H. Lundbeck A/S, the Nordic region’s second-largest drugmaker, failed to win recommendation from the European Union’s drug regulator for a treatment for Alzheimer’s disease.
Studies presented by the company had negative results or didn’t demonstrate a clear benefit for Acrescent, which combines two substances, memantine hydrochloride and donepezil hydrochloride, which already have approval in the European Union as separate treatments, the European Medicines Agency said in a statement today.
“The company had not provided enough evidence to support the use of a combination tablet” in patients with moderate to moderately severe Alzheimer’s disease, the EMA said.
Lundbeck is also developing another treatment for Alzheimer’s disease, AE58054, and released positive results from a mid-stage study in May. Late-stage trials will begin as early as the end of this year, and the company is in talks with several potential partners to help develop the drug, Chief Executive Officer Ulf Wiinberg said in August.
“The assessment of success was very cautious” for this drug, Simon Augustesen, a spokesman for Lundbeck, said by phone. The company hasn’t factored in sales from the drug in any profit forecasts, he said.
The company expects to announce a partner for AE58054 by the end of the first half of next year, Augustesen also said.
Donepezil is sold as Aricept by Eisai Co. and Pfizer Inc. Forest Laboratories Inc. sells memantine as Namenda.