Cambridge, MA, September 19, 2005 Curis, Inc. (NASDAQ: CRIS), a therapeutic drug development company, today announced that the Company has entered into an exclusive worldwide research and development agreement with Procter & Gamble Pharmaceuticals, a division of The Procter & Gamble Company (NYSE: PG), to evaluate and develop potential treatments for hair growth regulation utilizing Curis' Hedgehog agonist technology. Future efforts may be expanded to address other skin disorders. To date, Curis scientists have demonstrated that small molecule Hedgehog agonists can induce hair growth in pre-clinical models.
Under the terms of the agreement, the Company has granted P&G an exclusive, worldwide royalty-bearing license for the non-systemic, dermatological use of Curis' Hedgehog agonist technology, via topical administration. Curis will have an option to co-develop a development candidate through Phase II clinical trials. Curis will retain rights to veterinary applications of the technology. P&G has a first option to negotiate a collaboration for veterinary indications in the field of dermatology. Curis continues to retain rights to certain non-systemic applications of the Hedgehog agonist technology, specifically for local cardiovascular and ex vivo use.
"Procter & Gamble's expertise in pharmaceutical development, combined with their solid track record in creating market-leading hair and skin care products, makes them an excellent choice as a partner for our hair program," said Daniel R. Passeri, President and Chief Executive Officer of Curis, Inc. "This is the second collaboration agreement structured to provide Curis possible co-development opportunities. Collaborating with major pharmaceutical companies to execute clinical programs is one way to build Curis' internal development capabilities to re-apply to our in-house programs."
P&G has agreed to pay Curis a $0.5 million initial payment and up to $2.8 million in preclinical milestones, contingent upon achievement of certain preclinical goals. P&G has agreed to make cash payments to Curis assuming successful completion of certain clinical development and drug approval milestones. If a development candidate derived from the collaboration is successfully commercialized, P&G has agreed to pay a royalty on net product sales. At the time of filing an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration, Curis will have the option to co-develop a product candidate through Phases 1 and 2 of clinical development. If Curis exercises its co-development option it will be entitled to a higher royalty percentage on net product sales of any successfully co-developed products although Curis would forgo two early clinical milestone payments from P&G. Assuming that the collaboration continues for its full term, with at least one product commercialized by P&G worldwide in two indications and developed directly by P&G on a global basis, Curis could receive more than $100 million in milestone payments. Such milestones would be payable whether Curis elected to co-develop a candidate or not.
Curis' Hedgehog agonist program was exclusively licensed to Wyeth Pharmaceuticals in January of 2004. Under the terms of the license agreement, Curis retained the right to develop Hedgehog agonists for topical treatment to stimulate hair growth. The license agreement was subsequently amended to broaden Curis' development rights to include topical applications to treat or prevent skin diseases or disorders and Wyeth has approved a group of Hedgehog agonist compounds for use in Curis' retained programs.
Curis scientists have demonstrated that small molecule Hedgehog agonists can induce hair growth in pre-clinical models. These results were presented in February of 2005 at the annual meeting of the American Academy of Dermatology. In this study, a small molecule Hedgehog agonist, when topically formulated and applied to the skin, triggers the transition of hair follicles from the resting to the growth phase of the hair cycle. The authors of the study conclude that the topical application of a Hedgehog agonist may be effective in treating hair disorders, such as male pattern baldness and female pattern hair loss. In the United States alone, approximately 80 million men and women suffer from hair loss.
"We believe that this collaboration with P&G provides additional validation of Curis' proprietary expertise in the field of signaling pathways," said Passeri.
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 cancer (under collaboration with Genentech, which also includes a co-development arrangement for a basal cell carcinoma product candidate), kidney disease (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with P&G), and cardiovascular disease. For more information, please visit the Curis web site at www.curis.com.
Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements concerning Curis' expectations regarding potential payments under its research and development agreement with P&G. These forward-looking statements may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates" or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other factors that may cause Curis' actual results to be materially different from those indicated by such forward-looking statements including, among other things: adverse results in Curis' and its strategic collaborators' and licensees' product development programs; difficulties or delays in obtaining or maintaining required regulatory approvals; Curis' ability to obtain or maintain the patent and other proprietary intellectual property protection necessary for the development and commercialization of products based on its technologies; the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates, fund its co-development obligations under its collaboration with Genentech and execute its business plan; unplanned cash requirements; risks relating to Curis' ability to enter into and maintain its strategic collaborations, including its collaborations with Genentech, Ortho Biotech Products, Wyeth and P&G; competitive risks; and the risk factors identified in Curis' most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other reports periodically filed with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.