Teva Pharmaceutical Industries Ltd.’s (TEVA - Free Report) DuoResp Spiromax inhalation powder is one of the most promising candidates in the company’s pipeline. The company is looking to get EU approval of DuoResp Spiromax for the treatment of patients suffering from asthma and chronic obstructive pulmonary disease (COPD) when a combination of inhaled corticosteroid and long-acting beta2-adrenoceptor (ICS/LABA) agonist is appropriate.
Last week, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion on the approval of DuoResp Spiromax inhalation powder. Teva is looking to get DuoResp Spiromax inhalation powder approved for the treatment of patients suffering from asthma and chronic obstructive pulmonary disease (COPD) when a combination of inhaled corticosteroid and long-acting beta2-adrenoceptor (ICS/LABA) agonist is appropriate.
A final verdict from the European Commission on the approval of DuoResp Spiromax inhalation powder is expected within a few months. We note that though the European Commission is not bound to follow the CHMP’s decision, it generally does so.
Teva is currently running two late-stage studies on DuoResp Spiromax versus Budesonide/Formoterol Multi-dose dry powder inhaler in patients suffering from persistent asthma. Results from these studies are expected later this year. However, these studies need not be completed in order to gain final approval.
On approval, DuoResp Spiromax will enter the ICS/LABA fixed combination inhaled market which has total product sales of $4.4 billion in the EU. The global market is worth around $13.9 billion. Separately, the COPD and the asthma markets cost €48.4 billion and €33.9 billion respectively in the EU.
We remind investors that Teva is not the only company eying the lucrative COPD and asthma markets. In November last year, the European Commission approved GlaxoSmithKline (GSK - Free Report) and Theravance, Inc.’s Relvar Ellipta for the regular treatment of asthma and for the symptomatic treatment of COPD. Glaxo and Theravance also have Anoro Ellipta and Breo Ellipta approved for the COPD indication.
We are encouraged by the positive CHMP opinion on DuoResp Spiromax’s marketing authorization. However, on approval it will be entering a highly competitive ICS/LABA fixed combination inhaled market.
Teva currently carries a Zacks Rank #3 (Hold). Some better-ranked companies include Actavis (ACT - Free Report) . Actavis is a Zacks Rank #1 (Strong Buy) stock.