12:00 AM
 | 
Nov 23, 2009
 |  BioCentury  |  Product Development

Nycomed Holding its Breath

Following the May expiry of European patents protecting its biggest-selling drug, Nycomed is hoping COPD compound Daxas roflumilast will help fill part of the revenue gap. If approved, the nonsteroidal phosphodiesterase-4 inhibitor would be the first innovative COPD treatment to reach the market in 30 years and potentially the first disease-modifying drug ever approved for the disease.

However, proving the latter will take three-to-five year mortality trials that the company and partner Forest Laboratories Inc. haven't yet designed. In the meantime, Nycomed hopes that improved safety and efficacy will drive use of Daxas, which could both replace steroids in later-stage patients with chronic obstructive pulmonary disease and potentially be used earlier in the course of disease than steroids.

An NDA for Daxas is under FDA review. While a PDUFA date hasn't been announced, the companies are hoping to receive approval in 2010. Nycomed expects a decision next year from EMEA on its MAA.

"COPD therapy has seen very little innovation over the years and what this compound does is provide a new perspective on how to tackle the disease," Klaus Rabe, professor of medicine at Leiden University Medical Center, told BioCentury.

Rabe was a lead investigator in one of the four Phase III trials of Daxas published in The Lancet in August and presented at the CHEST meeting early this month.

Based on those data, clinicians contacted by BioCentury said the drug's ability to improve lung function and reduce exacerbations shows exciting potential. But since all the studies so far have tested Daxas as an add-on to bronchodilators, the physicians said more work needs to be done if it is going to compete with current treatments. This would include trials comparing Daxas head to head with marketed drugs, as well as long-term studies to determine the compound's effect on mortality and its ability to alter disease progression.

Anders Ullman, EVP of R&D at Nycomed, noted "demonstrating an effect on disease progression and mortality will take several years to answer." Median survival is about 10 years for COPD patients who have lost about two-thirds of their normally expected lung function at diagnosis.

"Our collaboration with Forest has only just been established, so it is difficult to say what we will do," Ullman told BioCentury. "But I can say that after the expected approval, we are committed to optimizing the clinical usefulness, and understanding and demonstrating disease modification will be an important part of these discussions."

He added: "We would hope to have our Phase IV studies up and running as soon after we get approval as we can."

Under an August deal, Forest paid $100 million upfront for exclusive U.S. rights. The company, which also agreed to undisclosed milestones and royalties, is responsible for U.S. regulatory approval and commercialization.

Sizing the opportunity

Nycomed needs to replace declining revenues from Protonix pantoprazole, which lost patent protection in Europe in May and is scheduled to lose U.S. patent protection in 2010, although those patents have already been challenged by generics companies trying to end them earlier. The proton pump inhibitor (PPI) is approved to treat reflux symptoms.

Pfizer Inc. markets Protonix in the U.S.

Protonix was responsible for almost 41% of Nycomed's 2008 sales, down from 49% of total sales in 2007. The product posted revenues of €1.3 billion ($1.95 billion) in 2008, down 22% from the €1.7 billion posted in 2007. Sales in 3Q09, after the substance patent expired, were €272.8 million ($408.3 million), down 15.7% from 3Q08.

Nycomed is actively in-licensing assets to make up for...

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