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Teva Announces FDA Approval of QNASL for Children with Seasonal and Perennial Allergic Rhinitis

JERUSALEM--(BUSINESS WIRE)--Dec. 19, 2014-- Teva Pharmaceutical Industries Ltd., announced today that the U.S. Food and Drug Administration (FDA) approved QNASL (beclomethasone dipropionate) 40 mcg for the treatment of nasal symptoms associated with allergic rhinitis (AR) in children 4-11 years of age.

QNASL 40 mcg is a lower dose formulation of QNASL Nasal Aerosol (80 mcg), a waterless (non-aqueous) intranasal corticosteroid (INS) spray currently available by prescription for adults and adolescents (12 years of age and older) for the treatment of nasal symptoms associated with AR. QNASL 40 mcg delivers effective symptom relief at one-fourth of the dosage approved to treat adults and is the first and only waterless hydrofluoroalkane (HFA) nasal allergy treatment to be approved for use in patients as young as four years of age. The drug is expected to become available by prescription in February 2015.

“The approval of QNASL for use in children aged 4-11 is an important advancement for an often difficult-to-treat patient group,” said Dr. Todd Mahr, MD, Director of Pediatric Allergy and Immunology at Gundersen Lutheran Medical Center in La Crosse, Wisconsin. “QNASL 40 mcg has several characteristics that provide prescribers with a treatment option specifically designed for children with allergic rhinitis, including its ‘waterless’ aerosol method of delivery and lower dose formulation.”

FDA approval was based on data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL 40 mcg in children (ages 4-11) with AR. Data demonstrated that once-daily treatment with QNASL 40 mcg provided significant nasal allergy symptom relief in children with seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in comparison to placebo. In all three studies, the safety profile of QNASL® 40 mcg was similar to that of placebo and the most common adverse events were nosebleeds and ulcers, which is consistent with those seen in previous clinical studies of QNASL Nasal Aerosol.

“The approval of this lower dose formulation of QNASL for children reaffirms Teva’s deep-rooted commitment to developing treatment options to help address respiratory conditions among all patient populations,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “Through the availability of QNASL 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies.”

About QNASL (Beclomethasone Dipropionate)

QNASL (beclomethasone diproprionate) Nasal Aerosol is a prescription corticosteroid medication that treats nasal symptoms associated with seasonal and year-round allergies. QNASL is manufactured in two formulations: 80 mcg for patients 12 years of age and older and recently FDA-approved 40 mcg for children ages 4-11. QNASL® 40 mcg is expected to become available by prescription in February 2015 and QNASL 80 mcg is currently available by prescription to adults and adolescents 12 years of age and older. QNASL is administered as a waterless spray delivered by hydrofluoroalkane (HFA), an environmentally friendly propellant. It 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.

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 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.

Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which 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 orally-administered alternatives, as well as from potential purported generic equivalents); the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; our potential exposure to product liability claims that are not covered by insurance; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; uncertainties related to our recent management changes; the effects of increased leverage and our resulting reliance on access to the capital markets; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; 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 internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; the impact of continuing consolidation of our distributors and customers; significant impairment charges relating to intangible assets and goodwill; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2013 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 we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Source: Teva Pharmaceutical Industries Ltd.

Posted: December 2014

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