Upcoming events: FDA decisions for Incruse and Epanova

Welcome to your weekly digest of approaching regulatory and clinical readouts. US approvals are expected for GlaxoSmithKline’s LAMA monotherapy Incruse by April 30 and AstraZeneca’s hypertriglyceridaemia treatment Epanova by May 5.

Incruse is yet another addition to Glaxo’s dominant respiratory franchise. As one part of Anoro Ellipta, and with positive European opinion already in the bag, US approval looks likely. Meanwhile, AstraZeneca will be hoping that, should a green light be given for its fish oil project, it manages to avoid the market struggles of Amarin.

GlaxoSmithKline: Incruse

Incruse, known generically as umeclidinium, is a once-daily maintenance treatment for adults with COPD. It is a LAMA monotherapy delivered via the Ellipta inhaler. Anoro Ellipta, a separate project, is a combination of umeclidinium with the LABA vilanterol.

Incruse received a positive CHMP opinion in February, and was recently approved in Canada. US approval is expected before the end of April.

Boehringer Ingelheim’s Spiriva, which reported sales of $4.7bn last year, owned the LAMA monotherapy market for more than a decade, but competition is now emerging. Forest launched Tudorza Pressair in 2012 in the US and Novartis has won approval for Seebri Breezhaler in Europe; the Glaxo products will represent the first big threat to the market incumbent in the US.

Franchise

Glaxo's respiratory division remains one of its most important revenue generators, and it is clear that it will remain a central plank of the company after this week's asset swap with Novartis.

The UK company reported respiratory sales of $11.8bn last year, but little growth is forecast over the next few years and sales are seen edging only marginally higher to $12.5bn by 2018, according to EvaluatePharma. Growth of the new COPD combination drugs Anoro and Breo Ellipta are seen being offset by the pending entry of generic versions of Advair, which will itself be cannibalised by the new products.

Glaxo intends to start a phase III programme called Diamond, looking to combine an inhaled corticosteroid, LABA and LAMA in a single inhaler, and this triple combination would represent a significant advance in the respiratory space. 

AstraZeneca: Epanova

AstraZeneca gained Epanova when it acquired Omthera for an intial $323m last May. Omthera had only completed a $64m IPO the previous month (Omthera takeover leaves Amarin as last man standing, May 28, 2013).

Epanova is a free fatty acid of omega-3 oil indicated for the treatment of patients with severe hypertriglyceridaemia, whose triglyceride levels greater than or equal to 500mg/dL. The phase III trials Evolve and Esprit, the latter testing it as an add on to statins, met both primary and secondary endpoints. Epanova significantly lowered triglycerides and reduced non-HDL cholesterol.

Should approval be forthcoming, Astra will hope to avoid the travails of Amarin, whose own fish oil product, Vascepa, has been approved in the same population but has not received NCE status, restricting its market exclusivity period to three rather than five years. The FDA has also refused to grant broader approval pending the results of a long-term outcomes study due in 2016.

Omthera had said that because Epanova is a free fatty acid form of omega-3 oils, as opposed to ethyl-ester forms like Vascepa, it is eligible for NCE designation. And AstraZeneca will be starting an outcomes study called Strength shortly. According to clinicaltrials.gov this will enrol 28,890 patients with hypertriglyceridaemia and at high risk of cardiovascular disease. It will test Epanova and a statin against a statin alone. The primary completion date is 2019.

The statin Crestor, Astra's top cardiovascular medicine, sold $5.6bn last year but revenues are forecast to plummet to $2.0bn by 2018 after US patent expiry. Astra is also said to be developing a fixed-dosed combination of Epanova with Crestor.

According to EvaluatePharma, Epanova sales are expected to reach $194m by 2018, so its prospects need to improve substantially for it to help limit the loss of the blockbuster statin.

Product Study name Trial ID
Epanova  Evolve NCT01242527
Esprit NCT01408303
Strength NCT02104817

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @JoEPVantage on Twitter

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