West Coast Editor

About a year after its deal for the compound ended with Bayer AG, Paratek Pharmaceuticals Inc. entered a license and development deal with Merck & Co. Inc. worth up to $127 million plus royalties if the FDA approves PTK 0796, a broad-spectrum antibiotic with oral and intravenous versions in Phase I clinical trials.

Under the terms, Paratek gets an undisclosed up-front payment, and Merck, of Whitehouse Station, N.J., will take primary responsibility for development, keeping the marketing rights worldwide. Paratek also has an option to co-promote the IV form of PTK 0796 in the U.S.

"They’re going to be in the lead position in terms of providing the manpower and brute force," said Thomas Bigger, CEO of Boston-based Paratek. "Our role is going to be more strategic. The up-front payment is "reflective of a Phase I deal," he said. "We feel that they have fairly valued the asset we have" and the arrangement is "not all back ended, where everything comes upon approval."

PTK 0796 is an aminomethylcycline antibiotic that has been shown effective in animal models for treating infections caused by Gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus, and by Gram-negative, atypical and anaerobic bacteria, including antibiotic-resistant bugs known to cause diseases such as pneumonias, urinary tract infections, skin diseases and blood-borne infections in the hospital community.

"It pretty much gets everything," Bigger said, adding that Phase II trials are expected to start later this year.

Bayer, of Leverkusen, Germany, "in the early part of last year" backed out of its deal for PTK 0796, entered into in the fall of 2003. "Basically, they got out of the anti-infectives business" to focus on cardiovascular and metabolic diseases, Bigger said. "We parted friends and reacquired all the rights to PTK 0796." (See BioWorld Today, Sept. 16, 2003.)

Paratek’s work with tetracycline derivatives also has yielded a deal focused on a multiple sclerosis therapy with Geneva-based Serono SA, which is paying as much as $38 million in the agreement, not counting an initial cash payment, a loan convertible into Paratek stock, research funding and milestone payments if additional drugs are developed for MS or other indications. (See BioWorld Today, Oct. 28, 2004.)

"There’s a bit of similarity [between the Serono and the Merck deals] in that the compounds we’re using for both diseases are tetracyclines, but the intent of our Serono deal is to inactivate the antibacterial part" and enhance the anti-inflammatory properties of the molecule, Bigger said, noting that Paratek also is investigating such disorders as rheumatoid arthritis, stroke and Huntington’s disease.

In terms of cash, "we’re probably good for at least a couple of years, and if we continue to execute on the deal, we’re good into the 2008 and 2009 time frame," he said.

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