JERUSALEM & VANCOUVER, British Columbia & BOTHELL, Wash.--(BUSINESS WIRE)--Apr. 28, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and OncoGenex
Pharmaceuticals, Inc. (NASDAQ:OGXI) today announced results from
the Phase III SYNERGY trial, a randomized, open-label, two-arm study
comparing the combination of custirsen and standard first-line
docetaxel/prednisone therapy to docetaxel/prednisone alone in men with
metastatic castrate-resistant prostate cancer (CRPC).
Top-line survival results indicate the addition of custirsen to standard
first-line docetaxel/prednisone therapy did not meet the primary
endpoint of a statistically significant improvement in overall survival
(OS) in men with metastatic CRPC, compared to docetaxel/prednisone alone
(median survival 23.4 months vs 22.2 months, respectively; hazard ratio
0.93 and one-sided p-value 0.207).
“We are disappointed with these results. Addressing treatment resistance
is critical in the fight against cancer. We are working with OncoGenex
to more fully understand these data,” said Michael Hayden, MD, president
of global R&D and chief scientific officer at Teva Pharmaceutical
Industries Ltd.
The adverse events (AEs) observed for custirsen were similar to its
known AE profile.
Full efficacy and safety data from SYNERGY will be submitted for
presentation at an upcoming scientific conference.
About Custirsen
Custirsen is an experimental drug that is designed to block the
production of the protein clusterin, which may play a fundamental role
in cancer cell survival and treatment resistance. Clusterin is
upregulated in tumor cells in response to treatment interventions such
as chemotherapy, hormone ablation and radiation therapy and has been
found to be overexpressed in a number of cancers, including prostate,
lung, breast and bladder. Increased clusterin production has been linked
to faster rates of cancer progression, treatment resistance and shorter
survival duration. By inhibiting clusterin, custirsen is designed to
alter tumor dynamics, slowing tumor growth and resistance to partner
treatments, so that the benefits of therapy, including survival, may be
extended.
As part of Phase 1 and Phase 2 clinical trials, custirsen was
administered to 294 patients with various types of cancer. The majority
of adverse events were mild. The most common adverse events associated
with custirsen consisted of flu-like symptoms. The most common serious
adverse events (SAE) associated with custirsen were febrile neutropenia,
fever, pleural effusion, and dyspnea. Each SAE event was observed in
approximately 2%-4% of patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: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
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in approximately 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 45,000 people around the world and reached $20.3
billion in net revenues in 2013.
About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development
and commercialization of new 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. have entered a global collaboration and
licensing agreement to develop and commercialize OncoGenex' lead drug
candidate, custirsen. Custirsen utilizes second-generation antisense
technology, licensed from Isis Pharmaceuticals (NASDAQ: ISIS), to
effectively target and inhibit production of clusterin. OncoGenex and
Isis partnered in the successful discovery of custirsen and in its
initial development. Custirsen is currently in Phase 3 clinical
development as a treatment in men with metastatic castrate-resistant
prostate cancer and in patients with advanced, unresectable non-small
cell lung cancer. Apatorsen is in Phase 2 clinical development and
OGX-225 is currently in pre-clinical development. More information is
available at www.OncoGenex.com
and at the company’s Twitter account: https://twitter.com/OncoGenex_IR.
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 the potential benefits 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, including, among others, the risk that our product
candidates will not demonstrate the hypothesized or expected benefits,
the risk of delays in our expected clinical trials 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 Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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.
Teva's Safe Harbor Statement under the U.S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which 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 for our innovative products, especially COPAXONE® (including
competition from orally-administered alternatives, as well as from
potential purported generic equivalents); the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
by insurance; increased government scrutiny in both the U.S. and Europe
of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
of our patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the effects
of reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
the capital markets; any failure to recruit or retain key personnel, or
to attract additional executive and managerial talent; adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our generic products,
both from other pharmaceutical companies and as a result of increased
governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the
impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; the
effect on our overall effective tax rate of the termination or
expiration of governmental programs or tax benefits, or of a change in
our business; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
Forward-looking statements speak only as of the date on which they are
made and we assume no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical
IR:
United States
Kevin C. Mannix,
215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
OncoGenex
Susan Specht,
425-686-1535
or
PR
Israel
Iris Beck Codner, 972 (3)
926-7687
or
United States
Denise Bradley, 215-591-8974
or
Nancy
Leone, 215-284-0213
or
OncoGenex
Jaime Welch, 604-630-5403