Almirall Rises After Lung Disease Drug Clears FDA: Madrid Mover

Almirall SA rose the most in five months in Madrid trading after it won U.S. approval for a drug developed with Forest Laboratories Inc. to help people with a chronic lung disease breathe more easily.

Almirall gained as much as 13 percent, and traded up 11 percent at 6.26 euros as of 11:27 a.m. in Madrid. It was the biggest gain since Feb. 24.

The Food and Drug Administration cleared Tudorza Pressair for narrowing of the airways associated with chronic obstructive pulmonary disease, the agency said yesterday in a statement. The condition is typically caused by smoking and is the third-leading cause of death in the U.S., according to the National Institutes of Health.

“This is the first respiratory drug to receive first-cycle approval from the FDA,” Luis de Blas, an analyst at Banesto Bolsa, wrote in a note to investors today. “Almirall will start to receive royalties on sales in addition to the milestone payment due from Forest for approval.”

The twice-daily medicine, known as aclidinium bromide, will compete with Boehringer Ingelheim GmbH and Pfizer Inc.’s inhaled Spiriva, both of which are a non-steroidal option to AstraZeneca Plc’s Symbicort and GlaxoSmithKline Plc’s Advair. About 12 million people in the U.S. have been diagnosed with chronic obstructive pulmonary disease, which results from damage to the airways and lungs, causing coughing, wheezing and shortness of breath that becomes worse over time.

Large Market

Glaxo, based in London, is developing a once-daily treatment with South San Francisco, California-based Theravance Inc. Spiriva generated $4.4 billion in revenue last year for Boehringer, a closely held company based in Ingelheim, Germany. Tudorza Pressair may generate $267 million in 2016 for New York-based Forest, according to the average estimate of nine analysts compiled by Bloomberg.

“COPD is a very large market, similar to the way asthma is, and the market is big enough for multiple players,” Annabel Samimy, an analyst with Stifel Nicolaus & Co. in New York, said in a telephone interview before the approval.

Tudorza Pressair is not a rescue therapy to treat sudden breathing problems and isn’t recommended for people younger than 18, the FDA said. The drug also can cause serious side effects, including coughing or trouble breathing, eye pressure and urinary retention.

Forest has the rights to sell the medicine in the U.S. while Almirall, based in Barcelona, owns rights for the rest of the world.

Sales forecasts are lower than Spiriva because aclidinium bromide fills a need for new drugs yet “it’s not the most efficacious,” Samimy said.

Forest also is studying aclidinium bromide in combination with formoterol, a long-acting beta agonist that relaxes and opens air passages in the lungs. Aclidinium bromide inhibits smooth muscle contraction in the airway, making it easier to breathe.

Makiko Kitamura in London at

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