The accompanying table presents an updated calendar of 30 decision dates which either have deadlines before year-end or represent delays in previously expected decisions in which the FDA has not issued a new date for a final decision.
After the close today, Pain Therapeutics (PTIE) and King Pharma (KG) announced mixed results from a FDA panel review of Remoxy, which is designed to be an abuse-resistant opiate pain drug in response to abuse and diversion issues with drugs such as Purdue Pharma's OxyContin. At least 10 members of the panel felt Remoxy demonstrated a lower abuse potential compared to existing drugs in the same class, while eight members did not agree – although a formal vote on the issue was not conducted.
Yesterday, the FDA raised similar questions regarding the abuse-resistant claims of Alpharma's (ALO) morphine-based drug Embeda. The FDA questioned the ability of Embeda to deter abuse by injection and also and the safety of exposing patients to naltrexone, which is the abuse deterrent sequestered in the pills which becomes activated if the tablets are dissolved, chewed, or crushed. An outside panel of advisers is set to vote on the abuse-resistant claims for Embeda tomorrow. Also King Pharma has an outstanding bid to acquire Alpharma for $1.6B or $37 per share, with its tender offer set to expire 11/21/08.
AMAG Pharma (AMAG) more than doubled today (up 103%) on word that the FDA accepted its complete response for a NDA of iron-deficiency anemia drug ferumoxytol in patients with chronic kidney disease and will issue a final ruling before year-end by 12/30/08. The news is a major relief for AMAG as no new clinical trials were required and the quick decision deadline before year-end is encouraging for the approval prospects of ferumoxytol.
$9.64 (11/13/08)
