Advanced Life Sciences, Wyeth in Asian marketing pact for new drug

To push the development of its long-delayed antibiotic cethromycin, Advanced Life has signed its first commercial partnership with Wyeth, which will sell the novel once-a-day oral antibiotic used in the treatment of mild-to-moderate community-acquired pneumonia,  in Asia excluding Japan, where Abbott Labs has already secured rights to the drug.

However, additional clinical trials will be required before Advanced Life Sciences and Wyeth gain regulatory approval for the drug in Asia, for which Advanced Life Sciences and Wyeth will collaborate to develop additional clinical data in the Asia Pacific region to support regulatory filings in that region. The overall value of thetransaction could potentially exceed $100 million.

Advanced Life Sciences, a pre-commercial stage biopharmaceutical company engaged in the discovery, development and commercialisation of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases, will retain exclusive rights tocethromycin in the rest of the world. It has already filed  a new drug application with the US FDA for the drug.

Under the terms of the agreement, Wyeth made an up-front equity investmentin Advanced Life Sciences through the purchase of common stock representingapproximately 4.9v per cent of the company's total outstanding shares. In addition tofuture royalty payments, Advanced Life Sciences would receive milestone and regulatory payments based on successful achievement of clinical, regulatory and commercial objectives in specific markets.

"We are very pleased to be working with Wyeth to support development andcommercialization efforts in the Asia Pacific region. We believe thispartnership validates our scientific achievements and the commercial potentialfor cethromycin," said Michael T Flavin chairman and CEO. "The need for new antibiotics and subsequent marketgrowth in this region is outpacing that of the rest of the world due to high bacterial resistance rates. Wyeth is a worldwide leader in the development and commercialisation of novel respiratory therapeutics with a strong positionin the Asia Pacific region and we are excited to be working with their team tobe successful in bringing cethromycin to this key geography."

"Antibiotic resistance in the community is a serious public health problem worldwide. Data suggest that cethromycin has a favorable efficacy and safetyprofile in community acquired pneumonia and we view this product as apotential option to aid in the battle against potentially deadly pathogens,"said Mark Larsen, President, Asia-Pacific and Nutritionals, for Wyeth. "If approved, we view cethromycin as an excellent addition to our strong portfolioof existing anti-infective agents, Tygacil (tigecyline) and Zosyn piperacillin / tazobactam, and it is in line with our corporate objectives in a key growth region for Wyeth."