OP-1 Receives Canadian Approval
Fourth Major Market Approval for Regenerative Product
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 15, 2002--Curis, Inc. (NASDAQ: CRIS - news) reported that Stryker Corporation (NYSE: SYK - news) has received Canadian approval to market the bone regenerative product OP-1, developed by Curis for Stryker, for the clinical indication of long bone nonunions. Stryker has reported that commercial shipments are expected to begin in the second quarter.
The approval marks the fourth regulatory clearance for OP-1 in a major market, following approvals earlier last year in Australia, the European Union, and the United States for specific trauma indications. Stryker is responsible for marketing and approval of OP-1 worldwide and will pay Curis royalties from sales in all territories. OP-1, which stands for Osteogenic Protein-1, is a class of proteins produced by the human body to form tissue during development, and is used in adults to repair and remodel damaged tissue, such as bone.
``The fourth major market approval for OP-1 further confirms our confidence in focusing our resources and efforts on the identification and development of therapeutics based on signaling pathways, like BMP 7 (OP-1) and Hedgehog, that regulate cell proliferation and differentiation,'' stated Daniel R. Passeri, President and Chief Executive Officer. ``The approval provides additional validation of the Curis strategy, as delineated in yesterday's realignment, to pursue a targeted partnering initiative encompassing collaborations with major pharmaceutical companies that will generate revenues and defray the significant expenditures of capital required by clinical trials.''
About Curis
Curis, Inc. is generating therapies that regulate the pathways used by the body to maintain and restore health. The company focuses on signaling pathways that govern the proliferation and differentiation of cells. These same pathways control maintenance, repair, and regeneration of tissues and organs from infancy through old age. This approach has created an approved product for bone regeneration and enables Curis to build a portfolio of product candidates in neurology, kidney disease, and cancer. For more information, please visit the Curis web site at www.curis.com.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements address a variety of subjects, including, for example, cost savings, cash burn rate, operating capital requirements, operating efficiencies, strategic collaboration efforts and product development efforts. Statements in this press release that state Curis' or management's intentions, plans, expectations or predictions of future events are forward- looking statements. The matters discussed in this press release also involve risks and uncertainties that may cause Curis' actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statements. The following important factors and uncertainties, among others, could cause actual results to differ materially from those described in these forward-looking statements: the size of royalty payments from Stryker derived from sales of OP-1, Curis' need for partnerships to move forward its programs, the early stage of product development of Curis' programs, uncertainties related to future clinical trials, uncertainties related to Curis' ability to raise additional capital, and other risk factors described from time to time in Curis' periodic reports and registration statements filed with the Securities and Exchange Commission, including, without limitation, Curis' Annual Report on Form 10-K for the year ended December 31, 2000 filed on March 30, 2001 and the Company's Post Effective Amendment No. 1 on Form S-3 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 10, 2001. Curis cannot guarantee any future results, levels of activity, performance, or achievements. Moreover, neither Curis nor anyone else assumes responsibility for the accuracy and completeness of any forward- looking statements. Curis undertakes no obligation to update any of the forward-looking statements after the date of this press release.
--------------------------------------------------------------------------------
Contact:
Curis, Inc.
Henry W. McCusker, 617/503-6641
or
Noonan/Russo Communications
Melissa Wainberg, 212/696-4455, ext. 220 (Media)
Sharon Weinstein, 212/696-4455, ext. 334 (Investor) |
