San Francisco and Hopkinton, MA, January 8, 1997--Creative BioMolecules (Nasdaq: CBMI) is a presenter at the 1997 Hambrecht & Quist Healthcare Conference. Creative BioMolecules' lead program is a collaboration with Stryker Corporation (Nasdaq: STRY) directed at orthopaedic indications. The Company made real progress this year.
Stryker has completed the pivotal clinical trial in non-union fractures and are in the process of analyzing the data and preparing a premarket approval application for submission to the FDA later in 1997. The first presentation of human data from this trial will be seen at next month's American Academy of Orthopaedic Surgeons Meeting. Data from a major investigational center will be presented.
Stryker will initiate additional clinical trials in North America and in Europe in 1997. These will likely include trials for the treatment of fresh fractures and other reconstructive procedures. Where a bone graft is now indicated, Creative believes that OP-1 will become the preferred therapy. Stryker has the reach and presence to market this product worldwide. Creative and Stryker see great commercial potential in treating periodontal disease and are assembling the filing to put this program in the clinic in 1997.
The July agreement with Genetics Institute significantly strengthened Creative's patent
position across many disease categories. Over 100 patents were cross-licensed. Creative
received exclusive worldwide rights to OP-1 as well as clear patent rights in many other
Studies conducted in Creative's laboratories and by academic collaborators point to uses for OP-1 in the treatment of both acute and chronic renal disorders. Stabilizing kidney function in chronic renal failure may well mean delaying or actually avoiding dialysis.
As Creative begins the next round of renal studies aiming at clinical entry, the
Company is extremely pleased to be working with Biogen (Nasdaq: BGEN). Briefly, the new
agreement provides $28 million upfront in technology access fees and equity, $25.5 million
in research support through committed funds and a line of credit, and $69 million in
clinical milestone payments. In addition, Biogen will fully fund clinical development.
While early, Creative's research in neurological disorders indicates a
potentially similar and important role for OP-1. OP-1 is a powerful stimulator of neuronal growth.
What To Expect From Creative BioMolecules During This Year:
Creative BioMolecules, Inc. is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Companys therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in tissue regeneration and organ formation.
The statements in this news release that are not historical facts include forward-looking statements that involve risks and uncertainties. Factors which could cause actual results to differ from the Companys expectations include, without limitation, the achievement of product development milestones by the Company, the impact of competitive products, the timely receipt of regulatory clearances required for clinical testing, manufacturing and marketing of products and the other risks and uncertainties detailed from time to time in the Companys periodic reports.
Creative BioMolecules is a discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Companys therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in cell and tissue formation.
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