1. THOUSAND OAKS, Calif. and SEATTLE, March 30, 2021 /PRNewswire/ -- Amgen Inc. (NASDAQ:AMGN) and Rodeo Therapeutics Corporation (Rodeo) today announced an agreement under which Amgen will acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo's 15-PGDH program is a strong strategic fit with Amgen's inflammation portfolio and efforts to develop first-in-class therapeutics for patients.

    Under terms of the agreement, Amgen will acquire all outstanding shares of Rodeo in exchange for a $55 million upfront payment as well as future contingent milestone payments potentially worth up to an additional $666 million in cash…

    THOUSAND OAKS, Calif. and SEATTLE, March 30, 2021 /PRNewswire/ -- Amgen Inc. (NASDAQ:AMGN) and Rodeo Therapeutics Corporation (Rodeo) today announced an agreement under which Amgen will acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Rodeo's 15-PGDH program is a strong strategic fit with Amgen's inflammation portfolio and efforts to develop first-in-class therapeutics for patients.

    Under terms of the agreement, Amgen will acquire all outstanding shares of Rodeo in exchange for a $55 million upfront payment as well as future contingent milestone payments potentially worth up to an additional $666 million in cash. The transaction has been approved by the shareholders and the Board of Directors of Rodeo.

    Rodeo is focused on developing first-in-class, orally available modulators of prostaglandin biology that play an important role in tissue regeneration and repair. Rodeo's lead 15-prostaglandin dehydrogenase (15-PGDH) modulators have generated compelling data in extensive preclinical studies and have clinical potential in multiple indications.

    "The enzyme 15-PGDH plays a key role in many disease-relevant processes such as stem cell self-renewal and epithelial barrier repair. Given the encouraging preclinical data to date, we are excited about the opportunity to develop a novel therapy with potential in a range of important inflammatory disease indications," said Raymond Deshaies, Ph.D., senior vice president of Global Research at Amgen.

    Thong Q. Le, president and chief executive officer of Rodeo commented, "We are thrilled that Amgen recognizes the potential value and differentiated profile of our 15-PGDH inhibitor program.  With decades of experience in developing, manufacturing and commercializing innovative therapies for patients suffering from a broad range of immunologic diseases and conditions, Amgen is ideally positioned to rapidly advance our program into the clinic."

    Cooley LLP acted as legal advisor to Rodeo and Gunderson Dettmer LLP acted as legal advisor to Amgen on this transaction.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    About Rodeo Therapeutics

    Rodeo Therapeutics (Rodeo) was founded in July 2017 by Accelerator Life Science Partners (ALSP), a venture capital firm that catalyzes the creation of high-quality, cutting edge life science companies.  Rodeo focuses on developing small-molecule therapies that increase tissue levels of prostaglandin PGE2.  Preclinical studies have shown that increasing PGE2 through modulation of a prostaglandin-degrading enzyme (15-PGDH) protects against colitis and idiopathic pulmonary fibrosis (IPF), accelerates hematopoietic stem cell reconstitution following bone marrow transplant, and promotes liver regeneration in a variety of animal models.  Since its founding, Rodeo has been exclusively managed by ALSP, validating the firm's ability to identify, nurture, and efficiently manage ground-breaking start-up companies that address unmet medical needs and advance patient care and outcomes.  For more information, please visit: www.rodeotherapeutics.com and www.acceleratorlsp.com.

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19), the integration of Otezla® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Rodeo Therapeutics acquisition, as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

    Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for Amgen's manufacturing activities, the distribution of Amgen's products, the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect Amgen's business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT:



    Amgen, Thousand Oaks

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631 (media)

    Arvind Sood, 805-447-1060 (investors)



    Rodeo Therapeutics Corporation, Seattle, Washington

    Jessica Burback, 206-234-6481,   (media and investors)

    Rodeo Therapeutics Corporation Logo

     

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  2. THOUSAND OAKS, Calif., March 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the virtual Oppenheimer 31st Annual Healthcare Conference at 2:30 p.m. ET on Tuesday, March 16, 2021. David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability…

    THOUSAND OAKS, Calif., March 11, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the virtual Oppenheimer 31st Annual Healthcare Conference at 2:30 p.m. ET on Tuesday, March 16, 2021. David M. Reese, M.D., executive vice president of Research and Development at Amgen will present at the conference. Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631 (media) 

    Arvind Sood, 805-447-1060 (investors) 

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  3. THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., March 4, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Five Prime Therapeutics (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, today announced an agreement under which Amgen will acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. This acquisition adds Five Prime's innovative pipeline to Amgen's leading oncology portfolio.

    • Five Prime's lead asset, bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ…

    THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., March 4, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Five Prime Therapeutics (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, today announced an agreement under which Amgen will acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. This acquisition adds Five Prime's innovative pipeline to Amgen's leading oncology portfolio.

    • Five Prime's lead asset, bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors.
    • The bemarituzumab Phase 2 FIGHT trial demonstrated clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) in the frontline treatment of patients with advanced gastric or GEJ cancer. Additional analysis showed a positive correlation between efficacy and expression of FGFR2b on tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.
    • This correlation suggests that FGFR2b could play a role in other epithelial cancers, including lung, breast, ovarian and other cancers. 
    • The acquisition of Five Prime also supports Amgen's international expansion strategy. Gastric cancer is one of the world's most common forms of cancer and is particularly prevalent in the Asia-Pacific region, where Amgen expects to generate significant volume growth in the coming years. Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential. In addition, as part of this transaction, Amgen will receive a royalty percentage on future net sales in Greater China ranging from the high teens to the low twenties from a pre-existing co-development and commercialization agreement between Five Prime and Zai Lab (Shanghai) Co., Ltd.
    • Five Prime's additional innovative pipeline programs complement Amgen's efforts to bring meaningful therapies to oncology patients. 

    "The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realize the full potential of bemarituzumab for even more patients around the world as quickly as possible."

    "This is an exciting day for patients who may one day benefit from the promise of bemaritizumab and our full pipeline. I'm so proud of the Five Prime team and the science we've pioneered," said Tom Civik, president and chief executive officer of Five Prime. "We see tremendous complementarity between the two companies. Amgen has global reach, world-class resources, and they share our deep passion for science and commitment to patients.  I have full confidence that Amgen is the right company to work with us to bring our innovative cancer treatments to patients and to achieve our mission to rewrite cancer." 

    Transaction Terms

    Under the terms of the merger agreement, which was approved by the Boards of Directors of both companies, Amgen will commence a tender offer to acquire all of the outstanding shares of Five Prime's common stock for $38.00 per share in cash. Following the completion of the tender offer, a wholly-owned subsidiary of Amgen will merge with Five Prime and shares of Five Prime that have not been tendered and purchased in the tender offer will be converted into the right to receive the same price per share in cash as paid in the tender offer (other than shares held by stockholders who properly demand and perfect appraisal rights under Delaware law).

    The transaction is expected to close by the end of the second quarter and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Five Prime's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

    Amgen reaffirmed its full-year outlook with Revenue guidance of $25.8 to $26.6 billion and non-GAAP EPS guidance of $16.00-$17.00.

    Goldman Sachs acted as financial advisor to Amgen and Sullivan & Cromwell LLP as its legal advisor. Lazard acted as financial advisor to Five Prime and Cooley LLP as its legal advisor.

    Amgen Webcast Investor Call

    Amgen will host a webcast call for the investment community on Thursday, March 4, 2021, at 10:30 a.m. EST. Peter H. Griffith, executive vice president and chief financial officer, David M. Reese, M.D., executive vice president of Research and Development, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate. 

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event. 

    About FGFR2b

    The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a splice variant of FGFR2 which can be found in tumors of epithelial origin. Data from the FIGHT trial suggests that approximately 30 percent of patients with non-HER2 positive gastroesophageal cancers overexpress FGFR2b.1 FGFR2b has also been shown to be overexpressed in numerous other cancers, including lung, breast, ovarian and other cancers.

    About Bemarituzumab

    Bemarituzumab (anti-FGFR2b) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Five Prime Therapeutics granted an exclusive license to Zai Lab Limited to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime Therapeutics on the Phase 2 FIGHT trial in Greater China.

    About the FIGHT Trial

    The FIGHT study was a randomized, placebo controlled trial that evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo arm.

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2 negative patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    About  Five Prime Therapeutics

    Five Prime Therapeutics is a clinical stage biotechnology company relentlessly focused on rewriting cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development.

    About Amgen Oncology

    Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

    For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in our history, moving with great speed to advance those innovations for the patients who need them.

    At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    Important Information

    This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities.  The tender offer for the outstanding shares of common stock of Five Prime described in this press release has not commenced.  At the time the tender offer is commenced, Amgen and its acquisition subsidiary, Franklin Acquisition Sub, Inc. ("Purchaser"), will file, or will cause to be filed, tender offer materials on Schedule TO with the U.S. Securities and Exchange Commission (the "SEC") and Five Prime will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, in each case with respect to the tender offer.  THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY WHEN THEY BECOME AVAILABLE AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER.  Those materials and all other documents filed by, or caused to be filed by, Amgen and Purchaser and Five Prime with the SEC will be available at no charge on the SEC's website at www.sec.gov.  The tender offer materials and related materials also may be obtained for free (when available) under the "Investors – Financials" section of Amgen's website at https://investors.amgen.com/financials/sec-filings, and the Solicitation/Recommendation Statement and such other documents also may be obtained for free (when available) from Five Prime under the "Investors & Media – Financial Information" section of Five Prime's website at https://investor.fiveprime.com/index.php/sec-filings. FIVE PRIME'S SHAREHOLDERS ARE ADVISED TO READ THE TENDER OFFER MATERIALS AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED BY FIVE PRIME OR AMGEN WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER. THESE MATERIALS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER, FIVE PRIME AND AMGEN.

    Forward Looking Statements

    This press release contains forward-looking statements. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as "expect," "anticipate," "outlook," "could," "target," "project," "intend," "plan," "believe," "seek," "estimate," "should," "may," "assume" and "continue" as well as variations of such words and similar expressions.  By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed transaction; the prospective performance and outlook of Five Prime's business, performance and opportunities; any potential strategic benefits, synergies or opportunities expected as a result of the proposed transaction; the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction; potential marketing or regulatory approvals for bemarituzumab, or potential future revenues from such product; as well as any assumptions underlying any of the foregoing.

    These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements.  There can be no guarantee that the proposed tender offer or the transaction described in this press release will be completed, or that it will be completed as currently proposed, or at any particular time.  Neither can there be any guarantee that Amgen or Five Prime's product, bemarituzumab, will achieve any particular future financial results, or that Amgen will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the proposed acquisition.  Nor can there be any guarantee that bemarituzumab will be submitted or approved for sale in any market, or at any particular time.  Neither can there be any guarantee that such product will be successfully commercialized even if regulatory approvals are obtained.  In particular, our expectations could be affected by, among other things: uncertainties as to the timing of the tender offer and the merger; the risk that the proposed transaction may not be completed in a timely manner or at all; uncertainties as to the percentage of Five Prime's stockholders tendering their shares in the tender offer; the possibility that competing offers or acquisition proposals for Five Prime will be made; the possibility that any or all of the various conditions to the consummation of the tender offer or the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction described in this release, as well as potential regulatory actions or delays with respect to the development of bemarituzumab; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of this announcement or pendency of the proposed transaction on Five Prime's ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to diverting management's attention from Five Prime's ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the successful integration of Five Prime into Amgen subsequent to the closing of the transaction and the timing of such integration; and other risks and factors referred to from time to time in Amgen's and Five Prime's filings with the SEC, including Amgen's current Form 10-K and Five Prime's current Form 10-K on file with the SEC, including those related to the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues; changes in expected or existing competition; and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors.  Amgen and Five Prime are providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Five Prime Media and Investor Contact

    Martin Forrest, 415-365-5625

    References

    1. Data on file. Five Prime Therapeutics; 2020.
    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492
    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4
    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

     

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  4. Acquisition Includes Bemarituzumab, A Phase 3 Ready, First-In-Class Program For Gastric Cancer, the Third Leading Cause of Cancer Mortality Worldwide

    Bemarituzumab is a Strong Strategic Fit With Amgen's Innovative Oncology Portfolio

    Amgen to Host Investor Call at 10:30 a.m. EST

    Amgen (NASDAQ:AMGN) and Five Prime Therapeutics (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, today announced an agreement under which Amgen will acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. This acquisition adds Five Prime's innovative pipeline to Amgen's leading oncology portfolio.

    • Five Prime's lead asset, bemarituzumab…

    Acquisition Includes Bemarituzumab, A Phase 3 Ready, First-In-Class Program For Gastric Cancer, the Third Leading Cause of Cancer Mortality Worldwide

    Bemarituzumab is a Strong Strategic Fit With Amgen's Innovative Oncology Portfolio

    Amgen to Host Investor Call at 10:30 a.m. EST

    Amgen (NASDAQ:AMGN) and Five Prime Therapeutics (NASDAQ:FPRX), a clinical-stage biotechnology company focused on developing immuno-oncology and targeted cancer therapies, today announced an agreement under which Amgen will acquire Five Prime Therapeutics for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. This acquisition adds Five Prime's innovative pipeline to Amgen's leading oncology portfolio.

    • Five Prime's lead asset, bemarituzumab, is a first-in-class, Phase 3 ready anti-FGFR2b antibody with positive data from a randomized, placebo-controlled Phase 2 study in frontline advanced gastric or gastroesophageal junction (GEJ) cancer. Bemarituzumab targets FGFR2b, which has been found to be overexpressed in approximately 30% of patients with non-HER2 positive gastric cancer, as well as other solid tumors.
    • The bemarituzumab Phase 2 FIGHT trial demonstrated clinically meaningful improvements in progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) in the frontline treatment of patients with advanced gastric or GEJ cancer. Additional analysis showed a positive correlation between efficacy and expression of FGFR2b on tumor cells, confirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target.
    • This correlation suggests that FGFR2b could play a role in other epithelial cancers, including lung, breast, ovarian and other cancers.
    • The acquisition of Five Prime also supports Amgen's international expansion strategy. Gastric cancer is one of the world's most common forms of cancer and is particularly prevalent in the Asia-Pacific region, where Amgen expects to generate significant volume growth in the coming years. Amgen plans to leverage its presence in Japan and other Asia-Pacific markets to maximize bemarituzumab's potential. In addition, as part of this transaction, Amgen will receive a royalty percentage on future net sales in Greater China ranging from the high teens to the low twenties from a pre-existing co-development and commercialization agreement between Five Prime and Zai Lab (Shanghai) Co., Ltd.
    • Five Prime's additional innovative pipeline programs complement Amgen's efforts to bring meaningful therapies to oncology patients.

    "The acquisition of Five Prime offers a compelling opportunity for Amgen to strengthen our oncology portfolio with a promising late-stage, first-in-class global asset to treat gastric cancer," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We look forward to welcoming the Five Prime team to Amgen and working with them to leverage our best-in-class monoclonal antibody manufacturing capabilities to supply additional clinical materials, as well as expanded production quantities, to realize the full potential of bemarituzumab for even more patients around the world as quickly as possible."

    "This is an exciting day for patients who may one day benefit from the promise of bemaritizumab and our full pipeline. I'm so proud of the Five Prime team and the science we've pioneered," said Tom Civik, president and chief executive officer of Five Prime. "We see tremendous complementarity between the two companies. Amgen has global reach, world-class resources, and they share our deep passion for science and commitment to patients. I have full confidence that Amgen is the right company to work with us to bring our innovative cancer treatments to patients and to achieve our mission to rewrite cancer."

    Transaction Terms

    Under the terms of the merger agreement, which was approved by the Boards of Directors of both companies, Amgen will commence a tender offer to acquire all of the outstanding shares of Five Prime‘s common stock for $38.00 per share in cash. Following the completion of the tender offer, a wholly-owned subsidiary of Amgen will merge with Five Prime and shares of Five Prime that have not been tendered and purchased in the tender offer will be converted into the right to receive the same price per share in cash as paid in the tender offer (other than shares held by stockholders who properly demand and perfect appraisal rights under Delaware law).

    The transaction is expected to close by the end of the second quarter and is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of Five Prime's common stock and the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

    Amgen reaffirmed its full-year outlook with Revenue guidance of $25.8 to $26.6 billion and non-GAAP EPS guidance of $16.00-$17.00.

    Goldman Sachs acted as financial advisor to Amgen and Sullivan & Cromwell LLP as its legal advisor. Lazard acted as financial advisor to Five Prime and Cooley LLP as its legal advisor.

    Amgen Webcast Investor Call

    Amgen will host a webcast call for the investment community on Thursday, March 4, 2021, at 10:30 a.m. EST. Peter H. Griffith, executive vice president and chief financial officer, David M. Reese, M.D., executive vice president of Research and Development, and Murdo Gordon, executive vice president of Global Commercial Operations at Amgen will participate.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public. The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About FGFR2b

    The fibroblast growth factor (FGF)/fibroblast growth factor receptor (FGFR) pathway is implicated in the development and growth of cancer cells. FGFR2b is a splice variant of FGFR2 which can be found in tumors of epithelial origin. Data from the FIGHT trial suggests that approximately 30 percent of patients with non-HER2 positive gastroesophageal cancers overexpress FGFR2b.1 FGFR2b has also been shown to be overexpressed in numerous other cancers, including lung, breast, ovarian and other cancers.

    About Bemarituzumab

    Bemarituzumab (anti-FGFR2b) is a first-in-class targeted antibody that blocks fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Five Prime Therapeutics granted an exclusive license to Zai Lab Limited to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime Therapeutics on the Phase 2 FIGHT trial in Greater China.

    About the FIGHT Trial

    The FIGHT study was a randomized, placebo controlled trial that evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus placebo plus chemotherapy in patients with fibroblast growth factor receptor 2b-positive (FGFR2b+), non HER2 positive frontline advanced gastric or GEJ cancer. The trial enrolled 155 patients in 15 countries across Asia, the European Union, and the United States, with 77 patients randomized to the bemarituzumab arm and 78 patients to the placebo arm.

    About Gastric Cancer and GEJ Cancer

    Gastric cancer, also known as stomach cancer, is the third most common cause of cancer death worldwide and, excluding non-melanoma skin cancer, the fifth most common cancer worldwide, with over 1,000,000 new cases diagnosed each year.2 For HER2 negative patients, frontline therapy available today is the same systemic chemotherapy available since the 1990s.3,4

    About Five Prime Therapeutics

    Five Prime Therapeutics is a clinical stage biotechnology company relentlessly focused on rewriting cancer. By tackling the tough scientific questions and untapped pathways, we aim to offer new hope by developing novel, breakthrough therapies that have potential to alter the course of disease in cancers with few treatment options. This vision is what defines us and guides our research, clinical development and partnerships. To build a better tomorrow for people with cancer, we are teaming up with patients, physicians, scientists, and industry partners to make a meaningful difference in patients' lives. Five Prime collaborates with leading global pharmaceutical companies and has therapies in pre-clinical and clinical development.

    About Amgen Oncology

    Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

    For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in our history, moving with great speed to advance those innovations for the patients who need them.

    At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Important Information

    This press release is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities. The tender offer for the outstanding shares of common stock of Five Prime described in this press release has not commenced. At the time the tender offer is commenced, Amgen and its acquisition subsidiary, Franklin Acquisition Sub, Inc. ("Purchaser"), will file, or will cause to be filed, tender offer materials on Schedule TO with the U.S. Securities and Exchange Commission (the "SEC") and Five Prime will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC, in each case with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND OTHER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT WILL CONTAIN IMPORTANT INFORMATION THAT SHOULD BE READ CAREFULLY WHEN THEY BECOME AVAILABLE AND CONSIDERED BEFORE ANY DECISION IS MADE WITH RESPECT TO THE TENDER OFFER. Those materials and all other documents filed by, or caused to be filed by, Amgen and Purchaser and Five Prime with the SEC will be available at no charge on the SEC's website at www.sec.gov. The tender offer materials and related materials also may be obtained for free (when available) under the "Investors – Financials" section of Amgen's website at https://investors.amgen.com/financials/sec-filings, and the Solicitation/Recommendation Statement and such other documents also may be obtained for free (when available) from Five Prime under the "Investors & Media – Financial Information" section of Five Prime's website at https://investor.fiveprime.com/index.php/sec-filings. FIVE PRIME'S SHAREHOLDERS ARE ADVISED TO READ THE TENDER OFFER MATERIALS AND THE SOLICITATION/RECOMMENDATION STATEMENT, AS EACH MAY BE AMENDED OR SUPPLEMENTED FROM TIME TO TIME, AND ANY OTHER RELEVANT DOCUMENTS FILED BY FIVE PRIME OR AMGEN WITH THE SEC WHEN THEY BECOME AVAILABLE BEFORE THEY MAKE ANY DECISION WITH RESPECT TO THE TENDER OFFER. THESE MATERIALS WILL CONTAIN IMPORTANT INFORMATION ABOUT THE TENDER OFFER, FIVE PRIME AND AMGEN.

    Forward Looking Statements

    This press release contains forward-looking statements. These forward-looking statements generally include statements that are predictive in nature and depend on or refer to future events or conditions, and include words such as "expect," "anticipate," "outlook," "could," "target," "project," "intend," "plan," "believe," "seek," "estimate," "should," "may," "assume" and "continue" as well as variations of such words and similar expressions. By their nature, forward-looking statements involve risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements include, among other things, statements about the potential benefits of the proposed transaction; the prospective performance and outlook of Five Prime's business, performance and opportunities; any potential strategic benefits, synergies or opportunities expected as a result of the proposed transaction; the ability of the parties to complete the proposed transaction and the expected timing of completion of the proposed transaction; potential marketing or regulatory approvals for bemarituzumab, or potential future revenues from such product; as well as any assumptions underlying any of the foregoing.

    These statements are not guarantees of future performance and they involve certain risks, uncertainties and assumptions that are difficult to predict. We caution you that actual outcomes and results may differ materially from what is expressed, implied or forecasted by our forward-looking statements. There can be no guarantee that the proposed tender offer or the transaction described in this press release will be completed, or that it will be completed as currently proposed, or at any particular time. Neither can there be any guarantee that Amgen or Five Prime's product, bemarituzumab, will achieve any particular future financial results, or that Amgen will be able to realize any of the potential strategic benefits, synergies or opportunities as a result of the proposed acquisition. Nor can there be any guarantee that bemarituzumab will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that such product will be successfully commercialized even if regulatory approvals are obtained. In particular, our expectations could be affected by, among other things: uncertainties as to the timing of the tender offer and the merger; the risk that the proposed transaction may not be completed in a timely manner or at all; uncertainties as to the percentage of Five Prime's stockholders tendering their shares in the tender offer; the possibility that competing offers or acquisition proposals for Five Prime will be made; the possibility that any or all of the various conditions to the consummation of the tender offer or the merger may not be satisfied or waived, including the failure to receive any required regulatory approvals from any applicable governmental entities (or any conditions, limitations or restrictions placed on such approvals); regulatory actions or delays or government regulation generally, including potential regulatory actions or delays relating to the completion of the potential transaction described in this release, as well as potential regulatory actions or delays with respect to the development of bemarituzumab; the occurrence of any event, change or other circumstance that could give rise to the termination of the merger agreement; the effect of this announcement or pendency of the proposed transaction on Five Prime's ability to retain and hire key personnel, its ability to maintain relationships with its customers, suppliers and others with whom it does business, its business generally or its stock price; risks related to diverting management's attention from Five Prime's ongoing business operations; the risk that stockholder litigation in connection with the proposed transaction may result in significant costs of defense, indemnification and liability; the potential that the strategic benefits, synergies or opportunities expected from the proposed acquisition may not be realized or may take longer to realize than expected; the successful integration of Five Prime into Amgen subsequent to the closing of the transaction and the timing of such integration; and other risks and factors referred to from time to time in Amgen's and Five Prime's filings with the SEC, including Amgen's current Form 10-K and Five Prime's current Form 10-K on file with the SEC, including those related to the uncertainties inherent in the research and development of new healthcare products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection; safety, quality or manufacturing issues; changes in expected or existing competition; and global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures. The effects of the COVID-19 pandemic may give rise to risks that are currently unknown or amplify the risks associated with many of these factors. Amgen and Five Prime are providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

    References

    1. Data on file. Five Prime Therapeutics; 2020.

    2. Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424. doi:10.3322/caac.21492

    3. Wagner AD, Syn NL, Moehler M, et al. Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev. 2017;8(8):CD004064. doi:10.1002/14651858.CD004064.pub4

    4. Drugs approved for stomach (gastric) cancer. Food and Drug Administration. Updated April 21, 2020. Accessed October 14, 2020. https://www.cancer.gov/about-cancer/treatment/drugs/stomach#1

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  5. THOUSAND OAKS, Calif., March 3, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.76 per share dividend for the second quarter of 2021. The dividend will be paid on June 8, 2021, to all stockholders of record as of the close of business on May 17, 2021.

    About Amgen 
    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for…

    THOUSAND OAKS, Calif., March 3, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.76 per share dividend for the second quarter of 2021. The dividend will be paid on June 8, 2021, to all stockholders of record as of the close of business on May 17, 2021.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits  and  synergies  of collaborations,  or  potential  collaborations,  with  any  other  company,  including BeiGene,  Ltd. or any collaboration to  manufacture therapeutic antibodies against  COVID-19,  or the Otezla® (apremilast) acquisition (including  anticipated  Otezla  sales growth  and  the  timing  of  non-GAAP EPS  accretion),  as  well  as estimates  of  revenues,  operating  margins,  capital expenditures,  cash,  other financial metrics, expected legal,  arbitration, political, regulatory  or clinical results or practices, customer and prescriber  patterns  or  practices,  reimbursement  activities  and  outcomes,  effects  of  pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress,  or  effects  relating  to  studies  of  Otezla  as  a  potential  treatment  for  COVID-19, and  other  such estimates  and  results. Forward-looking  statements  involve  significant risks  and  uncertainties,  including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to  update  any  forward-looking  statements  contained  in  this  document  as  a  result  of  new  information, future events or otherwise.

    No  forward-looking  statement can  be  guaranteed  and  actual  results  may  differ materially  from  those  we project. Our results may be affected by our ability to successfully market both new and existing products domestically  and  internationally,  clinical  and  regulatory  developments  involving  current  and  future products,   sales   growth   of recently   launched   products,   competition   from other   products   including biosimilars,  difficulties  or  delays in  manufacturing  our  products  and  global  economic  conditions. In addition,  sales  of  our  products  are  affected  by  pricing  pressure,  political  and  public scrutiny  and reimbursement policies  imposed by  third-party  payers,  including  governments,  private  insurance  plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic  and  international  trends  toward  managed  care  and  healthcare  cost  containment. Furthermore, our  research,  testing,  pricing,  marketing  and  other  operations  are  subject  to  extensive  regulation  by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems  with  our  products,  including  our  devices, after  they  are  on  the  market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our  business  may  be  impacted  by the  adoption  of  new  tax legislation  or  exposure  to  additional  tax liabilities. If  we  fail  to  meet  the  compliance obligations  in  the  corporate  integrity  agreement  between  us and  the  U.S.  government,  we  could  become  subject  to  significant  sanctions.  Further, while we  routinely obtain  patents  for  our  products  and  technology,  the  protection  offered  by  our  patents and  patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in  present  and  future  intellectual property  litigation. We perform  a  substantial  amount of  our  commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for  a  portion  of  our  manufacturing  activities,  and  limits  on supply  may  constrain  sales  of  certain of  our current  products  and product  candidate  development.  An  outbreak  of  disease or  similar  public  health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease,  could  have a significant  adverse  effect on  the  supply  of materials  for  our  manufacturing activities,  the  distribution of  our  products,  the  commercialization  of  our  product  candidates,  and  our clinical  trial  operations,  and  any  such  events  may  have  a  material  adverse effect  on  our  product development,  product  sales,  business  and  results  of  operations. We  rely  on  collaborations with  third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our  marketed  products  as  well  as for  the  discovery  and  development  of  new  products.  Discovery  or identification  of  new  product  candidates or  development  of  new  indications  for  existing  products cannot be  guaranteed  and  movement from  concept  to  product  is  uncertain;  consequently,  there  can  be  no guarantee  that  any  particular  product  candidate or  development  of a new  indication  for an existing product will  be  successful  and  become  a  commercial  product.  Further,  some  raw  materials, medical devices  and  component  parts  for  our  products  are  supplied by  sole  third-party  suppliers. Certain  of  our distributors,  customers  and  payers  have  substantial  purchasing  leverage  in  their  dealings  with  us. The discovery  of  significant problems  with  a product  similar  to  one  of our products  that  implicate  an  entire class  of  products  could  have  a  material  adverse  effect  on  sales  of  the  affected  products  and  on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and  to  integrate  the  operations of  companies or  to  support  the  products  or  technology we have acquired,  may  not  be  successful. A  breakdown,  cyberattack  or  information  security  breach could compromise  the  confidentiality,  integrity  and  availability  of  our  systems  and  our  data. Our  stock  price  is volatile  and  may be  affected  by  a  number  of  events. Global  economic  conditions may  magnify certain risks  that  affect  our  business. Our  business  performance  could  affect  or limit the  ability  of  our Board  of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-announces-2021-second-quarter-dividend-301240017.html

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  6. THOUSAND OAKS, Calif., March 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

    BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69…

    THOUSAND OAKS, Calif., March 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that data from a multicenter, randomized Phase 3 study evaluating the efficacy, safety and tolerability of BLINCYTO® (blinatumomab) compared with consolidation chemotherapy before allogeneic hematopoietic stem cell transplantation (alloHSCT) in pediatric patients with high-risk first-relapse B-cell precursor acute lymphoblastic leukemia (B-ALL) were published in The Journal of the American Medical Association (JAMA).1

    BLINCYTO demonstrated significantly prolonged event-free survival (events were defined by relapse, death, second malignancy, or failure to achieve complete remission) compared with chemotherapy. After a median of 22.4 months follow-up, 69% of patients treated with BLINCYTO were alive and event-free compared with 43% of patients treated with chemotherapy. Additionally, following treatment with BLINCYTO, 93% of patients with MRD at baseline achieved MRD negative remission compared with 24% of patients treated with chemotherapy. The 36-month overall survival (OS) estimate in the BLINCYTO group was 81.1% versus 55.8% in the chemotherapy group, and the median OS has not been met.

    "Acute lymphoblastic leukemia is the most common type of cancer in children. Unfortunately, approximately 15% of children with high-risk B-ALL relapse after frontline chemotherapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "There remains an urgent need for novel treatment options for these patients, and the study results support BLINCYTO as a new standard of care consolidation therapy for patients with this aggressive disease."

    In the BLINCYTO group versus the chemotherapy group, the incidence of serious adverse events (AEs) was 24.1% vs. 43.1%, respectively, and the incidence of adverse events of grade 3 or higher was 57.4% vs. 82.4% respectively. No fatal adverse events were reported. The most common adverse events (AEs) in the BLINCYTO treatment arm were pyrexia (81.5%), nausea (40.7%), headache (35.2%), stomatitis (35.2%) and vomiting (29.6%).

    "I am thrilled the study results demonstrated that BLINCYTO was more effective and associated with fewer and less severe toxicities compared to intensive chemotherapy," said study investigator, Franco Locatelli, M.D., PhD, Sapienza, University of Rome, Department of Pediatric Hematology and Oncology, Bambino Gesù Children's Hospital, Rome. "Chemotherapy has been used as primary consolidation treatment for ALL patients before receiving a stem cell transplant, despite this approach being only partially effective and associated with relevant toxicity. BLINCYTO has now been shown to be a more effective and safer consolidation therapy option for children with high-risk first-relapse B-ALL."

    Results from the Children's Oncology Group (COG) Phase 3 study (AALL1331) evaluating BLINCYTO in children, adolescents, and young adults with first-relapse B-ALL have also been published today in JAMA.2 In both studies, treatment with BLINCYTO resulted in less severe toxicities and higher rates of MRD remission.

    BLINCYTO, a bispecific CD19-directed CD3 T cell BiTE® (bispecific T cell engager) molecule, is the first approved molecule from Amgen's BiTE immuno-oncology platform, and the first and only therapy to receive regulatory approval globally for the treatment of MRD-positive B-cell precursor ALL.

    About the 20120215 Study

    Study 20120215 is a Phase 3 open-label, multicenter, randomized, controlled trial evaluating event-free survival after treatment with BLINCYTO compared with standard of care consolidation chemotherapy in pediatric patients with high-risk first-relapse B-cell ALL. Study enrollment was terminated early in September 2019 due to encouraging efficacy in the BLINCYTO arm and was based on a recommendation from the Independent Data Monitoring Committee (DMC) in accordance with a prespecified stopping rule. Key secondary endpoints included overall survival and MRD response, AEs, 100-day mortality after alloHSCT, incidence of anti-blinatumomab antibody formation, cumulative incidence of relapse. This is a global study that is being conducted as part of the PIP (Pediatric Investigation Plan) agreed to between Amgen and the EMA and is being conducted in Australia and various countries in the EU and Latin America. Click here to read about the trial on ClinicalTrials.gov.

    About the COG AALL1331 Study

    The COG AALL1331 study is a risk-stratified, randomized, Phase 3 trial of blinatumomab in first relapse of pediatric B-ALL to evaluate disease-free survival (DFS) of high-risk (HR) and intermediate-risk (IR) relapsed B-ALL patients who are randomized following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab. It also compares the DFS of low risk (LR) relapse B-ALL patients who are randomized following block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab. Key secondary endpoints include overall survival of HR, IR, and LR relapsed B-ALL patients. This is a global study that is being conducted in Australia, Canada, New Zealand and the United States. Click here to read about the trial on ClinicalTrials.gov. AALL1331 is supported by the National Cancer Institute (NCI), part of the National Institutes of Health under award number NCTN Operations Center Grant U10CA 180886 to COG. The study is sponsored by NCI and designed and conducted by the NCI-funded COG. Amgen provided BLINCYTO for AALL1331 under a Cooperative Research and Development Agreement between the NCI and Amgen.

    About The Children's Oncology Group (COG)

    COG (childrensoncologygroup.org), a member of the NCI National Clinical Trials Network (NCTN), is the world's largest organization devoted exclusively to childhood and adolescent cancer research. COG unites over 10,000 experts in childhood cancer at more than 200 leading children's hospitals, universities, and cancer centers across North America, Australia, and New Zealand in the fight against childhood cancer. Today, more than 90% of the 14,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. Research performed by COG institutions over the past 50 years has transformed childhood cancer from a virtually incurable disease to one with a combined 5-year survival rate of 80%. COG's mission is to improve the cure rate and outcomes for all children with cancer.

    About BiTE® Technology

    BiTE® (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient's own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

    About BLINCYTO® (Blinatumomab)

    BLINCYTO is a BiTE® (bispecific T-cell engager) immuno-oncology therapy that targets CD19 surface antigens on B cells. BiTE molecules fight cancer by helping the body's immune system detect and target malignant cells by engaging T cells (a type of white blood cell capable of killing other cells perceived as threats) to cancer cells. By bringing T cells near cancer cells, the T cells can inject toxins and trigger cancer cell death (apoptosis). BiTE immuno-oncology therapies are currently being investigated for their potential to treat a wide variety of cancers.

    BLINCYTO was granted breakthrough therapy and priority review designations by the U.S. Food and Drug Administration and is approved in the U.S. for the treatment of:

    • relapsed or refractory B-cell precursor ALL in adults and children.
    • B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

    In the European Union (EU), BLINCYTO is indicated as monotherapy for the treatment of:

    • adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
    • adults with Philadelphia chromosome negative CD19 positive B-precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
    • paediatric patients aged 1 year or older with Philadelphia chromosome negative CD19 positive B-precursor ALL which is refractory or in relapse after receiving at least two prior therapies or in relapse after receiving prior allogeneic hematopoietic stem cell transplantation

    IMPORTANT SAFETY INFORMATION

    WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGICAL TOXICITIES

    • Cytokine Release Syndrome (CRS), which may be life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® and treat with corticosteroids as recommended.
    • Neurological toxicities, which may be severe, life-threatening or fatal, occurred in patients receiving BLINCYTO®. Interrupt or discontinue BLINCYTO® as recommended.

    Contraindications

    BLINCYTO® is contraindicated in patients with a known hypersensitivity to blinatumomab or to any component of the product formulation.

    Warnings and Precautions

    • Cytokine Release Syndrome (CRS): CRS, which may be life-threatening or fatal, occurred in 15% of patients with R/R ALL and in 7% of patients with MRD-positive ALL. The median time to onset of CRS is 2 days after the start of infusion and the median time to resolution of CRS was 5 days among cases that resolved. Closely monitor and advise patients to contact their healthcare professional for signs and symptoms of serious adverse events such as fever, headache, nausea, asthenia, hypotension, increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), increased total bilirubin (TBILI), and disseminated intravascular coagulation (DIC). The manifestations of CRS after treatment with BLINCYTO® overlap with those of infusion reactions, capillary leak syndrome, and hemophagocytic histiocytosis/macrophage activation syndrome. If severe CRS occurs, interrupt BLINCYTO® until CRS resolves. Discontinue BLINCYTO® permanently if life-threatening CRS occurs. Administer corticosteroids for severe or life-threatening CRS.
    • Neurological Toxicities: Approximately 65% of patients receiving BLINCYTO® in clinical trials experienced neurological toxicities. The median time to the first event was within the first 2 weeks of BLINCYTO® treatment and the majority of events resolved. The most common (≥ 10%) manifestations of neurological toxicity were headache and tremor. Severe, life–threatening, or fatal neurological toxicities occurred in approximately 13% of patients, including encephalopathy, convulsions, speech disorders, disturbances in consciousness, confusion and disorientation, and coordination and balance disorders. Manifestations of neurological toxicity included cranial nerve disorders. Monitor patients for signs or symptoms and interrupt or discontinue BLINCYTO® as outlined in the PI.
    • Infections: Approximately 25% of patients receiving BLINCYTO® in clinical trials experienced serious infections such as sepsis, pneumonia, bacteremia, opportunistic infections, and catheter-site infections, some of which were life-threatening or fatal. Administer prophylactic antibiotics and employ surveillance testing as appropriate during treatment. Monitor patients for signs or symptoms of infection and treat appropriately, including interruption or discontinuation of BLINCYTO® as needed.
    • Tumor Lysis Syndrome (TLS), which may be life-threatening or fatal, has been observed. Preventive measures, including pretreatment nontoxic cytoreduction and on-treatment hydration, should be used during BLINCYTO® treatment. Monitor patients for signs and symptoms of TLS and interrupt or discontinue BLINCYTO® as needed to manage these events.
    • Neutropenia and Febrile Neutropenia, including life-threatening cases, have been observed. Monitor appropriate laboratory parameters (including, but not limited to, white blood cell count and absolute neutrophil count) during BLINCYTO® infusion and interrupt BLINCYTO® if prolonged neutropenia occurs.
    • Effects on Ability to Drive and Use Machines: Due to the possibility of neurological events, including seizures, patients receiving BLINCYTO® are at risk for loss of consciousness, and should be advised against driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO® is being administered.
    • Elevated Liver Enzymes: Transient elevations in liver enzymes have been associated with BLINCYTO® treatment with a median time to onset of 3 days. In patients receiving BLINCYTO®, although the majority of these events were observed in the setting of CRS, some cases of elevated liver enzymes were observed outside the setting of CRS, with a median time to onset of 19 days. Grade 3 or greater elevations in liver enzymes occurred in approximately 7% of patients outside the setting of CRS and resulted in treatment discontinuation in less than 1% of patients. Monitor ALT, AST, gamma-glutamyl transferase, and TBILI prior to the start of and during BLINCYTO® treatment. BLINCYTO® treatment should be interrupted if transaminases rise to > 5 times the upper limit of normal (ULN) or if TBILI rises to > 3 times ULN.
    • Pancreatitis: Fatal pancreatitis has been reported in patients receiving BLINCYTO® in combination with dexamethasone in clinical trials and the post-marketing setting. Evaluate patients who develop signs and symptoms of pancreatitis and interrupt or discontinue BLINCYTO® and dexamethasone as needed.
    • Leukoencephalopathy: Although the clinical significance is unknown, cranial magnetic resonance imaging (MRI) changes showing leukoencephalopathy have been observed in patients receiving BLINCYTO®, especially in patients previously treated with cranial irradiation and antileukemic chemotherapy.
    • Preparation and administration errors have occurred with BLINCYTO® treatment. Follow instructions for preparation (including admixing) and administration in the PI strictly to minimize medication errors (including underdose and overdose).
    • Immunization: Vaccination with live virus vaccines is not recommended for at least 2 weeks prior to the start of BLINCYTO® treatment, during treatment, and until immune recovery following last cycle of BLINCYTO®.
    • Risk of Serious Adverse Reactions in Pediatric Patients due to Benzyl Alcohol Preservative: Serious and fatal adverse reactions including "gasping syndrome," which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol-preserved drugs including BLINCYTO® (with preservative). When prescribing BLINCYTO® (with preservative) for pediatric patients, consider the combined daily metabolic load of benzyl alcohol from all sources including BLINCYTO® (with preservative) and other drugs containing benzyl alcohol. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Due to the addition of bacteriostatic saline, 7-day bags of BLINCYTO® solution for infusion with preservative contain benzyl alcohol and are not recommended for use in any patients weighing < 22 kg.

    Adverse Reactions

    • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with MRD-positive B-cell precursor ALL (BLAST Study) treated with BLINCYTO® were pyrexia (91%), infusion-related reactions (77%), headache (39%), infections (pathogen unspecified 39%), tremor (31%), and chills (28%). Serious adverse reactions were reported in 61% of patients. The most common serious adverse reactions (≥ 2%) included pyrexia, tremor, encephalopathy, aphasia, lymphopenia, neutropenia, overdose, device related infection, seizure, and staphylococcal infection.
    • The most common adverse reactions (≥ 20%) in clinical trial experience of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL (TOWER Study) treated with BLINCYTO® were infections (bacterial and pathogen unspecified), pyrexia, headache, infusion-related reactions, anemia, febrile neutropenia, thrombocytopenia, and neutropenia. Serious adverse reactions were reported in 62% of patients. The most common serious adverse reactions (≥ 2%) included febrile neutropenia, pyrexia, sepsis, pneumonia, overdose, septic shock, CRS, bacterial sepsis, device related infection, and bacteremia.
    • Adverse reactions that were observed more frequently (≥ 10%) in the pediatric population compared to the adults with relapsed or refractory B-cell precursor ALL were pyrexia (80% vs. 61%), hypertension (26% vs. 8%), anemia (41% vs. 24%), infusion-related reaction (49% vs. 34%), thrombocytopenia (34% vs. 21%), leukopenia (24% vs. 11%), and weight increased (17% vs. 6%).
    • In pediatric patients less than 2 years old (infants), the incidence of neurologic toxicities was not significantly different than for the other age groups, but its manifestations were different; the only event terms reported were agitation, headache, insomnia, somnolence, and irritability. Infants also had an increased incidence of hypokalemia (50%) compared to other pediatric age cohorts (15-20%) or adults (17%).

    Dosage and Administration Guidelines

    • BLINCYTO® is administered as a continuous intravenous infusion at a constant flow rate using an infusion pump which should be programmable, lockable, non-elastomeric, and have an alarm.
    • It is very important that the instructions for preparation (including admixing) and administration provided in the full Prescribing Information are strictly followed to minimize medication errors (including underdose and overdose).

    Please see full Prescribing Information and medication guide for BLINCYTO at www.BLINCYTO.com.

    About Amgen Oncology

    Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

    For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

    At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (Media)

    Jessica Akopyan, 805-447-0974 (Media)

    Arvind Sood, 805-447-1060 (Investors)

    References

    1. Locatelli F, Zugmaier G, Rizzari C, et al. Effect of blinatumomab vs chemotherapy on event-free survival among children with high-risk first-relapse B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. Published March 2, 2021. doi: 10.1001/jama.2021.0987  



    2. Brown PA, Ji L, Xu X, et al. Effect of postreinduction consolidation with blinatumomab vs chemotherapy on disease-free survival in children, adolescents, and young adults with first relapse of B-cell acute lymphoblastic leukemia: a randomized clinical trial. JAMA. Published March 2, 2021. doi:10.1001/jama.2021.0669

     

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  7. THOUSAND OAKS, Calif., Feb. 26, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. When added to standard of care (SoC), tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma, compared to placebo.1 The results were presented at the American Academy of Asthma Allergy & Immunology Annual Meeting. NAVIGATOR is a pivotal Phase 3 trial that will form the basis of regulatory filing.

    Tezepelumab, a potential first-in-class medicine, when added to…

    THOUSAND OAKS, Calif., Feb. 26, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced positive full results from the pivotal NAVIGATOR Phase 3 trial, which showed the potential of tezepelumab to be a first-in-class medicine in severe asthma. When added to standard of care (SoC), tezepelumab demonstrated a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) in patients with severe, uncontrolled asthma, compared to placebo.1 The results were presented at the American Academy of Asthma Allergy & Immunology Annual Meeting. NAVIGATOR is a pivotal Phase 3 trial that will form the basis of regulatory filing.

    Tezepelumab, a potential first-in-class medicine, when added to standard of care (SoC) achieved a 56% reduction (p<0.001) in AAER over 52 weeks in the overall patient population, compared to placebo when added to SoC.2 Tezepelumab is the only biologic to consistently and significantly reduce AAER in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across Phase 2 and Phase 3 clinical trials.2-10

    "We believe the full results of the NAVIGATOR trial are a breakthrough for the millions of people living with severe asthma," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "The reduction in exacerbation rates tezepelumab demonstrated, regardless of eosinophil or allergic status, is impressive. We are thrilled with these results and what they could mean for patients suffering with severe asthma."

    In a pre-specified analysis of the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, tezepelumab achieved a statistically significant and clinically meaningful 41% reduction (p<0.001) in AAER.2 Importantly, clinically meaningful reductions in AAER were also observed in two additional subgroups: a 39% reduction in patients with baseline eosinophil counts less than 150 cells per microliter and a 70% reduction in patients with greater than or equal to 300 cells per microliter.2

    Additionally, clinically meaningful reductions in AAER compared to placebo were observed in the tezepelumab-treated patients irrespective of allergy status and fractional exhaled nitric oxide (FeNO) level, biomarkers used by clinicians to inform treatment options.2

    "These are ground-breaking results for the many patients with severe asthma who continue to face debilitating symptoms despite receiving standard of care inhaled medicines and currently approved biologics," said Professor Andrew Menzies-Gow, director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR Phase 3 trial. "Tezepelumab has the potential to transform treatment for a broad population of patients with severe asthma regardless of their type of inflammation, including those with and without an eosinophilic phenotype."   

    Tezepelumab also demonstrated statistically significant improvements in every key secondary endpoint compared to placebo, including lung function measurements, asthma control, and health-related quality of life.2

    There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups. The most frequently reported adverse events were nasopharyngitis, upper respiratory tract infection and headache.2

    Tezepelumab blocks the action of thymic stromal lymphopoietin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation.3,10 NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma by targeting TSLP.2

    The statistically significant and clinically meaningful exacerbation rate reductions demonstrated with tezepelumab in patients with baseline eosinophil counts less than 300 cells per microliter support the U.S. Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.2-3 Tezepelumab is being developed by AstraZeneca in collaboration with Amgen (see AstraZeneca and Amgen collaboration below).

    About Severe Asthma

    Asthma is a complex and heterogeneous disease affecting an estimated 339 million people worldwide.11,12 Approximately 10% of asthma patients have severe asthma.11,12 Globally, there are approximately 2.5 million severe asthma patients who are uncontrolled or biologic eligible, with approximately 1 million in the U.S. Many severe asthma patients have an inadequate response to currently available biologics and oral corticosteroids and thus fail to achieve asthma control.11-13 Severe, uncontrolled asthma is debilitating with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life.11-13 Patients with severe asthma have twice the risk of asthma-related hospitalizations.14,15 There is also a significant socio-economic burden, with these patients accounting for 50% of asthma-related costs.16

    Multiple inflammatory pathways are involved in the pathogenesis of asthma.17,18,19 Eosinophilic asthma, and more broadly, T2 inflammation-driven asthma, accounts for about two-thirds of patients with severe asthma.19 These patients are typically characterized as having elevated levels of inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO).20,21 However, many patients do not fit the criteria for eosinophilic or allergic asthma, may have unclear or multiple drivers of inflammation, and may not qualify for or respond well to a current biologic medicine.21

    NAVIGATOR and the PATHFINDER Clinical Trial Program

    Building on the positive Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE.22-25 The program includes additional planned mechanistic and long-term safety trials.

    NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in 1,061 adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving treatment with medium- or high-dose ICS plus at least one additional controller medication with or without OCS. NAVIGATOR met the primary endpoint with tezepelumab added to SoC demonstrating a statistically significant and clinically meaningful reduction in the AAER over 52 weeks in the overall patient population, compared to placebo added to SoC. The trial also met the primary endpoint in the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER in that patient population. Similar reductions in AAER were observed in the subgroup of patients with baseline eosinophil counts less than 150 cells per microliter.25

    NAVIGATOR primary endpoints2

    Endpoint

    Timepoint

    Results

    Tezepelumab added to SoC vs placebo

    added to SoC

    AAER – overall patient

    population

    Over 52 weeks

    56% reduction* (95% CI: 47, 63; p<0.001)

    AAER – baseline

    eosinophil counts < 300

    cells/µL

    Over 52 weeks

    41% reduction* (95% CI: 25, 54; p<0.001)



    CI: confidence interval

    SOURCE is a Phase 3 multicenter, randomized, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance OCS therapy.23  In the trial, patients were randomized to receive tezepelumab 210 mg every four weeks or placebo as add-on therapy, with patients maintained on their currently prescribed ICS plus LABA, with or without other asthma controller therapy.23

    Patients who participated in the NAVIGATOR and SOURCE trials were eligible to continue in DESTINATION, a Phase 3 extension trial assessing long term safety and efficacy.26

    About Tezepelumab

    Tezepelumab is an investigational, potential first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental insults. Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.3,9,22

    TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles. 3,9 Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.3,22 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control. 3,22 By working at the top of the cascade, tezepelumab helps stop inflammation at the source and has the potential to treat a broad population of severe asthma patients.3,22

    Amgen and AstraZeneca Collaboration

    In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for tezepelumab. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialize tezepelumab. Amgen will record sales in the U.S. and AstraZeneca will record sales in Canada. Outside the U.S., Amgen will record sales as collaboration revenue.

    Amgen Inflammation

    Amgen brings therapies to millions of people with inflammatory diseases, with a focus on serving unmet patient needs. For those with debilitating moderate to severe rheumatoid arthritis, psoriatic arthritis, moderate to severe plaque psoriasis, ankylosing spondylitis, asthma, and other chronic conditions, the suffering and needs are severe. Complex diseases of inflammation have defied simple solutions, and the breadth of inflammatory disease and the burden patients bear is not well understood.

    For more than two decades, Amgen has been committed to advancing the science and the understanding around inflammation to address the unmet patient needs that exist and expanding our portfolio. We lead with science through discovery research that is disease-agnostic and biology-first, modality-second. In doing so, we have introduced and evolved novel therapies that have changed the lives of patients.

    Our commitment to patients is reflected not only in where we have succeeded, but in where we have failed and opened new doors. Throughout, we have remained dedicated to the principle of leading with science, pursuing where pathways and promising discoveries in inflammation take us, and not relenting until innovative solutions for patients are found. It's a commitment that extends beyond introducing novel therapies. We are focused on improving the entire patient journey.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    Amgen Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on Amgen's business, outcomes, progress, or effects relating to studies of Otezla as a potential  treatment  for  COVID-19, and  other  such  estimates  and  results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including its most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those Amgen projects. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for Amgen to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and Amgen expects similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints Amgen has selected. Amgen develops product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as Amgen may have believed at the time of entering into such relationship. Also, Amgen or others could identify safety, side effects or manufacturing problems with its products, including its devices, after they are on the market.

    Amgen's results may be affected by its ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing its products and global economic conditions. In addition, sales of Amgen's products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, Amgen's research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Amgen's business may be impacted by government investigations, litigation and product liability claims. In addition, Amgen's business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If Amgen fails to meet the compliance obligations in the corporate integrity agreement between Amgen and the U.S. government, Amgen could become subject to significant sanctions. Further, while Amgen routinely obtains patents for its products and technology, the protection offered by its patents and patent applications may be challenged, invalidated or circumvented by its competitors, or Amgen may fail to prevail in present and future intellectual property litigation. Amgen performs a substantial amount of its commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depends on third parties for a portion of its manufacturing activities, and limits on supply may constrain sales of certain of its current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials  for Amgen's manufacturing  activities,  the  distribution  of Amgen's products,  the commercialization of Amgen's product candidates, and Amgen's clinical trial operations, and any such events may have a material adverse effect on Amgen's product development, product sales, business and results of operations. Amgen relies on collaborations with third parties for the development of some of its product candidates and for the commercialization and sales of some of its commercial products. In addition, Amgen competes with other companies with respect to many of its marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for Amgen's products are supplied by sole third-party suppliers. Certain of Amgen's distributors, customers and payers have substantial purchasing leverage in their dealings with Amgen. The discovery of significant problems with a product similar to one of Amgen's products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on its business and results of operations. Amgen's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology Amgen has acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of Amgen's systems and Amgen's data. Amgen's stock price may be volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Amgen's business performance could affect or limit the ability of the Amgen Board of Directors to declare a dividend or its ability to pay a dividend or repurchase its common stock. Amgen may not be able to access the capital and credit markets on terms that are favorable to it, or at all.

    The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

    Further, any scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    References

    1. Bonini M, Di Paolo M, Bagnasco D, et al. Minimal clinically important difference for asthma endpoints: an expert consensus report. Eur Respir Rev. 2020; 29: 190137.
    2. Menzies-Gow A, Corre J, Bourdin A, et al. Efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma: results from the phase 3 NAVIGATOR study. L 46. AAAAI poster. February 2021. 
    3. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma [published correction appears in N Engl J Med. 2019 May 23; 380 (21): 2082]. N Engl J Med. 2017; 377 (10): 936-946.
    4. Wenzel S, Castro M, Corren J, et al. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016;388 (10039): 31-44.
    5. Castro M, Corren J, Pavord I.D, et al. Dupilumab Efficacy and Safety in Moderate-to-Severe Uncontrolled Asthma. N Engl J Med 2018; 378:2486-2496.
    6. Bleecker ER, FitzGerald JM, Chanez P, et al, on behalf of the SIROCCO study investigators. Efficacy and safety of benralizumab for patients with severe asthma uncontrolled with high-dosage inhaled corticosteroids and long-acting beta2-agonists (SIROCCO): a randomised, multicentre, placebo-controlled phase 3 trial. Lancet 2016: 388 (10056): 2115-2127.
    7. 7.  FitzGerald JM, Bleecker ER, Nair P, et al, on behalf of the CALIMA study investigators. Benralizumab, an anti-interleukin-5 receptor alpha monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2016: 388(10056): 2128-2141.
    8. FitzGerald JM, Bleecker ER, Menzies-Gow A, et al. Predictors of enhanced response with benralizumab for patients with severe asthma: pooled analysis of the SIROCCO and CALIMA studies. Lancet Respir Med. 2018; 6 (1): 51-64.
    9. Varricchi G, Pecoraro A, Marone G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018; 9: 1595.
    10. Ortega HG, Liu MC, Pavord ID, et al; on behalf of the MENSA Investigators. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198-207.
    11. Kupczyk M, Wenzel S. U.S. and European severe asthma cohorts: what can they teach us about severe asthma? J Intern Med 2012;272:121–32.
    12. Wenzel S. Severe Asthma in Adults. Am J Respir Crit Care Med. 2005; 172; 149–60.
    13. Chung KF, Wenzel SE, Brozek JL, et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43: 343–73.
    14. Price D, Fletcher M, van der Molen T. Asthma control and management in 8,000 European patients: the REcognise Asthma and LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care Respir Med. 2014; 12; 24: 14009.
    15. World Allergy Organization (WAO). The management of severe asthma: economic analysis of the cost of treatments for severe asthma. Available at: https://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php [Last accessed: February 2021].
    16. Busse WW. Biological Treatments for Severe Asthma: A Major Advance in Asthma Care. Allergol Int 2019; 68: 158–66.
    17. Godar M, Blanchetot C, de Haard H, et al. Personalized medicine with biologics for severe type 2 asthma: current status and future prospects. MAbs. 2018; 10 (1): 34–45.
    18. Rabe KF, Busse W, Pavord I, Castro M. Raising the clinical bar beyond current biologics in uncontrolled persistent asthma: translating emerging data in future clinical decisions. EMJ Allergy Immunol. 2018; 3: 60-9.
    19. Peters MC, Mekonnen ZK, Yuan S, et al. Measures of gene expression in sputum cells can identify TH2-high and TH2-low subtypes of asthma. J Allergy Clin Immunol. 2014; 133: 388–94.
    20. Clinicaltrials.gov. Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma (SOURCE) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03406078. [Last accessed: February 2021].
    21. Fahy JV. Type 2 inflammation in asthma--present in most, absent in many. Nat Rev Immunol. 2015; 15: 57-65.
    22. Roseti S, Corren J, Parnes JR, et al. Efficacy and safety of tezepelumab in adults with severe asthma: A randomized phase 2 study. European Respiratory Journal 2017; 50: OA3189.
    23. Wechsler, M.E., Colice, G., Griffiths, J.M. et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma. Respir Res 2020; 21: 264.
    24. Clinicaltrials.gov. Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma (NAVIGATOR) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03347279. [Last accessed: February 2021].
    25. AstraZeneca plc. Tezepelumab NAVIGATOR Phase III trial met primary endpoint of a statistically significant and clinically meaningful reduction in exacerbations in a broad population of patients with severe asthma. Available at: https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/tezepelumab-navigator-phase-iii-trial-met-primary-endpoint.html. [Last accessed: February 2021].
    26. Clinicaltrials.gov. Extension Study to Evaluate the Safety and Tolerability of Tezepelumab in Adults and Adolescents With Severe, Uncontrolled Asthma (DESTINATION) [Online]. Available at: https://clinicaltrials.gov/ct2/show/NCT03706079. [Last accessed: February 2021].

     

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  8. The new report by Expert Market Research titled, ‘Global Anaemia Drugs Market Report and Forecast 2021-2026', gives an in-depth analysis of the Global Anaemia Drugs market, assessing the market based on its segments like iron deficiency, CKD (chronic kidney disease), sickle cell, aplastic and major regions.

    The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porter’s Five Forces models.

    Note 1: For a snapshot of the primary and secondary data of the market (2015-2025), along with business strategies and detailed market segmentation, please click on the request

    The new report by Expert Market Research titled, ‘Global Anaemia Drugs Market Report and Forecast 2021-2026', gives an in-depth analysis of the Global Anaemia Drugs market, assessing the market based on its segments like iron deficiency, CKD (chronic kidney disease), sickle cell, aplastic and major regions.

    The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porter’s Five Forces models.

    Note 1: For a snapshot of the primary and secondary data of the market (2015-2025), along with business strategies and detailed market segmentation, please click on the request sample report. The sample report shall be delivered to you within 24 hours.

    Request a free sample copy in PDF or view the report  https://www.expertmarketresearch.com/reports/anaemia-drugs-market/requestsample

    The key highlights of the report include:

    Market Overview (2016-2026)

    • Forecast CAGR (2021-2026): 8%

    The rising prevalence of the CKD anaemia segment over the forecast period is driving the global demand for anaemia drugs as chronic kidney diseases are becoming prevalent across many regions. In addition, due to consumer convenience, the exponential growth of the e-commerce segment as a distribution channel is projected to promote the market growth of anaemic drugs. The market depends on many factors that are expected to drive the overall growth of the market, such as the increasing geriatric population, rapid R&D operations, and better healthcare infrastructure. The market is further motivated by the ongoing development of key players in the industry.

    Industry Definition and Major Segments

    Anaemia is a medical disorder where the number of red blood cells (RBC) or haemoglobin is below average. The results of anaemia are shortness of breath, tiredness, palpitations, and dizziness. In the treatment of this disease, anaemic medicines are used.

    Explore the full report with the table of  https://www.expertmarketresearch.com/reports/anaemia-drugs-market

    On the basis of anaemia type, the market is divided into:

    • Iron Deficiency
    • CKD (Chronic Kidney Disease)
    • Sickle Cell
    • Aplastic
    • Others

    Based on drugs, the industry can be segmented into:

    • Dietary Supplements
    • Medicines

    The dietary supplements are further divided on the basis of types:

    • Iron supplements
    • Vitamin supplements
    • Others

    Medicines are further divided into:

    • Antibiotics
    • Hormones (erythropoietin)
    • Chelation therapy (lead poisoning)
    • Others

    By distribution channel, the industry is categorised into:

    • Hospital Pharmacy
    • Store Pharmacy
    • Online
    • Others

    Latest Global News on Anaemia Drugs  https://www.expertmarketresearch.com/pressrelease/global-anaemia-drugs-market

    On the basis of regional markets, the industry is divided into:

    1 North America
    1.1 United States of America
    1.2 Canada
    2 Europe
    2.1 Germany
    2.2 United Kingdom
    2.3 France
    2.4 Italy
    2.5 Others
    3 Asia Pacific
    3.1 China
    3.2 Japan
    3.3 India
    3.4 ASEAN
    3.5 Others
    4 Latin America
    4.1 Brazil
    4.2 Argentina
    4.3 Mexico
    4.4 Others
    5 Middle East & Africa
    5.1 Saudi Arabia
    5.2 United Arab Emirates
    5.3 Nigeria
    5.4 South Africa
    5.5 Others

    Market Trends

    The demand is further influenced by the continuing growth of key players in the industry, such as Pfizer Inc. and Amgen Inc. (NASDAQ:AMGN). On 15 May 2018, Pfizer Inc. reported that RETACRIT® (epoetin alfa-epbx), which is biosimilar to Epogen® and Procrit® (epoetin alfa)1, has been approved by the US Food and Drug Administration (FDA) for all indications of the product listed. RETACRIT® is believed to provide more access to high-quality, lower-cost alternative treatment options for anaemia and a reduction in RBC allogeneic transfusions in some patients for patients and their physicians. Such advances in the field of anaemia drugs are expected to support market growth over the forecast period to meet the advancing needs of patients and the large healthcare population.

    Key Market Players

    The major players in the market are Amgen Inc, Pieris Pharmaceuticals, Inc., Pfizer Inc., Akebia Therapeutics, Inc., and Takeda Pharmaceutical Company Limited. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

    Related Reports:

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    Note 2: As the novel coronavirus (COVID-19) continues to spread across the world, our analysts are constantly tracking the impact of this rapidly evolving situation on the markets and the consumer purchase behaviours. Thus, our latest estimates and analysis about the current market trends and forecast will exhaustively reflect the effects of this emerging pandemic.

    About Us:

    Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

    At Expert Market Research, we tailor our approach according to our clients’ needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

    We also provide state-of-the-art procurement intelligence through our platform, https://www.procurementresource.com. Procurement Resource is a leading platform for digital procurement solutions, offering daily price tracking, market intelligence, supply chain intelligence, procurement analytics, and category insights through our thoroughly researched and infallible market reports, production cost reports, price analysis, and benchmarking.

    Informes de Expertos (https://informesdeexpertos.com), the Spanish variant of Expert Market Research, is a platform that offers market research and consultancy services to a broad clientele base across Spanish speaking countries. With our primary focus on the Latin America and Spain markets, our research experts provide relevant and actionable insights into the markets and track major trends, economic developments, and global trade data.

    Determined to bring client satisfaction, we make sure that our tailored approach meets the client’s unique market intelligence requirements. Our syndicated and customized research reports cover a wide spectrum of industries ranging from pharmaceuticals and food and beverage to packaging, logistics, and transportation.

    Media Contact
    Company Name: Expert Market Research
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    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: Global Anaemia Drugs Market to be Driven by Growing Prevalence of CKD Anaemia in the Forecast Period of 2021-2026

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  9. 2021 Vaccine Manufacturing: Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; manufacturing is still working to supply up to 1 billion doses for 2021

    2022 Vaccine Manufacturing: Based on the high demand from around the world for our COVID-19 vaccine and variant-based boosters, making new capital investments to increase capacity up to 1.4 billion doses in 2022

    Commercial Subsidiaries: Company established 8 commercial subsidiaries in 2020 in North America and Europe and plans to expand in 2021 to Japan, South Korea and Australia

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business…

    2021 Vaccine Manufacturing: Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; manufacturing is still working to supply up to 1 billion doses for 2021

    2022 Vaccine Manufacturing: Based on the high demand from around the world for our COVID-19 vaccine and variant-based boosters, making new capital investments to increase capacity up to 1.4 billion doses in 2022

    Commercial Subsidiaries: Company established 8 commercial subsidiaries in 2020 in North America and Europe and plans to expand in 2021 to Japan, South Korea and Australia

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the fourth quarter and fiscal year 2020 and highlighted pipeline progress.

    "2020 was a historic year for Moderna. The team rose to the challenge to address the devastating COVID-19 pandemic in less than one year with our authorized vaccine. It is encouraging and humbling that more than 32 million doses of our vaccine have been administered in the U.S. and that millions of people around the world have been vaccinated with our vaccine to date. 2020 demonstrated the power of harnessing mRNA to make medicines and also demonstrated the speed and scalability of the Moderna platform that we have built over the last 10 years," said Stéphane Bancel, Chief Executive Officer of Moderna. "I believe that 2021 will be an inflection year for Moderna. We previously believed that mRNA would lead to approved medicines, and we were limited in our ambitions by the need for regular capital raises and keeping several years of cash to manage financing risk. We now know that mRNA vaccines can be highly efficacious and authorized for use, and we are a cash-flow generating commercial company. We opened commercial subsidiaries in 8 countries in 2020 and plan to add Japan, South Korea and Australia in 2021. We plan to accelerate and significantly increase our investments in science and grow our development pipeline faster. By executing on our 2021 priorities, we will advance our mission of delivering on the promise of mRNA science to create a new generation of transformative medicines for patients. This is just the beginning."

    New updates and recent progress include:

    COVID-19 Vaccine Development

    • Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; making capital investments to increase capacity up to an expected 1.4 billion doses in 2022
    • Phase 2/3 study of mRNA-1273 in adolescents has completed enrollment of 3,000 participants

    Infectious Diseases

    • First cohort in the Phase 1 study of hMPV/PIV3 vaccine candidate (mRNA-1653) fully enrolled
    • First older adult in the Phase 1 study of RSV vaccine candidate (mRNA-1345) has been dosed
    • First 3 cohorts in age de-escalation study of RSV vaccine candidate (mRNA-1345) for the pediatric population fully enrolled

    Rare Diseases

    • Study start-up activities for Phase 1/2 study of PA candidate (mRNA-3927) ongoing

    Cardiovascular Diseases

    • Regained all rights to the Relaxin development candidate from AstraZeneca

    Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered clinical studies. The Company's updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 65 peer-reviewed papers.

    Summary of Program Highlights by Modality

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.

    COVID-19 Vaccine Development

    • Moderna COVID-19 Vaccine: On December 30, 2020, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Today, the Company is sharing an update on the Phase 3 COVE study. An updated total of adjudicated COVID-19 cases among baseline seronegative participants in the COVE study starting two weeks following the second dose showed 690 cases to date, of which 639 cases of COVID-19 were observed in the placebo group versus 51 cases observed in the Moderna COVID-19 Vaccine group. Participants in the Phase 3 COVE study are in the process of being unblinded and cases will continue to accrue. On December 18, 2020, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age and older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and Qatar. Moderna is working with additional health agencies and with the World Health Organization on the authorization of its vaccine in additional jurisdictions. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of the Moderna COVID-19 Vaccine with federal funding under Contract no. 75A50120C00034. Moderna retains worldwide rights to develop and commercialize the Moderna COVID-19 Vaccine.
    • Addressing Variants of Concern: On February 24, Moderna announced that it completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa and has shipped doses to the NIH for a Phase 1 clinical trial that will be led and funded by the NIH's NIAID. The Company also provided an update on its strategy for addressing SARS-CoV-2 variants of concern.

      • Publication of Note: Letter to the editor in the New England Journal of Medicine published February 17, 2021, showed vaccination with the Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant relative to prior variants.
    • Further Clinical Studies of mRNA-1273

      • Phase 2/3 "TeenCOVE" study of mRNA-1273 in adolescents: The Phase 2/3 study of mRNA-1273 in adolescents ages 12-17 years has completed enrollment of 3,000 participants in the U.S.
      • Phase 2 "KidCOVE" study of mRNA-1273 in young children: The Phase 2 study of mRNA-1273 in pediatric population ages 6 months to 11 years will start in the near-term.
      • Phase 1/2 study of mRNA-1273 in Japan: The Phase 1/2 study of Moderna's vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd is ongoing.
    • Next-generation vaccine against COVID-19 (mRNA-1283): mRNA-1283 is a next-generation vaccine candidate against COVID-19 that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). The encoded mRNA-1283 antigen is shorter than mRNA-1273, and is being developed as a potential refrigerator stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers. mRNA-1283 is intended to be evaluated for use as a booster dose for previously vaccinated or infected individuals as well as in a primary series for seronegative individuals.

    Vaccines requiring complex antigens and against highly prevalent infections

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from the Phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. Based on the interim analysis of the Phase 2 study, the 100 μg dose has been chosen for the Phase 3 pivotal study, which is expected to begin in 2021. Moderna owns worldwide commercial rights for mRNA-1647.
    • Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. Moderna is planning to begin a Phase 1 study of mRNA-1189 in 2021. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.

    Vaccines against respiratory infections

    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Moderna is enrolling seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653). The first cohort in this study has been fully enrolled. Moderna owns worldwide commercial rights to mRNA-1653.
    • Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. On January 11, Moderna announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults (greater than 50 years), in addition to the pediatric population, who are also at risk of significant RSV disease. In the pediatric population, the first three cohorts of younger adults in the Phase 1 age de-escalation study of mRNA-1345 are fully enrolled. The age range of toddlers in this de-escalation Phase 1 study has been amended to 12-59 months (from 12-36 months). In the older adult population, the first participant in the Phase 1 study of mRNA-1345 in the adult RSV vaccine has been dosed. The Company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.
    • Seasonal influenza vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of seasonal influenza is approximately $11 billion per year. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin Phase 1 clinical trials for this program in 2021.

    Public health vaccines

    • Zika virus vaccine (mRNA-1893):Moderna is preparing for a Phase 2 study of mRNA-1893, which is expected to begin in 2021. mRNA-1893 is being developed in collaboration with BARDA. Moderna owns worldwide commercial rights to mRNA-1893.
    • HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF), is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the NIH and includes multiple native-like trimer antigens. The Company expects to begin Phase 1 studies for both mRNA-1644 and mRNA-1574 in 2021.
    • Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).
    • Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.

    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day in September and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.
    • IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a long-acting tolerizing IL-2. This new autoimmune development candidate is designed to preferentially activate and expand the regulatory T cell population. The Company plans to conduct a Phase 1 study of mRNA-6231 in healthy adult volunteers. mRNA-6231 uses the same LNP formulation as mRNA-1944. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Moderna owns worldwide commercial rights to mRNA-6231.
    • PD-L1 (mRNA-6981): mRNA-6981 is an mRNA encoding for PD-L1. This new autoimmune development candidate is designed to augment cell surface expression of PD-L1 on myeloid cells to provide co-inhibitory signals to self-reactive lymphocytes. As an initial step to addressing a range of autoimmune indications, the Company intends to pursue proof-of-concept in a Phase 1 study of mRNA-6981 in type 1 autoimmune hepatitis (AIH), a condition that involves liver inflammation and can lead to cirrhosis and liver failure. mRNA-6981 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-6981.
    • Relaxin (AZD7970): Moderna has regained all rights to the Relaxin development candidate from AstraZeneca. Moderna now owns worldwide commercial rights to this development candidate.

    Exploratory Modalities

    Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

    • Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. Phase 1 in multiple cohorts is ongoing. The upsized head & neck cohort is recruiting additional patients. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.
    • Mutant KRAS vaccine (mRNA-5671 or V941): The Phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.

    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The Phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.
    • OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The Phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.
    • IL-12 (MEDI1191): The Phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

    Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

    • VEGF-A (AZD8601): The Phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.

    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Propionic acidemia (PA) (mRNA-3927): Study start-up activities for the Phase 1/2 study of PA candidate (mRNA-3927) have resumed following COVID-19 related pause and protocol amendment. mRNA-3927 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3927.
    • Methylmalonic acidemia (MMA) (mRNA-3705): Moderna received rare pediatric designation for its next generation MMA candidate (mRNA-3705). The Company plans to file new IND and CTA applications for mRNA-3705 and will focus development efforts on that candidate going forward. mRNA-3705 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3705.
    • Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU have a deficiency in phenylalanine hydroxylase (PAH) resulting in a reduced or complete inability to metabolize the essential amino acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to restore the deficient or defective intracellular enzyme activity in patients with PKU. mRNA-3283 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3283.
    • Glycogen storage disease type 1a (GSD1a) (mRNA-3745): Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV-administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. mRNA-3745 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3745.

    Information about each development candidate in Moderna's pipeline can be found on the investor relations page of its website: investors.modernatx.com.

    Fourth Quarter and Full Year 2020 Financial Results (Unaudited)

    • Cash Position: Cash, cash equivalents and investments as of December 31, 2020 and 2019 were $5.25 billion and $1.26 billion, respectively.
    • Net Cash Provided by (Used in) Operating Activities: Net cash provided by operating activities was $2.03 billion for the year ended December 31, 2020 compared to net cash used in operating activities of $(459) million for the year ended December 31, 2019.
    • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $67 million for the year ended December 31, 2020 compared to $32 million for the same period in 2019.
    • Revenue: Total revenue was $571 million for the fourth quarter of 2020 compared to $14 million for the fourth quarter of 2019. Total revenue was $803 million for the year ended December 31, 2020 compared to $60 million for the year ended December 31, 2019. The increases in both periods in 2020 were driven by increases in grant revenue and product sales. The increase in grant revenue was primarily due to the BARDA award to accelerate development of our COVID-19 vaccine. We began to recognize revenue in December 2020 from our COVID-19 vaccine subsequent to its authorization for emergency use by the FDA and Health Canada.
    • Cost of Sales: Costs of sales were $8 million, or 4% of Moderna's product sales, in 2020, primarily comprised of third-party royalties as the associated inventory costs were expensed previously. If inventory sold during 2020 was valued at cost, Moderna's cost of sales for 2020 would have been $62 million, or 31% of Moderna's product sales.
    • Research and Development Expenses: Research and development expenses were $759 million for the fourth quarter of 2020 compared to $118 million for the fourth quarter of 2019. Research and development expenses were $1.37 billion for the year ended December 31, 2020 compared to $496 million for the year ended December 31, 2019. The increases in 2020 were largely attributable to mRNA-1273 clinical development, pre-launch inventory buildup prior to the emergency use authorization from the FDA and to a lesser extent, an increase in personnel related costs, primarily driven by an increase in the number of employees supporting our mRNA-1273 development activities.
    • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $79 million for the fourth quarter of 2020 compared to $26 million for the fourth quarter of 2019. Selling, general and administrative expenses were $188 million for the year ended December 31, 2020 compared to $110 million for the year ended December 31, 2019. The increases in 2020 were mainly due to an increase in personnel costs, and outside services, primarily attributable to increased headcount and mRNA-1273 vaccine candidate commercialization-related activities.
    • Net Loss: Net loss was $272 million for the fourth quarter of 2020 compared to $123 million for the fourth quarter of 2019. Net loss was $747 million for the year ended December 31, 2020 compared to $514 million for the year ended December 31, 2019.

    Moderna's COVID-19 Vaccine Supply Agreements & Regulatory Updates

    Moderna has confirmed the following supply agreements of committed orders:

    • United States: 300 million doses with options to purchase an additional 200 million doses; the U.S. Food and Drug Administration (FDA) has authorized emergency use in individuals 18 years of age and older
    • European Union: 310 million doses with option to purchase an additional 150 million doses in 2022; the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna in individuals 18 years of age and older1
    • Japan: 50 million doses
    • Canada: 44 million doses; Health Canada authorized COVID-19 Vaccine Moderna for the immunization of people 18 years of age and older under an Interim Order
    • Republic of Korea: 40 million doses
    • United Kingdom: 17 million doses; the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 Vaccine Moderna for use under Regulation 174, a temporary authorization
    • Switzerland: 13.5 million doses; Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland
    • Colombia: 10 million doses
    • Israel: 6 million doses; Israel's Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna
    • Taiwan: 5 million doses
    • Singapore: (undisclosed); the Singapore Health Sciences Authority (HSA) approved the interim authorization of the COVID-19 Vaccine Moderna for use under the Pandemic Special Access Route (PSAR)
    • Qatar (undisclosed); the Qatar Ministry of Public Health issued an emergency use authorization for the COVID-19 Vaccine Moderna

    Management Updates

    • Moderna's Chief Medical Officer (CMO), Tal Zaks, M.D., Ph.D., will be leaving the Company in late September after six years of service. The Company has retained Russell Reynolds to recruit for a new CMO with global and commercial experience as the Company scales up the launch of its COVID-19 Vaccine and prepares to file several biologics license applications (BLAs) over the next few years.

    "I would like to thank Tal for his tremendous impact on Moderna's success over the last six years. Tal joined us when we were a pre-clinical company. His guidance and contributions were important in helping Moderna get to where we are today. Through his leadership over the past year in Moderna's response to the COVID-19 pandemic, Tal has made a contribution that extends beyond Moderna to all of society. I have enjoyed having him as my partner and wish him all the best as he embarks on the next leg of his career," said Stéphane Bancel.

    • Corinne Le Goff, Pharm.D., M.B.A., joined Moderna as the Company's first Chief Commercial Officer on January 19, 2021. Dr. Le Goff previously served as SVP and President U.S. Business Organization at Amgen (NASDAQ:AMGN). During her nearly 6-year tenure at Amgen, she also served as SVP of the Europe Region and oversaw 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality and affordable healthcare.

    2020 Commercial Network

    The Company started to build a global commercial network. This infrastructure will enable Moderna's entire portfolio, which means that Moderna can commercialize its entire pipeline without a large pharmaceutical partner. The Company now has subsidiaries, distributors or partners in the following geographies:

    • Moderna USA
    • Moderna Canada
    • Moderna France
    • Moderna Germany
    • Moderna Italy
    • Japan (Partner: Takeda)
    • Moderna Spain
    • Moderna UK
    • Moderna Switzerland

    Corporate Updates

    • Shareholder letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.
    • Annual Meeting of Shareholders: The Moderna Annual Meeting of Shareholders will be held on April 28, 2021 at 8:00 a.m. ET. The meeting will be held virtually at www.virtualshareholdermeeting.com/MRNA2021. The record date for voting or attendance as a stockholder is 4:00 p.m. ET on March 1, 2021.

    2021 Financial Considerations

    • Advance Purchase Agreements (APAs): Already signed APAs for scheduled delivery in 2021, reflecting a total of $18.4 billion in anticipated product sales. Additional discussions ongoing with several governments relating to APAs for scheduled deliveries in 2021 and 2022. Moderna responded to a tender to UNICEF to supply COVAX in 2021 and 2022 and discussions are ongoing with COVAX/UNICEF.
    • Cost of Sales: Expected at approximately 20% of product sales for fiscal year 2021.
    • 2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: For the first quarter 2021, expect low double-digit percent increase versus adjusted fourth quarter 2020 results of $0.5 billion. The fourth quarter 2020 reported expense was $0.8 billion. Adjusted Q4 expense, totaling $0.5 billion, excludes $0.3 billion of reported expenses, which are now capitalized and expensed through cost of sales, based on our change from a research and development to a commercial organization.
    • Tax Rate: Effective tax rate expected in the mid-teen percentage level as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of $2.3 billion.
    • Capital Expenditures: $350-400 million of capital investments currently planned for 2021.

    2021 New Commercial Networks

    In 2021, the Company plans to further expand its commercial network to enable Moderna's entire portfolio.

    • Moderna Australia
    • Moderna Japan
    • Moderna South Korea

    Key 2021 Investor and Analyst Event Dates

    • Vaccines Day – April 14
    • Science Day – May 27
    • R&D Day – September 9

    Investor Call and Webcast Information

    Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, February 25, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 4066945. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    MODERNA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, in thousands)

     

     

    Three Months Ended December 31,

     

    Years Ended December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

    Grant revenue

    $

    341,370

     

     

    $

    3,502

     

     

    $

    528,905

     

     

    $

    12,173

     

    Product sales

    199,872

     

     

     

     

    199,872

     

     

     

    Collaboration revenue

    29,503

     

     

    10,553

     

     

    74,618

     

     

    48,036

     

    Total revenue

    570,745

     

     

    14,055

     

     

    803,395

     

     

    60,209

     

    Operating expenses:

     

     

     

     

     

     

     

    Cost of sales

    7,933

     

     

     

     

    7,933

     

     

     

    Research and development

    758,860

     

     

    117,954

     

     

    1,370,339

     

     

    496,309

     

    Selling, general and administrative

    78,990

     

     

    25,707

     

     

    188,267

     

     

    109,620

     

    Total operating expenses

    845,783

     

     

    143,661

     

     

    1,566,539

     

     

    605,929

     

    Loss from operations

    (275,038

    )

     

    (129,606

    )

     

    (763,144

    )

     

    (545,720

    )

    Interest income

    4,200

     

     

    7,984

     

     

    24,715

     

     

    38,530

     

    Other expense, net

    (174

    )

     

    (1,837

    )

     

    (6,084

    )

     

    (7,526

    )

    Loss before provision for (benefit from) income taxes

    (271,012

    )

     

    (123,459

    )

     

    (744,513

    )

     

    (514,716

    )

    Provision for (benefit from) income taxes

    1,473

     

     

    (169

    )

     

    2,551

     

     

    (695

    )

    Net loss

    $

    (272,485

    )

     

    $

    (123,290

    )

     

    $

    (747,064

    )

     

    $

    (514,021

    )

    Net loss per share, basic and diluted

    $

    (0.69

    )

     

    $

    (0.37

    )

     

    $

    (1.96

    )

     

    $

    (1.55

    )

    Weighted average common shares used in net loss per share, basic and diluted

    396,697,168

     

    334,392,128

     

    381,333,059

     

    330,802,136

    MODERNA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

    (Unaudited, in thousands)

     

     

    December 31,

     

    2020

     

    2019

    Cash, cash equivalents and investments

    $

    5,246,456

     

     

    $

    1,262,987

     

    Total assets

    7,336,750

     

     

    1,589,422

     

    Total liabilities

    4,775,375

     

     

    414,612

     

    Total stockholders' equity

    2,561,375

     

     

    1,174,810

     

     

     

    Years Ended December 31,

     

    2020

     

    2019

    Net cash provided by (used in) operating activities

    $

    2,026,971

     

     

    $

    (458,968

    )

    Cash used for purchases of property and equipment (1)

    (67,448

    )

     

    (31,554

    )

    (1)

    Includes $41.7 million and $14.6 million for the years ended December 31, 2020 and 2019, respectively, related to our Moderna Technology Center facilities.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's development of the Moderna COVID-19 Vaccine (mRNA-1273); the number of doses of the Moderna COVID-19 Vaccine that the Company anticipates being able to manufacture in 2021 and 2022 and on a quarterly basis, and investments to facilitate that manufacturing; the Company's efforts to continue developing vaccines against COVID-19, including efforts to develop vaccines against variant strains of SARS-CoV-2 and for booster doses; the Company's establishment of additional subsidiaries and development of its commercial network; the status of developments for programs in the Company's pipeline, including with respect to the timing, enrollment and potential results of clinical trials; future growth prospects for the Company; the efficacy of mRNA vaccines and their potential for regulatory approval or authorization; expected timing of execution of the Purchase Agreement by the European Commission for additional vaccine doses; future research and development expenses; sales, general and administrative expenses; and capital expenditures, as well as other expenses; orders for the Company's Moderna COVID-19 Vaccine, both inside and outside the U.S.; anticipated doses to be delivered under advance purchase agreement in 2021 and the associated dollar amounts to be received, which should not be construed as expected 2021 revenue; the anticipated cost of sales associated with the Moderna COVID-19 Vaccine; the Company's future tax rate; and personnel recruitment efforts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    1 On February 18, 2021, the European Commission advised Moderna it had successfully tendered for the provision of 150 million doses of COVID-19 Vaccine Moderna in 2021 and an option to purchase an additional 150 million doses in 2022; this tender is subject to execution of the Purchase Agreement, which is expected February 26, 2021, following an opt out period for individual Member States.

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  10. THOUSAND OAKS, Calif., Feb. 24, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 41st Annual Virtual Healthcare Conference at 12:50 p.m. ET on Thursday, March 4, 2021. Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event.

    About Amgen 
    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing…

    THOUSAND OAKS, Calif., Feb. 24, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 41st Annual Virtual Healthcare Conference at 12:50 p.m. ET on Thursday, March 4, 2021. Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

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  11. THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Friday, Feb. 26, at 1:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with clinical trial investigators, will discuss the results of the tezepelumab Phase 3 NAVIGATOR study in patients with severe asthma.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business…

    THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Friday, Feb. 26, at 1:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with clinical trial investigators, will discuss the results of the tezepelumab Phase 3 NAVIGATOR study in patients with severe asthma.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

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  12. THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.

    "Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing…

    THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.

    "Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing topical therapies and still have challenges managing their disease, particularly those with disease in hard-to-treat locations. Results from the ADVANCE trial demonstrated the potential of Otezla to provide an oral, non-biologic option for these patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with the FDA to potentially expand access to Otezla and deliver on our commitment to improve outcomes for people living with mild-to-moderate plaque psoriasis."

    Otezla also demonstrated statistically significant improvements in key secondary endpoints compared to placebo, including achieving at least a 75% improvement from baseline in the percent of affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16. Adverse events observed in the ADVANCE trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection.

    Detailed results will be submitted for presentation at an upcoming medical meeting.

    In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet's Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the U.S.1

    About ADVANCE (PSOR-022)

    ADVANCE (PSOR-022) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with mild-to-moderate plaque psoriasis (defined as BSA involvement of 2% to 15%, Psoriasis Area and Severity Index (PASI) score of 2 to 15, sPGA score of 2 to 3). The study randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 32.

    The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline] at week 16.

    About Psoriasis

    Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.2 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 7.5 million people in the United States.3,4 About 80% of those patients have plaque psoriasis.5 



    About Otezla® (apremilast)

    OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

    Otezla® (apremilast) U.S. INDICATIONS 

    Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

    Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

    Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

    Contraindications

    • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

    Warnings and Precautions

    • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
    • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur
      • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
      • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
      • Behcet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
    • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
      • Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
      • Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
      • Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
    • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

    Adverse Reactions

    • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
    • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
    • Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

    Use in Specific Populations

    • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
    • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
    • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

    Please click here for Otezla® Full Prescribing Information.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks 

    Trish Rowland, 805-447-5631 (Media) 

    Megan Fox, 805-447-1423 (Media)

    Arvind Sood, 805-447-1060 (Investors) 

    1 Data on File at Amgen Inc.

    2 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed September 22, 2020.

    3 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed September 22, 2020.

    4 Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45.

    5 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed September 22, 2020.

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  13. THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.

    The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard…

    THOUSAND OAKS, Calif., Feb. 16, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for sotorasib for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.

    The FDA grants Priority Review to applications for medicines that offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. Based on the Priority Review designation, the Prescription Drug User Fee Action (PDUFA) date for sotorasib is Aug. 16, 2021, which is four months earlier than the standard review cycle.

    The New Drug Application (NDA) is based on the Phase 2 results from the CodeBreaK 100 clinical trial that studied patients with locally advanced or metastatic NSCLC whose cancer had progressed despite treatment with chemotherapy and/or immunotherapy. Full results from the study were recently presented during the Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC).

    Amgen submitted the sotorasib NDA on Dec. 16, 2020. The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR), a pilot program that aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Amgen submitted a Marketing Authorization Application (MAA) in the EU in Dec. 2020. Additionally, Amgen submitted MAAs for sotorasib in Australia, Brazil, Canada and the United Kingdom in Jan. 2021 to participate in the FDA's Project Orbis initiative. Sotorasib has achieved Breakthrough Therapy Designation in the U.S. and China.

    About Sotorasib

    Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, a KRASG12C inhibitor.1 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest global clinical program exploring 10 combinations with clinical sites spanning five continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 700 patients studied across 13 tumor types.

    About Non-Small Cell Lung Cancer and the KRAS G12C Mutation

    NSCLC accounts for 80%-85% of all lung cancers, and most patients (66%) have advanced or metastatic disease at initial diagnosis.2,3 KRAS G12C is one of the most common driver mutations in NSCLC and there is a high unmet need and poor outcomes associated in the second-line treatment of KRAS G12C driven NSCLC.4 In the U.S., approximately 25,000 new patients are diagnosed with KRAS G12C-mutated NSCLC each year.5

    About CodeBreaK

    The CodeBreaK clinical development program for Amgen's investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers.

    CodeBreaK 100, the Phase 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

    A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel (CodeBreaK 200) is currently recruiting patients with KRAS G12C-mutant NSCLC. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

    For information, please visit www.codebreaktrials.com.

    About Amgen Oncology

    Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient's life – not just their cancer journey – so they can take control of their lives.

    For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company's history, moving with great speed to advance those innovations for the patients who need them.

    At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

    To learn more about Amgen's innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks

    Trish Rowland, 805-447-5631 (Media)

    Jessica Akopyan, 805-447-0974 (Media)

    Arvind Sood, 805-447-1060 (Investors)

    References

    __________________________

    1 Canon J, et al. Nature. 2019;575:217-223.

    2 American Cancer Society. https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Accessed January 2021.

    3 Ahmadzada T, et al. J Clin Med. 2018;7:153.

    4 Pakkala S, et al. JCI Insights. 2018;3:3120858.

    5 American Cancer Society, Cancer Facts and Figures. 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. Accessed November 23, 2020.

     

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  14. THOUSAND OAKS, Calif., Feb. 9, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Greg Friberg, vice president and global oncology therapeutic area head at Amgen, will participate in a fireside chat as part of the Guggenheim Healthcare Talks 2021 Oncology Day on Friday, Feb. 12 at 12:30 p.m. ET.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability…

    THOUSAND OAKS, Calif., Feb. 9, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that Greg Friberg, vice president and global oncology therapeutic area head at Amgen, will participate in a fireside chat as part of the Guggenheim Healthcare Talks 2021 Oncology Day on Friday, Feb. 12 at 12:30 p.m. ET.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

     

     

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  15. THOUSAND OAKS, Calif., Feb. 3, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced a three-year, Golden Ticket sponsorship of the BioLabs LA at The Lundquist Institute (TLI) life sciences co-working space to accelerate the development of new therapies, medical devices, and diagnostics to advance and improve human health. The BioLabs at TLI shared laboratory space was created to help high-potential life science and biotech startups overcome key obstacles for many early stage organizations, including: access to laboratory infrastructure, programming, and business development mentorship.

    As part of the sponsorship, Amgen will launch one "Amgen Golden Ticket" award each year for three years, providing winners with one year of lab space at…

    THOUSAND OAKS, Calif., Feb. 3, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced a three-year, Golden Ticket sponsorship of the BioLabs LA at The Lundquist Institute (TLI) life sciences co-working space to accelerate the development of new therapies, medical devices, and diagnostics to advance and improve human health. The BioLabs at TLI shared laboratory space was created to help high-potential life science and biotech startups overcome key obstacles for many early stage organizations, including: access to laboratory infrastructure, programming, and business development mentorship.

    As part of the sponsorship, Amgen will launch one "Amgen Golden Ticket" award each year for three years, providing winners with one year of lab space at BioLabs as well as additional facility benefits and connections to Amgen's scientific and business leaders.

    "Recognizing the growing biotech ecosystem in Southern California, Amgen's sponsorship of the Golden Ticket with BioLabs aims to further foster early-stage life science companies right in the backyard of Amgen's headquarters," said Philip Tagari, Ph.D., vice president of Therapeutic Discovery at Amgen. "It's very rewarding to be part of the growing energy, reach, and enthusiasm of the many talented scientific entrepreneurs across the broader Los Angeles area. BioLabs is a model for how life science startups can grow and thrive in a rapidly emerging bioscience community."

    "Having Amgen join BioLabs at TLI as a significant sponsor sends a clear message about how Los Angeles has progressed as a major bioscience hub and how far our shared laboratory facility has come in just over a year of operation," said Keith B. Hoffman, Ph.D., senior vice president of Business Development and Technology Transfer at the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center. "I'm extremely proud that we were able to bring the BioLabs organization to Los Angeles and that the BioLabs facility at TLI now houses the highest concentration of promising bioscience startups in the greater Los Angeles region. This partnership with Amgen represents another significant step in the rapid expansion and reach of the Los Angeles bioscience community within and surrounding counties in Southern California. I'm honored to add Amgen's substantial reputation and reach to our member companies already in the space, and those who will join us in the future."

    "We're thrilled that Amgen has joined as our newest sponsor and look forward to working with the Amgen team to support these early-stage entrepreneurs and to help accelerate development of new therapies to improve human health," said BioLabs President & CEO Johannes Fruehauf, M.D., Ph.D. "With their deep expertise as developers of biotech-based drugs, Amgen is an ideal partner for many of BioLabs' resident companies working on promising new biopharmaceuticals."

    Amgen supports life science start-ups through Golden Ticket awards and affiliated engagement in other Biotech Innovative hubs, including San Francisco, Boston and Toronto.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    About The Lundquist Institute: Research with reach™

    The Lundquist Institute is an engine of innovation with a global reach and a 68-year reputation of improving and saving lives. With its new medical research building, its state-of-the-art incubator, "BioLabs at The Lundquist," existing laboratory and support infrastructure, and a 15-acre tech park in the planning stages, the Lundquist Institute serves as a hub for the Los Angeles area's burgeoning biotech scene. The research institute has over 100 principal investigators (Ph.D.s, M.D.s, and M.D./Ph.D.s) working on more than 600 research studies, including therapies for numerous, and often fatal orphan diseases. Find out more at https://lundquist.org.

    About BioLabs LA at The Lundquist Institute

    Encompassing the entire third floor of The Lundquist Institute's new Medical Research Lab building, BioLabs LA offers shared lab facilities designed for high-potential, early-stage life since companies. BioLabs creates co-working communities that pair premium, fully equipped and supported lab and office space with unparalleled access for entrepreneurs to networking, industry partners, and capital. Find out more at https://www.biolabs.io/la.

    CONTACT:

    Amgen

    Jessica Akopyan, (805) 447-0974,  (media)

    The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Keith B. Hoffman, Ph.D., (310) 974-9301,  

    BioLabs LA

    Gary Olsem, (310) 618-6892,  

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  16. THOUSAND OAKS, Calif., Feb. 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2020 versus comparable periods in 2019. Key results include:

    • For the fourth quarter, total revenues increased 7% to $6.6 billion in comparison to the fourth quarter of 2019, driven by higher volume growth, partially offset by lower net selling prices.
      • Product sales increased 8% globally, driven by 13% volume growth across the portfolio, including Otezla® (apremilast), MVASI® (bevacizumab-awwb), KANJINTI® (trastuzumab-anns), and Repatha® (evolocumab), partially offset by declines in mature products that resulted from biosimilar and generic competition.
    • For the full year, total revenues increased 9% to…

    THOUSAND OAKS, Calif., Feb. 2, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced financial results for the fourth quarter and full year 2020 versus comparable periods in 2019. Key results include:

    • For the fourth quarter, total revenues increased 7% to $6.6 billion in comparison to the fourth quarter of 2019, driven by higher volume growth, partially offset by lower net selling prices.
      • Product sales increased 8% globally, driven by 13% volume growth across the portfolio, including Otezla® (apremilast), MVASI® (bevacizumab-awwb), KANJINTI® (trastuzumab-anns), and Repatha® (evolocumab), partially offset by declines in mature products that resulted from biosimilar and generic competition.
    • For the full year, total revenues increased 9% to $25.4 billion driven by higher volume growth, partially offset by lower net selling prices and the effects of the COVID-19 pandemic.
    • GAAP earnings per share (EPS) decreased 3% to $2.76 in the fourth quarter and 4% to $12.31 for the full year primarily driven by the amortization of costs associated with our November 2019 acquisition of Otezla, partially offset by an increase in revenues.
      • For the fourth quarter, GAAP operating income decreased 2% to $2.0 billion and GAAP operating margin decreased 3.1 percentage points to 31.7%, primarily driven by the amortization of intangible assets from our Otezla acquisition. For the full year, GAAP operating income decreased 6% to $9.1 billion and GAAP operating margin decreased 5.9 percentage points to 37.7%.
    • Non-GAAP EPS increased 5% in the fourth quarter to $3.81, and 12% to $16.60 for the full year, driven by increased revenues, partially offset by increased operating expenses.
      • For the fourth quarter, non-GAAP operating income increased 4% to $2.7 billion and non-GAAP operating margin decreased 1.5 percentage points to 43.1%. For the full year, non-GAAP operating income increased 11% to $12.3 billion and non-GAAP operating margin increased 0.7 percentage points to 50.9%.
    • The Company generated $9.9 billion of free cash flow for the full year versus $8.5 billion in 2019.
    • 2021 total revenues guidance of $25.8-$26.6 billion; EPS guidance of $12.12-$13.17 on a GAAP basis and $16.00-$17.00 on a non-GAAP basis.

    "In a year marked by the disruption of COVID-19, we served patients around the world without interruption, advanced our pipeline and delivered strong financial performance, all while keeping our employees safe," said Robert A. Bradway, chairman and chief executive officer. "As we move into 2021, we look forward to commercializing our pipeline successes."

    $Millions, except EPS, dividends paid per share and percentages



    Q4 '20



    Q4 '19



    YOY Δ



    FY'20



    FY'19



    YOY Δ

    Total Revenues



    $

    6,634





    $

    6,197





    7%



    $

    25,424





    $

    23,362





    9%

    GAAP Operating Income



    $

    2,008





    $

    2,048





    (2%)



    $

    9,139





    $

    9,674





    (6%)

    GAAP Net Income



    $

    1,615





    $

    1,703





    (5%)



    $

    7,264





    $

    7,842





    (7%)

    GAAP EPS



    $

    2.76





    $

    2.85





    (3%)



    $

    12.31





    $

    12.88





    (4%)

    Non-GAAP Operating Income



    $

    2,728





    $

    2,621





    4%



    $

    12,334





    $

    11,157





    11%

    Non-GAAP Net Income



    $

    2,229





    $

    2,174





    3%



    $

    9,795





    $

    9,028





    8%

    Non-GAAP EPS



    $

    3.81





    $

    3.64





    5%



    $

    16.60





    $

    14.82





    12%

    Dividends Paid Per Share



    $

    1.60





    $

    1.45





    10%



    $

    6.40





    $

    5.80





    10%

    References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.

    Product Sales Performance

    Total product sales increased 8% for the fourth quarter of 2020 versus the fourth quarter of 2019 driven by 13% volume growth, partially offset by lower net selling price. Product sales increased 9% for the full year driven by 15% volume growth, partially offset by lower net selling price. Full-year product sales in the U.S. grew 9%. Full-year product sales outside the U.S. grew 10%, with revenues in the Asia-Pacific region exceeding $1 billion for the first time.

    COVID-19 update: During the fourth quarter, physician-patient interactions continued to rebound but remained below pre-COVID-19 levels on a portfolio basis. We expect continued COVID-19 impact and quarter-to-quarter variability throughout 2021, with recovery in the latter part of the year contingent upon the speed and effectiveness of the global vaccination rollout. Recall, Q1 2020 also benefited from ~$100 million in inventory stocking across the portfolio related to COVID-19, which we do not expect to repeat in Q1 2021. 

    Results for individual products are as follows:

    • Prolia® (denosumab) sales were flat year-over-year for the fourth quarter, and increased 3% for the full year. Given the impact of the pandemic in the second quarter of 2020 and the 6-month dosing regimen of Prolia, the number of repeat patients in the fourth quarter was lower than historical trends. We saw a sustained positive trend in new patients starting treatment, as osteoporosis diagnosis levels in the U.S. reached ~80% of pre-COVID-19 levels in the fourth quarter, and we remain confident in the continued recovery and growth of Prolia. With approximately 9 million osteoporotic fractures each year globally, our efforts remain focused on ensuring that post-menopausal women receive appropriate screening, diagnosis and treatment.
    • EVENITY® (romosozumab-aqqg) sales increased 6% year-over-year for the fourth quarter and increased 85% for the full year, driven by volume growth. We expect the second half 2020 inventory drawdown in Japan from our partner Astellas to be largely complete. We expect strong volume growth for Evenity to continue in 2021.
    • Repatha sales increased 27% year-over-year for the fourth quarter, and increased 34% for the full year, driven by 49% and 67% volume growth, respectively. These volume gains in 2020 were partially offset by price declines resulting from contracting to improve Medicare Part D patient access and patient affordability. With comprehensive payer coverage now secured in the U.S., we expect net selling price to remain relatively stable in 2021. Repatha remains the global proprotein convertase subtilisin/kexin type 9 (PCSK9) segment leader, and we remain confident in our ability to grow Repatha given the millions of high-risk cardiovascular patients worldwide.
    • Aimovig® (erenumab-aooe)* sales increased 6% year-over-year for the fourth quarter, and increased 24% for the full year, driven by volume growth, partially offset by lower net selling price. Aimovig remains the leader within the preventive calcitonin gene-related peptide (CGRP) segment, with 46% average share of total prescriptions (TRx), and 38% average share of new-to-brand prescriptions (NBRx) in the fourth quarter. The impact of the COVID-19 pandemic has dampened new patient starts for this segment. However, with strong payer access as well as recent positive efficacy and safety data versus topiramate, Aimovig is well positioned for long-term growth in the preventive segment, which impacts more than 4 million individuals in the U.S.
    • Parsabiv® (etelcalcetide) sales decreased 4% year-over-year for the fourth quarter, and increased 14% for the full year. Parsabiv sales benefited in the quarter from an end customer inventory build ahead of the inclusion of calcimimetics in the end-stage renal disease (ESRD) bundled payment system. With Parsabiv's inclusion in the bundle, we expect sales to decline by approximately 40-50% in 2021 as U.S. dialysis centers update their treatment protocols to shift utilization from Parsabiv to generic oral calcimimetics. Additionally, we expect sales in Q1 2021 to be impacted as customers draw down the approximately $40 million in inventory built in the second half of 2020.
    • Otezla* generated $617 million of sales in the fourth quarter of 2020, and $2.2 billion for the full year. Full-year U.S. Otezla TRx increased 13% year-over-year, and NBRx volumes continued to recover from the effects of COVID-19. Looking forward, we see growth opportunities with continued geographic expansion and the planned U.S. submission of the mild-to-moderate psoriasis indication.
    • Enbrel® (etanercept)* sales decreased 5% year-over-year for the fourth quarter, and decreased 4% for the full year, driven by volume declines. In addition, the full year decrease was driven by lower net selling price, partially offset by favorable changes to estimated sales deductions. Enbrel share declined modestly in the fourth quarter, and that loss was compounded by lower growth of the rheumatology segment due to COVID-19. Enbrel benefited from ~$115M in favorable changes to estimated sales deductions in Q1 2020 which will unfavorably impact the year-over-year comparison in Q1 2021.
    • AMGEVITA (adalimumab) increased 45% year-over-year for the fourth quarter, and increased 54% for the full year driven by volume growth, partially offset by lower net selling price. AMGEVITA continues to be the most prescribed adalimumab biosimilar in Europe. We expect volume trends to continue into 2021 as we launch into additional markets across the world.
    • KYPROLIS® (carfilzomib) sales increased 2% year-over-year for the fourth quarter, and increased 2% for the full year. Uptake of KYPROLIS in combination with DARZALEX® (daratumumab) plus dexamethasone (DKd) in the U.S. has been encouraging as reflected in new patient share, and we expect this momentum to continue into 2021 with additional global regulatory approvals of the DKd combination.
    • XGEVA® (denosumab) sales increased 3% year-over-year for the fourth quarter driven by volume growth. The full year decline of 2% was driven by the impacts of the COVID-19 pandemic, including a decrease in patient visits and revised treatment recommendations to prioritize primary cancer treatments over bone-targeting agents. In 2021, we expect volume growth to continue.
    • Vectibix® (panitumumab) sales increased 21% year-over-year for the fourth quarter, and increased 9% for the full year, driven by volume growth. In the fourth quarter, volume growth benefited from the timing of shipments to Takeda, our partner in Japan.
    • Nplate® (romiplostim) sales increased 8% year-over-year for the fourth quarter, benefited by favorable changes in inventory and volume growth, and increased 7% for the full year, driven by volume growth.
    • BLINCYTO® (blinatumomab) sales increased 29% year-over-year for the fourth quarter, and increased 21% for the full year, driven by volume growth as we continued to see broader adoption in the community hospital setting.
    • MVASI generated $280 million of sales in the fourth quarter of 2020, and $798 million of sales for the full year. In the U.S., MVASI became the leader of the bevacizumab segment in the fourth quarter with an average share of 48%. Sales increased 21% quarter-over-quarter driven by 25% volume growth, partially offset by a decline in net selling price. Heading into 2021, we expect MVASI to be launched across multiple new markets and expect worldwide volume growth, partially offset by a decline in net selling price due to increased competition.
    • KANJINTI generated $158 million of sales in the fourth quarter of 2020, and $567 million for the full year, with a 41% average share of the trastuzumab segment in the U.S for the fourth quarter. Sales declined quarter-over-quarter as volume gains were offset by price declines and unfavorable changes to estimated sales deductions. Given the number of competitors in the trastuzumab segment, we expect the fourth quarter sequential sales trend to continue in 2021.
    • Neulasta® (pegfilgrastim) sales decreased 19% year-over-year for the fourth quarter, and decreased 29% for the full year, driven by declines in net selling price and volumes due to increased biosimilar competition. Within the long-acting granulocyte colony-stimulating factor (G-CSF) segment, Neulasta Onpro® continues to be the preferred choice for physicians and patients with volume share of 54% in the quarter. The most recent published Average Selling Price for Neulasta in the U.S. showed a decline of 28% year-over-year. In 2021, we expect the pricing and volume dynamics to continue as biosimilar competition increases.
    • NEUPOGEN® (filgrastim) sales decreased 26% year-over-year for the fourth quarter, and decreased 15% for the full year, driven by volume decline due to competition.
    • EPOGEN® (epoetin alfa) sales decreased 37% year-over-year for the fourth quarter, and decreased 31% for the full year, driven by volume declines, as well as lower net selling price resulting from our existing contractual commitment with DaVita. We expect these volume and pricing trends to continue in 2021.
    • Aranesp® (darbepoetin alfa) sales decreased 12% year-over-year for the fourth quarter, and decreased 9% for the full year, driven by lower net selling price and volume declines due to competition.
    • Sensipar/Mimpara® (cinacalcet) sales decreased 58% year-over-year for the fourth quarter, and decreased 48% for the full year, driven by declines in volume due to generic competition.

    * We expect Aimovig, Otezla and Enbrel to follow the historic pattern of lower Q1 sales relative to subsequent quarters due to the impact of benefit plan changes, insurance reverification and increased co-pay expenses as U.S. patients work through deductibles.

    Product Sales Detail by Product and Geographic Region

    $Millions, except percentages



    Q4 '20



    Q4 '19



    YOY Δ





    US



    ROW



    TOTAL



    TOTAL



    TOTAL

    Prolia®



    $

    489





    $

    260





    $

    749





    $

    752





    —%

    EVENITY®



    60





    30





    90





    85





    6%

    Repatha®



    128





    125





    253





    200





    27%

    Aimovig®



    104









    104





    98





    6%

    Parsabiv®



    143





    29





    172





    179





    (4%)

    Otezla®



    510





    107





    617





    178





    *

    Enbrel®



    1,236





    36





    1,272





    1,346





    (5%)

    AMGEVITA™







    103





    103





    71





    45%

    KYPROLIS®



    183





    89





    272





    266





    2%

    XGEVA®



    369





    133





    502





    489





    3%

    Vectibix®



    93





    128





    221





    182





    21%

    Nplate®



    133





    94





    227





    210





    8%

    BLINCYTO®



    64





    39





    103





    80





    29%

    MVASI®



    214





    66





    280





    84





    *

    KANJINTI®



    129





    29





    158





    103





    53%

    Neulasta®



    463





    73





    536





    665





    (19%)

    NEUPOGEN®



    27





    19





    46





    62





    (26%)

    EPOGEN®



    133









    133





    210





    (37%)

    Aranesp®



    140





    235





    375





    427





    (12%)

    Sensipar®/Mimpara®



    11





    34





    45





    107





    (58%)

    Other**



    31





    45





    76





    87





    (13%)

    Total product sales



    $

    4,660





    $

    1,674





    $

    6,334





    $

    5,881





    8%























    * Change in excess of 100%





















    ** Other includes GENSENTA, IMLYGIC®, Corlanor®, Bergamo and AVSOLA®

     

    $Millions, except percentages



    FY'20



    FY'19



    YOY Δ





    US



    ROW



    TOTAL



    TOTAL



    TOTAL

    Prolia®



    $

    1,830





    $

    933





    $

    2,763





    $

    2,672





    3%

    EVENITY®



    191





    159





    350





    189





    85%

    Repatha®



    459





    428





    887





    661





    34%

    Aimovig®



    378









    378





    306





    24%

    Parsabiv®



    605





    111





    716





    630





    14%

    Otezla®



    1,790





    405





    2,195





    178





    *

    Enbrel®



    4,855





    141





    4,996





    5,226





    (4%)

    AMGEVITA™







    331





    331





    215





    54%

    KYPROLIS®



    710





    355





    1,065





    1,044





    2%

    XGEVA®



    1,405





    494





    1,899





    1,935





    (2%)

    Vectibix®



    342





    469





    811





    744





    9%

    Nplate®



    485





    365





    850





    795





    7%

    BLINCYTO®



    231





    148





    379





    312





    21%

    MVASI®



    656





    142





    798





    127





    *

    KANJINTI®



    475





    92





    567





    226





    *

    Neulasta®



    2,001





    292





    2,293





    3,221





    (29%)

    NEUPOGEN®



    144





    81





    225





    264





    (15%)

    EPOGEN®



    598









    598





    867





    (31%)

    Aranesp®



    629





    939





    1,568





    1,729





    (9%)

    Sensipar®/Mimpara®



    92





    196





    288





    551





    (48%)

    Other**



    109





    174





    283





    312





    (9%)

    Total product sales



    $

    17,985





    $

    6,255





    $

    24,240





    $

    22,204





    9%























    * Change in excess of 100%





















    ** Other includes GENSENTA, IMLYGIC®, Corlanor®, Bergamo and AVSOLA®

    Operating Expense, Operating Margin and Tax Rate Analysis

    On a GAAP basis:

    • Total Operating Expenses increased 11% in the fourth quarter and 19% for the full year. Cost of Sales margin increased 3.9 percentage points in the fourth quarter primarily driven by the amortization of intangible assets acquired in the Otezla acquisition, product mix, profit share and royalties. For the full year, Cost of Sales margin increased 5.8 percentage points, primarily driven by the amortization of intangible assets acquired in the Otezla acquisition, royalties, and profit share, partially offset by lower manufacturing costs. Research & Development (R&D) expenses decreased 6% in the fourth quarter driven by lower spend in research and early pipeline, which includes recoveries from our collaboration with BeiGene. For the full year, R&D expenses increased 2% driven by higher spend in support of our late-stage development programs, primarily sotorasib, our biosimilars and Otezla, partially offset by recoveries from our collaboration with BeiGene, and lower spend in certain oncology programs included in research and early pipeline. Selling, General & Administrative (SG&A) expenses increased 17% in the fourth quarter and 11% for the full year primarily due to investments in marketed product support, including Otezla, and product launches. The full-year increase was partially offset by a reduction in certain expenses due to the impact of COVID-19.
    • Operating Margin decreased 3.1 percentage points in the fourth quarter to 31.7% primarily driven by the amortization of intangible assets from our Otezla acquisition, and decreased 5.9 percentage points for the full year to 37.7%.
    • Tax Rate decreased 0.1 percentage points in the fourth quarter and 3.5 percentage points for the full year. The full year tax rate decrease is primarily driven by audit settlements, adjustments to prior year tax liabilities and lower interest expense on tax accruals.

    On a non-GAAP basis:

    • Total Operating Expenses increased 9% in the fourth quarter and 7% for the full year. Cost of Sales margin increased 1.7 percentage points in the fourth quarter primarily due to product mix, profit share, and royalties. For the full year, Cost of Sales margin increased 0.1 percentage points primarily driven by royalties, profit share and product mix, offset by lower manufacturing costs. R&D expenses decreased 8% in the fourth quarter driven by lower spend in research and early pipeline, which includes recoveries from our collaboration with BeiGene. For the full year, R&D expenses increased 1% driven by the higher spend in support of our late-stage development programs, primarily sotorasib, our biosimilars and Otezla, partially offset by recoveries from our collaboration with BeiGene, and lower spend in certain oncology programs included in research and early pipeline. SG&A expenses increased 17% in the fourth quarter and 10% for the full year, primarily due to investments in marketed product support, including Otezla, and product launches. The full-year increase was partially offset by a reduction in certain expenses due to the impact of COVID-19.
    • Operating Margin decreased 1.5 percentage points to 43.1% in the fourth quarter, and increased 0.7 percentage points to 50.9% for the full year.
    • Tax Rate increased 0.5 percentage points in the fourth quarter and decreased 1.2 percentage points for the full year. The fourth quarter tax rate increase is primarily driven by changes in foreign loss utilization, partially offset by lower interest expense on tax accruals. The full year tax rate decrease is primarily driven by adjustments to prior year tax liabilities and lower interest expense on tax accruals.

     

    $Millions, except percentages



    GAAP



    Non-GAAP





    Q4 '20



    Q4 '19



    YOY Δ



    Q4 '20



    Q4 '19



    YOY Δ

    Cost of Sales



    $

    1,597





    $

    1,253





    27%



    $

    959





    $

    790





    21%

    % of product sales



    25.2%





    21.3%





    3.9 pts



    15.1%





    13.4%





    1.7 pts

    Research & Development



    $

    1,229





    $

    1,312





    (6%)



    $

    1,185





    $

    1,285





    (8%)

    % of product sales



    19.4%





    22.3%





    (2.9) pts



    18.7%





    21.9%





    (3.2) pts

    Selling, General & Administrative



    $

    1,773





    $

    1,513





    17%



    $

    1,762





    $

    1,501





    17%

    % of product sales



    28.0%





    25.7%





    2.3 pts



    27.8%





    25.5%





    2.3 pts

    Other



    $

    27





    $

    71





    (62%)



    $





    $





    —%

    Total Operating Expenses



    $

    4,626





    $

    4,149





    11%



    $

    3,906





    $

    3,576





    9%



























    Operating Margin

























    operating income as % of product sales



    31.7%





    34.8%





    (3.1) pts



    43.1%





    44.6%





    (1.5) pts



























    Tax Rate



    14.0%





    14.1%





    (0.1) pts



    15.4%





    14.9%





    0.5 pts



























    pts: percentage points

























     

    $Millions, except percentages



    GAAP



    Non-GAAP





    FY'20



    FY'19



    YOY Δ



    FY'20



    FY'19



    YOY Δ

    Cost of Sales



    $

    6,159





    $

    4,356





    41%



    $

    3,362





    $

    3,065





    10%

    % of product sales



    25.4%





    19.6%





    5.8 pts



    13.9%





    13.8%





    0.1 pts

    Research & Development



    $

    4,207





    $

    4,116





    2%



    $

    4,085





    $

    4,027





    1%

    % of product sales



    17.4%





    18.5%





    (1.1) pts



    16.9%





    18.1%





    (1.2) pts

    Selling, General & Administrative



    $

    5,730





    $

    5,150





    11%



    $

    5,643





    $

    5,113





    10%

    % of product sales



    23.6%





    23.2%





    0.4 pts



    23.3%





    23.0%





    0.3 pts

    Other



    $

    189





    $

    66





    *



    $





    $





    —%

    Total Operating Expenses



    $

    16,285





    $

    13,688





    19%



    $

    13,090





    $

    12,205





    7%



























    Operating Margin

























    operating income as % of product sales



    37.7%





    43.6%





    (5.9) pts



    50.9%





    50.2%





    0.7 pts



























    Tax Rate



    10.7%





    14.2%





    (3.5) pts



    13.8%





    15.0%





    (1.2) pts



























    * Change in excess of 100%

























    pts: percentage points

























    Cash Flow and Balance Sheet

    • The Company generated $2.0 billion of free cash flow in the fourth quarter of 2020 versus $2.3 billion in the fourth quarter of 2019. The Company generated $9.9 billion of free cash flow for the full year 2020 versus $8.5 billion in 2019.
    • The Company's fourth quarter 2020 dividend of $1.60 per share was declared on October 21, 2020, and was paid on December 8, 2020, to all stockholders of record as of November 16, 2020, representing a 10% increase from 2019.
    • During the fourth quarter of 2020, the Company repurchased 5.3 million shares of common stock at a total cost of $1.2 billion. For the full year, the Company repurchased 15.2 million shares of common stock at a total cost of $3.5 billion. At the end of the fourth quarter, the Company had $3.0 billion remaining under its stock repurchase authorization.
    • Cash and investments totaled $10.6 billion and debt outstanding totaled $33.0 billion at the end of Q4 2020.

     

    $Billions, except shares



    Q4 '20



    Q4 '19



    YOY Δ

    FY'20



    FY'19



    YOY Δ



    Operating Cash Flow



    $

    2.2





    $

    2.5





    $

    (0.4)



    $

    10.5





    $

    9.2





    $

    1.3





    Capital Expenditures



    0.2





    0.2





    0.0



    0.6





    0.6





    0.0





    Free Cash Flow



    2.0





    2.3





    (0.3)



    9.9





    8.5





    1.4





    Dividends Paid



    0.9





    0.9





    0.1



    3.8





    3.5





    0.2





    Share Repurchases



    1.2





    1.1





    0.1



    3.5





    7.6





    (4.1)





    Average Diluted Shares (millions)



    585





    598





    (13)



    590





    609





    (19)































    Note: Numbers may not add due to rounding

























     





    12/31/20



    12/31/19



    YOY Δ

    Cash and Investments



    10.6





    8.9





    1.7



    Debt Outstanding



    33.0





    29.9





    3.1



    2021 Guidance

    For the full year 2021, the Company expects:

    • Total revenues in the range of $25.8 billion to $26.6 billion.
    • On a GAAP basis, EPS in the range of $12.12 to $13.17 and a tax rate in the range of 11.0% to 12.5%.
    • On a non-GAAP basis, EPS(1) in the range of $16.00 to $17.00 and a tax rate in the range of 13.0% to 14.0%.
    • Capital expenditures to be approximately $900 million.
    • Quarterly dividend increased to $1.76 per share.
    • Share repurchases in the range of $3.0B to $4.0B subject to our Board's authorization.

    (1) Effective January 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to interest and other income pursuant to an update to our non-GAAP policy. This policy update does not apply to our strategic investment in BeiGene, which is included in our non-GAAP results, and is accounted for under the equity method of accounting. Please note that this updated non-GAAP policy will become the basis for our comparisons going forward in 2021 and is reflected in our 2021 guidance.  For convenience, we are providing additional information in the attached reconciliations to show the effects of the application of the new policy as if it had been adopted at the beginning of 2020.

    Fourth Quarter Product and Pipeline Update

    The Company provided the following updates on selected product and pipeline programs:

    Sotorasib

    • Regulatory submissions have been completed in the U.S., EU, Canada, Australia, Brazil and the United Kingdom for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), following at least one prior systemic therapy.
    • Sotorasib has received Breakthrough Therapy Designation in the U.S. and China and is being reviewed under the Real-Time Oncology Review pilot program in the U.S.
    • The positive results of the registrational Phase 2 monotherapy study in patients with KRAS G12C-mutated advanced NSCLC were presented at the World Conference on Lung Cancer in January 2021. Sotorasib demonstrated a confirmed objective response rate of 37.1%, including 3 complete responses, a median duration of response of 10 months and median progression-free survival of 6.8 months. Sotorasib had a favorable benefit-risk profile with most treatment-related adverse events mild-to-moderate and no treatment-related deaths. In exploratory analyses, encouraging tumor response to sotorasib was observed across a range of biomarker subgroups, including patients with negative or low programmed death-ligand 1 (PD-L1) expression levels and those with serine threonine kinase 11 (STK11) mutation.
    • Data from the Phase 2 monotherapy study in advanced colorectal cancer patients are expected in H1 2021.
    • A Phase 2 monotherapy study is expected to initiate in H1 2021 for previously untreated NSCLC patients with the highest unmet need, including STK11 mutations, as determined by biomarker analyses.
    • Ten Phase 1b combination cohorts with sotorasib are enrolling patients with some initial data expected in H1 2021. The safety hurdle has been cleared for the 960mg sotorasib dose in combination with a mitrogen-activated protein kinase kinase (MEK) inhibitor and an expansion cohort has been enrolled to assess efficacy. A triplet cohort combining sotorasib, a MEK inhibitor and an epidermal growth factor receptor (EGFR) antibody has also been initiated.

    Tezepelumab

    • Data from the pivotal Phase 3 NAVIGATOR study will be presented at the American Academy of Allergy Asthma and Immunology Virtual Annual Meeting in February.
    • Regulatory submissions in the U.S. and EU are expected in H1 2021.

    Otezla

    • The Company expects to submit a supplemental New Drug Application to the FDA in Q1 2021 for the treatment of adults with mild-to-moderate plaque psoriasis.

    Oncology / Hematology Pipeline

    • In December, the European Commission approved an expanded indication for the use of BLINCYTO in patients with Philadelphia chromosome positive B-precursor ALL that have failed treatment with at least two tyrosine kinase inhibitors and have no alternative treatment options.
    • Dose escalation data for AMG 757, a half-life extended BiTE molecule targeting delta-like ligand 3 (DLL3) for relapsed or refractory small cell lung cancer, were presented at the Society for Immunotherapy of Cancer 35th Annual Meeting in October 2020 and the World Conference on Lung Cancer in January 2021, and the Company expects to enter AMG 757 into expansion cohorts over the next several months.
    • Dose escalation data for AMG 701 (pavurutamab), a half-life extended BiTE molecule targeting B-cell maturation antigen (BCMA) for relapsed or refractory multiple myeloma, were presented at the American Society of Hematology Annual Meeting in December. Enrollment in the Phase 1 study has been paused while we discuss protocol modifications to optimize safety monitoring and mitigation with the FDA. Currently enrolled patients who are demonstrating benefit may continue to receive investigational product and the Company expects to resume patient enrollment in H1 2021.
    • Clinical development of AMG 673, a half-life extended BiTE molecule targeting CD33, is paused while we gather further information on the CD33 program through progression of AMG 330.
    • Clinical development of AMG 596, a BiTE molecule targeting EGFR variant III for glioblastoma, has been stopped as we prioritize our portfolio.
    • Phase 1 development of the oral MCL-1 inhibitor AMG 397 was paused with focus shifting to the intravenous MCL-1 inhibitor AMG 176, currently in Phase 1 for the treatment of hematologic malignancies.

    Nplate

    • In December, the European Commission approved an expanded indication for use in adult patients who have had immune thrombocytopenia for 12 months or less and who have had an insufficient response to corticosteroids or immunoglobulins.
    • The FDA has approved Nplate for the treatment of Hematopoietic Syndrome of Acute Radiation Syndrome.*

    IMLYGIC

    • A Phase 3 study evaluating IMLYGIC in combination with pembrolizumab (KEYTRUDA®) versus pembrolizumab alone for treatment of unresectable stage IIIB to IVM1c melanoma was stopped for futility after an interim analysis by the Data Monitoring Committee. No new safety signals were observed.

    Aimovig

    • In November, Novartis announced positive results from a head-to-head trial where Aimovig demonstrated superiority vs. topiramate in achieving at least a 50% reduction from baseline in monthly migraine days. Aimovig also demonstrated a significantly lower rate of discontinuation due to AEs vs. topiramate.

    Repatha

    • In November, a supplemental Biologics License application was submitted to the FDA for the treatment of pediatric patients with heterozygous familial hypercholesterolemia.

    ABP 959 (biosimilar SOLIRIS®)

    • A Phase 3 study evaluating the efficacy and safety of ABP 959 compared with Soliris (eculizumab) in adults with paroxysmal nocturnal hemoglobinuria has completed enrollment.

    * Funding and execution of the pivotal study was provided by the National Institute of Allergy and Infectious Diseases (NIAID) and the Priority Review regulatory submission was conducted in partnership with the Biomedical Advanced Research and Development Authority (BARDA).

    KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.

    Tezepelumab is being developed in collaboration with AstraZeneca

    SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc.

    Non-GAAP Financial Measures

    In this news release, management has presented its operating results for the fourth quarters and full years of 2020 and 2019, in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and on a non-GAAP basis. In addition, management has presented its full year 2021 EPS and tax rate guidance in accordance with GAAP and on a non-GAAP basis. These non-GAAP financial measures are computed by excluding certain items related to acquisitions, restructuring and certain other items from the related GAAP financial measures. Reconciliations for these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the news release. Management has also presented Free Cash Flow (FCF), which is a non-GAAP financial measure, for the fourth quarters and full years of 2020 and 2019. FCF is computed by subtracting capital expenditures from operating cash flow, each as determined in accordance with GAAP.

    The Company believes that its presentation of non-GAAP financial measures provides useful supplementary information to and facilitates additional analysis by investors. The Company uses certain non-GAAP financial measures to enhance an investor's overall understanding of the financial performance and prospects for the future of the Company's ongoing business activities by facilitating comparisons of results of ongoing business operations among current, past and future periods. The Company believes that FCF provides a further measure of the Company's liquidity.

    The Company uses the non-GAAP financial measures set forth in the news release in connection with its own budgeting and financial planning internally to evaluate the performance of the business, including to allocate resources and to evaluate results relative to incentive compensation targets. The non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP.

    Beginning January 1, 2021, we began to exclude the gains and losses on our investments in equity securities from our non-GAAP measures that are recorded to interest and other income. This exclusion will not apply to our share of the earnings and losses of our strategic investments in corporations accounted for under the equity method of accounting, such as our investment in BeiGene. The Company will be excluding gains and losses from equity investments for the purpose of calculating the non-GAAP financial measures presented because the Company believes the results of such gains and losses are not representative of our normal business operations. We are making this change beginning in 2021 because, as we have increased our investments in these companies, we recognized that the resulting variability can impede comparability between periods of our financial performance for our ongoing business operations.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    CONTACT: Amgen, Thousand Oaks

    Trish Hawkins, 805-447-5631 (media)

    Arvind Sood, 805-447-1060 (investors)

     

    Amgen Inc.

    Consolidated Statements of Income - GAAP

    (In millions, except per-share data)

    (Unaudited)





    Three months ended

    December 31,



    Twelve months ended

    December 31,



    2020



    2019



    2020



    2019

    Revenues:















    Product sales

    $

    6,334





    $

    5,881





    $

    24,240





    $

    22,204



    Other revenues

    300





    316





    1,184





    1,158



    Total revenues

    6,634





    6,197





    25,424





    23,362



















    Operating expenses:















    Cost of sales

    1,597





    1,253





    6,159





    4,356



    Research and development

    1,229





    1,312





    4,207





    4,116



    Selling, general and administrative

    1,773





    1,513





    5,730





    5,150



    Other

    27





    71





    189





    66



    Total operating expenses

    4,626





    4,149





    16,285





    13,688



















    Operating income

    2,008





    2,048





    9,139





    9,674



















    Interest expense, net

    318





    301





    1,262





    1,289



    Interest and other income, net

    187





    236





    256





    753



















    Income before income taxes

    1,877





    1,983





    8,133





    9,138



















    Provision for income taxes

    262





    280





    869





    1,296



















    Net income

    $

    1,615





    $

    1,703





    $

    7,264





    $

    7,842



















    Earnings per share:















    Basic

    $

    2.78





    $

    2.87





    $

    12.40





    $

    12.96



    Diluted

    $

    2.76





    $

    2.85





    $

    12.31





    $

    12.88



















    Weighted-average shares used in calculation of earnings per share:















    Basic

    581





    593





    586





    605



    Diluted

    585





    598





    590





    609



     

    Amgen Inc.

    Consolidated Balance Sheets - GAAP

    (In millions)





    December 31,



    December 31,



    2020



    2019



    (Unaudited)





    Assets

    Current assets:







    Cash, cash equivalents and marketable securities

    $

    10,647





    $

    8,911



    Trade receivables, net

    4,525





    4,057



    Inventories

    3,893





    3,584



    Other current assets

    2,079





    1,888



    Total current assets

    21,144





    18,440











    Property, plant and equipment, net

    4,889





    4,928



    Intangible assets, net

    16,587





    19,413



    Goodwill

    14,689





    14,703



    Other assets

    5,639





    2,223



    Total assets

    $

    62,948





    $

    59,707











    Liabilities and Stockholders' Equity

    Current liabilities:







    Accounts payable and accrued liabilities

    $

    11,562





    $

    9,882



    Current portion of long-term debt

    91





    2,953



    Total current liabilities

    11,653





    12,835











    Long-term debt

    32,895





    26,950



    Long-term tax liabilities

    6,968





    8,037



    Other noncurrent liabilities

    2,023





    2,212



    Total stockholders' equity

    9,409





    9,673



    Total liabilities and stockholders' equity

    $

    62,948





    $

    59,707











    Shares outstanding

    578





    591



     

    Amgen Inc.

    GAAP to Non-GAAP Reconciliations

    (Dollars in millions)

    (Unaudited)





    Three months ended

    December 31,



    Twelve months ended

    December 31,



    2020



    2019



    2020



    2019

    GAAP cost of sales

    $

    1,597





    $

    1,253





    $

    6,159





    $

    4,356



    Adjustments to cost of sales:















    Acquisition-related expenses (a)

    (638)





    (463)





    (2,797)





    (1,291)



    Non-GAAP cost of sales

    $

    959





    $

    790





    $

    3,362





    $

    3,065



















    GAAP cost of sales as a percentage of product sales

    25.2

    %



    21.3

    %



    25.4

    %



    19.6

    %

    Acquisition-related expenses (a)

    -10.1





    -7.9





    -11.5





    -5.8



    Non-GAAP cost of sales as a percentage of product sales

    15.1

    %



    13.4

    %



    13.9

    %



    13.8

    %

















    GAAP research and development expenses

    $

    1,229





    $

    1,312





    $

    4,207





    $

    4,116



    Adjustments to research and development expenses:















    Acquisition-related expenses (a)

    (43)





    (25)





    (120)





    (87)



    Certain net charges pursuant to our restructuring initiatives

    (1)





    (2)





    (2)





    (2)



    Total adjustments to research and development expenses

    (44)





    (27)





    (122)





    (89)



    Non-GAAP research and development expenses

    $

    1,185





    $

    1,285





    $

    4,085





    $

    4,027