Teva Announces Launch of Generic Beyaz® in the United States
JERUSALEM–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the launch of RAJANITM (drospirenone, ethinyl
estradiol and levomefolate calcium tablets, 3 mg/0.02 mg/0.451 mg and
levomefolate calcium tablets, 0.451 mg) in the United States. RAJANITM,
the generic equivalent of Beyaz®1, is an oral contraceptive,
available in a 28-day blister pack dispenser, for use by women to:
- prevent pregnancy;
-
treat symptoms of premenstrual dysphoric disorder (PMDD) in women
choosing to use an oral contraceptive for contraception; -
treat moderate acne for women at least 14 years old if the patient
desires an oral contraceptive for birth control; and -
raise folate levels in women who choose to use an oral contraceptive
for contraception.
Teva is committed to strengthening its generics business through
continued investment in complex, high-quality products. With nearly 600
generic medicines available, Teva has the largest portfolio of
FDA-approved generic products on the market. This product
enhances Teva’s already comprehensive oral contraceptive portfolio.
Teva has over 300 product registrations pending FDA approval 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.
Beyaz® had annual sales of approximately $133 million in the
U.S., according to IMS data as of July 2016.
About RAJANITM
RAJANITM is indicated for
use by women to prevent pregnancy. RAJANITM
does not protect against HIV infection (AIDS) and other sexually
transmitted diseases.
RAJANITM is indicated for
the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in
women who choose to use an oral contraceptive as their method of
contraception. The effectiveness of RAJANITM
for PMDD when used for more than three menstrual cycles has not been
evaluated. Diagnosis is made by healthcare providers according to DSM-IV
criteria, with symptomatology assessed prospectively over at least two
menstrual cycles. In making the diagnosis, care should be taken to rule
out other cyclical mood disorders. RAJANITM
has not been evaluated for the treatment of premenstrual syndrome (PMS).
RAJANITM is indicated for
the treatment of moderate acne vulgaris in women at least 14 years of
age, who have no known contraindications to oral contraceptive therapy
and have achieved menarche. RAJANITM
should be used for the treatment of acne only if the patient desires an
oral contraceptive for birth control.
RAJANITM is indicated in
women who choose to use an oral contraceptive as their method of
contraception, to raise folate levels for the purpose of reducing the
risk of a neural tube defect in a pregnancy conceived while taking the
product or shortly after discontinuing the product.
Important Safety Information
WARNING: Cigarette smoking increases the risk of serious cardiovascular
events from combination oral contraceptives (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.
RAJANITM is
contraindicated in women who are known to have the following: renal
impairment; adrenal insufficiency; a high risk of arterial or venous
thrombotic diseases; undiagnosed abnormal uterine bleeding; breast
cancer or other estrogen- or progestin-sensitive cancer, now or in the
past; liver tumors, benign or malignant, or liver disease; or
pregnancy.
COCs may be associated with a higher risk of venous thromboembolism
(VTE) than COCs containing the progestin levonorgestrel or some other
progestins. Use of COCs also increases the risk of arterial thromboses
such as strokes and myocardial infarctions, especially in women with
other risk factors for these events. RAJANITM
contains 3 mg of the progestin DRSP, which has antimineralocorticoid
activity, including the potential for hyperkalemia in high-risk
patients. Other serious adverse reactions associated with the use of
COCs include: carcinoma of breast or cervix; impaired liver function or
liver tumors; hypertension; gallbladder disease; carbohydrate and lipid
metabolic effects; new or worsening headaches, including migraines;
bleeding irregularities; depression; elevations of binding globulins;
angioedema; and chloasma.
The most frequent adverse reactions (greater than or equal to 2%) in
contraception, acne and folate clinical trials are headache/migraine
(5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and
breast pain/tenderness (3.2%).
The most frequent adverse reactions (greater than or equal to 2%) in
PMDD clinical trials are menstrual irregularities (24.9%), nausea
(15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%),
irritability (2.8%), decreased libido (2.8%), increased weight (2.5%),
and affect lability (2.1%).
For more information, please see accompanying full Prescribing
Information, including the boxed warnings.
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 millions of patients 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 a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva’s net
revenues in 2015 amounted to $19.7 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 release contains forward-looking statements, which 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 specialty products, especially Copaxone® (which
faces competition from orally-administered alternatives and a generic
version); our ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of realizing
such benefits); the fact that following the consummation of the Actavis
Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount of
debt incurred to finance the Actavis Generics acquisition; the fact that
for a period of time following the Actavis Generics acquisition, we will
have significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material fines,
penalties and other sanctions and other adverse consequences arising out
of our ongoing FCPA investigations and related matters; our ability to
achieve expected results from investments in our pipeline of specialty
and other products; our ability to identify and successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; the extent to which any
manufacturing or quality control problems damage our reputation for
quality production and require costly remediation; increased government
scrutiny in both the U.S. and Europe of our patent settlement
agreements; our exposure to currency fluctuations and restrictions as
well as credit risks; the effectiveness of our patents, confidentiality
agreements and other measures to protect the intellectual property
rights of our specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
governmental investigations into sales and marketing practices,
particularly for our specialty pharmaceutical products; adverse effects
of political or economic instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
or breaches of our data security; competition for our specialty
pharmaceutical businesses from companies with greater resources and
capabilities; the impact of continuing consolidation of our distributors
and customers; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; our potential exposure to
product liability claims that are not covered by insurance; any failure
to recruit or retain key personnel, or to attract additional executive
and managerial talent; any failures to comply with complex Medicare and
Medicaid reporting and payment obligations; significant impairment
charges relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting reliance
on access to the capital markets; potentially significant increases in
tax liabilities; 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; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2015 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, whether as a
result of new information, future events or otherwise.
1 Beyaz® is a registered trademark of Bayer
Healthcare.
Contacts
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213
