Curis Announces Strategic Partnership with Wyeth Pharmaceuticals to Develop Therapeutics for Neurological Disorders.Business Editors/Health/Medical Writers CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 12, 2004 Potential value to Curis of more than $170 million including license payments, research support, and development and approval milestones 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) has licensed its Hedgehog proteins hedgehog proteins a family of secreted signaling proteins that are involved in the embryogenesis; mutations in these proteins are implicated in some birth defects and cancers. and novel small molecule Hedgehog pathway agonists (activators) to Wyeth Pharmaceuticals, a division of Wyeth (NYSE NYSE See: New York Stock Exchange : WYE), for therapeutic applications in the treatment of neurological and other disorders. The transaction is subject to compliance with applicable antitrust laws antitrust laws n. acts adopted by Congress to outlaw or restrict business practices considered to be monopolistic or which restrain interstate commerce. The Sherman Antitrust Act of 1890 declared illegal "every contract, combination.... . Under the terms of the agreement, Wyeth Pharmaceuticals will pay Curis a license fee (in cash and equity), financial support for a minimum of two years of Curis research dedicated to the program, and additional cash payments to Curis upon the successful achievement of clinical development and drug approval milestones. Wyeth Pharmaceuticals will also pay a royalty on net product sales that escalates with increasing sales volume. Excluding product royalties, the transaction has a potential value to Curis of more than $170 million, assuming at least two products are successfully developed. As part of the agreement, Curis has retained development and licensing options for certain therapeutic applications of the Hedgehog activator technologies, including those applications that qualify as orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the indications, topical applications for hair growth, local delivery applications for treatment of cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , and use of the technology with 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 . Wyeth has an option to acquire the orphan drug indications and the cardiovascular applications, pending certain success criteria. Daniel Passeri, Curis' President and Chief Executive Officer, stated, "We are very pleased to have Wyeth Pharmaceuticals as a partner for our Hedgehog activator technologies. Wyeth is one of the world's largest research-driven pharmaceutical companies. Wyeth's broad range of pharmaceutical interests is an excellent match with Curis to fully exploit the wide array of potential indications for the Hedgehog activator technologies. We believe that this agreement will provide the most effective clinical path forward for Curis' neurology drug development candidates." The Hedgehog signaling pathway The hedgehog signaling pathway is one of the key regulators of animal development conserved from flies to humans. The pathway takes its name from its polypeptide ligand, an intercellular signaling molecule called Hedgehog (Hh) found in fruit flies of the genus Drosophila. has many biological properties, the best known of these being the promotion of healing of nerve tissues. Curis' small molecule Hedgehog agonists are orally available compounds that can cross the blood-brain barrier blood-brain barrier n. Abbr. BBB A physiological mechanism that alters the permeability of brain capillaries so that some substances, such as certain drugs, are prevented from entering brain tissue, while other substances are allowed to and have demonstrated therapeutic efficacy in several models of neurological disease, including Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease. and stroke. Parkinson's disease and stroke are two areas of significant unmet medical need. The National institutes of Health estimates that there are at least 500,000 people in the United States who suffer from the effects of Parkinson's disease, with approximately 50,000 new cases reported annually. It is also estimated that there are as many as 700,000 strokes each year in the U.S. Dr. Lee Rubin, Curis' Chief Scientific Officer, commented, "Curis' success in discovering small molecules that can stimulate the Hedgehog signaling pathway has provided a significant opportunity to develop a novel class of drugs for the treatment of damaged nerve tissues. In addition, recent observations indicate that these same small molecules can also stimulate the replication of stem cells in the brain, which may open a much larger opportunity of promoting the regeneration of new nerve tissues following injury or disease." 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, 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, including statements regarding the potential value of the Company's strategic partnership with Wyeth Pharmaceuticals, the Company's expectations regarding the successful development of neurological drugs based upon its Hedgehog technologies and other statements concerning Curis' or management's intentions, plans, expectations or predictions of future. 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 important 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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