Curis Licensee Amylin Pharmaceuticals Files IND Application with the FDA for a PYY Compound in the Treatment of Obesity.Business Editors/Health/Medical Writers CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 12, 2004 Curis, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : CRIS) today announced that Amylin Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical company based in San Diego, CA, that was founded in 1987. Currently, Amylin produces two drugs, Symlin (pramlintide acetate) and Byetta (exenatide). Amylin also is working on producing a drug based on Leptin. (NASDAQ:AMLN) 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 PYY Peptide YY 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 in vivo /in vi·vo/ (ve´vo) [L.] within the living body. in vi·vo adj. Within a living organism. in vivo adv. 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 stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young 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 Kidney Disease Definition Kidney disease is a general term for any damage that reduces the functioning of the kidney. Kidney disease is also called renal disease. , neurological disorders This is a list of major and frequently observed neurological disorders (e.g. Alzheimer's disease), symptoms (e.g.back pain), signs (e.g. aphasia) and syndromes (e.g. Aicardi syndrome). , cancer, and alopecia alopecia (ăl'əpē`shēə): see baldness. (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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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. |
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