CAMBRIDGE, Mass., Sep 19, 2005 (BUSINESS WIRE) -- 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
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.
SOURCE: Curis, Inc.
For Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Financial Officer
Megan E. Burling, 617-503-6658
Director, Corporate Communications