Curis Announces Completion of Enrollment In Pivotal Phase III Clinical Trial With Chondrogel; Minimally Invasive Cell-Based Product Targets Severe Pediatric Urological Disorder.

Business Editors and Health/Medical Writers

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sept. 19, 2000

Curis, Inc. (NASDAQ:CRIS) today announced the completion of enrollment in a pivotal Phase III clinical trial with Chondrogel, a cell-based, minimally invasive tissue augmentation product for the treatment of a pediatric urological disorder known as vesicoureteral reflux. Data from this trial is expected to be available in late 2001.

Vesicoureteral reflux (VUR) is a congenital condition in children in which urine flows backward from the bladder through the ureter toward the kidney and results in urinary tract infection and kidney damage. Chondrogel is a structural tissue product comprised of autologous cartilage cells taken from the patient's own ear, expanded in culture and injected into the bladder.

"Chondrogel exemplifies how regenerative medicine and tissue engineering can be used to restore function, improve the quality of health for the patient, decrease morbidity and decrease costs," said Doros Platika, M.D., president and chief executive officer of Curis.

Typically, surgeries for VUR are two-to-three hour procedures, involve two to five day hospital stays and require a four to six week recuperation. Due to the inherent risks and invasiveness of open reflux surgery, both physicians and parents seek to avoid this procedure. The endoscopic implantation of Chondrogel at the defective vesicoureteral junction, if effective, should obviate the need for surgery in significant cases of reflux and may provide an attractive option for standard care, which can include chronic administration of antibiotics, frequent urine cultures and invasive examinations to monitor the condition.

Up to three percent of all children experience VUR, with 24,500 suffering a form of the condition that does not resolve itself. The total market for these non-resolving VUR patients, if treated with Chondrogel, is estimated to be in excess of $300 million. Approximately 15,000 surgical procedures per year are performed to address this problem, representing a market of $200 million based on replacement treatment with Chondrogel.

The Phase III trial includes 61 patients between the ages of six months and 18 years, treated at eight sites in the U.S. The primary endpoint, or outcome measure, of this trial is the resolution of reflux as determined by an x-ray image of the bladder and ureters known as a voiding cystourethrogram.

Pending evaluation of data from this trial, Curis expects to submit a BLA (Biologics License Application) to the U.S. Food and Drug Administration in the first half of 2002. Curis intends to market Chondrogel directly to the approximately 250 pediatric urologists who treat VUR in the U.S.

Curis, Inc. is developing products based on technologies in the emerging field of regenerative medicine. The Company is combining insights gained through the study of developmental biology with high-throughput screening capabilities, proteins, cells and biocompatible materials to facilitate the development of new regenerative medicine therapies. For more information, please visit the Curis web site at http://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 and mergers generally. For additional factors that could cause actual results to differ materially, please refer to the risk factors section of the Curis joint proxy statement/prospectus filed with the Securities and Exchange Commission on June 19, 2000.