Orthovita and BioMimetic Enter into a Supply Agreement
MALVERN, Pennsylvania, USA, Wednesday, August 21, 2002 – Orthovita, Inc. (NASDAQ NM / NASDAQ Europe: VITA), a leading developer of orthopaedic biomaterials, and BioMimetic Pharmaceuticals, Inc., (BMPI) a leading tissue engineering company, reported today that they have entered into a worldwide supply agreement that allows BMPI to use its recombinant human platelet derived growth factor (rhPDGF) in combination with Orthovita's proprietary VITOMATRIX™ particulate synthetic scaffold biomaterial. Orthovita will manufacture and supply VITOMATRIX, a resorbable beta-tricalcium phosphate scaffold, to BMPI for its clinical and commercial use in conjunction with rhPDGF. Upon obtaining the requisite regulatory approvals, BMPI will market and sell the combined product, which is currently for investigational use only in the United States, in the dental, periodontal, oral and cranio-maxillofacial bone grafting markets.
"We believe that this collaboration offers the potential to expand the reach and utility of our proprietary biomaterials into new products for additional markets outside of orthopedics, our main area of focus," said Antony Koblish, President and Chief Executive Officer of Orthovita, Inc. "It also provides an opportunity to evaluate the potential utility of our VITOMATRIX biomaterial as a matrix for use in conjunction with growth factors and other substances for a variety of indications." "Tissue engineering is most effective when conductive matrices and the appropriate tissue growth factors are combined. Our strategy is to combine an FDA-approved growth factor, e.g. rhPDGF, with a new-generation, osteoconductive scaffold, thus providing superior products to the clinician in a reasonable development cycle" said Dr. Samuel E. Lynch, President and Chief Executive Officer of BioMimetic Pharmaceuticals, Inc. "This supply agreement with Orthovita, coupled with our existing supply agreement with Chiron Corporation for rhPDGF, is a key milestone in this strategy."
About the Orthovita
Orthovita is a biomaterials company with proprietary technologies applied to the development of biostructures, synthetic biologically active tissue engineering products for restoration of the human skeleton. Our focus is on developing novel products for use in spine surgery and in the repair of osteoporotic fractures. We are also addressing a broad range of clinical needs in the trauma market.
We have applied our technologies to the development of three products, VITOSS(R) synthetic cancellous bone void filler, CORTOSS(TM) synthetic cortical bone void filler and RHAKOSS(TM) synthetic bone spinal implant, that we believe offer a wide range of clinical applications at various anatomical sites.
VITOSS is a resorbable calcium phosphate scaffold that is highly porous and composed of extremely fine calcium phosphate mineral that allows for resorption, cell seeding and ingrowth of host bone. VITOSS was cleared for sale in the U.S. and Australia, and approved for sale under a CE Mark in Europe.
CORTOSS is a high-strength, bone-bonding, self-setting composite engineered specifically to mimic the strength characteristics of human cortical bone. CORTOSS is approved for sale in Australia and is approved for sale under a CE Mark in Europe. CORTOSS is not available for commercial distribution in the U.S.
In addition to the recent approval to study CORTOSS in vertebroplasty, we are conducting clinical studies of CORTOSS required for approval in the U.S. for its use to augment screws that fail to hold in osteoporotic bone, as well as studies in Europe required to expand its label under the CE Mark for its use in vertebroplasty.
RHAKOSS is under development as a preformed composite that mimics the natural dual cortical-cancellous composition of human bone, providing high strength while also allowing for the ingrowth of host bone to address the vertebral interbody fusion and spinal reconstruction market. We are conducting clinical studies of RHAKOSS in Europe required to obtain a CE Mark in Europe for its use as an interbody fusion device.
About BioMimetic Pharmaceuticals, Inc.
BMPI is focused on the development, commercialization and ultimate marketing of protein therapeutics for tissue regeneration. BMPI's lead technologies are for the healing and restoration of bone and other tissues.
The first therapeutic indication to be targeted by BMPI is the treatment of bone defects resulting from periodontal diseases. Periodontal (gum) diseases represent a substantial emerging market opportunity. It is estimated that 10%-15% of the US population has advanced forms of disease that often require surgery or tooth extraction. Approximately 2 million periodontal surgeries are performed annually in the US. Consequently, periodontal surgery is one of the most common surgical procedures performed today. In addition, there are numerous other potential indications for BMPI's lead rhPDGF-VITOMATRIX therapeutic product. For example, there are about 10 million surgical extractions annually, many of which could potentially benefit from the Company's technologies.
This press release contains forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties, including without limitations, Orthovita's VITOSS, CORTOSS and RHAKOSS products and other aspects of Orthovita's business. Such statements are based on Orthovita's current expectations and are subject to a number of substantial risks and uncertainties that could cause actual results or timeliness to differ materially from those addressed in the forward-looking statements. Factors that may cause such a difference include, but are not limited to, Orthovita's dependence on the commercial success of Orthovita's approved products, Orthovita's history of operating losses and Orthovita's need for additional funds, Orthovita's need to obtain and maintain regulatory approvals to sell Orthovita's products, Orthovita's ability to manage commercial scale manufacturing capability and capacity, risks and uncertainties in pre-clinical and clinical trial results, market acceptance of Orthovita's products, the sales levels of Orthovita's products, research and development, competition and other risk factors listed from time to time in reports filed by the Company with the Securities and Exchange Commission, including but not limited to risks described in Orthovita's most recently filed Form 10-K under the caption "Certain Risks Related to Our Business." Further information about these and other relevant risks and uncertainties may be found in the Company's filings with the Commission, all of which are available from the Commission as well as other sources. Orthovita undertakes no obligation to publicly update any forward-looking statements.
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