NEW YORK, NY / ACCESSWIRE / November 6, 2015 / Trader's Choice has initiated research coverage on Pfizer Inc. (NYSE: PFE). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.
Today, membership is open to readers on a complementary basis at the following URL: http://www.traders-choice.com/pdf?s=PFE
Highlights from our PFE Report include:
- Avelumab received Fast Track Designation from the USFDA - On October 07, 2015, Pfizer, one of the world's premier biopharmaceutical companies, announced that the investigational immuno-oncology therapy, Avelumab, has been granted Fast Track designation from the US Food and Drug administration (USFDA). The move will allow Pfizer and its partner, Merck KGaA, to accelerate the development of Avelumab. On September 21, 2015, Avelumab had been granted Orphan Drug designation by the USFDA for the treatment of metastatic Merkel cell carcinoma (MCC). Pfizer noted that the clinical development program for Avelumab in metastatic MCC includes the Phase II study, JAVELIN Merkel 200, to assess the safety and efficacy of Avelumab in patients who have progressed after at least one prior chemotherapy regimen.
- Management Commentary - Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology, remarked, "We look forward to working with our partners at Merck KGaA, Darmstadt, Germany, on the development of Avelumab in patients with relapsed and refractory Merkel cell carcinoma. Fast Track designation will enable us to coordinate these efforts more closely with the FDA."
- Understanding the concept of Fast Track designation - Elaborating on the designation, the Company said that Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. Following the granting of the Fast Track designation, early and frequent communication between the USFDA and a Pharma company is encouraged throughout the entire drug development and review process, which helps resolve queries and issues quickly, often leading to earlier drug approval and patient access to important new therapies.
- About Avelumab - Avelumab, also known as MSB0010718C, is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody for the treatment of a rare and aggressive type of skin cancer, metastatic Merkel cell carcinoma (MCC). Pfizer informed that Avelumab is thought to potentially enable the activation of T cells and the adaptive immune system, by inhibiting PD-L1 interactions. By retaining a native Fc-region, Avelumab is thought to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). Merck and Pfizer had announced a strategic alliance in November 2014, to co-develop and co-commercialize Avelumab.
To find out how this influences our rating on Pfizer Inc., read the full report in its entirety here: http://www.traders-choice.com/pdf?s=PFE
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