Thursday, May 21, 2009

Notes from BIO: Positive Message from Anti-Infective Development

Cempra closed a $46 million Series C funding in mid-May. Any fund-raising in biotech these days is noteworthy, but there is an extra layer of significance to this one as a vote of confidence in anti-infectives drug development.

Capital is hard to come by for anyone, but the ability of an anti-infective development firm to raise capital from at least six private funding sources sends as strong signal that the uncertainty in anti-infective development stemming from regulatory delays experienced by projects like telavancin and ceftobiprole may be fading into the background.

Prabhavathi Fernades, the CEO of Cempra, told a BIO breakout session today that FDA's recent work on anti-infective development guidelines is starting to send a clearer message. The objectives and targets for anti-infectives are going to be tougher, she thinks, and skewed towards more serious disease, but that is adding a sense of clarity to development projects. The clarity is what is important.

Fernandes, who has extensive experience in antibiotic development at Bristol-Myers Squibb and Abbott (where she took a lead role in the regulatory development of Biaxin) prior to starting Cempra, also said that developers have learned some harsh lessons on accountability and keeping close control on clinical trials based on the non-approvable and complete response letters from FDA during the past 18 months.

Cempra's CEO thinks that sponsors were getting a little lax and failed to follow up on issues such as big geographical differences in efficacy in clinical trials. From that perspective, the reaction from FDA is not a full-stop to anti-infective development, just a reminder to sponsors to pay closer attention to the details of their applications.

To Fernandes and her backers, it looks like the period of regulatory uncertainty at FDA may be coming to a close. Cempra has a macrolide-ketolide compound, CEM-101 (oral and IV) headed into Phase II trials this year. With bacterial resistance and pandemic influenza alternating for headlines, it might just be a good time to be developing a new generation of anti-infectives -- especially with clearer guidance from FDA and a new public health-oriented team leading the agency.

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