Treatment has been submitted to the FDA for review and could become the first oral therapy.

Forest Laboratories is paying $100 up front for U.S. rights to Nycomed’s investigational compound for chronic obstructive pulmonary disease (COPD). An NDA for Daxas®, a selective phosphodiesterase 4 (PDE4) enzyme inhibitor, was submitted to the FDA in July.

Under the definitive collaboration and distribution agreement, Nycomed will receive milestones and royalties. Forest will assume responsibility for U.S. approval and commercialization, the firms will work together on future development.

If approved, Daxas will represent 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, points out Howard Solomon, chairman and CEO of Forest.

“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 U.S.,” remarks Håkan Björklund, CEO of Nycomed. “Forest Laboratories has a significant U.S. sales force, an increasing focus on respiratory products, and an unrivalled track record of partnering with European companies to build hugely successful franchises.” Mitsubishi Tanabe is Nycomed’s Japanese collaborator.

Forest markets three respiratory-related products: Aerobid®, a metered-dose inhaler medication, to help manage inflammation caused by asthma; AeroChamber Plus®, a holding chamber device designed to maximize the delivery of metered-dose inhaler medications to patients’ lungs; and Infasurf® for respiratory distress syndrome seen in infants.

Additionally, Forest has a COPD and asthma candidate called oglemilast that is reportedly in Phase II trials, which it believes will complement Daxas. Oglemilast is a PDE4 inhibitor licensed from Glenmark Pharmaceuticals.

In Phase III pivotal studies, which included over 3,000 patients with severe and very severe COPD, Daxas demonstrated statistically significant improvements compared to placebo on the co-primary endpoints of moderate to severe exacerbations and prebronchodilator FEV1 over a 12-month treatment period in both studies.

Daxas also demonstrated a statistically significant improvement compared to placebo on the primary endpoint, prebronchodilator FEV1, in two supportive studies over a six-month period when used in conjunction with commonly used long-acting bronchodilators. These were conducted in 1,500 patients, the majority with moderate COPD.

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