Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) announced today the
commercial availability of BENDEKA™, (bendamustine hydrochloride)
injection, a liquid, low-volume (50 mL) and short-time 10-minute
infusion formulation of bendamustine. BENDEKA is approved for the
treatment of patients with chronic lymphocytic leukemia (CLL) and
for the treatment of patients with indolent B-cell non-Hodgkin
lymphoma (NHL) that has progressed during or within six months of
treatment with rituximab or a rituximab-containing regimen.
Efficacy in CLL relative to first-line therapies other than
chlorambucil has not been established.
“With the launch of BENDEKA, Teva furthers our commitment to
providing treatment options for patients with these rare forms of
cancer,” said Paul Rittman, Senior Vice President and General
Manager, Teva Oncology. “We believe BENDEKA represents an important
benefit to both patients and healthcare providers, and are pleased
it is now available. Based on the product profile, we expect
BENDEKA to replace TREANDA® liquid.”
“We are pleased to announce that Teva has shipped Bendeka
injection per our exclusive license agreement with them, and that
the product will be in the hands of health care professionals and
patients alike, as scheduled,” stated Scott Tarriff, President and
Chief Executive Officer of Eagle Pharmaceuticals.
Under a February 2015 exclusive license agreement for BENDEKA,
Teva is responsible for all U.S. commercial activities for the
product including promotion and distribution.
Indications for BENDEKA and TREANDA (bendamustine
hydrochloride) Injection
Indicated for the treatment of patients with chronic lymphocytic
leukemia (CLL). Efficacy relative to first-line therapies other
than chlorambucil has not been established.
Indicated for the treatment of patients with indolent B-cell
non-Hodgkin lymphoma (NHL) that has progressed during or within six
months of treatment with rituximab or a rituximab-containing
regimen.
Important Safety Information for BENDEKA and TREANDA
Contraindication: Patients with a known hypersensitivity
(e.g., anaphylactic and anaphylactoid reactions) to bendamustine.
BENDEKA is also contraindicated in patients with a known
hypersensitivity to polyethylene glycol 400, propylene glycol, or
monothioglycerol.
Myelosuppression: Bendamustine hydrochloride caused
severe myelosuppression (Grade 3-4) in 98% of patients in the two
NHL studies. Three patients (2%) died from myelosuppression-related
adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb),
and neutrophils frequently. Myelosuppression may require dose
delays and/or subsequent dose reductions if recovery to the
recommended values has not occurred by the first day of the next
scheduled cycle.
Infections: Infection, including pneumonia, sepsis,
septic shock, hepatitis and death has occurred. Patients with
myelosuppression following treatment with bendamustine
hydrochloride are more susceptible to infections. Patients treated
with bendamustine hydrochloride are at risk for reactivation of
infections including (but not limited to) hepatitis B,
cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster.
Patients should undergo appropriate monitoring, prophylaxis, and
treatment measures prior to administration.
Anaphylaxis and Infusion Reactions: Infusion reactions to
bendamustine hydrochloride have occurred commonly in clinical
trials. Symptoms include fever, chills, pruritus, and rash. In rare
instances severe anaphylactic and anaphylactoid reactions have
occurred, particularly in the second and subsequent cycles of
therapy. Monitor clinically and discontinue drug for severe (Grade
3-4) reactions. Ask patients about symptoms suggestive of infusion
reactions after their first cycle of therapy. Consider measures to
prevent severe reactions, including antihistamines, antipyretics,
and corticosteroids in subsequent cycles in patients who have
experienced Grade 1 or 2 infusion reactions.
Tumor Lysis Syndrome: Tumor lysis syndrome associated
with bendamustine hydrochloride has occurred. The onset tends to be
within the first treatment cycle of bendamustine hydrochloride and,
without intervention, may lead to acute renal failure and death.
Preventive measures include vigorous hydration and close monitoring
of blood chemistry, particularly potassium and uric acid levels.
There may be an increased risk of severe skin toxicity when
bendamustine hydrochloride and allopurinol are administered
concomitantly.
Skin Reactions: Skin reactions have been reported with
bendamustine hydrochloride treatment including rash, toxic skin
reactions, and bullous exanthema. In a study of bendamustine
hydrochloride (90 mg/m2) in combination with rituximab, one case of
toxic epidermal necrolysis (TEN) occurred. TEN has been reported
for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN,
some fatal, have been reported when bendamustine hydrochloride was
administered concomitantly with allopurinol and other medications
known to cause these syndromes. Where skin reactions occur, they
may be progressive and increase in severity with further treatment.
Monitor patients with skin reactions closely. If skin reactions are
severe or progressive, withhold or discontinue BENDEKA or
TREANDA.
Other Malignancies: There are reports of pre-malignant
and malignant diseases that have developed in patients who have
been treated with bendamustine hydrochloride, including
myelodysplastic syndrome, myeloproliferative disorders, acute
myeloid leukemia, and bronchial carcinoma. The association with
either BENDEKA or TREANDA therapy has not been determined.
Extravasation Injury: Extravasations resulting in
hospitalizations from erythema, marked swelling, and pain have been
reported with bendamustine hydrochloride. Assure good venous access
prior to starting drug infusion and monitor the intravenous
infusion site for redness, swelling, pain, infection, and necrosis
during and after administration of either BENDEKA or TREANDA.
Embryo-fetal Toxicity: Bendamustine hydrochloride can
cause fetal harm when administered to a pregnant woman. Women
should be advised to avoid becoming pregnant while using either
BENDEKA or TREANDA.
Most Common Adverse Reactions:
- The most common non-hematologic adverse
reactions for CLL (frequency ≥15%) are pyrexia, nausea, and
vomiting.
- The most common non-hematologic adverse
reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting,
diarrhea, pyrexia, constipation, anorexia, cough, headache, weight
decreased, dyspnea, rash, and stomatitis.
- The most common hematologic
abnormalities for both indications (frequency ≥15%) are
lymphopenia, anemia, leukopenia, thrombocytopenia, and
neutropenia.
- During BENDEKA infusion and within 24
hours post-infusion, adverse reactions (frequency >5%) are
nausea and fatigue
For BENDEKA Full Prescribing Information, please visit:
http://www.bendeka.com/PrescribingInformation.PDF
For TREANDA Full Prescribing Information, please visit:
http://www.treanda.com/pdf/TREANDA_final_PI.pdf
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)
is a leading global pharmaceutical company that delivers
high-quality, patient-centric healthcare solutions to millions of
patients every day. Headquartered in Israel, Teva is the
world’s largest generic medicines producer, leveraging its
portfolio of more than 1,000 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 2014
amounted to $20.3 billion. For more information,
visit www.tevapharm.com.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on
developing and commercializing injectable products that address the
shortcomings, as identified by physicians, pharmacists and other
stakeholders, of existing commercially successful injectable
products. Eagle’s strategy is to utilize the FDA's 505(b)(2)
regulatory pathway. Additional information is available on the
company’s website at www.eagleus.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® (including competition from
orally-administered alternatives, as well as from generic
equivalents such as the recently launched Sandoz product) and our
ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s
generic business and Rimsa), or to consummate and integrate
acquisitions; 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 the research and development efforts
invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; 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; 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 generic
products, both from other pharmaceutical companies and as a result
of increased governmental pricing pressures; 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, 2014 and
in our other filings with the U.S. Securities and Exchange
Commission.
Eagle’s Forward-Looking Statements:
This press release contains forward-looking information within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended and other securities laws. Forward-looking
statements are statements that are not historical facts. Words such
as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,”
“potentially,” “entitles,” and similar expressions are intended to
identify forward-looking statements. These statements include, but
are not limited to, statements regarding future events including,
but not limited to: difficulties or delays in manufacturing; the
availability and pricing of third party sourced products and
materials, and products licensed to third-parties for promotion and
distribution; successful compliance with FDA and other governmental
regulations applicable to manufacturing facilities, products and/or
businesses; and other factors that are discussed in Eagle’s Annual
Report on Form 10-K for the year ended September 30, 2014, and its
other filings with the U.S. Securities and Exchange Commission. All
of such statements are subject to certain risks and uncertainties,
many of which are difficult to predict and generally beyond Eagle’s
control, that could cause actual results to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. Such risks include, but are not limited
to risks described in Eagle’s filings with the U.S. Securities and
Exchange Commission. Readers are cautioned not to place undue
reliance on these forward-looking statements that speak only as of
the date hereof, and we do not undertake any obligation to revise
and disseminate forward-looking statements to reflect events or
circumstances after the date hereof, or to reflect the occurrence
of or non-occurrence of any events.
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version on businesswire.com: http://www.businesswire.com/news/home/20160128006079/en/
Eagle Pharmaceuticals, Inc:In-Site Communications,
Inc.Lisa M. Wilson, 212-452-2793PresidentorTeva Pharmaceutical
Industries Ltd.IR:Kevin C. Mannix, 215-591-8912United
StatesorRan Meir, 215-591-3033United StatesorTomer Amitai, 972 (3)
926-7656IsraelorPR:Iris Beck Codner, 972 (3) 926-7687IsraelorDenise
Bradley, 215-591-8974United StatesorNancy Leone, 215-284-0213United
States
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