GSK gets FDA approval for COPD drug

GSK gets FDA approval for COPD drug

Steve’s breakdown: COPD drugs spend a lot of cash and this one will be no different. We believe their Phily office will be handling the account. Their number is 215-751-5000.

PHILADELPHIA, PA: The US Food and Drug Administration on Friday approved Breo Ellipta (fluticasone furoate, an inhaled corticosteroid, and vilanterol inhalation powder, a long-acting beta2-adrenergic agonist), from UK pharma giant GlaxoSmithKline (LSE: GSK) and US biotech firm Theravance (Nasdaq: THRX).

The drug was cleared for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. The FDA decision was largely expected, given the positive backing from the agency’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) last month (The Pharma Letter April 18).

Breo Ellipta sales forecasts range from $560 million to $4 billion

Theravance shares rose as much as 14% in afternoon trading on Friday. GSK’s stock was up less than 2% in afternoon trading Friday on the news, perhaps because the estimated $560 million in peak sales would be just a drop in the ocean in its $42 billion annual revenue stream, commented the Investors Business Daily. Some observers have suggested that Breo Ellipta could bring in sales of over $1 billion. Ian Somaiya, a senior research analyst with Piper Jaffray & Co quoted by Bloomberg, is even more optimistic, saying that global sales could peak at $4 billion, translating into $500 million in royalties for Theravance.

Breo (trade name Relvar ex-USA) will enter a market sector where GSK’s own asthma and COPD drug Advair (fluticasone and salmeterol) generated around $8 billion). It would also compete with AstraZeneca twice-a-day Symbicort (corticosteroid budesonide and formoterol) inhaled treatment. GSK and Theravance are hoping the once-daily delivery of Breo will make their drug more attractive to patients.

Darrell Baker, senior vice president and head of the GSK Global Respiratory Franchise, said: “This approval means that we can now realize our plan to bring Breo Ellipta to appropriate COPD patients in the USA. We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation.”

US launch anticipated in third-quarter 2013

Following this approval by the FDA, it is anticipated that Breo Ellipta REO will be available in the USA during the third quarter of 2013. Under the terms of the 2002 LABA collaboration agreement, Theravance is obligated to make a milestone payment of $30 million to GSK on FDA approval of the product.

“COPD is a serious disease that makes breathing difficult,” said Curtis Rosebraugh, director, Office of Drug Evaluation II, Center for Drug Evaluation and Research, at the FDA, adding: “The availability of new long-term maintenance medications provides additional treatment options for the millions of Americans who suffer with COPD.”

The drug carries a boxed warning that long-acting beta2-adrenergic agonists (LABAs) increase 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 approved Breo Ellipta with a patient medication guide that includes instructions for use and information about the potential risks of taking the drug.

Royalties for Skyepharma

Breo Ellipta incorporates one of UK-based Skyepharma’s (LSE: SKP) proprietary dry powder formulation technologies for inhalation products licensed to GSK. Skyepharma is entitled to a low single digit royalty on net sales of products using the licensed technology.

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ACLink: [acLink name=”GlaxoSmithKline, Inc.” type=”advertiser” id=”a2Zpnas=”]

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