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Japan's Takeda Pharmaceutical said today that a successor to its blockbuster anti-ulcer drug Prevacid would move into Phase III trials in the U.S.
A spokesman for Takeda told Reuters the FDA had allowed the company to skip Phase II clinical trials of the compound, known as TAK-390MR, because its molecular structure is a mirror image of Prevacid.
"Phase I clinical trial data have shown that TAK-390MR may have the potential to bring additional benefits to patients who suffer from acid-related diseases," said Francois-Xavier Frapaise, vice president of research and development for TAP Pharmaceutical Products, the joint venture between Takeda and Abbott Laboratories which, pending approval, would market the compound in the U.S. "We are enthusiastic to initiate a comprehensive Phase III clinical program involving more than 5,000 patients."
Takeda's president Yasuchika Hasegawa first revealed TAK-390MR earlier this month. Hasegawa said in published reports that the company aimed to release the drug in 2008.
Analysts are closely eyeing development of TAK-390MR. The compound's success could help cushion the huge losses expected for Takeda's profits when Prevacid's patent expires in 2009.
Global sales of Prevacid reached $3.4 billion last year – 37 percent of Takeda's total sales