Welcome to your weekly digest of approaching regulatory and clinical readouts. The FDA decision for Valeant’s (NYSE:VRX) Vesneo in glaucoma is fast approaching and by July 21 the company could have approval. This project faces a competitive market and pricing pressure from generics will be intense.
Meanwhile, the results of two studies of fostamatinib in immune thrombocytopenic purpura are expected shortly. Fostamatinib has been a big disappointment in the clinic and was previously abandoned in rheumatoid arthritis; Rigel has however ploughed on with its development and will be hoping it has not all been for nothing.
Given all that has happened with Valeant in the past eight months, the FDA decision deadline for Vesneo seems rather routine. But the speciality pharma could use a dose of good news on the product side, and the glaucoma drug seems poised to deliver just that.
Valeant acquired rights to Vesneo through its 2013 acquisition of Bausch + Lomb, and originator Nicox has exercised US co-promotion rights.
In two phase III glaucoma trials Vesneo hit the primary endpoint of non-inferiority to the generic beta-blocker timolol on the reduction of mean intraocular pressure (IOP). The result was not surprising because Vesneo, known generically as latanoprostene bunod, is a prostaglandin, and these molecules are known to be more potent than beta-blockers.
More importantly a phase IIb study showed superiority to Xalatan, the off-patent original formulation of latanoprost. The greater efficacy is believed to be due to the addition of a nitric oxide donating moiety provided by Nicox’s technology, which also has an IOP-reducing benefit.
The commercial challenge will be for a new glaucoma drug to prove itself in a crowded market with numerous generic options and combat Allergan’s (NYSE:AGN) dominance in the branded space (Despite blockbuster hopes Valeant’s glaucoma drug will have to fight for share, September 25, 2014). Sales of marketed glaucoma drugs are expected to shrink by 2% a year between 2015 and 2022, so the partners will have some work to do. EvaluatePharma forecasts Vesneo sales of $336m in 2022.
FIT but you know it
The phase III programme called FIT is testing fostamatinib in immune thrombocytopenic purpura, an autoimmune disease leading to reduced platelet counts with symptoms ranging from mild bruising to severe bleeding. The two identical trials have enrolled 75 adult patients each.
The primary endpoint is a stable platelet response by week 24 with platelet counts at or above 50,000 per microlitre of blood for at least four of the final six qualifying blood draws. The company plans to file in the first quarter of next year if the FIT trials are positive.
Fostamatinib is a spleen tyrosine kinase inhibitor and will, if approved, likely be used in a third-line setting behind first-line corticosteroids or intravenous immunogloblins and second-line Rituximab or splenectomy.
It was initially being developed in rheumatoid arthritis but phase III trials were terminated in 2013 due to lack of efficacy and AstraZeneca (NYSE:AZN) subsequently returned its rights (Rigel falls to earth as fosta is returned, June 4, 2013).
This did not deter Rigel, although forecasts now sit at $153m by 2022 according to EvaluatePharma consensus. 2018 sales were once pegged at nearer $500m showing just how far it has fallen.
As of the end of March Rigel had $103.6m in cash – sufficient to fund operations into the third quarter of 2017. Rigel has suffered previous pipeline setbacks including R343 in asthma and R348 in dry eye disease, and so far this year shares are off nearly 25%. Some good news is very much needed.