Novacea and Schering-Plough Enter into Worldwide Development and Commercialization Agreement for Asentar, a Novel Treatment for
May 30 2007 - 10:57AM
PR Newswire (US)
SOUTH SAN FRANCISCO, Calif. and KENILWORTH, N.J., May 30
/PRNewswire/ -- Novacea, Inc. (NASDAQ:NOVC) and Schering-Plough
Corporation (NYSE:SGP) today announced that they have entered into
an exclusive worldwide license agreement for the development and
commercialization of Asentar(TM) (DN-101). Novacea is currently
conducting a large international Phase 3 trial (ASCENT-2)
evaluating Asentar in 900 patients with androgen-independent
prostate cancer (AIPC). Asentar is a novel, proprietary, high-dose
oral formulation of calcitriol, a potent hormone that exerts its
effects through the vitamin D receptor (VDR). Under the terms of
the agreement, Novacea will receive an upfront payment of $60
million, including $35 million as reimbursement for past research
and development expenses, a license fee of $25 million, as well as
a commitment by Schering-Plough to purchase $12 million of Novacea
common stock at a predetermined price within ten days of the
closing. Additionally, the agreement provides Novacea with
potential pre-commercial milestone payments of up to $380 million,
and tiered royalties on worldwide sales of Asentar. Closing of the
transaction is subject to clearance under the Hart-Scott-Rodino
Antitrust Improvements Act (HSR) and is anticipated to occur
following HSR clearance. Schering-Plough will be responsible for
all forward development costs in exploring indications for earlier
stages of prostate cancer, such as androgen- dependent prostate
cancer (ADPC) and adjuvant therapy and will lead all global
commercialization efforts for Asentar. Novacea will provide medical
support to Schering-Plough's commercial operations for Asentar in
the United States, including deployment of their Medical Science
Liaisons, which will be funded by Schering-Plough. "A corporate
partnership has been a significant corporate goal for 2007, and we
are proud to be co-developing Asentar with a highly-respected
pharmaceutical company such as Schering-Plough. The partnership
leverages Novacea's existing capabilities with Schering-Plough's
experienced development, regulatory and commercial teams and will
provide Novacea with an opportunity to support the
commercialization of Asentar in the United States. Additionally,
this agreement provides us with substantial funding for the
continued development of our operations," said John P. Walker,
Novacea's chairman and interim chief executive officer. "This
agreement with Novacea allows us the potential opportunity to
extend our oncology pipeline into a tumor with significant unmet
need," said Thomas P. Koestler, Ph.D. executive vice president and
president of Schering-Plough Research Institute. "Asentar
represents an innovative research development and reinforces our
continual commitment to patients." About Asentar Asentar is
currently being developed as an oral treatment in combination with
Taxotere(R) (docetaxel) for the treatment of AIPC. Prostate cancer
is the second leading cause of cancer death in men with
approximately 232,000 new cases and 30,000 deaths in the U.S. in
2005. AIPC is an advanced disease state of prostate cancer. Based
on results of Novacea's completed Phase 2 clinical trial, known as
ASCENT, the use of weekly Asentar in combination with weekly
Taxotere may provide AIPC patients with an innovative cancer
therapy that may prolong survival with the potential in reducing
some of the toxicities and complications normally associated with
chemotherapy. Novacea is now evaluating the benefits of Asentar in
a 900-patient Phase 3 trial, known as ASCENT-2, which uses overall
survival as the primary endpoint and compares weekly Asentar plus
Taxotere to the current standard of care in the treatment of AIPC.
Conference Call and Webcast Information Members of Novacea's
management team will discuss the agreement via a webcast and
conference call today at 10:00 am Eastern Time. The webcast can be
accessed in the Investor Relations section of Novacea's Web site at
http://www.novacea.com/. The live audio of the conference call is
also accessible via telephone to investors, members of the news
media and the general public by dialing either 866-770-7129 (United
States and Canada) or 617-213-8067 (International) and typing in
the passcode 46251887. An archived replay of the webcast will be
available via Novacea's Web site until June 30, 2007. The replay
will also be available via telephone by dialing 888-286-8010
(United States and Canada) or 617-801-6888 (International) and
typing in the passcode 43282090 until June 30, 2007. About
Schering-Plough Schering-Plough Corporation is a global
science-based health care company with leading prescription,
consumer and animal health products. Through internal research and
collaborations with partners, Schering-Plough discovers, develops,
manufactures and markets advanced drug therapies to meet important
medical needs. Schering-Plough's vision is to earn the trust of the
physicians, patients and customers served by its more than 33,500
people around the world. The company's Web site is
http://www.scheringplough.com/. About Novacea Novacea, Inc. is a
biopharmaceutical company focused on in-licensing, developing and
commercializing novel cancer therapies. Novacea has two product
candidates in clinical trials, including Asentar(TM), which
currently is in a Phase 3 clinical trial for androgen-independent
prostate cancer, or AIPC. Novacea's second product candidate, AQ4N,
is a hypoxia-activated prodrug that is currently in a Phase 1b/2a
clinical trial in glioblastoma multiforme. More information on any
of Novacea's trials can be found at http://www.clinicaltrials.gov/.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press
release includes certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements relating to the potential market and prospects
for Asentar. Forward-looking statements relate to expectations or
forecasts of future events. Schering- Plough does not assume the
obligation to update any forward-looking statement. Many factors
could cause actual results to differ materially from Schering-
Plough's forward-looking statements, including uncertainties in the
development process and the regulatory process, any developments
following regulatory approval, patent and other intellectual
property protection, and current and future branded, generic or
over-the-counter competition, among other uncertainties. For
further details about these and other factors that may impact the
forward-looking statements, see Schering-Plough's Securities and
Exchange Commission filings, including Item 1A, "Risk Factors" in
the Company's first quarter 2007 10-Q. Note: Except for the
historical information contained herein, the matters set forth in
this press release, including statements as to financial guidance,
development, clinical studies, regulatory review and approval, and
commercialization of products, are forward-looking statements
within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking
statements speak only as of the date the statements are made and
are based on information available at the time those statements are
made and/or management's good faith belief as of that time with
respect to future events. You should not put undue reliance on any
forward- looking statements. Important factors that could cause
actual performance and results to differ materially from the
forward-looking statements we make include: early stage of
development; the focus, conduct, enrollment and timing of our
clinical trials; regulatory review and approval of product
candidates; commercialization of products; developments relating to
our licensing and collaboration agreements; market acceptance of
products; funding requirements; intellectual property protection
for our product candidates; competing products and other risks
detailed from time to time under the heading "Risk Factors" in our
most recent Quarterly Report on Form 10-Q or Annual Report on Form
10-K, as may be updated from time to time by our future filings
under the Securities Exchange Act. If one or more of these risks or
uncertainties materialize, or if any underlying assumptions prove
incorrect, our actual performance or results may vary materially
from any future performance or results expressed or implied by
these forward-looking statements. We assume no obligation to update
forward-looking statements to reflect actual performance or
results, changes in assumptions or changes in other factors
affecting forward-looking information, except to the extent
required by applicable securities laws. Novacea is a registered
trademark of Novacea, Inc., and Asentar is a trademark of Novacea,
Inc. All other trademarks are property of their respective owners.
DATASOURCE: Novacea, Inc. CONTACT: Media, Mary-Frances Faraji,
+1-908-298-7109, or cell, +1-908-432-2404, or Cathy Cantone,
+1-908-327-3013, or Investors, Alex Kelly, +1-908-298-7436, all of
Schering-Plough Corporation; or Media, Paul Laland,
+1-650-228-1811, or Investors, Nina Ferrari, +1-415-264-8796, both
of Novacea, Inc. Web site: http://www.novacea.com/
http://www.scheringplough.com/ http://www.clinicaltrials.gov/
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