Teva announces additional data from QNASL Phase III program on seasonal allergic rhinitis

Nov 7 2012

Teva Pharmaceutical Industries Ltd. announced today that additional data from the Phase III clinical program for QNASL- (beclomethasone dipropionate) Nasal Aerosol will be presented at the 2012 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI) in Anaheim, CA on November 8-13, 2012. QNASL- is a recently approved "dry" nasal aerosol corticosteroid that treats seasonal and year-round nasal allergy symptoms in adults and adolescents 12 years of age and older.

Findings from one clinical study being presented at the meeting highlight the nasal symptom improvement and efficacy profile of QNASL- in children ages 6-11 with seasonal allergic rhinitis (SAR), while others reinforce ocular safety, appropriate dosing and device performance.

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 nonaqeous or "dry" 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.

"QNASL has provided an alternative therapy for patients suffering from 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. "The dry mode of delivery of QNASL, along with the performance and functionality of the device, offers patients a safe and effective way to manage and control their nasal allergy symptoms. The data to be presented at ACAAI this year further demonstrate the efficacy profile of QNASL, especially among the pediatric population and confirm the product's ocular safety profile in adolescents and adults."

The following QNASL- (beclomethasone dipropionate) data will be presented during poster sessions on Saturday, November 10 from 12:30 - 1:30 p.m. PST and Sunday, November 11 from 12:00 - 1:00 p.m. PST in Hall C (first floor) of the Anaheim Convention Center at the ACAAI Annual Meeting:

• #P314: Device and Integrated Dose Counter Performance of Beclomethasone Dipropionate Nasal Aerosol During Daily Use
• #P329: Nasal Symptom Improvement Following Once-Daily Treatment With Beclomethasone Dipropionate Nasal Aerosol (80 -g or 160 -g) in Children With Seasonal Allergic Rhinitis
• #P330: Efficacy, Safety, and Optimal Dose Selection of Beclomethasone Dipropionate Nasal Aerosol for the Treatment of Seasonal Allergic Rhinitis
• #P331: Evaluation of Ocular Safety Following Long-Term Treatment With Beclomethasone Dipropionate Nasal Aerosol in Subjects With Perennial Allergic Rhinitis
• #P325: Nasal Deposition of Beclomethasone Dipropionate Nasal Aerosol Versus Fluticasone Propionate and Mometasone Furoate Aqueous Nasal Sprays

"The data to be presented at ACAAI provide additional evidence that QNASL is a generally well-tolerated and effective treatment option for people suffering with seasonal and year-round nasal allergies," said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. "We are committed to the development of novel therapies to help the millions of Americans who suffer from allergic rhinitis effectively manage and control their burdensome symptoms."