Forest Laboratories Inc. (FRX:US) and Almirall SA (ALM) won approval for a drug to help people with a chronic lung disease breathe more easily, U.S. regulators said.
The Food and Drug Administration cleared Tudorza Pressair for narrowing of the airways associated with chronic obstructive pulmonary disease, the agency said today 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.
The twice-daily medicine, known as aclidinium bromide, will compete with Boehringer Ingelheim GmbH and Pfizer Inc. (PFE:US)’s inhaled Spiriva, both of which are a non-steroidal option to AstraZeneca Plc (AZN)’s Symbicort and GlaxoSmithKline Plc (GSK:US)’s Advair. About 12 million people in the U.S. are 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.
“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.
Glaxo, based in London, is developing a once-daily treatment with South San Francisco, California-based Theravance Inc. (THRX:US) 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 (FRX:US) of nine analysts compiled by Bloomberg.
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 fills a need for new drugs yet “it’s not the most efficacious,” Samimy said. Patients who took the highest dose in studies also may have increased heart risks.
While not a major revenue generator, Tudorza Pressair may help Forest become a bigger player in the chronic obstructive pulmonary disease market.
“It seems like a strategic play to have more of a presence in the respiratory space,” Samimy said.
Forest also sells Daliresp, approved last year, for adults with a severe form of the lung disease. The drug is marketed mainly to pulmonologists. Daliresp had about $18 million in revenue (FRX:US) in the company’s fiscal first quarter ended June 30, according to data compiled by Bloomberg.
Forest also is studying aclidinium in combination with formoterol, a long-acting beta agonist that relaxes and opens air passages in the lungs. Aclidinium inhibits smooth muscle contraction in the airway, making it easier to breathe.
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