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
JERUSALEM & LONDON -- (Business Wire)
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151125005141/en/
Contacts:
For Teva Pharmaceutical Industries Ltd.:
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir,215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
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
Heptares:
Malcolm
Weir (CEO), +44 1707 358 629
or
Dan Grau (President),
857-222-4586
or
Citigate Dewe Rogerson (for Heptares)
Mark
Swallow, +44 207 282 2948
or
David Dible, +44 207
282 2949
Source: Teva Pharmaceutical Industries Ltd.
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