TB), or have been in close contact with someone who has TB, have or had hepatitis B, have or had liver or kidney problems, are on dialysis, have a high level of fat in your blood (high blood cholesterol or triglycerides), had skin cancer or have any other medical condition. Take Jakafi exactly as your healthcare provider tells you. Do not change or stop taking Jakafi without first talking to your healthcare provider.

    Women should not take Jakafi while pregnant or planning to become pregnant. Do not breast-feed during treatment with Jakafi and for 2 weeks after the final dose.

    Full Prescribing Information, which includes a more complete discussion of the risks associated with Jakafi, is available at www.jakafi.com.

    Conference Call Information

    Incyte will host an investor conference call and webcast at 10:00 a.m. ET (7:00 a.m. PT) on Monday, December 7, 2020—the call and webcast can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 90 days.

    To access the conference call, please dial 877-407-3042 for domestic callers or +1 201-389-0864 for international callers. When prompted, provide the conference identification number, 13713399.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about the REACH3 data, the effect of the REACH3 results on patients with GVHD, and the overall REACH program, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Zeiser R, M.D., et al. Ruxolitinib (RUX) vs Best Available Therapy (BAT) in Patients with Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease (cGVHD): Primary Findings from the Phase 3, Randomized REACH3 Study. 62nd American Society of Hematology Annual Meeting & Exposition (ASH). Abstract #77.

    2 Zeiser R, M.D., et al. Ruxolitinib for Glucocorticoid-Refractory Acute Graft-versus-Host Disease. New England Journal of Medicine. 2020;382:1800-1810.

    3 Ferrara JL., et al. Graft-versus-host disease. Lancet. 2009;373(9674):1550-1561.

    4 Jaglowski SM, et al. Graft-versus-Host Disease: Why Haven't We Made More Progress? Curr Opin Hematol. 2014;21(2):141-147.

    5 Descriptive P value given for ORR at the primary analysis as the efficacy boundary was crossed at the interim analysis (ORR, P = 0.0003).

    6 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration; May 2019.

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  11. INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

    "Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," said David A. Ricks, Lilly chairman and CEO…

    INDIANAPOLIS, Nov. 19, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

    "Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," said David A. Ricks, Lilly chairman and CEO. "Today's FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralizing antibody EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease. This is an important milestone for hospitalized patients on oxygen, as baricitinib may help speed their recovery."

    The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available. This use of baricitinib is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless the authorization is terminated or revoked sooner. The authorization is temporary and does not replace the formal review and approval process. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy, safety and optimal duration of treatment of baricitinib for COVID-19 has not been established. This is the first combination regimen authorized by FDA. Evaluation of baricitinib's efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.

    Scientific evidence supporting this EUA:

    The EUA is based on data from the Adaptive COVID-19 Treatment Trial (ACTT-2), a randomized double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib in combination with remdesivir versus placebo with remdesivir in hospitalized patients with or without oxygen requirements conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). All patients received standard supportive care by the trial site hospital. The recommended dose for this EUA is baricitinib 4-mg once daily for 14 days or until hospital discharge.

    Summary of Key Efficacy and Safety Findings

    • Patients treated with baricitinib in combination with remdesivir had a significant reduction in median time to recovery from 8 to 7 days (12.5% improvement) compared to remdesivir [hazard ratio: 1.15; 95% CI 1.00, 1.31; p=0.047].
    • Patients treated with baricitinib in combination with remdesivir were more likely to have a better clinical status at Day 15 compared to patients treated with remdesivir [odds ratio: 1.26; 95% CI 1.01, 1.57; p=0.044].
    • The proportion of patients who progressed to ventilation (non-invasive or invasive) or died by Day 29 was lower in baricitinib in combination with remdesivir (23%) compared to remdesivir (28%) [odds ratio: 0.74; 95% CI 0.56, 0.99; p=0.039].
    • The proportion of patients who died by Day 29 was 4.7% for baricitinib in combination with remdesivir vs. 7.1% for remdesivir, a relative reduction of 35% [Kaplan Meier estimated difference in Day 29 probability of mortality: -2.6% (95% CI -5.8%, 0.5%)].
    • Adverse events and serious adverse events were reported in 41% and 15% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 48% and 20% in patients treated with remdesivir. Infections and venous thromboembolism (VTE) occurred in 6% and 4% of patients treated with baricitinib in combination with remdesivir, respectively, vs. 10% and 3% of patients treated with remdesivir. No new safety signals were identified for baricitinib-treated patients.

    "The results of ACTT-2 provide physicians and the medical community much-needed insights and randomized placebo-controlled evidence supporting the use of baricitinib in combination with remdesivir for the treatment of hospitalized patients with COVID-19; also importantly, the progression to ventilation or death was significantly reduced with the baricitinib-remdesivir combination," said Andre Kalil, M.D., professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. "Few treatment options have received an EUA to treat COVID-19 so the authorization of baricitinib is an important step that will give healthcare providers another clinical tool to help patients with advanced disease."

    NIAID and the study investigators expect to have the full analysis published in a peer-reviewed manuscript soon.

    Baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA) and was recently approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. 

    "As a company, we have worked quickly and collaboratively to determine the potential utility of our medicines as treatments for COVID-19 and its related complications," said Hervé Hoppenot, Incyte CEO. "We are pleased that the FDA has authorized the use of baricitinib in combination with remdesivir for COVID-19, and look forward to the opportunity to make more therapies available to patients around the world affected by the global pandemic."     

    Access to baricitinib

    Under the EUA, inpatient pharmacies in the U.S. may order OLUMIANT (baricitinib) 1-mg and 2-mg tablets through Lilly authorized specialty distributors. A current list of Lilly's authorized distributors of record for the EUA is available at lillytrade.com. More details about these efforts are available here or by contacting Lilly's 24-hour support line at 1-855-LillyC19 (1-855-545-5921).

    Lilly is working with hospitals, healthcare professionals and governments to facilitate patient access to baricitinib and continues to explore the medicine's potential use in COVID-19 with other regulatory agencies outside the U.S. With respect to supply, Lilly remains confident in being able to meet the needs of patients under the EUA in the U.S., as well as for existing approved indications around the world.  

    Important information about baricitinib for COVID-19

    This EUA permits the emergency use of baricitinib, in combination with remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Although there is limited safety data, no new safety issues have been identified. Physicians should avoid the use of baricitinib in patients with known active tuberculosis and consider if the potential benefits outweigh the potential risks in patients with active serious infections other than COVID-19 or chronic/recurrent infections. Prophylaxis for VTE is recommended unless contraindicated. If clinical features of deep vein thrombosis/pulmonary embolism occur, patients should be evaluated promptly and treated appropriately. Evaluate renal, hematologic and hepatic laboratory values at baseline and thereafter, and monitor closely when treating patients with abnormal baseline and post-baseline laboratory values. Avoid use of live vaccines with baricitinib. If a serious hypersensitivity occurs, discontinue baricitinib while evaluating the potential causes of the reaction. Serious venous thrombosis, including pulmonary embolism, and serious infections have been observed in COVID-19 patients treated with baricitinib.

    For more information about the authorized use of baricitinib in COVID-19 and mandatory requirements of the EUA, please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers (English) (Spanish). For media resources, including product images and fact sheets, please click here.

    There are other ongoing trials with baricitinib in COVID-19 hospitalized patients. In June 2020, Lilly initiated a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib versus background therapy in hospitalized adults with COVID-19. The study includes a diverse patient population from Latin America, the U.S., Europe and Asia. Further information about this Phase 3 trial and other investigator-initiated trials can be accessed here or www.lillytrialguide.com.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click here for resources related to Lilly's COVID-19 efforts.

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 Olumiant is also approved in the European Union for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom

    P-LLY

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.  

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and about the supply of OLUMIANT, and reflects Lilly's and Incyte's current beliefs. This press release also contains forward-looking statements about Lilly's neutralizing antibodies as potential treatments for patients with or at risk of infection from COVID-19 and reflects Lilly current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT or Lilly's neutralizing antibody treatments will prove to be safe and effective treatments for patients with COVID-19, that OLUMIANT or Lilly's neutralizing antibody treatments will receive additional regulatory approvals or authorizations, that OLUMIANT will continue to be commercially successful, or that we can provide an adequate supply of OLUMIANT or Lilly's neutralizing antibody treatments in all circumstances. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    PP-BC-US-0007 11/2020 ©Lilly USA, LLC 2020. All rights reserved.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    Refer to:

    Kristen Basu; ; +1-317-447-2199 (Lilly media)



    Kevin Hern; ; +1-317-277-1838 (Lilly investors)



    Catalina Loveman; ; +1-302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

     

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-receives-emergency-use-authorization-from-the-fda-for-the-treatment-of-hospitalized-patients-with-covid-19-301177712.html

    SOURCE Eli Lilly and Company

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  12. Incyte (NASDAQ:INCY) announced today that it will present at the 3rd Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, December 1, 2020 at 10:30 a.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte
    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Incyte (NASDAQ:INCY) announced today that it will present at the 3rd Annual Evercore ISI Virtual HealthCONx Conference on Tuesday, December 1, 2020 at 10:30 a.m. EST.

    The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  13. Xencor (NASDAQ:XNCR), MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201111005844/en/

    ‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb® bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma…

    Xencor (NASDAQ:XNCR), MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced a clinical collaboration to investigate the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), first-line DLBCL, and relapsed or refractory follicular lymphoma (FL).

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201111005844/en/

    ‟Xencor is pleased to partner with MorphoSys and Incyte to advance the development of plamotamab, our CD20 x CD3 XmAb® bispecific antibody that has demonstrated encouraging clinical activity as a monotherapy in non-Hodgkin lymphoma," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Plamotamab, which redirects T cells to tumors, and tafasitamab, a CD19-directed XmAb antibody, combine powerful and distinct immune pathways, and this collaboration is designed to enable us to generate new clinical insights and accelerate development timelines for patients who may need additional therapeutic options. It builds upon many years of partnership between Xencor and MorphoSys following MorphoSys' in-licensing of tafasitamab in 2010."

    ‟Tafasitamab in combination with lenalidomide is an important new relapsed/refractory DLBCL treatment option for appropriate patients in the United States today, and its mechanism of action, efficacy and safety profile make it an attractive combination partner," said Jean-Paul Kress, M.D., chief executive officer of MorphoSys. "We believe that tafasitamab as a backbone can add value to new combinations such as with CD20 x CD3 bispecifics, and we are excited about this collaboration with Xencor and Incyte aiming to help more patients in areas of unmet need."

    ‟This collaboration has the potential to advance patient care and Incyte is proud to join Xencor and MorphoSys in evaluating this new combination approach for these serious cancers," said Hervé Hoppenot, chief executive officer of Incyte.

    Xencor's plamotamab is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). Tafasitamab is MorphoSys' CD19-directed antibody which was recently approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    Under the terms of the agreement, the companies plan to initiate a Phase 1/2 study evaluating the combination of tafasitamab, plamotamab and lenalidomide in patients with relapsed or refractory DLBCL. Additionally, the companies are planning to evaluate the combination in relapsed or refractory FL and first-line DLBCL in multiple Phase 1b studies. MorphoSys and Incyte will provide tafasitamab for the studies, which will be sponsored and funded by Xencor and are planned to be conducted in North America, Europe and Asia-Pacific.

    The collaboration is effective immediately upon the execution of the agreement.

    About Plamotamab (XmAb®13676)

    Plamotamab (XmAb®13676) is a tumor-targeted bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3), which is currently in a Phase 1 clinical study for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). An XmAb Bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture on plamotamab. CD20 is highly expressed on B-cell tumors, including NHL and CLL. Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    About Xencor

    Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases. Currently, 18 candidates engineered with Xencor's XmAb® technology are in clinical development internally and with partners. Xencor's XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. For more information, please visit www.xencor.com.

    About MorphoSys

    MorphoSys ((FSE &, NASDAQ:MOR) is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of exceptional, innovative therapies for patients suffering from serious diseases. The focus is on cancer. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of MorphoSys' proprietary product Monjuvi® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

    Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has ~500 employees. More information at www.morphosys.com or www.morphosys-us.com.

    Monjuvi® is a registered trademark of MorphoSys AG.

    Tremfya® is a registered trademark of Janssen Biotech, Inc.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Xencor Forward-looking Statements

    Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from Xencor's president and chief executive officer; the outcome of the collaboration with MorphoSys and Incyte, including the ability of the collaboration to generate new clinical insights, accelerate development timelines and advance patient care; the ability of the proposed combination treatment to improve response rates and address more patients in areas of unmet need; and the timing and success of the Phase 1/2 study and multiple Phase 1b studies contemplated by the agreement. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2019 as well as Xencor's subsequent filings with the Securities and Exchange Commission. All forward-looking statements are based on Xencor's current information and belief as well as assumptions made by Xencor. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This cautionary statement is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

    MorphoSys Forward-Looking Statements

    This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

    Incyte Forward-looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, and the development of tafasitamab-cxix in combination with plamotamab, contain predictions, estimates and other forward-looking statements. These forward-looking statements are based on the Incyte's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by regulatory authorities; the efficacy or safety of Incyte's or its collaborators' products; the acceptance of Incyte's products and the products of its collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. Incyte disclaims any intent or obligation to update these forward-looking statements.

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  14. Incyte (NASDAQ:INCY) today announced that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually from November 11-14, 2020.

    "We are excited to join the oncology community at the SITC 35th anniversary annual meeting and look forward to sharing data from our immuno-oncology portfolio," said Lance Leopold, Group Vice President, Immuno-Oncology, Incyte. "In particular, initial translational data from the ongoing clinical trial support further development of our orally administered PD-L1 inhibitor INCB86550 — a novel small-molecule discovered at Incyte."

    E-Poster Presentations:

    Pharmacodynamic Biomarkers Demonstrate T-Cell Activation in Patients

    Incyte (NASDAQ:INCY) today announced that abstracts highlighting data from its oncology portfolio will be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually from November 11-14, 2020.

    "We are excited to join the oncology community at the SITC 35th anniversary annual meeting and look forward to sharing data from our immuno-oncology portfolio," said Lance Leopold, Group Vice President, Immuno-Oncology, Incyte. "In particular, initial translational data from the ongoing clinical trial support further development of our orally administered PD-L1 inhibitor INCB86550 — a novel small-molecule discovered at Incyte."

    E-Poster Presentations:

    Pharmacodynamic Biomarkers Demonstrate T-Cell Activation in Patients Treated with the Oral PD-L1 Inhibitor INCB086550 in a Phase 1 Clinical Trial [Poster #419]

    Retrospective Pooled Analysis of Epacadostat Clinical Studies Identifies Doses Required for Maximal Pharmacodynamic Effect in Anti-PD-1 Combination Studies [Poster #28]

    MCLA-145 (CD137xPD-L1): A Potent CD137 Agonist and Immune Checkpoint Inhibitor That Does Not Show Signs of Peripheral Toxicity [Poster #814]1

    MCLA-145 is a Bispecific IgG1 Antibody that Inhibits PD-1/PD-L1 Signaling While Simultaneously Activating CD137 Signaling on T Cells [Poster #820]1

    A Phase 1 Study of Retifanlimab (INCMGA00012), a PD-1 Inhibitor, in Patients with Advanced Solid Tumors: Preliminary Results in Recurrent MSI-High or dMMR Endometrial Cancer (POD1UM-101) [Poster #268]

    A Phase 2 Umbrella Study of Retifanlimab (INCMGA00012) Alone or in Combination with Other Therapies in Patients with Advanced or Metastatic Endometrial Cancer (POD1UM-204, GOG 3038, ENGOT-en12/NOGGO) [Trial in Progress; Poster #348]2

    All posters will be on display from Monday, November 9, 2020 until the virtual poster hall closes on December 31, 2020.

    Abstracts are available on the SITC 2020 website at https://www.sitcancer.org/2020.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    1Merus-sponsored; 2In collaboration with the Gynecologic Oncology Group and the European Network for Gynecological Oncological Trial (ENGOT) groups.

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    • Total product and royalty revenues of $621 million (+16% vs Q3 2019) for the quarter ended September 30, 2020; Jakafi® (ruxolitinib) revenues of $488 million in Q3 2020 (+13% vs Q3 2019); Incyte tightens full year 2020 Jakafi revenue guidance to a range of $1.910 to $1.940 billion
    • Strong momentum behind commercial launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.
    • Incyte Dermatology established as a new franchise in the U.S.; priority review voucher acquired and expected to be used in NDA seeking approval for ruxolitinib cream in atopic dermatitis
    • Late-stage clinical development pipeline continues to progress with multiple pivotal trials in oncology and dermatology

    Conference Call and Webcast Scheduled…

    • Total product and royalty revenues of $621 million (+16% vs Q3 2019) for the quarter ended September 30, 2020; Jakafi® (ruxolitinib) revenues of $488 million in Q3 2020 (+13% vs Q3 2019); Incyte tightens full year 2020 Jakafi revenue guidance to a range of $1.910 to $1.940 billion
    • Strong momentum behind commercial launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.
    • Incyte Dermatology established as a new franchise in the U.S.; priority review voucher acquired and expected to be used in NDA seeking approval for ruxolitinib cream in atopic dermatitis
    • Late-stage clinical development pipeline continues to progress with multiple pivotal trials in oncology and dermatology

    Conference Call and Webcast Scheduled Today at 8:00 a.m. EDT

    Incyte (NASDAQ:INCY) today reports 2020 third quarter financial results, and provides a status update on the Company's development portfolio.

    "We are pleased to report another strong quarter for Incyte, with continued strength across all Jakafi® (ruxolitinib) indications, good momentum behind the U.S. launches of both Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib), as well as increasing royalty contributions from our partnered medicines globally," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "In addition, we have now established Incyte Dermatology as a new franchise for Incyte in the U.S., and we are on track to submit the NDA for ruxolitinib cream at the end of this year which, by using our priority review voucher, could lead to an FDA decision in the middle of next year."

    Portfolio Update

    LIMBER – key highlights

    Two pivotal trials are being initiated to evaluate the combination of ruxolitinib and parsaclisib as both first-line therapy for myelofibrosis (MF) patients and in MF patients with an inadequate response to ruxolitinib monotherapy.

    The Phase 2 monotherapy trial of INCB57643 (BET) in patients with refractory myelofibrosis are now recruiting and the Phase 2 monotherapy trial of INCB00928 (ALK2) in patients with myelofibrosis is being opened. Both programs are expected to proceed to ruxolitinib combination trials upon completion of monotherapy cohorts.

     

    Indication and status

    Once-a-day ruxolitinib

    (JAK1/JAK2)

    Myelofibrosis and polycythemia vera: clinical pharmacology studies

    ruxolitinib + parsaclisib

    (JAK1/JAK2 + PI3Kδ)

    Myelofibrosis: Phase 3 in preparation

    Myelofibrosis: Phase 3 in preparation (inadequate responders to ruxolitinib)

    ruxolitinib + INCB57643

    (JAK1/JAK2 + BET)

    Myelofibrosis: Phase 2 in preparation

    ruxolitinib + INCB00928

    (JAK1/JAK2 + ALK2)

    Myelofibrosis: Phase 2 in preparation

    Oncology beyond MPNs – key highlights

    In August, Monjuvi® (tafasitamab-cxix) in combination with lenalidomide was included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas with a Category 2A designation as an option for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) and who are not eligible for autologous stem cell transplant (ASCT).

    The European Marketing Authorization Application (MAA) for tafasitamab as a treatment for patients with r/r DLBCL is under review. Incyte has exclusive development and commercialization rights to tafasitamab outside of the U.S.

    Incyte and MorphoSys plan to further broaden the development program of tafasitamab in other B-cell malignancies. Multiple trials are in preparation, including Phase 3 trials in both first line DLBCL and relapsed/refractory follicular lymphoma, as well as a proof-of-concept trial of tafasitamab plus parsaclisib (PI3Kδ).

    In September, initial results from the Phase 2 POD1UM-202 trial of retifanlimab in previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy were presented at the European Society for Medical Oncology (ESMO) annual meeting. The Phase 3 POD1UM-303 trial of retifanlimab in combination with platinum-based chemotherapy as a first-line treatment for patients with SCAC is open for recruitment.

    Given the rapidly evolving treatment landscape for bladder cancer and recent regulatory feedback, Incyte is reevaluating its development strategy for pemigatinib in bladder cancer. As part of that reevaluation, new patient recruitment into FIGHT-205, which is assessing pemigatinib in cisplatin-ineligible bladder cancer patients whose tumors express FGFR3 mutation or rearrangement, has been stopped, and Incyte no longer intends to use data from FIGHT-201 to seek accelerated approval for pemigatinib in patients with previously treated bladder cancer whose tumors express FGFR3 mutation or rearrangement.

     

    Indication and status

    ruxolitinib

    (JAK1/JAK2)

    Steroid-refractory chronic GVHD: Phase 3 (REACH3)1 primary endpoint met

    itacitinib

    (JAK1)

    Treatment-naïve chronic GVHD: Phase 3 (GRAVITAS-309)

     

    pemigatinib

    (FGFR1/2/3)

    CCA: Phase 2 (FIGHT-202), Phase 3 (FIGHT-302); MAA, NDS and J-NDA under review

    8p11 MPN: Phase 2 (FIGHT-203)

    Tumor agnostic: Phase 2 (FIGHT-207)

    tafasitamab

    (CD19)2

    r/r DLBCL: Phase 2 (L-MIND); Phase 3 (B-MIND); MAA under review

    1L DLBCL: Phase 1b (First-MIND); Phase 3 (Front-MIND) in preparation

    r/r follicular lymphoma: Phase 3 in preparation

    r/r B-cell malignancies: PoC with parsaclisib (PI3Kδ) in preparation

    parsaclisib

    (PI3Kδ)

    r/r follicular lymphoma: Phase 2 (CITADEL-203)

    r/r marginal zone lymphoma: Phase 2 (CITADEL-204)

    r/r mantle cell lymphoma: Phase 2 (CITADEL-205)

    retifanlimab

    (PD-1)3

    MSI-high endometrial cancer: Phase 2 (POD1UM-101); Phase 2 (POD1UM-204) in preparation

    Merkel cell carcinoma: Phase 2 (POD1UM-201)

    SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303) open for recruitment

    NSCLC: Phase 3 (POD1UM-304)

    CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma

    1)

     

    Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

    2)

     

    Development of tafasitamab in collaboration with MorphoSys

    3)

     

    retifanlimab licensed from MacroGenics

    Inflammation and Autoimmunity (IAI) – key highlights

    Dermatology

    Incyte Dermatology has been established as a new franchise for Incyte in the U.S., which will include dedicated teams for the development and commercialization of Incyte's dermatology portfolio.

    The NDA for ruxolitinib cream in atopic dermatitis is on track for submission at the end of 2020. Incyte has acquired a priority review voucher, which it intends to use to accelerate the timeline to FDA decision.

    Pooled results from the TRuE-AD studies were presented at the European Academy of Dermatology and Venereology (EADV) Congress. Ruxolitinib cream demonstrated clinically meaningful improvements in patient-reported quality of life assessments, such as the PROMIS (patient-reported outcomes measurement information system) sleep disturbance (8b) score, as well as substantial and sustained itch reduction, reinforcing its potential as an important treatment option for atopic dermatitis patients.

    The two randomized Phase 3 trials in the TRuE-V pivotal program evaluating ruxolitinib cream in patients with vitiligo are fully recruited, with results expected in 2021.

    Other IAI

    Initial clinical results from INCB54707, a JAK1 selective inhibitor, were presented in October. INCB54707 demonstrated preliminary efficacy, improved quality of life (QoL) including a reduction in skin pain and a tolerable safety profile in patients with moderate-to-severe hidradenitis suppurativa (HS). A Phase 2b, randomized, double-blind, placebo-controlled trial evaluating INCB54707 in HS is ongoing.

     

    Indication and status

    ruxolitinib cream

    (JAK1/JAK2)

    Atopic dermatitis: Phase 3 (TRuE-AD1, TRuE-AD2; primary endpoints met)

    Vitiligo: Phase 3 (TRuE-V1, TRuE-V2)

    INCB54707

    (JAK1)

    Hidradenitis suppurativa: Phase 2b

     

    parsaclisib

    (PI3Kδ)

    Autoimmune hemolytic anemia: Phase 2

     

    INCB00928

    (ALK2)

    Fibrodysplasia ossificans progressiva: Phase 2 in preparation

    Discovery and early development – key highlights

    Incyte's portfolio of other earlier-stage clinical candidates is summarized below.

    Clinical translational data from the ongoing proof-of-concept trial of INCB86550, Incyte's first-in-class oral small molecule inhibitor of PD-L1, have been accepted for presentation at the 2020 Society for Immunotherapy for Cancer (SITC) meeting. As previously disclosed, initial clinical efficacy and safety data from this trial are expected to be presented in 2021, once these data mature.

     

    Modality

    Candidates

    Small molecules

    INCB01158 (ARG)1, INCB81776 (AXL/MER), epacadostat (IDO1), INCB86550 (PD-L1)

     

    Monoclonal antibodies2

    INCAGN1876 (GITR), INCAGN2385 (LAG-3), INCAGN1949 (OX40), INCAGN2390 (TIM-3)

    Bispecific antibodies

    MCLA-145 (PD-L1xCD137)3

     

    1)

    INCB01158 licensed from Calithera

    2)

    Discovery collaboration with Agenus

    3)

    MCLA-145 development in collaboration with Merus

    Potential therapies for patients with COVID-19

    Patient recruitment into the Phase 3 RUXCOVID study evaluating ruxolitinib versus standard-of-care in hospitalized patients with COVID-19 associated cytokine storm has been completed, and topline results are expected to be available before the end of 2020.

    In September, Incyte and Eli Lilly announced initial results from the baricitinib arm of the National Institute of Allergy and Infectious Diseases (NIAID) Adaptive COVID-19 Treatment Trial (ACTT-2), where baricitinib in combination with remdesivir reduced the time to recovery (primary endpoint) in comparison with remdesivir alone.

    Additional data announced in October showed that baricitinib plus remdesivir resulted in a numerical decrease in mortality through Day 29 compared to remdesivir alone, with a more pronounced reduction seen in more severely ill patients.

     

    Status

    ruxolitinib

    (JAK1/JAK2)

    COVID-19 associated cytokine storm: Phase 3 (RUXCOVID1; DEVENT)

     

    baricitinib

    (JAK1/JAK2)2

    Hospitalized patients with COVID-19: Phase 3 (ACTT-23; COV-BARRIER)

     

    1)

    Sponsored by Incyte in the United States and by Novartis outside of the United States

    2)

    Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis; approved as Olumiant in EU for moderate to severe atopic dermatitis.

    3)

    ACTT-2 agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health

    Partnered – key highlights

    In October, Lilly announced that the European Commission granted marketing authorization for Olumiant® (baricitinib) 4mg and 2mg tablets in Europe for the treatment of adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy, becoming the first JAK-inhibitor indicated to help treat patients with AD.

    In September, Incyte and Novartis announced that GEOMETRY mono-1 results of TabrectaTM (capmatinib) in patients with METex14 metastatic non-small cell lung cancer (NSCLC) were published in The New England Journal of Medicine.

     

     

    Indication and status

    baricitinib

    (JAK1/JAK2)1

    Atopic dermatitis: Phase 3 (BREEZE-AD); approved in EU

    Systemic lupus erythematosus: Phase 3

    Severe alopecia areata: Phase 3 (BRAVE-AA1, BRAVE-AA2)

    capmatinib

    (MET)2

    NSCLC (with MET exon 14 skipping mutations): Approved as Tabrecta in U.S. and Japan

     

    1)

    Worldwide rights to baricitinib licensed to Lilly: approved as Olumiant in multiple territories globally for certain patients with moderate-to-severe rheumatoid arthritis

    2)

    Worldwide rights to capmatinib licensed to Novartis

    2020 Third Quarter Financial Results

    The financial measures presented in this press release for the three and nine months ended September 30, 2020 and 2019 have been prepared by the Company in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"), unless otherwise identified as a Non-GAAP financial measure. Management believes that Non-GAAP information is useful for investors, when considered in conjunction with Incyte's GAAP disclosures. Management uses such information internally and externally for establishing budgets, operating goals and financial planning purposes. These metrics are also used to manage the Company's business and monitor performance. The Company adjusts, where appropriate, for expenses in order to reflect the Company's core operations. The Company believes these adjustments are useful to investors by providing an enhanced understanding of the financial performance of the Company's core operations. The metrics have been adopted to align the Company with disclosures provided by industry peers.

    Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used in conjunction with and to supplement Incyte's operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in our industry.

    Financial Highlights

    Financial Highlights

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

    2020

     

     

     

    2019

    Total GAAP revenue

    $

    620,643

     

    $

    551,581

    $

    1,877,193

     

    $

    1,579,370

     

    Total GAAP operating income (loss)

     

    5,326

     

     

    134,316

     

    (427,905

    )

     

    306,998

    Total Non-GAAP operating income (loss)

     

    61,619

     

     

    186,338

     

    (259,347

    )

     

    464,274

    GAAP net income (loss)

     

    (15,203

    )

     

    128,271

     

    (445,547

    )

     

    335,901

    Non-GAAP net income (loss)

     

    50,059

     

     

    179,019

     

    (295,283

    )

     

    476,030

     

    GAAP basic EPS

    $

    (0.07

    )

    $

    0.60

    $

    (2.05

    )

    $

    1.57

    Non-GAAP basic EPS

    $

    0.23

     

    $

    0.83

    $

    (1.36

    )

    $

    2.22

    GAAP diluted EPS

    $

    (0.07

    )

    $

    0.59

    $

    (2.05

    )

    $

    1.55

    Non-GAAP diluted EPS

    $

    0.23

     

    $

    0.82

    $

    (1.36

    )

    $

    2.19

    Revenue Details

    Revenue Details

    (unaudited, in thousands)

     

    Three Months Ended

     

     

     

    Nine Months Ended

     

     

    September 30,

     

    %

     

    September 30,

     

    %

     

    2020

     

     

    2019

     

    Change

     

     

    2020

     

     

    2019

     

    Change

    Revenues:

    Jakafi net product revenue

    $

    487,783

    $

    433,387

    13

    %

    $

    1,420,968

    $

    1,218,504

    17

    %

    Iclusig net product revenue

     

    26,380

     

    20,611

    28

    %

     

    76,426

     

    65,640

    16

    %

    Pemazyre net product revenue

     

    8,089

     

    -

     

    11,875

     

    -

    Jakavi product royalty revenues

     

    68,306

     

    58,440

    17

    %

     

    190,856

     

    160,906

    19

    %

    Olumiant product royalty revenues

     

    28,647

     

    21,643

    32

    %

     

    79,924

     

    56,820

    41

    %

    Tabrecta product royalty revenues

     

    1,438

     

    -

     

    2,144

     

    -

    Product and royalty revenues

     

    620,643

     

    534,081

    16

    %

     

    1,782,193

     

    1,501,870

    19

    %

    Milestone and contract revenues

     

    -

     

    17,500

    (100

    %)

     

    95,000

     

    77,500

    23

    %

    Total GAAP revenues

    $

    620,643

    $

    551,581

    13

    %

    $

    1,877,193

    $

    1,579,370

    19

    %

    Product and Royalty Revenues Product and royalty revenues for the three and nine months ended September 30, 2020 increased 16% and 19%, respectively, over the prior year comparative periods primarily as a result of increases in Jakafi net product revenues, the launch of Pemazyre and higher product royalty revenues from Jakavi and Olumiant. Jakafi net product revenues for the three and nine months ended September 30, 2020 increased 13% and 17%, respectively, over the prior year comparative periods, primarily driven by growth in patient demand across all indications.

    Operating Expenses

    Operating Expense Summary

    (unaudited, in thousands)

     

    Three Months Ended

     

     

     

    Nine Months Ended

     

     

    September 30,

     

    %

     

    September 30,

     

    %

     

    2020

     

     

    2019

     

    Change

     

     

    2020

     

     

    2019

     

    Change

    GAAP cost of product revenues

    $

    34,322

    $

    30,040

    14

    %

    $

    95,005

    $

    82,034

    16

    %

    Non-GAAP cost of product revenues1

     

    28,693

     

    24,483

    17

    %

     

    78,137

     

    65,357

    20

    %

     

    GAAP research and development

     

    438,109

     

    281,336

    56

    %

     

    1,809,997

     

    841,244

    115

    %

    Non-GAAP research and development2

     

    409,134

     

    250,910

    63

    %

     

    1,719,816

     

    755,780

    128

    %

     

    GAAP selling, general and administrative

     

    120,788

     

    102,608

    18

    %

     

    349,934

     

    332,534

    5

    %

    Non-GAAP selling, general and administrative3

     

    106,208

     

    89,850

    18

    %

     

    308,215

     

    293,959

    5

    %

     

    GAAP change in fair value of acquisition-related contingent consideration

     

    7,109

     

    3,281

    117

    %

     

    19,790

     

    16,560

    20

    %

    Non-GAAP change in fair value of acquisition-related contingent consideration4

     

    -

     

    -

     

    -

     

    -

     

    GAAP collaboration loss sharing

     

    14,989

     

    -

     

    30,372

     

    -

    Non-GAAP collaboration loss sharing

     

    14,989

     

    -

     

    30,372

     

    -

    1. Non-GAAP cost of product revenues excludes the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the cost of stock-based compensation.

    2. Non-GAAP research and development expenses exclude the cost of stock-based compensation.

    3. Non-GAAP selling, general and administrative expenses exclude the cost of stock-based compensation.

    4. Non-GAAP change in fair value of acquisition-related contingent consideration is null.

    Research and development expenses GAAP and Non-GAAP research and development expense for the three months ended September 30, 2020 increased 56% and 63%, respectively, compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of an FDA priority review voucher from a third party, which we intend to use to accelerate the FDA review of ruxolitinib cream for the treatment of atopic dermatitis and an increase in milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020, GAAP and Non-GAAP research and development expense increased 115% and 128%, respectively, compared to the same period in 2019, primarily due to upfront consideration of $805 million related to our collaborative agreement with MorphoSys and expense related to the purchase of the FDA priority review voucher.

    Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the three months and nine months ended September 30, 2020 increased 18% and 5%, respectively, compared to the same periods in 2019, primarily due to increased headcount and activities supporting the commercialization of our products and the timing of certain expenses.

    Other Financial Information

    Operating income (loss) GAAP and Non-GAAP operating income for the three months ended September 30, 2020 decreased compared to the same period in 2019, primarily due to $120 million of expense related to the purchase of the FDA priority review voucher and milestone expenses related to our collaborative agreements. For the nine months ended September 30, 2020 we recorded an operating loss compared to operating income for the same period in 2019, on both a GAAP and Non-GAAP basis, primarily due to upfront consideration related to our collaboration with MorphoSys and expense related to the FDA priority review voucher, partially offset by the growth in product and royalty revenues.

    Cash, cash equivalents and marketable securities position As of September 30, 2020 and December 31, 2019, cash, cash equivalents and marketable securities totaled $1.7 billion and $2.1 billion, respectively. The decrease is primarily driven by the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the FDA priority review voucher and is partially offset by the cash flow generated during this nine-month period.

    2020 Financial Guidance

    Incyte has tightened its full year 2020 guidance for Jakafi net product revenues, as detailed below. The company's full year 2020 financial guidance is summarized in the following table. The R&D expense guidance excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher (PRV). The financial guidance also excludes the impact of any potential future strategic transactions.

     

    All data in millions1

     

    Current

     

    Previous

    Jakafi net product revenues

     

    $1,910 - $1,940

     

    $1,880 - $1,950

    Iclusig net product revenues

     

    $100 - $105

     

    Unchanged

    Cost of product revenues

     

    $130 - $135

     

    Unchanged

    Research and development expenses (Excl. MOR upfront cons. & PRV)

     

    $1,210 - $1,280

     

    Unchanged

    Selling, general and administrative expenses

     

    $505 - $535

     

    Unchanged

    Change in fair value of acquisition-related contingent consideration

     

    $25 - $27

     

    Unchanged

    1. Amounts exclude Non-GAAP adjustments (e.g., stock based comp, amortization of acquired product rights for Iclusig and change in fair value of estimated future royalties for Iclusig). Research and development expenses also excludes $805 million of upfront consideration paid under the MorphoSys collaboration and $120 million of expense related to the purchase of the FDA priority review voucher.

    Conference Call and Webcast Information

    Incyte will hold a conference call and webcast this morning at 8:00 a.m. EDT. To access the conference call, please dial 877-407-3042 for domestic callers or 201-389-0864 for international callers. When prompted, provide the conference identification number, 13711777.

    If you are unable to participate, a replay of the conference call will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference identification number, 13711777.

    The conference call will also be webcast; the livestream and the replay can be accessed at investor.incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.

    For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is also indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea as well as adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    About Monjuvi® (tafasitamab-cxix)

    Monjuvi is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize Monjuvi globally. Monjuvi will be co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi is a registered trademark of MorphoSys AG. XmAb® is a registered trademark of Xencor, Inc.

    About Pemazyre® (pemigatinib)

    Pemazyre is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

    Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

    Pemazyre is marketed by Incyte in the United States. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

    Additionally, Incyte's marketing authorization application (MAA) seeking the approval of pemigatinib for patients with cholangiocarcinoma in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.

    Pemazyre is a trademark of Incyte Corporation.

    About Iclusig® (ponatinib) tablets

    Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

    In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

    Incyte has an exclusive license from ARIAD Pharmaceuticals, Inc., since acquired by Takeda Pharmaceutical Company Limited, to develop and commercialize Iclusig in the European Union and 22 other countries, including Switzerland, Norway, Turkey, Israel and Russia.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the expected use of the priority review voucher and its effect on the timing of the FDA review process, the expected timing for the submission of the an NDA for ruxolitinib cream for atopic dermatitis and the expected timing of any FDA decision with respect to such NDA; plans for ruxolitinib combination trials with INCB57643 (BET) and INCB00928 (ALK2); plans to further broaden the development program of tafasitamab in other B-cell malignancies and clinical trial plans for such program; the expected timing of receipt of clinical trial results for ruxolitinib cream for vitiligo and ruxolitinib for COVID-19; the expected timing of receipt and announcement of clinical trial results for INCB86550; and the Company's reaffirmed and updated financial guidance for 2020 and the expectations underlying such guidance.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays in the submission of the Company's NDA for ruxolitinib cream for atopic dermatitis; the actual time required by the FDA to review the Company's NDA for approval for ruxolitinib cream in atopic dermatitis, should such NDA be submitted, and the results of such review; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials and the ability to enroll subjects in accordance with planned schedules; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical trials, supply chain and other third-party providers, sales and marketing efforts, and business, development and discovery operations; determinations made by the FDA and regulatory agencies outside of the United States; the Company's dependence on its relationships with and changes in the plans of its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; unexpected variations in the demand for the Company's products and the products of the Company's collaboration partners; the effects of announced or unexpected price regulation or limitations on reimbursement or coverage for the Company's products and the products of the Company's collaboration partners; sales, marketing, manufacturing and distribution requirements, including the Company's and its collaboration partners' ability to successfully commercialize and build commercial infrastructure for newly approved products and any additional products that become approved; greater than expected expenses, including expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its quarterly report on Form 10-Q for the quarter ended June 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

     

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

    GAAP

     

    GAAP

    Revenues:

    Product revenues, net

    $

    522,252

     

    $

    453,998

     

    $

    1,509,269

     

    $

    1,284,144

     

    Product royalty revenues

     

    98,391

     

     

    80,083

     

     

    272,924

     

     

    217,726

     

    Milestone and contract revenues

     

    -

     

     

    17,500

     

     

    95,000

     

     

    77,500

     

    Total revenues

     

    620,643

     

     

    551,581

     

     

    1,877,193

     

     

    1,579,370

     

     

    Costs and expenses:

    Cost of product revenues (including definite-lived intangible amortization)

     

    34,322

     

     

    30,040

     

     

    95,005

     

     

    82,034

     

    Research and development

     

    438,109

     

     

    281,336

     

     

    1,809,997

     

     

    841,244

     

    Selling, general and administrative

     

    120,788

     

     

    102,608

     

     

    349,934

     

     

    332,534

     

    Change in fair value of acquisition-related contingent consideration

     

    7,109

     

     

    3,281

     

     

    19,790

     

     

    16,560

     

    Collaboration loss sharing

     

    14,989

     

     

    -

     

     

    30,372

     

     

    -

     

    Total costs and expenses

     

    615,317

     

     

    417,265

     

     

    2,305,098

     

     

    1,272,372

     

     

    Income (loss) from operations

     

    5,326

     

     

    134,316

     

     

    (427,905

    )

     

    306,998

     

    Other income (expense), net

     

    4,917

     

     

    11,961

     

     

    18,396

     

     

    36,334

     

    Interest expense

     

    (544

    )

     

    (597

    )

     

    (1,746

    )

     

    (1,248

    )

    Unrealized gain (loss) on long term investments

     

    (13,207

    )

     

    2,339

     

     

    10,935

     

     

    18,703

     

    Income (loss) before provision for income taxes

     

    (3,508

    )

     

    148,019

     

     

    (400,320

    )

     

    360,787

     

    Provision for income taxes

     

    11,695

     

     

    19,748

     

     

    45,227

     

     

    24,886

     

    Net income (loss)

    $

    (15,203

    )

    $

    128,271

     

    $

    (445,547

    )

    $

    335,901

     

     

    Net income (loss) per share:

    Basic

    $

    (0.07

    )

    $

    0.60

     

    $

    (2.05

    )

    $

    1.57

     

    Diluted

    $

    (0.07

    )

    $

    0.59

     

    $

    (2.05

    )

    $

    1.55

     

     

    Shares used in computing net income (loss) per share:

    Basic

     

    218,784

     

     

    215,199

     

     

    217,684

     

     

    214,628

     

    Diluted

     

    218,784

     

     

    217,791

     

     

    217,684

     

     

    217,393

     

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands)

     

    September 30,

    December 31,

     

    2020

     

    2019

    ASSETS

    Cash, cash equivalents and marketable securities

    $

    1,734,800

    $

    2,117,554

    Accounts receivable

     

    356,182

     

    308,809

    Property and equipment, net

     

    498,335

     

    377,567

    Finance lease right-of-use assets, net

     

    29,123

     

    29,058

    Inventory

     

    25,709

     

    16,505

    Prepaid expenses and other assets

     

    107,203

     

    94,179

    Long term investments

     

    222,810

     

    133,657

    Other intangible assets, net

     

    177,675

     

    193,828

    Goodwill

     

    155,593

     

    155,593

    Total assets

    $

    3,307,430

    $

    3,426,750

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued expenses and other liabilities

    $

    597,871

    $

    500,462

    Finance lease liabilities

     

    34,826

     

    32,582

    Convertible senior notes

     

    11,900

     

    18,300

    Acquisition-related contingent consideration

     

    272,000

     

    277,000

    Stockholders' equity

     

    2,390,833

     

    2,598,406

    Total liabilities and stockholders' equity

    $

    3,307,430

    $

    3,426,750

    INCYTE CORPORATION

    RECONCILIATION OF GAAP NET INCOME (LOSS) TO SELECTED NON-GAAP ADJUSTED INFORMATION

    (unaudited, in thousands, except per share amounts)

     

    Three Months Ended

     

    Nine Months Ended

    September 30,

     

    September 30,

     

    2020

     

     

     

    2019

     

     

     

    2020

     

     

     

    2019

     

     

    GAAP Net Income (Loss)

    $

    (15,203

    )

    $

    128,271

     

    $

    (445,547

    )

    $

    335,901

     

    Adjustments1:

    Non-cash stock compensation from equity awards (R&D)2

     

    28,975

     

     

    30,426

     

     

    90,181

     

     

    85,464

     

    Non-cash stock compensation from equity awards (SG&A)2

     

    14,580

     

     

    12,758

     

     

    41,719

     

     

    38,575

     

    Non-cash stock compensation from equity awards (COGS)2

     

    245

     

     

    173

     

     

    716

     

     

    525

     

    Non-cash interest expense related to convertible notes3

     

    168

     

     

    218

     

     

    617

     

     

    646

     

    Changes in fair value of equity investments4

     

    13,207

     

     

    (2,339

    )

     

    (10,935

    )

     

    (18,703

    )

    Amortization of acquired product rights5

     

    5,384

     

     

    5,384

     

     

    16,152

     

     

    16,152

     

    Change in fair value of contingent consideration6

     

    7,109

     

     

    3,281

     

     

    19,790

     

     

    16,560

     

    Tax effect of Non-GAAP adjustments7

     

    (4,406

    )

     

    847

     

     

    (7,976

    )

     

    910

     

    Non-GAAP Net Income (Loss)

    $

    50,059

     

    $

    179,019

     

    $

    (295,283

    )

    $

    476,030

     

     

    Non-GAAP net income (loss) per share:

    Basic

    $

    0.23

     

    $

    0.83

     

    $

    (1.36

    )

    $

    2.22

     

    Diluted

    $

    0.23

     

    $

    0.82

     

    $

    (1.36

    )

    $

    2.19

     

     

    Shares used in computing Non-GAAP net income (loss) per share:

    Basic

     

    218,784

     

     

    215,199

     

     

    217,684

     

     

    214,628

     

    Diluted

     

    221,357

     

     

    217,791

     

     

    217,684

     

     

    217,393

     

    1. Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and nine months ended September 30, 2020 are milestones of $0 and $95,000, respectively, earned from our collaborative partners as compared to upfront consideration and milestones of $17,500 and $77,500, respectively, for the same periods in 2019. Included within the Research and development expenses line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and nine months ended September 30, 2020 are upfront consideration and milestones of $141,450 and $950,482, respectively, related to our collaborative partners and FDA priority review voucher as compared to $0 and $25,000, respectively, for the same periods in 2019.

    2. As included within the Cost of product revenues (including definite-lived intangible amortization) line item; the Research and development expenses line item; and the Selling, general and administrative expenses line item in the Condensed Consolidated Statements of Operations.

    3. As included within the Interest expense line item in the Condensed Consolidated Statements of Operations.

    4. As included within the Unrealized gain (loss) on long term investments line item in the Condensed Consolidated Statements of Operations.

    5. As included within the Cost of product revenues (including definite-lived intangible amortization) line item in the Condensed Consolidated Statements of Operations. Acquired product rights of licensed intellectual property for Iclusig is amortized utilizing a straight-line method over the estimated useful life of 12.5 years.

    6. As included within the Change in fair value of acquisition-related contingent consideration line item in the Condensed Consolidated Statements of Operations.

    7. As included within the Provision for income taxes line item in the Condensed Consolidated Statements of Operations. Income tax effects of Non-GAAP adjustments are calculated using the applicable statutory tax rate for the jurisdictions in which the charges are incurred, while taking into consideration any valuation allowances.

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  15. - Numerous abstracts, including 7 oral presentations, highlighting data for ruxolitinib, parsaclisib, tafasitamab and ponatinib to be exhibited

    Incyte (NASDAQ:INCY) today announced that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually December 5–8, 2020.

    "We are thankful for the American Society of Hematology's efforts to hold ASH 2020 – a key event for the scientific community – virtually, and are proud the Incyte portfolio will be represented in more than 40 abstracts," said Steven Stein, M.D., Chief Medical Officer, Incyte. "The presentations, including the oral presentation of the Phase 3 REACH3…

    - Numerous abstracts, including 7 oral presentations, highlighting data for ruxolitinib, parsaclisib, tafasitamab and ponatinib to be exhibited

    Incyte (NASDAQ:INCY) today announced that numerous abstracts highlighting data from its oncology portfolio will be presented at the upcoming 62nd American Society of Hematology Annual Meeting and Exposition (ASH 2020), held virtually December 5–8, 2020.

    "We are thankful for the American Society of Hematology's efforts to hold ASH 2020 – a key event for the scientific community – virtually, and are proud the Incyte portfolio will be represented in more than 40 abstracts," said Steven Stein, M.D., Chief Medical Officer, Incyte. "The presentations, including the oral presentation of the Phase 3 REACH3 study for ruxolitinib in chronic graft-versus-host disease (GVHD), reflect the strength of our diverse oncology portfolio and our partnerships, and reinforce our commitment to finding solutions that can improve the lives of patients with multiple rare cancers and serious conditions where there is significant medical need."

    Select key abstract presentations from Incyte-developed and partnered programs include:

    Oral Presentations

    Ruxolitinib: Graft-Versus-Host Disease (GVHD)

    Ruxolitinib vs Best Available Therapy in Patients with Steroid-Refractory/Steroid-Dependent Chronic Graft-vs-Host Disease (cGVHD): Primary Findings from the Phase 3, Randomized REACH3 Study1 (Abstract #77, Session: 732. Clinical Allogeneic Transplantation: Results I. Saturday, December 5, 7:30-9:00 a.m. PT)

    Ruxolitinib: Myeloproliferative Neoplasms (MPN)

    To Treat or Not To Treat? Understanding Treatment Patterns in Patients with Lower-Risk Myelofibrosis Enrolled in the MOST Study (Abstract #152, Session: 904. Outcomes Research – Non-Malignant Conditions: Bleeding, Immune Thrombocytopenia, and Other Hematologic Disorders. Saturday, December 5, 9:30-11:00 a.m. PT)

    Mortality and Causes of Death of Patients with Polycythemia Vera: Analysis of the REVEAL Prospective, Observational Study (Abstract #484, Session: 634. Myeloproliferative Syndromes: Clinical: Clinical Trials in Polycythemia Vera. Sunday, December 6, 2:00-3:30 p.m. PT)

    Parsaclisib

    Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Marginal Zone Lymphoma (CITADEL-204) (Abstract #338, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Clinical studies in Waldenstrom's Macroglobulinemia, Marginal Zone Lymphoma and Hairy Cell Leukemia. Sunday, December 6, 9:30-11:00 a.m. PT)

    Ponatinib

    Outcome by Mutation Status and Line of Treatment in OPTIC, a Dose-Ranging Study of 3 Starting Doses of Ponatinib in Patients with CP-CML2 (Abstract #48, Session: 632. Chronic Myeloid Leukemia: Therapy—Building The Future CML. Saturday, December 5, 7:30-9:00 a.m. PT)

    Efficacy and Safety of Ponatinib (PON) in Patients with Chronic-Phase Chronic Myeloid Leukemia (CP-CML) Who Failed One or More Second-Generation (2G) Tyrosine Kinase Inhibitors (TKIs): Analyses Based on PACE and OPTIC2 (Abstract #647, Session: 632. Chronic Myeloid Leukemia: Therapy: CML: New and Beyond. Monday, December 7, 11:30 a.m.-1:00 p.m. PT)

    Itacitinib

    A Single-Arm, Open-Label, Phase 1 Study of Itacitinib (ITA) with Calcineurin Inhibitor (CNI)-Based Interventions for Prophylaxis of Graft-Versus-Host Disease (GVHD; GRAVITAS-119) (Abstract #356, Session: 722. Clinical Allogeneic Transplantation; Acute and Chronic GvHD, Immune Reconstitution: Phase I and II Trials. Sunday, December 6, 9:30-11:00 a.m. PT)

    Poster Presentations

    All accepted posters in Poster I and Poster II sessions are available from 7:00 a.m.-3:30 p.m. PT on Saturday and Sunday, December 5 and 6. All accepted posters in the Poster III sessions are available from 7:00 a.m.-3:00 p.m. PT on Monday, December 7.

    Ruxolitinib: Graft-Versus-Host Disease (GVHD)

    Biomarker Analysis in Patients with Steroid-Refractory Acute Graft-Versus-Host Disease (aGVHD) Treated with Ruxolitinib (RUX) or Best Available Therapy (BAT) in the Randomized, Phase 3 REACH2 Study1 (Abstract #1519, Session: 732. Clinical Allogeneic Transplantation: Results: Poster I. Saturday, December 5)

    Ruxolitinib, a JAK1/2 Inhibitor, is Efficacious in a Novel Humanized GVHD Model Characterized by Enhanced NK, NK-T and T-Cell Engraftment (Abstract #1422, Session: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster I. Saturday, December 5)

    Safety Analysis of Patients Who Received Ruxolitinib for the Treatment of Steroid-Refractory Chronic Graft-Versus-Host Disease in an Expanded Access Program (Abstract #1488, Session: 722. Clinical Allogeneic Transplantation: Acute and Chronic GVHD, Immune Reconstitution: Poster I. Saturday, December 5)

    Safety Analysis of Ruxolitinib (RUX) vs. Best Available Therapy (BAT) in Patients (pts) with Steroid-Refractory (SR) Acute Graft-Versus-Host Disease (aGVHD) in the Randomized Phase 3 REACH2 Study1 (Abstract #2440, Session: 732. Clinical Allogeneic Transplantation: Results: Poster II. Sunday, December 6)

    Ruxolitinib: Myeloproliferative Neoplasms (MPN)

    An International Multicentric Observational Study on the Use of Ruxolitinib in Patients with Polycythemia Vera Resistant or Intolerant to Hydroxyurea: Results from Interim Analysis1 (Abstract #1256, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

    Clinical Characteristics and Treatment Patterns by Risk Stratification in Patients with Essential Thrombocythemia: An Analysis of the MOST Study (Abstract #1258, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

    The Final Analysis of EXPAND: A Phase 1b, Open-Label, Dose-Finding Study of Ruxolitinib (RUX) in Patients (pts) with Myelofibrosis (MF) and Low Platelet (PLT) Count (50 × 109/L to < 100 × 109/L) at Baseline1 (Abstract #1252, Session: 634. Myeloproliferative Syndromes: Clinical: Poster I. Saturday, December 5)

    Thrombotic Events and Mortality Risk in Patients Newly Diagnosed with Intermediate- to High-Risk Essential Thrombocythemia in the United States (Abstract #1622, Session: 904. Outcomes Research – Non-Malignant Conditions: Poster I. Saturday, December 5)

    Changes in the Incidence and Overall Survival of Patients with Myeloproliferative Neoplasms Between 2002 and 2016 in the United States (Abstract #2160, Session: 634. Myeloproliferative Syndromes: Clinical: Poster II. Sunday, December 6)

    Clinical & Economic Implications of Hydroxyurea Intolerance in Polycythemia Vera in Routine Clinical Practice1 (Abstract #2477, Session: 901. Health Services Research-Non-Malignant Conditions: Poster II. Sunday, December 6)

    Interactions of Key Hematological Parameters with Red Cell Distribution Width (RDW) are Associated with Incidence of Thromboembolic Events (TEs) in Polycythemia Vera (PV) Patients: A Machine Learning Study (PV-AIM)1 (Abstract #2991, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

    Long-Term Effect of Ruxolitinib (RUX) in Inadequately Controlled Polycythemia Vera (PV) Without Splenomegaly: 5-Year Results from the Phase 3 Response-2 Study1 (Abstract #2987, Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

    Real-World Survival Among Patients with Intermediate- to High-Risk Myelofibrosis in the United States: Impact of Ruxolitinib Approval (Abstract #3089, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

    Thrombosis and Risk of Mortality in Newly Diagnosed High-Risk Polycythemia Vera: An Analysis of the Medicare Claims Database in the United States (Abstract #3458, Session: 904. Outcomes Research—Non-Malignant Conditions: Poster III. Monday, December 7)

    ADORE: A Randomized, Open-Label, Phase 1/2 Open-Platform Study Evaluating Safety and Efficacy of Novel Ruxolitinib Combinations in Patients with Myelofibrosis1 (Abstract #2997, Session: 624. Hodgkin Lymphoma and T/NK Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

    Parsaclisib

    Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Not Previously Treated with a BTK Inhibitor (CITADEL-205) (Abstract #1121, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster I. Saturday, December 5)

    Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Mantle Cell Lymphoma Previously Treated with Ibrutinib (CITADEL-205) (Abstract #2044, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster II. Sunday, December 6)

    Phase 2 Study Evaluating the Efficacy and Safety of Parsaclisib in Patients with Relapsed or Refractory Follicular Lymphoma (CITADEL-203) (Abstract #2935, Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III. Monday, December 7)

    Ponatinib

    Ponatinib Versus Imatinib with Reduced-Intensity Chemotherapy in Patients with Newly Diagnosed Philadelphia Chromosome–Positive (Ph+) Acute Lymphoblastic Leukemia (ALL): PhALLCON Study2 (Abstract #1026, Session: 615. Acute Myeloid Leukemia: Commercially Available Therapy, excluding Transplantation: Poster I. Saturday, December 5)

    A Phase 1/2 Study to Evaluate the Safety and Efficacy of Ponatinib with Chemotherapy in Pediatric Patients with Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL)2 (Abstract #2842, Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster III. Monday, December 7)

    Treatment of Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Using Tyrosine Kinase Inhibitors in Combination with Chemotherapy: A Patient-Centered Benefit-Risk Assessment2 (Abstract #3471, Session: 905. Outcomes Research—Malignant Conditions (Lymphoid Disease): Poster III. Monday, December 7)

    Tafasitamab

    The Combination of Tafasitamab and Rituximab Increases Cytotoxicity Against Lymphoma Cells In Vitro3 (Abstract #2095, Session: 625. Lymphoma: Pre-Clinical-Chemotherapy and Biologic Agents: Poster II. Sunday, December 6)

    A Phase 1b, Open-label, Randomized Study to Assess Safety and Preliminary Efficacy of Tafasitamab (MOR208) or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma: Analysis of the Safety Run-In Phase3 (Abstract #3028, Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III. Monday, December 7)

    Long-Term Subgroup Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma3 (Abstract #3021, Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Poster III. Monday, December 7)

    Blockade of the CD47/SIRPα Checkpoint Potentiates the Anti-Tumor Efficacy of Tafasitamab3 (Abstract #3008, Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster III. Monday, December 7)

    INCB057643

    A Phase 1 Study of INCB057643 Monotherapy in Patients with Relapsed or Refractory Myelofibrosis (INCB57643-103) (Abstract #2166, Session: 634. Myeloproliferative Syndromes: Clinical: Poster II. Sunday, December 6)

    INCB000928

    A Phase 1/2 Study of INCB000928 as Monotherapy or in Combination with Ruxolitinib in Patients with Anemia Due to Myelofibrosis (INCB00928-104) (Abstract #3000, Session: 634. Myeloproliferative Syndromes: Clinical: Poster III. Monday, December 7)

    Characterization of INCB000928, a Potent and Selective ALK2 Inhibitor for the Treatment of Anemia (Abstract #3095, Session: 635. Myeloproliferative Syndromes: Basic Science: Poster III. Monday, December 7)

    Full session details and listings for oral presentations and poster sessions are available in the ASH 2020 program: https://ash.confex.com/ash/2020/webprogram/start.html.

    About Jakafi® (ruxolitinib)

    Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, in adults with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF and for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older.

    Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi is a registered trademark of Incyte Corporation. Jakavi is a registered trademark of Novartis AG in countries outside the United States.

    About Iclusig® (ponatinib) Tablets

    Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

    Iclusig is approved in the U.S., EU, UK, Australia, Switzerland, Israel and Canada. In the EU, Iclusig is approved for the treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or the treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

    About Monjuvi® (tafasitamab-cxix)

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi®(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT).This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with lenalidomide in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adult patients with relapsed or refractory DLBCL, including DLBCL arising from low grade lymphoma, who are not candidates for ASCT.

    Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in a number of ongoing combination trials.

    Monjuvi® is a registered trademark of MorphoSys AG.

    XmAb® is a registered trademark of Xencor, Inc.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding: the presentation of data from the Company's oncology development portfolio, alone and in conjunction with its collaboration partners; whether or when any such compounds will be approved or commercially available for use in humans anywhere in the world or will improve the lives of patients; and the likelihood of continued approval of Monjuvi in DLBCL in the U.S. and whether it will also be approved by the EMA, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA or the EMA; the efficacy or safety of the Company's products; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended September 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Novartis-sponsored abstract.

    2 Takeda-sponsored abstract.

    3 MorphoSys-sponsored abstract.

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  16. INDIANAPOLIS, Nov. 2, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today positive data for Olumiant® (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology's virtual annual meeting taking place November 5-9, 2020. The Olumiant data being presented at this year's meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.

    At this year's meeting, results from a post-hoc analysis evaluating the long-term efficacy of Olumiant for patients with active RA who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic…

    INDIANAPOLIS, Nov. 2, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today positive data for Olumiant® (baricitinib) will be presented at ACR Convergence 2020, the American College of Rheumatology's virtual annual meeting taking place November 5-9, 2020. The Olumiant data being presented at this year's meeting include new long-term studies in adult patients living with rheumatoid arthritis (RA), along with real-world evidence (RWE) on safety and efficacy.

    At this year's meeting, results from a post-hoc analysis evaluating the long-term efficacy of Olumiant for patients with active RA who were inadequate responders (IR) to conventional synthetic disease-modifying antirheumatic drugs (csDMARD) or biologic DMARDs (bDMARD) (Abstract #0224) will be shared. In this analysis, 27.5% of the csDMARD-IR and 18.4% of the bDMARD-IR patients had Low Disease Activity defined by Simple Disease Activity Index (LDA; SDAI ≤11) after 2.3 years (at week 120) in a Non-responder Imputation analysis. For those patients who remained in the study, 85% and 86% of csDMARD-IR and bDMARD-IR respectively, maintained low disease activity at 2.3 years. No new safety concerns were identified.

    "In this analysis of the long-term studies of Olumiant in adults with RA, the medicine demonstrated efficacy over more than two years as measured by the proportion of patients who achieved low disease activity," said Alvin Wells, M.D., Ph.D., director of the Aurora Rheumatology and Immunotherapy Center. "The safety and efficacy from this study helps support Olumiant 2-mg once daily as a long-term treatment for patients with moderate to severe RA."

    Lilly will also highlight data from a long-term extension study that evaluated radiographic progression of structural joint damage in adult patients with active RA over 5 years of treatment with Olumiant (Abstract # 1235). The study enrolled patients who had completed treatment in one of three Phase 3 trials, including patients who were DMARD-naïve, csDMARD-IR and methotrexate (MTX)-IR, and assessed baricitinib 4-mg once daily as monotherapy or in combination with MTX or other csDMARDs and baricitinib 2-mg once daily in combination with other csDMARD. The data suggest that the different RA patient populations treated with baricitinib for up to 5 years can maintain low rates of radiographic progression, as assessed by the van der Heijde modified Total Sharp Score (mTSS).

    "We are pleased with the data being presented at this year's virtual ACR meeting highlighting the depth of Lilly's immunology portfolio and the potential impact our medicines may have for patients," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "Furthermore, the data being showcased at this meeting demonstrate our commitment to ongoing evaluation of the long-term safety and efficacy of Olumiant in patients living with RA."

    Additionally, Lilly will showcase RWE from a postmarketing safety surveillance study (Abstract # 0203). Results include 24-week safety data from 1,992 patients consecutively prescribed Olumiant in Japan. No new safety signals were observed during the initial analysis, and the study will continue to collect serious adverse events for three years.

    An integrated safety analysis of pooled data from nine clinical trials of Olumiant is also being presented (Abstract # 0202). Across the trials, 3,770 patients with RA received Olumiant for a total of 13,148 patient-years of exposure with a median time on treatment of 4.2 years and up to a maximum of 8.4 years. The data reinforce the safety profile of Olumiant in the treatment of RA, with no new safety concerns reported in the analysis.

    For more information about the Lilly data being presented at this year's virtual ACR, please visit https://www.rheumatology.org/Annual-Meeting

    Olumiant, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.



    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020 

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries.

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Lilly in Immunology

    Lilly is bringing our heritage of championing groundbreaking, novel science to immunology and is driven to change what's possible for people living with autoimmune diseases. There are still significant unmet needs, as well as personal and societal costs, for people living with a variety of autoimmune diseases and our goal is to minimize the burden of disease. Lilly is investing in leading-edge clinical approaches across its immunology portfolio in hopes of transforming the autoimmune disease treatment experience. We've built a deep pipeline and are focused on advancing cutting edge science to find new treatments that offer meaningful improvements to support the people and the communities we serve.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with rheumatoid arthritis reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee the future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    Kristen Porter Basu, ; 317-447-2199 (media)

    Kevin Hern; ; 317-277-1838 (investors)

    Catalina Loveman; ; +1-302-498-6171 (Incyte media)

    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)  

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

     

     

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/acr-2020-lilly-and-incyte-highlight-positive-data-for-olumiant-in-rheumatoid-arthritis-301164307.html

    SOURCE Eli Lilly and Company

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  17. INDIANAPOLIS, Oct. 31, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today new data for baricitinib will be presented at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress taking place virtually October 29-31, 2020. The data reinforce Lilly's commitment to developing medicines for the treatment of dermatologic diseases such as moderate to severe atopic dermatitis (AD). AD—also known as eczema—is a chronic inflammatory skin disorder that causes intense skin itching, redness, rash and sores.

    At this year's virtual EADV meeting, data from BREEZE-AD3, a Phase 3 study evaluating the long-term efficacy and safety of baricitinib in adult patients with moderate to severe AD will…

    INDIANAPOLIS, Oct. 31, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today new data for baricitinib will be presented at the 29th annual European Academy of Dermatology and Venereology (EADV) Congress taking place virtually October 29-31, 2020. The data reinforce Lilly's commitment to developing medicines for the treatment of dermatologic diseases such as moderate to severe atopic dermatitis (AD). AD—also known as eczema—is a chronic inflammatory skin disorder that causes intense skin itching, redness, rash and sores.

    At this year's virtual EADV meeting, data from BREEZE-AD3, a Phase 3 study evaluating the long-term efficacy and safety of baricitinib in adult patients with moderate to severe AD will be shared. In the study, responders as assessed by the validated Investigator Global Assessment score of "clear or almost clear" skin (vIGA 0,1) and partial responders (vIGA 2) from one of the 16-week originating studies entered and continued treatment with baricitinib 2-mg or 4-mg once daily for an additional 52 weeks. At the start of BREEZE-AD3 (after 16 weeks of treatment in the originating studies), 45.7% of responders and partial responders on 4-mg of baricitinib had a vIGA-AD score of 0 or 1, while 40% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. Similarly, at the start of BREEZE-AD3 46.3% of responders and partial responders on 2-mg of baricitinib had a vIGA-AD score of 0 or 1, while 50% had a vIGA-AD score of 0 or 1 after 68 weeks of continuous therapy. These results indicate that baricitinib 4-mg and 2-mg dose groups were able to maintain clear or almost clear skin response rates through the 68-week treatment period. The safety profile in this study was consistent with the known safety findings of baricitinib in previous 16-week, placebo-controlled AD studies. 

    "Baricitinib is part of a class of oral medicines called JAK inhibitors. These data support its potential use as a treatment for adults with moderate to severe AD," said Jonathan Silverberg, director of clinical research at The George Washington University School of Medicine and Health Sciences. "These results demonstrate that baricitinib's efficacy at achieving clear or almost clear skin could be sustained with continuous treatment."

    "At Lilly, we recognize the sacrifices that people living with dermatologic diseases like AD are making to address the symptoms of this chronic, relapsing skin disease," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We're encouraged by the long-term baricitinib efficacy and safety data being presented at EADV, which reinforce the potential role this medicine could play in helping people living with AD."

    Earlier this week, Lilly announced baricitinib received approval in the European Union for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. The approved EU Product Information for baricitinib can be found here. Lilly has submitted these data to major regulatory authorities around the world and continues to interact with several regulators to seek approval for baricitinib as a medicine for AD.

    For more information about the Lilly data being presented at this year's virtual EADV meeting, please visit https://eadvvirtualcongress.org/.  

    Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries.

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Atopic Dermatitis

    Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.6 

    Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

    About Lilly in Dermatology

    By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with moderate to severe atopic dermatitis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee the future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    Refer to:

    Kristen Porter Basu, ; 317-447-2199 (media)



    Kevin Hern; ; 317-277-1838 (investors)



    Catalina Loveman; ; +1-302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)



    ______________________________

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.

    Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.

    5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.

    6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.

    7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.

    8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/eadv-2020-lilly-and-incyte-showcase-new-data-for-baricitinib-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-301163842.html

    SOURCE Eli Lilly and Company

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  18. - Incyte placed in the top three for third consecutive year

    Incyte (NASDAQ:INCY) today announced that the company has again been named a top biopharma employer by Science magazine through its Top Employers Survey of the global pharmaceutical and biotech industry. This year, Incyte ranked second, marking the third consecutive year the company has been included in the top three on this prestigious industry list.

    Incyte was acknowledged as an innovative leader in the industry and was recognized specifically for being socially responsible, having loyal employees and treating employees with respect. Furthermore, according to Science magazine, the survey results not only highlighted the best working environments in the pharmaceutical and biotech…

    - Incyte placed in the top three for third consecutive year

    Incyte (NASDAQ:INCY) today announced that the company has again been named a top biopharma employer by Science magazine through its Top Employers Survey of the global pharmaceutical and biotech industry. This year, Incyte ranked second, marking the third consecutive year the company has been included in the top three on this prestigious industry list.

    Incyte was acknowledged as an innovative leader in the industry and was recognized specifically for being socially responsible, having loyal employees and treating employees with respect. Furthermore, according to Science magazine, the survey results not only highlighted the best working environments in the pharmaceutical and biotech industry, but also addressed the unique opportunities that arose this year, including the global pandemic. The magazine recognized that top employers were "agile enough to grant their staff the opportunity to shift their focus and assets to confront an emerging plague," and worked to make a difference in the fight against COVID-19.

    From Science magazine:

    "Incyte mobilized its resources to enable employees to work from home. ‘While working remotely after March 13th, we launched a new product and in addition realized that two of our established products could be helpful with the respiratory issues attached to COVID,' shares [Hervé] Hoppenot, [CEO of Incyte]. ‘We had our teams on nights and weekends putting together a clinical program to send to the FDA [U.S. Food and Drug Administration] and get it approved. All of this was done remotely and was an enormous amount of work. Having an active role in the fight against COVID was important for all of us, and being able to do it while working remotely was even more motivating.'"

    Incyte is proud to foster a workplace that enables our colleagues to thrive and innovate, even amid uncertain times, to provide solutions for patients. In addition, we are pleased to provide support and benefits that empower our employees to take care of their health and well-being.

    Rankings were determined based on the Science and Science Careers' 2020 Top Employers Survey, which polled employees in biotechnology and pharmaceutical industries to identify the 20 best employers and the driving characteristics associated with each company.

    The 2020 Top Employer results were based on approximately 7,600 completed surveys from North America (67%), Europe (19%), Asia/Pacific Rim (10%) and Rest of World (4%). The complete Top Biotech, Biopharma and Pharma Employers feature, including individual company rankings, can be found in the October 29 print edition of Science, and online at: https://www.sciencemag.org/features/2020/10/top-employers-rapid-response-covid-19-diversity-and-innovation.

    To explore opportunities at Incyte, please visit: https://www.incyte.com/join-us/join-incyte.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  19. INDIANAPOLIS, Oct. 30, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today new data for baricitinib (marketed as OLUMIANT®) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. The data underscore Lilly's commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). AA is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.

    Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared. The study included adult patients with…

    INDIANAPOLIS, Oct. 30, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today new data for baricitinib (marketed as OLUMIANT®) will be presented at the annual Fall Clinical Dermatology meeting taking place virtually October 29-November 1, 2020. The data underscore Lilly's commitment to providing medicines for dermatologic diseases that have high unmet need, including alopecia areata (AA). AA is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body.

    Data from the Phase 2 portion of BRAVE-AA1, an ongoing Phase 2/3 study evaluating the safety and efficacy of baricitinib in adult patients with AA will be shared. The study included adult patients with a current episode of AA lasting for 6 months to 8 years with a Severity of Alopecia Tool (SALT) score ≥50 (i.e. who had ≥50% scalp hair loss) and no spontaneous improvement over six months prior to screening. In the Phase 2 portion, patients were randomized to oral baricitinib 1-mg, 2-mg, 4-mg or placebo once daily, in order to identify up to two doses for the Phase 3 portion. Interim analyses were conducted after patients completed 12 and 36 weeks of treatment, the latter for the primary endpoint of the Phase 2 part of the study.  At Week 36, the proportion of patients achieving the primary endpoint of SALT ≤20 defined as having 20% or less of scalp hair loss and considered as clinically meaningful improvement, was significantly greater in baricitinib 2-mg (33.3%, p=0.016), and 4-mg (51.9%, p=0.001) groups compared to placebo (3.6%). Based on the interim results of the Phase 2 part of the study, the Phase 3 portion of BRAVE-AA1 and an additional Phase 3 trial (BRAVE-AA2) were initiated and are ongoing to assess the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.

    "Alopecia areata is a challenging disease that currently has no FDA-approved treatment options, making it difficult for healthcare providers to best serve the needs of these patients," said Brett King, MD, PhD associate professor of Dermatology at Yale School of Medicine. "I'm encouraged by the results of this study which support the therapeutic potential of baricitinib and look forward to further evaluating its ability to help the community of those affected by alopecia areata."

    The proportion of adult patients achieving no hair loss or limited hair loss on the patient-reported outcomes (PRO) for scalp hair assessment were significantly greater in the 2-mg and 4-mg groups compared to placebo (p<0.05) by Week 36. Similarly, patients receiving the 4-mg dose of baricitinib improved growth of eyebrows and eyelashes as assessed by the clinician-reported outcome and PRO measures (p<0.05 versus placebo). In the Phase 2 portion, the most common adverse event was upper respiratory tract infection which occurred in 17.9%, 11.1% and 22.2% of patients in placebo, 2-mg and 4-mg groups, respectively. No serious adverse events, deaths, thrombotic events or new safety concerns were reported.

    "Patients with alopecia areata deal with unpredictable and long-lasting episodes of hair loss and many don't find relief from the therapies that are currently used," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "The results of this study underscore baricitinib's potential in alopecia areata, and we look forward to continuing the clinical development program for baricitinib in hopes of becoming the first FDA approved treatment option for adults with AA."

    "Alopecia areata carries a considerable emotional burden for people living with the disease, affecting their quality of life and wellbeing, social interactions and ability to live a normal life," said Abby Ellison, Research Director at the National Alopecia Areata Foundation (NAAF). "Although there has been some progress in our understanding of this disease, there remains a significant unmet need to improve treatment strategies and the options available to people with alopecia areata. Today's news builds upon this progress and provides hope to people living with alopecia areata."

    In March, the FDA granted Breakthrough Therapy designation to baricitinib for the treatment of AA based on positive Phase 2 results from BRAVE-AA1. Breakthrough Therapy designation aims to expedite the development and review of drugs where preliminary data indicates they may demonstrate substantial improvement over already available therapies.

    For more information about the Lilly data being presented at this year's virtual Fall Clinical Dermatology meeting, please visit https://fallclinical.health/fall-clinical-20.

    Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed by Lilly under license from Incyte.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Alopecia Areata

    Alopecia areata (AA) is a common autoimmune skin disease which results in hair loss on the scalp, face and sometimes other areas of the body. AA often first appears during childhood and can be different for everyone who has it. People of all ages, males/females and all ethnic groups can develop AA.

    About Lilly in Dermatology

    By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with moderate to severe atopic dermatitis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee the future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

     

    Refer to:        

    Kristen Porter Basu, ; 317-447-2199 (media)



    Kevin Hern; ; 317-277-1838 (investors)



    Catalina Loveman; ; +1-302-498-6171 (Incyte media)



    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

     

    Eli Lilly and Company logo. (PRNewsfoto/Eli Lilly and Company)

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/fall-clinical-dermatology-2020-lilly-and-incyte-showcase-positive-new-data-for-baricitinib-in-adult-patients-with-alopecia-areata-301163497.html

    SOURCE Eli Lilly and Company

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  20. - Results reinforce that ruxolitinib cream treatment results in a rapid, substantial and sustained reduction in itch
    -
    Results also demonstrate improvement in patient-reported perceptions of sleep quality, sleep depth and restoration associated with sleep as measured by the PROMIS® Short Form-Sleep Disturbance (8b) questionnaire
    -
    Oral presentation will be available on-demand as part of the 29th EADV Virtual Congress

    Incyte (NASDAQ:INCY) today announced efficacy and safety results from a pooled analysis of two randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream for the treatment of patients with mild-to-moderate atopic dermatitis (AD). The presentation (FC08.08) will be available…

    - Results reinforce that ruxolitinib cream treatment results in a rapid, substantial and sustained reduction in itch

    -
    Results also demonstrate improvement in patient-reported perceptions of sleep quality, sleep depth and restoration associated with sleep as measured by the PROMIS® Short Form-Sleep Disturbance (8b) questionnaire

    -
    Oral presentation will be available on-demand as part of the 29th EADV Virtual Congress

    Incyte (NASDAQ:INCY) today announced efficacy and safety results from a pooled analysis of two randomized, double-blind, vehicle-controlled Phase 3 studies – TRuE-AD1 and TRuE-AD2 – evaluating ruxolitinib cream for the treatment of patients with mild-to-moderate atopic dermatitis (AD). The presentation (FC08.08) will be available on-demand as part of the 29th European Academy of Dermatology and Venereology (EADV) Congress, held virtually from October 29-31, 2020.

    Key findings from the individual TRuE-AD1 and TRuE-AD2 studies were previously reported.

    The new, pooled data reinforce that treatment with ruxolitinib cream resulted in a rapid, substantial and sustained reduction in itch; and improved the extent and severity of AD as measured by the Eczema Area Severity Index (EASI) and Scoring Atopic Dermatitis (SCORAD) assessment tools.

    In addition, treatment with ruxolitinib cream resulted in notable improvements in quality of life measures such as the PROMIS (Patient-Reported Outcomes Measurement Information System)1 sleep disturbance (8b)2 score. PROMIS is a set of well-accepted patient-reported outcome measurement tools that are psychometrically supported.1 In the TRuE-AD trials, the PROMIS Short Form-Sleep Disturbance (8b) questionnaire was used to assess patients' self-reported perceptions of sleep quality, sleep depth and restoration associated with sleep.

    Key results from the pooled analysis include:

     

    Ruxolitinib cream 0.75% BID

    Ruxolitinib cream 1.5% BID

    Vehicle

    Primary endpoint

    IGA-TS, responders

    n=483

    n=481

    n=244

    44.7%*

    52.6%*

    11.5%

    Key secondary endpoints

    EASI-75, responders

    n=483

    n=481

    n=244

    53.8%*

    62.0%*

    19.7%

    Itch NRS (≥4-point improvement), responders

    n=313

    n=307

    n=158

    41.5%*

    51.5%*

    15.8%

    PROMIS Short Form-Sleep Disturbance (8b) (≥6-point improvement), responders

    n=446

    n=449

    n=226

    20.9%**

    23.8%**

    14.2%

    Secondary endpoint

    SCORAD, mean change from baseline

    n=483

    n=481

    n=244

    -62.9%*

    -67.3%*

    -30.4%

    Additional efficacy analysis

    Daily Itch NRS Score, mean change from baseline within 12 hours

    n=483

    n=481

    n=244

    -0.4***

    -0.5***

    -0.1

    IGA-TS: Investigator's Global Assessment (IGA)-Treatment Success defined as an IGA score of 0 (clear) or 1 (almost clear) with ≥2-point improvement from baseline at Week8; BID: twice daily; EASI-75: ≥75% improvement from baseline at Week 8 in the Eczema Area and Severity Index (EASI) score; NRS: Numerical Rating Scale; PROMIS: Patient-Reported Outcomes Measurement Information System; SCORAD: Scoring Atopic Dermatitis.

    Patients included in the analysis had an Itch NRS score ≥4 at baseline; Patients included in the analysis had a PROMIS Short Form-Sleep Disturbance (8b) score of ≥6 at baseline.

    *P<0.0001 vs. vehicle at Week 8; **P<0.05 vs. vehicle at Week 8; ***P<0.02 vs. vehicle.

    The overall safety profile of ruxolitinib cream was consistent with previously reported data, with no new safety signals observed in this pooled analysis.

    "Atopic dermatitis is a chronic inflammatory skin condition that may result in decreased quality of life for patients; attributable in part to sleep disturbances resulting from intense and persistent itch," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & AutoImmunity, Incyte. "Pooled results from the TRuE-AD studies reinforce the potential of ruxolitinib cream to become an important antipruritic and anti-inflammatory treatment option for patients with atopic dermatitis and we are on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration at the end of this year."

    About Atopic Dermatitis

    Atopic dermatitis (AD) is a common chronic and intensely pruritic disease characterized by inflammation of the skin. AD affects more than 30 million individuals in the United States and 80-90% of patients have mild-to-moderate disease. Signs and symptoms of AD include irritated and itchy skin that can cause red lesions that may ooze and crust. Patients with AD are also more susceptible to bacterial, viral and fungal infections.

    About TRuE-AD

    The TRuE-AD clinical trial program consists of two randomized, double-blind, vehicle-controlled Phase 3 studies, TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD). Both studies enrolled more than 600 patients (age ≥12 years) diagnosed with AD for at least two years and who were candidates for topical therapy.

    Patients with an Investigator's Global Assessment (IGA) score of 2 to 3, and with AD on 3% to 20% of their Body Surface Area (excluding scalp) were randomized 2:2:1 into one of three arms for eight weeks: ruxolitinib cream 0.75% applied twice daily (BID); ruxolitinib cream 1.5% applied BID; and vehicle. Participants who successfully completed an assessment at Week 8 were offered participation in the 44-week long-term safety treatment extension period with ruxolitinib cream 0.75% or 1.5% applied BID.

    The primary endpoint of the TRuE-AD studies was the proportion of participants achieving an Investigator's Global Assessment Treatment Success (IGA-TS), defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline at Week 8. Key secondary endpoints include: the proportion of patients achieving at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75) score, the proportion of participants with at least a 4-point improvement in the itch Numerical Rating Scale, and the proportion of participants with at least a 6-point improvement in the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form – Sleep Disturbance (8b) 24-hour recall score. Additional secondary endpoints include mean percentage change from baseline in Scoring Atopic Dermatitis (SCORAD) score. The studies have also been tracking the frequency, duration and severity of adverse events associated with the use of ruxolitinib cream.

    For more information about the TRuE-AD studies, please visit http://clinicaltrials.gov/ct2/show/NCT03745638 and http://clinicaltrials.gov/ct2/show/NCT03745651.

    About Ruxolitinib Cream

    Ruxolitinib cream is a proprietary formulation of Incyte's selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application. Ruxolitinib cream is currently in Phase 3 development for the treatment of patients with mild-to-moderate atopic dermatitis (TRuE-AD) and for the treatment of adolescents and adults with vitiligo (TRuE-V). Incyte has worldwide rights for the development and commercialization of ruxolitinib cream.

    About Incyte Dermatology

    Incyte's science-first approach and expertise in immunology has formed the foundation of the company. In Dermatology, the Company's research and development efforts are focused on leveraging our knowledge of the JAK-STAT pathway to identify and develop topical and oral therapies with the potential to modulate immune pathways driving uncontrolled inflammation and help restore normal immune function.

    Currently, Incyte is exploring the potential of JAK inhibition for a number of immune-mediated dermatologic conditions with a high unmet medical need, including atopic dermatitis, vitiligo and hidradenitis suppurativa. To learn more, visit the Dermatology section of Incyte.com.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of ruxolitinib cream to provide a meaningful treatment for patients with atopic dermatitis, the TRuE-AD clinical program, the Company's Dermatology program, the safety and efficacy of ruxolitinib cream in patients with atopic dermatitis, and expected timing of the filing of the NDA for ruxolitinib cream for the treatment of atopic dermatitis, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the efficacy or safety of the Company's products; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    PROMIS® is a registered trademark of the U.S. Department of Health and Human Services.

    References:

    1. PROMIS. HealthMeasures. Available at: https://www.healthmeasures.net/explore-measurement-systems/promis. Accessed on October 28, 2020.
    2. Buysse DJ, et. al. Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments. Sleep 2010; 33:781-792.

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  21. MONTREAL, Oct. 26, 2020 /CNW/ - Incyte (NASDAQ:INCY) today announced that Health Canada has accepted its New Drug Submission (NDS) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or other rearrangement.

    The NDS is based on data from the FIGHT-202 study evaluating pemigatinib as a treatment for patients with previously treated, locally advanced or metastatic cholangiocarcinoma. Study results demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A), pemigatinib monotherapy resulted in an overall response rate (ORR) of 36 percent (primary endpoint), and median duration of response (DOR) of 9.1 months (secondary endpoint) with a median follow-up of 21 months. Adverse events observed included Retinal Pigment Epithelial Detachment (RPED) and hyperphosphatemia. The most common adverse reactions (incidence ≥ 20%) are hyperphosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, arthralgia, abdominal pain, hypophosphatemia, back pain, and dry skin.

    "The need for new therapies for patients with cholangiocarcinoma remains urgent, as they have limited treatment options beyond first-line chemotherapy and often face a poor prognosis," said Josée Brisebois, Ph.D., Head of Medical Affairs, Incyte Biosciences Canada. "We intend to work closely with Health Canada as we seek to bring this innovative targeted therapy to patients suffering from this difficult disease as soon as possible." This NDS marks the first marketing application that Incyte Biosciences Canada has made to Health Canada since establishing operations in Canada in April 2020.

    Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.1,2 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe.1 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients.3-5,1 FGFRs play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

    About FIGHT-202

    The FIGHT-202 is a multi-center, open-label, single-arm, Phase 2 study (NCT02924376) that evaluated the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement.

    Incyte Announces Health Canada Acceptance of the New Drug Submission 

    for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma

    Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genomic alterations) or Cohort C (no FGF/FGFR genomic alterations). All patients received 13.5 mg pemigatinib orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

    The primary endpoint of FIGHT-202 was overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; and duration of response (DOR).

    For more information about FIGHT-202, visit https://clinicaltrials.gov/ct2/show/NCT02924376.

    About FIGHT

    The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating the safety and efficacy of pemigatinib therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating pemigatinib in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or translocations, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating pemigatinib plus pembrolizumab combination therapy and pemigatinib monotherapy as first-line treatment for metastatic or unresectable bladder cancer harboring FGFR3 mutations or rearrangements who are not eligible to receive cisplatin.  FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

    About Pemigatinib

    Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

    The safety and efficacy of pemigatinib is under review and the market authorization in Canada has not yet been obtained.

    Pemigatinib is marketed by Incyte in the United States. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Incyte Announces Health Canada Acceptance of the New Drug Submission

    for Pemigatinib as a Treatment for Patients with Cholangiocarcinoma

    Forward Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: whether or when pemigatinib might be approved in Canada, for the treatment of, and whether or when pemigatinib might provide a treatment option for, patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements, and the FIGHT clinical trial program. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ending June 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    References

    1.

    Banales JM, et al. Nat Rev Gastroenterol Hepatol. 2016;13:261‒280.

    2.

    Uhlig J, et al. Ann Surg Oncol. 2019;26:1993–2000.

    3.

    Graham RP, et al. Hum Pathol. 2014;45:1630‒1638.

    4.

    Farshidfar F, et al. Cell Rep. 2017;18(11):2780–2794.

    5.

    Ross JS et al. The Oncologist. 2014;19:235–242.

     

    SOURCE Incyte Biosciences Canada

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/October2020/26/c1583.html

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  22. Incyte (NASDAQ:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Thursday, November 5, 2020.

    The schedule for the press release and conference call/webcast is as follows:

    Q3 2020 Press Release:

    November 5, 2020 at 7:00 a.m. ET

     

    Q3 2020 Conference Call:

    November 5, 2020 at 8:00 a.m. ET

    Domestic Dial-In Number:

    877-407-3042

    International Dial-In Number:

    201-389-0864

    Conference ID Number:

    13711777

    If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international…

    Incyte (NASDAQ:INCY) announced today that it has scheduled its third quarter financial results conference call and webcast for 8:00 a.m. ET on Thursday, November 5, 2020.

    The schedule for the press release and conference call/webcast is as follows:

    Q3 2020 Press Release:

    November 5, 2020 at 7:00 a.m. ET

     

    Q3 2020 Conference Call:

    November 5, 2020 at 8:00 a.m. ET

    Domestic Dial-In Number:

    877-407-3042

    International Dial-In Number:

    201-389-0864

    Conference ID Number:

    13711777

    If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853 and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13711777.

    The live webcast with slides can be accessed at Investor.Incyte.com and will be available for replay for 90 days.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

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  23. INDIANAPOLIS, Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) are sharing additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir. This finding was part of additional efficacy and safety data from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) presented today by John Beigel, M.D., associate director for clinical research in the Division of Microbiology and Infectious Diseases at NIAID. These data were presented at a special International Society for Influenza…

    INDIANAPOLIS, Oct. 8, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) are sharing additional data showing baricitinib in combination with remdesivir reduced time to recovery and improved clinical outcomes for patients with COVID-19 infection compared with remdesivir. This finding was part of additional efficacy and safety data from the Adaptive COVID-19 Treatment Trial (ACTT-2) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) presented today by John Beigel, M.D., associate director for clinical research in the Division of Microbiology and Infectious Diseases at NIAID. These data were presented at a special International Society for Influenza and other Respiratory Virus Diseases Antiviral Group (isirv-AVG) Virtual Conference on 'Therapeutics for COVID-19.' The largest benefits were observed in patients requiring supplemental oxygen (grade 5 on the eight-point ordinal scale) and those who required high-flow oxygen/non-invasive ventilation (grade 6) at baseline.

    New data presented today provide a better understanding of the improved clinical outcomes in hospitalized adults with COVID-19 infection who received baricitinib, including data for mortality. As previously reported, ACTT-2 achieved the primary endpoint, demonstrating that the overall patient population treated with baricitinib in combination with remdesivir improved their median time to recovery from 8 to 7 days in comparison to remdesivir, a 12.5% improvement (incidence rate ratio: 1.16; 95% CI: 1.01, 1.32; p=0.04). Recovery was defined as the participant being well enough for hospital discharge, meaning the participant either no longer required supplemental oxygen or ongoing medical care in the hospital, or was no longer hospitalized at Day 29. The study also met a pre-specified secondary endpoint. Using the ordinal scale that ranged from recovered to death, the odds of improvement in clinical status at Day 15 were 30% greater in patients being treated with baricitinib in combination with remdesivir compared with remdesivir (odds ratio 1.3; 95% CI: 1.0, 1.6; p=0.04).

    A numerical decrease in death (35%) through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir in the overall population (5.1% vs. 7.8%, respectively; hazard ratio: 0.65; 95% CI: 0.39, 1.08; p=0.09). The reduction in mortality was more pronounced for patients receiving oxygen, as mortality at Day 29 was 60% lower and 43% lower for the OS5 and OS6 subgroups respectively. No new safety signals were observed for baricitinib-treated patients in this study. NIAID authors are working to have the full analysis completed and a peer-reviewed manuscript will be made available soon.

    "We are excited that these results add to the potential role for baricitinib to treat hospitalized COVID-19 patients," said Ilya Yuffa, Lilly senior vice president and president of Lilly Bio-Medicines. "Lilly is committed to identifying impactful preventions and treatments, and we are engaged in discussions with the FDA regarding the potential to make baricitinib available to hospitalized patients as quickly as possible."

    Lilly is continuing conversations with the U.S. Food and Drug Administration (FDA) around the potential for Emergency Use Authorization (EUA) of baricitinib, a JAK1/JAK2 inhibitor licensed to Lilly from Incyte, to treat hospitalized patients with COVID-19. In the U.S., baricitinib has not been approved by the FDA to treat COVID-19, and the efficacy and safety of baricitinib for the treatment of COVID-19 has not been established.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious Infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About Lilly's COVID-19 Efforts

    Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are now being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with two partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click here for media resources related to Lilly's COVID-19 efforts.

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1

    In December 2009, Lilly and Incyte announced an exclusive worldwide license and collaboration agreement for the development and commercialization of baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases.

    About Eli Lilly and Company 

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom

    P-LLY

    About Incyte 

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a potential treatment for patients with COVID-19 and as a treatment for patients with rheumatoid arthritis, and reflects Lilly's and Incyte's current beliefs. This press release also contains a forward-looking statement about Lilly's potential antibody treatments for COVID-19. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals or continue to be commercially successful, or that potential antibody treatments will be safe and effective. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    Refer to:                     

    Kristen Basu; ; +1-317-447-2199 (Lilly media)

    Kevin Hern; ; +1-317-277-1838 (Lilly investors)

    Catalina Loveman; ; +1-302-498-6171 (Incyte media)

    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

    Incyte logo. (PRNewsFoto/Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-has-significant-effect-on-recovery-time-most-impactful-in-covid-19-patients-requiring-oxygen-301148840.html

    SOURCE Eli Lilly and Company

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  24. Nimble Therapeutics Inc. today announced the company has entered into a strategic collaboration with Incyte (NASDAQ:INCY) to discover first-in-class peptide therapies across various disease areas.

    "This is an important collaboration for both companies to discover novel peptide based therapeutics," said Jigar Patel, Ph.D., CEO of Nimble Therapeutics. "We are excited to partner with Incyte, an organization with world-class drug discovery, development and commercialization capabilities, to ensure maximal patient impact across multiple disease indications."

    The collaboration will leverage Nimble's proprietary peptide synthesis, screening and optimization platform, coupled with its high chemical diversity and integrated suite of assays to enable…

    Nimble Therapeutics Inc. today announced the company has entered into a strategic collaboration with Incyte (NASDAQ:INCY) to discover first-in-class peptide therapies across various disease areas.

    "This is an important collaboration for both companies to discover novel peptide based therapeutics," said Jigar Patel, Ph.D., CEO of Nimble Therapeutics. "We are excited to partner with Incyte, an organization with world-class drug discovery, development and commercialization capabilities, to ensure maximal patient impact across multiple disease indications."

    The collaboration will leverage Nimble's proprietary peptide synthesis, screening and optimization platform, coupled with its high chemical diversity and integrated suite of assays to enable faster discovery and optimization of promising compounds for intracellular and extracellular targets.

    Under the terms of the agreement, Nimble will receive an undisclosed upfront payment, reimbursement of certain research program costs and may become eligible for downstream milestone payments and royalties. Incyte has exclusive rights to develop and commercialize any peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.

    About Nimble Therapeutics

    Nimble Therapeutics is bringing the power of parallel chemical synthesis to drug discovery. Nimble's proprietary technology enables the rapid synthesis, screening and engineering of millions of scaffolded natural and modified macrocyclic peptidomimetics. Nimble has also developed a variety of biological assays that aid in the empirical screening and optimization of molecules with more favorable drug-like properties. The company is developing partnerships with leading pharmaceutical companies to leverage its technology across many therapeutic areas. For more information please see www.nimbletherapeutics.com.

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  25. INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT®) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision…

    INDIANAPOLIS, Sept. 18, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    This opinion marks the first step toward European regulatory approval for baricitinib (marketed as OLUMIANT®) for patients with AD. If approved, baricitinib would become the first JAK inhibitor indicated to help treat patients with AD. The CHMP opinion is now referred for action to the European Commission, which grants approval in the European Union. A final decision is expected from the European Commission in the next one-two months.

    "Due to the limited treatment options currently available for adult patients with AD, we're excited to further explore baricitinib's potential benefit for patients," said Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines. "At Lilly, we aspire to elevate treatment standards for patients with dermatologic conditions. Today's CHMP opinion brings us closer to providing a new medicine for adults living with AD in Europe."

    The positive opinion was based on Lilly's Phase 3 BREEZE-AD clinical development program for baricitinib evaluating the medicine's potential to treat AD including BREEZE-AD1 and BREEZE-AD2, monotherapy studies investigating the efficacy and safety of baricitinib in moderate to severe AD patients; BREEZE-AD4, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD who have failed or who are intolerant to, or have contraindications to cyclosporine; and BREEZE-AD7, a study evaluating the efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate to severe AD.

    "Patients living with AD face difficulties on a daily basis, and this CHMP opinion marks an important milestone in providing adult AD patients with a new potential treatment option," said Prof. Thomas Bieber, M.D., Ph.D., M.D.R.A., Professor of Dermatology and Allergy, University Hospital in Bonn, Germany.

    OLUMIANT® is already approved in more than 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).

    Lilly has exclusive worldwide development and commercialization rights for baricitinib and certain follow-on compounds for patients with inflammatory and autoimmune diseases under a license and collaboration agreement with Incyte.

    Information on the previously approved EU OLUMIANT indication (Rheumatoid Arthritis) can be found here.

    Indication and Usage for OLUMIANT (baricitinib) tablets (in the United States) for RA patients

    OLUMIANT® (baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation of Use: Not recommended for use in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine.

    IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS 

    WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS

    SERIOUS INFECTIONS: Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:

    • Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. If positive, start treatment for latent infection prior to Olumiant use.
    • Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, and other infections due to opportunistic pathogens.

    Carefully consider the risks and benefits of Olumiant prior to initiating therapy in patients with chronic or recurrent infection.

    Closely monitor patients for the development of signs and symptoms of infection during and after treatment with Olumiant including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

    MALIGNANCIES: Lymphoma and other malignancies have been observed in patients treated with Olumiant.

    THROMBOSIS: Thrombosis, including deep venous thrombosis (DVT) and pulmonary embolism (PE), has been observed at an increased incidence in patients treated with Olumiant compared to placebo. In addition, there were cases of arterial thrombosis. Many of these adverse events were serious and some resulted in death. Patients with symptoms of thrombosis should be promptly evaluated.

    WARNINGS AND PRECAUTIONS

    SERIOUS INFECTIONS: The most common serious infections reported with Olumiant included pneumonia, herpes zoster and urinary tract infection. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, esophageal candidiasis, pneumocystosis, acute histoplasmosis, cryptococcosis, cytomegalovirus and BK virus were reported with Olumiant. Some patients have presented with disseminated rather than local disease and were often taking concomitant immunosuppressants such as methotrexate or corticosteroids. Avoid Olumiant in patients with an active, serious infection, including localized infections. Consider the risks and benefits of treatment prior to initiating Olumiant in patients:

    • with chronic or recurrent infection
    • who have been exposed to TB
    • with a history of a serious or an opportunistic infection
    • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
    • with underlying conditions that may predispose them to infection.

    Closely monitor patients for infections during and after Olumiant treatment. Interrupt Olumiant if a patient develops a serious infection, an opportunistic infection, or sepsis. Do not resume Olumiant until the infection is controlled.

    Tuberculosis Before initiating Olumiant evaluate and test patients for latent or active infection and treat patients with latent TB with standard antimycobacterial therapy. Olumiant should not be given to patients with active TB. Consider anti-TB therapy prior to initiating Olumiant in patients with a history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but who have risk factors for TB infection. Monitor patients for TB during Olumiant treatment.

    Viral Reactivation – Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical studies with Olumiant. If a patient develops herpes zoster, interrupt Olumiant treatment until the episode resolves.

    The impact of Olumiant on chronic viral hepatitis reactivation is unknown. Screen for viral hepatitis in accordance with clinical guidelines before initiating Olumiant.

    MALIGNANCY AND LYMPHOPROLIFERATIVE DISORDERS: Malignancies were observed in Olumiant clinical studies. Consider the risks and benefits of Olumiant prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing Olumiant in patients who develop a malignancy. NMSCs were reported in patients treated with Olumiant. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS:  Thrombosis, including DVT and PE, has been observed at an increased incidence in Olumiant-treated patients compared to placebo. In addition, arterial thrombosis events in the extremities have been reported in clinical studies with Olumiant. Many of these adverse events were serious and some resulted in death. There was no clear relationship between platelet count elevations and thrombotic events. Use Olumiant with caution in patients who may be at increased risk of thrombosis. If clinical features of DVT/PE or arterial thrombosis occur, evaluate patients promptly and treat appropriately.

    GASTROINTESTINAL PERFORATIONS: Gastrointestinal perforations have been reported in Olumiant clinical studies, although the role of JAK inhibition in these events is not known. Use Olumiant with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis). Promptly evaluate patients who present with new onset abdominal symptoms for early identification of gastrointestinal perforation.

    LABORATORY ABNORMALITIES:

    Neutropenia – Olumiant treatment was associated with an increased incidence of neutropenia (absolute neutrophil count [ANC] <1000 cells/mm3) compared to placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ANC <1000 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Lymphopenia – Absolute lymphocyte count (ALC) <500 cells/mm3 were reported in Olumiant clinical trials. Lymphocyte counts less than the lower limit of normal were associated with infection in patients treated with Olumiant, but not placebo. Avoid initiation or interrupt Olumiant treatment in patients with an ALC <500 cells/mm3. Evaluate at baseline and thereafter according to routine patient management.

    Anemia – Decreases in hemoglobin levels to <8 g/dL were reported in Olumiant clinical trials. Avoid initiation or interrupt Olumiant treatment in patients with hemoglobin <8 g/dL. Evaluate at baseline and thereafter according to routine patient management.

    Liver Enzyme Elevations – Olumiant treatment was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5x upper limit of normal (ULN) and increases of AST ≥10x ULN were observed in patients in Olumiant clinical trials.

    Evaluate at baseline and thereafter according to routine patient management. Promptly investigate the cause of liver enzyme elevation to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt Olumiant until this diagnosis is excluded.

    Lipid Elevations – Treatment with Olumiant was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol. Assess lipid parameters approximately 12 weeks following Olumiant initiation. Manage patients according to clinical guidelines for the management of hyperlipidemia.

    VACCINATIONSAvoid use of live vaccines with Olumiant. Update immunizations in agreement with current immunization guidelines prior to initiating Olumiant therapy.

    HYPERSENSITIVITY: Reactions such as angioedema, urticaria, and rash that may reflect drug sensitivity have been observed in patients receiving Olumiant, including serious reactions. If a serious hypersensitivity reaction occurs, promptly discontinue Olumiant while evaluating the potential causes of the reaction.

    ADVERSE REACTIONS

    Most common adverse reactions include: upper respiratory tract infections (16.3%, 11.7%), nausea (2.7%, 1.6%), herpes simplex (0.8%, 0.7%) and herpes zoster (1.0%, 0.4%) for Olumiant 2 mg and placebo, respectively.

    USE IN SPECIFIC POPULATIONS

    PREGNANCY AND LACTATION: No information is available to support the use of Olumiant in pregnancy or lactation. Advise women not to breastfeed during treatment with Olumiant.

    HEPATIC AND RENAL IMPAIRMENT: Olumiant is not recommended in patients with severe hepatic impairment or in patients with severe renal impairment.

    Please click to access full Prescribing Information, including Boxed Warning about Serious infections, Malignancies, and Thrombosis, and Medication Guide.

    BA HCP ISI 09JUL2020

    About OLUMIANT®

    OLUMIANT is a once-daily, oral JAK inhibitor approved in the U.S. for the treatment of adults with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more TNF inhibitor therapies, and approved outside of the U.S. for patients with moderately- to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs.1 There are four known JAK enzymes: JAK1, JAK2, JAK3 and TYK2. JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases.2 OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2 relative to JAK3; however, the relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.1 OLUMIANT is approved in more than 70 countries. OLUMIANT is developed by Lilly under license from Incyte Corporation.

    About Atopic Dermatitis

    Atopic dermatitis (AD), or atopic eczema, is a chronic, relapsing skin disease characterized by intense itching, dry skin and inflammation that can be present on any part of the body.3 AD is a heterogeneous disease both biologically and clinically, but may be characterized by chronic symptoms of itch, redness and skin damage that are often punctuated with episodic, sometimes unpredictable, flares or exacerbations.4,5 AD affects approximately one-three percent of adults worldwide.

    Moderate to severe AD is characterized by intense itching, resulting in visibly damaged skin.7 Like other chronic inflammatory diseases, AD is immune-mediated and involves a complex interplay of immune cells and inflammatory cytokines.8

    About Lilly in Dermatology

    By following the science through unchartered territory, we continue Lilly's legacy of delivering innovative medicines that address unmet needs and have significant impacts on people's lives around the world. Skin-related diseases are more than skin deep. We understand the devastating impact this can have on people's lives. At Lilly, we are relentlessly pursuing a robust dermatology pipeline to provide innovative, patient-centered solutions so patients with skin-related diseases can aspire to live life without limitations.

    About Eli Lilly and Company

    Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom.

    About Incyte 

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    P-LLY

    This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about OLUMIANT (baricitinib) as a treatment for patients with atopic dermatitis and reflects Lilly's and Incyte's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that OLUMIANT will receive additional regulatory approvals, or that it will be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's and Incyte's most recent respective Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly and Incyte undertake no duty to update forward-looking statements to reflect events after the date of this release.

    1 Olumiant Prescribing Information, 2020.

    2 Walker JG and Smith MD. J Rheumatol. 2005;32;1650-1653.

    3 Zuberbier T, Orlow SJ, Paller AS, et al. Patient perspectives on the management of atopic dermatitis. The Journal of Allergy and Clinical Immunology. 2006;118: 226-32.

    4 Thijs JL, Strickland I, Bruijnzeel-Koomen C, et. al. Moving toward endotypes in atopic dermatitis: identification of patient clusters based on serum biomarker analysis. The Journal of Allergy and Clinical Immunology. 2017.

    5 Langan SM, Thomas KS, Williams HC. What is meant by "flare" in atopic dermatitis? A systematic review and proposal. Arch Dermatol. 2006;142:1190-1196.

    6 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Annals of Nutrition and Metabolism. 2015;66(suppl 1): 8-16.

    7 Yosipovitch G, Papoiu AD. What causes itch in atopic dermatitis? Current Allergy and Asthma Reports. 2008;8:306-311.

    8 Weidinger, S, Novak, N. Atopic dermatitis. The Lancet Volume 387. 2016;10023:1109-1122.

    Refer to: 

    Kristen Porter Basu; ; 317-447-2199 (media)

    Kevin Hern; ; 317-277-1838 (investors)

    Catalina Loveman; ; +1-302-498-6171 (Incyte media)

    Michael Booth, DPhil; ; +1-302-498-5914 (Incyte investors)

    Eli Lilly and Company logo. (PRNewsFoto, Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

    Incyte logo. (PRNewsFoto/Eli Lilly and Company) (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/chmp-recommends-approval-of-lillys-baricitinib-for-the-treatment-of-adults-with-moderate-to-severe-atopic-dermatitis-301133876.html

    SOURCE Eli Lilly and Company

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    • Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
    • Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020
    • POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

    Incyte (NASDAQ:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with…

    • Independent central review confirmed responses include 1 complete response, 12 partial responses and 33 stable disease for an objective response rate of 14% and disease control rate of 49%
    • Responses were observed regardless of PD-L1 status, presence of liver metastases or HIV+ status
    • Presentation is available on-demand as part of the ESMO Virtual Congress 2020
    • POD1UM-303/InterAACT 2, a Phase 3 trial evaluating retifanlimab plus chemotherapy in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal is now open and recruiting patients.

    Incyte (NASDAQ:INCY) today announced results from its Phase 2 POD1UM-202 trial evaluating retifanlimab, a PD-1 inhibitor, in previously treated patients with advanced squamous cell carcinoma of the anal canal (SCAC) who have progressed following standard platinum-based chemotherapy. The trial enrolled 94 patients, including those with well-controlled human immunodeficiency virus (HIV) infection (10%).

    Retifanlimab monotherapy resulted in a confirmed objective response rate (ORR) of 14% as determined by independent central review (ICR) using RECIST v1.1. Responses were observed regardless of PD-L1 status, presence of liver metastases, age or HIV+ status. Retifanlimab was generally well-tolerated with a safety profile as expected of a PD-1 inhibitor and no loss of HIV infection control.

    Key findings from POD1UM-202:

     

    N=94

    ORR* (95% CI)

    13.8% (7.6-22.5)

    Best OR*, n

    1 CR

    12 PR

    33 SD

    DCR

    48.9%

    DOR, median (95% CI), months

    9.5 (5.6-NE)

    PFS, median (95% CI), months

    2.3 (1.9-3.6)

    OS, median (95% CI), months

    10.1 (7.9-NE)

    *Confirmed responses as determined by independent central review (ICR) using RECIST v1.1.

    ORR: objective response rate; CI: confidence interval; OR: objective response; CR: complete response; PR: partial response; SD: stable disease; DCR: disease control rate; DOR: duration of response; PFS: progression-free survival; OS: overall survival; NE: not estimable.

    "The results from the POD1UM-202 trial highlight the potential of retifanlimab to provide a meaningful treatment for patients with SCAC who have progressed following standard platinum-based chemotherapy and therefore have a very poor prognosis," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "These data are especially important because this trial enrolled HIV+ patients who are at the greatest risk of developing SCAC and are typically systematically excluded from oncology clinical trials."

    These results are available on-demand as part of the European Society for Medical Oncology (ESMO) 2020 Virtual Congress mini-oral sessions beginning at 9:00 am CEST on September 18th, 2020; Presentation #LBA42.

    "SCAC is a rare cancer with increasing incidence, including in patients who are HIV+, and represents a strong unmet medical need," said Sheela Rao, M.D., Consultant Medical Oncologist, The Royal Marsden NHS Foundation Trust. "Data from the POD1UM-202 trial are encouraging and support further investigation of the potential of retifanlimab to become a much needed treatment option for patients with SCAC."

    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 Patients with metastatic SCAC have a poor 5-year survival and there are no standard treatments for patients who have progressed after first-line chemotherapy treatment.2

    POD1UM-303/InterAACT 2 (NCT04472429), a Phase 3 trial of retifanlimab in combination with carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic SCAC is now open and recruiting patients.

    About POD1UM

    The POD1UM (PD1 Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 and several other Phase 1, 2 and 3 studies for patients with solid tumors including squamous cell carcinoma of the anal canal (SCAC), microsatellite instability-high endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, among others.

    About POD1UM-202

    POD1UM-202 (NCT03597295) is an open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell carcinoma of the anal canal (SCAC) who have progressed following platinum-based chemotherapy. Retifanlimab 500 mg is administered intravenously every 4 weeks.

    The primary endpoint is objective response rate (ORR) as determined by independent central review using RECIST v1.1. Secondary endpoints include additional measures of clinical benefit ‒ duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS); safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT03597295.

    About POD1UM-303/InterAACT 2

    POD1UM-303/InterAACT 2 (NCT004472429) is a Phase 3, randomized, multicenter, double-blind study evaluating retifanlimab or placebo plus carboplatin and paclitaxel in patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC).

    Adult patients, including those with well-controlled HIV infection, who have not been previously treated with systemic chemotherapy will be randomized to receive retifanlimab or placebo with standard therapy of carboplatin and paclitaxel.

    The primary endpoint is progression-free survival (PFS) as determined by blinded independent central review using RECIST v1.1. Key secondary endpoint is overall survival (OS). Other secondary endpoints include: objective response rate (ORR), duration of response (DOR), disease control rate (DCR), safety and pharmacokinetics.

    For more information about the study, please visit https://clinicaltrials.gov/ct2/show/NCT04472429.

    About Retifanlimab

    Retifanlimab (formerly INCMGA0012), an investigational anti-PD1 antibody, is currently under evaluation in registration-directed trials as a monotherapy for patients with microsatellite instability-high endometrial cancer, Merkel cell carcinoma and squamous cell carcinoma of the anal canal (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer and SCAC.

    Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of anal cancer.

    In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab. In 2019, Incyte and Zai Lab announced a collaboration and license agreement for the development and commercialization of retifanlimab in Greater China.

    About Incyte

    Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics. For additional information on Incyte, please visit Incyte.com and follow @Incyte.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements about the potential of retifanlimab to provide a meaningful treatment for patients with SCAC, the retifanlimab development program, and the safety and efficacy of retifanlimab in patients with squamous cell carcinoma of the anal canal, contain predictions, estimates and other forward-looking statements.

    These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA; the Company's dependence on its relationships with its collaboration partners; the efficacy or safety of the Company's products and the products of the Company's collaboration partners; the acceptance of the Company's products and the products of the Company's collaboration partners in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; greater than expected expenses; expenses relating to litigation or strategic activities; and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    References

    1. Ghosn M, et.al. Anal cancer treatment: current status and future perspectives. World J Gastroenterol 2015;21:2294-2302.
    2. Eng C, et al. The role of systemic chemotherapy and multidisciplinary management in improving the overall survival of patients with metastatic squamous cell carcinoma of the anal canal. Oncotarget 2014;5:11133-11142.

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  26. Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    PLANEGG/MUNICH and WILMINGTON, DE / ACCESSWIRE / September 17, 2020 / MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &amp, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join MorphoSys and Incyte leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating…

    Analyst and investor conference call and webcast scheduled for Tuesday, September 29, 2020 at 9:00 a.m. EDT / 3:00 p.m. CEST

    PLANEGG/MUNICH and WILMINGTON, DE / ACCESSWIRE / September 17, 2020 / MorphoSys AG ((FSE: MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR) and Incyte (NASDAQ:INCY) today announced that the companies intend to host a conference call and webcast to discuss global development, unmet need and commercial opportunities for tafasitamab.

    Dr. Gilles Salles will join MorphoSys and Incyte leadership as an expert speaker. Dr. Salles was the principal investigator and first author of the ICML 2019 and EHA 2020 data presentations, as well as first author of the 2020 Lancet Oncology publication of the L-MIND trial investigating tafasitamab in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

    The conference call and webcast will be held on Tuesday, September 29, 2020 from 9:00 - 11:00 a.m. EDT / 3:00 - 5:00 p.m. CEST. The live webcast and replay will be available via www.morphosys.com and investor.incyte.com.

    To access the conference call, U.S. domestic callers please dial 877-423-0830. Callers outside of the U.S. please dial +49 69201744220 or +44 2030092470. When prompted, provide the conference pin number, 83557299#.

    About Tafasitamab

    Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb(R) engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Monjuvi(R)(tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In January 2020, MorphoSys and Incyte entered into a collaboration and licensing agreement to further develop and commercialize tafasitamab globally. Monjuvi(R) is being co-commercialized by Incyte and MorphoSys in the United States. Incyte has exclusive commercialization rights outside the United States.

    A marketing authorization application (MAA) seeking the approval of tafasitamab in combination with l