European Commission Approves Bavencio (avelumab) for Metastatic Merkel Cell Carcinoma (3)

This release contains forward-looking information about BAVENCIO (avelumab), including a new indication in Europe as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma, the Merck-Pfizer 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 any other drug applications may be filed in any jurisdictions for potential indications for BAVENCIO, combination therapies or other product candidates; whether and when regulatory authorities in any other jurisdictions where applications are pending or may be submitted for BAVENCIO, combination therapies or other product candidates may approve any such applications, 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 www.pfizer.com [http://www.pfizer.com ].

References    

1) BAVENCIO(R) (avelumab) EU SmPC. Available from: http://www.ema.europa.eu/ema: Accessed September 2017. 2) Fitzgerald T et al. Dramatic increase in the incidence and mortality from Merkel cell carcinoma in the United States. Am Surg 2015;81(8):802-6. 3) Stokes JB et al. Patients with Merkel cell carcinoma tumors < or = 1.0 cm in diameter are unlikely to harbor regional lymph node metastasis. J Clin Oncol 2009;27(23) :3772-7. 4) Allen PJ et al. Merkel cell carcinoma: prognosis and treatment of Patients from a single institution. J Clin Oncol 2005;23(10):2300-9. 5) IMMOMEC (European Commission). Merkel Cell Carcinoma. Available from: http://www.immomec.eu/project/objectives/background/merkel-c.... Accessed September 2017. 6) Lemos B 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;63:751-761. 7) Schadendorf D et al. Merkel cell carcinoma: epidemiology, prognosis, therapy and unmet medical needs. European Journal of Cancer 2017;71;53-69 8) American Cancer Society. What is Merkel cell carcinoma? Available from: http://www.cancer.org/cancer/skincancer-merkelcell/detailedg... . Accessed September 2017. 9) Nghiem P. Systematic literature review of efficacy, safety and tolerability outcomes of chemotherapy regimens in patients with metastatic Merkel cell carcinoma. Future Oncology 2017;13(14):1263-1279. 10) Heath M, Jaimes N and Lemos B. Clinical characteristics of Merkel cell carcinoma at diagnosis in 195 patients: the AEIOU features. Journal of the American Academy of Dermatology 2008;58:375-81. http://www.pnlab.org/clinical/documents/.... Accessed September 2017. 11) NCCN Merkel Cell Carcinoma Guidelines version I. 2017. www.nccn.org/professionals/physician_gls... [http://www.nccn.org/professionals/physic... ]. Last accessed June 2017. 12) BAVENCIO Prescribing Information. 2017. Rockland, MA: EMD Serono Inc.

Your Contacts Merck Media Friederike Segeberg +49-6151-72-6328 Investor Relations +49-6151-72-3321 Pfizer Media (US) Sally Beatty +1-212-733-6566 Media (EU) Lisa O'Neill +44-1737-331536 Investor Relations Ryan Crowe +1-212-733-8160

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