Teva Presents Positive Safety and Efficacy Data for QNASL® (Beclomethasone Dipropionate) Nasal Aerosol in Treating Children with Perennial Allergic Rhinitis

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.

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