Healthcare Industry News: Ortho Biotech Products
News Release - October 5, 2006
Curis, Inc. Announces Genentech Filing of Investigational New Drug Application for Systemic Administration of a Hedgehog AntagonistFiling Triggers a Milestone Payment of $3 Million to Curis
CAMBRIDGE, Mass.--(HSMN NewsFeed)--Curis, Inc., (NASDAQ: CRIS ), a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, announced today that Genentech, a collaborator, has filed an Investigational New Drug (IND) application with the Food and Drug Administration (FDA) to initiate Phase I clinical testing of a systemically administered small molecule Hedgehog antagonist for the treatment of cancer. Under the terms of the parties' June 2003 collaboration agreement, Genentech will pay Curis a $3 million dollar cash payment after filing the IND application. Should this small molecule drug candidate successfully continue its development into subsequent stages of clinical testing and regulatory approval, Curis would be eligible to receive additional cash payments. Should this drug candidate be commercialized, Curis would also receive royalties on any product sales.
"We believe that the IND filing demonstrates Genentech's continued interest in the importance of the Hedgehog pathway as a potential therapy for the treatment of various cancers," said Curis President and CEO Dan Passeri. "We're extremely pleased that our Hedgehog antagonist collaboration with Genentech has produced a clinical candidate for systemic administration and we are looking forward to working with Genentech in seeking to advance the drug candidate through the clinic. Cancer is a serious healthcare challenge in the U.S., and we are hopeful that our Hedgehog antagonist technologies will one day provide an effective treatment for a variety of cancers."
Curis anticipates providing additional information about the program, including information on the expected Phase I clinical trial, within its third quarter earnings conference call and press release.
About the Genentech Curis Collaboration
In June 2003, Curis and Genentech entered into a collaboration for the development of Hedgehog pathway inhibitors. The focus of the collaboration is to identify lead clinical candidates for topical and systemic treatment of cancers. Numerous preclinical reports have linked abnormal activation of the Hedgehog pathway to the growth of several cancers, including basal cell carcinoma, pancreatic cancer, small cell lung cancer, prostate cancer, and others.
About Curis's Other Hedgehog Drug Development Programs
In addition to its Hedgehog antagonist program under development with Genentech, Curis is collaborating to advance two additional Hedgehog-based therapies. These additional Hedgehog-based programs are as follows:
Systemically administered small molecule Hedgehog agonist for the treatment of neurological disorders (in collaboration with Wyeth):
In January 2004, Curis licensed its Hedgehog proteins and small molecule Hedgehog pathway agonists to Wyeth for therapeutic applications in the treatment of neurological diseases and other disorders.
Curis is currently working with Wyeth to test Hedgehog agonist compounds in various preclinical toxicology and efficacy models. If these tests are satisfactorily completed, Curis is hopeful that Wyeth will select a lead clinical development candidate during either the second half of 2006 or the first half of 2007, triggering a cash payment to Curis. Curis is also continuing to screen for additional back up Hedgehog agonist compound classes.
Topically applied small molecule Hedgehog agonist for the treatment of hair growth disorders (in collaboration with Procter & Gamble):
In September 2005, Curis entered into a collaboration agreement with Procter & Gamble to evaluate and develop potential treatments for hair growth regulation and skin disorders utilizing Hedgehog agonist compounds.
Curis is hopeful that, during the first half of 2007, Procter & Gamble will achieve the second preclinical development objective under the topically applied Hedgehog agonist hair growth partnership. This development objective is met upon the selection by Procter & Gamble of a lead clinical candidate for hair growth and results in a $1.8 million cash payment to Curis.
About Curis, Inc.
Curis, Inc. is a therapeutic drug development company focusing on cancer, neurological and dermatological disease indications, with technologies that utilize regulatory pathways that control repair and regeneration. Curis' product development involves the use of small molecules or proteins to modulate these pathways. The company 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, as well as new proprietary cancer programs that target multiple validated cancer pathways), neurological disorders (under collaboration with Wyeth), hair growth (under collaboration with Procter & Gamble), kidney and other diseases (licensed to Ortho Biotech Products and under development at Centocor, both subsidiaries of Johnson & Johnson), and cardiovascular disease. For more information, please visit 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' expectation that it will achieve a $3.0 million milestone as a result of Genentech's IND filing, Curis' expectations about the potential therapeutic benefit of the Hedgehog pathway in treating certain cancers, the Company's expectations about future advances in its programs with Wyeth and Procter & Gamble, and Curis' anticipation that it will provide additional information about the expected Phase I clinical trial with Genentech for a systemically administered small molecule Hedgehog antagonist within its third quarter earnings conference call and press release. Forward-looking statements used in this press release 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 the Company's actual results to be materially different from those indicated by such forward-looking statements including, among other things:
- adverse results, delays and/or failures in the Company's and its strategic collaborators' and licensees' product development programs;
- difficulties or delays in obtaining or maintaining required regulatory approvals for products being developed by the Company and its collaborators and licensees;
- the Company's 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;
changes in or the Company's inability to execute its business plan;
- the risk that Curis does not obtain the additional funding required to conduct research and development of its product candidates and execute the Company's business plan;
unplanned cash requirements and expenditures;
- risks relating to the Company's ability to enter into and maintain important strategic collaborations, including its ability to maintain its current collaboration agreements with Genentech, Wyeth, and Procter & Gamble as well as its license agreement with Ortho Biotech Products;
- the risk that competitors will discover and develop signaling pathway-based or other competing therapeutics faster and more successfully than the Company and its collaborators are able to;
- and other risk factors identified in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and subsequent reports periodically filed with the Securities and Exchange Commission.
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