Advanced Life Sciences (ADLS Quote) announced Wednesday steps to push forward the development of its long-delayed antibiotic cethromycin.
The company made good on its commitment to complete the drug's filing with U.S. regulators by the end of the third quarter and to sign its first commercial partnership. Wyeth (WYE Quote) will market cethromycin in Asia for the treatment of mild-to-moderate community-acquired pneumonia, the companies said Wednesday. The Asian marketing agreement excludes Japan, where Abbott Labs (ABT Quote) has rights to the drug. Additional clinical trials will be required before Advanced Life Sciences and Wyeth can seek regulatory approval for cethromycin in Asia. 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. Cethromycin belongs to the relatively new ketolide class of antibiotics used to treat respiratory infections. Sanofi-Aventis' (SNY Quote) Ketek was the first Food and Drug Administration-approved ketolide, but reports of liver toxicities and patient deaths led regulators to place restrictions on Ketek's use last year. Ketek worldwide sales totaled about $300 million in 2005, before the safety concerns and labeling restrictions.
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