Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the exclusive launch of a generic version of Reyataz®1
(atazanavir) capsules in the U.S.
Atazanavir sulfate capsules are a protease inhibitor indicated
for use in combination with other antiretroviral agents for the
treatment of HIV-1 infection for patients 6 years and older
weighing at least 15 kg.
“The exclusive launch of our generic version of Reyataz marks
our fifth generic product offering for the treatment of HIV-1
infection,” said Brendan O’Grady, Executive Vice President, North
America Commercial at Teva. “Antiviral medications continue to be a
focus for Teva Generics, and this is an important addition to our
portfolio.”
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.
Reyataz® had annual sales of approximately $402 million in the
U.S., according to IMS data as of October 2017.
About Atazanavir Sulfate Capsules
Atazanavir sulfate capsules are indicated in combination with
other antiretroviral agents for the treatment of HIV-1 infection
for patients 6 years and older weighing at least 15 kg. Limitations
of Use: Atazanavir is not recommended for use in pediatric patients
below the age of 3 months due to the risk of kernicterus. Use of
atazanavir/ritonavir in treatment-experienced patients should be
guided by the number of baseline primary protease inhibitor
resistance substitutions.
Important Safety Information
Atazanavir sulfate capsules are contraindicated:
- in patients with previously
demonstrated clinically significant hypersensitivity (e.g.,
Stevens-Johnson syndrome, erythema multiforme, or toxic skin
eruptions) to any of the components of atazanavir sulfate
capsules.
- when coadministered with drugs that are
highly dependent on CYP3A or UGT1A1 for clearance, and for which
elevated plasma concentrations of the interacting drugs are
associated with serious and/or life-threatening events.
- when coadministered with drugs that
strongly induce CYP3A and may lead to lower exposure and loss of
efficacy of atazanavir sulfate.
Atazanavir sulfate has been shown to prolong the PR interval of
the electrocardiogram. In healthy volunteers and in patients,
abnormalities in atrioventricular (AV) conduction were asymptomatic
and generally limited to first-degree AV block. There have been
reports of second-degree AV block and other conduction
abnormalities.
In controlled clinical trials, rash (all grades, regardless of
causality) occurred in approximately 20% of patients treated with
atazanavir sulfate. Rashes were generally mild-to-moderate
maculopapular skin eruptions. Cases of Stevens-Johnson syndrome,
erythema multiforme, and toxic skin eruptions, including drug rash,
eosinophilia, and systemic symptoms (DRESS) syndrome, have been
reported in patients receiving atazanavir sulfate.
Patients with underlying hepatitis B or C viral infections or
marked elevations in transaminases before treatment may be at
increased risk for developing further transaminase elevations or
hepatic decompensation. Chronic kidney disease in HIV-infected
patients treated with atazanavir, with or without ritonavir, has
been reported during postmarketing surveillance. Cases of
nephrolithiasis and/or cholelithiasis have been reported during
postmarketing surveillance in HIV-infected patients receiving
atazanavir sulfate therapy.
Initiation of medications that inhibit or induce CYP3A may
increase or decrease concentrations of atazanavir sulfate with
ritonavir, respectively. These interactions may lead to:
- clinically significant adverse
reactions potentially leading to severe, life-threatening, or fatal
events from greater exposures of concomitant medications.
- clinically significant adverse
reactions from greater exposures of atazanavir sulfate with
ritonavir.
- loss of therapeutic effect of
atazanavir sulfate with ritonavir and possible development of
resistance.
Other possible serious adverse reactions include
hyperbilirubinemia; diabetes mellitus/hyperglycemia; immune
reconstitution syndrome; redistribution/accumulation of body fat;
and hemophilia. Various degrees of cross-resistance among protease
inhibitors have been observed.
The most common adverse reactions (≥ 2%) in clinical trials were
nausea, jaundice/scleral icterus, rash, headache, abdominal pain,
vomiting, insomnia, peripheral neurologic symptoms, dizziness,
myalgia, diarrhea, depression, and fever.
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 approximately 200
million patients in 60 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.
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 Reyataz®, 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 atazanavir sulfate;
- 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 Reyataz® is a registered trademark of Bristol-Myers Squibb
Company
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version on businesswire.com: http://www.businesswire.com/news/home/20171227005094/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesElizabeth DeLuca, 484-612-5407
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