French biotech NicOx has signed up leading U.S. eye health firm Bausch & Lomb to collaborate on its Phase II nitric oxide-donating glaucoma therapy, NCX116, six months after losing Pfizer as its development partner for the product.
There have been no new analyses or data collected on NCX116, previously known as PF03187207, between last August and now, said NicOx spokesman Karl Hank. At that time, NCX116 had been evaluated in Phase II trials, in which it had failed to meet certain desired clinical endpoints related to lowering diurnal ocular pressure better than Pfizer's glaucoma blockbuster, Xalatan (latanoprost). (PharmAsia News, Aug 26, 2008). Pfizer also said it was pursuing a policy of returning non-core products to their originators.
Bausch & Lomb said that the clinical studies performed to date showed that the compound had the potential for increased intra-ocular pressure lowering compared with latanoprost. NCX116 will be one of the first glaucoma products to be developed by Bausch & Lomb, and it is forming a joint steering committee with NicOx to decide the next steps in its clinical development.
Since being taken private in 2007 by the private equity player Warburg Pincus, Bausch & Lomb has focused on bolstering its pipeline by acquiring or licensing innovative device or drug offerings. Its most substantial bet to date has been the 2008 take-out of intraocular lens maker eyeonics ( 'The Gray Sheet,' Jan. 28, 2008, p.3).
Although Bausch & Lomb has yet to do a major drug-related acquisition, it has struck a number of interesting agreements to increase its portfolio of marketed products. These include a September 2009 co-promotion agreement with Croma Pharma for that firm's anti-inflammatory eye medicine bromfenac, and the purchase of privately-held Tubilux Pharma's assets, which include Timolux for glaucoma and Vitadrop for dry eye. Roughly one year ago, the eye specialist also signed a co-promote arrangement with Pfizer in which it will help market Xalatan as well as four other drugs.
Ophthalmology has caught the attention of a number of Big Pharma companies, attracted by the high margins on its products, their specialist nature, and continued unmet need. Novartis is in the process of acquiring Alcon, for example, and Sanofi-Aventis in October 2009 announced an earn-out acquisition of compatriot Fovea, thereby creating an ophthalmology business unit ('The Pink Sheet,' Oct. 2, 2009).
No taint on NicOx product
In August 2009, NicOx announced it was buying back rights to NCX116, after Pfizer decided Phase II data provided only marginal improvement over the soon to be generic Xalatan. At the time, the company made clear it would not advance the compound into pivotal trials on its own, preferring instead to find a partner with ophthalmology expertise. "Our primary focus isn't ophthalmology. Pain and inflammation are where we want to have a commercial future," Hank said at the time ('The Pink Sheet' DAILY, Aug. 6, 2009).
Six months later the company has found its partner in Bausch & Lomb. But the deal's modest upfront--just $10 million for worldwide rights to NCX116 and follow on combination products--suggests that the Bausch & Lomb is also hedging its bets, limiting the amount of upfront cash its willing to shell out for a product that ultimately may not prove significantly better than Xalatan.
Development, regulatory, commercialization and sales success-based milestones help sweeten the deal, driving the total deal value up to nearly $170 million for NicOx. The French company will also receive tiered double-digit royalties on any sales of NCX116, and an option to co-promote the product in the US, while Bausch & Lomb will have an option to license additional nitric oxide-donating compounds for the treatment of glaucoma and ocular hypertension, including other prostaglandin F2-alpha analogs arising from NicOx's research.
Improving Sentiment
The new agreement will give a much-needed boost to the way potential collaborators look at NicOx's lead product, naproxcinod, which also lost its original development partner, AstraZeneca, back in 2003. Naproxcinod is also a nitric oxide donating compound, this time based on the NSAID, naproxen.
Naproxcinod was submitted for US and EU marketing approvals last year ('The Pink Sheet' DAILY, Sep. 25, 2009). Despite claiming to be in partnership discussions for months, even years, NicOx is now not expected to sign up a collaborator until regulators decide on the relative benefits of the product compared with marketed NSAIDs. The company aims to retain co-commercialization rights in select markets in order to further its goal of becoming a fully-integrated company.
Naproxcinod's value would be increased if its labeling included a positive statement about its lack of effect on blood pressure. This would differentiate it from a number of other NSAIDs, which tend to increase blood pressure.
At the end of the third quarter, NicOx had cash and cash equivalents of € 66.8 million (US$91.5 million), while in the first nine months of last year the company had operating expenses of € 45.7 million, and recorded a net loss of € 39.9 million.
- John Davis (j.davis@elsevier.com)
