Teva to Receive Worldwide Development and
Commercial Rights to Novel CGRP Antagonists
Heptares to Receive $10 Million Upfront with
up to $400 Million in Potential Milestone Payments
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and
Heptares Therapeutics (“Heptares”), a wholly owned subsidiary of
Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565) announce
that they have entered into a licensing and drug-discovery
agreement under which Teva will receive exclusive global rights to
develop, manufacture and commercialize novel, small-molecule
calcitonin gene-related peptide (CGRP) antagonists discovered by
Heptares for the treatment of migraine.
Under the terms of the agreement, Heptares will receive an
upfront payment of $10 million, research funding, and is eligible
to receive additional research, development and commercialization
milestone payments of up to $400 million. In addition, Heptares
will be eligible to receive royalties on net sales of products
resulting from the alliance.
“We are delighted to begin this partnership with Heptares, which
through its industry-leading, structure-based design approach has
generated novel CGRP antagonists with significant promise for
treating migraine,” said Michael Hayden, MD, PhD, President of
Global R&D and Chief Scientific Officer at Teva. “CGRP
antagonism represents an exciting opportunity to treat migraine. We
believe small-molecule CGRP antagonists offer further opportunities
that are highly complementary to our promising candidate,
TEV-48125, an anti-CGRP antibody.”
“This agreement is an exciting development for our CGRP
antagonist program,” added Malcolm Weir, Chief Executive Officer of
Heptares. “Teva brings world-leading clinical and commercial
expertise in migraine to advance this program based on
differentiated small-molecule CGRP antagonists discovered using our
novel structure-based drug design technologies. The commitment Teva
is making allows us to expand this promising program.”
About Migraine
Approximately 36 million people in the United States and 8
million people in Japan suffer from migraine. Migraine is three
times more common in women than in men and affects more than 10
percent of people worldwide. Migraine is defined as recurring
attacks of moderate to severe headache pain. The International
Headache Society defines chronic migraine as more than 15
headache days per month over a three-month period of which more
than eight are migraines, in the absence of medication over use.
Episodic migraine is the
other migraine sub-type, which is defined as less
than 15 headache days per month. During migraines, people can
experience varying characteristics such as being very sensitive to
light and sound and may also experience nausea and vomiting. There
is no absolute cure for migraine since its pathophysiology has yet
to be fully understood.
About CGRP Antagonists for Migraine
Calcitonin gene-related peptide (CGRP) is released during
migraine attacks and can trigger migraine in patients. CGRP is
found in small to medium-sized neurons in the trigeminal ganglion
and mediates its activity through G protein-coupled receptors
located throughout the body. Elevated levels of CGRP are found in
migraineurs during an attack and blocking CGRP activity is a
validated mechanism of action for relieving pain, and also for
preventing migraine.
About Heptares Therapeutics
Heptares is a clinical-stage company creating transformative
medicines targeting G protein-coupled receptors (GPCRs), a
superfamily of 375 receptors linked to a wide range of human
diseases. Heptares proprietary structure-based drug design
technology enables us to engineer drugs for highly validated, yet
historically undruggable or challenging, GPCRs. Using this
approach, we have built an exciting pipeline of new medicines with
the potential to transform the treatment of Alzheimer’s disease,
schizophrenia, cancer immuno-oncology, migraine, addiction,
metabolic disease, and other indications. Pharmaceutical partners
include AstraZeneca, MedImmune, MorphoSys, Takeda and Teva.
Heptares is a wholly owned subsidiary of Sosei Group Corporation.
For more information, please visit www.heptares.com.
HEPTARES is a registered trademark in the EU, Switzerland, US
and Japan;
About Sosei
Sosei is a biopharmaceutical company originating from Japan but
with global presence. Sosei’s primary business model is based on
identifying novel and/or differentiated product assets or
technology platforms and, through supporting these in preclinical
and clinical development and establishing commercial partnerships,
advancing new medicines to patients worldwide. For more information
about Sosei, please visit www.sosei.com.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,000
molecules to produce a wide range of generic products in nearly
every therapeutic area. In specialty medicines, Teva has a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
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 specialty
products, especially Copaxone® (including competition from
orally-administered alternatives, as well as from generic
equivalents such as the recently launched Sandoz product) and our
ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s
generic business and Rimsa), or to consummate and integrate
acquisitions; 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; the extent to
which any manufacturing or quality control problems damage our
reputation for quality production and require costly remediation;
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; adverse effects of political or economic
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; the impact of continuing consolidation
of our distributors and customers; 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; our potential exposure to product
liability claims that are not covered by insurance; any failure to
recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare
and Medicaid reporting and payment obligations; significant
impairment charges relating to intangible assets, goodwill and
property, plant and equipment; the effects of increased leverage
and our resulting reliance on access to the capital markets;
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, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission.
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For Teva Pharmaceutical Industries Ltd.:IR:United StatesKevin
C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213orHeptares:Malcolm
Weir (CEO), +44 1707 358 629orDan Grau (President),
857-222-4586orCitigate Dewe Rogerson (for Heptares)Mark
Swallow, +44 207 282 2948orDavid Dible, +44 207 282
2949
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