Technical Milestones Achieved By Pfizer Inc. (NYSE:PFE)

Posted by Samantha Donahue October 25, 2013 0 Comment 2358 views


Yesterday, Pfizer Inc. (NYSE:PFE) announced about having achieved manufacturing related technical milestones as it would continue the development program for extended release of Remoxy capsules that contains therapeutic molecule oxycodone. The company received the guidance from the United States Food and Drug Administration (USFDA) earlier this year. Now Pfizer is working to proceed with the additional clinical evaluations and other actions that may be required in the course to address the CRL (Complete Response Letter) received in June 2011.

The new clinical studies will include an abuse potential study with the modified formulation and a pivotal bio-equivalence study to address the clinical data related to the original drug formulation using the modified Remoxy formulation. However given the anticipated duration to accomplish these new clinical studies, the company expects complete response submission no earlier than mid-2015.

Remoxy, an oxycodone drug therapy, is extended release oral formulation intended for the management of moderate to severe pain, especially when the continuous opioid analgesic is needed for an extended period of time. The drug was originally developed by Pain Therapeutics, Inc. (NASDAQ:PTIE) and the initial NDA (New Drug Application) for Remoxy was filed late in June 2008 and a CRL was received in December 2008. Later King Pharmaceuticals, Inc. entered into an agreement with Pain Therapeutics towards development and commercialization of Remoxy and assumed full control of Remoxy in March 2009. Pfizer got rights to Remoxy following its acquisition of King Pharmaceuticals, Inc. in February 2011.

As pharmaceutical industry faces strife competition, the larger companies are resolving to acquisitions, licensing and development and/or commercialization agreements to enhance their product portfolio and maintain substantial revenues and cash in-flows to further their research and development activities including ongoing clinical studies.

On a similar note, AstraZeneca plc (ADR) (NYSE:AZN) entered into a couple of acquisition deals including that of Omthera Pharmaceuticals Inc. (NASDAQ:OMTH) and Pearl Therapeutics in the past few months and also signed an agreement with FibroGen, Inc. Earlier this week, AstraZeneca also announced to have initiated a Phase III study for its oncology product, selumetinib, for which the company acquired exclusive global rights from Array Biopharma Inc. (NASDAQ:ARRY) back in 2003



About Samantha Donahue

Samantha Donahue is a digital fellow with GDP insider. Samantha earned a Bachelor's degree in Government from Cornell University and later his Master's degree in Journalism from Columbia University. She has also received numerous awards from the Associated Press, Society of Professional Journalists, and other media organizations for many of her exclusive stories. Samantha thrives reporting on breaking news and as a general assignments news reporter.

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