Eagle has Submitted NDA for Bendamustine Rapid Infusion to FDA
JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Feb. 17, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Eagle
Pharmaceuticals, Inc. (NASDAQ:EGRX) today announce that the companies
have entered into an exclusive license agreement for EP-3102, Eagle’s
bendamustine hydrochloride (HCl) rapid infusion product for the
treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell
non-Hodgkin lymphoma (NHL). 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.
Eagle has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) 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. Eagle has requested
Priority Review of the NDA; 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 Eagle’s recently-completed clinical trials
demonstrating that the rapid infusion bendamustine HCl product can be
administered in ten minutes in a low-volume, 50 mL admixture.
“Since 2008, Teva’s bendamustine HCl product, TREANDA®, has
played a valuable role in the treatment of patients with CLL or indolent
B-cell NHL that has progressed,” stated Paul Rittman, Vice President and
General Manager, Teva Oncology. “With a substantially shorter infusion
time, Eagle’s rapid infusion bendamustine HCl represents an important
and improved benefit to both patients and healthcare providers. By
adding this product to Teva’s Oncology portfolio, we are furthering our
commitment to enhancing treatment options for patients affected by
cancer and executing on a business development strategy to pursue
opportunities in therapeutic areas where we can apply our expertise,
commercial infrastructure and experience.”
“We are very pleased to partner with Teva for the commercialization of
our rapid infusion bendamustine product,” said Scott Tarriff, President
and Chief Executive Officer of Eagle Pharmaceuticals. “Given their
strong presence and unsurpassed knowledge of this market, we believe
there is no better company than Teva to optimize the market potential of
this product.”
As part of the agreement, Teva will waive its orphan drug exclusivities
for NHL and CLL with respect to EP-3102, which should allow the product
to come to market more quickly. Under the terms of the exclusive license
agreement, Eagle will receive an upfront cash payment of $30 million and
is eligible to receive up to $90 million in additional milestone
payments. In addition, Eagle will receive double-digit royalties on net
sales of the product, assuming FDA approval.
The companies will also settle the pending patent infringement action
between them in the United States District Court for the District of
Delaware involving Teva’s U.S. Patent No. 8,791,270.
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.
TREANDA® (bendamustine HCI) Injection Indications
TREANDA®
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.
TREANDA® 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
-
Allergic Reactions: Patients with a known allergic response to
bendamustine should not take TREANDA®.
-
Serious Side Effects: TREANDA® may cause serious
side effects, including low blood cell counts, infections, unexpected
responses to TREANDA® when placed in your blood, sudden and
severe allergic responses, kidney failure due to fast breakdown of
cancer cells, other cancers, and leaking of TREANDA® out of
your vein and into your surrounding skin. Some of these side effects,
such as low blood counts, infections, and severe allergic skin
responses (when TREANDA® was given with allopurinol and
other medications known to cause severe allergic skin responses), have
caused death. Tell your doctor right away if you have any of these
side effects.
-
Changes in Therapy: Some serious side effects may require
changes in therapy, such as lowering the amount of TREANDA®
given, stopping the use of TREANDA® or waiting longer than
expected between doses of TREANDA®.
-
Pregnancy: Women should avoid becoming pregnant while using
TREANDA® because it may cause fetal harm if you take TREANDA®
while pregnant.
-
Most Common Side Effects: The most common non-blood-related
side effects associated with TREANDA® (occurring in ≥15% of
patients) are nausea, fatigue, vomiting, diarrhea, fever,
constipation, loss of appetite, cough, headache, weight loss,
difficulty breathing, rash, and mouth irritation. The most common
blood-related side effects associated with TREANDA®
(frequency ≥15%) are decreased number of three different types of
white blood cells (infection-fighting cells), low red blood cells
(oxygen-carrying cells), and low platelets (blood-clotting cells).
You are encouraged to report side effects of prescription drugs to the
FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
Please click
here for TREANDA® Full Prescribing Information.
TREANDA® is a registered trademark of Cephalon, Inc., a
wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd.
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 new 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: acceptance for filing by the FDA of the 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; the decision of the FDA on Eagle’s request for Priority Review
for this NDA; 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 accept
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 the FDA will grant
Priority Review of the NDA or whether the FDA will ultimately approve
the NDA, at all; 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.
Teva Pharmaceutical Industries Ltd.
IR:
United States
Kevin
C. Mannix, 215-591-8912
or
United States
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
United States
Nancy Leone,
215-284-0213
or
Eagle
In-Site Communications
Lisa
Wilson, 212-452-2793
or
Amy Raskopf, 917-673-5775