JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Apr. 14, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle
Pharmaceuticals, Inc. (NASDAQ:EGRX) today announce that the New Drug
Application (NDA) for a liquid bendamustine hydrochloride (HCl) rapid
infusion product has been accepted for filing by the U.S. Food and Drug
Administration (FDA). The Prescription Drug User Fee Act (PDUFA) goal
date for a decision on this NDA by the FDA is December 2015.
This NDA requests FDA approval of the rapid infusion bendamustine HCl
product for the treatment of patients with chronic lymphocytic leukemia
(CLL) and 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. This product candidate has received
Orphan Drug Designations for both CLL and indolent B-cell NHL, and
therefore may be eligible for seven years of exclusivity upon approval.
The NDA is supported by data from a clinical trial completed in November
2014, which demonstrated that the rapid infusion bendamustine HCl
product can be administered in ten minutes in a low-volume, 50 mL
admixture.
“The rapid infusion bendamustine product, if approved, will be an
important new treatment option for patients with CLL or indolent B-cell
NHL that has progressed and their healthcare providers,” said Scott
Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
“We look forward to continuing to work closely with the FDA through the
review process, and to their decision on the NDA in December of this
year.”
“We are very pleased the FDA has accepted the rapid infusion
bendamustine NDA for review,” stated Paul Rittman, Vice President and
General Manager, Teva Oncology. “Teva looks forward to the opportunity
to bring this product to market, if approved, and we believe it
represents an important and improved benefit to both patients and
healthcare providers.”
In February 2015, Eagle and Teva Pharmaceutical Industries Ltd. entered
into an exclusive license agreement for the rapid infusion bendamustine
product. Teva will be responsible for all U.S. commercial activities for
the product including promotion and distribution. Eagle has
responsibility for obtaining all regulatory approvals, conducting
post-approval clinical studies, if required, and initially supplying
drug product to Teva.
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. Eagle currently markets RYANODEX®
(dantrolene sodium) in the U.S. for the treatment of malignant
hyperthermia. Additional information is available on the company’s
website at www.eagleus.com.
RYANODEX® is a registered trademark of Eagle Pharmaceuticals,
Inc.
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 innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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; 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; 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. 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 statement, whether as a result of new information,
future events or otherwise.
Eagle's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
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: success in gaining timely FDA approval of the rapid infusion
bendamustine product for the treatment of patients with CLL and patients
with indolent B-cell NHL that has progressed during or within six months
of treatment with rituximab or a rituximab-containing regimen; the
timing and level of success of a future launch of the rapid infusion
bendamustine product by Teva; the success of Eagle’s commercial
arrangement with Teva and the parties’ ability to work effectively
together; difficulties or delays in manufacturing; the availability and
pricing of third party sourced products and materials; 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: whether the FDA will ultimately
approve Eagle’s NDA for the rapid infusion bendamustine product for the
treatment of patients with CLL and patients with indolent B-cell NHL
that has progressed during or within six months of treatment with
rituximab or a rituximab-containing regimen; whether Teva will be
successful at commercializing the rapid infusion bendamustine product;
whether Eagle and Teva will successfully perform each of their
respective obligations under the exclusive license agreement; 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.
Source: Teva Pharmaceutical Industries Ltd. and Eagle Pharmaceuticals, Inc.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C.
Mannix, 215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley,
215-591-8974
United States
or
Nancy Leone,
215-284-0213
United States
or
Eagle Pharmaceuticals,
Inc:
In-Site Communications
Lisa Wilson,
212-452-2793
United States
or
Amy Raskopf,
917-673-5775
United States