Alcon announces nasal spray approval, board appointments

Huenenberg, Switzerland-Alcon Inc.’s olopatadine HCl nasal spray (Patanase) has been approved by the FDA for the relief of the symptoms of seasonal allergic rhinitis in patients aged 12 or more years, the company announced.

The approval primarily was based on multiple clinical studies for the evaluation of safety, efficacy, and onset of action. The studies were 2-week, randomized, double-blind clinical trials in patients with seasonal allergic rhinitis and were conducted to determine the ability of the spray to relieve allergy symptoms based on total nasal symptom scores (TNSS), a composite of stuffy, runny, itchy nose, and sneezing. The results of these clinical studies were that patients treated with olopatadine, two sprays per nostril, twice daily, demonstrated significantly greater decreases in TNSS compared with the placebo nasal spray.

Additionally, onset of action was evaluated in three environmental exposure unit studies. In these studies, patients with seasonal allergic rhinitis were exposed to high levels of pollen and then treated with either olopatadine or placebo nasal spray, two sprays in each nostril, after which they self-reported their allergy symptoms hourly for the subsequent 12 hours. Olopatadine nasal spray was found to have an onset of action of 30 minutes and a 12-hour duration of effect after dosing, which was statistically significant compared with the placebo spray.

In other news, Alcon Inc. announced several appointments to its board of directors.

Thomas G. Plaskett, Paul Polman, and Cary R. Rayment have been re-elected to the board for 3-year terms. The board subsequently re-elected Rayment as its chairman and Francisco Castañer as its vice chairman.

Paul Bulcke has been elected to the board as a new member for a 1-year term.

Bulcke, who replaces Joseph Weller on the board, also is a member of the board of directors of Alcon’s majority shareholder, Nestlé S.A., and serves as Nestlé’s chief executive officer (CEO).

He has been part of the Nestlé group since 1979 and advanced through the sales and marketing divisions and then into regional executive management. Most recently, Bulcke was executive vice president (VP) and director for Zone Americas in addition to serving as co-chairman of Beverage Partners Worldwide S.A. and co-chairman of the supervisory board of Cereal Partners Worldwide.

Additionally, James Singh and Daniel Vasella, MD, have been elected as new members to the board with 3-year terms subject to and effective as of the closing of the sale of at least 74 million shares of Alcon Inc. by Nestlé S.A. to Novartis AG.

Singh was appointed executive VP and chief financial officer of Nestlé S.A. this year. Prior to this appointment, he was senior VP, acquisitions and business development, of Nestlé S.A., during which period he was involved in Alcon’s initial public offering in 2002.

Dr. Vasella has served as CEO of the Novartis Group and as executive member of the board of Novartis AG since 1996. In 1999, he additionally was appointed chairman of the board of Novartis AG. Before  joining Novartis, he held several positions at Sandoz Pharmaceutical Corp., including the position of CEO.