Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the exclusive launch of generic Viread®1 (tenofovir
disoproxil fumarate) tablets 300 mg in the U.S.
Tenofovir disoproxil fumarate tablets are a nucleotide analog
HIV-1 reverse transcriptase inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1 infection in
adults and pediatric patients 2 years of age and older.
Additionally, tenofovir disoproxil fumarate tablets are an HBV
reverse transcriptase inhibitor, indicated for the treatment of
chronic hepatitis B in adults and pediatric patients 12 years of
age and older.
“Currently, 1.1 million people in the U.S are living with HIV2
and an estimated 850,000 to 2.2 million have chronic hepatitis B
virus infection,”3 said Brendan O’Grady, Executive Vice President,
North America Commercial at Teva.. “The launch of generic Viread is
an important addition to our portfolio; but, more importantly, it
brings an effective, affordable treatment option to these patients
in an area that’s lacking.”
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.
Viread® had annual sales of approximately $762 million in the
U.S., according to IMS data as of October 2017.
About Tenofovir Disoproxil Fumarate Tablets
Tenofovir disoproxil fumarate tablets are indicated in
combination with other antiretroviral agents for the treatment of
HIV-1 infection in adults and pediatric patients 2 years of age and
older.
Tenofovir disoproxil fumarate tablets are indicated for the
treatment of chronic hepatitis B in adults and pediatric patients
12 years of age and older. The indication in adults is based on
safety and efficacy data from treatment of subjects who were
nucleoside-treatment-naïve and subjects who were
treatment-experienced with documented resistance to lamivudine.
Subjects were adults with HBeAg-positive and HBeAg-negative chronic
hepatitis B with compensated liver disease. Tenofovir disoproxil
fumarate tablets were evaluated in a limited number of subjects
with chronic hepatitis B and decompensated liver disease. The
numbers of subjects in clinical trials who had adefovir
resistance-associated substitutions at baseline were too small to
reach conclusions of efficacy.
Important Safety
InformationSevere acute exacerbations of hepatitis have
been reported in HBV-infected patients who have discontinued
anti-hepatitis B therapy, including tenofovir disoproxil
fumarate.
Renal impairment, including cases of acute renal failure and
Fanconi syndrome (renal tubular injury with severe
hypophosphatemia), has been reported with the use of tenofovir
disoproxil fumarate. Lactic acidosis and severe hepatomegaly with
steatosis, including fatal cases, have been reported with the use
of nucleoside analogs, including tenofovir disoproxil fumarate,
alone or in combination with other antiretrovirals.
Tenofovir disoproxil fumarate tablets should not be used in
combination with other drugs containing tenofovir disoproxil
fumarate or tenofovir alafenamide, including ATRIPLA®, COMPLERA®,
DESCOVY®, GENVOYA®, ODEFSEY®, STRIBILD®, TRUVADA®, or VEMLIDY®.
Tenofovir disoproxil fumarate should not be administered in
combination with HEPSERA® (adefovir dipivoxil).
Due to the risk of development of HIV-1 resistance, tenofovir
disoproxil fumarate should only be used in HIV-1 and HBV coinfected
patients as part of an appropriate antiretroviral combination
regimen. Bone effects, including decreases in bone mineral density
(BMD), increases in biochemical markers of bone metabolism, and
mineralization defects, have been reported in association with the
use of tenofovir disoproxil fumarate. Immune reconstitution
syndrome has been reported in HIV-infected patients treated with
combination antiretroviral therapy, including tenofovir disoproxil
fumarate.
Clinical trials in HIV-infected subjects have demonstrated that
certain regimens that only contain three nucleoside reverse
transcriptase inhibitors (NRTI) are generally less effective than
triple drug regimens containing two NRTIs in combination with
either a non-nucleoside reverse transcriptase inhibitor or a HIV-1
protease inhibitor.
In clinical trials of adult subjects with HIV-1 infection, the
most common adverse reactions (incidence greater than or equal to
10%, Grades 2 to 4) were rash, diarrhea, headache, pain,
depression, asthenia, and nausea. Adverse reactions in pediatric
subjects with HIV-1 infection were consistent with those observed
in adults.
In clinical trials of adult subjects with chronic hepatitis B
and compensated liver disease, the most common adverse reaction
(all grades) was nausea (9%). In a clinical trial of adult subjects
with chronic hepatitis B and decompensated liver disease, the most
common adverse reactions (incidence greater than or equal to 10%,
all grades) were abdominal pain, nausea, insomnia, pruritus,
vomiting, dizziness, and pyrexia. Adverse reactions in pediatric
subjects with chronic hepatitis B were consistent with those
observed in adults.
For more information, please see accompanying Full Prescribing
Information, including Boxed Warning.
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 StatementsThis
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 Viread®, 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 tenofovir disoproxil fumarate, including due to a
potential launch of an Authorized Generic vesrion;
- 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 Viread® is a registered trademark of Gilead Sciences, Inc.
2 https://www.cdc.gov/hiv/statistics/overview/ataglance.html
3 https://www.cdc.gov/hepatitis/hbv/hbvfaq.htm#ref2
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171215005157/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
StatesDenise Bradley, 215-591-8974Kaelan Hollon,
202-412-7076
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Aug 2024 to Sep 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Sep 2023 to Sep 2024