Drugs

Advanced Life, Wyeth Ink Marketing Deal

 

Advanced Life Sciences (ADLS) 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) 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) 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) 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.

Biotech Select

Safety concerns over the entire ketolide class of antibiotics has hampered and delayed efforts by Advanced Life Sciences to get cethromycin approved. These delays have been especially damaging to Advanced Life Sciences because of the company's precarious financial health.

The company finished the second quarter with $9 million in cash and was expected to burn through another $3.5 million in the third quarter just completed. Advanced Life Sciences owes Abbott a payment of $10 million now that cethromycin has been filed with the FDA.

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