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JERUSALEM--(BUSINESS WIRE)--Dec. 15, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the exclusive launch of a generic version of 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 our generic version of Viread® is an
important addition to our portfolio; but, more importantly, it brings an
effective, affordable treatment option to these patients in an area
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
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
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.
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,
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:
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 Viread® is a registered trademark of Gilead
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Source: Teva Pharmaceutical Industries Ltd.
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