FDAnews Drug Daily Bulletin


March 20, 2006

Merck and Paratek Pharmaceuticals have signed a development and licensing agreement for Paratek's novel antibiotic PTK 0796, which is now in Phase I trials.

Under the deal, Merck has provided undisclosed upfront funding and will assume primary responsibility for clinical development of the intravenous (IV) and oral formulations of PTK 0796. Merck also has the right to market such products worldwide, the firms said.

Paratek will participate in clinical development and be eligible to receive payments upon achievement of certain milestones. Payments could total as much as $127 million once PTK 0796 is approved for marketing, according to the companies. Paratek also will receive royalties on net sales and have the opportunity to copromote the IV formulation of PTK 0796 in the U.S.

PTK 0796 is a novel, broad-spectrum aminomethylcycline (AMC) antibiotic. PTK 0796 represents a significant advance over the well-known tetracycline family, the firms said.

PTK 0796 has been shown to be highly effective in animal models at treating increasingly problematic, clinically prevalent infections caused by gram-positive bacteria such as methicillin-resistant Staphylococcus aureus (MRSA). Studies also show it is highly effective in treating infections caused by gram-negative, atypical and anaerobic bacteria, including those resistant to currently available classes of antibiotics and known to cause conditions such as pneumonia, urinary tract infections, skin diseases and blood-borne infections in both hospital and community settings.