NiCox, Bausch&Lomb Ink $179.5M Deal in Glaucoma
mars, 10, 2010 12:01 - BioWorld International
Shares in NiCox SA gained almost 11 percent during trading on news that privately held eyecare firm Bausch & Lomb Inc. is stepping in to fill the gap created by the departure of its former partner Pfizer Inc. on the development of the glaucoma and ocular hypertension drug NCX 116 (previously PF-03187207).
NiCox, of Sophia Antipolis, France, is banking an initial license payment of $10 million, and it could eventually earn up to $169.5 million more in development, regulatory and commercial milestones. Should the drug reach the market, NicOx would also receive tiered double-digit royalties on sales, and it retains an option to co-promote the product in the U.S.
NiCox regained control over NCX 116, a nitric-oxide-donating prostaglandin F2a analogue, last year, after Pfizer Inc., of New York, decided to opt out, following the failure of the drug to meet the primary endpoint of two Phase II trials. Pfizer retains a residual interest in NCX116, however. It will receive regulatory and commercial milestone payments, as well as undisclosed royalties on product sales. (See BioWorld International, Aug. 12, 2009.)
NiCox always has maintained that the drug was clinically effective, with a more prolonged effect on lowering intraocular pressure (IOP) than Xalatan (latanoprost), Pfizer's existing glaucoma drug, which is coming off patent a year from now.
The apparent superiority of NCX116 wasn't sufficient to sustain Pfizer's interest, however. "They were looking for a replacement for a blockbuster, essentially," Karl Hanks, director of investor relations and corporate communications at NiCox, told BioWorld International. Xalatan was Pfizer's sixth biggest seller last year, with sales in excess of of $1.7 billion.
Subsequent to the Pfizer withdrawal, several parties expressed interest in partnering NCX116, Gavin Spencer, NiCox vice president of business development, told BioWorld International.
Bausch & Lomb, now owned by New York-based private equity group Warburg Pincus LLC, offered the most immediate means of resuming clinical trials, he said.
"At this time, Bausch & Lomb is not a major player in glaucoma, so this represents their first opportunity to have a global product in that area," Spencer said.
A joint steering committee will guide future development of the compound, which will compete not only with generic latanoprost, but also with Saflutan (tafluprost), which Merck & Co. Inc., of Whitehouse Station, N.J., has launched in Europe, following a licensing deal last year with Santen Pharmaceutical Co. Ltd., of Osaka, Japan. The same drug is undergoing Phase III trials in the U.S.
Saflutan is part of the same prostaglandin analogue drug class as Xalatan and several other products, including Travatan (travoprost), marketed by Huenenberg, Switzerland-based Alcon Inc., and Lumigan (bimatoprost), marketed by Irvine, Calif.-based Allergan Inc. Those act by lowering IOP by promoting fluid drainage from the eye.
NCX116 has an additional nitric-oxide-donating moiety, which, it hopes, could provide a point of differentiation. "Mechanistically you would expect nitric oxide to improve the intraocular-pressure-lowering effect of a prostaglandin," Hanks said.
The gas relaxes the eye's ciliary muscles, leading, he said, to greater drainage of fluid from the eye.
In a head-to-head comparison with latanoprost, it showed a statistically significant improvement in lowering IOP at hour 20 of a 24-hour dosing cycle.
Although that effect needs to be confirmed in additional studies, it could be clinically relevant.
"If you can control IOP for a longer portion of the day, you can slow damage to the optic nerve and slow progression to blindness," Hanks said.
Partnering the drug will enable NiCox to focus its attention - and its resources - on its lead drug, Naproxcinod, a first-in-class nitric oxide-donating cyclooxygenase inhibitor, which is undergoing regulatory review in the U.S. and the European Union as a treatment for osteoarthritis.
The FDA has set a PDUFA date for July 24, and the company said on Monday that the FDA's Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee would meet to consider the application on May 12.
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