Teva targets GlaxoSmithKline's Advair with US launch of AirDuo RespiClick

Teva announced the launch in the US of AirDuo RespiClick (fluticasone/salmeterol), along with its authorised generic version, for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an inhaled corticosteroid (ICS) or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist combination. The drugmaker noted that the fixed-dose combination products contain the same active ingredients as GlaxoSmithKline's Advair.

AirDuo RespiClick, as well as Teva's ArmonAir RespiClick (fluticasone), which contains the same active ingredient as GlaxoSmithKline's Flovent, were approved by the FDA in January. Rob Koremans, CEO of the Israeli company's global specialty medicines unit, said the "launch marks…the first available generic ICS/LABA product in the US," which is delivered via the RespiClick breath-activated, multi-dose dry powder inhaler.

According to Teva spokeswoman Michelle Larkin, AirDuo RespiClick will cost wholesalers or direct purchasers $285, while the generic version will be priced at $90. The Israeli drugmaker said it "is launching both products at the same time in an effort to address the need for more affordable asthma treatment options in the US."  Teva added that it "expects that sales of the authorised generic will represent most of the sales of the two products."

Bernstein analyst Erica Kazlow noted that the pricing of the branded product was in line with that of its peers. "Teva's willingness to use generic strategy for the product is encouraging as it relates to the company's willingness to look at a tough reality and take appropriate action," Kazlow added. Meanwhile, Raymond James analyst Elliot Wilbur suggested that "there should be sufficient time window for AirDuo to be the sole competing product to Advair," estimating that Teva's product will capture 25 percent of the market by 2018.

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Advair, which is also approved as a treatment for chronic obstructive pulmonary disease, generated sales of 1.8 billion pounds ($2.3 billion) last year in the US. Commenting on the launch of Teva's products, GlaxoSmithKline spokeswoman Sarah Alspach said "neither branded AirDuo, nor its authorised generic are therapeutically equivalent or substitutable for Advair." The company has previously estimated that if a generic version of Advair is launched in the US by the middle of the year, sales of the product in the country will decline to about 1 billion pounds ($1.3 billion) for 2017.

In March, the FDA issued a complete response letter regarding Mylan's filing to market a generic version of Advair. Meanwhile, Hikma Pharmaceuticals and Vectura are expecting approval for their generic version of GlaxoSmithKline's product by May 10. For related analysis, see ViewPoints: GlaxoSmithKline, Innoviva, Teva and Hikma toast to Mylan’s misfortune with Advair generic.

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