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EMA Backs Generic Versions of AstraZeneca’s Symbicort

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Feb. 21 (Bloomberg) -- Teva Pharmaceutical Industries Ltd. won the backing of a European Medicines Agency committee for a new version of lung therapy Symbicort, paving the way for competition to one of AstraZeneca Plc’s best-selling drugs.

The generic formulation of budesonide and formoterol, to be marketed as DuoResp Spiromax and BiResp Spiromax, should be approved for the treatment of asthma and chronic obstructive pulmonary disease, the London-based EMA’s Committee for Medicinal Products for Human Use, or CHMP, said today in a statement.

The decision increases pressure on Symbicort, which generated $3.48 billion in sales for London-based AstraZeneca last year. Symbicort also faces competition from GlaxoSmithKline Plc’s Breo and generic versions of Glaxo’s Advair. The EMA committee also recommended approval of another potential Symbicort rival, Glaxo’s Anoro Ellipta, for the treatment of COPD, also known as smoker’s cough.

AstraZeneca, the U.K.’s second-biggest drugmaker, is trying to protect its respiratory franchise with PT003, a combination treatment for COPD which is in late-stage clinical testing. AstraZeneca said this month that data from the trial is expected during the fourth quarter of this year and that it could file for market approval in the U.S. next year.

The combination of two long-acting drugs in one therapy represents a new class of drugs for COPD. If successful, AstraZeneca’s PT003 treatment would compete with Anoro and Novartis AG’s Ultibro, which is already on the market in Europe, as well as a similar experimental drug from Forest Laboratories Inc.

A study of Teva’s generic version of Symbicort showed it was as effective as the brand-named drug, Bloomberg Industries wrote in a report, citing data from the European Respiratory Society conference in September.

To contact the reporter on this story: Allison Connolly in London at aconnolly4@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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