Late Stage Data to be Presented at ACAAI 2014
JERUSALEM--(BUSINESS WIRE)--Nov. 7, 2014--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced
positive findings from a Phase III clinical study that examined the
safety and efficacy of QNASL® (beclomethasone dipropionate)
Nasal Aerosol 80 μg/day in children 4-11 years of age with perennial –
or “year round” – allergic rhinitis (PAR). QNASL is a waterless aerosol
intranasal corticosteroid spray currently available for the treatment of
PAR and seasonal allergic rhinitis (SAR) in patients 12 years of age and
older. The data will be presented at the 2014 American College of
Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting in
Atlanta, Georgia on Saturday, November 8 and Sunday, November 9.
“As a company deep-rooted in its commitment to helping people living
with respiratory conditions, such as allergic rhinitis, we look forward
to the potential for bringing this new, specially formulated treatment
option to market,” said Tushar Shah, MD, Senior Vice President, Teva
Global Respiratory Research and Development. “It is our goal at Teva to
address patients’ unmet needs and we believe these findings support
QNASL as a prospective treatment for children suffering from the
symptoms associated with nasal allergies.”
On May 13, 2014, the U.S. Food and Drug Administration (FDA) accepted
the supplemental new drug application (sNDA) for a lower dose QNASL for
the treatment of PAR and SAR in children 4-11 years of age. The
submission was based on a comprehensive clinical development program
consisting of three Phase III clinical trials designed to evaluate the
safety and efficacy of QNASL 80 μg/day in children with allergic
rhinitis (AR). If approved, QNASL will be the first and only waterless
HFA nasal allergy treatment available for patients as young as four
years of age.
“Since there are limited new treatment options available to help manage
allergic rhinitis in the pediatric patient population, it is certainly
exciting to see these results for QNASL,” said study investigator Dr.
William Berger of the Allergy and Asthma Associates of Southern
California in Mission Viejo, California. “This treatment features a
low-dose formulation and ‘waterless’ aerosol delivery, making it a
promising option for children with allergic rhinitis.”
The 12-week, Phase III, randomized, double-blind, placebo-controlled,
parallel-group clinical trial enrolled 547 patients ages 4 to 11 to
receive two actuations (one 40 μg/actuation per nostril) of QNASL or
placebo nasal aerosol once daily. Symptoms were measured at 6 weeks and
12 weeks using average morning (AM) and evening (PM) reflective and
instantaneous nasal symptom scores. Results indicate that patients
treated with QNASL experienced a significantly greater improvement in
PAR symptoms than patients treated with placebo. Overall, QNASL was well
tolerated throughout the duration of the study with a safety profile
comparable to placebo.
About the Study
A total of 547 patients, 4-11 years of age, were randomized to receive
two actuations (one 40 μg/actuation per nostril) of QNASL or placebo
nasal aerosol once daily. The primary endpoint was change from baseline
in average morning (AM) and evening (PM) reflective total nasal symptom
score (rTNSS) through the first six weeks of treatment in patients 6-11
years of age. Additional efficacy endpoints included change from
baseline in average AM and PM instantaneous TNSS (iTNSS) in children
6-11 years of age and change from baseline in average rTNSS and iTNSS in
children ages 4-11.
Results from the study revealed improvement was significantly greater
with QNASL than with placebo over the first six weeks of treatment in
children 6-11 years of age AM and PM rTNSS and iTNSS (mean [95% CI]
treatment difference: –0.66 [–1.08, –0.24], P = 0.002 and –0.58
[–0.99, –0.18], P = 0.004, respectively). Improvement in PAR
symptoms in children ages 4-11 was significantly greater with QNASL than
placebo in average AM and PM rTNSS and iTNSS at week six (P =
0.002 and P = 0.004, respectively). Similar results were observed
over 12 weeks (P < 0.001). In addition, improvement in average AM
and PM reflective individual nasal symptoms over the first six weeks of
treatment in children ages 6-11 was significantly greater for rhinorrhea
(P = 0.004), nasal congestion (P = 0.001) and sneezing (P
= 0.002) with QNASL versus placebo. Overall, QNASL was well-tolerated
throughout the duration of the study with a safety profile comparable to
placebo.
About Allergic Rhinitis
Allergic rhinitis is a chronic inflammatory disease characterized by
symptoms such as sneezing, nasal itch, runny nose and nasal congestion.
For many AR patients, nasal congestion or a stuffy nose may be the most
frequent and bothersome symptom. Based on the available evidence,
intranasal corticosteroids are the most effective treatment options for
patients with AR.
According to the American Academy of Allergy, Asthma and Immunology
(AAAAI), the prevalence of AR in the U.S. has increased during the past
three decades; it is recently estimated at 20 percent in the general
adult and adolescent populations. Of those Americans affected with AR,
approximately 20 percent have SAR, 40 percent have perennial allergic
rhinitis (PAR) and 40 percent have a combination of the two (i.e., PAR
with seasonal exacerbation) depending on the allergen sensitivity.
Because of its prevalence and health effect, AR is associated with
considerable direct and indirect costs.
About QNASL®
(Beclomethasone Dipropionate)
QNASL® (beclomethasone diproprionate) Nasal Aerosol 320
μg/day is a prescription corticosteroid medication that treats nasal
symptoms associated with seasonal and year-round allergies in adults and
adolescents 12 years of age and older. It is administered as a waterless
spray delivered by hydrofluoroalkane (HFA), an environmentally friendly
propellant. QNASL® contains beclomethasone dipropionate,
which is a man-made (synthetic) corticosteroid. Corticosteroids are
natural substances found in the body that reduce inflammation. When QNASL®
is sprayed into the nose, it helps reduce the nasal symptoms of allergic
rhinitis (inflammation of the lining of the nose), such as stuffy nose,
runny nose, nasal itching and sneezing.
Important Safety Information
In clinical studies, nosebleeds and nose ulcers were more common in
patients treated with QNASL® Nasal Aerosol than patients who
received placebo. Some nosebleeds were more severe in patients treated
with QNASL® Nasal Aerosol than in patients who received
placebo. Tell your healthcare provider if you start to have nosebleeds
or nasal ulcers after using QNASL® Nasal Aerosol.
Thrush (Candida), a fungal infection in your nose, mouth, or throat may
occur. Tell your healthcare provider if you have any redness or white
colored patches in your mouth or throat.
You should avoid using QNASL® Nasal Aerosol until your nose
is healed if you have a sore in your nose, you have had recent surgery
on your nose or if your nose has been injured, because QNASL®
Nasal Aerosol may cause slow wound healing.
Some people who use corticosteroids may have eye problems such as
increased pressure in the eye (glaucoma) or cataracts. If you have a
history of glaucoma or cataracts or have a family history of eye
problems, you should have regular eye exams while you use QNASL®
Nasal Aerosol.
Serious allergic reactions can happen in people taking QNASL®
Nasal Aerosol. Stop using QNASL® Nasal Aerosol and call your
healthcare provider right away or get emergency help if you experience
shortness of breath or trouble breathing, skin rash, redness, swelling,
severe itching, or swelling of your lips, tongue or face.
People are more likely to get infections if they have immune system
problems or use drugs, including corticosteroids, which may weaken the
body’s ability to fight infections. Avoid contact with people who have
infections like chickenpox or measles while using QNASL®
Nasal Aerosol.
Speak to your healthcare provider before using QNASL® Nasal
Aerosol if you have tuberculosis or untreated fungal, bacterial, or
viral infections, or eye infections caused by herpes. Symptoms of an
infection include: fever, pain, aches, chills, feeling tired, nausea and
vomiting.
A condition in which the adrenal glands do not make enough steroid
hormones may occur. Symptoms can include tiredness, weakness, dizziness,
nausea and vomiting. Tell your healthcare provider if you experience
these symptoms.
Children taking QNASL® (beclomethasone dipropionate) Nasal
Aerosol should have their growth checked regularly, since
corticosteroids may slow growth in children.
The most common side effects with QNASL® Nasal Aerosol are
nasal discomfort, nosebleeds and headache.
Tell your healthcare provider if you have any side effect that bothers
you or that does not go away.
These are not all of the possible side effects of QNASL®
(beclomethasone dipropionate) Nasal Aerosol. For more information, ask
your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch,
or call 1-800-FDA-1088.
Visit http://qnasl.com/Content/pdf/pi.pdf
for full prescribing information.
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 approximately 60 countries.
Teva's Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, and women's health therapeutic areas as well as
biologics. Teva currently employs approximately 45,000 people around the
world and reached $20.3 billion in net revenues in 2013.
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); 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;
our potential exposure to product liability claims that are not covered
by insurance; 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,
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marketing practices, particularly for our specialty pharmaceutical
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effects of increased leverage and our resulting reliance on access to
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to attract additional executive and managerial talent; adverse effects
of political or economical 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; 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; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the
impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; 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, 2013 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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