Nycomed and Forest Laboratories Holdings Limited, a subsidiary of Forest Laboratories, have announced a new collaboration to distribute Daxas, a promising treatment for chronic obstructive pulmonary disease (COPD) in the US.
Daxas is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor developed by Nycomed, for which the company submitted a New Drug Application with the US Food and Drug Administration in July 2009.
Under the terms of the agreement, Forest will pay Nycomed $100m upfront as well as future undisclosed milestone payments. In addition, Nycomed will receive royalties based on Daxas sales.
Forest will then assume responsibility for the US regulatory approval and commercialisation of Daxas in the US and the companies will collaborate on future development programmes.
Forest chairman and chief executive officer Howard Solomon said that 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,” Solomon said.
“In addition, oglemilast, our Phase II PDE4 inhibitor licensed from Glenmark remains in active development for COPD and asthma and represents a potentially complementary opportunity.”
In two Phase III trials conducted on over 3,000 patients with COPD, Daxas demonstrated statistically significant improvements compared to placebo over a 12-month treatment period in both studies.