Orphan Designation combined with pediatric
extension provides regulatory exclusivity through April 2016 for
indolent B-cell non-Hodgkin lymphoma indication
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
that the U.S. Food and Drug Administration (FDA) has granted orphan
drug exclusivity for TREANDA through October 2015 for indolent
B-cell non-Hodgkin lymphoma (iNHL) that has progressed during or
within six months of treatment with rituximab or a
rituximab-containing regimen. Orphan status is granted to therapies
intended to treat diseases or conditions that affect fewer than
200,000 patients in the United States. With the previously granted
six months of pediatric exclusivity for TREANDA, regulatory
exclusivity for this indication is now extended through April
2016.
“Since 2008, TREANDA has played a significant role in the
treatment of patients with iNHL that has progressed,” said Bill
Campbell, Vice President and General Manager, Teva Oncology. “We
are pleased the FDA has recognized our commitment to treating
patients with this rare form of cancer.”
TREANDA is also indicated for the treatment of patients with
chronic lymphocytic leukemia (CLL). TREANDA has orphan drug
exclusivity for this indication through March 2015. With the
previously granted six months of pediatric exclusivity for TREANDA,
regulatory exclusivity for this indication lasts until September
20, 2015.
Net sales for Treanda in the United States through the third
quarter of 2013 were $531 million.
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).
For full prescribing information, click here
http://www.treanda.com.
You are encouraged to report side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About TREANDA (bendamustine HCI) Injection
TREANDA was approved by the FDA for the treatment of chronic
lymphocytic leukemia (CLL) in March 2008. Efficacy relative to
first line therapies other than chlorambucil has not been
established. TREANDA received its second approval in October 2008
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.
TREANDA has a unique chemical structure that is synthesized to
combine an alkylating group and a purine-like benzimidazole
component. Though the exact mechanism of action of TREANDA remains
unknown, bendamustine is active against both quiescent and dividing
cells. Preclinical studies suggest that TREANDA may lead to cell
death by a process known as apoptosis (programmed cell death) as
well as by an alternate cell death pathway which disrupts normal
cell division known as mitotic catastrophe (a non-apoptotic
pathway).
About Indolent Non-Hodgkin lymphoma (NHL)
Non-Hodgkin lymphoma (NHL) is a disease in which cancer cells
form in the lymphatic tissue in the body. Because lymph tissue is
found throughout the body, NHL can begin almost anywhere in the
body and spread to almost any tissue or organ. There are
approximately 60 different types of NHL, which are formed from
either B-cells or T-cells. The majority of non-Hodgkin lymphomas
(80 to 90 percent) are formed by B-cells. Types of NHL are
generally divided into two categories–indolent and aggressive. The
American Cancer Society (ACS) estimates that in the U.S., 69,740
people will be diagnosed with NHL and 19,020 will die from the
disease in 2013.
Indolent non-Hodgkin lymphomas (iNHL) are slow-growing
lymphomas. The median survival of patients with indolent lymphoma
is approximately 10 years. Indolent lymphomas are often responsive
to therapy but usually relapse. According to the Leukemia and
Lymphoma Society, about 40 percent of NHL cases are indolent in the
U.S. Patients living with NHL may experience signs and symptoms
such as fever, sweating, excessive fatigue and weight loss.
About Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia (CLL) is one of four main types of
leukemia. CLL begins with a change to a single white blood cell, or
lymphocyte, of the bone marrow. Over time, the CLL cells multiply,
replacing normal lymphocytes in the marrow and lymph nodes. As the
amount of lymphocytes increases in the blood and bone marrow, there
is less room for healthy white and red blood cells as well as
platelets, which may result in infection, anemia and bleeding.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading
global pharmaceutical company, committed to increasing access to
high-quality healthcare by developing, producing and marketing
affordable generic drugs as well as innovative and specialty
pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is the world's leading generic drug
maker, with a global product portfolio of more than 1,000 molecules
and a direct presence in about 60 countries. Teva's branded
businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently
employs approximately 46,000 people around the world and reached
$20.3 billion in net revenues in 2012.
Teva's Safe Harbor Statement under the U. S. Private
Securities Litigation Reform Act of 1995:
This release contains forward-looking statements, which express
the current beliefs and expectations of management. Such statements
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, including our ability to
develop, manufacture, market and sell biopharmaceutical products,
competition for our innovative medicines, especially Copaxone®
(including competition from innovative orally-administered
alternatives, as well as from potential purported generic
equivalents), competition for our generic products (including from
other pharmaceutical companies and as a result of increased
governmental pricing pressures), competition for our specialty
pharmaceutical businesses, our ability to achieve expected results
through our specialty, including innovative, R&D efforts, the
effectiveness of our patents and other protections for innovative
products, decreasing opportunities to obtain U.S. market
exclusivity for significant new generic products, our ability to
identify, consummate and successfully integrate acquisitions and
license products, our ability to reduce operating expenses to the
extent and during the timeframe intended by our cost restructuring
program, uncertainties relating to the replacement of and
transition to a new President & Chief Executive Officer, the
effects of increased leverage as a result of recent acquisitions,
the extent to which any manufacturing or quality control problems
damage our reputation for high quality production and require
costly remediation, our potential exposure to product liability
claims to the extent not covered by insurance, increased government
scrutiny in both the U.S. and Europe of our settlement agreements
with brand companies and liabilities arising from class action
litigation and other third-party claims relating to such
agreements, potential liability for sales of generic medicines
prior to a final resolution of outstanding patent litigation, our
exposure to currency fluctuations and restrictions as well as
credit risks, the effects of reforms in healthcare regulation and
pharmaceutical pricing and reimbursement, any failures to comply
with complex Medicare and Medicaid reporting and payment
obligations, governmental investigations into sales and marketing
practices ,particularly for our specialty medicines (and our
ongoing FCPA investigations and related matters), uncertainties
surrounding the legislative and regulatory pathways for the
registration and approval of biotechnology-based medicines, adverse
effects of political or economic instability, corruption, major
hostilities or acts of terrorism on our significant worldwide
operations, interruptions in our supply chain or problems with our
information technology systems that adversely affect our complex
manufacturing processes, any failure to retain key personnel or to
attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers,
variations in patent laws that may adversely affect our ability to
manufacture our products in the most efficient manner, potentially
significant impairments of intangible assets and goodwill,
potential increases in tax liabilities resulting from challenges to
our intercompany arrangements, the termination or expiration of
governmental programs or tax benefits, environmental risks, and
other factors that are discussed in our Annual Report on Form 20-F
for the year ended December 31, 2012 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 the
Company undertakes no obligation to update or revise any forward
looking statement, whether as a result of new information, future
events or otherwise.
Teva Pharmaceutical Industries Ltd.IR:Kevin C.
MannixUnited States215-591-8912orRan MeirUnited
States215-591-3033orTomer AmitaiIsrael972 (3)
926-7656orPR:Iris Beck CodnerIsrael972 (3)
926-7687orDenise BradleyUnited States215-591-8974
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