Despite blockbuster hopes Valeant’s glaucoma drug will have to fight for share
Valeant sees a bright future for a novel formulation of the off-patent glaucoma treatment, Xalatan. Alongside the release of positive top-line results from two pivotal studies of the drug, the company reiterated its forecast that global peak sales could top $1bn.
Generating demand anything close to this will depend on whether the product, now dubbed Vesneo, can demonstrate advantages over the cheap incumbents, and on this the data looks encouraging. But even so, for a product that will enter a heavily genericised market this is a bold projection and even typically bullish sell-side analysts are taking a much more conservative view (see table below).
Given Valeant’s current situation it is perhaps not surprising it is emphasising the bull case for its top line. But many analysts have yet to even assign a contribution from the product, acquired with Bausch + Lomb, to their models. Of those that have UBS forecasts sales of $50m in 2020, while ISI Group has peak sales of $150m.
The release of phase III data could change that, although the full results will not become available until 12 months of safety data is collected. And given that tolerability as well as efficacy will play a big part in positioning this product, some may choose to wait for a fuller picture.
The top-line data showed that the two identical studies, called Apollo and Lunar and which enrolled 840 patients, met the primary endpoint of demonstrating non-inferiority to the generic beta-blocker timolol. Vesneo, or latanoprostene bunod, showed a reduction in mean intraocular pressure (IOP) of 7.5 to 9.1 mmHg from baseline between two and 12 weeks of treatment in the two studies, statistically better than the result achieved by timolol.
This is not a surprising finding as the prostaglandin class, to which Vesneo belongs, is suspected to be more potent than beta blocker on this measure. Which in turn raises the question of why the pivotal studies were conducted versus a different class, rather than the original formulation of latanoprost, the former Pfizer blockbuster Xalatan.
Vesneo was developed using nitric oxide-donating technology from the French drug company Nicox and is believed to act via both the prostaglandin and NO pathways, enhancing the compound’s mechanism of action. It was licensed to Bausch + Lomb in 2010 and hence is now in Valeant’s hands.
Gavin Spencer, head of corporate development at Nicox, says the trial designs were approved by the FDA, and that previously-approved glaucoma drugs have all been tested against beta blockers in phase III.
An earlier phase IIb was study was conducted against latanoprost, he points out, in which Vesneo demonstrated better efficacy. “It showed a significant improvement over latanaprost on both in mmHG [a measure of pressure in the eye] and the percentage of patients reaching target IOP,” he says.
Safety was comparable between the two groups, and today Valeant reported no significant safety findings in either phase III study.
Mr Spencer declined to comment on how Valeant might chose to position Vesneo on the market. However the results suggest the message will be one of greater efficacy.
Nicox has a considerable vested interest in this message – it recently moved to exercise an option to co-promote the drug in the US and Nicox shares surged 26% to €2.73 in afternoon trading, a seven month high, on the results today. Vesneo is the most advanced product in its pipeline.
Still, launch is some way away. A filing is planned for the middle of next year, which would see a market debut well into 2016. By this time there will be few branded competitors in the glaucoma space. Merck & Co’s Zioptan, another prostaglandin, was the most recent entrant in 2009 but it has made little impact on the market.
Vesneo will arguably have more motivated marketers and Valeant is already a strong player in this space so must know it well. But however good the data – and most of that remains to be revealed – the pricing pressure exerted by generics will be intense.
|The branded glaucoma market from peak in 2010 - selected products|
|Annual sales ($m)|
|Product||Company||Pharmacological Class||Patent Expiry||2010||2014||2018||2020|
|Combigan||Allergan||Alpha 2 blocker & beta blocker||Jan '23||171||277||332||360|
|Xalatan||Pfizer/Valeant US co-promote||Prostaglandin||Dec '12||1,749||502||339||294|
|Alphagan||Allergan||Alpha 2 blocker||Oct '09||231||217||221||216|
|Trusopt||Merck & Co||Carbonic anhydrase inhibitor||Oct '08||484||348||171||142|
|Simbrinza||Novartis||Carbonic anhydrase inhibitor & alpha 2 blocker||Dec '19||-||43||92||105|
|Azarga||Novartis||Beta blocker & carbonic anhydrase inhibitor||-||10||55||75||85|
|Zioptan||Merck & Co||Prostaglandin||Dec '22||20||45||66||73|
|Azopt||Novartis||Carbonic anhydrase inhibitor||Apr '13||67||280||110||50|
|Total market (excl generics, includes NDAs)||4,646||3,810||3,115||3,295|