Pain Therapeutics Inc. (PTIE:US) plunged as much as 50 percent in its biggest drop ever after Pfizer Inc. (PFE:US) said it was reassessing their partnership on the experimental painkiller Remoxy. A third partner, Durect Corp. (DRRX:US), also fell.
Pain Therapeutics tumbled 48 percent to $2.78 at 10:11 a.m. New York time, after earlier touching $2.67 in its steepest intraday fall since the shares were first sold in July 2000. Durect declined 42 percent to 93 cents. The companies said in regulatory filings (PTIE:US) today that New York-based Pfizer, the world’s biggest drugmaker, was evaluating its plans for Remoxy.
The medicine is an extended-release oxycodone capsule formulated to limit abuse. The U.S. Food and Drug Administration postponed approval in June 2011, after a delay in 2008 when the regulators asked for more laboratory data. In a letter disclosed by Austin, Texas-based Pain Therapeutics, Pfizer said it doesn’t anticipate submitting a response to the FDA before mid-2015.
“Given the years of delay, additional cost incurred to bring the program to this point and development work left in the program, there will be much to consider,” Pfizer said in the letter dated May 9.
Nonetheless, “there is a regulatory pathway forward” for Remoxy, Pfizer said, citing the FDA’s comments after a March 28 hearing. Pfizer’s Remoxy team will recommend to management that it endorse the program, Alan Litwack, Pfizer’s vice president for global commercial development, said in the letter. There isn’t “an exact time frame” on when a decision will be made.
Pfizer will be “reaching out to you shortly” for “a confidential discussion relating to contractual terms” between the two companies, Litwack wrote to Pain Therapeutics.
Pfizer believes additional clinical studies will be needed to win approval, Durect said in its filing.
Matthew Hogan, chief financial officer for Cupertino, California-based Durect, and Pain Therapeutics CFO Peter Roddy didn’t immediately return messages seeking comment left before regular business hours.
Pfizer shares rose less than 1 percent to $28.77.
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