CORRECTED-UPDATE 2-FDA reviewers give mixed views on Glaxo lung drug
FDA reviewers say data for Glaxo's BREO not consistent
8:30am EDT
Mon Apr 15, 2013 11:30am EDT
(Changes headline to reflect that FDA reviewers, not advisory panel, gave opinion on drug)
* FDA reviewers: efficacy data not entirely consistent
* Say safety data generally consistent with other products
* Analysts interpret FDA reviewer opinions positively
* Theravance shares up 22 pct; Glaxo up 3.7 pct
By Toni Clarke
WASHINGTON, April 15 (Reuters) - Reviewers for the U.S. Food and Drug Administration said on Monday that efficacy data for an experimental drug made by GlaxoSmithKline Plc and Theravance Inc was somewhat inconsistent but that its overall safety appears consistent with similar drugs, a relief to investors.
GSK's shares were up 3.7 percent at 1,628 pence on Monday while shares of the smaller Theravance were up 22 percent at $28.98.
The drug, Breo, treats a lung disease that causes breathing difficulties and includes chronic bronchitis, emphysema, or both.
The reviewers' opinions were posted on the FDA's website ahead of a meeting scheduled for Wednesday in which a panel of expert advisers will discuss the drug and recommend whether it should be approved. Their views were interpreted in a generally positive way by investment analysts.
"The FDA review is benign and a relief given the issues that emerged in this clinical trial programme," said Alistair Campbell, an analyst at Berenberg Bank in a research note.
Breo is made up of 100 micrograms of a corticosteroid, fluticasone furoate (FF), and 25 micrograms of a long-acting beta-agonist, or LABA, called vilanterol (VI). The drug is administered via a new dry powder inhaler called Ellipta.
The FDA's advisory panel will be examining whether the benefits of Breo outweigh the risks, and whether the drug combination confers additional benefit over and above the LABA component alone.
"On the positive side, the FDA appears happy with the dosing for Breo, which has marginally increased the probability of approval in our opinion," said Jeffrey Holford, an analyst at Jefferies, in a research note. He estimates peak annual sales of the drug in COPD of $1.5 billion.
COPD refers to a group of lung diseases that block airflow and make breathing difficult. Emphysema, which is most frequently caused by smoking, and chronic bronchitis, an inflammation of the lining of the bronchial tubes, are the two most common conditions that make up COPD.
COPD became the third-leading cause of death in the United States in 2008, according to the U.S. Centers for Disease Control and Prevention, affecting more than 12 million Americans.
The reviewers questioned the contribution of the corticosteroid in improving lung function, saying the data was inconsistent, though they suggested the data appears to support a benefit in limiting COPD exacerbations.
They said the drug's safety profile appears generally consistent with that of similar drugs, though they pointed out an increase in cases of pneumonia and fractures.
"The main question mark appears to be the relative benefit of adding a steroid onto the bronchodilator," said Berenberg's Campbell.
He said he expects the advisory panel meeting "may be less contentious than feared and this should give Breo a very good chance of a positive recommendation."
Glaxo owns 27 percent of Theravance and speculation has risen that Glaxo might buy the remaining 73 percent in order to gain full control of their portfolio of jointly developed respiratory drugs.
The market for COPD drugs has until now been dominated by Glaxo's Advair and Pfizer Inc's Spiriva. Glaxo is seeking a successor to Advair, its twice-daily medication for COPD and asthma which generates some $8 billion a year. (Editing by Maureen Bavdek and Matthew Lewis)
