Nycomed and Forest Laboratories to Collaborate on Daxas® (roflumilast) for COPD
NEW YORK--(BUSINESS WIRE)--Nycomed and Forest Laboratories Holdings Limited, a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX), today announced that they 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 Mr. 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 program 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. Daxas is expected to act on an underlying mechanism of COPD and related inflammatory diseases. If approved, Daxas, a once-a-day tablet, will be the first drug in its class. It will also be the first oral anti-inflammatory treatment for COPD patients. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.
Nycomed's most recent and very extensive program for Daxas included two international Phase III, 12-month trials, HERMES and AURA, which included over 3,000 patients. The primary aim of both studies was to investigate the effect of Daxas on exacerbation rates and pulmonary function (pre-bronchodilator FEV1) in predominantly severe and very severe COPD patients. Daxas (500 μg roflumilast) was administered orally once daily for up to 52 weeks. The randomized, double-blind, placebo-controlled studies were conducted in a number of territories, including the US, Europe, Canada, Australia, Russia, India and South Africa. Both HERMES and AURA met their primary endpoint objectives.
Two additional supportive double-blind, placebo-controlled Phase III studies, EOS and HELIOS, evaluated the efficacy of Daxas in more than 1,500 patients, the majority with moderate COPD, when used concomitantly with standard bronchodilator treatments for COPD, i.e., tiotropium or salmeterol. The primary endpoint was the mean change from baseline in pre-bronchodilator FEV1. Both EOS and HELIOS demonstrated a statistically significant improvement in the primary endpoint with Daxas given in combination with a long acting bronchodilator compared to the same bronchodilator given alone.
Full data from all four studies are to be published in a leading peer-reviewed journal later this year and will be presented at the annual European Respiratory Society (ERS) Congress in Vienna, Austria, in September.
Two earlier double-blind placebo-controlled Phase III studies in COPD with Daxas demonstrated statistically significant effects on FEV1 compared to placebo treatment and showed a positive trend with respect to exacerbation improvement which was not statistically significantly different than placebo.
Daxas is protected by a composition of matter patent through January 27, 2015 and is eligible for patent term extension which should provide an additional five years of exclusivity beyond the life of the patent.
COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterized by severe episodes of worsening, called exacerbations. According to World Health Organization (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. The WHO predicts that total deaths from COPD could increase by more than 30% in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.
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. An extensive range of OTC products completes the portfolio.
Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.
Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialized through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.
Headquartered in Zurich, Switzerland, the company generated total sales of €3.4 billion in 2008 and an adjusted EBITDA of €1.2 billion.
For more information visit www.nycomed.com.
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-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. In addition to its well-established franchises in therapeutic areas of the central nervous and cardiovascular systems, Forest's current pipeline includes product candidates in all stages of development and across a wide range of therapeutic areas. The company is headquartered in New York, NY. To learn more about Forest Laboratories, visit www.FRX.com.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, the acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products, and the risk factors listed from time to time in Forest Laboratories' Annual Report on Form 10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.