Decision solely based on published academic
data endorsing the benefit of Trisenox® as first
chemotherapy-free treatment for APL and marks important advancement
for patients in Europe
- EU Commission grants an extension of
indication to first line use of Trisenox® in combination with
retinoic acid
- APL0406 study revealed a 99% overall
survival rate in low to intermediate risk APL patients with first
line treatment with Trisenox® in combination with retinoic
acid1
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced it has obtained approval from the European Commission for
an indication extension of Trisenox® (arsenic trioxide). This marks
an important advancement in treatment for Acute Promyelocytic
Leukemia (APL) patients in Europe, as it is the first time that a
form of acute leukemia can be effectively treated with a regimen
that is entirely chemotherapy-free. APL is a rare and aggressive
type of acute leukemia that can kill within hours or days if left
untreated2. Trisenox®, in combination with retinoic acid, has shown
a 99% overall survival rate with almost no relapses after more than
four years (50 months) of median follow-up1.
“Teva is committed to providing wider access to high-quality
medicines to ensure more people can benefit from the treatments
they need. We’re very pleased by this decision of the European
Commission, and we look forward to offering a chemotherapy-free
treatment option for all newly diagnosed APL patients,” said Rob
Koremans, MD, President & CEO, Teva Global Specialty
Medicines.
The decision by the European Commission, which follows a
positive recommendation from the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) on
October 13, grants marketing authorization for first line use of
Trisenox® in the 28 countries of the European Union. The indication
extension is for newly diagnosed low to intermediate risk Acute
Promyelocytic Leukemia (APL) in combination with retinoic acid.
Today’s announcement points to a recognition by the European
Commission that treating low to intermediate risk APL with a
chemo-free regimen of Trisenox® plus retinoic acid can increase
survival rates, dramatically reduce the risk of relapse, and help
avoid chemotherapy-related side effects, such as the risk of
life-threatening infections.
Welcoming the approval, 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 approval by the
European Commission is good news for APL patients as we now have
access to a cure for an acute leukemia without using chemotherapy.
Moreover, this decision is a very positive endorsement by the
European Commission, as it was made based solely on published
academic research and studies. From now on, APL patients with
non-high risk disease will have access to this chemotherapy-free
regimen of Trisenox® plus retinoic acid at diagnosis, which has the
potential to increase survival rates while minimizing side effects
associated with chemotherapy.”
In Europe, approximately 1,500 to 2,000 people are diagnosed
with APL each year3. APL, a life-threatening form of leukemia, can
cause uncontrollable bleeding leading rapidly to death if left
untreated2. The rapid progression of APL leading to early mortality
is a substantial problem, affecting up to 30% of patients4. Rapid
diagnosis and commencement of treatment is essential to avoid early
mortality2,5.
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 5% to 10% of patients initially diagnosed with AML
present with the aggressive sub-type of the condition, APL6.
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 most important lethal bleeding
sites are pulmonary (35%) and intracranial (65%)7. The abnormal
bleeding and bruising occur because leukemic blasts produce
anticoagulant factors and substances are released that cause
excessive blood clotting, leading as a consequence 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 mid-408,9 for APL patients and 67
for AML patients10), 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 observed11.
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
study1. 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.
References:
1. Journal of Clinical Oncology, July 11, 2016 as
10.1200/JCO.2016.67.1982.Improved Outcomes With Retinoic Acid and
Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in
Non–High-Risk Acute Promyelocytic Leukemia: Final Results of the
Randomized Italian-German APL0406 Trial. Professor Uwe Platzbecker
et al. http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2016.67.1982
2. Coombs CC, et al. Blood Cancer J. 2015;5,e304.
3. Sant M, Allemani C, Tereanu C, De Angelis R, Capocaccia R,
Visser O, et al. Incidence of hematologic malignancies in Europe by
morphologic subtype: results of the HAEMACARE project. Blood
2010;116(19):3724-34.
4. Lehmann S, Ravn A, Carlsson L, et al. Continuing high early
death rate in acute promyelocytic leukemia: a population based
report from the Swedish Adult Acute Leukemia Registry. Leukemia
2011;25:1128–34
5. Lo-Coco F. Blood. 2011;118:1188-9
6. Cicconi L, Lo-Coco F. Ann Oncol. 2016;27:1847-81
7. De la Serna J, et al. Blood. 2008;111:3395-402
8. Howlader N, Noone AM, Krapcho M, et al, eds. SEER Cancer
Statistics Review, 1975-2012, National Cancer Institute. Bethesda,
MD. http://seer.cancer.gov/csr/1975_2012/, based on November 2014
SEER data submission, posted to the SEER web site, April 2015.
Accessed June 8, 2016.
9. Lo-Coco F, Cicconi L, Breccia M. Current standard treatment
of adult acute promyelocytic leukaemia. Br J Haematol. 2015.
doi.10.1111.bjh.13890.
10. National Cancer Institute SEER Stat Factsheet Acute
Promyelocytic Leukemia
http://seer.cancer.gov/statfacts/html/amyl.html accessed 16 Nov
2016
11. Soignet SL, et al. J Clin Oncol. 2001;19:3852-3860.
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 were $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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IR:Kevin C. Mannix, (215) 591-8912United StatesorRan
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926-7656IsraelorPR:Iris Beck Codner, 972 (3)
926-7687IsraelorDenise Bradley, (215) 591-8974United
StatesorPaul Williams, +31 (0)20 2193 312Europe
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