Teva's Advair rival joins the hopefuls gunning for GSK's blockbuster sales

Teva

Welcome to the Advair challenger queue, Teva.

The Israeli drugmaker Tuesday announced that the FDA had accepted its approval application for a competitor to the GlaxoSmithKline respiratory blockbuster, and the company should have a verdict on its submission by the first quarter of next year, it said.

As Evercore ISI analyst Umer Raffat explained in a note to clients, the Teva product isn’t an exact replica of Advair--though “that will come later,” he noted.  Teva’s candidate delivers the same drug as Advair--an ICS/LABA combo of fluticasone propionate and salmeterol--though it’s a lower dose of salmeterol. And instead of using Advair’s hard-to-copy Diskus device, it uses Teva’s Respiclick inhaler. Teva’s AB rated Advair generic--still in the works--will use a Diskus copy.

Still, Teva’s product will go up against the aged GSK giant--and its knockoffs, when they hit the scene. Fierce rival Mylan, for one, saw its application accepted by U.S. regulators in February, and it’s expecting a decision by March 28. A rival version from U.K.-based Vectura and Jordan’s Hikma Pharmaceuticals isn’t far behind, with its own decision date scheduled for May 10.

Teva may be able to carve out a place in the sun, though, considering that LABAs have known side effects in asthma--meaning its med may trigger fewer of them with a lower LABA dose. Establishing a safety benefit would require a mammoth trial, though, and in the absence of one, “commercial opportunity will have to rely on ‘perception’ of safety … rather than actual clinical data,” Raffat has said.

- read Teva's release 

Special Reports: The 10 best-selling drugs of 2013 - Advair/Seretide | Top 20 generics companies by 2014 revenue - Teva 

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