Brian Marckx, CFA,
Today Pernix Therapeutics (PTX) announced a joint venture with a U.K-based company for the development and commercialization of BC1036. BC1036, also known as theobromine, is the highly-anticipated antitussive drug candidate that Pernix management had yet to disclose the name of but previously noted could have enormous potential. Terms of the JV with SEEK, a U.K.-based drug incubator, were not disclosed in Pernix’s press release.
Theobromine is an alkaloid of the cacao plant and is found in chocolate. It is in the methylxanthine class of compounds which also includes caffeine. It has been used clinically as a vasodilator, diuretic and heart stimulant but has yet to be patented in the U.S. for cough suppression. Theobromine has been shown to be as effective as codeine in suppressing cough without the adverse side effects. Codeine has been widely regarded as the most effective antitussive and is the API for cough suppression in several popular brand name and generic prescription medicines including Robitussin AC and Dimetane DC. However, codeine’s serious adverse side effects, including being highly addictive and causing drowsiness, limits its use. Codeine, for all practical purposes can only be used at night and should only be used sparingly (or not at all) in pediatric patients.
Seoul Korea-based Ahn-Gook Pharmaceutical launched the drug in Korea in 2009. The patent-trail was not disclosed in Pernix’s press release but from what we can tell the JV licensed global rights (ex-Korea) from Ahn-Gook.
Based on the safety history of the drug, at least a portion of which presumably came from clinical trials undertaken in support of the approval in Korea, the JV expects to be able to move the candidate directly to phase III testing. The companies are in the process of gaining regulatory clearance in Europe for protocol of a single phase III trial. Discussions are also underway with FDA to confirm a regulatory program for approval in the U.S. The companies hope to start clinical testing in mid-2011 and, if all goes well, Pernix thinks the drug could be on the market in both Europe and the U.S. sometime in 2013.
Manfred Scheske will lead the development effort of BC1036. Scheske came to SEEK in October 2010 and from what we can tell he’s a pretty big hitter. At his previous post as Glaxo-Smith Kline’s President of Consumer Healthcare in Europe he led the pan-European launch of OTC alli, which has been a tremendous success for GSK’s consumer business. Prior to that he spent six years as GSK’s head of U.S. consumer healthcare products.
As we have noted in our report on PTX, we have yet to model any sales of this (prior mystery) candidate but, depending on the outcome of clinical trials, believe it could potentially have multi-million dollar potential. We hope to hear more details about BC1036, the JV arrangement and the proposed clinical trial protocol on the next earnings call.
For a copy of the full research report, please email scr@zacks.com with the ticker PTX as the title.
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