e c Medicines Agency in a centralized procedure. In 2014, the company launched Duoresp Spiromax in various EU countries, including Germany, the U.K. and Spain. Competition: The main competitors for Duoresp Spiromax are Symbicort Turbuhaler (Budesonide/Formoterol) by AstraZeneca, Seretide (fluticasone propionate/salmeterol) by GlaxoSmithKline and Foster (beclomathasone/formoterol) by Chiesi. The company’s respiratory portfolio also includes Qnasl Nasal Aerosol (beclomethasone dipropionate HFA in a nasal actuator), for the treatment of seasonal and year-round nasal allergy symptoms in the United States, which was also approved by the FDA for a pediatric indication in 2014. Respiratory—Pipeline The company’s delivery systems include an advanced breath-actuated inhaler (BAI) called Easi-Breathe; Spiromax/ RespiClick (US), an inhalation-driven multi-dose powder inhaler (MDPI); and Tidal Inhaler, a nebulization device, being evaluated for use in early stage development programs. The company’s devices and delivery systems are protected by various patents and applications, such as The Easi-Breathe BAI device is protected by applications and patents expiring between June 2021 and July 2031; the Spiromax/ RespiClick (US) device is protected by patents and applications expiring between June 2021 and October 2034; and the Tidal Inhaler device is protected by patents and applications expiring between February 2025 and April 2036. ProAir RespiClick US is a dry-powder inhaler formulation of albuterol in the company’s multi-dose powder inhaler device that is designed to be an improvement to its ProAir product. ProAir RespiClick was approved by the FDA in 2015 for use in adults and adolescents (12 years of age and older) to treat asthma and exercise-induced bronchospasm. The product was accepted for filing by the FDA on September 8, 2015 for pediatric use in patients aged 4 years and older. Reslizumab is an investigational humanized monoclonal antibody (MAb) against interleukin-5 (IL-5). The reslizumab BLA submission for the intravenous product was accepted by the FDA in 2015. The Phase 3 clinical program for the subcutaneous reslizumab product was initiated in August 2015. Reslizumab is protected by patents in the United States that expire in 2017. Fluticasone Salmeterol Spiromax EU is being developed per EU guidance to achieve the same clinical outcomes as Seretide Accuhaler. QVAR BAI US (beclomethasone) is an oral aerosol corticosteroid in development for the treatment of asthma for ages four years and older. The product is delivered using the company’s advanced breath-actuated inhaler. The Phase 3 clinical program was initiated in December 2013 and is expected to be completed in mid-2016. The QVAR BAI product is protected by Easi-Breathe BAI device patents and applications expiring between June 2021 and June 2030. The actuator with dose counter is protected by patents and applications expiring between December 2017 and July 2030. Fluticasone Propionate MDPI US is a new formulation of long acting corticosteroid (LCS) using the company’s multi-dose powder inhaler device, with an enhanced lung delivery that is designed to allow lower doses to achieve the same clinical outcomes as Flovent Diskus. Fluticasone Salmeterol MDPI US is a new formulation of LCS/LABA using the company’s multi dose powder inhaler device, designed to achieve comparable efficacy to Advair Diskus at lower doses. Fluticasone Salmeterol (MDI) EU is designed to be comparable to Advair/Seretide HFA, delivered in a press-and-breath device. Clinical studies were completed and submission plans are in development. TV-44649 (Budesonide Formoterol HFA MDI) is a long acting ß2-agonist and an inhaled corticosteroid combined for the treatment of asthma in patients 12 years of age and older. TV-44649 is in phase 1 clinical development and initiation of pivotal clinical studies to demonstrate therapeutic equivalency to Symbicort is planned in 2016. TV-44664 (Fluticasone Salmeterol DPI) is a long acting ß2-agonist and an inhaled corticosteroid combined for the treatment of asthma in patients 4 years of age and older. TV-44664 is in phase
teva pharmaceutical-sp adr
(TEVA:New York Consolidated)
5 Basel Street
PO Box 3190
Petach Tikva, 49131
Phone: 972- 3-926 7267
Fax: 972 3-9-234050www.tevapharm.com
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