Curis' OP-1 Receives HDE Status in the United States; Third Major Market Approval for Regenerative Product.

Attention Business & Science Editors

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Oct. 18, 2001

Curis, Inc. (NASDAQ: CRIS) today reported that the U.S. Food and Drug Administration (FDA) has granted Stryker Corporation (NYSE: SYK) Humanitarian Device Exemption (HDE) status for Curis' regenerative product OP-1. The approved indication is for use as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. Stryker reported that commercial launch of the OP-1 Implant in the U.S. is expected to commence later this quarter.

The approval marks the third regulatory clearance for OP-1 in a major market following approvals earlier this year in Australia and the European Union for specific trauma indications. Stryker is presently marketing OP-1 in Australia and the European Union, and will pay Curis royalties from sales in all territories. Under the HDE, OP-1 Implant will be made available as a humanitarian use device. HDE program information is available at http://www.fda.gov/cdrh/ode/hdeinfo.html. OP-1, which stands for Osteogenic Protein, 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.

"Regenerative medicine products, such as OP-1, hold tremendous promise for enhancing the body's natural mechanisms for self-repair and regeneration. Curis is a pioneer in this field and has a broad portfolio with multiple clinical indications in development," said Daniel Passeri, President and Chief Executive Officer of Curis. "The past several years have resulted in many advances and breakthroughs in the human genome project, stem cell biology and the understanding of the human body's capacity to repair and regenerate itself when damaged by trauma or disease. At Curis, we believe the next several years will see the realization of that promise with a new generation of therapeutic products being launched to treat many of the debilitating diseases affecting the world's aging population. OP-1 demonstrates that the first wave of these next generation therapies are already being used by physicians treating patients."

"The third major market approval for OP-1 confirms our confidence in the role of regenerative therapeutics in the future of medicine," stated Doros Platika, MD, Chairman of Curis. "The approval further validates the Curis approach for creating a successful and sustainable biopharmaceutical company by combining near-term product revenue opportunities with a productive discovery engine that has generated two new INDs this year and a broad portfolio of product candidates at various stages of development."

About Curis

Curis is developing products that restore health through regenerative therapeutics. Curis utilizes technologies and insights gained through the study of developmental biology to facilitate the discovery and development of new approaches to repair and regeneration of tissues and organs damaged by disease and/or trauma. Through these discoveries, Curis has developed a pipeline of promising new therapies for the treatment of major diseases, including neurological disorders, diabetes, oncology, cardiovascular and renal disease.

The Curis technology platform and product development pipeline is based on developmental biology signaling pathways, adult stem cells, and cell-based therapies. The Curis research program is conducted both internally and through alliances, partnerships and joint ventures with companies and organizations including Aegera Therapeutics and McGill University, Montreal, Canada; Micromet AG, Munich, Germany; and Elan Corporation, Dublin, Ireland.

For more information, please visit the Curis web site at www.curis.com.

The statements in this news release that are not historical facts are forward-looking statements that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of pharmaceutical research, product development, regulatory approval and commercialization, the impact of competitive products, patents, patent litigation, product liability, third party reimbursement, and other risks and uncertainties associated with the biotechnology industry. For additional factors that could cause actual results to differ materially, please refer to the risk factors section of the Post-Effective Amendment No. 1 on Form S-3 (File No. 333-50906) to the Curis Registration Statement on Form S-1 as filed with the Securities and Exchange Commission on August 10, 2001. The forward-looking statements contained herein represent the judgment of Curis, as of the date of this release, and Curis disclaims any intent or obligation to update such forward-looking statements to reflect any change in Curis' expectations with regard thereto or any change in events, conditions, circumstances on which such statements are based.