Nicox eyes partner after first approval
After 20 years Nicox finally has an FDA approval under its belt, for the topical antihistamine Zerviate for ocular itching. But it cannot relax just yet – the next challenge will be finding a US partner.
Ideally, Nicox will team up with a company with access to both the ophthalmology market and the primary care sector, Gavin Spencer, the company's executive vice-president of corporate development, told EP Vantage. The reach of its ally – and the level of royalties Nicox can secure – will be vital for the French company, which only had €25m ($34m) in the bank at the end of March.
One of the group’s existing partners, Valeant, fits this bill but is unlikely to be interested as it already markets a rival topical ocular antihistamine, Bepreve.
And another big ophthalmology player, Novartis’s Alcon division, seems to have the US topical allergic conjunctivitis sector sewn up – Mr Spencer estimates that its products Patanol and Pataday account for $500m of the $800m annual market. Allergan's Lastacaft is another contender.
Nicox and its future partner will therefore have their work cut out dislodging these bigger competitors. But Mr Spencer believes that the “heritage” of Zerviate’s active ingredient cetirizine, plus the fact that this is the first eye drop formulation of the antihistamine, should help.
He suggests Zerviate's annual sales could reach the region of $30-50m, in line with Stifel analysts’ peak estimate of $35m, and just below Bryan Garnier’s €60m. The former are more optimistic about the level of royalties Nicox can achieve, putting this at 25% versus Bryan Garnier’s 8-12%.
Investors sent Nicox's share price up 21% yesterday. But with the company needing a partner to proceed – it does not have a commercial operation of its own – and running short of cash, it will not be in the strongest negotiating position.
In any case, Nicox has a bigger catalyst coming up in the form of an August approval decision on the Valeant-partnered glaucoma project Vyzulta, which has peak sales potential of $500m according to the Stifel analysts. Nicox is due net royalties of 6-11% from this project and will also receive a net milestone payment of $132.5m upon approval, according to Mr Spencer.
This will help the company fund phase II trials of two more pipeline projects: NCX 4251, an ophthalmic suspension of the corticosteroid fluticasone propionate for blepharitis; and NCX 470, a nitric oxide-donating bimatoprost analogue, for the lowering of intra-ocular pressure.
Mr Spencer would not give details on Nicox’s expected cash burn rate or say how long these funds will last.
|Vyzulta||NO-donating prostaglandin||IOP lowering in glaucoma/ ocular hypertension||PDUFA date August 24, 2017||Licensed to Bausch + Lomb (Valeant) worldwide|
|NCX 4251||Ophthalmic suspension of fluticasone propionate nanocrystals||Blepharitis||Phase II to begin Q4 2017||-|
|NCX 470||Ophthalmic solution of NO‐donating bimatoprost analogue||IOP lowering||Phase II to begin Q1 2018||-|
The company still has hurdles to overcome but at least it can now boast its first approved product – the drug came via the 2014 acquisition of Aciex Therapeutics. That deal, worth $65m up front and up to $55m in milestones, also gave it Vyzulta and NCX 4251, then known as AC-155.
The French company had hoped that the FDA approval process for Zerviate would be straightforward as it had already completed phase III trials. However, its first attempt resulted in a complete response letter in October regarding electronic data storage issues at the manufacturing site.
Those worries are now behind it, but Nicox still has to find a suitable partner.