Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today its
decision to exercise its option to make an additional $19 million
investment in CureTech Ltd., and to finance up to $50 million of the
company's R&D program. Teva’s decision follows the positive final
results from a phase II trial in diffuse large B-Cell lymphoma (DLBCL)
using CT-011, an investigational anti-PD-1 monoclonal antibody. The
study met its primary end point and results showed significant
improvement in both the overall survival and the
progression-free-survival of the patients.
Under the terms of the recently amended agreements between Teva,
CureTech, and its shareholders, Teva’s investment will bring its
holdings in CureTech to 75%. Teva holds the option to reach full
ownership of CureTech.
"We are excited at this opportunity to continue working with CureTech on
the development of CT-011. We believe CT-011 has great potential to help
many currently unserved cancer patients," said Dr. Aharon Schwartz, Head
of Teva's Innovative Ventures. "This investment is part of Teva's
strategy to expand our branded activities into specialty therapeutic
areas, such as oncology."
Commenting on the phase II results, Dr. Leo Gordon, Director of the
Lymphoma Program at Northwestern University School of Medicine, Chicago
and Principal Investigator in this study, said, "The observation that
there is a surge of effector memory cells and the signal that there is
an improvement in PFS in a high risk group of patients with relapsed
large cell lymphoma suggests considerable biologic and clinical
relevance to CT-011 and is a compelling argument for a Phase III trial.
A successful trial could make this the standard of care in the setting
of relapsed lymphoma or even in high risk lymphoma after initial
therapy, but more importantly, lead the way towards the use of PD-1
inhibitors in settings in which enhanced innate immunity is desirable."
Based on the phase II results in DLBCL, CureTech intends to initiate a
phase III trial in this indication. A phase II trial for colorectal
cancer is on going, and CureTech intends to start a third phase II trial
in metastatic melanoma in the near future. Additional potential
indications are also being explored.
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 neurological, respiratory and women's health
therapeutic areas as well as biologics. Teva currently employs
approximately 42,000 people around the world and reached $16.1 billion
in net sales in 2010.
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
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 version of Protonix®, the extent
to which any manufacturing or quality control problems damage our
reputation for high quality production, the effects of competition on
sales of our innovative products, especially Copaxone® (including
potential generic and oral competition for Copaxone®), the impact of
continuing consolidation of our distributors and customers, our ability
to identify, consummate and successfully integrate acquisitions
(including the acquisition of Cephalon), interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, intense competition in our
specialty pharmaceutical businesses, 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, 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, dependence on the effectiveness of our patents and other
protections for innovative products, our ability to achieve expected
results through our innovative R&D efforts, the difficulty of predicting
U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority approvals, uncertainties surrounding the
legislative and regulatory pathway for the registration and approval of
biotechnology-based products, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities
resulting from challenges to our intercompany arrangements, our
potential exposure to product liability claims to the extent not covered
by insurance, the termination or expiration of governmental programs or
tax benefits, current economic conditions, 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 20-F and other filings with the U.S. Securities and
Exchange Commission.
