BioMimetic Therapeutics (BioMimetic) has amended and restated its manufacturing and
supply agreement with Novartis Vaccines and Diagnostics, effective December 31, 2009, for the supply
of bulk rhPDGF-BB
The agreement sets forth a strengthened mutual exclusivity commitment whereby Novartis is expected
to manufacture rhPDGF-BB exclusively for BioMimetic for therapeutic applications covering bone,
cartilage, tendon and ligaments.
As per 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.
Reportedly, 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 fulfill 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 orthopedic applications.
Samuel Lynch, president and CEO of BioMimetic, said: “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.
“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 commercialisation of rhPDGF-BB within the orthopedic space.”