Miércoles 22 de Agosto 2018

Teva Announces Launch of Authorized Generic of Minastrin® 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) in the United States

JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced the launch of the Authorized Generic of Minastrin®
24 Fe1 (norethindrone acetate and ethinyl estradiol tablets
and ferrous fumarate tablets) 1 mg/20 mcg in the U.S.

The Authorized Generic of Minastrin® 24 Fe is an
estrogen/progestin combined oral contraceptive indicated for use by
women to prevent pregnancy.

This Authorized Generic of Minastrin® 24 Fe adds to Teva’s
existing portfolio of more than 50 oral contraceptives. In the U.S., one
of every two oral contraceptive prescriptions is filled with a product
marketed by Teva.2

With nearly 600 generic medicines available, Teva has the largest
portfolio of FDA-approved generic products on the market and holds the
leading position in first-to-file opportunities, with over 100 pending
first-to-files in the U.S. Currently, one in six generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.

Minastrin® 24 Fe had annual sales of approximately $361
million in the U.S. according to IMS data as of December 2016.3

About the Authorized Generic of Minastrin®
24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous
fumarate tablets)

INDICATIONS AND USAGE
The Authorized Generic of Minastrin®
24 Fe
is an estrogen/progestin combination oral contraceptive (COC)
indicated for use by females of reproductive age to prevent pregnancy.
Efficacy in women with a body mass index (BMI) of more than 35 kg/m2 has
not been evaluated.

IMPORTANT SAFETY INFORMATION

 
 

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular
events from combination oral contraceptive (COC) use. This risk
increases with age, particularly in women over 35 years of age,
and with the number of cigarettes smoked. For this reason, COCs
should not be used by women who are over 35 years of age and smoke.

 
 

Contraindications
The Authorized Generic of Minastrin®
24 Fe
is contraindicated in pregnant patients, and those with a high
risk of arterial or venous thrombotic diseases, liver tumors (benign or
malignant) or liver disease, undiagnosed abnormal uterine bleeding, or
breast cancer or other estrogen- or progestin-sensitive cancer, now or
in the past.

Warnings and Precautions
Discontinue norethindrone acetate
and ethinyl estradiol tablets and ferrous fumarate tablets if a
thrombotic event occurs, and at least 4 weeks before and through 2 weeks
after major surgery. Norethindrone acetate and ethinyl estradiol tablets
and ferrous fumarate tablets should not be started any earlier than 4
weeks after delivery, in women who are not breastfeeding. If jaundice
occurs, treatment should be discontinued.

The Authorized Generic of Minastrin® 24 Fe
should not be prescribed for women with uncontrolled hypertension or
hypertension with vascular disease. Women who are prediabetic or
diabetic, should be monitored while using the Authorized Generic of
Minastrin
® 24 Fe. Alternate contraceptive
methods should be considered for women with uncontrolled dyslipidemia.
Patients using the Authorized Generic of Minastrin®
24 Fe
who have a significant change in headaches or irregular
bleeding or amenorrhea should be evaluated.

Adverse Reactions
In the clinical trial for the
Authorized Generic of Minastrin
® 24 Fe, the
most common adverse reactions (incidence ≥2%) were headache, vaginal
candidiasis, nausea, menstrual cramps, breast tenderness, bacterial
vaginitis, abnormal cervical smear, acne, mood swings, and weight gain.

Patients should be counseled that COCs do not protect against HIV
infection (AIDS) and other sexually transmitted diseases.

Please
see full Prescribing Information, including Boxed Warning
.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200 million
patients in 100 markets every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its portfolio of
more than 1,800 molecules to produce a wide range of generic products in
nearly every therapeutic area. In specialty medicines, Teva has the
world-leading innovative treatment for multiple sclerosis as well as
late-stage development programs for other disorders of the central
nervous system, including movement disorders, migraine, pain and
neurodegenerative conditions, as well as a broad portfolio of
respiratory products. Teva is leveraging its generics and specialty
capabilities in order to seek new ways of addressing unmet patient needs
by combining drug development with devices, services and technologies.
Teva’s net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.

Teva’s Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:

This press release contains forward-looking statements, which are
based on management’s current beliefs and expectations and are subject
to substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to differ
significantly from that expressed or implied by such forward-looking
statements. Important factors that could cause or contribute to such
differences include risks relating to:

  • our generics medicines business, including: that we are
    substantially more dependent on this business, with its significant
    attendant risks, following our acquisition of Actavis Generics; our
    ability to realize the anticipated benefits of the acquisition (and
    any delay in realizing those benefits) or difficulties in integrating
    Actavis Generics; the increase in the number of competitors targeting
    generic opportunities and seeking U.S. market exclusivity for generic
    versions of significant products; price erosion relating to our
    generic products, both from competing products and as a result of
    increased governmental pricing pressures; and our ability to take
    advantage of high-value biosimilar opportunities;
  • our specialty medicines business, including: competition for our
    specialty products, especially Copaxone
    ®, our
    leading medicine, which faces competition from existing and potential
    additional generic versions and orally-administered alternatives; our
    ability to achieve expected results from investments in our product
    pipeline; competition from companies with greater resources and
    capabilities; and the effectiveness of our patents and other measures
    to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly
    decreased cash on hand, which may limit our ability to incur
    additional indebtedness, engage in additional transactions or make new
    investments, and may result in a downgrade of our credit ratings;
  • our business and operations in general, including: uncertainties
    relating to our recent senior management changes; our ability to
    develop and commercialize additional pharmaceutical products;
    manufacturing or quality control problems, which may damage our
    reputation for quality production and require costly remediation;
    interruptions in our supply chain; disruptions of our information
    technology systems or breaches of our data security; the failure to
    recruit or retain key personnel, including those who joined us as part
    of the Actavis Generics acquisition; the restructuring of our
    manufacturing network, including potential related labor unrest; the
    impact of continuing consolidation of our distributors and customers;
    variations in patent laws that may adversely affect our ability to
    manufacture our products; adverse effects of political or economic
    instability, major hostilities or terrorism on our significant
    worldwide operations; and our ability to successfully bid for suitable
    acquisition targets or licensing opportunities, or to consummate and
    integrate acquisitions;
  • compliance, regulatory and litigation matters, including: costs and
    delays resulting from the extensive governmental regulation to which
    we are subject; the effects of reforms in healthcare regulation and
    reductions in pharmaceutical pricing, reimbursement and coverage;
    potential additional adverse consequences following our resolution
    with the U.S. government of our FCPA investigation; governmental
    investigations into sales and marketing practices; potential liability
    for sales of generic products prior to a final resolution of
    outstanding patent litigation; product liability claims; increased
    government scrutiny of our patent settlement agreements; failure to
    comply with complex Medicare and Medicaid reporting and payment
    obligations; and environmental risks;
  • other financial risks, including: our exposure to currency
    fluctuations and restrictions as well as credit risks; the significant
    increase in our intangible assets, which may result in additional
    substantial impairment charges; potentially significant increases in
    tax liabilities; and the effect on our overall effective tax rate of
    the termination or expiration of governmental programs or tax
    benefits, or of a change in our business;

and other factors discussed in our Annual Report on Form 20-F for the
year ended December 31, 2016 (“Annual Report”) and in our other filings
with the U.S. Securities and Exchange Commission (the “SEC”).
Forward-looking statements speak only as of the date on which they are
made, and we assume no obligation to update or revise any
forward-looking statements or other information contained herein,
whether as a result of new information, future events or otherwise. You
are advised to consult any additional disclosures we make in our reports
to the SEC on Form 6-K, as well as the cautionary discussion of risks
and uncertainties under “Risk Factors” in our Annual Report. These are
factors that we believe could cause our actual results to differ
materially from expected results. Other factors besides those listed
could also materially and adversely affect us. This discussion is
provided as permitted by the Private Securities Litigation Reform Act of
1995.

__________

1 Minastrin® is a registered trademark of Allergan
Pharmaceuticals International Limited.
2 IMS Health NPA
data as of November 2016.
3 IMS Health NPA data as of
December 2016.

Contacts

Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix
, 215-591-8912
or
Ran Meir,
215-591-3033
or
Israel
Tomer Amitai, 972 (3)
926-7656
or
PR Contacts:
Israel
Iris Beck Codner,
972 (3) 926-7208
or
United States
Denise Bradley,
215-591-8974