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."

Advanced Life Sciences also entered into a new round of debt and equity financing agreements aimed at shoring up the company's balance sheet so that it can remain in business until cethromycin is approved and revenue starts flowing.

Advace Life Sciences says Cethromycin has shown higher in vitro potency and a broader range ofactivity than macrolides against gram-positive bacteria associated withr espiratory tract infections. In in vitro tests, cethromycin appears to beeffective against penicillin- and macrolide-resistant bacteria. Cethromycinhas a mechanism of action that may slow the ability of bacteria to developresistance to the drug.

In addition to its utility in CAP, cethromycin is also being investigatedfor the prophylactic treatment of inhalation anthrax post-exposure and otherpathogens of bioterror including tularemia, plague and melioidosis. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment ofinhalation anthrax post-exposure, but the drug is not yet approved for this orany other indication.

CAP is the sixth most common cause of death in the United States. CAP andother respiratory tract infections are caused by pathogens such asStreptococcus pneumoniae and Haemophilus influenzae. If not treated properly,CAP is potentially fatal and the bacteria that cause CAP are developingresistance to current standard of care treatments.

Macrolides and penicillins are currently the first-line treatments forrespiratory tract infections such as CAP. Streptococcus pneumoniae is themost prevalent pathogen that causes CAP and resistance rates to this organismrange between 40 per cent for macrolides and 60 per cent for penicillins in the U.S.Streptococcus pneumoniae resistance is more common in the Asia Pacific region,where rates exceed 50 per cent for penicillin and 80 per cent for macrolides. As macrolide andpenicillin resistance grows and has the potential to cause more clinicalfailures, there is a need for new antibiotics with unique mechanisms of actionthat can overcome emerging bacterial resistance.