Life sciences company Royal DSM hopes to make a splash in generic pharmaceuticals with its purchase of Ocean Nutrition Canada, a leader in fish-oil-derived omega-3 fatty acids for dietary supplements. DSM says the generic-drug market for omega-3s is largely unexplored ahead of this year's patent expiration for GlaxoSmithKline's lipid regulator Lovaza.
Amarin intends to submit cholesterol drug candidate AMR101 for FDA approval by the end of next month. The compound proved safe and well-tolerated among clinical-trial patients with a high level of triglycerides, Amarin said.
Pronova BioPharma, which makes a fish-oil-derived prescription drug for treating high triglycerides, landed a deal with a generic drugmaker to hold off a copycat drug. Under the agreement, Apotex won't market its generic version of Lovaza until 2015. GlaxoSmithKline, which markets the drug in the U.S., gained $847 million in sales of Lovaza last year.
Amarin plans to file by the third quarter for FDA approval of AMR101, a treatment for patients with a high level of triglycerides. Amarin said data from an early-stage trial are sufficient to support a filing. "Our focus is to become the leader in the market for triglyceride-lowering drugs," CEO Joseph Zakrzewski said.