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First EU launch for LONQUEX® (long-acting G-CSF) in Germany; Teva
launches GRANIX™ (short-acting G-CSF) launched in the US
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Balugrastim Biologics License Application (BLA) withdrawn from FDA
review process pending provision of additional confirmatory data
JERUSALEM--(BUSINESS WIRE)--Nov. 18, 2013--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced two
significant additions to its global oncology biologic portfolio with the
recent launches of LONQUEX® (lipegfilgrastim) and GRANIX™
(tbo-filgrastim) Injection, and an update on the review status of
balugrastim by the U.S. Food and Drug Administration (FDA).
Teva launched LONQUEX® (long-acting G-CSF) in Germany on November 4,
2013 – the first launch as part of an EU-wide approval. Teva plans to
continue the roll-out of Lonquex across additional countries covered by
the European Marketing Approval over the coming months. Also this month,
Teva launched GRANIX™ (short-acting G-CSF) in the U.S. on November 11,
2013, marking the entry of the first new G-CSF to the US market in more
than ten years. LONQUEX® and GRANIX™ provide new treatment
options for physicians who are seeking to reduce the duration of severe
neutropenia in patients with non-myeloid malignancies, who are receiving
myelosuppressive anticancer drugs associated with a clinically
significant incidence of febrile neutropenia.
“Managing the duration of severe neutropenia is critical to optimal
cancer care, because it can disrupt the delivery of cancer treatments,”
said Lee S. Schwartzberg, M.D., Division Chief, Hematology & Oncology,
at the University of Tennessee Health Science Center. “With the
availability of more G-CSF treatment options, healthcare professionals
and their patients with non-myeloid malignancies undergoing
myelosuppressive chemotherapy will be able to choose the G-CSF that best
suits their needs.”
“Teva is committed to commercializing G-CSFs globally and is continuing
to build the portfolio of short- and long-acting G-CSFs in this
important, patient-focused category of medicines,” said Rob Koremans,
M.D., President and CEO of Teva Global Specialty Medicines. “By making
these treatment options available to physicians and their patients, our
goal is to make a meaningful difference in the lives of those with
cancer.”
Last week, the company withdrew its balugrastim Biologics License
Application (BLA) from the FDA review process following ongoing
consultation with the agency in preparation for the late cycle review
meeting, pending the provision of additional confirmatory data. The FDA
has agreed to work with Teva in designing any additional studies that
may be required in support of the BLA for balugrastim. The company is
currently assessing its options with regard to its long-acting G-CSF
program in order to define an approach that will best serve patient
needs going forward.
About Neutropenia
Neutropenia is a hematological disorder characterized by an abnormally
low number of neutrophils. A person with severe neutropenia has an
absolute neutrophil count that is less than 500 mm2 and has a
high risk of infection. Neutrophils usually make up 40-60 percent of
circulating white blood cells and serve as the primary defense against
infections by destroying bacteria in the blood. When chemotherapy agents
attack cancer cells in the body, neutrophils and other cells are also
attacked. This results in a decrease in healthy white blood cells,
making it harder for the body to fight infections. Patients receiving
chemotherapy are at risk of becoming neutropenic and can become
susceptible to infections that may become life-threatening.
About G-CSF
G-CSF is a naturally occurring hormone that is produced by the body to
stimulate the bone marrow to produce neutrophils, a type of white blood
cell that helps the immune system fight infection. A recombinant form of
G-CSF is used to treat certain cancer patients with neutropenia in order
to stimulate the bone marrow to produce more white blood cells.
About Granix™
GRANIX™ is a leukocyte growth factor indicated for reduction in the
duration of severe neutropenia in patients with non-myeloid malignancies
receiving myelosuppressive anticancer drugs associated with a clinically
significant incidence of febrile neutropenia.
The safety of GRANIXTM was evaluated in three Phase 3
clinical trials in patients receiving myelosuppressive chemotherapy for
breast cancer, lung cancer, and non-Hodgkin lymphoma (NHL). In a Phase 3
clinical study, GRANIXTM demonstrated a 71 percent
reduction in the duration of severe neutropenia when compared to
placebo. GRANIXTM significantly reduced the duration
of severe neutropenia when compared to placebo (1.1 days vs. 3.8 days).
The efficacy of GRANIX was evaluated in a multinational, multicenter,
randomized, controlled Phase 3 study of chemotherapy-naïve patients with
high-risk stage II, stage III, or stage IV breast cancer receiving a
myelosuppressive regimen of doxorubicin (60 mg/m2 IV bolus)
and docetaxel (75 mg/m2). Comparisons with placebo occurred
in the first cycle.
Important Safety Information
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Splenic rupture: Splenic rupture, including fatal cases, can
occur following the administration of human granulocyte
colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate
for an enlarged spleen or splenic rupture in patients who report upper
abdominal or shoulder pain after receiving GRANIX.
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Acute respiratory distress syndrome (ARDS): ARDS can occur in
patients receiving hGCSFs. Evaluate patients who develop fever and
lung infiltrates or respiratory distress after receiving GRANIX, for
ARDS. Discontinue GRANIX in patients with ARDS.
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Allergic reactions: Serious allergic reactions, including
anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can
occur on initial exposure. Permanently discontinue GRANIX in patients
with serious allergic reactions. Do not administer GRANIX to patients
with a history of serious allergic reactions to filgrastim or
pegfilgrastim.
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Use in patients with sickle cell disease: Severe and sometimes
fatal sickle cell crises can occur in patients with sickle cell
disease receiving hG-CSFs. Consider the potential risks and benefits
prior to the administration of GRANIX in patients with sickle cell
disease. Discontinue GRANIX in patients undergoing a sickle cell
crisis.
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Potential for tumor growth stimulatory effects on malignant cells:
The granulocyte colony-stimulating factor (G-CSF) receptor, through
which GRANIX acts, has been found on tumor cell lines. The possibility
that GRANIX acts as a growth factor for any tumor type, including
myeloid malignancies and myelodysplasia, diseases for which GRANIX is
not approved, cannot be excluded. 4
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Most common treatment-emergent adverse reaction: The most
common treatment-emergent adverse reaction that occurred in patients
treated with GRANIX at the recommended dose with an incidence of at
least 1% or greater and two times more frequent than in the placebo
group was bone pain.
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
to view the Full Prescribing Information for GRANIX.
To view multimedia content for GRANIXTM, please click: www.TheGranixchoice.com
About Lonquex® (lipegfilgrastim)
Lonquex® is a new long-acting recombinant granulocyte
colony-stimulating factor (G-CSF) treatment granted approval by the
European Medicines Agency indicated for reduction in the duration and
incidence of febrile neutropenia in adult patients treated with
cytotoxic chemotherapy for malignancy (with the exception of chronic
myeloid leukemia and myelodysplastic syndromes).
Human G-CSF (filgrastim) is a polypeptide that regulates the production
and release of functional neutrophils from the bone marrow. Lonquex®
is a glycoPEGylated, long-acting form of recombinant human filgrastim,
classified with a unique Anatomical Therapeutic Chemical (ATC)
Classification System code, with a sustained duration of action due to
decreased renal clearance.
The efficacy and tolerability of Lonquex® has been assessed
in a full clinical development program. Phase I PK and PD studies in
healthy volunteers demonstrate a marked increase in blood neutrophil
counts within 24 hours of administration, as well as an increase in the
antibacterial activities of neutrophils.
In a pivotal Phase III active-controlled study in 202 patients with
stage II-IV breast cancer receiving up to four cycles of chemotherapy
consisting of doxorubicin and docetaxel, patients were randomized 1:1 to
receive 6 mg Lonquex® or 6 mg pegfilgrastim. The study
met the primary efficacy endpoint, DSN in the first cycle of
chemotherapy, demonstrating non-inferiority of 6 mg Lonquex®
to 6 mg pegfilgrastim (p=0.126), with a comparable tolerability profile.
(DSN was calculated as the sum of all days after CTX with ANC <0.5 x 109/L.)
Secondary endpoints were favorable for Lonquex®, including an
overall mean faster time of 1.5 days to Absolute Neutrophil Count (ANC)
recovery of in cycle 1, a trend that was maintained up to cycle 3 (ATP
population). (ANC recovery defined as a return of ANC to ≥ 2.0x109/L.)
A second Phase III study in 375 patients at low risk of febrile
neutropenia (FN 10-20%) with non-small cell lung cancer was undertaken,
comparing 6 mg Lonquex® (n=250) with placebo (n=125). The
primary endpoint, incidence of FN in the first cycle of chemotherapy,
did not reach statistical significance (p=0.1151). FN is defined as an
ANC count of <0.5×109/L with fever (oral body temperature
>38.5°C on ≥2 consecutive measurements ≥60 minutes apart.) Secondary
endpoint analyses showed a positive trend in favor of Lonquex®
vs placebo: duration and incidence of severe neutropenia in cycle 1 was
consistently shorter (mean 2.3 ± 2.5 days; p<0.0001) and lower (32.1% vs
59.2%; p<0.0001) in the lipegfilgrastim group overall (mean 0.6 ± 1.1
days) compared with the placebo group. (SN defined as grade 4
neutropenia with an ANC <0.5 x 109/L.) Although incidence
of death at study end was 7.2 % (placebo) and 12.5 % (6 mg
lipegfilgrastim), the overall incidence of death at the 360-day
follow-up was similar between placebo and lipegfilgrastim (44.8 % and
44.0 %, respectively; safety population).
The tolerability of lipegfilgrastim has been evaluated based on results
from clinical studies including 506 patients and 76 healthy volunteers
treated at least once with lipegfilgrastim. The most common adverse
reactions (≥ 1/100 to < 1/10) included: thrombocytopenia, hypokaleamia,
headache, erythema and chest pain, with musculoskeletal pains listed as
very common (≥ 1/10).
One 6 mg dose of Lonquex® (a single pre-filled syringe) is
recommended for adults for each chemotherapy cycle, given approximately
24 hours after cytotoxic chemotherapy.
Lonquex® treatment should be initiated and supervised by
physicians experienced in oncology or haematology. Please consult the
SmPC for further information, including regarding adverse events,
special warnings and precautions for use.
This medicinal product is subject to additional monitoring which will
allow Teva to quickly identify new safety information. Healthcare
professionals are encouraged to report any suspected adverse reactions
to PatientSafety@tevapharm.com
About Balugrastim
Balugrastim is a once per cycle leukocyte growth factor. The proposed
indication is to decrease the duration of severe neutropenia in patients
with nonmyeloid malignancies receiving myelosuppressive anticancer drugs
associated with a clinically significant incidence of febrile
neutropenia.
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.
Source: Teva Pharmaceutical Industries Ltd.
IR Contacts:
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 Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974