New Data Presented Demonstrates Ovulatory Effect of Teva Women’s Health’s Investigational 28-Day Oral Contraceptive

  New Data Presented Demonstrates Ovulatory Effect of Teva Women’s Health’s
  Investigational 28-Day Oral Contraceptive

 - Results from Phase I Clinical Trial Presented at the 61^st Annual Clinical
    Meeting of the American Congress of Obstetricians and Gynecologists -

Business Wire

NORTH WALES, Pa. -- May 8, 2013

Teva Women’s Health, a U.S.-based subsidiary of Teva Pharmaceutical Industries
Ltd., presented new data on ovulation inhibition and ovarian activity from a
Phase I clinical trial of Teva’s investigational 28-day oral contraceptive
(OC) (150 mcg desogestrel (DSG)/20 mcg ethinyl estradiol (EE) for 21 days,
followed by 7 days of 10 mcg EE), an investigational monthly regimen. The
results were presented at the 61^st Annual Clinical Meeting of the American
Congress of Obstetricians and Gynecologists (ACOG).

Data were presented from a randomized, open-label comparative study of 142
women, aged 18 to 35 years, which compared ovulation inhibition and ovarian
activity of Teva’s investigational 28-day OC to two contraceptive regimens
containing different synthetic progestins. The primary endpoints were ovarian
follicular development, and progesterone and estradiol levels. Women in the
study were randomized to one of the following groups for three consecutive
28-day cycles:

  *Treatment 1: Teva’s investigational 28-day OC, 150 mcg DSG/20 mcg EE for
    21 days, followed by seven days of 10 mcg EE
  *Treatment 2: 3 mg drospirenone and 20 mcg EE for 24 days, followed by four
    days of placebo pills
  *Treatment 3: 1 mg levonorgestrel and 20 mcg EE for 21 days, followed by
    seven days of placebo pills

Results showed that, following the three-month treatment period, ovarian
activity was reduced in subjects receiving treatments with modified
hormone-free intervals. Although all three treatment groups showed reduced
ovarian activity, Teva’s investigational 28-day OC reduced ovarian activity
more than Treatment 3, the levonorgestrel regimen, and had effects similar to
Treatment 2, the drospirenone regimen. In addition, Teva’s investigational
28-day OC presented a safety profile that was similar to that of the two
commercial comparators in the study as well as other commercially available
28-day OCs on the market. The most common treatment-emergent adverse events
were upper respiratory tract infection (19%) and headache (17%).

“These data support the potential of Teva’s new investigational 28-day oral
contraceptive to prevent pregnancy by inhibiting ovulation,” said Larry
Seidman, D.O., principal investigator at Clinical Research of Philadelphia.
“Although many contraceptive options are available, studying new regimens
provides additional choices for women deciding on the appropriate
contraception for them.”

Traditional “21/7” oral contraceptive regimens include 21 days of “active
pills” and a hormone-free interval (HFI) during which a woman takes placebo
pills. Teva’s investigational DSG OC regimen eliminates the HFI by adding
seven days of 10 mcg EE during the traditional HFI.

“We are encouraged by the data presented on Teva’s investigational 28-day oral
contraceptive at ACOG this year, which demonstrated that the regimen achieves
an ovulatory effect,” said Nancy Ricciotti, senior director of clinical
affairs, Teva Women’s Health R&D. “These data are a testament to our
dedication to provide women with innovative contraceptive and family planning

About Teva’s Investigational 28-Day Oral Contraceptive

Teva’s investigational 28-day oral contraceptive (150 mcg desogestrel/20 mcg
ethinyl estradiol for 21 days, followed by seven days of 10 mcg ethinyl
estradiol) is a desogestrel regimen that is being evaluated as a 28-day oral
contraceptive. Teva’s investigational 28-day oral contraceptive eliminates the
traditional hormone-free interval (HFI), which means that there are no
placebos (sugar pills) in the regimen. Instead, the regimen adds seven days of
10 mcg ethinyl estradiol during the traditional HFI.

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:

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 recent acquisitions, 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 pathways for the registration and approval of
biotechnology-based products, adverse effects of political or economical
instability, corruption, 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, 2012 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.


Teva Women’s Health, Inc.
Shannon Oates-Rivera, 484-318-0512
Press spacebar to pause and continue. Press esc to stop.