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Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair

Almirall has opened a new affiliate in Toronto, Canada. Having a presence in Canada will help the company roll out its recently approved aclidinium DPI for COPD, among other drugs, Almirall says. The company will co-market aclidinium as Tudorza Pressair with Forest Laboratories. In Europe, aclidinium bromide inhalers are being marketed as the Eklira Genuair and Bretaris Genuair.

Almirall CEO Eduardo Sanchiz commented, “Almirall will now have the opportunity to make directly available to Canadian patients a range of innovative medicines, especially in the respiratory and dermatology fields. This is another milestone in our internationalisation process: a substantial challenge that we take on with enthusiasm.”

Almirall also has presented data from two Phase 3 studies, one that demonstrated statistically significant improvement in 24-hour FEV1 compared to placebo, and another that showed patient preference for the Genuair device compared to the HandiHaler.

The six-week efficacy, safety, and tolerability study compared 400μg inhaled aclidinium twice daily to tiotropium 18μg once daily and placebo in patients with moderate-to-severe COPD. According to the company, aclidinium showed superiority to placebo beginning on the first day of the study and to tiotropium for the first 24 hours.

The patient preference study showed that almost 80% of patients preferred the Genuair inhaler to the HandiHaler, and only about 10% of patients made critical errors using Genuair compared to about 27% of patients making one or more critical errors with the HandiHaler.

Chief Scientific Officer Bertil Lindmark said, “The reliable bronchodilation and symptom improvements demonstrated by Eklira Genuair (aclidinium) during the day and at night provide a new valuable treatment option to COPD patients. The Genuair inhaler delivers this in an easy to use device, which patients prefer and can handle easily.”

Read the Almirall press release on the Canadian affiliate.

Read the Almirall press release on the Eklira Genuair studies.

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published on September 5, 2012

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