Community-acquired pneumonia (CAP) occurs when individuals who have not been recently hospitalized develop a pneumonia infection. This disease is the sixth most common cause of death in the United States, affecting people of all ages. If not properly treated, CAP can be fatal. Researchers are finding it harder to treat CAP as it grows more resistant to current antibiotics, leaving drug company researchers scrambling to develop an efficient treatment.
Last week, Advanced Life Sciences Holdings Inc. (Nasdaq: ADLS) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced they have signed a development and commercialization agreement for an oral antibiotic for the treatment of community respiratory tract infections in the Asia Pacific region, excluding Japan.
Cethromycin is a novel drug, administered once-a-day, which is shown to have a higher potency and broader range of activity than other treatments. According to the press release, during in-vitro tests, Cethromycin appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin provides a mechanism that may slow the ability of bacteria to develop resistance to the drug.
Per the agreement, Advanced Life Sciences will keep exclusive rights to Cethromycin in the rest of the world, including North America and Europe, excluding Japan. The company said its collaborative efforts with Wyeth support the potential of the treatment.
“We are very pleased to be working with Wyeth to support development and commercialization efforts in the Asia Pacific region. We believe this partnership validates our scientific achievements and the commercial potential for cethromycin,” Michael T. Flavin, Ph.D., Advanced Life Sciences’ chairman and CEO stated in the press release.
Dr. Flavin added that the Asian region is in dire need of such antibiotics and that Wyeth’s position in the industry will assist Advanced Life Sciences’ to address the growing need for treatments for CAP.
“The need for new antibiotics and subsequent market growth 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 commercialization of novel respiratory therapeutics with a strong position in the Asia Pacific region and we are excited to be working with their team to be successful in bringing cethromycin to this key geography,” Dr. Flavin stated.
Mark Larsen, president of Asia-Pacific and Nutritionals for Wyeth, said the bacterial resistance to treatment poses a serious threat not only to the Asia-Pacific region, but to the entire world.
“Antibiotic resistance in the community is a serious public health problem worldwide. Data suggest that cethromycin has a favorable efficacy and safety profile in community acquired pneumonia and we view this product as a potential option to aid in the battle against potentially deadly pathogens,” Larsen stated. “If approved, we view cethromycin as an excellent addition to our strong portfolio of 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.”
Wyeth made the up-front equity investment in Advanced Life Sciences through the purchase of roughly 4.9 percent of the company’s outstanding shares. Advanced Life Sciences will receive future royalty payments, as well as milestone and regulatory payments based on achievements in specific markets. The aggregate value of the transaction could potentially exceed $100 million.
In a separate announcement, Advanced Life Sciences said it filed a new drug application (NDA) to the U.S. FDA for Cethromycin for the indication of mild-to-moderate CAP.
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