[Editor's note: Keep up with this topic in 'The Tan Sheet,' your source for nonprescription pharmaceutical and nutritional industry news. For more information call 1-800-332-2181.Or you can request a free sample issue of 'The Tan Sheet' here.]
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.
"The market in Europe is large," she said. "Reflux symptoms, including heartburn are suffered by up to 45 percent of adults across Europe and frequent heartburn is a major burden for millions of Europeans."
Brian McNamara, European region head for Novartis OTC, said in a release, "Until now the effective treatment choices available over-the-counter were fairly limited."
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 European Commission authorized nonprescription sale of Pantoloc Control June 12. 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.
Novartis Leadership
Novartis also announced Jan. 26 that its CEO of 14 years, Daniel Vasella, will hand the reins to Joe Jimenez, the current head of pharmaceutical business. Jimenez will become CEO Feb. 1.
"Vasella has put Novartis on a very solid path for growth," said Morningstar equity analyst Damien Conover in a Jan. 26 research note. "We believe Joe Jimenez will continue similar strategic goals as his predecessor," he added.
Mainly Conover expects Jimenez will continue to focus on improving margins and cost cutting.
Other leadership changes include the promotion of David Epstein to replace Jimenez as head of the pharmaceuticals division, and the retirement of Novartis' Chief Financial Officer Raymond Breu, who Jon Symonds will replace, Novartis said.
George Gunn remains division head, Consumer Health, according to the firm. Jimenez served as CEO of the firm's consumer business prior to heading the pharma division in 2007.
– Elizabeth Crawford (e.crawford@elsevier.com)
