King Pharma Resubmits Remoxy NDA - Analyst Blog

King Pharmaceuticals Inc. (KG) and partner Pain Therapeutics Inc. (PTIE) recently announced that they have resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for their pain candidate Remoxy. Remoxy has been developed using Durect Corporation's (DRRX) ORADUR technology for moderate to severe pain that requires continuous, round-the-clock opioid treatment for an extended period of time.

King Pharma said that the resubmission is being treated as a Class II review which means a response should be out in 6 months. King Pharma had initially submitted the Remoxy NDA in June 2008. However, in late December 2008, the FDA issued a complete response letter for Remoxy asking for additional information. As part of the resubmission plan, and in order to strengthen the NDA, King Pharma conducted a likeability study and a pharmacokinetic trial with volunteers.

We believe that Remoxy will eventually receive approval given the need for abuse-deterrent products in the pain management market.

The Remoxy NDA resubmission comes a few days after King Pharma and partner Acura Pharmaceuticals, Inc. (ACUR) submitted a new drug application for their opioid candidate, Acurox. The companies are seeking FDA approval for the use of Acurox (without niacin) for providing relief from moderate to severe pain.

Neutral on King Pharma

We currently have a 'Neutral' recommendation on King Pharma, which is supported by a Zacks #3 Rank (short-term “Hold” rating). In October 2010, the company entered into an agreement with Pfizer (PFE) whereby Pfizer will acquire King Pharma for $14.25 per share.

The offer price represents a 40% premium on King Pharma's closing price as of October 11, 2010. The Boards of both companies have approved the deal, which is scheduled to close by early next year.