West Coast Editor
Skin rashes apparently caused in Phase II trials by its proposed anxiety drug, NS2710, are causing NeuroSearch A/S and collaborator Grupo Ferrer Internacional SA to stop development but they’re not giving up on the deal, and may even broaden it.
“According to our specialists, [the rashes] might be dose related,” said Jorgen Buus Lassen, president of Ballerup, Denmark-based NeuroSearch. “It could be the same kind of reaction that you see after morphine and all opiate drugs. It’s a well-known side effect at high doses. We tested for allergic reactions, and [NS2710] was totally clean. We’re studying the mechanism in an in vitro model now, to be sure the next one doesn’t cause the same.”
NeuroSearch signed the deal in December 2000 with Grupo Ferrer, of Barcelona, Spain, to develop and commercialize NS2710, a modulator of gamma amino butyric acid (GABA). Grupo Ferrer took Latin American and European rights to the product, excluding the Nordic and Baltic countries, and NeuroSearch retained rights for the rest of the world.
“In the first U.S. study, in 1999, we didn’t really know if it was the drug [causing rashes] or not,” Buus Lassen told BioWorld Today. Five patients in the active group developed rashes, but so did one in the placebo group.
“The skin rashes disappeared, and we had no good description,” he said. “Now, we’ve clarified that it’s drug related.”
In another, even more comprehensive trial in 2000 in the UK, no skin rashes appeared at all, he noted.
Finding another drug with a similar method of action means a costly delay, Buus Lassen conceded.
“It all boils down to economics,” he said. “If we have to perform three months of talks and upscaling, it’s quite a financial burden. We could select two or three compounds that have a good profile. But even in our major collaborations with companies like GlaxoSmithKline [plc, of London], it’s very hard to get a decision.”
In the case of the Grupo Ferrer focus, though, a potential alternate is in testing for pharmacokinetics.
“It will be almost a year before we can be in the clinic, if we’re lucky,” Buus Lassen said.
NeuroSearch’s deal with GlaxoSmithKline, entered in the beginning of 2000, is worth as much as $57 million, including a $10 million up-front payment, for the antidepressant NS2389, which blocks serotonin, noradrenaline and dopamine. (See BioWorld Today, Jan. 24, 2000.)
NeuroSearch also has a deal worth a potential $80 million with Boehringer Ingelheim International GmbH, of Ingelheim, Germany, to develop and market NS2330, a monoamine re-uptake inhibitor for the treatment of Alzheimer’s and Parkinson’s diseases. (See BioWorld Today, Feb. 11, 2002.)
Another collaboration joins NeuroSearch with N.V. Organon, a pharmaceutical business unit of Akzo Nobel NV, of Oss, the Netherlands, and is related to agonists of GABA that act on GABAA receptor complexes. Focused on treating anxiety, the deal is worth up to $12.8 million for Neuro-Search. (See BioWorld Today, Nov. 28, 2000.)