Breo Ellipta: Victory No. 1 for a respiratory superteam

Breo Ellipta
Project name: vilanterol and fluticasone furoate
Disease: COPD
Peak sales estimate: $1 billion
Approved: May 10
Companies: GlaxoSmithKline and Theravance

The Scoop:
Partners GlaxoSmithKline ($GSK) and Theravance ($THRX) had been toiling away since 2002 when they finally hit pay dirt in their respiratory alliance, winning the FDA's blessing for a once-a-day treatment with the promise of relieving symptoms for millions of chronic obstructive pulmonary disease (COPD) sufferers and helping GSK absorb the pain of the soon-to-go-generic Advair.

The inhalable drug Breo Ellipta combines the already-approved corticosteroid fluticasone furoate with a long-acting beta agonist (LABA) called vilanterol, which the partners co-discovered. In tandem, the active ingredients work to decrease inflammation in the lungs and help keep surrounding muscles relaxed to increase airflow in patients with COPD.

Like all LABA treatments, Breo carries a boxed warning over its risks of asthma-related death, but few expect those worries to scare off physicians, and analysts figure Breo will rake in up to $1 billion by 2018.

That's welcome news for Theravance, which is due a 15% royalty on any drug born out of the partnership, and even more so for GSK, which is working to build a respiratory failsafe to ward off the effects of Advair's patent loss. That drug still brings in about $8 billion a year for the U.K. pharma giant, and while Advair's delivery mechanism has so far thwarted would-be generics makers, GSK knows it needs to diversify if it wants to keep its respiratory revenue even remotely intact.

COPD affects about 27 million people in the U.S. alone, GSK says, and Citigroup estimates the market for treatments will soar from $10 billion this year to $14 billion in 2018. The Theravance partnership has put GSK in the lead among COPD drug developers, but its competitors are hardly sitting idle. Novartis ($NVS) and Boehringer Ingelheim are in the midst of late-stage studies for new treatments, and AstraZeneca ($AZN) made a splash with its $1.2 billion Pearl Therapeutics buyout last year, elbowing its way into the world of next-generation COPD treatments.

Breo's success is only round one for GSK and Theravance. Just over 6 months after that approval, the duo won an FDA nod for Anoro Ellipta, the first once-a-day COPD cocktail to combine a LABA drug with a long-acting muscarinic antagonist (LAMA). That treatment is expected to top out around $1.4 billion a year, giving GSK reason for optimism about its 2014 respiratory sales. Meanwhile, the partners are working through clinical studies for a spate of pipeline lung drugs, including the mid-stage GSK961081, a bifunctional muscarinic antagonist-beta agonist (MABA) for COPD and patients with severe asthma. -- Damian Garde (email | Twitter)

For more:
GlaxoSmithKline gains blockbuster FDA approval of lung drug Breo
GlaxoSmithKline picks up FDA panel plug for Breo approval
GlaxoSmithKline snags FDA approval for blockbuster COPD contender

Breo Ellipta: Victory No. 1 for a respiratory superteam

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