With Teva's Symbicort copy nearing EU launch, AstraZeneca preps for battle

Courtesy of AstraZeneca

AstraZeneca ($AZN) is girding itself to defend Symbicort from a generics assault in Europe. An EU drug-review committee recommended Teva Pharmaceutical Industries' ($TEVA) knockoff version of the respiratory med Friday. With key patents already expired, Teva's DuoResp Spiromax could soon put AstraZeneca's brand under siege.Teva's version likely wouldn't be substitutable, meaning the Israeli generics maker would have to mount its own marketing offensive. But Teva has plenty of motivation to help DuoResp catch on; its top-selling drug, Copaxone, goes off patent in May, and generics makers have promised immediate launch.

May is expected to be D-Day for Symbicort generics, too. Last month, AstraZeneca CEO Pascal Soriot said he's expecting European competition for the drug then, and the company's 2014 forecasts are built around that date. The European Commission still has to ratify the Committee for Medicinal Products for Human Use recommendation, but that's expected within three months.

Meanwhile, Teva has a couple of head-to-head studies with Symbicort going, which might help its version compete. (Or not, depending on the outcome.) That data is due this year. And Teva's DuoResp isn't the only threat to Symbicort. GlaxoSmithKline ($GSK) is rolling out its next generation of respiratory products, Breo Ellipta and Anoro Ellipta, aiming to backfill sales lost to generic versions of its top-selling Advair. So, Symbicort will have to contend with new branded rivals as well as Teva's copy.

AstraZeneca has been driving Symbicort market-share gains in countries outside Europe--including a 7-percentage-point gain in the U.S. last year--so growth elsewhere could counterbalance any siphoning-off by Teva's product. Stepped-up rebates and other discounts have helped Symbicort move in on Glaxo's Advair in the U.S., and the drug is also gaining ground in Japan and China. This all helped the company reap some $3.5 billion in Symbicort sales last year.

And Glaxo's experience with Advair copies could give AstraZeneca some hope. The knockoff versions haven't taken a big bite out of Advair sales, at least not yet. But unlike GSK, AstraZeneca doesn't have a Symbicort follow-up ready to go. The company's potential offering--a combination drug candidate, PT003, that it acquired with Pearl Therapeutics last year--won't be ready to go to the FDA till next year.

- read the PMLive story

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