Solzira is the subject of a new drug application (NDA) that is under review by the FDA as a potential treatment for moderate-to-severe primary restless legs syndrome (RLS). Assuming FDA approval of the Solzira NDA for RLS, XenoPort will field a US sales force of between 50 and 100 representatives to promote Solzira. This sales force will be geographically distributed across the US and will call on prescribers of drugs that treat neurological diseases.
XenoPort has also announced changes to the terms of its right to co-detail in the US Requip XL, GSK’s product for Parkinson’s disease. Previously, XenoPort was entitled to detail Requip XL commencing upon its exercise of the co-promotion option and ending upon the launch of Solzira.
Under the revised terms, XenoPort has the right to commence the detailing of Requip XL around the time of the Solzira launch. XenoPort would be entitled to continue these detailing activities until the earlier of the launch of a generic form of Requip XL or July 1, 2011. XenoPort would be compensated for each detail of Requip XL completed by its sales representatives through a fee that is separate from the Solzira joint profit and loss statement.
XenoPort’s exercise of the co-promotion option and its participation in the profit share arrangement may be reversed at any time upon notice to GlaxoSmithKline with no penalty to XenoPort, in which case the original royalty-based compensation structure would apply for Solzira sales in the US.
Ronald Barrett, CEO of XenoPort, said: “We have carefully analyzed this choice from both the economic and strategic perspectives. We believe this decision positions us as one of the few biotechs with the potential to become an integrated biopharmaceutical company, capable of discovering, developing and commercializing innovative products that will benefit both patients and our stockholders.”