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news.Baxter Healthcare has signed a licensing agreement with Innocoll Pharmaceuticals, a division of Innocoll, granting Baxter exclusive rights to market and distribute the company's gentamicin surgical implant in the US.
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Under the terms of the agreement, Baxter will pay a license fee and will make contingent clinical, regulatory and commercial milestone payments. Baxter will also contribute to the Phase III clinical costs and a portion of the registration fees.
Innocoll will be responsible for the continued management of the clinical programs and the regulatory filing. Innocoll will manufacture and supply product to Baxter.
The gentamicin surgical implant will be the first and only biodegradable, leave-behind antibiotic surgical sponge to be used as an adjunct therapy for prevention and treatment of surgical site infections (SSIs) in the US.
This agreement is expected to add to Baxter’s biosurgical portfolio by giving surgeons an innovative option to help reduce risk of post-operative complications of SSIs during surgery.
The implant is approved in 49 countries spanning Europe, Latin America, the Middle East, Africa and Asia. It is currently in two Phase III clinical trials in the US to support a planned 2009 new drug application for US regulatory approval.