Alizyme: Can Low Risk Last Forever?
Alizyme's GBP16.1 million, barely discounted placing and open offer illustrates its investors' faith in its low-risk business model and maturing pipeline. It also provides leverage for negotiating the out-licensing deals those investors now expect.
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Alizyme's out-licensing pact with Takeda for Japanese rights to the UK biotech's Phase II anti-obesity compound ATL-962 underscores the practical and funding advantages of a Japanese-market deal as a precursor to negotiating US and European licenses. Opportunities for other European biotechs to do the same may increase: Takeda's willingness to develop a still relatively early-stage compound in a tricky development area highlights Japanese firms' particularly acute need for pipeline products.
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.
A bunch of UK biotech firms are in trouble, some forced to restructure and others to seek financing on miserably expensive terms. All wish they'd raised more money during the funding bonanza of 2000. Challenging times such as these reveal lingering cracks--and lack of experience--in strategy and business management. This suggests that UK industry, although it has matured significantly since the brutal blow to confidence dealt by a major product failure at British Biotech during the sector's tender early years, still has some way to go.