Forest outpaces major league rivals in race for a COPD drug approval

Forest Laboratories ($FRX) has taken another stride forward in its race to expand revenue from respiratory drugs. The FDA has given its blessing to Forest to start selling aclidinium for COPD in the U.S., but analysts are only expecting it to lead to a possible bump in annual revenue. And as long as it falls well short of blockbuster status, don't expect Carl Icahn to back away from his email offensive against CEO Howard Solomon anytime soon.

Forest gains access to a big market for this drug, a long-acting muscarinic antagonist, or LAMA, which will be sold as Tudorza Pressair. Some 12 million Americans suffer from COPD. Spiriva, from Pfizer ($PFE) and Boehringer Ingelheim, earns $4.4 billion a year. But Bloomberg's survey of analysts rings up a peak sale estimate for this new drug at a modest $267 million. That income can be added to revenue from Daliresp, another COPD drug Forest markets. And then there's a combo COPD drug in development, which adds formoterol to aclidinium.

"As the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option available for the millions of patients living with this serious disease," noted Solomon in a statement. 

Forest officials had sighed recently that Icahn's criticisms of Forest, part of a calculated campaign aimed at wresting control of the company from Solomon, had neglected to mention the upside of drugs like these. But with Forest's net income in free fall as its antidepressant Lexapro faces generic competition, anything less than a blockbuster earner would be unlikely to appease critics like Icahn or his confederates.

COPD may be a big market, but Forest is likely to face plenty of new competition in the not-too-distant future. GlaxoSmithKline ($GSK) and Theravance ($THRX) recently filed Relovair, a LABA drug, for approval--one of three COPD programs Theravance has in the pipeline. Their 125/25mcg combination of GSK573719, a long-acting muscarinic antagonist, and vilanterol, a long-acting beta2 agonist (LABA), bested Spiriva in a head-to-head study, with a statistically significant improvement for patients on the combo approach. Novartis ($NVS) has rested its hopes on the late-stage QVA149--though it has run into dosage issues at the FDA--while Pearl Therapeutics' PT003 has already posted positive results compared with Spiriva. Earlier this year, PhRMA found a total of 54 COPD studies in the works.  

Forest licensed in the U.S. rights to Tudorza from Almirall, which holds the rights in the rest of the world.

- here's the press release
- see the Bloomberg report