BioMimetic Therapeutics, Inc. announced that effective December 31, 2009, the company amended and restated its manufacturing and supply agreement with Novartis Vaccines and Diagnostics, Inc. for the supply of bulk rhPDGF-BB to BioMimetic. The agreement sets forth a clear and strengthened mutual exclusivity commitment whereby Novartis shall manufacture rhPDGF-BB exclusively for BioMimetic for therapeutic applications covering bone, cartilage, tendon and ligaments.
Under the revised agreement, the contract was extended by three years with successive three year evergreen extension periods. Further, either company must give a six month termination notice in any extension period if they wish to discontinue the agreement for any reason. In the event that Novartis terminates the agreement, or if BioMimetic terminates the agreement for cause, Novartis is required to support technology transfer by providing to a new manufacturer all Novartis technology and supporting documentation necessary to produce bulk rhPDGF-BB and to supply BioMimetic sufficient bulk rhPDGF-BB to fulfil its needs during the technology transfer process. Finally, the companies reduced certain minimum purchase obligations through 2011, by which time the parties anticipate that BioMimetic’s Augment will be FDA approved for orthopaedic applications.
“Novartis has been an excellent partner in the supply of our bulk rhPDGF-BB, enabling the successful approval and product launch of our first regenerative product, GEM 21S, and more recently, facilitating our orthopaedic development programs for Augment and Augment Injectable,” said Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. “The conclusion of this amended agreement reaffirms and strengthens the ongoing relationship between our two companies for the future. Our exclusive agreement covering bone, cartilage, tendon and ligaments, combined with our own patent portfolio further raises the already high barrier to entry for development and commercialization of rhPDGF-BB within the orthopaedic space.”
BioMimetic Therapeutics is a biotechnology company utilizing purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue specific matrices as its primary technology platform for promotion of tissue healing and regeneration.