By Anna Yukhananov
WASHINGTON, July 23 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.
WORLD'S THIRD KILLER
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
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