07/23/2012 03:21 pm ET Updated Sep 23, 2012

Tudorza Pressair: COPD Drug Approved By FDA

By Anna Yukhananov

WASHINGTON, July 23 (Reuters) - Forest Laboratories Inc's inhaled treatment for smoker's cough, commonly called COPD and the fourth leading killer in America, has been approved by U.S. drug regulators, bolstering the company's plans to grow profits through new medicines.

The U.S. Food and Drug Administration approved the twice-daily drug, to be sold as Tudorza Pressair, to treat symptoms of chronic obstructive pulmonary disease (COPD), a serious lung disease that makes breathing difficult and is often caused by cigarette smoking.

Forest developed the drug, which loosens the muscles around the lungs to improve airflow, with Spanish company Almirall SA and will market it in the United States.

"The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease," said Dr. Curtis Rosebraugh, director of the FDA's Office of Drug Evaluation II.

About 14 million people in the United States and 64 million worldwide have COPD, which worsens with age and can persist even if smokers with the disease quit the habit.

The FDA was originally supposed to decide on the drug by April 23, but delayed the decision to review data. It said the drug can cause serious side effects such as increasing bronchospasm, pressure in the eyes and urinary retention.


The World Health Organization forecast that COPD could be the third-leading cause of death in the world by 2030 as more people in developing countries start smoking and smoke pollution increases. Wall Street analysts have forecast that sales of COPD treatments will exceed $5 billion in 2014.

Tudorza enters an already crowded field of COPD treatments. It will compete with Boehringer Ingelheim and Pfizer Inc's Spiriva, which is also an inhaled drug that opens airways.

Other treatments for chronic lung disease are inhaled steroids such as AstraZeneca Plc's Symbicor and GlaxoSmithKline Plc's Advair.

Aclidinium sales are expected to reach $164 million in 2015, according to analysts at Sanford Bernstein. The average forecast of analysts polled by Thomson Reuters is $248 million.

The relatively modest sales forecasts - and the widely expected approval - may explain why shares of Forest closed down 1.8 percent on Monday afternoon at $34.28.

The drug is one of several that Forest is counting on to increase profits now that its blockbuster antidepressant, Lexapro, faces generic competition. Last week, the company said profits declined 79 percent after Lexapro lost patent protection in March, with sales of the drug falling to $110 million from $585.7 million last year.

The embattled company is also facing a protracted proxy fight with activist investor Carl Icahn, Forest's second-largest shareholder, who is trying to push through his own nominees to Forest's board.