ZOELY? (nomegestrol acetate/ 17ß-estradiol) Approved in the European Union: A Unique Monophasic Combination Oral Contraceptive

UTRECHT, The Netherlands and WHITEHOUSE STATION, New Jersey,
August 2, 2011 (ots/PRNewswire) --

- MSD and Teva Bring Forward New Contraception Option for Women

Teva Pharmaceuticals Europe BV, a wholly-owned subsidiary of Teva
Pharmaceutical Industries Ltd. , and MSD (known as Merck in the
United States and Canada) , today announced that ZOELY(TM), a new
oral contraceptive (nomegestrol acetate 2.5 mg /17beta-estradiol 1.5
mg), has been granted Marketing Authorization by the European
Commission for the prevention of pregnancy in women.

ZOELY is a combined oral contraceptive (COC) tablet containing a
unique monophasic combination of two hormones; nomegestrol acetate, a
highly selective progesterone-derived progestin and 17beta estradiol,
an estrogen that is similar to the one naturally present in a woman's
body. This innovative combination will be made available to women in
a regimen that contains twenty-four days of active pills and four
days of placebo pills. ZOELY is more than 99 percent effective in
preventing pregnancy when used as directed.

"The approval of ZOELY further reinforces MSD's longstanding
commitment to providing women with greater choice in contraceptive
options," said Terrie Curran, general manager and global franchise
leader, Women's Health, MSD. "We're delighted to add ZOELY to our
robust women's health portfolio through the strong collaborative
relationship we have established with our colleagues at Théramex, now
a subsidiary of Teva."

"The EU Marketing Authorization for ZOELY marks an important step
in creating a strong women's healthcare franchise for Teva in
Europe," said Christophe Hubert, vice-president Women's Health Teva
Europe and president of Théramex, Teva's Women's Health specialist
subsidiary. "The acquisition of Théramex in January this year gives
us a platform to leverage our capability in women's healthcare, and
the launch of ZOELY is part of our developing business in this area."

The Marketing Authorization of ZOELY applies to all 27 European
Union (EU) Member States plus the EEA-EFTA states (Iceland,
Liechtenstein and Norway).

Information on the clinical program for ZOELY

The efficacy and safety of ZOELY has been demonstrated in two
randomized, open-label comparative trials with more than 3,200 women
treated for up to 13 consecutive cycles. The Pearl Index (PI) was the
primary efficacy endpoint used to assess the contraceptive
reliability for both studies and found ZOELY to be highly effective
in preventing pregnancy.

In the clinical trial performed in the European Union, 1589 women
were treated with ZOELY for up to 13 cycles. The Pearl Index for
women aged 1835, (n=1315) including method and user failure, was
calculated as 0.38 (upper limit 95% confidence interval 0.97). The PI
calculation was based on pregnancies that occurred after the onset of
treatment and within two days after the last pill intake.

In a separate randomized, open label trial, 32 women were treated
for six cycles with ZOELY. After discontinuation of ZOELY, 79% of
women returned to ovulation within the first twenty-eight days.

Important Safety Information

ZOELY is contraindicated in patients with hypersensitivity to the
active substance or to any of the excipients. Like other COCs, ZOELY
also is contraindicated in patients with presence or history of
venous thrombosis (deep venous thrombosis, pulmonary embolism),
arterial thrombosis (e.g., myocardial infarction) or prodromal
conditions (e.g. transient ischaemic attack, angina pectoris).
Furthermore, ZOELY is contraindicated in patients with the presence
or history of cerebrovascular accident, and those with history of
migraine with focal neurological symptoms. ZOELY is also
contraindicated in patients with the presence of a severe or multiple
risk factor(s) for venous or arterial thrombosis such as: diabetes
mellitus with vascular symptoms, severe hypertension, and severe
dyslipoproteinemia.

ZOELY is contraindicated in patients with hereditary or acquired
predisposition for venous or arterial thrombosis, such as activated
protein C (APC) resistance, antithrombin-III-deficiency, protein C
deficiency, protein S deficiency, hyperhomocysteinaemia and
antiphospholipid antibodies (anticardiolipin antibodies, lupus
anticoagulant). Furthermore, ZOELY is contraindicated in patients
with pancreatitis or a history thereof if associated with severe
hypertriglyceridaemia, patients with the presence or history of
severe hepatic disease as long as liver function values have not
returned to normal, and patients with the presence or history of
liver tumours (benign or malignant). ZOELY is also contraindicated in
patients with known or suspected sex steroid-influenced malignancies
(e.g., of the genital organs or the breasts), and patients with
undiagnosed vaginal bleeding.

The use of any COC, including ZOELY, carries an increased risk of
venous thromboembolism (VTE) compared with no use. The excess risk of
VTE is highest during the first year a woman ever uses a COC.
Epidemiological studies have also associated the use of COCs with an
increased risk for arterial (myocardial infarction, transient
ischaemic attack) thromboembolism. The risk of arterial
thromboembolic complications or of a cerebrovascular accident in COC
users increases with age and smoking. Women over 35 years of age
should be strongly advised not to smoke if they wish to use a COC. An
increase in frequency or severity of migraine during COC use (which
may be prodromal of a cerebrovascular event) may be a reason for
immediate discontinuation of ZOELY use.

An increased risk of cervical cancer in long-term users of COCs (>
5 years) has been reported in some epidemiological studies, but there
continues to be controversy about the extent to which this finding is
attributable to the confounding effects of sexual behaviour and other
factors such as human papilloma virus (HPV). No epidemiological data
on the risk of cervical cancer in users of ZOELY are available. A
meta-analysis from 54 epidemiological studies reported that there is
a slightly increased relative risk (RR = 1.24) of having breast
cancer diagnosed in women who are currently using COCs. The excess
risk gradually disappears during the course of the 10 years after
cessation of COC use.

Women with hypertriglyceridaemia, or a family history thereof, may
be at an increased risk of pancreatitis when using COCs. Although
small increases in blood pressure have been reported in many women
taking COCs, clinically relevant increases are rare. A relationship
between COC use and clinical hypertension has not been established.
Acute or chronic disturbances of liver function may necessitate the
discontinuation of COC use until markers of liver function return to
normal. Diabetic women should be carefully observed while taking a
COC, especially in the first few months of use.

Women should be advised that oral contraceptives do not protect
against HIV infections (AIDS) and other sexually transmitted
diseases.

With all COCs, irregular bleeding (spotting or breakthrough
bleeding) may occur, especially during the first months of use.

In clinical studies, adverse reactions that were reported by
greater than 10% of users as possibly treatment related included acne
and changes to menstrual periods. In addition 1%-10% of users
reported the following adverse events as possibly treatment related:
decreased interest in sex, depression, headache or migraine, nausea,
heavy menstrual periods, weight gain, breast pain, and pelvic pain.

Before initiating ZOELY treatment, the full prescribing
information should be consulted.

About Teva

Teva Pharmaceutical Industries Ltd. 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 largest generic drug maker, with a
global product portfolio of more than 1,300 molecules and a direct
presence in about 60 countries. Teva's branded businesses focus on
neurological, respiratory and women's health therapeutic areas as
well as biologics. Teva currently employs approximately 42,000 people
around the world and reached $16.1 billion in net sales in 2010.

About Teva Women's Health in Europe

Teva's Women's Health business in Europe was established following
the acquisition of Théramex in January 2010. Teva offers a large
portfolio of products in the areas of gynaecology, osteoporosis,
peri-menopause, menopause and contraceptives, and includes trusted
brand names such as Orocal(R), Colpotrophine(R), Lutenyl(R),
Monazol(R), Estreva(R), Antadys(R) and Leeloo Ge(R), sold primarily
in France and Italy.

About MSD

Today's MSD is a global healthcare leader working to help the
world be well. MSD is a tradename of Merck & Co., Inc., with
headquarters in Whitehouse Station, N.J., U.S.A. Through our
prescription medicines, vaccines, biologic therapies, and consumer
care and animal health products, we work with customers and operate
in more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to healthcare
through far-reaching policies, programs and partnerships.

Teva's SafeHarbor 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 successfully develop and commercialize additional
pharmaceutical products, the introduction of competing generic
equivalents, the extent to which we may obtain U.S. market
exclusivity for certain of our new generic products and regulatory
changes that may prevent us from utilizing exclusivity periods,
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(R), the extent to which any
manufacturing or quality control problems damage our reputation for
high quality production, the effects of competition on sales of our
innovative products, especially Copaxone(R) (including potential
generic and oral competition for Copaxone(R)), the impact of
continuing consolidation of our distributors and customers, our
ability to identify, consummate and successfully integrate
acquisitions (including the acquisition of Cephalon), interruptions
in our supply chain or problems with our information technology
systems that adversely affect our complex manufacturing processes,
intense competition in our specialty pharmaceutical businesses, 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, adverse effects of political or economical
instability, 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,
dependence on the effectiveness of our patents and other protections
for innovative products, our ability to achieve expected results
through our innovative R&D efforts, the difficulty of predicting U.S.
Food and Drug Administration, European Medicines Agency and other
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any failure to retain key personnel or to attract additional
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with the U.S. Securities and Exchange Commission.

Forward-Looking Statement

This news release includes "forward-looking statements" within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. Such statements may
include, but are not limited to, statements about the benefits of the
merger between Merck and Schering-Plough, including future financial
and operating results, the combined company's plans, objectives,
expectations and intentions and other statements that are not
historical facts. Such statements are based upon the current beliefs
and expectations of

Merck's management and are subject to significant risks and
uncertainties. Actual results may differ from those set forth in the
forward-looking statements.

The following factors, among others, could cause actual results to
differ from those set forth in the forward-looking statements: the
possibility that the expected synergies from the merger of Merck and
Schering-Plough will not be realized, or will not be realized within
the expected time period; the impact of pharmaceutical industry
regulation and health care legislation; the risk that the businesses
will not be integrated successfully; disruption from the merger
making it more difficult to maintain business and operational
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changing regulation and health policies in the U.S. and
internationally and the exposure to litigation and/or regulatory
actions.

Merck undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in Merck's 2010 Annual Report
on Form 10-K and the company's other filings with the Securities and
Exchange Commission (SEC) available at the SEC's Internet site
(http://www.sec.gov).

Media Contacts: Ian McConnell Merck/MSD
+1(908)423-3046 Megan Wilkinson Merck/MSD
+1(267)305-6463 Paul Williams Teva Pharmaceuticals
Europe BV +44-7798-582889 Investor Contacts:
Carol Ferguson Merck +1(908)-423-4465 Elana
Holzman Teva +972(3)926-7554

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