Takeda Pharmaceutical Co and the Japanese division of Eli Lilly are to terminate development of ruboxistaurin mesylate (known elsewhere as Arxxant) for the treatment of diabetes microvascular complications on the back of disappointing mid-stage trial data.
The two companies announced that an agreement on joint development and co-marketing for ruboxistaurin (discovered by Lilly) in Japan, signed at the end of 2003, has been terminated. They had been conducting a Phase II trial into the compound for the treatment of diabetic peripheral neuropathy (damage to the blood vessels in the retina which can cause severe vision loss or even blindness) and diabetic macular oedema but the overall results “did not meet its pre-specified go/no go decision criteria for Phase III” so the plug has been pulled.
The decision to end development comes as little surprise, especially given the problems that Lilly has had with Arxxant. In March, the company withdrew its marketing application in Europe for ruboxistaurin after the European Medicines Agency’s Committee for Medicinal Products for Human Use asked for more information on the drug, something Lilly said it could not provide within the allowed timeframe.
That came on the back of the US Food and Drug Administration’s rejection of an appeal by the company over the agency’s request for more detailed studies of Arxxant, which would take three years. All these setbacks suggest that the compound, which had previously been touted as a potential blockbuster, is not going to make it to market.
The news is also a blow for Takeda which announced only a day ago, along with partner Merck Serono, that disappointing data from a Phase II trial means that they may discontinue development of its investigational compound matuzumab as a treatment for colorectal cancer.