Pharmacy Times, Volume 0,0

OTC Prevacid(lansoprazole)will be available by 2009, according to anagreement between TAP PharmaceuticalProducts Inc and Novartis. The protonpump inhibitor (PPI) is indicated for theshort-term treatment of heartburn andother symptoms of gastroesophagealreflux disease.

Under the terms of the agreement, TAPhas agreed to license its Prevacid trademarkand certain other intellectual propertyto Novartis for development andfuture commercialization in the OTC market.TAP will continue to market and sellprescription Prevacid until at least 2009,when the compound patent expires,while Novartis takes on full responsibilityfor what is anticipated to be a multiyearOTC development. The developmentincludes the design and conduct of allclinical studies, product developmentactivities, regulatory submissions to theFDA, commercialization, manufacturing,product launch, and distribution.

Industry experts predict that thePrevacid agreement will bring about oneof the most significant switches of a prescriptiondrug to OTC status in NorthAmerica in the next decade. The OTCmarket in the United States was valued at$17.4 billion in annual sales in 2004, withthe gastrointestinal category ranking thirdat $2.3 billion in sales, according toNovartis. Currently, Prilosec (Procter &Gamble) is the only OTC PPI available.That drug received FDA approval for theprescription-to-OTC switch in June 2003and was launched over the counter inSeptember 2003.