Novartis has bought a pair of biotech assets, adding more candidates to its medicines pipeline as the year starts to draw to a close.
The Swiss pharma major is paying $50m upfront to license a non-alcoholic steatohepatitis (NASH) drug candidate developed by Californian firm Conatus Pharmaceuticals and buying out Texas-based eye disease specialist Encore Vision for an undisclosed amount. Both deals involve first-in-class medicines for disorders that currently have no treatment options.
The takeover of Encore gives Novartis rights to EV06 (lipoic acid choline ester), a disease-modifying treatment for age-related loss of near distance vision (presbyopia) that can be delivered in an eyedrop formulation. Presbyopia affects 80% of people aged over 45 and makes everyday tasks such as reading challenging.
At the moment people with presbyopia can use glasses to manage the progressive condition, but at the moment there is no treatment that can prevent the loss of vision getting worse or – potentially – reverse the decline. EV06 is designed to increase the elasticity of the lens of the eye by reducing protein disulphide groups that stiffen its structure.
In a phase I/II trial, EV06 promised to do just that, achieving a statistically significant improvement in distant corrected near vision compared to placebo after 90 days’ treatment. All told, 82% of the EV06-treated group scored 20/40 for near vision on eye tests, compared to 48% of those on placebo.
EV06 will flesh out the pipeline of Novartis’ Alcon eyecare division, which has been underperforming of late, leading to rumours of a possible sale. Those only gathered pace after a late-stage setback for age-related macular degeneration (AMD) therapy Fovista (pegpleranib), which was licensed by the company in 2014 in a deal valued at up to $1bn.
The Conatus licensing deal brings in another candidate vying to grab a slice of the market for non-alcoholic fatty liver disease (NAFLD) treatments, which analysts have predicted could become a $35bn to $40bn market by 2025 with NASH accounting for the lion’s share of the sector.
These diseases often progress to liver cirrhosis, which kills 32,000 people in the US a year and can only be treated effectively with a liver transplant. By 2020, the leading cause of liver transplants is expected to be NASH.
Novartis is already active in this area with its farnesoid X receptor (FXR) agonist programme – currently headed by LJN 452 – and the Conatus deal brings in an oral pan-caspase inhibitor called emricasan.
Under the terms of the deal, Conatus will conduct phase IIb trials with emricasan in NASH and – if all goes according to plan – Novartis will take over phase III development of the drug both as a single treatment and sin combination with its FXR agonist.
Conatus already has a body of trial data from phase II trials of emricasan across a broad range of liver diseases, with data suggesting the drug can achieve “significant, rapid and sustained reductions in elevated levels of key biomarkers of inflammation and cell death”.
Conatus has the option to co-commercialize emricasan in US. Shares in the company doubled in the wake of the announcement.