Takeda: Prevacid/Takepron (lansoprazole)
Prevacid/Takepron (lansoprazole)
Prcvacid, marketed in Japan by Takeda as Takepron, is a proton pump inhibitor (PPI) that is used in the treatment of peptic ulcers. It was launched in 1992 and is indicated for the short-term treatment of duodenal and gastric ulcers, and for the long-term treatment of hypersecretory conditions, as well as for the maintenance treatment of healed erosive esophagitis. Drugs in this class act directly to inhibit the action of the acid-producing pump within the stomach and are more potent than older H2 receptor antagonists. Lansoprazole is a second generation PPI and offers significant benefits over existing therapies, principally by exerting a greater effect on gastric pH.In Japan, Takepron has been approved for the additional indication of reflux esophagitis and is in phase 11 trials for gastritis. Lansoprazole is in registration for the treatment of non-ulcer dyspepsia in the US, where it is marketed by TAP. Since Takeda receives 50% of TAP's profits, the performance of lansoprazole in the US is key to Takeda's bottom line growth.
In June 1999, the FDA approved new administration options for Prevacid delayed-release capsules. The approval allows patients suffering from acid-related disorders, such as gastroesophageal reflux disease, and those who have difficulty swallowing capsules to open the capsules and sprinkle the granules on soft foods or into juices.
In December 2000, TAP announced that the FDA had approved lansoprazole for the treatment of ulcers resulting from the administration of non-steroidal anti-inflammatory drugs. It will compete directly with AstraZeneca's Nexium, approved in February 2001, and generic versions of Losec.
Takeda's domestic sales of Takepron reached S222m in 2001, up from $125m in 2000. Takeda reported global sales of Prevacid of $912m in 2001, rising to $ 1,064m in 2002. The leading PPI in 2002 was Losec, although the entry of Schwarz's generic version of omeprazole in December has affected its sales. Prevacid has a key advantage that could boost its position in this lucrative market. Approval has been granted to market Prevacid in combination with clarithromycin and amoxicillin as a triple therapy for the eradication of. pylori in patients with active or recurrent duodenal ulcers. In two US studies, Prevacid triple therapy was administered for two weeks and pylori was eradicated in 86-92% of patients studied. This is the first two-week triple therapy to be approved for this indication.
The future performance of Prevacid in the US will depend mainly on the approval of the drug for new indications. It will also be affected by the increasing intensity of competition from generics, following Losec's loss of patent protection and the launch of over-the-counter Losec in the US in late 2003. In Japan, the performance of the drug largely depends on the rate at which physicians switch from H2 blockers to PPls, and on whether Takepron gains approval for new indications. An additional threat is presented by the fact that Sepracor has been developing a single isomer version of the drug, to be launched as soon as key patents on the compound expire in 2009. However, it is not clear whether Sepracor is still developing its compound.
Until recently, H2 blockers were more popular than PPIs in Japan, which accounts for the relatively slow growth of Takepron in the Japanese market compared to the US. In addition, Takepron is not approved for the maintenance therapy of gastritis, which accounts for almost 66% of the total ulcer market in Japan.
Total sales of Prevacid are forecast to rise slightly to $ 1,088m in 2003, falling to $950m in 2005 and S764m in 2008.