More Trouble at Endo?

More Trouble at Endo?

February 7th, 2013 // 4:12 pm @

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As if Endo Health Solutions did not have enough trouble. First, 2013 revenue may not meet earlier projections. A replacement for its retiring ceo has yet to be named. Its biggest shareholder, Fidelity Investments, is pushing for a sale. And now we learn that the FDA was not convinced of the tamper-resistance of its latest version of the Opana ER painkiller, suggesting more generics of the older pill will be on the market in a few months.

In a research note, RBC Capital Markets analyst Shibani Malhotra writes the FDA medical review of the new Opana ER formulation, which was approved in December 2011, indicates the agency “seriously considered adding tamper-resistance language to the label,” but decided not to do so because it may have been misleading. As a result, she is “incrementally less confident” the FDA believes tamper-resistance properties “warrant inclusion” in the label.

On that basis, she foresees “the likelihood that further generics could be approved” for the older version of Opana after the 180-day exclusivity period expires for the copycat now being sold by Impax Laboratories, which was launched last month. As she sees it, if the FDA is believes the Opana ER is less meaningful than previously though, it raises fresh concerns about the future of the Endo (ENDP) product franchise.

Of course, the FDA may still give credence to real-life data showing suggesting abusers have shifted away from Opana ER once the tamper-resistance formulation was approved. She notes that IMS data indicates market share for the new formulation has increased from 2.6 percent to 4.5 percent. Nonetheless, “we believe this new information could decrease the chance that a bidder steps in ahead of such uncertainty on this key franchise,” she writes.

She makes one further point. Despite earlier impressions, the agency apparently concluded that the tamper-resistant form of OxyContin is less likely to be tampered with than Opana ER, even though they have similar poperties and both were developed in partnership with Grunenthal. And she cites the FDA medical review for OxyContin TR.

“Specifically, the agency appears to concur with Purdue’s tamper resistance claims; however, the company was asked for epidemiology data to substantiate these. This is in contrast to the review of Opana ER, where the agency did not ask for specific epidemiology studies to support claims but instead questioned the tamper resistance properties of the formulation.”


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