Curis Licensee Amylin Pharmaceuticals Files IND Application with the FDA for a PYY Compound in the Treatment of Obesity
Monday January 12, 9:15 am ET
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 12, 2004--Curis, Inc. (NASDAQ: CRIS - News) today announced that Amylin Pharmaceuticals (NASDAQ:AMLN - News) filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration in late December to initiate clinical studies with the compound AC162352 (PYY 3-36) for the potential treatment of obesity. In an announcement released this morning, Amylin Pharmaceuticals stated that it plans to initiate its first Phase 1 study of this compound in the first quarter of this year.
In December of 2002 Curis licensed and assigned patents covering the use of PYY, a peptide made in the gut, to Amylin Pharmaceuticals for the in vivo treatment of metabolic diseases, including diabetes and obesity. Clinical research published earlier this year in Europe has demonstrated that administration of PYY to humans can suppress appetite and reduce food intake, suggesting that PYY may have therapeutic potential in the large and growing obesity market.
The agreement between Curis and Amylin Pharmaceuticals provides for an up-front licensing fee and additional milestone cash payments from Amylin Pharmaceuticals to Curis, based primarily upon obtaining regulatory approval and sales goals, and a royalty on future product sales. Amylin Pharmaceuticals is solely responsible for development and clinical testing of the PYY compound.
The agreement with Amylin covers a subset of Curis' PYY patent applications that relate to the use of PYY for the treatment of metabolic diseases, such as diabetes and obesity. Curis retains rights to other PYY patent applications that relate to the use of PYY to transform stem cells into insulin-producing cells and other types of specialized cells.
Daniel Passeri, Curis' President and Chief Executive Officer, said, "Curis would like to congratulate Amylin on the submission of this IND application. This IND filing is the first of what we hope will be several IND filings involving Curis licensees and Curis technology over the next 12 to 18 months."
About Curis, Inc.
Curis, Inc. is a therapeutic drug development company. The Company's technology focus is on regulatory pathways that control repair and regeneration. Curis' product development involves the use of proteins or small molecules to modulate these pathways. Curis has successfully used this technology and product development approach to produce several promising drug product candidates in the fields of kidney disease, neurological disorders, cancer, and alopecia (hair loss). For more information, please visit the Curis web site at www.curis.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements concerning Curis' or management's intentions, plans, expectations or predictions of future events are forward-looking statements. Such statements may contain the words "believes", "expects", "anticipates", "plans", "estimates" or similar expressions. Forward looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from those indicated by such forward-looking statements. Actual results can be affected by, among other things, uncertainties relating to product development, clinical trials, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, changes in or an inability to execute Curis' realigned business strategy and other risk factors identified in Curis' most recent Annual Report on Form 10-K and subsequent reports filed with the Securities and Exchange Commission. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release.
Contact:
For Curis, Inc.
Christopher U. Missling, Ph.D., 617-503-6587
Marc F. Charette, Ph.D., 617-503-6629
Source: Curis, Inc. |
