BioMimetic Therapeutics has amended its manufacturing and supply agreement with Novartis Vaccines and Diagnostics for the supply of bulk rhPDGF-BB. Accordingly, Novartis will manufacture rhPDGF-BB exclusively for BioMimetic for therapeutic applications covering bone, cartilage, tendon, and ligaments.
BioMimetic is utilizing purified recombinant human platelet-derived growth factor (rhPDGF-BB) in combination with tissue-specific matrices as its primary platform for promotion of tissue healing and regeneration. rhPDGF-BB is a synthetic form of one of the body's principal agents that stimulates and directs healing and regeneration. The mechanism of action of this technology suggests that it may be effective in a broad array of musculoskeletal applications.
“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 orthopedic space,” remarks Samuel Lynch, DMD, president and CEO of BioMimetic.
“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 orthopedic development programs for Augment and Augment Injectable,” Dr. Lynch continues.
GEM 21S is approved as a grafting material for bone and periodontal indications. It is a trademark of Luitpold Pharmaceuticals, which now owns this dentally related product and markets it through its Osteohealth Company in the U.S. and Canada.
Augment and Augment Injectable are being tested in multiple orthopedic bone-healing indications like the treatment of foot and ankle fusions and the stimulation of healing of fractures of the wrist. In November 2009, BioMimetic received approval from Health Canada to begin marketing Augment as an alternative to the use of autograft in foot and ankle fusion indications in Canada.
Under the revised deal, the contract has been 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 arrangement for any reason. In the event of a termination Novartis is required to support technology transfer by providing a new manufacturer with all Novartis technology and supporting documentation necessary to produce and supply sufficient bulk rhPDGF-BB to fulfill all BioMimetic’s needs.
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 orthopedic applications.