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news.Under a newly signed licensing agreement, Prism Pharmaceuticals has been granted exclusive rights to market Penwest Pharmaceuticals' beta blocker PW2101 in the US and Canada.
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PW2101 is intended for the treatment of hypertension and angina and is currently under review by the FDA. The Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA review is June 30, 2005.
Under terms of the agreement, Penwest will be responsible for certain pre-launch development activities, including activities related to the FDA application and review. Prism will be responsible for the commercialization and marketing of PW2101 in the US and Canada.
Prism made a $4 million payment to Penwest upon signing the agreement and Penwest may receive additional clinical and regulatory milestone payments of up to a total of $9.5 million, if certain conditions of the agreement are met, including final FDA approval before December 31, 2005.
Upon product launch, Penwest will receive royalties ranging from 15% to 18% of net sales of the product, depending on sales levels.
“This agreement represents a significant step for Penwest in the development of this product, the first that we have fully developed and submitted to the FDA on our own, and it marks the achievement of one of our company’s priorities for 2005,” remarked Robert Hennessey, president and CEO of Penwest. “We continue to expect to receive an action letter from the FDA for this product by the end of June, and look forward to the approval and commercial launch.”