Teva Women’s Health, Inc. Announces for the First Time Results of Pivotal Phase III Study of QuartetteTM

  Teva Women’s Health, Inc. Announces for the First Time Results of Pivotal
  Phase III Study of QuartetteTM (levonorgestrel/ethinyl estradiol tablets and
  ethinyl estradiol tablets) at the 68th Annual Meeting of ASRM

 - Data Demonstrate that Efficacy of a Novel Ascending-Dose, Extended-Regimen
         Oral Contraceptive is Similar to Other Oral Contraceptives -

Business Wire

FRAZER, Pa. -- October 24, 2012

Teva Women’s Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical
Industries Ltd. (NYSE: TEVA), today announced the findings from a Phase III
pivotal trial of Quartette^TM (levonorgestrel/ethinyl estradiol tablets and
ethinyl estradiol tablets), an investigational ascending-dose,
extended-regimen oral contraceptive for the prevention of pregnancy that is
currently under review by the U.S. Food and Drug Administration. These data
were presented for the first time as a poster at the 68^th Annual Meeting of
the American Society of Reproductive Medicine (ASRM).

The Phase III, multicenter, open-label, single arm study evaluated the
efficacy and safety of Quartette^TM over one year; 3,701 sexually active women
18 to 40 years old were enrolled and 2,144 completed the study. Data
demonstrated Quartette^TM is efficacious for the prevention of pregnancy and
has a safety profile similar to that of other oral contraceptives.^1

“As a practicing OB/GYN, I continue to see women struggle with choosing an
optimal contraceptive that fits their needs, so studying new contraceptive
options with innovative designs is important,” said Dr. David J. Portman, MD,
founder and principal investigator at the Columbus Center for Women’s Health
Research, director of the Menopause Center of Columbus, clinical instructor at
Ohio State University and an obstetrician/gynecologist with Portman OB/GYN.
“The data presented at ASRM suggest that Quartette^TM will be effective at
preventing pregnancy.”

Quartette^TM features a 91-day regimen, with an 84-day ascending ethinyl
estradiol dose designed to minimize unscheduled or breakthrough bleeding,
followed by period-stabilizing 10 mcg ethinyl estradiol pills during the
traditional seven-day hormone-free interval.

Efficacy in the study was measured using the Pearl Index (PI) to report
pregnancy rates. The PI was 2.92 (95% CI, 2.26-3.72), based on 65 pregnancies
that occurred after the onset of treatment and within 7 days after the last
combination tablet in women 18 to 35 years old, and excluding cycles in which
another method of birth control was used. Adverse effects were similar to
those seen with other oral contraceptives. The most common treatment-related
adverse effects were metrorrhagia (5.9%) and headache (4.5%).^i

“We are pleased to showcase these new data on a novel ascending-dose, extended
regimen oral contraceptive for the prevention of pregnancy as part of the
official ASRM program,” said Marty Berndt, vice president and general manager,
US Brand Pharmaceuticals, Teva Women’s Health. “Quartette^TM is an exciting
advancement for women of reproductive age, as it offers them a unique
contraceptive option. It also builds upon our heritage of providing women with
innovative, extended-cycle contraceptive products, further reflecting our
longtime commitment to women’s reproductive health.”

About Quartette™

Quartette™ is an investigational extended regimen combination oral
contraceptive in development for the prevention of pregnancy. Each 91-day
cycle consists of ethinyl estradiol 20/ levonorgestrel 150 mcg for 42 days,
ethinyl estradiol 25/ levonorgestrel 150 mcg for 21 days, ethinyl estradiol
30/ levonorgestrel 150 mcg for 21 days, and ethinyl estradiol 10 mcg for 7
days.

About Teva Women’s Health, Inc.

Teva Women’s Health, Inc. is a U.S.-based subsidiary of Teva Pharmaceutical
Industries Ltd. (NYSE: TEVA), headquartered in Israel. The company produces a
wide range of women’s healthcare products including oral contraceptives,
intrauterine contraception and hormone therapy treatments for menopause and
perimenopause. Teva Women’s Health, Inc. maintains a strong commitment to
enhancing women’s lives by actively pursuing new areas of research and
providing distinct pharmaceutical options that meet women’s needs and fit
their lifestyles. Through close engagement with women and healthcare
providers, the company maintains an in-depth understanding of the important
health matters that affect women.

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995: 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, in this report 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. You are advised, however, to consult
any additional disclosures we make in our reports to the SEC on Form 6-K. Also
note that we provide a cautionary discussion of risks and uncertainties under
“Risk Factors” in our Annual Report on Form 20-F for the year ended December
31, 2011. These are factors that we believe could cause our actual results to
differ materially from expected results. Other factors besides those listed
could also adversely affect us. This discussion is provided as permitted by
the Private Securities Litigation Reform Act of 1995.

^1 Portman D, et al. Multicenter, Open-Label Study to Evaluate Efficacy and
Safety of an Ascending-Dose, Extended-Regimen Ethinyl Estradiol/Levonorgestrel
Combination Oral Contraceptive for Preventing Pregnancy in Women. Presented at
68th Annual Meeting of the American Society for Reproductive Medicine. October
20-24, 2012; San Diego, Calif.

122598

Contact:

Teva USA
Denise Bradley, 215-591-8974
denise.bradley@tevapharm.com
 
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