XEN402 is a Strategic Fit for Teva’s Commercial, R&D and Technology
focus in CNS and Pain
JERUSALEM & BURNABY, British Columbia--(BUSINESS WIRE)--Dec. 11, 2012--
Teva Pharmaceutical Industries Ltd (NYSE: TEVA) and Xenon
Pharmaceuticals Inc. (Xenon) announced today that they have entered into
a collaborative development and exclusive worldwide license for XEN402.
XEN402 is currently in clinical development for a variety of painful
disorders. This product specifically targets sodium channels which are
abundantly found in sensory nerve endings that can increase in chronic
painful conditions. Under the Agreement, Teva will pay Xenon an upfront
fee of $41 million. In addition Teva shall pay development, regulatory,
and sales-based milestones totaling up to $335M. Xenon is entitled to
royalties payable on sales and an option to participate in
commercialization in the U.S.
“Teva is building a focused pipeline of novel medicines in select areas
of medical need,” stated Dr. Jeremy Levin, President and CEO of Teva
Pharmaceutical Industries Ltd. “XEN402 fits this strategy. It holds the
potential to address the significant unmet medical need for the many
patients who suffer from chronic pain. In addition, XEN402 has the
potential for broader therapeutic use across other pain conditions.”
“We are delighted to be collaborating with Teva,” said Simon Pimstone,
M.D., Ph.D., President and CEO of Xenon. “Teva is among the world’s
leading pharmaceutical companies and is building a significant global
presence in innovative drug development and commercialization. This
partnership with Teva is Xenon’s seventh major pharmaceutical alliance,
once again highlighting the value of Xenon’s unique genetics approach
and translational R&D capabilities.”
About XEN402
XEN402 treats pain locally at its source through blocking of Nav1.7 and
Nav1.8 sodium channels. XEN402 has been studied in human subjects as
both oral and topical forms. In a published study, oral XEN402 was shown
to be effective at relieving the pain associated with the rare
neuropathic pain condition, erythromelalgia (Pain 2012 Jan;153(1):80-5).
Topical XEN402 was studied in a phase 2 trial to evaluate for
effectiveness in alleviating the pain of post herpetic neuralgia. In
this study the proportion of patients reporting clinically meaningful
reductions in pain was significantly greater for topical XEN402 than for
placebo (p=0.049 for >30% response and p=0.0078 for >50% response).
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 specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is a world leading 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 CNS, oncology, pain, respiratory and women's health therapeutic
areas. Teva currently employs approximately 46,000 people around the
world and reached $18.3 billion in net revenues in 2011.
About Xenon Pharmaceuticals Inc.
Xenon is a privately owned, clinical genetics-based drug discovery and
development company engaged in developing novel therapies based on the
genetic causes of select metabolic, neurological and cardiovascular
diseases. For more information, visit the Company’s website at http://www.xenon-pharma.com.
Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific
Officer, is a director and founder of Xenon.
Teva Safe Harbor
The following discussion and analysis contains forward-looking
statements, which express the current beliefs and expectations of
management. Such statements 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 from the introduction of
competing generic equivalents and due to increased governmental pricing
pressures, the effects of competition on sales of our innovative
medicines, especially Copaxone® (including competition from innovative
orally-administered alternatives as well as from potential generic
equivalents), potential liability for sales of generic medicines prior
to a final resolution of outstanding patent litigation, including that
relating to our generic version of Protonix®, the extent to which we may
obtain U.S. market exclusivity for certain of our new generic medicines,
the extent to which any manufacturing or quality control problems damage
our reputation for high quality production and require costly
remediation, our ability to identify, consummate and successfully
integrate acquisitions (including the acquisition of Cephalon), our
ability to achieve expected results through our innovative R&D efforts,
dependence on the effectiveness of our patents and other protections for
innovative medicines, intense competition in our specialty
pharmaceutical businesses, uncertainties surrounding the legislative and
regulatory pathway for the registration and approval of
biotechnology-based medicines, our potential exposure to product
liability claims to the extent not covered by insurance, 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
and pharmaceutical pricing and reimbursement, adverse effects of
political instability and adverse economic conditions, 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, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, the impact of continuing consolidation of our
distributors and customers, the difficulty of complying with U.S. Food
and Drug Administration, European Medicines Agency and other regulatory
authority requirements, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities
resulting from challenges to our intercompany arrangements, the
termination or expiration of governmental programs or tax benefits, 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 for the year ended December
31, 2011 and in our other filings with the U.S. Securities and Exchange
Commission (“SEC”). Forward-looking statements speak only as of the date
on which they are made, and we undertake no obligation to update any
forward-looking statements or other information contained in this
report, whether as a result of new information, future events or
otherwise.
Xenon Safe Harbor
This release contains forward-looking statements that are not based on
historical fact. These forward-looking statements involve risks,
uncertainties and other factors that may cause the actual results,
events or developments to be materially different from those expressed
or implied by such forward-looking statements. Readers are cautioned not
to place undue reliance on such forward-looking statements.

Source: Teva Pharmaceutical Industries Ltd.
Teva IR:
United States
Kevin C. Mannix, 215-591-8912
Joseph
Marczely, 267-468-4281
or
Israel
Tomer Amitai,
972 (3) 926-7656
or
Teva PR:
Israel
Hadar
Vismunski-Weinberg, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Xenon
Canada
Dr.
Robin Sherrington, (604) 484-3363
SVP, Business & Corporate
Development