Shares in NicOx SA rose more than 44 percent Tuesday on news that its glaucoma drug BOL-303259-X, which is partnered with Bausch & Lomb Inc., met the primary endpoint in a Phase IIb trial and will progress to a global Phase III development program within a year.

Shares (PARIS:COX) hit a one-year high, closing at €2.64 (US$3.46), up €0.81.

NicOx also is picking up a $10 million milestone payment as a result.

B&L acquired rights to the compound, a nitric-oxide-donating version of the prostaglandin F2a analogue latanoprost, in a licensing deal worth up to $179.5 million two years ago, after New York-based Pfizer Inc. exited an earlier alliance following disappointing Phase II data. Sophia Antipolis, France-based NicOx has an option to co-promote the product in the U.S. (See BioWorld International, March 10, 2010.)

In the present study, which recruited 413 patients, BOL-303259-X met its primary endpoint, a reduction in mean diurnal intraocular pressure (IOP) on day 28. Two of the four doses demonstrated a significant difference in IOP reduction vs. latanoprost, which Pfizer markets as Xalatan.

"We have a statistically significant difference – 1 millimeter (mm) vs. Xalatan – 1 mm is important in reducing the progression of glaucoma," NicOx's vice president of business development, Gavin Spencer, told BioWorld International. A 1 mm reduction correlates with a 10 percent to 13 percent reduction in the risk of glaucoma progression, he added.

BOL-303259-X, formerly known as NCX 116 and as PF-3187207, also demonstrated a higher response rate. Of those receiving the optimum dose of the drug, 68.7 percent attained a target IOP of 18 mm of mercury (Hg), whereas 47.5 percent of those on Xalatan did likewise.

Although BOL-303259-X also had appeared to demonstrate superior efficacy vs. Xalatan when in Pfizer's hands, the big pharma opted to bail on the partnership as it did not anticipate that the drug would achieve the blockbuster-level sales needed to compensate for Xalatan's imminent patent expiry. (See BioWorld International, Aug. 12, 2009.)

NicOx is not commenting on the drug's commercial potential as yet. "At the moment, there's more R&D needed to tease out the profile of this," Spencer said.

Rochester, New York-based B&L is responsible for conducting the Phase III program, although NicOx will also provide input on trial design. Studies are slated to commence late this year or early next year.

By then, the profile of NicOx could have changed quite radically. The company is, compared to many of its European peers, cash-rich, having exited 2011 with €93.1 million on its balance sheet. "We're evaluating several different M&A opportunities to become a late-stage development/commercialization organization," Spencer said.

Discussions with several prospects are ongoing, although he was unable to state when those might culminate in a transaction.

NicOx suffered a significant setback almost two years ago, when it received a complete response letter from the FDA on its new drug application for naproxcinod, a first-in-class nitric oxide-donating cyclooxygenase inhibitor in development for osteoarthritis. The company appealed the decision and now is waiting on a response from the FDA. "It was in July we submitted the appeal," Spencer said.

The company, together with its European partner, Grupo Ferrer Internacional SA, of Barcelona, Spain, also is evaluating its options in Europe, having withdrawn a marketing authorization application in April 2011.