Additional Phase III Data Show Long-Term Ocular Safety Profile and
Support Device Functionality and Reliability
JERUSALEM--(BUSINESS WIRE)--Nov. 9, 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® 80 mcg, 160 mcg or placebo. The primary endpoint, the
results for which were previously released1, 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 placebo.
“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 reported2, 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 Proceedings3,
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 friendly5
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.”
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 of age.
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
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
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.
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
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. 2012.
4 Allergic Rhinitis Therapeutics – Pipeline Assessment and
Market Forecasts to 2018. Retrieved March 9, 2012, from ©Global
5 The Montreal Protocol on Substances that Deplete the Ozone
Layer. Retrieved March 12, 2012, from the United Nations Environment
Programme. Available at: http://www.unep.org/ozone/pdf/Montreal-Protocol2000.pdf.
Source: Teva Pharmaceutical Industries Ltd
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix