Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva
Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today
announced the availability of the first Food and Drug
Administration (FDA)-approved generic versions of TRUVADA®i and
ATRIPLA®i tablets.
“As the global leader in producing and supplying generics, Teva
is excited to launch these medications which further our commitment
to delivering more treatment options to patients,” said Brendan
O’Grady, Executive Vice President, North America Commercial, Teva.
“These products, in addition to our more than 10 HIV-related
medications already on the World Health Organization’s Essential
Medicines list, represent Teva’s continued pursuit of treatments
for HIV to improve health outcomes for the HIV community. During
the COVID-19 pandemic, access to treatment is more essential than
ever for those who are immunocompromised and at risk of developing
more severe disease.”
With 1.2 million people currently living with HIV-1 in the U.S.,
Teva is committed to increasing access to critical HIV therapies.ii
Despite significant advances in the treatment and prevention of HIV
over the last two decades, there are still 12.6 million people
globally who are unable to obtain treatment today.iii With the
introduction of these new generic HIV treatment options, Teva
strives to further increase access to important therapies.
These newly available generic medicines are indicated for:
- Emtricitabine and Tenofovir Disoproxil
Fumarate Tablets:
- Treatment of HIV-1 infection when used with other anti-HIV-1
medicines in adults and children who weigh at least 37 pounds (at
least 17 kilograms)
- HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of
getting HIV-1 infection in adults and adolescents who weigh at
least 77 pounds (at least 35 kilograms)
- Efavirenz, Emtricitabine and Tenofovir
Disoproxil Fumarate Tablets:
- Treatment of HIV-1 infection in people who weigh at least 88
pounds (40 kilograms), alone as a complete regimen, or in
combination with other anti-HIV-1 medicines
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets and
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Tablets
are both combination treatments available as a single pill with
similar safety profiles to their reference products.
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are
expected to be available through retailers and wholesalers at a
Wholesale Acquisition Cost (WAC) of $48.51 per tablet. Efavirenz,
Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are
expected to be available through retailers and wholesalers at a WAC
of $78.86 per tablet. Actual costs to individual patients and
providers are anticipated to be lower than WAC because WAC does not
account for additional rebates and discounts that may apply.
Savings on out-of-pocket costs may vary depending on the patient’s
insurance payer and eligibility for participation in the assistance
program. More information is available at TevaHIVgenerics.com.
Emtricitabine 200 Mg/Tenofovir Disoproxil Fumarate 300
Mg
IMPORTANT SAFETY INFORMATION
WARNING: POSTTREATMENT ACUTE
EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1
PREEXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1
INFECTION
Severe acute exacerbations of hepatitis
B (HBV) have been reported in HBV-infected individuals who have
discontinued emtricitabine and tenofovir disoproxil fumarate
tablets. Hepatic function should be monitored closely with both
clinical and laboratory follow-up for at least several months in
individuals who are infected with HBV and discontinue emtricitabine
and tenofovir disoproxil fumarate tablets. If appropriate,
anti-hepatitis B therapy may be warranted.
Emtricitabine and tenofovir disoproxil
fumarate tablets used for HIV-1 PrEP must only be prescribed to
individuals confirmed to be HIV-negative immediately prior to
initiating and at least every 3 months during use. Drug-resistant
HIV-1 variants have been identified with use of emtricitabine and
tenofovir disoproxil fumarate tablets for HIV-1 PrEP following
undetected acute HIV-1 infection. Do not initiate emtricitabine and
tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or
symptoms of acute HIV-1 infection are present unless negative
infection status is confirmed.
Contraindications: Emtricitabine and tenofovir disoproxil
fumarate tablets for HIV-1 PrEP is contraindicated in individuals
with unknown or positive HIV-1 status.
Severe Acute Exacerbation of Hepatitis B in Individuals with
HBV Infection: All individuals should be tested for the
presence of chronic hepatitis B virus (HBV) before or when
initiating emtricitabine and tenofovir disoproxil fumarate tablets.
Severe acute exacerbations of hepatitis B (e.g., liver
decompensation and liver failure) have been reported in
HBV-infected individuals who have discontinued emtricitabine and
tenofovir disoproxil fumarate tablets. Individuals infected with
HBV who discontinue emtricitabine and tenofovir disoproxil fumarate
tablets should be closely monitored with both clinical and
laboratory follow-up for at least several months after stopping
treatment.
Comprehensive Management to Reduce the Risk of Sexually
Transmitted Infections, Including HIV-1, and Development of HIV-1
Resistance When Emtricitabine and Tenofovir Disoproxil Fumarate
Tablets Is Used for HIV-1 PrEP: Use emtricitabine and tenofovir
disoproxil fumarate tablets for HIV-1 PrEP to reduce the risk of
HIV-1 infection as part of a comprehensive prevention strategy that
includes other prevention measures, including adherence to daily
administration and safer sex practices, including condoms, to
reduce the risk of sexually transmitted infections (STIs). The time
from initiation of emtricitabine and tenofovir disoproxil fumarate
tablets for HIV-1 PrEP to maximal protection against HIV-1
infection is unknown.
Use emtricitabine and tenofovir disoproxil fumarate tablets to
reduce the risk of acquiring HIV-1 only in individuals confirmed to
be HIV-negative. HIV-1 resistance substitutions may emerge in
individuals with undetected HIV-1 infection who are taking only
emtricitabine and tenofovir disoproxil fumarate tablets, because
emtricitabine and tenofovir disoproxil fumarate tablets alone does
not constitute a complete regimen for HIV-1 treatment; therefore,
care should be taken to minimize the risk of initiating or
continuing emtricitabine and tenofovir disoproxil fumarate tablets
before confirming the individual is HIV-1 negative. While using
emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1
PrEP, HIV-1 testing should be repeated at least every 3 months, and
upon diagnosis of any other STIs.
Counsel HIV-1uninfected individuals to strictly adhere to the
once daily emtricitabine and tenofovir disoproxil fumarate tablets
dosing schedule. The effectiveness of emtricitabine and tenofovir
disoproxil fumarate tablets in reducing the risk of acquiring HIV-1
is strongly correlated with adherence, as demonstrated by
measurable drug levels in clinical trials of emtricitabine and
tenofovir disoproxil fumarate tablets for HIV-1 PrEP. Some
individuals, such as adolescents, may benefit from more frequent
visits and counseling to support adherence.
New Onset or Worsening Renal Impairment: Emtricitabine
and tenofovir are principally eliminated by the kidney. Renal
impairment, including cases of acute renal failure and Fanconi
syndrome (renal tubular injury with severe hypophosphatemia), has
been reported with the use of TDF, a component of emtricitabine and
tenofovir disoproxil fumarate tablets. Emtricitabine and tenofovir
disoproxil fumarate tablets should be avoided with concurrent or
recent use of a nephrotoxic agent (e.g., high-dose or multiple
non-steroidal anti-inflammatory drugs [NSAIDs]). Cases of acute
renal failure after initiation of high-dose or multiple NSAIDs have
been reported in HIV-infected patients with risk factors for renal
dysfunction who appeared stable on TDF. Some patients required
hospitalization and renal replacement therapy. Alternatives to
NSAIDs should be considered, if needed, in patients at risk for
renal dysfunction.
Immune Reconstitution Syndrome: Immune reconstitution
syndrome has been reported in HIV-1 infected patients treated with
combination antiretroviral therapy, including emtricitabine and
tenofovir disoproxil fumarate tablets.
Bone Loss and Mineralization Defects: In clinical trials
in HIV-1 infected adults and in a clinical trial of HIV-1
uninfected individuals, TDF (a component of emtricitabine and
tenofovir disoproxil fumarate tablets) was associated with slightly
greater decreases in bone mineral density (BMD) and increases in
biochemical markers of bone metabolism, suggesting increased bone
turnover relative to comparators. Serum parathyroid hormone levels
and 1,25 Vitamin D levels were also higher in subjects receiving
TDF. Assessment of BMD should be considered for adult and pediatric
patients who have a history of pathologic bone fracture or other
risk factors for osteoporosis or bone loss. Cases of osteomalacia
associated with proximal renal tubulopathy, manifested as bone pain
or pain in extremities and which may contribute to fractures, have
been reported in association with TDF use.
Lactic Acidosis/Severe Hepatomegaly with Steatosis:
Lactic acidosis and severe hepatomegaly with steatosis, including
fatal cases, have been reported with the use of nucleoside analogs,
including FTC and TDF, components of emtricitabine and tenofovir
disoproxil fumarate tablets, alone or in combination with other
antiretrovirals.
Risk of Adverse Reactions Due to Drug Interactions: The
concomitant use of emtricitabine and tenofovir disoproxil fumarate
tablets and other drugs may result in known or potentially
significant drug interactions, some of which may lead to possible
clinically significant adverse reactions from greater exposures of
concomitant drugs. Consider the potential for drug interactions
prior to and during therapy with emtricitabine and tenofovir
disoproxil fumarate tablets; review concomitant medications during
therapy with emtricitabine and tenofovir disoproxil fumarate
tablets; and monitor for adverse reactions associated with the
concomitant drugs.
Pregnancy: There is an Antiretroviral Pregnancy Registry
that monitors pregnancy outcomes in women exposed to emtricitabine
and tenofovir disoproxil fumarate tablets during pregnancy. Data on
the use of emtricitabine and tenofovir disoproxil fumarate tablets
during pregnancy from observational studies have shown no increased
risk of major birth defects. Available data from the APR show no
significant difference in the overall risk of major birth defects
with first trimester exposure for emtricitabine or tenofovir
disoproxil fumarate compared with the background rate for major
birth defects in a U.S. reference population.
Lactation: Based on published data, FTC and tenofovir
have been shown to be present in human breast milk. Because of the
potential for: HIV transmission (in HIV-negative infants);
developing viral resistance (in HIV-positive infants); and adverse
reactions in a breastfed infant similar to those seen in adults,
instruct mothers not to breastfeed if they are taking emtricitabine
and tenofovir disoproxil fumarate tablets for the treatment of
HIV-1. In HIV-uninfected women, the developmental and health
benefits of breastfeeding and the mother’s clinical need for
emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1
PrEP should be considered along with any potential adverse effects
on the breastfed child from emtricitabine and tenofovir disoproxil
fumarate tablets and the risk of HIV-1 acquisition due to
nonadherence and subsequent mother to child transmission.
Common Adverse Reactions: In clinical trials, the most
common adverse reactions (incidence greater than or equal to 10%,
all grades) in HIV-1 infected subjects included diarrhea, nausea,
fatigue, headache, dizziness, depression, insomnia, abnormal
dreams, and rash. In HIV-1 uninfected adults in PrEP trials,
adverse reactions that were reported by more than 2% of
participants and more frequently than by placebo participants were
headache, abdominal pain, and decreased weight.
Please see full Prescribing Information, including Boxed
Warning.
Efavirenz 600 Mg/Emtricitabine 200 Mg/Tenofovir Disoproxil
Fumarate 300 Mg
IMPORTANT SAFETY INFORMATION
WARNING: POSTTREATMENT ACUTE
EXACERBATION OF HEPATITIS B
Severe acute exacerbations of hepatitis
B virus (HBV) have been reported in patients who are coinfected
with HIV-1 and HBV and have discontinued products containing
emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and
may occur with discontinuation of efavirenz, emtricitabine and
tenofovir disoproxil fumarate tablets.
Closely monitor hepatic function with
both clinical and laboratory follow-up for at least several months
in patients who are coinfected with HIV-1 and HBV and discontinue
efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets.
If appropriate, initiation of anti-hepatitis B therapy may be
warranted.
Contraindications: Efavirenz, emtricitabine and tenofovir
disoproxil fumarate tablets are contraindicated in patients with
previously demonstrated clinically significant hypersensitivity
(e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin
eruptions) to efavirenz, a component of efavirenz, emtricitabine
and tenofovir disoproxil fumarate tablets.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate
tablets are contraindicated to be coadministered with voriconazole
or elbasvir/grazoprevir.
Severe Acute Exacerbation of Hepatitis B in Patients
Coinfected with HIV-1 and HBV
All patients should be tested for the presence of chronic HBV
before or when initiating antiretroviral therapy. Severe acute
exacerbations of hepatitis B (e.g., liver decompensation and liver
failure) have been reported in patients who are coinfected with HBV
and HIV-1 and have discontinued FTC or TDF, two of the components
of efavirenz, emtricitabine and tenofovir disoproxil fumarate
tablets. Patients who are coinfected with HIV-1 and HBV should be
closely monitored, with both clinical and laboratory follow-up for
at least several months after stopping treatment with efavirenz,
emtricitabine and tenofovir disoproxil fumarate tablets. If
appropriate, initiation of antihepatitis B therapy may be
warranted, especially in patients with advanced liver disease or
cirrhosis, since posttreatment exacerbation of hepatitis may lead
to hepatic decompensation and liver failure.
Rash
In controlled clinical trials, 26% of adult subjects treated
with 600 mg EFV experienced new-onset skin rash compared with 17%
of those treated in control groups. Rashes are usually
mild-to-moderate maculopapular skin eruptions that occur within the
first 2 weeks of initiating therapy with EFV and, in most subjects
continuing therapy with EFV, rash resolves within 1 month.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets
should be discontinued in patients developing severe rash
associated with blistering, desquamation, mucosal involvement, or
fever. For patients who have had a life-threatening cutaneous
reaction (e.g., Stevens-Johnson syndrome), alternative therapy
should be considered.
Rash was reported in 32% of pediatric subjects treated with EFV.
The median time to onset of rash in pediatric subjects was 28 days.
Prophylaxis with appropriate antihistamines before initiating
therapy with efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets in pediatric patients should be considered.
Hepatotoxicity
Postmarketing cases of hepatitis, including fulminant hepatitis
progressing to liver failure requiring transplantation or resulting
in death, have been reported in patients treated with EFV, a
component of efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate
tablets are not recommended for patients with moderate or severe
hepatic impairment. Careful monitoring is recommended for patients
with mild hepatic impairment receiving efavirenz, emtricitabine and
tenofovir disoproxil fumarate tablets.
Monitoring of liver enzymes before and during treatment is
recommended for all patients. Consider discontinuing efavirenz,
emtricitabine and tenofovir disoproxil fumarate tablets in patients
with persistent elevations of serum transaminases to greater than
five times the upper limit of the normal range.
Discontinue efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets if elevation of serum transaminases is accompanied
by clinical signs or symptoms of hepatitis or hepatic
decompensation.
Risk of Adverse Reactions or Loss of Virologic Response Due
to Drug Interactions
The concomitant use of efavirenz, emtricitabine and tenofovir
disoproxil fumarate tablets and other drugs may result in
potentially significant drug interactions, some of which may lead
to:
- Loss of therapeutic effect of concomitant drug or efavirenz,
emtricitabine and tenofovir disoproxil fumarate tablets and
possible development of resistance.
- Possible clinically significant adverse reaction from greater
exposures of efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets or concomitant drug.
QTc prolongation has been observed with the use of EFV. Consider
alternatives to efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets when coadministered with a drug with a known risk
of Torsade de Pointes or when administered to patients at higher
risk of Torsade de Pointes.
Psychiatric Symptoms
Serious psychiatric adverse experiences have been reported in
patients treated with EFV, a component of efavirenz, emtricitabine
and tenofovir disoproxil fumarate tablets including severe
depression, suicidal ideation, nonfatal suicide attempts,
aggressive behavior, paranoid reactions, and manic reactions.
Patients with serious psychiatric adverse experiences should
seek immediate medical evaluation to assess the possibility that
the symptoms may be related to the use of EFV, and if so, to
determine whether the risks of continued therapy outweigh the
benefits.
Nervous System Symptoms
Fifty-three percent of subjects receiving EFV in controlled
trials reported central nervous system symptoms (any grade,
regardless of causality) compared to 25% of subjects receiving
control regimens. These symptoms included dizziness, insomnia,
impaired concentration, somnolence, abnormal dreams, and
hallucinations. Other reported symptoms were euphoria, confusion,
agitation, amnesia, stupor, abnormal thinking, and
depersonalization. Patients should be informed that these common
symptoms were likely to improve with continued therapy and were not
predictive of subsequent onset of the less frequent psychiatric
symptoms.
Late-onset neurotoxicity, including ataxia and encephalopathy
(impaired consciousness, confusion, psychomotor slowing, psychosis,
delirium), may occur months to years after beginning EFV therapy.
Patients presenting with signs and symptoms of serious neurologic
adverse experiences should be evaluated promptly to assess the
possibility that these events may be related to EFV use, and
whether discontinuation of efavirenz, emtricitabine and tenofovir
disoproxil fumarate tablets is warranted.
Patients receiving efavirenz, emtricitabine and tenofovir
disoproxil fumarate tablets should be alerted to the potential for
additive central nervous system effects when efavirenz,
emtricitabine and tenofovir disoproxil fumarate tablets are used
concomitantly with alcohol or psychoactive drugs.
Patients who experience central nervous system symptoms such as
dizziness, impaired concentration, and/or drowsiness should avoid
potentially hazardous tasks such as driving or operating
machinery.
New Onset or Worsening Renal Impairment
Emtricitabine and tenofovir are principally eliminated by the
kidney; however, EFV is not. Renal impairment, including cases of
acute renal failure and Fanconi syndrome (renal tubular injury with
severe hypophosphatemia), has been reported with the use of TDF, a
component of efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets.
Prior to initiation and during use of efavirenz, emtricitabine
and tenofovir disoproxil fumarate tablets, on a clinically
appropriate schedule, assess serum creatinine, estimated creatinine
clearance, urine glucose, and urine protein in all patients. In
patients with chronic kidney disease, also assess serum phosphorus.
Efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets
are not recommended in patients with moderate or severe renal
impairment (estimated creatinine clearance below 50 mL/min).
Efavirenz, emtricitabine and tenofovir disoproxil fumarate
tablets should be avoided with concurrent or recent use of a
nephrotoxic agent (e.g., high-dose or multiple non-steroidal
anti-inflammatory drugs [NSAIDs]). Cases of acute renal failure
after initiation of high-dose or multiple NSAIDs have been reported
in HIV-infected patients with risk factors for renal dysfunction
who appeared stable on TDF. Alternatives to NSAIDs should be
considered, if needed, in patients at risk for renal
dysfunction.
Persistent or worsening bone pain, pain in extremities,
fractures, and/or muscular pain or weakness may be manifestations
of proximal renal tubulopathy and should prompt an evaluation of
renal function in patients at risk of renal dysfunction.
Discontinue efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets in patients who develop clinically significant
decreases in renal function or evidence of Fanconi syndrome.
Embryo-Fetal Toxicity
Efavirenz may cause fetal harm when administered during the
first trimester of pregnancy. Advise adults and adolescents of
childbearing potential who are receiving efavirenz, emtricitabine
and tenofovir disoproxil fumarate tablets to avoid pregnancy while
receiving efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets and for 12 weeks after discontinuation.
Bone Loss and Mineralization Defects
Bone Mineral Density
In clinical trials in HIV-1 infected adults, TDF (a component of
efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets)
was associated with slightly greater decreases in bone mineral
density (BMD) and increases in biochemical markers of bone
metabolism, suggesting increased bone turnover relative to
comparators. Serum parathyroid hormone levels and 1,25 Vitamin D
levels were also higher in subjects receiving TDF.
Under normal circumstances, BMD increases rapidly in pediatric
patients. In HIV-1 infected subjects aged 2 years to less than 18
years, bone effects were similar to those observed in adult
subjects and suggest increased bone turnover. Total body BMD gain
was less in the TDF-treated HIV-1 infected pediatric subjects as
compared to the control groups. Similar trends were observed in
chronic hepatitis-B infected adolescent subjects aged 12 years to
less than 18 years.
Mineralization Defects
Cases of osteomalacia associated with proximal renal
tubulopathy, manifested as bone pain or pain in extremities and
which may contribute to fractures, have been reported in
association with TDF use. Arthralgias and muscle pain or weakness
have also been reported in cases of proximal renal tubulopathy.
Hypophosphatemia and osteomalacia secondary to proximal renal
tubulopathy should be considered in patients at risk of renal
dysfunction who present with persistent or worsening bone or muscle
symptoms while receiving TDF-containing products.
Convulsions
Convulsions have been observed in adult and pediatric patients
receiving EFV, generally in the presence of known medical history
of seizures. Caution must be taken in any patient with a history of
seizures.
Lactic Acidosis/Severe Hepatomegaly with Steatosis
Lactic acidosis and severe hepatomegaly with steatosis,
including fatal cases, have been reported with the use of
nucleoside analogs, including TDF and FTC, components of efavirenz,
emtricitabine and tenofovir disoproxil fumarate tablets, alone or
in combination with other antiretrovirals. Treatment with
efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets
should be suspended in any patient who develops clinical or
laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity (which may include hepatomegaly and steatosis even
in the absence of marked transaminase elevations).
Immune Reconstitution Syndrome
Immune reconstitution syndrome has been reported in patients
treated with combination antiretroviral therapy, including the
components of efavirenz, emtricitabine and tenofovir disoproxil
fumarate tablets. During the initial phase of combination
antiretroviral treatment, patients whose immune system responds may
develop an inflammatory response to indolent or residual
opportunistic infections (such as Mycobacterium avium infection,
cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or
tuberculosis), which may necessitate further evaluation and
treatment.
Autoimmune disorders (such as Graves’ disease, polymyositis,
Guillain-Barré syndrome, and autoimmune hepatitis) have also been
reported to occur in the setting of immune reconstitution; however,
the time to onset is more variable, and can occur many months after
initiation of treatment.
Fat Redistribution
Redistribution/accumulation of body fat, including central
obesity, dorsocervical fat enlargement (buffalo hump), peripheral
wasting, facial wasting, breast enlargement, and "cushingoid
appearance," has been observed in patients receiving antiretroviral
therapy, including EFV.
Common Adverse Reactions: In clinical trials, the most
common adverse reactions (incidence greater than or equal to 10%,
any severity) in HIV-1 infected subjects included diarrhea, nausea,
fatigue, headache, dizziness, depression, insomnia, abnormal
dreams, and rash.
Please see full Prescribing Information, including Boxed
Warning.
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 of our generic versions of Truvada®
(emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and
Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg) tablets, 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:
- The commercial success of our generics products portfolio,
including our generic versions of products for prevention and
treatment of HIV-1 in the U.S.;
- our ability to successfully compete in the marketplace,
including: that we are substantially dependent on our generic
products; consolidation of our customer base and commercial
alliances among our customers; the increase in the number of
competitors targeting generic opportunities and seeking U.S. market
exclusivity for generic versions of significant products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and
potential additional generic versions, competing glatiramer acetate
products and orally-administered alternatives; the uncertainty of
commercial success of AJOVY® or AUSTEDO®; competition from
companies with greater resources and capabilities; delays in
launches of new products and our ability to achieve expected
results from investments in our product pipeline; ability to
develop and commercialize biopharmaceutical products; efforts of
pharmaceutical companies to limit the use of generics, including
through legislation and regulations and the effectiveness of our
patents and other measures to protect our intellectual property
rights;
- our substantial indebtedness, which may limit our ability to
incur additional indebtedness, engage in additional transactions or
make new investments, may result in a further downgrade of our
credit ratings; and our inability to raise debt or borrow funds in
amounts or on terms that are favorable to us;
- our business and operations in general, including: uncertainty
regarding the magnitude, duration, and geographic reach of the
COVID-19 pandemic and its impact on our business, financial
condition, operations, cash flows, and liquidity and on the economy
in general; interruptions in our supply chain, including due to
potential effects of the COVID-19 pandemic on our operations and
business in geographic locations impacted by the pandemic and on
the business operations of our customers and suppliers; adequacy of
and our ability to successfully execute and maintain the activities
and efforts related to the measures we have taken or may take in
response to the COVID-19 pandemic and associated costs therewith;
effectiveness of our restructuring plan announced in December 2017;
challenges associated with conducting business globally, including
adverse effects of the COVID-19 pandemic, political or economic
instability, major hostilities or terrorism; our ability to
attract, hire and retain highly skilled personnel; our ability to
develop and commercialize additional pharmaceutical products;
compliance with anti-corruption sanctions and trade control laws;
manufacturing or quality control problems; disruptions of
information technology systems; breaches of our data security;
variations in intellectual property laws; significant sales to a
limited number of customers; our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions; our prospects and
opportunities for growth if we sell assets and potential
difficulties related to the operation of our new global enterprise
resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: our
ability to successfully defend against the DOJ criminal charges of
a Sherman Act violations; increased legal and regulatory action in
connection with public concern over the abuse of opioid medications
in the U.S. and our ability to reach a final resolution of the
remaining opioid-related litigation; costs and delays resulting
from the extensive governmental regulation to which we are subject
or delays in governmental processing time including due to modified
government operations due to the COVID-19 pandemic and effects on
product and patent approvals; the effects of reforms in healthcare
regulation and reductions in pharmaceutical pricing, reimbursement
and coverage; governmental investigations into S&M practices;
potential liability for patent infringement; 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;
- other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential
significant increases in tax liabilities; and the effect on our
overall effective tax rate of the termination or expiration of
governmental programs or tax benefits, or of a change in our
business;
and other factors discussed in our Quarterly Reports on Form
10-Q for the first and second quarters of 2020 and our Annual
Report on Form 10-K for the year ended December 31, 2019, including
in the sections captioned "Risk Factors” and “Forward Looking
Statements.” 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 put undue reliance on
these forward-looking statements.
###
_____________________ i TRUVADA and ATRIPLA are registered
trademarks of Gilead Sciences, Inc. ii Minority HIV/AIDS Fund. Fast
Facts. HIV.gov.
https://www.hiv.gov/hiv-basics/overview/data-and-trends/statistics#:~:text=An%20estimated%201.2%20million%20people,which%20this%20information%20is%20available.
Accessed September 2020. iii HIV.gov. The Global HIV/AIDS Epidemic.
Available:
https://www.hiv.gov/federal-response/pepfar-global-aids/global-hiv-aids-overview#:~:text=HIV%20Treatment%20Access%E2%80%94As%20of,as%20a%20public%20health%20threat.
Accessed August 2020.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201002005067/en/
IR Contacts United States Kevin C. Mannix (215)
591-8912 Yael Ashman 972 (3) 914-8262 PR Contacts United
States Doris Li (973) 265-3752 Israel Yonatan Beker 972
(54) 888 5898
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
From Apr 2023 to Apr 2024