- First EU launch for LONQUEX®
(long-acting G-CSF) in Germany; Teva launches GRANIX™ (short-acting
G-CSF) launched in the US
- Balugrastim Biologics License
Application (BLA) withdrawn from FDA review process pending
provision of additional confirmatory data
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
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
IR Contacts:United StatesKevin C. Mannix, 215-591-8912orUnited
StatesRan Meir, 215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR Contacts:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974
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