Provides Access for Patients and Streamlined Reimbursement
JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Nov. 2, 2016--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Eagle
Pharmaceuticals, Inc. (Nasdaq: EGRX) announced today that the Centers
for Medicare & Medicaid Services (CMS) has established a unique,
product-specific billing code, or J-code (J9034), for BENDEKA®
(bendamustine hydrochloride) Injection. The J-code will become effective
on January 1, 2017.
The new J-code provides reimbursement coding clarity to outpatient
facilities and physicians that administer BENDEKA, facilitating access
for patients and Medicare, Medicaid and commercial insurance
reimbursement.
“We are pleased that CMS recognized that the unique formulation and
delivery mechanism offered by BENDEKA required separate recognition from
other bendamustine products currently on the market. We expect the new
J-code will provide greater access for patients, facilitate
reimbursement and enable greater adoption of BENDEKA in the market,”
said Scott Tarriff, President and Chief Executive Officer of Eagle
Pharmaceuticals.
“This is an important milestone for Teva as we continue to advance our
bendamustine franchise with BENDEKA,” said Paul Rittman, Senior Vice
President and General Manager, Teva Oncology. “We are committed to
serving patients in need of this important therapy and are pleased that
a unique J-code has been established to assist providers in obtaining
reimbursement for BENDEKA.”
BENDEKA, a liquid, low-volume (50 mL) and short-time (10-minute)
infusion formulation of bendamustine hydrochloride, was approved by the
U.S. Food and Drug Administration (FDA) in December 2015 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.
Under a February 2015 exclusive license agreement for BENDEKA, Teva
Pharmaceutical Industries, Ltd. is responsible for all U.S. commercial
activities for the product including promotion and distribution. BENDEKA
was launched by Teva in late January 2016 and now is the most used
bendamustine product. Please see Important Safety Information below
including contraindication in patients with a known hypersensitivity
(e.g., anaphylactic and anaphylactoid reactions) to bendamustine,
polyethylene glycol 400, propylene glycol, or monothioglycerol.
Indications
BENDEKA is indicated for the treatment of patients with chronic
lymphocytic leukemia (CLL). Efficacy relative to first-line therapies
other than chlorambucil has not been established.
BENDEKA is 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
Contraindication: BENDEKA is contraindicated in patients with a
known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions)
to bendamustine, 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 BENDEKA 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.
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 with –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.
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 BENDEKA 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 BENDEKA.
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 BENDEKA.
Most Common Adverse Reactions:
• Adverse reactions (frequency >5%) during infusion and within 24 hours
post-infusion are nausea and fatigue.
• Most common non-hematologic adverse reactions for CLL (frequency ≥15%)
are pyrexia, nausea, and vomiting.
• 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.
• Most common hematologic abnormalities (frequency ≥15%) are
lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
For BENDEKA Full Prescribing Information, please visit: http://www.bendeka.com/PrescribingInformation.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 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.
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® (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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161102005659/en/
Source: Teva Pharmaceutical Industries Ltd.
For Teva:
IR:
United States
Kevin C. Mannix,
215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974
or
Nancy Leone, 215-284-0213
or
For
Eagle:
United States
Lisa M. Wilson (In-Site
Communications, Inc.), 212-452-2793