Phase III Study of Teva’s Milprosa™ (Progesterone) Vaginal Ring Published in Fertility and Sterility

  Phase III Study of Teva’s Milprosa™ (Progesterone) Vaginal Ring Published in
  Fertility and Sterility

 Data Demonstrated Once-Weekly Milprosa™ Provides Similar Pregnancy Rates to
                   Daily 8 Percent Progesterone Vaginal Gel

Business Wire

JERUSALEM -- March 4, 2013

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced the
publication of results of the Phase III clinical trial of Milprosa™
(progesterone) vaginal ring in Fertility and Sterility. The study compared the
efficacy and safety of once-weekly Milprosa™ to daily 8 percent progesterone
vaginal gel for luteal phase support in in vitro fertilization (IVF) and found
that clinical pregnancy rates per retrieval at eight and 12 weeks were
comparable between patient groups. Adverse event (AE) profiles were similar
between the two treatment groups and consistent with known AEs associated with
progesterone.

“The study results demonstrate that Milprosa™ may be an effective and safe
option for progesterone supplementation during the luteal phase among women
undergoing IVF,” said Laurel Stadtmauer, M.D., Ph.D., professor of Obstetrics
and Gynecology at Jones Institute for Reproductive Medicine at Eastern
Virginia Medical School and study author. “Since normal luteal function may be
compromised among women undergoing IVF, progesterone supplementation is
essential and the more options patients have, the better. If approved, the
once-weekly dosing of Milprosa™ may offer convenience for patients.”

The Phase III randomized, single-blinded, multicenter, noninferiority study
was conducted at 22 clinical sites in the U.S. and included 1,297 patients
between the ages of 18 and 42. Of enrolled patients, 646 were randomized to
Milprosa™ and 651 to the 8 percent progesterone vaginal gel.

“The Fertility and Sterility publication of the Milprosa™ Phase III data is a
significant milestone for Teva, especially because fertility is a meaningful
new area of specialization for the company and one in which significant unmet
need exists,” said Jill DeSimone, senior vice president & general manager,
Global Teva Women's Health. “We look forward to continuing to share important
updates about Milprosa™ and demonstrating our investment in and commitment to
women’s health.”

About the Study

The Phase III study randomized patients into two treatment groups: one group
received once-weekly Milprosa™ and the other received daily 8 percent
progesterone vaginal gel. Milprosa™ and the vaginal gel were initiated on the
day following egg retrieval and continued through 12 weeks’ gestation.
Efficacy was evaluated by comparing clinical pregnancy rates of patients at
eight and 12 weeks gestation.

  *At week eight, clinical pregnancy rates per retrieval were 48.0 percent
    for the Milprosa™ group and 47.2 percent for the vaginal gel group
    (between-group difference, 0.8%; 95% CI, -4.6%, 6.3%).
  *At week 12, clinical pregnancy rates per retrieval for Milprosa™ and the
    vaginal gel were 46.4 percent and 45.2 percent respectively (between-group
    difference, 1.3%; 95% CI, -4.1%, 6.7%).

A secondary efficacy endpoint was the rate of live birth.

  *The overall live birth rate per retrieval for women using Milprosa™ was
    45.2 percent; among women using the vaginal gel, the rate was 43.3
    percent.
  *The majority of patients pregnant at week 12, when progesterone treatment
    ended, went on to have a live birth: 97.4 percent for the Milprosa™ group
    and 96.5 percent for the vaginal gel group.

The most commonly reported adverse events (those greater than or equal to 10%
in the Milprosa™ treatment group) were nausea, headache, abdominal pain,
post-procedural discomfort, abdominal distension, back pain, fatigue, vomiting
and constipation. Serious adverse events (SAEs) occurred in approximately 12
percent of all patients, with no significant difference in the rate between
treatment groups. The majority of SAEs that occurred were mild to moderate in
severity and not related to treatment. Rates of discontinuation of treatment
due to AEs were low and similar between both groups (approximately 6%).

About Milprosa™ (Progesterone) Vaginal Ring

Milprosa™ is an investigational, once-weekly progesterone ring inserted in the
vagina. It is flexible and designed to continuously release a steady dose of
micronized progesterone. Milprosa™ is in development to support embryo
transplantation and early pregnancy (up to 10 weeks post-embryo transfer) by
supplementation of corpus luteal function as part of an Assisted Reproductive
Technology (ART) treatment program for infertile women.

About Supplementation of Corpus Luteal Function

The corpus luteum is a temporary endocrine gland that develops during the
luteal phase of a woman’s menstrual cycle. It is an important contributor of
progesterone and is critical for the maintenance of early pregnancy. During in
vitro fertilization, progesterone supplementation is needed because natural
levels of the hormone may be insufficient. This supplementation improves
implantation rates and thus pregnancy rates. Additionally, progesterone
supplementation supports early pregnancy.

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 innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 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 as well as
biologics. Teva currently employs approximately 46,000 people around the world
and reached $20.3 billion in net revenues in 2012.

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 develop and
commercialize additional pharmaceutical products, competition for our
innovative products, especially Copaxone® (including competition from
innovative orally-administered alternatives, as well as from potential
purported generic equivalents), competition for our generic products
(including from other pharmaceutical companies and as a result of increased
governmental pricing pressures), competition for our specialty pharmaceutical
businesses, our ability to achieve expected results through our innovative R&D
efforts, the effectiveness of our patents and other protections for innovative
products, decreasing opportunities to obtain U.S. market exclusivity for
significant new generic products, our ability to identify, consummate and
successfully integrate acquisitions, the effects of increased leverage as a
result of the acquisition of Cephalon, the extent to which any manufacturing
or quality control problems damage our reputation for high quality production
and require costly remediation, our potential exposure to product liability
claims to the extent not covered by insurance, increased government scrutiny
in both the U.S. and Europe of our agreements with brand companies, 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®, our exposure to currency fluctuations and restrictions as well
as credit risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply with complex
Medicare and Medicaid reporting and payment obligations, governmental
investigations into sales and marketing practices (particularly for our
specialty pharmaceutical products), uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, major hostilities or acts of terrorism on our significant
worldwide operations, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex manufacturing
processes, any failure to retain key personnel or to attract additional
executive and managerial talent, the impact of continuing consolidation of our
distributors and customers, variations in patent laws that may adversely
affect our ability to manufacture our products in the most efficient manner,
potentially significant impairments of intangible assets and goodwill,
potential increases in tax liabilities, the termination or expiration of
governmental programs or tax benefits, 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. Forward-looking statements speak only as of the date on
which they are made and the Company undertakes no obligation to update or
revise any forward-looking statement, whether as a result of new information,
future events or otherwise.

Contact:

IR:
United States
Kevin C Mannix, 215-591-8912
or
United States
Kristen Frank, 215-591-8908
or
Israel
Tomer Amitai, 972-3-926-7656
or
PR:
Israel
Hadar Vismunski-Weinberg, 972-3-926-7687
or
United States
Denise Bradley, 215-591-8974
 
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