Yondelis Experience Highlights EMEA Issues
The European regulators' rejection of PharmaMar's lead anti-cancer drug Yondelis in November 2003 was a significant setback for Spain's flagship biotech. But the decision was close; some experts still feel the drug should have been approved. Indeed, although critics claim PharmaMar could have done more to ensure its trial design was satisfactory, the experience highlights weaknesses in Europe's centralized drug approvals procedure of which other firms should be aware. All the more so since the centralized route will likely soon be compulsory not only for biologics, but also for all products in cancer, HIV/AIDS, neurodegenerative disease and diabetes, and all designated orphan drugs.
You may also be interested in...
Signs are that Spanish biotech, until now held back by a lack of capital and management expertise, may be about to receive the kick-start it badly needs. Newly-created Ysios Capital Partners is the country's first specialist VC. It's raising a first fund worth €65 million ($92 million)--and it's not alone.
Echoing other transatlantic rifts, FDA commissioner Mark McClellan argues that America, with its unrestricted drug pricing, is paying Europe's drug R&D bill. Pharma companies agree. European authorities-the only faction with the power to alter pricing policies-don't. But the public disagreement hasn't prevented closer cooperation between the FDA and the EMEA. The agencies' recently announced confidentiality agreement paves the way for better information sharing and could simplify the complex European regulatory arena. But it won't necessarily speed approvals-some drug firms argue that it may even slow them down.
Encouraged by successes in the biotech space, public market investors' interest in the device arena has returned in 2004 to support 10 companies' IPOs so far. Windhover's analysis of the valuations achieved indicate that private investors in these companies have, on average, enjoyed larger returns than their biotech counterparts.