JERUSALEM--(BUSINESS WIRE)--Feb. 20, 2018--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the exclusive launch of two strengths of a generic version of
Solodyn®1 (minocycline HCl) Extended Release Tablets, 65 and
115 mg, in the U.S.
Minocycline Hydrochloride Extended-Release Tablets are a
tetracycline-class drug indicated to treat only inflammatory lesions of
non-nodular moderate to severe acne vulgaris in patients 12 years of age
and older.
“The launch of these two strengths of our generic version of Solodyn®
brings an effective, affordable treatment option to patients who are
managing this condition, and marks our ninth generic medicine in the
tetracycline category,”2 said Brendan O’Grady, Executive Vice
President and Head of North America Commercial at Teva.
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 seven generic prescriptions
dispensed in the U.S. is filled with a Teva generic product.
Solodyn® Extended Release Tablets, 65 and 115 mg, had annual
sales of approximately $148 million in the U.S., according to IMS data
as of December 2017.
About Minocycline Hydrochloride Extended-Release Tablets
Minocycline Hydrochloride Extended-Release Tablets are indicated to
treat only inflammatory lesions of non-nodular moderate to severe acne
vulgaris in patients 12 years of age and older. Limitations of Use:
Minocycline Hydrochloride Extended-Release Tablets did not demonstrate
any effect on non-inflammatory acne lesions. Safety of Minocycline
Hydrochloride Extended-Release Tablets has not been established beyond
12 weeks of use. This formulation of minocycline has not been evaluated
in the treatment of infections. To reduce the development of
drug-resistant bacteria as well as to maintain the effectiveness of
other antibacterial drugs, Minocycline Hydrochloride Extended-Release
Tablets should be used only as indicated.
Important Safety Information
Minocycline Hydrochloride Extended-Release Tablets are contraindicated
in persons who have shown hypersensitivity to any of the tetracyclines.
MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM
WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED
DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE
DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE
FETUS. Minocycline Hydrochloride Extended-Release Tablets should not be
used during pregnancy or by individuals of either gender who are
attempting to conceive a child.
TETRACYCLINE-CLASS DRUGS SHOULD NOT BE USED DURING TOOTH DEVELOPMENT
(LAST HALF OF PREGNANCY AND UP TO 8 YEARS OF AGE) AS THEY MAY CAUSE
PERMANENT DISCOLORATION OF THE TEETH.
Other serious adverse reactions reported with minocycline use or
associated with the use of tetracycline-class drugs include pseudomembranous
colitis; hepatotoxicity; excessive systemic accumulation of drug
and possible liver toxicity in patients with renal impairment; central
nervous system effects, including light-headedness, dizziness or
vertigo; pseudotumor cerebri (benign intracranial hypertension);
autoimmune syndromes; photosensitivity; anaphylaxis, serious skin
reactions (e.g., Stevens Johnson syndrome), erythema multiforme, and
drug rash with eosinophilia and systemic symptoms (DRESS) syndrome;
tissue hyperpigmentation; development of drug-resistant bacteria; and
superinfection.
In clinical trials, the most commonly observed adverse reactions
(incidence ≥ 5%) were headache, fatigue, dizziness, and pruritus.
For more information, please see accompanying Full
Prescribing Information.
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 2017 were $22.4 billion. For more information, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the launch and potential benefits of Teva's generic version of
Solodyn®, 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:
-
commercial success of Teva's generic version of minocycline
hydrochloride extended-release tablets, including due to a potential
launch of an Authorized Generic version;
-
our generics medicines business, including: that we are
substantially more dependent on this business, with its significant
attendant risks, following our acquisition of Allergan plc’s worldwide
generic pharmaceuticals business (“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 business and operations in general, including: uncertainties
relating to the potential benefits and success of our new
organizational structure and recent senior management changes; the
potential success and our ability to effectively execute a
restructuring plan; 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 or third party information technology systems or
breaches of our data security; the failure to recruit or retain key
personnel; 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; and
-
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.
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 cautioned not to rely on these forward-looking statements. 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 Solodyn® is a registered trademark of Valeant
Pharmaceuticals International, Inc.
2 https://www.tevagenerics.com/products/product-search-results?TherapeuticCategory=Tetracyclines
View source version on businesswire.com: http://www.businesswire.com/news/home/20180220006096/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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or
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or
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