The launch of Pantoloc Control tablets follows the POM to P reclassification of PPI (proton pump inhibitor) pantoprazole, approved last year.
Novartis will launch the OTC proton pump inhibitor Pantoloc Control (pantoprazole 20 mg) in 14 European countries in the second quarter of 2010 under a co-marketing agreement with the product's originator Nycomed.
The deal, signed in the fourth quarter of 2009 and announced Jan. 26, is "a significant launch for us," a Novartis spokeswoman said in an email.
Novartis considers the European heartburn remedy market largely untapped. While AstraZeneca sells omeprazole OTC as Losec in some countries, the nonprescription stomach remedy market in Europe is less saturated than in the U.S.
Pantoprazole is the first PPI - and only the second product ever - approved by the European Medicines Agency's Committee for Medicinal Products for Human Use for nonprescription status via the centralized procedure in the EU. The first successful pan-European switch was GlaxoSmithKline's weight-loss aid alli .
EMA approved the switch of pantoprazole to nonprescription status in June, one month after the prescription product lost patent protection in 12 European countries, according to Nycomed.
At the time, Zurich-based Nycomed said it needed marketing partners to launch pantoprazole in member countries because the firm does not have a presence in all 27 EU member countries where the drug is approved for nonprescription sale.
As part of the deal, Novartis will "build consumer awareness and demand" for Pantoloc Control with a "fully integrated 360 degree campaign across TV, print, online, PR and consumer promotions," the spokeswoman said.
In addition, Novartis will train pharmacy teams extensively to identify and advise consumers who will benefit from the PPI, she added.
Novartis is counting on the Pantoloc Control launch to help its consumer health care business continue to grow ahead of the market in 2010.
The firm reported Jan. 26 that while consumer health net sales were flat at $5.8 billion in fiscal 2009, "all businesses achieved faster underlying growth than their respective markets despite the difficult economic conditions."
For example, the firm's OTC segment saw an "increasingly positive performance" in 2009 - thanks in part to the U.S. launch in November of another OTC PPI - Prevacid 24HR , Novartis said.
The two launches bring Novartis one step closer to its goal of becoming a significant player in the OTC digestive health market, the spokeswoman said.
Novartis' overall net sales for fiscal 2009 climbed 11 percent in local currencies to $44.26 billion.
