Eagle has Submitted NDA for Bendamustine Rapid
Infusion to FDA
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
IndicationsTREANDA® 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.
Teva Pharmaceutical Industries Ltd.IR:United
StatesKevin C. Mannix, 215-591-8912orUnited StatesRan
Meir, 215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974orUnited
StatesNancy Leone, 215-284-0213orEagleIn-Site
CommunicationsLisa Wilson, 212-452-2793orAmy Raskopf,
917-673-5775
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