Orphan Designation combined with pediatric extension provides
regulatory exclusivity through April 2016 for indolent B-cell
non-Hodgkin lymphoma indication
JERUSALEM--(BUSINESS WIRE)--Nov. 27, 2013--
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
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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
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our settlement agreements with brand companies and liabilities arising
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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
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,particularly for our specialty medicines (and our ongoing FCPA
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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.
Source: Teva Pharmaceutical Industries Ltd.