Teva Women’s Health, a U.S.-based subsidiary of Teva
Pharmaceutical Industries Ltd. (NYSE: TEVA), today announced new
data for the oral contraceptives (OC) QuartetteTM
(levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets
and an investigational 28-day OC regimen (150 mcg desogestrel
(DSG)/20 mcg ethinyl estradiol (EE) for 21 days, followed by 7 days
of 10 mcg EE) will be featured at the 61st Annual Meeting of the
American Congress of Obstetricians and Gynecologists (ACOG). The
meeting, held in New Orleans from May 4 – 8, 2013 features three
company-sponsored posters.
Presentation details:
Quartette™
- Bleeding Patterns with Three
Ascending-Dose, Extended-Cycle Oral Contraceptives vs.
Seasonale® (Poster # 3, Poster Session #1:
Contraception/Family Planning: Monday, May 6, 2013 from 10:30 a.m.
to 5:00 p.m. CT) Bruce Carr, MD, Dallas, TX
Results from a Phase II clinical trial
comparing bleeding patterns with Seasonale® (30 mcg EE/150
mcg levonorgestrel, followed by 7 days placebo) versus three 91-day
ascending EE dose combination oral contraceptive regimens,
including Quartette™, a next-generation extended-regimen oral
contraceptive approved by the U.S. Food and Drug Administration in
April 2013, which was designed to minimize breakthrough bleeding
between scheduled periods.
- Metabolic Changes Associated with an
Ascending-Dose, Extended-Regimen Combination Oral Contraceptive
(Poster #9, Poster Session #2: Contraception/Family Planning:
Tuesday, May 7, 2013 from 10:00 a.m. – 4:00 p.m. CT) James Simon,
MD, Washington, D.C.
Data from a Phase III, multicenter,
open-label, single-arm study assessed the metabolic changes
associated with an extended-regimen oral contraceptive that has an
increasing dose of EE.
Teva’s investigational 28-day OC
- Ovulatory Effects of Three Oral
Contraceptive Regimens: A Comparative Trial (Poster #8, Poster
Session #2: Contraception/Family Planning: Tuesday, May 7, 2013
from 10:00 a.m. – 4:00 p.m. CT) Larry Seidman, DO, Philadelphia,
Pa.
Data on ovulation inhibition and ovarian
activity from a Phase I open-label comparative study of Teva’s
investigational 28-day OC, a regimen currently in development,
compared to two marketed 28-day contraceptive regimens.
“These data highlight our leadership in developing novel oral
contraceptives that address women’s reproductive health needs and
concerns,” said Marty Berndt, VP & General Manager, US Brand
Pharmaceuticals, Teva Women’s Health. “Quartette™, the newest
product in our global women’s health franchise, and the
investigational 28-day oral contraceptive are two examples of our
dedication to providing a variety of contraceptive and family
planning options that fit women’s lifestyles.”
About Quartette™
Quartette™ is an extended regimen combination oral contraceptive
indicated 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 seven days.
IMPORTANT SAFETY INFORMATION
WARNING TO WOMEN WHO SMOKE
Do not use Quartette™ if you smoke cigarettes
and are over 35 years old. Smoking increases your risk of
serious cardiovascular side effects from birth control pills,
including death from heart attack, blood clots, or stroke.
The risk increases with age and the number of cigarettes you
smoke.
- The use of hormonal birth control is
associated with increased risks of several serious side effects,
including blood clots, stroke, and heart attack.
- You should not take the pill if you
have blood clots, certain cancers, a history of heart attack or
stroke, undiagnosed abnormal bleeding, or may be pregnant.
- The most common side effects of
Quartette™ are headaches, heavy/irregular vaginal bleeding,
nausea/vomiting, acne, pain with bleeding, weight gain, mood
changes, anxiety/panic attack, breast pain, and migraines.
- The pill does not protect against
HIV infection (AIDS) and other sexually transmitted
infections.
- The occurrence of fewer periods (4 per
year instead of 13 per year) should be weighed against the
occurrence of increased bleeding and/or spotting between periods.
Unscheduled bleeding and unscheduled spotting should decrease over
subsequent 91-day cycles.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please click here to see the full prescribing information,
including Boxed Warning.
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.
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