Peninsula Pharmaceuticals Inc. revealed its first in-licensed product, an antibiotic, and now will begin its North American development.
The product, doripenem, was in-licensed from Shionogi & Co. Ltd., of Osaka, Japan. Peninsula not only has rights to develop the drug, but to sublicense it as well. For a company that has a business plan centered on in-licensing, the move marks what it hopes is the first of many.
"Of course this fits in our strategy to in-license late-stage products from outside the U.S., and getting rights in the U.S. for development and registration," said Paul Truex, Peninsula's president. "It has completed Phase III trials in Japan and it falls into a disease category that has a high predictability of success."
Most of the details of the deal have not been disclosed. Shionogi will "manufacture the product for worldwide distribution," Truex said, adding that the financials of the agreement are what would be found in "a traditional biotech deal," including milestone payments.
Truex also was unwilling to disclose specific development plans for the drug, but the Japanese trials will factor into how things are structured in the U.S.
"We'll use the Japanese data to help streamline North American development," he told BioWorld Today, adding that the results will help craft "unique clinical studies" to prove what was seen in Japan and to best take advantage of doripenem's characteristics.
Truex said the companies have been working "for a while to put this together." Shionogi was interested in Peninsula as a development partner because that is all Peninsula does.
"We were set up for development only," Truex said. "We have no research labs."
Doripenem is a member of the carbapenem class of antibacterials. It has shown in vitro action against aerobic, anaerobic, Gram-positive and Gram-negative bacteria, the company said. It is designed to work by disrupting the cell wall synthesis of bacteria, Truex said.
Peninsula, of Alameda, Calif., raised $22.1 million in October in its Series B financing round. At the time, it said it had in-licensed an undisclosed product from an unnamed Japanese firm. That product turned out to be doripenem, and even with clinical work looming, Peninsula should have enough in the bank to push the company "well into 2004," Truex said. Regardless, there are plans for another financing round. (See BioWorld Today, Oct. 29, 2002.)
"We hope to close the Series C around the end of the year," he said.
The company has grown to 13 employees and added Matthew Wikler as chief medical officer since the Series B round closed. Since the company is "working on a number of [in-licensing] deals," the number of employees could grow to 25 to 30 people by the end of 2003 and should be in the range of 30 to 35 by the end of 2004. Looking ahead, attracting good talent is just one of the company's goals.
"Obviously, we'll accelerate doripenem for the North American market," he said. "We are in good shape to get that done. In the current financial market, getting a round of financing to get us through Phase III would be a significant goal for us. And we hope to have at least one other product by the end of this year that would enter the clinic shortly thereafter."