It might be another bad year for GlaxoSmithKline on the compliance front, but on the new products side the London-based group is experiencing a pretty good run. Relaxed US approvals for its melanoma drugs Mekinist and Tafinlar and HIV drug Tivicay, along with the defence of its respiratory franchise, have pushed shares up 24% in 2013 in a buoyant year for pharma and biotech.
The second phase of the respiratory defence will get a hearing soon with an FDA advisory committee of the combination project Anoro Ellipta in chronic obstructive pulmonary disease (COPD). With the US regulator signing off on both the Ellipta device and the long-acting beta agonist (LAMA) component in its Breo approval, the remaining questions are likely to focus on dosing for the long-acting muscarinic (LAMA) ingredient, umeclidinium.
|% of market cap||2%|
|Event||FDA advisory committee|
|Date||September 10, 2013|
Anoro could become the first branded combination of products from those two classes to be launched in the US. The COPD market has been well served by GSK’s Advair, the combination LABA/steroid that pulls in about 42% of its $8.2bn in forecast 2013 sales in the setting, with competition from Boehringer’s single-agent LAMA Spiriva, at a forecast $2.31bn in sales in 2013, according to EvaluatePharma’s consensus.
Patent expiries are creeping up on both products – Advair goes in 2016 and Spiriva in 2018 – although the patents on inhaler devices adds an element of market protection not offered by pills. Analysts expect some decline in Advair’s sales by 2018, although this will probably be the result of switching to Breo and Anoro in addition to generic competition.
Getting the LABA/steroid Breo registered earlier this year was an important step towards approval of the combination (Breo breezes past adcom and affirms GSK’s COPD lead, April 18, 2013). The worry is that Breo does not offer much differentiation from Advair, and thus would struggle against generics.
Anoro, on the other hand, can take share from multiple categories, write analysts from JP Morgan. As such, it represents a much more important bulwark against the generic threat.
Positive adcom votes and FDA approval are seldom a sure thing, and in respiratory care the scrutiny is strong because of heightened safety worries with the LABA class in particular (New LABA warnings unlikely to make big players pause for breath, June 3, 2010). Of course, Breo approval should put that worry to rest, but there are other issues that could trip up Anoro.
The first is dosing, with the once-daily measure of umeclidinium in monotherapy showing only limited efficacy over smaller puffs taken twice daily. FDA’s focus on the lowest necessary dose poses some risk here; it was this issue that tripped up Novartis and its newest respiratory products in the US (Vectura COPD news hiccup not trip up, October 26, 2011). Its LAMA monotherapy, Seebri Breezhaler, has received European Union approval, and the combination QVA149, now known as Ultibro Breezhaler, has European Medicines Agency backing.
The JP Morgan analysts do not believe that the dosing question will ultimately hold up Anoro, as the FDA accepted the filing while it would not even look at Novartis’s application without additional data. In addition, they note that the pulmonary response profile of Anoro is similar to Spiriva’s, supporting approval.
Cardiovascular worries could also arise at the meeting, as muscarinic receptors are also found in the heart. In addition, there could be some question as to the benefit the combination offers over monotherapy.
With expectation building that Anoro will pass the advisory committee’s muster, Glaxo has more to lose from a protracted debate than it has to gain from a relatively quiet passage. The UK group could use this win, though – while Advair might be resistant to generic competition, this cannot last forever.