Pfizer, Inc. (PFE) recently made a $20 million milestone payment to Acura Pharmaceuticals, Inc. (ACUR) based on the US Food and Drug Administration's (FDA) approval of Pfizer's new drug application (NDA) for Oxecta. Oxecta (formerly known as Acurox) is approved for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate. Acura could receive an additional $3 million on the achievement of certain non-US regulatory milestones for Oxecta.
Oxecta, which was approved in the US in June 2011, became a part of Pfizer’s portfolio following its acquisition of King Pharma earlier this year. Oxecta has been developed under an agreement for the licensing, development, and commercialization of immediate release (IR) pain medicines utilizing Acura's Aversion (abuse-deterrent) technology. The abuse-deterrent technology has been designed to discourage opioid abuse and misuse through common ways of tampering.
Pfizer and Acura’s agreement covers three additional Aversion technology products including oxycodone HCl/acetaminophen tablets and hydrocodone bitartrate/acetaminophen tablets. Acura could receive up to $23 million on the achievement of certain regulatory milestones for each of the three other candidates covered by the agreement.
Neutral on Pfizer
We currently have a Neutral recommendation on Pfizer. The stock carries a Zacks #3 Rank (Hold rating) in the short-run. 2011 should be a catalyst-filled year for the company, which is expecting to present phase III data on several candidates. However, Pfizer will face additional challenges later this year with the loss of US exclusivity on Lipitor in November.
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