COMUNICADO: FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma (y 3

 

COMUNICADO: FDA Grants Approval for BAVENCIO® (avelumab), the First Immunotherapy Approved for Metastatic Merkel Cell Carcinoma (y 3

Publicado 23/03/2017 22:31:14CET

EMD Serono is the biopharmaceutical business of Merck - a leading science and technology company - in the US and Canada, focused exclusively on specialty care. For more than 40 years, the business has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas. Today, the business has 1,200 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts.

https://www.emdserono.com 

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to https://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

For further details and press materials about Merck in oncology please visit

https://www.merckgroup.com/en/media/media_center_oncology.html 

About Merck    

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

About Pfizer Inc.: Working together for a healthier world(R)    

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice    

The information contained in this release is as of March 23, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including an indication in the US for BAVENCIO for the treatment of metastatic Merkel cell carcinoma (the Indication), Pfizer's and Merck's immuno-oncology alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any other jurisdictions for the Indication or in any jurisdictions for any other potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for the Indication in the EU) may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com. [http://www.pfizer.com ]

References    


1) BAVENCIO Prescribing Information. Rockland, MA: EMD Serono Inc.; 2017.
2) National Institutes of Health, U.S. National Library of Medicine, Daily Med. Available
at https://dailymed.nlm.nih.gov/dailymed/advanced-search.cfm. Accessed March 22,
2017.
3) Lemos B, Storer B, Iyer J, et al. Pathologic Nodal Evaluation Improves Prognostic
Accuracy in Merkel Cell Carcinoma: Analysis of 5,823 Cases as the Basis of the First
Consensus Staging System for this Cancer. Journal of the American Academy of
Dermatology. 2010;63(5):751-761.

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CONTACT: Your Contacts: Merck, Media, Gangolf Schrimpf, +49 6151 72 9591,Investor Relations, +49 6151 72 3321. Pfizer, Media (US), Sally Beatty, +1212 733 6566, Media (EU), Lisa O'Neill, +44 1737 331536. InvestorRelations, Ryan Crowe, +1 212 733 8160

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