Teva Announces Exclusive Launch of Two Strengths of a Generic Version of Solodyn® in the United States
February 20 2018 - 11:03AM
Business Wire
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
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version on businesswire.com: http://www.businesswire.com/news/home/20180220006096/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, (215) 591-8912Ran Meir, (215)
591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesElizabeth DeLuca, (267) 468-4329
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