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FDA approves Glaxo/Theravance drug for COPD lung disease

By Toni Clarke

(Reuters) - The Food and Drug Administration has approved a new drug to treat chronic obstructive pulmonary disease, a condition often associated with smoking that can include emphysema, chronic bronchitis, or both.

The drug, Breo, is an inhaled treatment made by British drugmaker GlaxoSmithKline Plc and Theravance Inc of the United States. It consists of a corticosteroid, fluticasone furoate, which reduces inflammation, and a novel long-acting beta-agonist, called vilanterol, which is designed to open the airways. The product is inhaled through a palm-sized device called Ellipta.

COPD is the third-leading cause of death in the United States, according to federal data.

Theravance shares were up 11 percent to $34.78 in afternoon trading. Glaxo's U.S. shares rose 1.95 percent to $51.69.

Breo, or Relvar as it would be called if approved outside the United States, will compete with GlaxoSmithKline's twice-daily asthma and COPD drug Advair, a roughly $8 billion-a-year drug that contains the steroid fluticasone propionate and the long-acting beta-agonist salmeterol.

Analysts on average expect the drug to generate annual sales of $559 million by 2015, according to Thomson Reuters data.

Breo would also compete with AstraZeneca Plc's twice-a-day Symbicort, an inhaled combination of the corticosteroid budesonide, and the long-acting beta-agonist formoterol. Glaxo and Theravance are hoping the once-daily delivery of Breo will make their drug more attractive to patients.

The drug carries a boxed warning, the most serious possible, about the risk of long-acting beta-agonists in increasing the risk of asthma-related death.

"The safety and efficacy of Breo Ellipta in patients with asthma have not been established and it is not approved for the treatment of asthma," the FDA said in a statement.

Potentially serious side effects associated with Breo include a heightened risk of pneumonia and bone fractures, the FDA said. The most common side effects reported by patients were inflammation of the nasal passage, upper respiratory tract infections, headache and oral candidiasis, also known as thrush.

The approval, which follows a more favorable-than-expected review by an FDA advisory panel, could increase investor optimism about another, potentially more profitable, COPD drug the two companies are developing called Anoro. The drug is an inhaled combination of vilanterol and umeclidinium, a long-acting muscarinic receptor antagonist, which works to relax the airways and improve lung function.

Analysts expect Anoro, if approved, to generate peak annual sales of nearly $1.4 billion, according to Thomson Reuters.

The approval of Breo comes just weeks after Theravance said it would split into two publicly traded companies, separating the more advanced respiratory drugs it is developing with Glaxo from its other operations. The move fueled speculation that Glaxo, which owns 27 percent of Theravance, could eventually buy Theravance's most lucrative products.

After the split, the company holding the respiratory drugs franchise will be called Royalty Management Co. The second company, called Theravance Biopharma, will focus on development of drugs for rare diseases.

Shares of Theravance rose as high as $35.80 earlier in the day.

(Reporting by Toni Clarke in Washington; Editing by Matthew Lewis, Steve Orlofsky and Carol Bishopric)

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