–Eagle’s bendamustine 500mL hydrochloride injectable will be sold as
BELRAPZO beginning June 3, 2019–
WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (Nasdaq:EGRX)
today announced that the Centers for Medicare & Medicaid Services (CMS)
has established a unique, product-specific billing code, or J-code
(J9036), for BELRAPZO™ (bendamustine 500mL
hydrochloride injection). The J-code will become effective on July 1,
2019. Eagle’s bendamustine 500mL hydrochloride injectable will be sold
as BELRAPZO beginning June 3, 2019.
“We launched our 500mL bendamustine hydrochloride injection, to address
the need in the market for our unique formulation at a lower price
point. The new J-code provides reimbursement coding clarity to
outpatient facilities and physicians that will administer BELRAPZO,
facilitating access for patients, and Medicare, Medicaid and commercial
insurance reimbursement,” said Scott Tarriff, Chief Executive Officer of
Eagle Pharmaceuticals.
About BELRAPZO
Indications
BELRAPZO 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.
BELRAPZO 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: BELRAPZO is contraindicated in patients with a history
of a hypersensitivity reaction to bendamustine, polyethylene glycol 400,
propylene glycol, or monothioglycerol. Reactions to bendamustine
hydrochloride have included anaphylaxis and anaphylactoid reactions.
Myelosuppression: Delay or reduce dose. Restart treatment based on ANC
and platelet count recovery. Complications of myelosuppression may lead
to death.
Infections: Monitor for fever and other signs of infection or
reactivation of infections and treat promptly.
Anaphylaxis and Infusion Reactions: Severe anaphylactic reactions have
occurred. Monitor clinically and discontinue bendamustine hydrochloride.
Pre-medicate in subsequent cycles for milder reactions.
Tumor Lysis Syndrome: Acute renal failure and death; anticipate and use
supportive measures.
Skin Reactions: Discontinue for severe skin reactions. Cases of SJS,
DRESS and TEN, some fatal, have been reported.
Hepatotoxicity: Monitor liver chemistry tests prior to and during
treatment.
Other Malignancies: Pre-malignant and malignant diseases have been
reported.
Extravasation Injury: Assure good venous access and monitor infusion
site during and after administration.
Embryo-fetal toxicity: Fetal harm can occur when administered to a
pregnant woman. Women should be advised to avoid becoming pregnant when
receiving bendamustine hydrochloride.
Most Common Adverse Reactions:
-
- Most common non-hematologic adverse reactions for CLL (frequency ≥15%)
are pyrexia, nausea, and vomiting.
- Most common non-hematologic adverse reactions for CLL (frequency ≥15%)
-
- 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 non-hematologic adverse reactions for NHL (frequency ≥15%)
-
- Most common hematologic abnormalities (frequency ≥15%) are
lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.
- Most common hematologic abnormalities (frequency ≥15%) are
For BELRAPZO Full Prescribing Information, please visit:
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.
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 and phrases such as
“will,” “expected,” “we believe,” “committed,” “plan,” “promise,” “may,”
“enables,” “potential,” and similar expressions are intended to identify
forward-looking statements. These statements include, but are not
limited to, statements regarding future events, including: the Company’s
plans with respect to the commercial availability of BELRAPZO; the
timing of effectiveness of the J-Code for BELRAPZO; the ability of the
J-Code to provide reimbursement clarity; and the Company’s plans and
ability to successfully commercialize BELRAPZO. All 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: whether the Company will incur
unforeseen expenses or liabilities or other market factors; whether the
Company can successfully advance BELRAPZO for the treatment of patients
with chronic lymphocytic leukemia and for the treatment of patients with
indolent B-cell non-Hodgkin lymphoma that has progressed during or
within six months of treatment with rituximab or a rituximab-containing
regimen; difficulties or delays in manufacturing; whether the Company
can continue to price BEPRAPZO competitively; the effect of competitive
factors and Eagle’s reactions to those factors; the pace and extent of
market adoption of Eagle’s products and technologies; uncertainty in the
process of obtaining regulatory approval or clearance for Eagle’s
products; the success of Eagle’s growth strategies; timing and
achievement of product development milestones; the outcome of ongoing or
future litigation; the impact and benefits of market development;
Eagle’s ability to protect its intellectual property; dependence upon
third parties; unexpected new data, safety and technical issues; market
conditions; other risks inherent to drug development and
commercialization; and other 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.
Contacts
Investor Relations for Eagle Pharmaceuticals, Inc.:
Lisa M.
Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com