Roche's October 2003 in-licensing of Ipsen's Phase I GLP-1 analog buys the Swiss group an initial stake in the fast-growing diabetes market. Most established diabetes players already have a compound in this class, but the partners hope that Ipsen's expertise in peptide delivery will set this program apart from competitors'. As the second licensing agreement between Roche and Ipsen in less than a year, the deal further validates Ipsen's pipeline, and suggests that Roche's carefully-managed partnership strategy continues to encourage repeat business.

Denmark's Zealand Pharma inked its second Big Pharma deal in as many months when it out-licensed its lead product, a Phase II diabetes treatment, to Aventis. Zealand's accelerated development of the product--which was tested immediately in patients, bypassing healthy volunteers--provided the firm with clinical proof of prinicple, on a budget.

Even if industry observers are correct and the US Food and Drug Administration has changed its rules for drug approval and is now tilting toward assessing safety, not efficacy, first, the current policy falls squarely within the agency's legislative mandate. Historically, it has asked companies to conduct additional clinical trials when doubts about safety remain. But even within that requirement, the FDA has room to maneuver. And a new school of thought is leaning toward post-marketing risk management to detect serious and rare adverse effects after a drug has reached the market on the basis that its benefits outweighs its risks.