1. INDIANAPOLIS, April 8, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death…

    INDIANAPOLIS, April 8, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today results of COV-BARRIER, a Phase 3 study evaluating baricitinib 4 mg once daily plus standard of care (SoC) versus placebo plus SoC. The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; p=0.1800). 

    In COV-BARRIER, treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction (nominal p-value=0.0018) in death from any cause by 38 percent (n/N: 62/764 [8.1%] baricitinib, 100/761 [13.1%] placebo; hazard ratio [HR]: 0.57; 95% CI: 0.41, 0.78) by Day 28. A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients and was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC; hazard ratio [HR]: 0.52; 95% CI: 0.33, 0.80; nominal p-value=0.0065). A reduction in mortality was also seen for the pre-specified subgroups of patients being treated with or without corticosteroids at baseline. 

    "There remains a driving unmet need for treatments with the potential to further decrease mortality for COVID-19 patients," said co-primary investigator E. Wesley Ely, M.D., MPH, professor of medicine and co-director of the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt University Medical Center. "While COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks. These important findings advance our pursuit of treatment options to save lives in hospitalized COVID-19 patients."

    The frequency of adverse events and serious adverse events were generally similar in the baricitinib (44.5% and 14.7%, respectively) and placebo (44.4% and 18.0%, respectively) groups. Serious infections and venous thromboembolism (VTE) occurred in 8.5 percent and 2.7 percent of patients treated with baricitinib, respectively, versus 9.8 percent and 2.5 percent of patients treated with placebo. No new safety signals potentially related to the use of baricitinib were identified.

    Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months. Lilly will share the data from COV-BARRIER with regulatory authorities in the U.S., European Union and other geographies to evaluate next steps for baricitinib for the treatment of hospitalized COVID-19 patients.

    "Since the beginning of the pandemic, we have worked to expand the science behind COVID-19 therapies," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "Even though the study did not show a statistically-significant benefit on the primary endpoint, this trial showed the largest effect reported to date for reduction in mortality observed for this patient population with COVID-19. As there remains an urgent need to reduce COVID-related deaths in hospitalized patients, we hope these results will provide further understanding and support for baricitinib's potential role in treatment on top of the current standard of care."

    COV-BARRIER (NCT04421027) is the first global, randomized, double-blind, placebo-controlled study to assess baricitinib versus placebo in patients hospitalized with COVID-19 receiving SoC which could include corticosteroids, antimalarials, antivirals, and/or azithromycin. This Phase 3 study of 1,525 patients began in June 2020 and enrolled hospitalized patients who did not require supplemental oxygen (ordinal scale [OS] 4), required supplemental oxygen (OS 5) or high-flow oxygen/non-invasive ventilation (OS 6). Patients were also required to have at least one increased marker of inflammation, an indicator of risk of disease progression. All patients were treated with SoC per local clinical practice including 79 percent receiving corticosteroids (with 91% of those patients receiving dexamethasone) and 19 percent receiving remdesivir at baseline, with some receiving both. Patients were randomized 1:1 to baricitinib 4 mg or placebo for up to 14 days or until discharge from the hospital. The study was global and included diverse patients from several countries with high prevalence of COVID-19 hospitalizations – the U.S., Brazil, Mexico, Argentina, Russia, India, UK, Spain, Italy, Germany, Japan and Korea. An addendum to the study was initiated in December 2020 to include mechanically ventilated (OS 7) patients at baseline and is currently enrolling.

    The COV-BARRIER trial was designed to complement 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). ACTT-2 began in May 2020 and has published results from 1,033 patients. Patients who received baricitinib in combination with remdesivir had a shorter median time to recovery compared to patients who received remdesivir alone. In ACTT-2, there was a significant reduction in the proportion of patients progressing to noninvasive ventilation, invasive mechanical ventilation or death, in the baricitinib plus remdesivir group compared to remdesivir. A numerical decrease in mortality risk through Day 29 was observed in patients treated with baricitinib plus remdesivir compared to remdesivir.

    "While the trend observed for the primary endpoint was not significant, the demonstration of a potential effect on mortality is a clinically important finding. This effect on mortality was seen with or without corticosteroids and/or remdesivir at the time of enrollment," said Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine and Emory's Rollins School of Public Health, a co-principal investigator of COV-BARRIER and a co-investigator on the ACTT-2 study. "These results – along with those from the NIAID-sponsored ACTT-2 study evaluating baricitinib in combination with remdesivir – add to the growing body of data supporting the use of baricitinib in certain hospitalized patients with COVID-19."

    Additional research is ongoing to further evaluate the potential role of baricitinib in COVID-19, including NIAID's ACTT-4 trial (evaluating the efficacy and safety of baricitinib or dexamethasone in combination with remdesivir in hospitalized adults with COVID-19 on supplemental oxygen), the RECOVERY trial in the UK and several investigator-initiated trials. 

    An emergency use authorization (EUA) was issued by the U.S. Food and Drug Administration (FDA) on Nov. 19, 2020 for baricitinib in combination with remdesivir in hospitalized patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Please see below for important warnings and information about the authorized use of baricitinib in the U.S.  More than 200,000 patients globally are estimated to have been treated with baricitinib for COVID-19.

    Baricitinib, an oral JAK inhibitor, was discovered by Incyte and licensed to Lilly. It 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 active rheumatoid arthritis (RA) and in the European Union and Japan for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.

    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.  

    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). 

    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 being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover and develop 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 OLUMIANT ® (baricitinib)

    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 and was recently approved in the European Union and Japan 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. Baricitinib is also being investigated in alopecia areata (AA), juvenile idiopathic arthritis (JIA) and systematic lupus erythematosus (SLE).

    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 reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals or authorizations or be commercially successful, 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)



    Christine Chiou; ; +1-302-274-4773 (Incyte investors)

     

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

     

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    SOURCE Eli Lilly and Company

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  2. INDIANAPOLIS, April 6, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).

    The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

    "We look forward to continuing to work closely with the FDA to bring baricitinib to patients living with moderate to severe atopic dermatitis," said…

    INDIANAPOLIS, April 6, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for baricitinib for the treatment of adults with moderate to severe atopic dermatitis (AD).

    The FDA extended the action date to allow time to review additional data analyses submitted by Lilly in response to recent information requests from the FDA. The Prescription Drug User Fee Act (PDUFA) action date has been extended three months to early Q3 2021.

    "We look forward to continuing to work closely with the FDA to bring baricitinib to patients living with moderate to severe atopic dermatitis," said Ilya Yuffa, senior vice president and president of Lilly Bio-Medicines. "We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients."

    This extension does not affect Lilly's previously-issued financial guidance for 2021. Ongoing research for baricitinib, an oral JAK inhibitor discovered by Incyte and licensed to Lilly, in adult and pediatric AD, alopecia areata (AA), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), COVID-19 and for its approved indication for rheumatoid arthritis (RA) continues.

    About OLUMIANT® (baricitinib)

    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 and Japan 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.

    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: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    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 localized 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.

    VACCINATIONS: Avoid 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

    Adverse reactions (occurring in ≥1% of Olumiant-treated patients in placebo-controlled trials) include: upper respiratory tract infections, headache, abdominal pain, nausea, herpes simplex, urinary tract infection, acne, and herpes zoster.

    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 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

    OLUMIANT® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. 

    Lilly 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 treatment for patients with rheumatoid arthritis and a possible treatment for patients with atopic dermatitis and other conditions and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, and that OLUMIANT will receive additional regulatory approvals, or 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.

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

    Incyte logo. (PRNewsfoto/Eli Lilly and Company)

    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)

    Christine Chiou; ; +1-302-274-4773 (Incyte investors)

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    SOURCE Eli Lilly & Company; Incyte

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  3. - Pemazyre is the first targeted therapy approved in the EU for this indication

    Incyte (NASDAQ:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.

    "Pemazyre's approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first…

    - Pemazyre is the first targeted therapy approved in the EU for this indication

    Incyte (NASDAQ:INCY) today announced that the European Commission (EC) has approved Pemazyre® (pemigatinib) for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy. The decision follows the positive opinion received from the European Medicines Agency's Committee for Medicinal Products for Human Use in January 2021 recommending the conditional marketing authorization of Pemazyre.

    "Pemazyre's approval is a crucial milestone for patients with FGFR2 positive cholangiocarcinoma. It is the first new treatment option to be made available to these patients in the EU in over a decade and has demonstrated a high rate of durable responses in a setting where historically there has been no effective standard of care," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We now look forward to working with individual countries in Europe to ensure eligible patients can access this new treatment as soon as possible."

    The EC decision is based on data from the FIGHT-202 study evaluating the safety and efficacy of Pemazyre in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. Interim results from FIGHT-202 demonstrated that in patients harboring FGFR2 fusions or rearrangements (Cohort A [108 patients]), Pemazyre monotherapy resulted in an overall response rate (ORR) of 37 percent (primary endpoint) and a median duration of response (DOR) of 8 months (secondary endpoint) based on an independent central radiographic review. Pemazyre was generally well tolerated. Warnings and precautions for Pemazyre include high and low levels of phosphate in the blood, vision or eye problems, blood creatinine increase and for women who are pregnant, a risk of harm to the fetus.

    "The data from the FIGHT-202 study has demonstrated the potential benefits that pemigatinib may have for eligible patients living with cholangiocarcinoma," said Eric Van Cutsem, M.D., Ph.D., Professor and Division Head of Digestive Oncology, University of Leuven (KUL) and University Hospitals Gasthuisberg, Leuven, Belgium. "Pemazyre offers a much-needed option to eligible patients that have only had few effective treatment options until today."

    Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its origin: intrahepatic cholangiocarcinoma 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 poor1,2. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0003,4. FGFR2 fusions or rearrangements occur almost exclusively in intrahepatic cholangiocarcinoma, where they are observed in 10-16 percent of patients5,6,7.

    "Historically, patients living with advanced cholangiocarcinoma have had very limited treatment options," said Helen Morement, CEO, AMMF – The Cholangiocarcinoma Charity. "We are encouraged to see new, targeted therapies starting to be approved in Europe, giving hope to those in desperate need of alternatives."

    About FIGHT-202

    The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

    Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5mg Pemazyre 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 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

    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 safety and efficacy of Pemazyre therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating Pemazyre 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 fusions/rearrangements, irrespective of tumor type.

    FIGHT-302 is a Phase 3 study investigating Pemazyre as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

    About Pemazyre® (pemigatinib)

    Pemazyre is a kinase inhibitor indicated in the United States 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 test8. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

    In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

    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, Europe and Japan. 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.

    Pemazyre is a trademark of Incyte Corporation.

    Safety Information from the EU Summary of Product Characteristics (SmPC)

    Pemazyre may cause serious adverse reactions. The most common serious adverse reactions were hyponatremia and blood creatinine increase.

    The most common adverse reactions were hyperphosphatemia, alopecia, diarrhoea, nail toxicity, fatigue, nausea, dysgeusia, stomatitis, constipation, dry mouth, dry eye, arthralgia, hypophosphatemia, dry skin and palmar-plantar erythrodysaesthesia syndrome.

    Prolonged hyperphosphatemia can cause precipitation of calcium-phosphate crystals that can lead to hypocalcemia, soft tissue mineralization, anemia, secondary hyperparathyroidism, muscle cramps, seizure activity, QT interval prolongation and arrhythmias. Soft tissue mineralization, including cutaneous calcification and calcinosis, have been observed with Pemazyre treatment. Recommendations for management of hyperphosphatemia include dietary phosphate restriction, administration of phosphate-lowering therapy and dose modification when required.

    Pemazyre can cause serous retinal detachment reactions, which may present with symptoms such as blurred vision, visual floaters or photopsia. Ophthalmological examination, including optical coherence tomography (OCT) should be performed prior to initiation of therapy and every 2 months for the first 6 months of treatment, every 3 months afterwards, and urgently at any time for visual symptoms. For serous retinal detachment reactions, the dose modification guidelines should be followed.

    Pemazyre should not be used during pregnancy unless the clinical condition of the women requires treatment with Pemazyre. Patients with cancer cells that have spread into the brain or spinal cord should notify their physician before initiating treatment with Pemazyre.

    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 whether or when Pemazyre might provide a successful treatment option for patients with locally advanced or metastatic cholangiocarcinoma, and the FIGHT clinical trial 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 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 and development and discovery operations; determinations made by European regulatory authorities or other regulatory authorities; 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-K for the quarter ending December 31, 2021. The Company disclaims any intent or obligation to update these forward-looking statements.



    _________________

    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 Kirstein MM, Vogel A. Visc Med 2016; 32: 395-400.

    4 Countries factored include: UK, Germany, France, Spain, Italy, Switzerland, Denmark, Finland, Poland and Austria

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

    6 Ang C. J. Gastroenterol Hepatol. 2015;30:1116‒1122.

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

    8 Pemazyre(pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

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  4. Incyte (NASDAQ:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy.

    "The MHLW approval of Pemazyre is an important milestone for the BTC community, and underscores our commitment to finding and delivering solutions for patients with significant unmet medical needs," said Lothar Finke, M.D., Ph.D., General Manager, Incyte Asia. "BTC is a rare and serious condition, and we are proud that with the support of the MHLW we will be able to…

    Incyte (NASDAQ:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Pemazyre® (pemigatinib), a selective fibroblast growth factor receptor (FGFR) inhibitor, for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene1, worsening after cancer chemotherapy.

    "The MHLW approval of Pemazyre is an important milestone for the BTC community, and underscores our commitment to finding and delivering solutions for patients with significant unmet medical needs," said Lothar Finke, M.D., Ph.D., General Manager, Incyte Asia. "BTC is a rare and serious condition, and we are proud that with the support of the MHLW we will be able to bring a new targeted treatment to more patients around the world."

    BTC is a rare cancer that forms in the bile duct. Cholangiocarcinoma, a subtype of BTC, is classified based on its origin: intrahepatic, which occurs in the bile duct inside the liver and extrahepatic, which occurs in the bile duct outside the liver. Patients with BTC are often diagnosed at a late or advanced stage when the prognosis is poor2,3. FGFR2 fusions or rearrangements, which occur almost exclusively in intrahepatic cholangiocarcinoma, are observed in a small percentage of Japanese patients with BTC4,5,6,7.

    The approval is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. In FIGHT-202 patients harboring FGFR2 fusions or rearrangements (Cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% (primary endpoint), and median DOR of 7.49 months (secondary endpoint). The most frequent treatment-emergent adverse event (TEAE) were grade ≤2 hyperphosphatemia (58.2%). Other frequent TEAEs (all grades) observed in ≥30% of patients were alopecia, diarrhea, fatigue, dysgeusia, nausea, constipation, stomatitis, dry mouth and decreased appetite. The majority of these TEAEs were grade ≤2. The TEAE with grade ≥3 that occurred in ≥10% of patients was hypophosphatemia.

    Previously, the MHLW granted Orphan Drug Designation for Pemazyre – a designation granted to investigational compounds intended to treat rare diseases that affect fewer than 50,000 people in Japan, and for which there is a high medical need8. Designated orphan drugs are eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity8.

    About FIGHT-202

    The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating the safety and efficacy of pemigatinib – a selective fibroblast growth factor receptor (FGFR) 1, 2, 3 inhibitor – in adult (age ≥ 18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status.

    Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic 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 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

    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 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 fusions/rearrangements, irrespective of tumor type.

    FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

    About Pemazyre® (pemigatinib)

    Pemazyre is a kinase inhibitor indicated in the United States 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 test9. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer (BTC) with a fibroblast growth factor receptor 2 (FGFR2) fusion gene, worsening after cancer chemotherapy.

    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 and will be marketed by Incyte in Japan. 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, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.

    Pemazyre is a trademark of Incyte Corporation.

    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.

    For more information on Incyte Biosciences Japan G.K., please visit Incyte.jp.

    Forward-Looking Statements

    Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding whether and/or when Pemazyre might provide a treatment option for patients with FGFR2 fusion positive locally advanced or metastatic cholangiocarcinoma, and further development of pemigatinib, 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 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 and development and discovery operations; determinations made by the FDA, EMA, PMDA or MHLW and other regulatory authorities; 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-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    Disclaimer

    The drug information contained herein is intended for the disclosure of Incyte corporate information and is not intended to advertise or promote any medicinal product, including those under development.


    1 In the approved Japanese indication, "fusion gene" includes both fusion genes and rearrangements.

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

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

    4 Liver Cancer White Paper 2015. Japan Society of Hepatology.

    5 Nakamura H, et al. Nat Genet. 2015;47:1003‒1010.

    6 Jang H, et al. J Gastroenterol. 2020;26:6207–6223.

    7 Japan Liver Cancer Study Group Follow-Up Survey Committee. The 20th National Primary Liver Cancer Follow-up Report (2008-2009). Liver. 2019;60: 258-293.

    8 Overview of Orphan Drug/Medical Device Designation System. Ministry of Health, Labour and Welfare. Available at: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000068484.html.

    9 Pemazyre(pemigatinib) [Package Insert]. Wilmington, DE: Incyte; 2020.

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  5. - Improvement in mortality for each dose compared to placebo, while trending toward positive, was not statistically significant for the overall study population

    - Significant improvement in mortality seen in U.S. study participants at both doses, and in the overall population when data from both treatment arms was pooled

    - Expanded Access Program to allow eligible patients in the United States with COVID-19 associated ARDS to receive ruxolitinib will be discussed with the U.S. Food and Drug Administration

    Incyte (NASDAQ:INCY) today announced results from the Phase 3 DEVENT study evaluating the efficacy and safety of ruxolitinib (5mg and 15mg) plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated…

    - Improvement in mortality for each dose compared to placebo, while trending toward positive, was not statistically significant for the overall study population

    - Significant improvement in mortality seen in U.S. study participants at both doses, and in the overall population when data from both treatment arms was pooled

    - Expanded Access Program to allow eligible patients in the United States with COVID-19 associated ARDS to receive ruxolitinib will be discussed with the U.S. Food and Drug Administration

    Incyte (NASDAQ:INCY) today announced results from the Phase 3 DEVENT study evaluating the efficacy and safety of ruxolitinib (5mg and 15mg) plus standard of care (SoC) versus SoC in patients on mechanical ventilation with COVID-19 associated Acute Respiratory Distress Syndrome (ARDS), a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs.

    While results indicate a trend towards an improvement in mortality in the overall study population (N=211), the DEVENT study did not meet its primary endpoint—mortality due to any cause through day 29—adjusted for ARDS severity between the two treatment arms versus placebo (55.2% vs. 74.3% [Odds Ratio (OR): 0.42 (95% CI: 0.171-1.023)], P=0.0280 in the 5mg arm and 51.8% vs. 69.6% [OR: 0.46 (95% CI: 0.201-1.028)], P=0.0292 in the 15mg arm). In the U.S. study population (N=191), which accounts for the majority (91%) of the DEVENT study patients, there was a clinically and statistically significant improvement in mortality in each of the 5mg (46.7% vs. 69.1% [OR: 0.39 (95% CI: 0.157-0.948)], P=0.0189) and 15mg treatment arms (47.1% vs. 66.7% [OR: 0.43 (95% CI: 0.188-0.974)], P=0.0215) versus placebo, respectively. Additionally, a post-hoc analysis of the overall study population pooling both the 5mg and 15mg ruxolitinib arms together versus placebo, showed a statistically significant improvement in mortality (53.6% vs. 70.7% [OR: 0.47 (95% CI: 0.219-0.996)], P=0.0244). More than half of study patients (55%) received remdesivir and 90% of study patients received corticosteroids prior to or during the study.

    The safety profile was generally consistent with hospitalized patients with COVID-19 and consistent with treatment with ruxolitinib. The most common adverse events on the ruxolitinib arms, regardless of dose, compared to placebo were anemia (20.7% vs. 22.2%), increased alanine aminotransferase (ALT, 14.6% vs. 13.3%), increased aspartate transaminase (AST, 14.0% vs. 8.9%) and hypertension (11.6% vs. 11.1%), respectively.

    "There remains a significant unmet medical need for treatments that may potentially improve survival outcomes for patients suffering from severe COVID-19 related complications, specifically those requiring mechanical ventilation," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We hope the results of this study, and the potential utility of ruxolitinib for treatment of patients with severe COVID-19 associated ARDS, will contribute to the advances being made across the scientific community to alleviate the burden this pandemic has placed on patients, as well as the healthcare system. We look forward to discussing the results of the DEVENT study with regulatory authorities in the United States."

    Given the urgent nature of the COVID-19 pandemic, Incyte plans to make ruxolitinib available to eligible patients in the United States at no cost via an Expanded Access Program (EAP) pending agreement with the U.S. Food and Drug Administration. The protocol will allow eligible patients with severe COVID-19 associated ARDS with disease severity requiring mechanical ventilation to receive ruxolitinib.

    At present, there is ample commercial and clinical supply of ruxolitinib in the United States to meet the needs of U.S. patients receiving ruxolitinib in its approved indications and those participating in clinical trials or the COVID-19 EAP.

    For more information about Incyte's response to COVID-19, including information on the DEVENT study and EAP, visit: Incyte.com/COVID-19.

    About DEVENT (NCT04377620)

    A Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trial, the DEVENT study evaluated the efficacy and safety of ruxolitinib 5mg and 15mg plus standard of care (SoC) compared to SoC plus placebo in patients with COVID-19 associated acute respiratory distress syndrome (ARDS) on mechanical ventilation. At initiation, the study aimed to enroll 500 patients; in December 2020, enrollment was stopped and the final analysis was conducted at the time of the planned interim analysis.

    The primary endpoint of the study evaluated the mortality rate at day 29 of ruxolitinib 5mg twice daily (BID) plus SoC therapy and ruxolitinib 15mg BID plus SoC compared with placebo plus SoC, in participants with COVID-19 associated ARDS who required mechanical ventilation. Secondary outcomes measures included number of days patients were ventilator free, did not receive supplemental oxygen, did not use vasopressor therapy, as well as the number of days patients were out of the hospital, clinical status at Day 15 and 29 using the COVID-19 ordinal scale, change in organ function or rate of failure (as measured by Sequential Organ Failure Assessment or SOFA Score) and safety.

    For more information about DEVENT, please visit: https://www.clinicaltrials.gov/ct2/show/NCT04377620.

    About the Ruxolitinib Expanded Access Program (EAP) in COVID-19

    The ruxolitinib Expanded Access Program (EAP) in COVID-19 will provide eligible patients with severe COVID-19 associated ARDS to receive ruxolitinib at no cost.

    For more information, please visit Incyte.com/COVID-19. Questions or inquiries regarding the EAP or independent research should be made to:

    U.S. Medical Information

    1-855-4MED-INFO (1-855-463-3463)

    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 the Company's ongoing clinical development program for ruxolitinib in patients with COVID-19, the enrollment, design, timing, efficacy and results of the DEVENT clinical trial program or any EAP study, whether ruxolitinib will become an approved or effective treatment option for any patients with COVID-19 infection, and whether commercial and clinical supply of ruxolitinib in the U.S. will continue to be sufficient to meet the current needs, 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: developments relating to the COVID-19 pandemic in the U.S. and around the world; 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 other regulators; 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-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

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  6. Incyte (NASDAQ:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during Week 1 of the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, held virtually from April 10-15, 2021.

    "At AACR 2021, we look forward to sharing clinical and pre-clinical data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody—both of which highlight our ongoing efforts targeting the adenosine pathway. Presentations at the congress will also feature updated data from our LIMBER development program, including results from our Phase 2 combination study of ruxolitinib, a janus kinase (JAK1/JAK2) inhibitor, and parsaclisib, a potent…

    Incyte (NASDAQ:INCY) today announced that multiple abstracts from across its oncology portfolio will be presented during Week 1 of the upcoming American Association for Cancer Research (AACR) Annual Meeting 2021, held virtually from April 10-15, 2021.

    "At AACR 2021, we look forward to sharing clinical and pre-clinical data from INCB106385, our novel A2A/A2B adenosine receptor antagonist, and INCA00186, our novel CD73 monoclonal antibody—both of which highlight our ongoing efforts targeting the adenosine pathway. Presentations at the congress will also feature updated data from our LIMBER development program, including results from our Phase 2 combination study of ruxolitinib, a janus kinase (JAK1/JAK2) inhibitor, and parsaclisib, a potent, highly selective oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ)," said Steven Stein, M.D., Chief Medical Officer, Incyte, adding, "We further look forward to sharing clinical and pre-clinical data on these and other targeted and immuno-oncology therapies in the Incyte portfolio."

    Key abstracts from Incyte-sponsored and partner programs include:

    Targeted Therapy

    Addition of Parsaclisib (INCB050465), a PI3Kδ Inhibitor, in Patients with Suboptimal Response to Ruxolitinib: A Phase 2 Study in Patients with Myelofibrosis (Abstract #CT162, Session: Phase II Clinical Trials.)

    The LSD1 Inhibitor INCB059872 is a Possible Therapeutic Option for Venetoclax-Resistant AML (Abstract #1134, Session: Epigenetic Targets.)

    Accurate Detection of MET Exon 14 Skipping Using Liquid Biopsy Assay in NSCLC Patients in the GEOMETRY Mono-1 Study1 (Abstract # LB056, Session: Liquid Biopsies: Circulating DNA.)

    Immuno-Oncology

    Discovery and Preclinical Characterization of INCB106385, a Novel A2A/A2B Adenosine Receptor Antagonist, as a Cancer Immunotherapy (Abstract #LB157, Session: Immune Checkpoints.)

    Discovery and Preclinical Characterization of INCA00186, a Humanized Monoclonal Antibody Antagonist of CD73, as a Cancer Immunotherapy (Abstract #LB174, Session: Therapeutic Antibodies, Including Engineered Antibodies.)

    All presentation sessions will be available on demand beginning April 10, 2021 at 8:30 a.m. ET, through June 21, 2021. Full session details and listings for oral and e-poster presentations are available online via the AACR 2021 program: https://www.abstractsonline.com/pp8/#!/9325.

    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 or partner company's ongoing clinical development pipeline, and whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, its presentation plans for the upcoming AACR meeting and its goal of improving the lives of patients, 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 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, and development and discovery operations; determinations made by the FDA and other regulatory authorities outside of the United States; [the Company's dependence on its relationships with its collaboration partners;] and other risks detailed from time to time in the Company's reports filed with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

    1 Novartis-sponsored abstract.

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  7. INDIANAPOLIS, March 3, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification…

    INDIANAPOLIS, March 3, 2021 /PRNewswire/ -- Eli Lilly and Company (NYSE:LLY) and Incyte (NASDAQ:INCY) announced today top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata (AA). Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of AA. This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint(s). There are currently no FDA-approved treatments for AA.

    "These positive results are very promising and suggest that baricitinib has the potential to address the urgent needs of people living with alopecia areata," said Brett King, M.D., Ph.D., associate professor of Dermatology at Yale School of Medicine. "This level of high-quality research is needed to advance our understanding and the treatment of this frequently devastating disease."

    This multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool (SALT) score ≥ 50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S.

    Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis (RA) and atopic dermatitis (AD). No deaths, major adverse cardiovascular events (MACE) or venous thromboembolic events (VTEs) were reported in the study.

    BRAVE-AA2 is the first Phase 3 study with positive results in patients with AA. Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after AD.

    "For patients who suffer from alopecia areata, it is not a cosmetic condition, it is a devastating autoimmune disease that can have significant psychological effects. They lose much more than just hair," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We are looking forward to sharing the totality of data from the overall clinical development program for baricitinib as a potential first-in-disease treatment for alopecia areata."

    "Significant unmet need exists in the treatment of alopecia areata," said Abby Ellison, research director at the National Alopecia Areata Foundation (NAAF). "We appreciate Lilly's important work in this area and are excited that these data could bring us closer to a potential new treatment option for patients."

    Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It 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 active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. Baricitinib is also being investigated in systematic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA) and COVID-19.

    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: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    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.

    VACCINATIONS: Avoid 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. 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 and Japan 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 Alopecia Areata

    Alopecia Areata (AA) is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. 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 rheumatoid arthritis and atopic dermatitis and as a potential treatment for patients with alopecia areata and other conditions and reflects Lilly's and Incyte's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of research, development, and commercialization. Among other things, there can be no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with the results to date, that OLUMIANT will receive additional regulatory approvals or 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 Basu; ; +1-317-447-2199 (Lilly media)



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



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



    Christine Chiou; ; +1-302-274-4773 (Incyte investors)

     

    Incyte logo. (PRNewsfoto/Eli Lilly and Company)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/baricitinib-is-first-jak-inhibitor-to-demonstrate-hair-regrowth-in-phase-3-alopecia-areata-aa-trial-301239291.html

    SOURCE Eli Lilly and Company; Incyte

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  8. Incyte (NASDAQ:INCY) today announced the validation of the Company's Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency's (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

    "While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group…

    Incyte (NASDAQ:INCY) today announced the validation of the Company's Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency's (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.

    "While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy," said Lance Leopold, M.D., Group Vice President, Immuno-Oncology Clinical Development, Incyte. "The EMA validation of the MAA for retifanlimab – which follows the recent U.S. Food & Drug Administration acceptance of our Biologics License Application for Priority Review – brings us closer to providing a new option for patients in Europe with this rarely studied tumor."

    The MAA 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 which were presented at the 2020 virtual ESMO Congress.

    SCAC is associated with human papillomavirus (HPV) and HIV infections and accounts for almost 3% of digestive system cancers.1 In Europe, each year approximately 12,000 patients receive SCAC diagnosis.2 Patients with metastatic SCAC have a poor 5-year survival and there are no approved treatments for patients who progress on platinum therapy.3

    About POD1UM-202

    POD1UM-202 (NCT03597295) is a global, open-label, single-arm, multicenter, Phase 2 study evaluating retifanlimab in patients with squamous cell anal carcinoma (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 Inhibitor Clinical Program in Multiple Malignancies) clinical trial program for retifanlimab includes POD1UM-202, POD1UM-303 in SCAC along with and benchmarking studies in endometrial cancer, Merkel cell carcinoma and other solid tumors. A Phase 3 trial in NSCLC (POD1UM-304) is also enrolling, as are studies in combination with epacadostat, pemigatinib, and other development compounds in the Incyte portfolio.

    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 anal carcinoma (SCAC); and in combination with platinum-based chemotherapy for patients with non-small cell lung cancer.

    Retifanlimab has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of anal cancer, and the Biologics License Application for retifanlimab has been accepted for Priority Review.

    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 EMA may authorize retifanlimab for the treatment of patients with squamous cell anal carcinoma (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 European 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-K for the year ending December 31, 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 Globocan

    3 Glynne-Jones R, et al. Ann Oncol. 2014;25(suppl 3):iii10–iii20.

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  9. Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

    The sNDA submission is based on results from the Phase 3, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT…

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for ruxolitinib (Jakafi®) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

    The sNDA submission is based on results from the Phase 3, randomized REACH3 study comparing ruxolitinib with best available therapy (BAT) in patients with steroid-refractory chronic GVHD. In the REACH3 study, which was recently presented at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, patients treated with ruxolitinib experienced a significantly greater overall response rate (ORR) compared to BAT at Week 24, the primary endpoint (49.7% vs. 25.6%; p<0.0001). For the key secondary endpoints, ruxolitinib was associated with a longer median failure-free survival (FFS) than BAT at Week 24 (not reached vs. 5.7 months; hazard ratio (HR), 0.370; p<0.0001), and greater symptom improvement per the modified Lee Symptom Scale (mLSS) at Week 24 (24.2% vs. 11.0%; odds ratio (OR), 2.62; p=0.0011). The best ORR for patients receiving ruxolitinib was 76.4%. No new safety signals were observed, and adverse events were consistent with the known safety profile of ruxolitinib.

    "Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte. "The acceptance of this sNDA represents an important milestone for Incyte as we continue our work towards helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States."

    GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor) in which 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 generally occurs within 100 days of transplant, and chronic, which generally occurs after 100 days of transplant1. Both forms can affect multiple organ systems, including the skin, gastrointestinal (digestive) tract and liver.

    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 to six months compared to 10 months for Standard Review. The Prescription Drug User Fee Act (PDUFA) target action date for Jakafi in steroid-refractory chronic GVHD is June 22, 2021.

    The sNDA is also being reviewed as part of the Project Orbis program, an initiative of the U.S. FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among international regulatory agencies. Participating countries for this application include Canada, Australia, Switzerland, Brazil and the United Kingdom.

    In 2019, Jakafi 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 older2.

    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 Week 24 (i.e., Cycle 7, Day 1), defined as the percentage of participants demonstrating a complete or partial response. Key secondary endpoints include failure-free survival (FFS) and change in the modified Lee Symptom Scale (mLSS) score at Week 24. Other secondary endpoints include best overall response (BOR), duration of response (DoR), overall survival (OS), and safety. 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, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults, 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 the Company's ongoing clinical development program for ruxolitinib, the REACH program and the Company's GVHD program generally, and whether and when ruxolitinib will be approved for use in the U.S. or elsewhere for steroid-refractory chronic GVHD or any other indication, 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 annual report on Form 10-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

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

    2 Jakafi (ruxolitinib) tablets: Prescribing Information. U.S. Food and Drug Administration; January 2020.

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  10. Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

    "Incyte's deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate…

    Incyte (NASDAQ:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application, as a treatment for atopic dermatitis (AD), a type of eczema.

    "Incyte's deep understanding of the pathways involved in immune-mediated skin conditions led us to investigate the potential for ruxolitinib cream to address key factors associated with atopic dermatitis, that is, inflammation of the skin and itch," said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation & Autoimmunity, Incyte. "We are grateful to the people living with atopic dermatitis whose participation in our clinical trials helped generate the evidence to support this regulatory submission, and we look forward to working with the FDA as we seek to bring forward a new topical treatment for people living with this chronic skin disease."

    The NDA is supported by data from the Phase 3 TRuE-AD clinical trial program, which included more than 1,200 people, age 12 years and older. Primary efficacy and safety results from both TRuE-AD trials were presented at the Revolutionizing Atopic Dermatitis Virtual Symposium in April 2020. Additional safety and efficacy data from the 44-week, open-label, long-term extension of both TRuE-AD1 and TRuE-AD2 were included in the NDA.

    Incyte submitted a priority review voucher (PRV) along with the NDA application for ruxolitinib cream. The use of the PRV shortens the review period by four months. The Prescription Drug User Fee Act (PDUFA) target action date is June 21, 2021.

    About Atopic Dermatitis

    Atopic dermatitis (AD) is a chronic skin disease, affecting more than 21 million people in the United States and is characterized by inflammation and intense itch. 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.

    TRuE-AD results presented at the 29th European Academy of Dermatology and Venereology (EADV) Congress in October 2020 examined sleep quality, sleep depth and restoration associated with sleep, key quality of life measures for people with AD.

    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 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 regarding the Company's ongoing clinical development program for ruxolitinib cream as well as its dermatology program generally, and whether and when ruxolitinib cream will be approved for use in the U.S. or elsewhere for atopic dermatitis or any other indication, 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-K for the year ended December 31, 2020. The Company disclaims any intent or obligation to update these forward-looking statements.

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  11. Incyte (NASDAQ:INCY) announced today that it will present at the virtual Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 2:00 p.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 virtual Cowen 41st Annual Health Care Conference on Wednesday, March 3, 2021 at 2:00 p.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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  12. - Total FY revenues of $2.67 billion (+24% y/y); total FY product and royalty revenues increased 18% to $2.46 billion; three new FDA approvals in 2020

    - Jakafi®(ruxolitinib) FY revenue increased to $1.94 billion (+15% y/y); Jakafi® guidance range of $2.125 to $2.20 billion for 2021

    - Successful launches of Monjuvi®(tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.

    - Opportunities for additional growth provided by broad late-stage pipeline, with the potential approval of ruxolitinib cream for atopic dermatitis in the U.S. and six other regulatory approval decisions expected across the U.S., EU and Japan during 2021

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

    Incyte (NASDAQ:INCY) today reports 2020 fourth quarter…

    - Total FY revenues of $2.67 billion (+24% y/y); total FY product and royalty revenues increased 18% to $2.46 billion; three new FDA approvals in 2020

    - Jakafi®(ruxolitinib) FY revenue increased to $1.94 billion (+15% y/y); Jakafi® guidance range of $2.125 to $2.20 billion for 2021

    - Successful launches of Monjuvi®(tafasitamab-cxix) and Pemazyre® (pemigatinib) in the U.S.

    - Opportunities for additional growth provided by broad late-stage pipeline, with the potential approval of ruxolitinib cream for atopic dermatitis in the U.S. and six other regulatory approval decisions expected across the U.S., EU and Japan during 2021

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

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

    "Our team achieved many important accomplishments in the past year. Revenue growth was strong, driven by demand for Jakafi® (ruxolitinib), and the launches of Monjuvi® (tafasitamab-cxix) and Pemazyre® (pemigatinib) continue to gain momentum. During 2020, we also announced positive results across multiple late-stage programs, including the pivotal trials of ruxolitinib in chronic GVHD, ruxolitinib cream in atopic dermatitis, parsaclisib in NHL, and retifanlimab in SCAC," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "During 2021, we expect regulatory decisions on seven applications seeking approval, including four in the U.S, two in Europe and one in Japan, and we are working towards the potential U.S. launch of ruxolitinib cream, which we expect to be approved by the FDA in the middle of the year."

    Portfolio Updates

    MPNs and GVHD – key highlights

    Our LIMBER development program, to improve patient outcomes in MPNs and GHVD, is progressing well.

    The two Phase 3 trials of ruxolitinib in combination with parsaclisib are both underway, evaluating the combination versus monotherapy ruxolitinib as a first-line therapy for patients with myelofibrosis (MF) (LIMBER-313) and as a therapy for MF patients with a suboptimal response to ruxolitinib monotherapy (LIMBER-304).

    Monotherapy trials of INCB57643 (BET) and INCB00928 (ALK2) are underway, and are expected to lead to proof-of-concept combination trials of both agents with ruxolitinib in patients with myelofibrosis. A monotherapy trial of itacitinib (JAK1) in patients previously treated with ruxolitinib is ongoing.

    In December 2020, Incyte and Cellenkos announced a development collaboration to investigate the combination of ruxolitinib and CK0804, Cellenkos' cryopreserved CXCR4 enriched, allogeneic, umbilical cord blood-derived T-regulatory cells, in patients with myelofibrosis. In addition, Incyte obtained an exclusive option to acquire sole rights to develop and commercialize CK0804, and genetically-modified variants of CK0804, in benign and malignant hematology indications.

    The sNDA seeking approval of Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) has been submitted, based on data from the successful results of the REACH3 trial, which were presented at ASH 2020.

    Indication and status

     

    Once-a-day ruxolitinib

    (JAK1/JAK2)

    Myelofibrosis, polycythemia vera & GVHD: clinical pharmacology studies

    ruxolitinib + parsaclisib

    (JAK1/JAK2 + PI3Kδ)

    Myelofibrosis: Phase 3 (first-line therapy) (LIMBER-313)

    Myelofibrosis: Phase 3 (suboptimal responders to ruxolitinib) (LIMBER-304)

     

    ruxolitinib + INCB57643

    (JAK1/JAK2 + BET)

    Myelofibrosis: Phase 2 in preparation

    ruxolitinib + INCB00928

    (JAK1/JAK2 + ALK2)

    Myelofibrosis: Phase 2 in preparation

    itacitinib

    (JAK1)

    Myelofibrosis: Phase 2 (low platelets)

    ruxolitinib + CK08041

    (JAK1/JAK2 + CB-Tregs)

    Myelofibrosis: PoC in preparation

    ruxolitinib

    (JAK1/JAK2)

    Steroid-refractory chronic GVHD2: sNDA submitted

     

    itacitinib

    (JAK1)

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

     

    1. Development collaboration with Cellenkos
    2. Clinical development of ruxolitinib in GVHD conducted in collaboration with Novartis

    Other Hematology/Oncology – key highlights

    Momentum is strong behind the U.S. launch of Monjuvi (tafasitamab-cxix), with good uptake in both academic and community settings and illustrated by the market share gained in the first several months since launch.

    The Phase 3 inMIND trial evaluating tafasitamab plus lenalidomide and rituximab (R-squared) versus R-squared in patients with relapsed or refractory follicular or marginal zone lymphoma is open for recruitment, and the Phase 3 frontMIND trial of tafasitamab plus lenalidomide and R-CHOP versus R-CHOP as a first-line treatment in patients with DLBCL is expected to open in the coming months.

    The U.S. launch of Pemazyre (pemigatinib) has been successful and, in January, Incyte announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement that is relapsed or refractory, after at least one line of systemic therapy.

    In December 2020, data from three ongoing Phase 2 studies evaluating parsaclisib for the treatment of patients with relapsed or refractory follicular (CITADEL-203), marginal zone (CITADEL-204) and mantle cell (CITADEL-205) lymphomas were presented at ASH 2020. Data from the CITADEL program are expected to form the basis of an NDA seeking FDA approval of parsaclisib, which is expected to be submitted in the second half of 2021.

    In January 2021, Incyte announced that the FDA had accepted for Priority Review its Biologics License Application (BLA) for retifanlimab as a treatment for previously treated patients with advanced squamous cell anal carcinoma (SCAC) who have progressed following standard platinum-based chemotherapy. The BLA submission was based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with advanced SCAC who have progressed following standard platinum-based chemotherapy; the Phase 3 POD1UM-303 trial in patients with SCAC is underway.

     

    Indication and status

     

    pemigatinib

    (FGFR1/2/3)

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

    8p11 MPN: Phase 2 (FIGHT-203)

    Tumor agnostic: Phase 2 (FIGHT-207)

     

    tafasitamab

    (CD19)1

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

    1L DLBCL: Phase 1b (firstMIND); Phase 3 (frontMIND) in preparation

    r/r FL and r/r MZL: Phase 3 (inMIND) open for recruitment

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

    r/r B-cell malignancies: PoC with lenalidomide and plamotamab in preparation2

     

    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

    SCAC: Phase 2 (POD1UM-202); Phase 3 (POD1UM-303); BLA under review

    MSI-high endometrial cancer: Phase 2 (POD1UM-101, POD1UM-204)

    Merkel cell carcinoma: Phase 2 (POD1UM-201)

    NSCLC: Phase 3 (POD1UM-304)

     

    CCA = cholangiocarcinoma; DLBCL = diffuse large B-cell lymphoma; SCAC = squamous cell anal carcinoma; FL = follicular lymphoma; MZL = marginal zone lymphoma

    1. Development of tafasitamab in collaboration with MorphoSys
    2. Clinical collaboration with MorphoSys and Xencor, Inc. to investigate the combination of tafasitamab plus lenalidomide in combination with Xencor's CD20xCD3 XmAb bispecific antibody, plamotamab.
    3. retifanlimab licensed from MacroGenics

    Incyte's emerging clinical candidates in hematology/oncology include INCB86550, the first in a series of selective oral inhibitors of PD-L1; INCB81776, a dual AXL/MER inhibitor; INCB106385, an adenosine (A2A/A2B) inhibitor and, via a collaboration with Merus, MCLA-145, a PD-L1xCD137 bispecific antibody.

    Inflammation and Autoimmunity (IAI) – key highlights

    Dermatology

    As planned, the NDA seeking approval of ruxolitinib cream as a treatment for patients with atopic dermatitis was submitted to the FDA late in the fourth quarter of 2020, including use of the previously acquired priority review voucher (PRV). The use of the PRV is expected to accelerate the time to an FDA decision.

    Recruitment has been completed in both Phase 3 trials in the TRuE-V development program evaluating ruxolitinib cream as a treatment for patients with vitiligo, and topline results are expected to be announced in the first half of 2021. If successful, data from TRuE-V are expected to form the basis of an sNDA seeking approval of ruxolitinib cream as a treatment for patients with vitiligo, which would be submitted as soon as practicable after the FDA decision on the atopic dermatitis NDA.

     

    Indication and status

     

    ruxolitinib cream

    (JAK1/JAK2)

    Atopic dermatitis: NDA submitted

    Vitiligo: Phase 3 (TRuE-V1, TRuE-V2; recruitment complete in both trials)

    INCB54707

    (JAK1)

    Hidradenitis suppurativa: Phase 2b

     

    parsaclisib

    (PI3Kδ)

    Autoimmune hemolytic anemia: Phase 2

     

    INCB00928

    (ALK2)

    Fibrodysplasia ossificans progressiva: Phase 2 in preparation

    Partnered – key highlights

    In December 2020, Incyte and Lilly announced that Olumiant had been approved in Japan as a treatment of patients with atopic dermatitis who have inadequate response to conventional therapies.

     

    Indication and status

     

    baricitinib

    (JAK1/JAK2)1

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

    Systemic lupus erythematosus: Phase 3 (BRAVE I, BRAVE II)

    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; approved as Olumiant in EU and Japan for certain patients with atopic dermatitis
    2. Worldwide rights to capmatinib licensed to Novartis

    Potential therapies for patients with COVID-19

    In November 2020, Incyte and Lilly announced 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.

    In December 2020, the New England Journal of Medicine 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 supported the EUA issued by the FDA.

    Status

    ruxolitinib

    (JAK1/JAK2)

    COVID-19 associated cytokine storm: Phase 3 (369-DEVENT)

     

    baricitinib

    (JAK1/JAK2)1

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

     

    1. 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 and Japan for certain patients with atopic dermatitis

    2020 Fourth Quarter and Year-End Financial Results

    The financial measures presented in this press release for the quarter and year ended December 31, 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

    Twelve Months Ended

    December 31,

    December 31,

     

    2020

     

     

    2019

     

    2020

     

     

    2019

    Total GAAP revenue

    $

    789,509

    $

    579,389

    $

    2,666,702

     

    $

    2,158,759

     

    Total GAAP operating income (loss)

     

    164,229

     

    95,008

     

    (263,676

    )

     

    402,006

    Total Non-GAAP operating income (loss)

     

    218,469

     

    145,538

     

    (40,878

    )

     

    609,812

    GAAP net income (loss)

     

    149,850

     

    111,005

     

    (295,697

    )

     

    446,906

    Non-GAAP net income (loss)

     

    204,773

     

    141,936

     

    (90,510

    )

     

    615,459

     

    GAAP basic EPS

    $

    0.68

    $

    0.51

    $

    (1.36

    )

    $

    2.08

    Non-GAAP basic EPS

    $

    0.93

    $

    0.66

    $

    (0.42

    )

    $

    2.86

    GAAP diluted EPS

    $

    0.68

    $

    0.51

    $

    (1.36

    )

    $

    2.05

    Non-GAAP diluted EPS

    $

    0.93

    $

    0.65

    $

    (0.42

    )

    $

    2.83

    Revenue Details

    Revenue Details

    (unaudited, in thousands)

     

    Three Months Ended

    Twelve Months Ended

    December 31,

    %

    December 31,

    %

     

    2020

     

     

    2019

    Change

     

    2020

     

    2019

    Change

    Revenues:

    Jakafi net product revenues

    $

    516,882

    $

    466,464

    11%

    $

    1,937,850

    $

    1,684,968

    15%

    Iclusig net product revenues

     

    28,576

     

    24,314

    18%

     

    105,002

     

    89,954

    17%

    Pemazyre net product revenues

     

    14,009

     

    -

    NM

     

    25,884

     

    -

    NM

    Jakavi product royalty revenues

     

    87,046

     

    65,007

    34%

     

    277,902

     

    225,913

    23%

    Olumiant product royalty revenues

     

    30,996

     

    23,604

    31%

     

    110,920

     

    80,424

    38%

    Tabrecta product royalty revenues

     

    2,000

     

    -

    NM

     

    4,144

     

    -

    NM

    Product and royalty revenues

     

    679,509

     

    579,389

    17%

     

    2,461,702

     

    2,081,259

    18%

    Milestone and contract revenues

     

    110,000

     

    -

    NM

     

    205,000

     

    77,500

    NM

    Total GAAP revenues

    $

    789,509

    $

    579,389

    36%

    $

    2,666,702

    $

    2,158,759

    24%

    NM = not meaningful

    Product and Royalty Revenues Product and royalty revenues for the quarter and year ended December 31, 2020 increased 17% and 18%, 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 quarter and year ended December 31, 2020 increased 11% and 15%, 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

    Twelve Months Ended

    December 31,

    %

    December 31,

    %

     

    2020

     

    2019

    Change

     

    2020

     

    2019

    Change

    GAAP cost of product revenues

    $

    36,323

    $

    32,215

    13%

    $

    131,328

    $

    114,249

    15%

    Non-GAAP cost of product revenues1

     

    30,693

     

    26,658

    15%

     

    108,830

     

    92,015

    18%

     

    GAAP research and development

     

    405,945

     

    312,867

    30%

     

    2,215,942

     

    1,154,111

    92%

    Non-GAAP research and development2

     

    375,770

     

    284,389

    32%

     

    2,095,586

     

    1,040,169

    101%

     

    GAAP selling, general and administrative

     

    166,988

     

    136,177

    23%

     

    516,922

     

    468,711

    10%

    Non-GAAP selling, general and administrative3

     

    152,148

     

    122,804

    24%

     

    460,363

     

    416,763

    10%

     

    GAAP change in fair value of acquisition-related contingent consideration

     

    3,595

     

    3,122

    15%

     

    23,385

     

    19,682

    19%

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

     

    -

     

    -

     

    -

     

    -

     

    GAAP collaboration loss sharing

     

    12,429

     

    -

    NM

     

    42,801

     

    -

    NM

    Non-GAAP collaboration loss sharing

     

    12,429

     

    -

    NM

     

    42,801

     

    -

    NM

    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 quarter ended December 31, 2020 increased 30% and 32%, respectively, compared to the same period in 2019 primarily due to our 55% share of the global and U.S. specific development costs for tafasitamab, product supply related costs to support the potential launch of ruxolitinib cream as a treatment for atopic dermatitis in 2021 and an increase in upfront and milestone payments under our collaborative agreements. Excluding the $42 million impact of product supply costs and the upfront and milestone payments, research and development expense for the quarter ended December 31, 2020 increased approximately 17% compared to the same period in 2019.

    For the year ended December 31, 2020, GAAP and Non-GAAP research and development expense increased 92% and 101%, respectively, compared to the year ended December 31, 2019 primarily due to higher upfront and milestone payments under our collaborative agreements which includes upfront consideration of $805 million related to our collaborative agreement with MorphoSys, $120 million of expense related to the purchase of an FDA priority review voucher ("PRV") utilized to accelerate the FDA review of ruxolitinib cream in atopic dermatitis, our 55% share of the global and U.S. specific development costs for tafasitamab, and product supply costs to support the potential launch of ruxolitinib cream. Excluding the $1.02 billion impact of upfront consideration and milestone payments, purchase of the PRV and product supply related costs, research and development expense for the year ended December 31, 2020 increased approximately 4% compared with the prior year period.

    Selling, general and administrative expenses GAAP and Non-GAAP selling, general and administrative expenses for the quarter ended December 31, 2020 increased 23% and 24%, respectively, compared to the same period in 2019, primarily due to the timing of certain expenses. GAAP and Non-GAAP selling, general and administrative expenses for the year ended December 31, 2020 increased 10% compared to the year ended December 31, 2019 primarily due to an increase in sales and marketing spend to support the commercialization of Pemazyre in the US and to prepare for the potential launch of ruxolitinib cream in the U.S. and pemigatinib and tafasitamab in the EU.

    Other Financial Information

    Operating income (loss) GAAP and Non-GAAP operating income for the quarter ended December 31, 2020 increased compared to the same period in 2019, due to the growth in total revenues exceeding the growth in operating expenses. For the year ended December 31, 2020, Incyte 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 PRV, partially offset by the growth in product and royalty revenues.

    Cash, cash equivalents and marketable securities position As of December 31, 2020 and 2019, cash, cash equivalents and marketable securities totaled $1.8 billion and $2.1 billion, respectively. The decrease is primarily due to the upfront payment and stock purchase related to our collaborative agreement with MorphoSys and purchase of the PRV, partially offset by the cash flow generated in 2020.

    2021 Financial Guidance

    Due to the continuing growth and diversification of Incyte's commercial product portfolio, 2021 net product revenue guidance is being provided for Jakafi and in total for other Hematology/Oncology products, which currently include Iclusig in Europe and Pemazyre in the U.S. Guidance does not include revenue from any potential new product launches. However, GAAP and Non-GAAP selling, general and administrative expense guidance for 2021 includes costs to support the potential launches of ruxolitinib cream as a treatment for atopic dermatitis in the U.S., pemigatinib as a treatment for cholangiocarcinoma in the EU and Japan, and tafasitamab as a treatment for DLBCL in the EU. The 2021 financial guidance does not include the impact of any potential future strategic transactions.

    Jakafi net product revenues

     

    $2,125 - $2,200 million

    Other Hematology/Oncology net product revenues

    $145 - $160 million

    GAAP Cost of product revenues

     

    6 – 7% of net product revenues

    Non-GAAP Cost of product revenues(1)

     

    5 – 6% of net product revenues

    GAAP Research and development expenses

     

    $1,350 - $1,390 million

    Non-GAAP Research and development expenses(2)

     

    $1,220 - $1,250 million

    GAAP Selling, general and administrative expenses

    $735 - $775 million

    Non-GAAP Selling, general and administrative expenses(2)

     

    $665 - $700 million

    (1) Adjusted to exclude the amortization of licensed intellectual property for Iclusig relating to the acquisition of the European business of ARIAD Pharmaceuticals, Inc. and the estimated cost of stock-based compensation.

    (2) Adjusted to exclude the estimated cost of stock-based compensation.

    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, 13715042.

    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, 13715042.

    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). 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 Pemazyre® (pemigatinib)

    Pemazyre is a kinase inhibitor indicated in the United States 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

    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, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable 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 expectations for up to seven drug application approvals in 2021 in the U.S, Europe and Japan; the Company's ongoing clinical development program for ruxolitinib cream as well as its dermatology program generally; whether and when ruxolitinib cream will be approved in the U.S. or elsewhere for atopic dermatitis and the extent of our launch readiness; the expected timing of receipt and announcement of results for ruxolitinib cream for vitiligo; continued development of our LIMBER program, including expectations for, and timing and results of, ruxolitinib combination trials with parsaclisib; expectations for our monotherapy trials for INCB57643 (BET), and INCB00928 (ALK2); our collaboration with Cellenkos investigating the combination of ruxolitinib and CK0804; whether and when Jakafi will be approved in the U.S. or elsewhere for steroid-refractory chronic graft-versus-host disease (GVHD); whether and when the BLA for retifanlimab for SCAC will be approved; expectations for tafasitamab development, including the inMIND and frontMIND trials and plans to further broaden the development program of tafasitamab in other B-cell malignancies and clinical trial plans for such program; whether or when the European Commission will grant marketing authorization for pemigatinib in Europe; plans for ongoing and further development of parsaclisib in the CITADEL program and the planned timing of an NDA submission based on that program; and the expected timing of receipt and announcement of clinical trial results for INCB86550; and our financial guidance for 2021 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:; the actual time required by the FDA to review the Company's NDA for approval for ruxolitinib cream in atopic dermatitis, the Company's sNDA for Jakafi in steroid-refractory chronic graft-versus-host disease (GVHD) and the Company's BLA for retifanlimab in SCAC, and the results of such reviews; 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 September 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

    Twelve Months Ended

    December 31,

    December 31,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    GAAP

    GAAP

    Revenues:

    Product revenues, net

    $

    559,467

     

    $

    490,778

     

    $

    2,068,736

     

    $

    1,774,922

     

    Product royalty revenues

     

    120,042

     

     

    88,611

     

     

    392,966

     

     

    306,337

     

    Milestone and contract revenues

     

    110,000

     

     

    -

     

     

    205,000

     

     

    77,500

     

    Total revenues

     

    789,509

     

     

    579,389

     

     

    2,666,702

     

     

    2,158,759

     

     

    Costs and expenses:

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

     

    36,323

     

     

    32,215

     

     

    131,328

     

     

    114,249

     

    Research and development

     

    405,945

     

     

    312,867

     

     

    2,215,942

     

     

    1,154,111

     

    Selling, general and administrative

     

    166,988

     

     

    136,177

     

     

    516,922

     

     

    468,711

     

    Change in fair value of acquisition-related contingent consideration

     

    3,595

     

     

    3,122

     

     

    23,385

     

     

    19,682

     

    Collaboration loss sharing

     

    12,429

     

     

    -

     

     

    42,801

     

     

    -

     

    Total costs and expenses

     

    625,280

     

     

    484,381

     

     

    2,930,378

     

     

    1,756,753

     

     

    Income (loss) from operations

     

    164,229

     

     

    95,008

     

     

    (263,676

    )

     

    402,006

     

    Other income (expense), net

     

    4,810

     

     

    15,848

     

     

    23,206

     

     

    52,182

     

    Interest expense

     

    (428

    )

     

    (607

    )

     

    (2,174

    )

     

    (1,855

    )

    Unrealized gain (loss) on long term investments

     

    (509

    )

     

    15,755

     

     

    10,426

     

     

    34,458

     

    Income (loss) before provision for income taxes

     

    168,102

     

     

    126,004

     

     

    (232,218

    )

     

    486,791

     

    Provision for income taxes

     

    18,252

     

     

    14,999

     

     

    63,479

     

     

    39,885

     

    Net income (loss)

    $

    149,850

     

    $

    111,005

     

    $

    (295,697

    )

    $

    446,906

     

     

    Net income (loss) per share:

    Basic

    $

    0.68

     

    $

    0.51

     

    $

    (1.36

    )

    $

    2.08

     

    Diluted

    $

    0.68

     

    $

    0.51

     

    $

    (1.36

    )

    $

    2.05

     

     

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

    Basic

     

    219,239

     

     

    215,770

     

     

    218,073

     

     

    214,913

     

    Diluted

     

    221,228

     

     

    218,542

     

     

    218,073

     

     

    217,657

     

    INCYTE CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (unaudited, in thousands)

     

    December 31,

    December 31,

    2020

    2019

    ASSETS

    Cash, cash equivalents and marketable securities

    $

    1,801,377

    $

    2,117,554

    Accounts receivable

     

    481,994

     

    308,809

    Property and equipment, net

     

    559,625

     

    377,567

    Finance lease right-of-use assets, net

     

    28,451

     

    29,058

    Inventory

     

    35,973

     

    16,505

    Prepaid expenses and other assets

     

    103,313

     

    94,179

    Long term investments

     

    222,301

     

    133,657

    Other intangible assets, net

     

    172,291

     

    193,828

    Goodwill

     

    155,593

     

    155,593

    Total assets

    $

    3,560,918

    $

    3,426,750

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    Accounts payable, accrued expenses and other liabilities

    $

    648,793

    $

    500,462

    Finance lease liabilities

     

    34,857

     

    32,582

    Convertible senior notes

     

    -

     

    18,300

    Acquisition-related contingent consideration

     

    266,000

     

    277,000

    Stockholders' equity

     

    2,611,268

     

    2,598,406

    Total liabilities and stockholders' equity

    $

    3,560,918

    $

    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

    Twelve Months Ended

    December 31,

    December 31,

    2020

    2019

    2020

    2019

     

    GAAP Net Income (Loss)

    $

    149,850

    $

    111,005

     

    $

    (295,697

    )

    $

    446,906

     

    Adjustments1:

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

     

    30,175

     

    28,478

     

     

    120,356

     

     

    113,942

     

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

     

    14,840

     

    13,373

     

     

    56,559

     

     

    51,948

     

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

     

    246

     

    173

     

     

    962

     

     

    698

     

    Non-cash interest expense related to convertible notes3

     

    66

     

    221

     

     

    683

     

     

    867

     

    Changes in fair value of equity investments4

     

    509

     

    (15,755

    )

     

    (10,426

    )

     

    (34,458

    )

    Amortization of acquired product rights5

     

    5,384

     

    5,384

     

     

    21,536

     

     

    21,536

     

    Change in fair value of contingent consideration6

     

    3,595

     

    3,122

     

     

    23,385

     

     

    19,682

     

    Tax effect of Non-GAAP adjustments7

     

    108

     

    (4,065

    )

     

    (7,868

    )

     

    (5,662

    )

    Non-GAAP Net Income (Loss)

    $

    204,773

    $

    141,936

     

    $

    (90,510

    )

    $

    615,459

     

     

    Non-GAAP net income (loss) per share:

    Basic

    $

    0.93

    $

    0.66

     

    $

    (0.42

    )

    $

    2.86

     

    Diluted

    $

    0.93

    $

    0.65

     

    $

    (0.42

    )

    $

    2.83

     

     

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

    Basic

     

    219,239

     

    215,770

     

     

    218,073

     

     

    214,913

     

    Diluted

     

    221,228

     

    218,542

     

     

    218,073

     

     

    217,657

     

    1. Included within the Milestone and contract revenues line item in the Condensed Consolidated Statements of Operations (in thousands) for the three and twelve months ended December 31, 2020 are milestones of $110,000 and $205,000, respectively, earned from our collaborative partners as compared to upfront consideration and milestones of $0 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 twelve months ended December 31, 2020 are upfront consideration and milestones of $25,600 and $976,082, respectively, related to our collaborative partners and FDA priority review voucher as compared to $2,500 and $27,500, 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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  13. - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication

    Incyte (NASDAQ:INCY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable 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.

    "The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying…

    - If approved, pemigatinib will be the first targeted therapy indicated in the EU for this indication

    Incyte (NASDAQ:INCY) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of pemigatinib for the treatment of adults with unresectable 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.

    "The positive CHMP opinion is a crucial milestone for patients with cholangiocarcinoma, who often have very limited treatment options due to the difficulty of identifying patients during the early disease stages," said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapeutics, Incyte. "Following the recent FDA approval of pemigatinib (Pemazyre®), we are delighted to be closer to offering the first targeted therapy in Europe to benefit these patients."

    The CHMP opinion is based on data from the FIGHT-202 study evaluating the safety and efficacy of pemigatinib in adult patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status. The CHMP's opinion to recommend the use of pemigatinib is now being reviewed by the European Commission, which has the authority to grant marketing authorizations for medicinal products in the European Union (EU). If approved, pemigatinib will be the first targeted treatment in the EU indicated for patients with unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement and would be commercialized under the brand name Pemazyre.

    Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its 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 poor1,2. In Europe, the incidence of cholangiocarcinoma ranges between 6,000 – 8,0003,4. FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16 percent of patients5,6,7.

    About FIGHT-202

    The FIGHT-202 Phase 2, open-label, multicenter study (NCT02924376) is evaluating 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 FGF/FGFR status.

    Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic 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 is overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR; progression free survival (PFS), overall survival (OS), duration of response (DOR), disease control rate (DCR) and safety in all cohorts.

    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 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 fusions/rearrangements, irrespective of tumor type.

    FIGHT-302 is a Phase 3 study investigating pemigatinib as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

    About FGFR and Pemigatinib

    Fibroblast growth factor receptors (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.

    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.

    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 whether or when pemigatinib might be approved in the EU for the treatment of, and whether or when pemigatinib might provide a successful treatment option for, patients with unresectable locally advanced or metastatic cholangiocarcinoma, 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 European 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.

    __________________

    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 Kirstein MM, Vogel A. Visc Med 2016; 32: 395-400.

    4 Countries factored include: UK, Germany, France, Spain, Italy, Switzerland, Denmark, Finland, Poland and Austria

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

    6 Ang C. J. Gastroenterol Hepatol. 2015;30:1116‒1122.

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

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  14. 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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  15. 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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  16. 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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  17. 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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  18. - 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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  19. 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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  20. 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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  21. - 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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  22. 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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  23. - 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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  24. 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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  25. 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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  26. 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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  27. 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 tr