Teva obtains EU approval for asthma inhaler

The DuoResp Spiromax is a dry-powder inhaler designed to provide dosage accuracy.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has obtained European Commission marketing approval for its DuoResp Spiromax inhaler for asthma and chronic obstructive pulmonary disease (COPD).

The DuoResp Spiromax is a new, multi-dose dry-powder inhaler containing a fixed dose combination of budesonide, a corticosteroid for the treatment of the underlying inflammation in asthma and COPD, and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2 agonist for the relief of bronchoconstriction in asthma and COPD. The inhaler uses a unique technology to deliver a consistent, effective and accurate dose.

The DuoResp Spiromax is undergoing two Phase III clinical trials in Europe with chronic asthma patients to compare its benefits with budesonide/formoterol multi-dose dry powder inhaler. Results are due later this year.

The Spiromax inhaler has been designed by looking at patient inhalation challenges not in terms of human error, but as a design problem to be solved. The result is an inhaler designed to improve ease of use and consistent delivery from the first to the last dose with three simple steps: open, breathe and close. Furthermore, it confirms to patients that a dose has been taken through a taste of lactose and a clear dose indicator.

"The DuoResp Spiromax is a major advance in inhalers," said Teva Global Specialty Medicines president and CEO Dr. Rob Koremans. "It is widely accepted that poor or inadequate inhaler technique not only negatively impacts treatment adherence, but means that patients do not obtain the full benefit from their medication." He added, "Our innovative approach to the development of the product means that it offers the key features required for an ideal inhaler. DuoResp Spiromax provides a valuable addition to currently available inhalation devices for the treatment of asthma and COPD. It is the first and important milestone in the rollout of our respiratory portfolio in Europe."

There are 30 million asthmatics in Europe and 82,000 hospital admissions a year costing €33.9 billion. COPD affects 23 million Europeans, resulting in 1.1 million hospital admissions annually and estimated indirect and direct costs of €48.4 billion.

Published by Globes [online], Israel business news - - on April 29, 2014

© Copyright of Globes Publisher Itonut (1983) Ltd. 2014

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