Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. (FRX) and Nycomed, a privately owned global pharmaceutical company, said Monday that they have entered into a definitive collaboration and distribution agreement for Daxas or roflumilast in the U.S.
Daxas is a proprietary selective phosphodiesterase 4 or PDE4 enzyme inhibitor that has been developed by Nycomed for the treatment of lung disease chronic obstructive pulmonary disease or COPD. Nycomed submitted an NDA with the FDA for Daxas in July.
As per the agreement, Forest will make an upfront payment of $100 million to Nycomed and will pay future, undisclosed milestone payments. Nycomed will additionally receive royalties based on Daxas sales. Forest will assume responsibility for the US regulatory approval and commercialization of Daxas in the U.S. and the companies will collaborate on future development programs.
According to Forest Laboratories , in a recently completed Phase III pivotal program consisting of two studies in a total of over 3,000 patients with COPD, Daxas demonstrated statistically significant improvements compared to placebo. The improvements were seen on the co-primary endpoints of moderate to severe exacerbations and pre-bronchodilator FEV1 over a 12 month treatment period in both studies.
Daxas also demonstrated a statistically significant improvement compared to placebo on the primary endpoint, pre-bronchodilator FEV1, in two supportive studies over a six month period when used in conjunction with commonly used long-acting bronchodilators, the company noted.
FRX is currently trading at $26.35, up $0.07 or 0.27%, on 364,188 shares.
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