Additional QNASL® (beclomethasone dipropionate) Nasal Aerosol Data to be
Presented at Annual Allergy Meeting
Data to be Presented Regarding Impact on Sleep Quality and Nasal Symptom
Relief at 24 Hours Post Dose in Patients with Seasonal and Perennial Allergic
JERUSALEM -- February 22, 2013
Teva Pharmaceutical Industries Ltd. announced today that additional data
analyzed from the Phase III clinical program for QNASL^® (beclomethasone
dipropionate) ^ Nasal Aerosol will be presented at the 2013 Annual Meeting of
the American Academy of Allergy, Asthma and Immunology (AAAAI) in San Antonio,
Texas on February 22-26, 2013. QNASL^® is a nonaqueous or “dry-mist” nasal
aerosol corticosteroid that treats seasonal and year-round nasal allergy
symptoms in adults and adolescents 12 years of age and older.
Data will be presented at the meeting regarding the efficacy of QNASL^® in
treating the symptoms associated with seasonal and perennial allergic rhinitis
(SAR and PAR), including the drug’s potential quality of life benefits and
sleep quality improvement. Furthermore, the data also demonstrated nasal
symptom relief in patients with SAR and PAR who received treatment with
QNASL^® 24 hours after dosing.
On March 23, 2012, the U.S. Food and Drug Administration (FDA) approved
QNASL^®. The product became available by prescription in April 2012, making it
the first marketed nonaqueous or “dry-mist” nasal aerosol product in a
category that reports annual sales of $2.5 billion. QNASL^® is delivered as a
once-daily, nonaqueous aerosol that uses an environmentally friendly
propellant (HFA) and contains a built-in dose counter.
“These studies are important because the impact of allergic rhinitis on a
patient’s quality of life is significant. Nasal allergies are often associated
with burdensome symptoms such as nasal congestion, sneezing, and itchy and
runny nose, which may contribute to disrupted sleep and impaired daytime
activities,” said Dr. Eli Meltzer, Senior Associate, Allergy & Asthma Medical
and Research Center, A.P.C. and Clinical Professor, Department of Pediatrics,
Division of Allergy and Immunology, University of California, San Diego.
“These findings reinforce the efficacy of QNASL^® to treat nasal symptoms and
to provide sustained relief from burden of allergic rhinitis.”
The following QNASL^® data will be presented during poster sessions on Sunday,
February 24 from 9:45 – 10:45 a.m. (CST) in Hall C (street level) of the Henry
B. Gonzalez Convention Center at the AAAAI Annual Meeting:
*#P409: Improvement of Nasal Congestion and Sleep Quality Following
Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol in
Patients with Seasonal Allergic Rhinitis
*#P413: Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol
Provides Long-Term and Sustained 24-Hour Nasal Symptom Relief in Patients
with Perennial Allergic Rhinitis
*#P414: Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol
Effectively Improves the Symptom of Itchy Ear or Palate Associated with
Seasonal Allergic Rhinitis
*#P415: Once-Daily Treatment with Beclomethasone Dipropionate Nasal Aerosol
320 mg Provides 24-Hour Nasal Symptom Relief in Patients with Seasonal
*#P144: QNASL^® (beclomethasone dipropionate) Nonaqueous Nasal Aerosol
Delivers Softer Sprays Than Aqueous Flonase^®, Nasacort AQ^®, and
“The data to be presented at AAAAI further explored the safety and efficacy of
QNASL^® and demonstrated its ability to benefit patients suffering from
seasonal and year-round nasal allergies,” said Tushar Shah, MD, Senior Vice
President, Teva Global Respiratory Research and Development. “Teva Respiratory
is committed to offering patients treatment options that deliver continued
relief of bothersome nasal allergy symptoms and help improve their quality of
ABOUT ALLERGIC RHINITIS
Allergic rhinitis (AR) 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. According to a recent survey, patients suffer
considerable discomfort during allergy attacks, such that nearly two out of
five (38 percent) said their discomfort was not tolerable without relief.
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. An estimate of
$11.2 billion in healthcare costs, 12 million physician office visits, 2
million days of school absences and 3.5 million lost work days per year are
attributed to AR. In addition, the presence of co-morbidities such as asthma
and sinusitis further increase AR-related treatment costs.
About QNASL^® (BECLOMETHASONE DIPROPIONATE)
QNASL^® Nasal Aerosol is a prescription corticosteroid medication that treats
seasonal nasal and year-round nasal allergy symptoms in adults and adolescents
12 years of age and older. It is administered as a nonaqueous or "dry-mist”
spray delivered by hydrofluoroalkane (HFA), an environmentally friendly
propellant. QNASL^® (beclomethasone dipropionate) ^ Nasal Aerosol contains
beclomethasone dipropionate, which is a man-made (synthetic) corticosteroid.
Corticosteroids are natural substances found in the body that reduce
inflammation. When QNASL^® (beclomethasone dipropionate) Nasal Aerosol 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,
itching and sneezing. It is not known whether QNASL^® (beclomethasone
dipropionate) Nasal Aerosol is safe and effective in children under 12 years
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
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
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.
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 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
innovative orally-administered alternatives, as well as from potential 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 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, 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 agreements with brand companies, potential liability
for sales of generic products prior to a final resolution of outstanding
patent litigation, including that relating to the generic version of
Protonix®, 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 pharmaceutical products), uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of
biotechnology-based products, 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 our
information technology systems that adversely affect our complex manufacturing
processes, any failure to retain key personnel (including Cephalon employees)
or to attract additional executive and managerial talent, the impact of
continuing consolidation of our distributors and customers, variations in
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in the most efficient manner, potentially significant impairments of
intangible assets and goodwill, potential increases in tax liabilities, 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.
Kevin C. Mannix, 215-591-8912
Kristen Frank, 215-591-8908
Tomer Amitai, 972 (3) 926-7656
Hadar Vismunski-Weinberg, 972 (3) 926-7687
Denise Bradley, 215-591-8974
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