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Teva's Symbicort generic backed for EU approval

AstraZeneca braces for competition to COPD drug
Teva Pharma

AstraZeneca's combination respiratory drug Symbicort could shortly face competition in the EU after a generic version of the product from Teva was recommended for approval.

The Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Teva's DuoResp Spiromax (budesonide and formoterol fumarate dihydrate) for the treatment of patients with asthma and chronic obstructive pulmonary disease (COPD).

If approved by the European Commission, DuoResp will be a direct competitor for Symbicort, which remains one of AZ's biggest-selling products with sales rising 10 per cent to $3.48bn last year.  It will also be sold under the BiResp brand name in some markets.

Basic patents on both the active ingredients in Symbicort have expired for some time, but AZ has protected Symbicort in a number of markets using additional intellectual property, covering the use of the two drugs in combination, formulations and the inhaler device used in the product.

The combination patent expired in the EU in 2012 and is due to go in the US later this year, although AZ claims it has formulation patent valid until 2018 in the EU and 2023 in the US.

Teva has predicted strong growth for its respiratory portfolio and sees DuoResp as a flagship product in the category, according to Michael Hayden, the company's chief scientific officer. The company expects respiratory to be a "multibillion dollar franchise by the end of the decade," he added.

The firm claims the design of the Spiromax inhaler is central to that ambition, as it is easy to use and provides consistent delivery of medicine to patients.

Two ongoing phase III studies are comparing the benefits of DuoResp to Symbicort in patients with persistent asthma are expected to complete in 2014. Teva noted that the trials are not required for final approval in Europe.

Symbicort and GlaxoSmithKline's rival product Advair/Seretide (fluticasone and salmeterol) have dominated the market for combination inhaled corticosteroids/beta agonists. However, the arrival of generics - as well as a new generation of combination drugs such as GSK's Breo (fluticasone/vilanterol) and Anoro (umeclidinium bromide and vilanterol) that promise to improve efficacy – are likely to take their toll on sales in the coming years.

Last December, Denmark became the first EU country to approve a generic equivalent to $8bn-a-year Advair from Sandoz and Vectura, although analysts have predicted the initial take-up for the generic will be slow. The Advair generic, called AirFluSal Forspiro, has since been given a green light in Germany and Sweden.

AZ is developing a new generation of respiratory drugs to try to maintain its position in the respiratory category, including COPD combination therapy PT003 (glycopyrrolate and formoterol fumarate), acquired with Pearl Therapeutics last year. The drug is due to be filed for approval in 2015 in the US and 2016 in the EU.

Article by
Phil Taylor

24th February 2014

From: Sales



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