Teva and OncoGenex Announce Updates to Custirsen Development Program in Advanced Prostate Cancer
Second Phase 3 Trial Evaluating Survival Benefit of Custirsen Planned
to Initiate in 2012
JERUSALEM & BOTHELL, Wash. & VANCOUVER, British Columbia--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) and OncoGenex
Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today an update on their
development program for custirsen, a product candidate being evaluated
in Phase 3 studies for castrate-resistant prostate cancer (CRPC).
In a revised agreement between the two companies, the clinical trial
program will now include the initiation of a Phase 3 study to evaluate
if custirsen has the potential to improve survival rates for prostate
cancer patients when combined with the recently-approved, second-line
chemotherapy drug Jevtana® (cabazitaxel).
The new trial, which aims to enroll approximately 630 men and is
expected to begin later this year, will be conducted in lieu of the
Prostate Cancer Saturn Study, a trial designed with a primary endpoint
of measuring a durable pain palliation benefit for custirsen in
second-line treatment of CRPC. The shift in focus to evaluate overall
survival in second-line prostate cancer is a result of numerous,
recently-approved agents that are redefining the standard of care in
this patient setting.
"The amendments made to the Phase 3 program reflect the rapidly-evolving
CRPC landscape and our commitment to ensure custirsen data are aligned
with requirements to demonstrate improvements in survival across the
treatment continuum," said Lesley Russell, Senior Vice President, Head
of R&D for Global Branded Products at Teva Pharmaceuticals. "Developing
custirsen for patients suffering from advanced prostate cancer remains a
top priority within the Teva Oncology product-line and we believe this
new trial is a reflection of that commitment."
Custirsen's other Phase 3 study, SYNERGY, evaluating a survival benefit
in the first-line CRPC setting, continues to accrue patients and is
expected to complete enrollment later this year. The companies are
increasing the enrollment from 800 to 1000 patients to optimize the
potential to be submitted to regulatory agencies independent of
additional Phase 3 studies. The increase in enrollment is not expected
to alter timelines for completion of the study.
Additional details on the updates to the custirsen development program
will be discussed during the OncoGenex Quarterly Earnings Call to be
held this afternoon, March 8, at 4:30pm EST. To join the call, dial
(877) 606-1416 (U.S. & Canada) or (707) 287-9313 (International).
About Custirsen
Custirsen is the only compound currently in development designed to
inhibit the production of clusterin, a protein commonly over-produced in
cancer cells, and one cause of treatment resistance. In Phase 2 trials
of patients with metastatic CRPC, custirsen combined with docetaxel
showed a 6.9 month improvement in overall survival over docetaxel alone.
Additionally, 50 percent of patients experienced durable pain palliation
for a duration of 12 weeks or longer. Custirsen has received Fast Track
designation from the U.S. Food and Drug Administration (FDA).
About Teva
Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
largest generic drug maker, with a global product portfolio of more than
1,300 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $18.3 billion
in net revenues in 2011.
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development
and commercialization of new cancer therapies that address treatment
resistance in cancer patients. OncoGenex has a diverse oncology
pipeline, with each product candidate having a distinct mechanism of
action and representing a unique opportunity for cancer drug
development. OncoGenex and Teva Pharmaceutical Industries
Ltd. (NASDAQ: TEVA) have entered a global collaboration and license
agreement to develop and commercialize OncoGenex' lead drug candidate,
custirsen. Custirsen is currently in Phase 3 clinical development as a
treatment in men with metastatic castrate-resistant prostate cancer. The
companies plan to begin Phase 3 development of custirsen in first-line
treatment of advanced, unresectable non-small cell lung cancer. OGX-427
is in Phase 2 clinical development; CSP-9222 and OGX-225 are currently
in pre-clinical development. More information is available at www.OncoGenex.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995: This release contains
forward-looking statements, which express the current beliefs and
expectations of management. Such statements are based on management's
current beliefs and expectations and involve a number of known and
unknown risks and uncertainties that could cause our future results,
performance or achievements to differ significantly from the results,
performance or achievements expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to: our ability to develop and
commercialize additional pharmaceutical products, competition from the
introduction of competing generic equivalents and the impact of
increased governmental pricing pressures, the effects of competition on
revenues of our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
from potential generic equivalents), potential liability for revenues of
generic products prior to a final resolution of outstanding patent
litigation, including that relating to the generic version of Protonix®,
the extent to which we may obtain U.S. market exclusivity for certain of
our new generic products, the extent to which any manufacturing or
quality control problems damage our reputation for high quality
production and require costly remediation, our ability to identify,
consummate and successfully integrate acquisitions (including the
acquisition of Cephalon), our ability to achieve expected results
through our innovative R&D efforts, dependence on the effectiveness of
our patents and other protections for innovative products, intense
competition in our specialty pharmaceutical businesses, uncertainties
surrounding the legislative and regulatory pathway for the registration
and approval of biotechnology-based products, our potential exposure to
product liability claims to the extent not covered by insurance, any
failures to comply with the complex Medicare and Medicaid reporting and
payment obligations, our exposure to currency fluctuations and
restrictions as well as credit risks, the effects of reforms in
healthcare regulation and pharmaceutical pricing and reimbursement,
adverse effects of political or economical instability, major
hostilities or acts of terrorism on our significant worldwide
operations, increased government scrutiny in both the U.S. and Europe of
our agreements with brand companies, interruptions in our supply chain
or problems with our information technology systems that adversely
affect our complex manufacturing processes, the impact of continuing
consolidation of our distributors and customers, the difficulty of
complying with U.S. Food and Drug Administration, European Medicines
Agency and other regulatory authority requirements, potentially
significant impairments of intangible assets and goodwill, potential
increases in tax liabilities resulting from challenges to our
intercompany arrangements, the termination or expiration of governmental
programs or tax benefits, any failure to retain key personnel or to
attract additional executive and managerial talent, environmental risks
and other factors that are discussed in our Annual Report on Form 20F
for the year ended December 31, 2011 and in our other filings with the
U.S. Securities and Exchange Commission.
OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, but not limited to, statements
concerning our anticipated product development activities, such as
expected clinical trial initiation and statements regarding the
potential benefits and potential development of our product candidates.
All statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These statements are
based on management's current expectations and beliefs and are subject
to a number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described in the
forward-looking statements. Such forward-looking statements are subject
to risks and uncertainties, including, among others, the risk that final
trial results will not demonstrate the same or any potential benefit as
observed in preliminary trial results, the risk that subsequent studies
may not confirm earlier trial results, the risk of delays in our
expected clinical trials, the risk that new developments in the rapidly
evolving cancer therapy landscape require changes in our clinical trial
plans or limit the potential benefits of our product and the other
factors described in our risk factors set forth in our filings with
the Securities and Exchange Commission from time to time, including the
Company's Quarterly Report on Form 10-Q for third quarter
ended September 30, 2011. The Company undertakes no obligation to update
the forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof, other than as may be
required by applicable law.
JEVTANA® is a registered trademark of sanofi-aventis
Teva IR:
Kevin C. Mannix, 215-591-8912
Tomer Amitai,
972 (3) 926-7656
or
Teva PR:
Denise Bradley,
215-591-8974
Shir Altay-Hagoel, 972 (3) 926-7590
or
OncoGenex
IR:
Susan Specht, 425-686-1535
or
OncoGenex PR:
Jaime
Welch, 604-630-5403
Source: Teva Pharmaceutical Industries Ltd.
News Provided by Acquire Media
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