- APL – a rare and aggressive type of
acute leukemia – can kill within hours or days if left
untreated
- Results of study APL0406 concluded
there was a 99% overall survival rate in low to intermediate risk
APL patients when receiving 1st line treatment with Trisenox® in
combination with retinoic acid
- CHMP opinion based on existing
published academic data endorsing the benefit of this
chemotherapy-free treatment regimen
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending an indication extension of Trisenox®
(arsenic trioxide). The indication extension is for use in newly
diagnosed low to intermediate risk Acute Promyelocytic Leukemia
(APL) in combination with retinoic acid. Trisenox®, in combination
with retinoic acid, has shown a very high overall survival rate
with almost no relapses after more than four years (50 months) of
median follow-up. If the European Commission approves this label
extension, it would mark the first time that a form of acute
leukemia can be effectively treated with a regimen that is entirely
chemotherapy-free.
APL is a life-threatening type of leukemia as it can cause
uncontrollable bleeding and can kill within hours or days if left
untreated. In Europe, approximately 1,500 to 2,000 people are
diagnosed with APL each year. In light of its rarity, and because
most cases present with low blood cell count and low leukemic cells
in the blood, diagnosis can be difficult. However, the rapid
progression of APL leading to early mortality is a substantial
problem, affecting up to 30% of patients. Rapid diagnosis and
commencement of treatment is essential to avoid early mortality.
Trisenox® is currently indicated for second line treatment of
patients, who have not responded to treatment with retinoids and
chemotherapy, or when their disease has returned after this type of
treatment.
Commenting on the announcement, Francesco Lo-Coco, Professor of
Haematology and Head of the Laboratory of Integrated Diagnosis of
Oncohematologic Diseases, Department of Biomedicine and Prevention,
University of Rome Tor Vergata, Italy said, “This CHMP opinion is
very encouraging. Considering it was based on existing published
academic data only, this opinion points to a recognition by the EMA
that treating low to intermediate risk APL with a chemo-free
regimen of Trisenox® plus retinoic acid can increase survival rates
and dramatically reduce the risk of relapse and
chemotherapy-related side effects in patients suffering from this
rare and aggressive form of leukemia. In particular, avoiding the
risk of life-threatening infection and that of developing secondary
leukemias due to chemotherapy is a great gain for patients. The
success of this regimen represents a major breakthrough and a
paradigm of targeted therapy in oncology and medicine. This is
therefore good news, not only for APL patients, but also for the
whole medical community.”
The CHMP positive opinion is a formal recommendation to grant
marketing authorization for an extended indication for first line
treatment for Trisenox®. The recommendation will now be reviewed by
the European Commission, which has authority to approve medicines
for use in the 28 countries of the European Union along with
Norway, Liechtenstein and Iceland. A final decision by the European
Commission is expected by the end of the year.
In commenting on the CHMP positive opinion, Rob Koremans,
President & CEO, Teva Global Specialty Medicines said, “As a
company committed to providing medicines and solutions that really
make a difference in patients’ lives, we’re pleased to reach this
important milestone, and hope soon to be able to offer a
chemotherapy-free treatment regimen for APL patients at the point
of diagnosis. Recognizing the high unmet patient need in this
orphan disease, we’ve put everything in place to obtain the label
extension for this life-saving treatment. We look forward to
receiving an approval from the European Commission for Trisenox® as
a first line treatment.”
About Acute Promyelocytic Leukemia
Acute Promyelocytic Leukemia is a form of acute myeloid leukemia
(AML), a cancer of the blood-forming tissue (bone marrow).
Approximately 10% to 15% of patients initially diagnosed with AML
present with the aggressive sub-type of the condition, APL.
In normal bone marrow, hematopoietic stem cells produce red
blood cells (erythrocytes) that carry oxygen, white blood cells
(leukocytes) that protect the body from infection, and platelets
(thrombocytes) that are involved in blood clotting. In APL,
immature white blood cells called promyelocytes accumulate in the
bone marrow. The overgrowth of promyelocytes leads to a shortage of
normal white and red blood cells and platelets in the body, which
causes many of the signs and symptoms of the condition.
People with APL are especially susceptible to developing
bruises, small red dots under the skin (petechiae), nosebleeds,
bleeding from the gums, blood in the urine (hematuria), or
excessive menstrual bleeding. The abnormal bleeding and bruising
occur because substances are released that cause excessive blood
clotting, and as a consequence lead to a low number of platelets in
the blood (thrombocytopenia). The low number of red blood cells
(anemia) can cause people with acute promyelocytic leukemia to have
pale skin (pallor) or excessive tiredness (fatigue). In addition,
affected individuals may heal slowly from injuries or have frequent
infections due to the decrease of normal white blood cells that
fight infection. Furthermore, the leukemic cells can expand into
the bones and joints, which may cause pain in those areas. Other
general signs and symptoms may occur as well, such as fever, loss
of appetite, and weight loss.
APL is generally diagnosed in much younger patients than in AML
(the median age is approximately 40 for APL patients and 70 for AML
patients), and can be diagnosed in patients of any age.
About Trisenox®
On 5 March 2002, the European Commission granted approval for
the Marketing Authorization Application (MAA) for Trisenox®. The
authorization, which was valid throughout the European Union (EU),
was granted to treat patients with relapsed or refractory acute
promyelocytic leukemia (APL) and characterized by the presence of
the t(15;17) translocation and/or the presence of the
Pro-Myelocytic Leukaemia/Retinoic-Acid-Receptoralpha (PML/(RARα)
gene. Trisenox®, a targeted drug, degrades the PML- RARα fusion
protein. Trisenox® received marketing authorization in 2000 by the
U.S. Food and Drug Administration.
The marketing approval for Trisenox® was granted based on
results from a multicenter study in which 40 relapsed APL patients
were treated with Trisenox® 0.15 mg/kg until bone marrow remission
or a maximum of 60 days. Thirty-four patients (85 percent) achieved
complete remission after two cycles. When the results for these 40
patients were combined with those for the 12 patients in a pilot
trial, an overall response rate of 87 percent was observed.
1mL of Trisenox® contains 1mg of arsenic trioxide. Trisenox® is
a concentrate for solution for infusion. It is a sterile, clear,
colorless, aqueous solution. Trisenox® must be administered under
the supervision of a physician who is experienced in the management
of acute leukaemias, and special monitoring procedures must be
followed.
Study Results
The APL0406 Intergroup GIMEMA-AMLSG-SAL study was a prospective,
randomized, multicenter, open-label, phase III non-inferiority
study. Eligible patients were adults between 18 and 71 years of age
with newly diagnosed, genetically proven low- or intermediate-risk
APL (WBC at diagnosis ≤ 103 x 109/L). Overall, 276 patients were
randomly assigned to receive ATRA-ATO or ATRA-CHT between October
2007 and January 2013. Of 263 patients evaluable for response to
induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients
achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms,
respectively (P = .12). After a median follow-up of 40.6 months,
the event-free survival, cumulative incidence of relapse, and
overall survival at 50 months for patients in the ATRA-ATO versus
ATRA-CHT arms were 97.3%v 80%, 1.9% v 13.9%, and 99.2% v 92.6%,
respectively (P , .001, P = .0013, and P = .0073,
respectively).
Post-induction events included two relapses and one death in CR
in the ATRA-ATO arm and two instances of molecular resistance after
third consolidation, 15 relapses, and five deaths in CR in the
ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a
therapy-related myeloid neoplasm.
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 millions of patients
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 a
world-leading position in innovative treatments for disorders of
the central nervous system, including pain, as well as a strong
portfolio of respiratory products. Teva integrates its generics and
specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by
combining drug development capabilities with devices, services and
technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which are
based on management’s current beliefs and expectations and involve
a number of known and unknown risks and uncertainties that could
cause our future results, performance or achievements to differ
significantly from the results, performance or achievements
expressed or implied by such forward-looking statements. Important
factors that could cause or contribute to such differences include
risks relating to: our ability to develop and commercialize
additional pharmaceutical products; competition for our specialty
products, especially Copaxone® (which faces competition from
orally-administered alternatives and a generic version); our
ability to integrate Allergan plc’s worldwide generic
pharmaceuticals business (“Actavis Generics”) and to realize the
anticipated benefits of the acquisition (and the timing of
realizing such benefits); the fact that following the consummation
of the Actavis Generics acquisition, we are dependent to a much
larger extent than previously on our generic pharmaceutical
business; potential restrictions on our ability to engage in
additional transactions or incur additional indebtedness as a
result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time
following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could
adversely affect our ability to grow; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters;
our ability to achieve expected results from investments in our
pipeline of specialty and other products; our ability to identify
and successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; the
extent to which any manufacturing or quality control problems
damage our reputation for quality production and require costly
remediation; increased government scrutiny in both the U.S. and
Europe of our patent settlement agreements; our exposure to
currency fluctuations and restrictions as well as credit risks; the
effectiveness of our patents, confidentiality agreements and other
measures to protect the intellectual property rights of our
specialty medicines; the effects of reforms in healthcare
regulation and pharmaceutical pricing, reimbursement and coverage;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability,
major hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with
internal or third-party information technology systems that
adversely affect our complex manufacturing processes; significant
disruptions of our information technology systems or breaches of
our data security; competition for our specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; decreased opportunities to obtain U.S. market
exclusivity for significant new generic products; potential
liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; potentially significant
increases in tax liabilities; 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; variations in
patent laws that may adversely affect our ability to manufacture
our products in the most efficient manner; environmental risks; and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2015 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, whether as a
result of new information, future events or otherwise.
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version on businesswire.com: http://www.businesswire.com/news/home/20161016005040/en/
Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orEuropePaul Williams, +31 (0) 20-2193-312
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