Altana, AHP get FDA OK for Protonix IV

The US Food and Drug Administration has approved an intravenousformulation of Altana's proton pump inhibitor pantoprazole, called Protonix IV, for the short-term treatment (seven to 10 days) of gastroesophageal reflux disease in patients who are unable to continue taking the drug in delayed-release tablet form. Protonix, which is marketed by American Home Products' subsidiary Wyeth-Ayerst in the USA, is the first PPI to be made available in that country in both tablet and IV forms. Protonix IV is already sold in 43 other countries worldwide.

Altana said in a statement that it expects Protonix IV to be launched in April, providing the first alternative to intravenous H2 receptor antagonist for the management of GERD patients who cannot take oral therapy. The latter class make up 25% of the overall hospital acid suppression market, according to AHP, which adds that oral drugs account for the remaining 75%, with oral PPIs making around $204 million a year.

Analyst Andreas Schmidt of Merrill Lynch told Reuters that he expects Protonix IV to have sales of $30 million in 2001, but noted that an added benefit for the whole franchise may come from patients using the intravenous form early on and then switching to the oral drug thereafter.