Nycomed and Forest Laboratories Holdings Limited, a wholly-owned subsidiary of Forest Laboratories, Inc, have entered into a definitive collaboration and distribution agreement for Daxas (roflumilast) in the United States. Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD (chronic obstructive pulmonary disease) and for which Nycomed submitted an NDA with the FDA in July.
Under the terms of the agreement, Forest will make an upfront payment to Nycomed of $100 million and will pay future, undisclosed milestone payments. In addition, Nycomed will receive royalties based on Daxas sales. Forest will assume responsibility for the US regulatory approval and commercialization of Daxas in the United States and the companies will collaborate on future development programs.
Håkan Björklund, chief executive officer of Nycomed, said, "We have received considerable interest in the marketing rights to Daxas and we believe Forest Laboratories is the best possible partner for Nycomed in the US. Forest Laboratories has a significant US sales force, an increasing focus on respiratory products and an unrivalled track record of partnering with European companies to build hugely successful franchises. We believe their absolute commitment to Daxas will help to bring this innovative new therapy to as many patients in the United Sates as possible who suffer from COPD, a disease which is predicted to become the third-leading cause of death worldwide by 2030."
Howard Solomon, chairman and chief executive officer of Forest, said, "We are pleased to have entered into this collaboration with Nycomed. Nycomed has demonstrated great dedication in bringing Daxas to its current NDA stage of development and we are looking forward to working with such a talented and committed group as we consider ways to further develop and expand the use of Daxas. Daxas represents the first in a new class of agents to treat COPD and would be the first oral agent to be approved for this debilitating disease. If approved, Daxas will give physicians and patients a much needed new treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies." In addition Solomon commented that 'oglemilast, our phase-II PDE4 inhibitor licensed from Glenmark remains in active development for both COPD and asthma and represents a potentially complementary opportunity'.
In a recently completed phase-III pivotal programme consisting of two studies in a total of over 3,000 patients with COPD, Daxas demonstrated statistically significant improvements compared to placebo 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.
Daxas is an orally administered phosphodiesterase 4 (PDE4) enzyme inhibitor, targeting cells and mediators in the body believed to be important in the COPD disease process.
Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management.
Forest Labs is a US-based pharmaceutical company with a long track record of building partnerships and developing and marketing products that make a positive difference in people's lives.