Phase III Data for Teva’s QNASL® (beclomethasone dipropionate) Demonstrate
Efficacy Profile in Pediatric Patients with Seasonal Allergic Rhinitis
Additional Phase III Data Show Long-Term Ocular Safety Profile and Support
Device Functionality and Reliability
JERUSALEM -- November 09, 2012
Teva Pharmaceutical Industries Ltd. announced today additional data from the
Phase III clinical program for QNASL^® (beclomethasone dipropionate) Nasal
Aerosol, highlighting the drug’s efficacy profile in treating children (ages
6-11) with nasal symptoms of seasonal allergic rhinitis (SAR). QNASL^® is a
nonaqueous, “dry” nasal aerosol corticosteroid currently approved for the
treatment of nasal symptoms associated with SAR and perennial allergic
rhinitis (PAR) in patients aged 12 years and older. The data are being
presented at the 2012 Annual Meeting of the American College of Allergy,
Asthma and Immunology (ACAAI) in Anaheim, CA. Additional data also presented
at the ACAAI meeting reinforce the long-term ocular safety profile of QNASL^®
and the functionality and reliability of the device.
In a two-week, randomized, double-blind, placebo-controlled study, 715
patients with SAR, aged 6-11 years, received once-daily treatment with QNASL^®
80mcg, 160 mcg or placebo. The primary endpoint, the results for which were
previously released^1, showed significantly greater (p<0.001) improvement in
nasal symptoms compared with placebo for both QNASL^® 160 mcg and 80 mcg over
the two-week treatment period. Additional data reported today further support
the efficacy of once-daily dosing with QNASL^®. The data show greater
(p<0.001) improvements from baseline in patient-reported AM and PM reflective
total nasal symptom scores (rTNSS) and patient-reported AM and PM
instantaneous total nasal symptom scores (iTNSS) with QNASL^® 160 mcg and 80
mcg as compared with placebo (p<0.01). Furthermore, physician-assessed nasal
symptom scores (PNSS) show greater improvement in patients receiving
QNASL^®160 mcg and 80 mcg as compared with placebo (-.096, 95% CI: -1.4, -.05,
P<0.001 [80 mcg]); (-.072, 95% CI: -1.2, -.02, P=0.004 [160mcg]). QNASL^® was
generally well-tolerated in children with a safety profile similar to that of
“QNASL is a much-needed treatment option for the millions of adults and
adolescents suffering from the burdensome symptoms of allergic rhinitis,” said
Dr. William Storms, MD, practicing allergist, clinical professor at the
University of Colorado Health Sciences Center and founder of the William
Storms Allergy Clinic in Colorado Springs, CO. “These data further showcase
the drug’s safety and efficacy profile in treating the pediatric population
and could prove beneficial to the 40 percent of children in the U.S. currently
living with allergic rhinitis.”
Highlights from a study evaluating ocular safety following long-term (52-week)
treatment of QNASL^® (beclomethasone dipropionate) 320 mcg once-daily were
also presented at ACAAI. The primary endpoint, which was previously
reported^2, showed statistically significant improvements in patient-reported
24-hour rTNSS in patients with PAR, aged 12 years and older, over the first 30
weeks of treatment. Data presented today demonstrate that at 30 and 52 weeks,
there were no clinically important differences in intraocular pressure (IOP),
which refers to the fluid pressure within the eye, between QNASL^® and
placebo. If IOP increases beyond the normal range of 10-20 mmHg, patients are
at an increased risk of developing glaucoma; however, during treatment with
QNASL^®, IOP remained within normal range (<21 mmHg) in 94 percent of
patients. Treatment with QNASL^® had a minimal impact on lens opacities
development or progression and there were no reports of development of
cataracts during the study. Physician-assessed nasal symptom scores in this
study show greater improvement from baseline across 30 and 52 weeks of
treatment (-0.63, 95% CI: -1.1, -0.2, P=0.005 [week 30]); (-0.60, 95% CI:
-1.0, -0.2, P=0.008 [week 52]).
QNASL^® is the first nasal aerosol spray to be available with an integrated
dose counter that numerically displays every actuation. Evaluations were
conducted to assess the accuracy and reliability of the device. To evaluate
the safety and efficacy profile of QNASL^®, a six-week, randomized,
double-blind, placebo-controlled study was conducted in 474 patients with PAR,
aged 12 years and older. As previously published in the Allergy & Asthma
Proceedings^3, the study showed significantly greater improvement in average
patient-reported AM and PM rTNSS compared to placebo. Additional data from
this study presented at ACAAI demonstrate the performance, functionality and
reliability of the integrated dose counter based on daily patient recordings
of actuations and dose counter readings. Agreement between subject recordings,
measured by a Nasal Device Performance Diary, and dose counter readings was
assessed by discrepancies in the following categories: fire not count, count
not fire, count unknown fire and count up unknown fire. Of 41,891
subject-reported actuations, only 159 discrepancies were reported in the diary
versus the counter. Nearly 80 percent (79.1) of subjects reported 0
discrepancies, 9.4 percent reported only one discrepancy and 6.4 percent
reported just two discrepancies. The dose counter had an overall discrepancy
rate of 0.38/100 actuations (0.41 [BDP nasal aerosol group]; 0.34 [placebo
group] and the discrepancy rate of fire not count was also low (0.09/100
actuations). These results further suggest that the reliable dose counter will
help patients track their remaining medication and help to determine when to
replace their device.
On March 23, 2012, the U.S. Food and Drug Administration (FDA) approved
QNASL^®. The product became available to patients by prescription in April
2012, making it the first marketed nonaqueous or “dry” nasal aerosol product
in a category that reports annual sales of $2.5 billion.^4 QNASL^® is
delivered as a once-daily, nonaqueous aerosol that uses an environmentally
friendly^5 propellant (HFA) and contains a built-in dose counter.
“The data presentations at ACAAI further emphasize the safety and efficacy
profile of QNASL for the treatment of seasonal and year-round nasal
allergies,” said Tushar Shah, MD, Senior Vice President, Teva Global
Respiratory Research and Development. “We remain firmly committed to the
development of novel therapies that present patients with new and innovative
treatment options to allow them to effectively manage their nasal allergy
symptoms and ultimately improve their quality of life.”
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” spray
delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant.
QNASL^® 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^® 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
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 Nasal Aerosol should have their growth checked
regularly, since corticosteroids may slow growth in children.
The most common side effects with QNASL (beclomethasone dipropionate) 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 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 specialty pharmaceuticals and active pharmaceutical ingredients.
Headquartered in Israel, Teva is a world leading generic drug maker, with a
global product portfolio of more than 1,300 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. Teva currently employs
approximately 46,000 people around the world and reached $18.3 billion in net
revenues in 2011.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation
Reform Act of 1995:
The following discussion and analysis 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, competition from
the introduction of competing generic equivalents and due to increased
governmental pricing pressures, the effects of competition on sales of our
innovative medicines, especially Copaxone® (including competition from
innovative orally-administered alternatives as well as from potential generic
equivalents), potential liability for sales of generic medicines prior to a
final resolution of outstanding patent litigation, including that relating to
our generic version of Protonix®, the extent to which we may obtain U.S.
market exclusivity for certain of our new generic medicines, the extent to
which any manufacturing or quality control problems damage our reputation for
high quality production and require costly remediation, our ability to
identify, consummate and successfully integrate acquisitions (including the
acquisition of Cephalon), our ability to achieve expected results through our
innovative R&D efforts, dependence on the effectiveness of our patents and
other protections for innovative medicines, intense competition in our
specialty pharmaceutical businesses, uncertainties surrounding the legislative
and regulatory pathway for the registration and approval of
biotechnology-based medicines, our potential exposure to product liability
claims to the extent not covered by insurance, any failures to comply with the
complex Medicare and Medicaid reporting and payment obligations, our exposure
to currency fluctuations and restrictions as well as credit risks, the effects
of reforms in healthcare regulation and pharmaceutical pricing and
reimbursement, adverse effects of political instability and adverse economic
conditions, major hostilities or acts of terrorism on our significant
worldwide operations, increased government scrutiny in both the U.S. and
Europe of our agreements with brand companies, interruptions in our supply
chain or problems with our information technology systems that adversely
affect our complex manufacturing processes, the impact of continuing
consolidation of our distributors and customers, the difficulty of complying
with U.S. Food and Drug Administration, European Medicines Agency and other
regulatory authority requirements, 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, any failure to retain key
personnel or to attract additional executive and managerial talent,
environmental risks, and other factors that are discussed in our Annual Report
on Form 20-F for the year ended December 31, 2011 and in our other filings
with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking
statements speak only as of the date on which they are made, and we undertake
no obligation to update any forward-looking statements or other information
contained in this report, whether as a result of new information, future
events or otherwise.
^1 Storms WW, Nayak N, Kelley L, Ding Y, Tantry SK (2012). Nasal Symptom
Improvement Following Once-Daily Treatment With Beclomethasone Dipropionate
Nasal Aerosol in Children With Seasonal Allergic Rhinitis. Annual Meeting of
the American Academy of Allergy, Asthma & Immunology (AAAAI), Orlando, FL,
March 2-6, 2012.
^2 Nayak AS, Andrews CP, Bernstein DI, Dorinsky PM, Tankelevich A, Ding Y,
Tantry SK. Long-term safety and efficacy of once-daily treatment with
beclomethasone dipropionate nasal aerosol in subjects with perennial allergic
rhinitis. Annual Meeting of the American College of Allergy, Asthma &
Immunology (ACAAI), Boston, MA, November 3-8, 2011.
^3 Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK. Safety
and efficacy of once-daily treatment with beclomethasone dipropionate nasal
aerosol in subjects with perennial allergic rhinitis. Allergy Asthma Proc.
^4 Allergic Rhinitis Therapeutics – Pipeline Assessment and Market Forecasts
to 2018. Retrieved March 9, 2012, from ^©Global Data.20: 2011.
^5 The Montreal Protocol on Substances that Deplete the Ozone Layer. Retrieved
March 12, 2012, from the United Nations Environment Programme. Available at:
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix
972 (3) 926-7656
972 (3) 926-7687
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