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Teva Contacts: |
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OncoGenex Contacts: |
Elana Holzman
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Scott Cormack |
Teva Pharmaceutical Industries Ltd.
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President & CEO |
972 (3) 926-7554
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(604) 736-3678 |
Kevin Mannix
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Jason Spark, Porter Novelli |
Teva North America
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Media and Investor Relations for OncoGenex |
(215) 591-8912
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(619) 849-6005 |
For Immediate Release
Teva Expands Innovative Pipeline with License Agreement
to Develop and Commercialize OncoGenex Late Stage Innovative
Treatment for Multiple Oncology Indications
Phase III trials of OGX-011 in first- and second-line advanced prostate cancer
and non-small cell lung cancer, expected to begin in 2010 and early 2011
Significantly strengthens Tevas oncology offerings with novel
therapeutic designed to target resistance to cancer treatments
JERUSALEM, ISRAEL, BOTHELL, WA and VANCOUVER, CANADA, December 21, 2009 Teva Pharmaceutical
Industries Ltd. (NASDAQ: TEVA) and OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today
that they have entered into a global license and collaboration agreement to develop and
commercialize OGX-011, as well as an agreement to purchase shares in OncoGenex. OGX-011 is a Phase
III cancer therapy designed to inhibit cancer treatment resistance. OGX-011 is expected to be used
as adjunct therapy to enhance the effectiveness of chemotherapy and has shown promising results
when added to currently available chemotherapies in several tumor types addressing a significant
unmet medical need.
The agreement will further enhance Tevas oncology offerings and strengthen its global branded
product pipeline with a promising product candidate entering three Phase III trials involving large
patient populations. Teva and OncoGenex will collaborate on a global Phase III clinical program,
with two Phase III clinical trials expected to be initiated in 2010: a Phase III Study for
Second-line Chemotherapy in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC) and a
Phase III Study in First-Line Chemotherapy for Metastatic CRPC. An additional Phase III Study in
First-Line Treatment of Advanced, Unresectable Non-Small Cell Lung Cancer (NSCLC) is intended to be
initiated by early 2011.
Under the terms of the collaboration and share purchase agreements, Teva will provide OncoGenex
with a $60 million initial cash payment, which includes a $10 million equity investment in
OncoGenex common stock at a price of $37.38 per share, upfront payment of $20 million and
prepayment of $30 million for OncoGenexs contribution to the development costs of OGX-011.
OncoGenex will be eligible to receive up to $370 million in additional cash payments upon
achievement of various milestones, including regulatory milestones and sales targets. In addition,
OncoGenex will receive tiered royalties on sales of the product with the royalty percentage ranging
from the mid-teens to the mid-twenties, depending upon the amount of net sales. Teva is responsible
for all commercialization and development expenses. OncoGenex retains an option to co-promote
OGX-011 in the U.S. and Canada.
We see OGX-011 as a key component of our branded oncology medicines franchise, expanding our
pipeline of existing oncology therapeutics and broadening the future available therapies made
by Teva for oncology patients and care providers, said Moshe Manor, Tevas Group VP, Global
Branded Products. OGX-011 is supported by compelling data demonstrating the drugs ability to
benefit patients on top of several currently available chemotherapies in a number of oncology
indications. In addition to prostate cancer, we are particularly enthusiastic about the therapeutic
activity seen in the Phase II clinical trial in lung cancer.
Together with Teva, we have forged a strong path moving forward for the development of OGX-011
that commits significant cash investment to a broadened Phase III clinical development plan that
includes first- and second-line castrate resistant prostate cancer as well as non-small cell lung
cancer, said Scott Cormack, President and CEO of OncoGenex. The agreement provides us with
capital resources for the development of OGX-011 through completion of the Phase III clinical
trials and into product commercialization. Were creating a solid foundation to maximize the broad
potential of OGX-011 and bring this important treatment option to cancer patients.
OncoGenex to Host Investor Conference Call Monday, December 21, 2009 at 8:30 a.m. ET
OncoGenex management will host a conference call at 8:30 a.m. Eastern Time Monday, December 21,
2009. A live webcast will be available through the Events and Presentations Web page found in the
Investor Relations section of the OncoGenex Web site at www.ir.oncogenex.com.
Alternatively, you may access the live conference call by dialing 888-747-4649 (U.S. & Canada) or
913-312-1507 (International). A webcast replay will be available approximately two hours after the
call and will be archived at the same Web location for 90 days.
About Prostate Cancer
The National Cancer Institute estimates that in 2009, approximately 192,280 new cases of prostate
cancer will be diagnosed in the U.S. As the most frequently diagnosed cancer among men, one in six
men will be diagnosed with prostate cancer during their lifetime. It is estimated that in 2009 in
the U.S., 27,360 deaths will result due to the disease.
About NSCLC Cancer
The National Cancer Institute estimates that in 2009, approximately 219,440 new cases of lung
cancer will be diagnosed in the U.S. Non-small cell lung cancer accounts for approximately 85% of
all lung cancer cases. With 159,390 deaths estimated for 2009 in the U.S., lung cancer remains
responsible for the most cancer-related deaths in both men and women, representing 28% of all
cancer-related deaths.
About OGX-011
OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with
cancer treatment resistance, and has completed Phase II clinical trials in prostate, lung and
breast cancer. OGX-011 has received Fast Track designation from the FDA for the treatment of
progressive metastatic prostate cancer in combination with docetaxel.
Clusterin is a protein that is over-produced in several types of cancer and in response to many
cancer treatments, including hormone ablation therapy, chemotherapy and radiation therapy.
Preclinical and other data suggest that clusterin promotes cell survival. Increased clusterin
production has been linked to faster rates of cancer progression, treatment resistance and shorter
survival duration. Since increased clusterin production is observed in many human cancers,
including prostate, non-small cell lung, breast, ovarian, bladder, renal, pancreatic, anaplastic
large cell lymphoma and colon cancers and melanoma, OGX-011 may have broad market potential to
treat many cancer indications and disease stages.
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About Teva
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is the worlds leading generic
pharmaceutical company and is among the top 20 pharmaceutical companies in the world. The Company
develops, manufactures and markets generic and innovative human pharmaceuticals
and active pharmaceutical ingredients, as well as animal health pharmaceutical products. Over 80
percent of Tevas sales are in North America and Europe.
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 deep
oncology pipeline, with each product candidate having a distinct mechanism of action and
representing a unique opportunity for cancer drug development. OGX-011, the lead candidate that has
completed five Phase II clinical trials in prostate, lung and breast cancers, is designed to
inhibit the production of a specific protein associated with treatment resistance; OGX-427 is in
Phase I clinical development; SN2310 has completed a Phase I clinical trial; and CSP-9222 and
OGX-225 are currently in pre-clinical development.
OGX-011, OGX-427 and OGX-225 utilize second-generation antisense technology, licensed from Isis
Pharmaceuticals (NASDAQ: ISIS), to target and inhibit production of specific proteins which
OncoGenex believes are important in tumor progression and treatment resistance. OncoGenex and Isis
partnered in the successful discovery of OGX-011, OGX-427 and OGX-225 and with respect to OGX-011,
in its initial development. In 2008, OncoGenex and Isis amended their OGX-011 agreement to provide
OncoGenex with sole rights to OGX-011 and sole responsibility for development and related costs and
partnering decisions, subject to financial obligations to Isis. OncoGenex is also solely
responsible for development and related costs and partnering decisions regarding OGX-427 and
OGX-225. Key intellectual property related to OGX-011, OGX-427 and OGX-225 were discovered by the
University of British Columbia and the Vancouver Prostate Centre, and were exclusively licensed to
OncoGenex.
More information about OncoGenex is available at www.oncogenex.com.
Tevas 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 managements 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: results of the phase III
clinical trials involving OGX-011, the potential efficacy or future market or marketability of
OGX-011, our ability to successfully develop and commercialize additional pharmaceutical products,
the introduction of competing generic equivalents, the extent to which we may obtain U.S. market
exclusivity for certain of our new generic products and regulatory changes that may prevent us from
utilizing exclusivity periods, potential liability for sales of generic products prior to a final
resolution of outstanding patent litigation, including that relating to the generic versions of
Neurontin®, Lotrel®, Protonix® and Eloxatin®, the current economic conditions, competition from
brand-name companies that are under increased pressure to counter generic products, or competitors
that seek to delay the introduction of generic products, the effects of competition on our
innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and
other protections for innovative products, the impact of consolidation of our distributors and
customers, the impact of pharmaceutical industry regulation and pending legislation that could
affect the pharmaceutical industry, our ability to achieve expected results though our innovative
R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines
Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and
regulatory pathway for the registration and approval of biotechnology-based products, the
regulatory environment and changes in the health policies and structures of various countries,
supply interruptions or delays that could result from the complex manufacturing of our products and
our global supply chain, our ability to successfully identify, consummate and integrate
acquisitions, the potential exposure to product liability claims to the extent not covered by
insurance, our exposure to fluctuations in currency, exchange and interest rates, significant
operations worldwide that may be adversely affected by terrorism, political or economical
instability or major hostilities, our ability to enter into patent litigation
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settlements and the
intensified scrutiny by the U.S. government, the termination or expiration of governmental programs
and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other
factors that are discussed in this report and in our other filings with the U.S. Securities and
Exchange Commission (SEC).
OncoGenexs 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 potential milestones, royalties and other payments that may be received by
OncoGenex in the future, anticipated clinical and other product development activities and timing
and costs of these activities, market potential for OGX-011 and success of activities to attain
market approval and sales. These statements are based on managements 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. All statements
other than statements of historical fact are statements that could be deemed forward-looking
statements. Such forward-looking statements are subject to risks and uncertainties, including,
among others, the risk factors set forth in the Companys filings with the Securities and Exchange
Commission, including the Companys Annual Report on Form 10-K for fiscal year 2008. 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.
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