Despite being rebuffed by the FDA and its drug experts, Switzerland's Nycomed has won EU approval for Daxas, its new therapy to treat chronic obstructive pulmonary disorder. The approval will usher in the first new drug for smoker's lung in more than a decade.
The OK marks a big step ahead for Merck, which holds European and Canadian marketing rights. The approval by the EU also marks a major advance for Nycomed, which has been working hard to develop a blockbuster market for the drug. Nycomed has discussed plans to file an IPO around its revenue prospects for the therapy. "This is an important step towards a possible IPO, but it does not change the timeline," a spokeswoman for Nycomed told Reuters. The spokesperson also told the Wall Street Journal that Nycomed is still reviewing its complete response letter on Daxas from the FDA.
"For Nycomed, this marks a very important milestone," Andrew Weiss, an analyst with Bank Vontobel, tells the Wall Street Journal. "The company is highly leveraged. An IPO or a takeover by another pharma company are options going forward."
Earlier this year an FDA panel voted nine to six that the drug appeared safe and effective, but weak efficacy data torpedoed their U.S. application. The experts voted against an approval by 10 to 5. Forest Laboratories paid $100 million upfront to license the therapy for the U.S. market.
- read the story from Reuters
- here's the report from the Wall Street Journal