Zoek in het archief

Check the original
News breaking: 2017-12-27

Teva Announces Exclusive Launch of a Generic Version of Reyataz® in..

Previous Article
FDA Accepts Biologics License Applicat...
Teva Announces Exclusive Launch of a Generic Version of Reyataz® in the United States
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
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
1 Reyataz® is a registered trademark of
Bristol-Myers Squibb Company
View source version on businesswire.com: http://www.businesswire.com/news/home/20171227005094/en/
Source: Teva Pharmaceutical Industries Ltd.

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
Share on FacebookShare on LinkedIn