Otsuka and Teva Sign Licensing Agreement for Japan on Prophylactic Migraine Drug Candidate Fremanezumab (TEV-48125)

TOKYO & JERUSALEM–(BUSINESS WIRE)– Otsuka Pharmaceutical Co., Ltd (Otsuka) and Teva Pharmaceutical
Industries, Ltd. (Teva) announce an agreement covering Japan for Otsuka
to develop and commercialize Teva’s investigational drug candidate
fremanezumab (TEV-48125), an anti-calcitonin gene-related peptide (CGRP)
monoclonal antibody for the prevention of migraine. Fremanezumab is
administered monthly as a subcutaneous injection. Through the agreement,
Otsuka secures exclusive rights in Japan to fremanezumab, which Teva is
globally developing in other countries.

The annual prevalence of migraine in Japan is 8.4% of adults and
approximately 8.4 million patients suffer from the condition. The
highest prevalence rate is among young women, with approximately 20% of
cases reported among women in their 30s.¹ Acute as well as
preventive treatments exist for migraine, but there is an unmet need for
targeted, preventive treatments.

In global Phase IIb studies conducted by Teva for episodic and chronic
migraine, all doses achieved their primary and secondary study
endpoints. The data indicated a significant reduction in both the number
of monthly cumulative headache hours (primary endpoint in chronic
migraine), and the number of migraine days (primary endpoint in episodic
migraine), relative to baseline. No treatment-related serious adverse
events were reported with the use of fremanezumab. Common adverse events
observed in clinical trials included mild injection-site pain or
erythema and pruritus.

About the Agreement

With the agreement consummated, Otsuka is to pay Teva a lump-sum payment
of $50 million. Milestone payments will be made upon filing and
regulatory approval in Japan and then upon achievement of specified
revenue targets. Future clinical trials in Japan will be carried out and
funded by Otsuka. In addition, Otsuka holds exclusive sales rights and
will pay royalties on revenues to Teva.

Tatsuo Higuchi, president and representative director of Otsuka
Pharmaceutical Co., Ltd. commented, « Through this agreement, we aim to
leverage our core strengths in the areas of neurology and psychiatry.
I’m confident that this new therapy, advanced to this development stage
by Teva, holds significant potential as a future new option in an area
with high patient needs in Japan. »

Gianfranco Nazzi, president & CEO growth markets at Teva Pharmaceutical
Industries, noted, “We have seen very promising preliminary results for
fremanezumab in our Phase IIb studies for both chronic and episodic
migraine. We believe the promise shown in these investigational trials
represents significant hope for patients suffering from debilitating
migraines, and we look forward to bringing this therapy to patients in
Japan in collaboration with Otsuka Pharmaceutical Co., Ltd.”

About Fremanezumab (TEV-48125)

Fremanezumab is a monthly subcutaneous injection that is under
development for the prevention of migraine, with clinical trials
conducted in chronic and episodic migraine as well as chronic and
episodic cluster headache. It is thought to prevent migraine by
selectively binding to CGRP ligand, a well-validated target in migraine.
The effectiveness and safety of four dose levels of fremanezumab were
previously studied in phase IIb, placebo-controlled, double-blind trials
(about 300 participants) for the prevention of recurrent, episodic
migraine and chronic migraine.

About Otsuka

Otsuka Pharmaceutical is a global healthcare company with the corporate
philosophy: “Otsuka – people creating new products for better health
worldwide.” Otsuka researches, develops, manufactures and markets
innovative and original products, with a focus on pharmaceutical
products to meet unmet medical needs and nutraceutical products for the
maintenance of everyday health.

In pharmaceuticals, Otsuka is a leader in the challenging area of mental
health and also has research programs on several under-addressed
diseases including tuberculosis, a significant global public health
issue. These commitments illustrate how Otsuka is a “big venture”
company at heart, applying a youthful spirit of creativity in everything
it does.

Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd.,
headquartered in Tokyo, Japan, with 2016 consolidated sales of
approximately $11 billion.

All Otsuka stories start by taking the road less travelled. Learn more
about Otsuka at www.otsuka.co.jp/en/.
Learn more about Otsuka in the U.S. at www.otsuka-us.com
and connect with us on Twitter at @OtsukaUS.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients in 100 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva’s net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.

^{1 Sakai F, Igarashi H. Prevalence of migraine in Japan: a
nationwide survey. Cephalalgia 1997; 17(1): 15-22.}

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the potential the research, development and commercialization
of TEV-48125 (fremanezumab), which are based on Teva’s management’s
current beliefs and expectations and are subject to substantial risks
and uncertainties, both known and unknown, that could cause Teva’s
future results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include risks
relating to:

• challenges inherent in product research and development, including
  uncertainty of clinical success and obtaining regulatory approvals;
• the potential that the expected benefits and opportunities related
  to the outlicense of TEV-48125 to Otsuka may not be realized;
• Teva’s specialty medicines business, including: competition for
  Teva’s specialty products, especially Copaxone^®,
  Teva’s leading medicine, which faces competition from existing and
  potential additional generic versions and orally-administered
  alternatives; Teva’s ability to achieve expected results from
  investments in Teva’s product pipeline; competition from companies
  with greater resources and capabilities; and the effectiveness of
  Teva’s patents and other measures to protect Teva’s intellectual
  property rights;
• Teva’s business and operations in general, including: Teva’s
  ability to develop and commercialize additional pharmaceutical
  products; manufacturing or quality control problems, which may damage
  Teva’s reputation for quality production and require costly
  remediation; interruptions in Teva’s supply chain; disruptions of
  Teva’s or third party information technology systems or breaches of
  Teva’s data security; the restructuring of Teva’s manufacturing
  network, including potential related labor unrest; the impact of
  continuing consolidation of Teva’s distributors and customers; and
  variations in patent laws that may adversely affect Teva’s ability to
  manufacture Teva’s products;
• compliance, regulatory and litigation matters, including: costs and
  delays resulting from the extensive governmental regulation to which
  Teva are subject; the effects of reforms in healthcare regulation and
  reductions in pharmaceutical pricing, reimbursement and coverage;
  potential additional adverse consequences following Teva’s resolution
  with the U.S. government of Teva’s FCPA investigation; governmental
  investigations into sales and marketing practices; potential liability
  for sales of generic products prior to a final resolution of
  outstanding patent litigation; product liability claims; increased
  government scrutiny of Teva’s patent settlement agreements; failure to
  comply with complex Medicare and Medicaid reporting and payment
  obligations; and environmental risks;
• and other factors discussed in Teva’s Annual Report on Form 20-F
  for the year ended December 31, 2016 (“Annual Report”), including in
  the section captioned “Risk Factors,” and in Teva’s other filings with
  the U.S. Securities and Exchange Commission, which are available at www.sec.gov
  and www.tevapharm.com.
  Forward-looking statements speak only as of the date on which they are
  made, and Teva assumes no obligation to update or revise any
  forward-looking statements or other information contained herein,
  whether as a result of new information, future events or otherwise.
  You are cautioned not to put undue reliance on these
  forward-looking statements.

Image may be NSFW.
Clik here to view.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170515005429/en/