MAIN, GERMANY / ACCESSWIRE / July 24, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Pfizer Inc. (NYSE: PFE), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=PFE. Pfizer, the developer of world's leading consumer healthcare products, and Merck KgaA, Germany, announced on July 21, 2017, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of avelumab (BAVENCIO) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive type of skin cancer. Merck operates its biopharmaceutical business as EMD Sereno in the US and Canada and operates through about 50,000 employees. In 2016, Merck reported net sales of ?15.0 billion in 66 countries. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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The Approval

This approval is viewed by Merck as a step to make avelumab available to patients, as there is currently no approved treatment in Europe for Metastatic Merkel cell carcinoma. The CHMP positive opinion is based on data from JAVELIN Merkel 200, a Phase-II study, split into two parts. Part A included 88 patients with mMCC, where the disease had progressed after at least one chemotherapy treatment, with 59% of the patients reported to have had one prior anti-cancer therapy for mMCC and 41% reported two or more therapies.

Pfizer viewed this announcement as a step to tackle hard-to-treat cancers as it continues to explore the potential of avelumab in other tumors. The clinical development program, i.e., JAVELIN involves about 30 clinical programs and more 6,000 patients evaluated across more than 15 different tumor types.

Under Part B, at the time of the data cut-off, the number of patients included was 39, with histologically confirmed mMCC who were treatment-naive systemic therapy in the metastatic setting, where 29 of the total patients had at least 13 weeks of follow-up. The enrollment for the Part B of the study is ongoing and is planned to include 112 treatment-naive patients. The European Commission (EC) will now review the CHMP's recommendation, with a decision expected in Q3 2017. Avelumab received the Orphan Drug Designation (ODD) from the EC for mMCC.

Avelumab

Avelumab is a human antibody specific for a protein called PD-L1, also known as, programmed death ligand-1. The antibody is designed to potentially engage and bind with the adaptive and innate immune systems. Post the binding to PD-L1, avelumab is expected to prevent tumor cells from using PD-L1 for protection against White Blood Cells, the original defense mechanism of the body. Merck and Pfizer announced in November 2014, a strategic alliance, pursuant to which the Companies would co-develop and co-commercialize avelumab.

The FDA Story

Initially, on October 07, 2015, Pfizer and Merck KgaA, collectively announced that the US Foods and Drug Administration (FDA) granted avelumab the Fast Track designation for the treatment of mMCC. The announcement followed the September 21, 2015, report where avelumab was granted the FDA Orphan Drug designation for the treatment of mMCC.

FDA later granted accelerated approval for avelumab in March 2017 for the treatment of mMCC in adults and pediatric patients 12 years or older, and in May 2017, for the treatment of patients with locally advanced or metastatic urothelial carcinoma, where the disease progressed during or following chemotherapy, or those with disease progression within 12 months of neoadjuvant or adjuvant treatment with chemotherapy.

Last Close Stock Review

On Friday, July 21, 2017, the stock closed the trading session at $33.48, slightly falling 0.18% from its previous closing price of $33.54. A total volume of 12.02 million shares have exchanged hands. Pfizer's stock price advanced 5.38% in the past six months. Furthermore, since the start of the year, shares of the Company have gained 3.08%. The stock is trading at a PE ratio of 28.06 and has a dividend yield of 3.82%. The stock currently has a market cap of $201.08 billion.

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