Teva's DuoResp Spiromax receives EC marketing authorization for treatment of asthma, COPD

Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the European Commission has granted marketing authorization for DuoResp Spiromax^® for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD) where the use of a combination of an inhaled corticosteroid and long-acting beta₂-adrenoceptor agonist is appropriate.

DuoResp Spiromax^® is a new, multi-dose dry-powder inhaler containing a Fixed Dose Combination (FDC) of budesonide, an inhaled corticosteroid to treat 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.

"We are delighted to receive approval for DuoResp Spiromax^®," said Rob Koremans, M.D., President and CEO, Teva Global Specialty Medicines. "This is a major advance in inhalers - the need for more intuitive devices is critical and has been highlighted by healthcare professionals and patient groups. 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."

Koremans added, "We are extremely proud of Spiromax. 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."

DuoResp Spiromax^® has been demonstrated to be therapeutically equivalent to the well-established budesonide/formoterol combination. The Spiromax inhaler uses a unique technology to deliver a consistent, effective and accurate dose.

Inhaled therapy with fixed dose combinations of inhaled corticosteroids and long-acting beta-agonists is an important step in achieving good asthma and COPD control. However a substantial percentage of users of inhalers worldwide have inadequate inhaler technique and increased inhalation errors.

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.

Two Phase III trials in patients with persistent asthma are ongoing in Europe to compare the benefits of DuoResp Spiromax and a budesonide/formoterol multi-dose dry powder inhaler. Both studies are expected to report out in 2014.