European regulatory authorities gave Teva ($TEVA) a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease (COPD). With the recommendation from the Committee for Medicinal Products for Human Use (CHMP), Teva hopes to have final approval within a few months.
Teva is testing its inhaler in two late-stage trials that are expected to be completed this year but that aren't required for the final market approval. DuoResp is a generic knockoff of AstraZeneca's ($AZN) Symbicort. The trials will pit Teva's version head-to-head against the branded incumbent.
The DuoResp Spiromax inhaler uses the corticosteroid budesonide to treat inflammation associated with the lung conditions, as well as the beta-2 agonist formoterol fumarate dihydrate to relieve constriction of the airways. Like Symbicort's Turbuhaler, DuoResp's Spiromax, the inhaler, uses breath-actuated technology to deliver a consistent dose of the dry powder.
For many patients with restricted airways, a normal inhaler can pose some problems with dosage, as the inhaler doesn't account for their limited breath. With breath-actuated technology, a patient's own respiratory rhythm gives the inhaler the power it needs to deliver the dose in a predictable way.
With key patents associated with Symbicort already expired, Teva is looking to fill that gap with its new inhaler. Analysts at Citigroup have reportedly given DuoResp a $350 million peak sales estimate for Europe, a mere fraction of Symbicort's $1.5 billion.
And according to a Zacks report this week, Teva is already a little behind in the asthma and COPD market with the November EU approval of GlaxoSmithKline's ($GSK) and Theravance's ($THRX) Relvar Ellipta, as well as their Anoro Ellipta and Breo Ellipta. So the competition could be rough for Teva as it enters the market.
"We have planned for strong growth in Respiratory," Teva Chief Scientific Officer Michael Hayden said in a statement. "The Spiromax inhaler is an important addition to our respiratory portfolio and supports our strategy to become a leading presence in Respiratory with a robust and differentiated pipeline, projected to be a multibillion dollar franchise by the end of the decade."
Teva expects DuoResp Spiromax to enter the market, upon approval, in the combination inhaled segment worth about $4.4 billion in Europe and $13.9 billion worldwide.
- here's the release
- and the Zacks report
- read Citigroup analysts' comments via ValueWalk
- get FiercePharma's take