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Orthovita Enters into License Agreement with Angiotech for VITAGEL(TM) Surgical Hemostat |
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22 Mar 2006 |
MALVERN, PA, USA | Mar 21, 2006 | Orthovita, Inc. (NASDAQ NM:VITA):
* Completes the Contractual Transfer of Manufacturing Responsibilities, and Extends and Expands the Relationship.
* Extends Term of License Agreement from 2009.
* Expands Territory Distribution Rights to Include Europe and the Rest of the World.
* Provides for retention by Orthovita of exclusive Product Rights in Orthopedics through 2014.
* Grants to Orthovita and Angiotech Co-Exclusive Rights to the Product Outside of Orthopedics beginning in 2007.
Orthovita, Inc. (NASDAQ NM:VITA), a leading developer of orthopedic biomaterials, announced today that it has entered into a license agreement for VITAGEL(TM) Surgical Hemostat with Angiotech Pharmaceuticals, Inc. VITAGEL is a surgical hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical, and is being targeted to address a market estimated to be approximately $700 million worldwide. The key terms of this agreement include the completion of the contractual transfer of manufacturing responsibilities from Angiotech to Orthovita, the extension of the contract term from 2009 to 2014, the expansion of distribution rights to Orthovita of the product in Europe and the rest of world, the retention by Orthovita of worldwide exclusive rights within orthopedics through 2014 and co-exclusive rights outside of orthopedics beginning in 2007 where Angiotech may distribute its own brand of the surgical hemostat on a co-exclusive basis outside of orthopedics, and the retention by Angiotech of exclusive rights to any drug-loaded version of the surgical hemostat. Orthovita will manufacture the hemostat product for both companies.
Orthovita previously announced that it has submitted a Pre-Market Approval ("PMA") for VITAGEL(TM) Surgical Hemostat to the FDA in November of 2005. If approved, this PMA will allow Orthovita to sell VITAGEL product that is manufactured on-site at its Malvern, Pennsylvania facility. Orthovita expects the FDA to make its determination in the second half of 2006. Orthovita has been distributing VITAGEL since the first quarter of 2005 through a distribution agreement with Angiotech. Orthovita will continue to distribute VITAGEL product that was produced by Angiotech prior to the closing of its manufacturing facility in November 2005.
"We are very pleased with the terms of this new license agreement that both extends and expands our relationship with Angiotech and completes the contractual transfer of manufacturing responsibilities," said Antony Koblish president and chief executive officer of Orthovita, Inc. "The extension of the term to 2014 from 2009 and the addition of European and rest of world distribution rights give us the opportunity to further develop VITAGEL into a significant growth product for Orthovita over the next several years. VITAGEL has started 2006 with strong sales and we remain very committed and optimistic on the prospects for VITAGEL in the future."
VITAGEL is a surgical hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. VITAGEL stimulates hemostasis and healing through multiple mechanisms, amplifying the patient's own biology. Upon application, VITAGEL works by combining a thrombin / collagen suspension with the patient's own plasma. The resultant fibrin / collagen clot stems bleeding and provides a robust three- dimensional matrix for soft tissue healing.
About the Company
Orthovita is a biomaterials company with proprietary technologies for the development and commercialization of synthetic, biologically active, tissue engineering products for orthopedic and neurosurgical applications. Our products are used in the regeneration of bone and soft tissue healing. Our near-term commercial business is based on our internally developed VITOSS(R) Bone Graft Substitute technology platforms, which are designed to address the non-structural bone graft market by offering synthetic alternatives to the use of autograft or cadaver-derived bone material to meet a broad range of orthopedic clinical needs in the spine, trauma, joint reconstruction, revision surgery and extremities markets, and VITAGEL(TM) Surgical Hemostat, which is an adherent matrix and an impermeable barrier to blood flow. Our longer-term U.S. clinical development program is focused on our internally developed CORTOSS(R) Synthetic Cortical Bone technology platform, which is designed for injections in osteoporotic spines to treat vertebral compression fractures. Orthovita works jointly with Kensey Nash Corporation and Angiotech Pharmaceuticals, Inc., to develop and market synthetic-based biomaterial products, and continues to pursue similar relationships with other companies in biomaterials.
Cautionary Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements regarding Orthovita's current expectations of future events that involve risks and uncertainties as listed from time to time in reports we file with the U.S. Securities and Exchange Commission (SEC), including but not limited to risks described in our most recently filed Form 10-K. Further information about these and other relevant risks and uncertainties may be found in Orthovita's filings with the SEC, all of which are available from the SEC as well as from Orthovita upon request. Orthovita undertakes no obligation to publicly update any forward-looking statements.
CONTACT: Orthovita, Inc., Malvern |
