Anoro Ellipta: GSK lands a first mover in COPD

Anoro Ellipta
Project name: umeclidinium and vilanterol
Disease: COPD
Peak sales estimate: $1.4 billion
Approved: Dec. 18
Companies: GlaxoSmithKline and Theravance

The Scoop:
GlaxoSmithKline ($GSK) and Theravance ($THRX) went two-for-two in 2013, picking up FDA approvals for a pair of chronic obstructive pulmonary disease (COPD) treatments. The second, Anoro Ellipta, has the chance to make some noise as the first to market among a new class of therapies.

Anoro combines vilanterol, a long-acting beta agonist (LABA) developed by the partners, with umeclidinium, a long-acting muscarinic antagonist (LAMA). The once-a-day drug is the first LABA/LAMA cocktail approved in the U.S., and analysts figure its sales will top out at around $1.4 billion.

That's blockbuster territory, to be sure, but it won't come close to replacing the $8 billion a year GSK currently reaps from Advair, a market-leading inhaler soon to face generic competition. Furthermore, Anoro's time atop the LABA/LAMA game may be short-lived, as Novartis ($NVS) is moving toward FDA approval for its QVA149 combo, and Boehringer Ingelheim and Forest Labs ($FRX) are developing their own cocktails. And now AstraZeneca ($AZN) is crashing the COPD gates, spending $1.2 billion on Pearl Therapeutics last year to get its hands on a LABA/LAMA drug.

But there may be room for more than one blockbuster: COPD, which includes emphysema and chronic bronchitis, affects about 27 million people in the U.S. alone, and analysts expect the market to reach $14 billion by 2018 from $10 billion last year.

In the meantime, it's all good news for GSK and Theravance. After winning approval for the LABA-powered Breo Ellipta in May, Anoro's FDA nod gives the U.K. pharma giant a promising fleet of respiratory treatments for the near future, with cumulative peak sales estimated at around $2.4 billion. For the California biotech, the approval spelled a lump $30 million milestone payment, and Theravance is due another $30 million upon launch, plus a cut of sales. The string of successes has also boosted Theravance's shares, which are up about 57% since the start of 2013.

And this likely isn't the last we'll hear from the partners. Under their now 12-year marriage, GSK and Theravance are working on pipeline respiratory treatments, headlined by GSK961081, a mid-stage bifunctional muscarinic antagonist-beta agonist (MABA) that has shown promise in COPD and patients with severe asthma. -- Damian Garde (email | Twitter)

For more:
GlaxoSmithKline snags FDA approval for blockbuster COPD contender
FDA experts endorse new COPD blockbuster from GlaxoSmithKline, Theravance
Crowded field of PhIII COPD contenders will compete for blockbuster market

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Anoro Ellipta: GSK lands a first mover in COPD