Monday, April 11, 2016 1:01:17 PM
11-04-2016
The news last week that China-based Humanwell Healthcare Group and PuraCap Pharmaceutical have entered into a definitive agreement to acquire 100% of privately-held US generic drugs marker Epic Pharma for $550 million (The Pharma Letter April 8), seems to have a sub-text: an unidentified product license asset.
In June 2015, Elite Pharmaceuticals (OTC: ELTP) licensed SequestOX (naltrexone and oxycodone hydrochloride), then known only as ELI-200, to Epic Pharma. This was Elite’s lead opioid abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Under the terms of the deal, Epic was due to pay Elite non-refundable milestone payments totaling $15 million and a royalty based on net product sales. The term of the license is five years and the license is renewable upon mutual agreement at the end of the initial term.
According to a long-term investor in Elite and other pharmaceutical companies working to help solve the opioid abuse epidemic who contacted TPL, “PuraCap wants in on the opioid market, and Elite's proprietary technology and its licensing deal with Epic was their way of gaining that access.”
He noted that, in March this year, the US Food and Drug Administration had fast-tracked the review for SequestOX and a decision is to be rendered by July 14, target action date under the Prescription Drug User Fee Act (PDUFA). The FDA granted priority review of the drug.
At that time, Elite’s president and chief executive Nasrat Hakim said: “The FDA’s decision to grant Priority Review to the SequestOX submission is an important milestone for Elite and an important step toward providing a new treatment option for physicians and patients that may deter some of the common methods of opioid abuse.”
“The purchase of Epic gives Humanwell and PuraCap a front row seat to SequestOX being approved by the FDA in July. Great acquisition on their part,” the investor told TPL.
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