You win some, you lose some. Pfizer has been actively searching for new products to help offset an expected sales decline when generic competition for its top-selling cholesterol drug Lipitor begins selling in November. The leading pharmaceutical company received mixed results after the U.S. Food and Drug Administration (FDA) approved one of its joint ventures while rejecting another. The FDA delayed approval of Pfizer’s new painkiller developed with Pain Therapeutics, using Durect’s (DRRX) technology, that’s designed to discourage common methods of tampering with the drug.
The regulators’ concerns about the medicine, a long-acting oxycodone pill called Remoxy, weren’t specified by any of the companies but sent shares of all three lower. Pfizer said it’s working to evaluate the issues raised by the regulator and plans to have further talks with the FDA.
Meanwhile, shares of Acura Pharmaceuticals got a boost after the FDA approved the marketing of its new pain drug Oxecta, also a collaboration with Pfizer, earlier this week. Acura had originally partnered on Oxecta with King Pharmaceuticals, which was acquired by Pfizer in February. The approval of Acura and Pfizer’s joint venture will boost Pfizer’s product line ahead of the expiration later this year of a patent on Lipitor.
The active ingredient in both the drugs, Oxecta and Remoxy, is the popular painkiller oxycodone called “Hillbilly heroin”, a narcotic derived from morphine that has resulted in its rampant abuse. In 2008, the FDA had declined to approve Pain Therapeutics’ marketing application, and sought additional non-clinical data to support the approval of Remoxy.
Pfizer (PFE : NYSE : US$20.08), Net Change: -0.57, % Change: -2.76%, Volume: 59,990,778
Pain Therapeutics (PTIE : NASDAQ : US$5.30), Net Change: -3.94, % Change: -42.64%, Volume: 9,568,759
Acura Pharma (ACUR : NASDAQ : US$4.10), Net Change: 0.37, % Change: 9.92%, Volume: 1,875,105