Acorda Therapeutics, Inc. announced that the European Patent Office (EPO) Opposition Division has upheld amended claims covering a sustained release formulation of fampridine (known under the trade name Fampyra), also known as dalfampridine or 4-aminopyridine, for increasing walking speed in patients with MS through twice daily dosing at 10 mg. The decision of the Opposition Division is open to appeal.
“We are pleased that the Opposition Division has recognised the validity of our patent claims for Fampyra,” said Ron Cohen, MD, Acorda’s president and CEO.
This European patent (EP-1 732 548 B) is set to expire in 2025, absent any additional exclusivity granted based on regulatory review timelines. In addition, Fampyra received 10-year market exclusivity upon approval by the European Commission that is set to expire in 2021.
Fampyra is exclusively developed and commercialized outside the United States by Biogen Idec under a collaboration and licensing agreement with Acorda. Fampyra is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7).
Fampyra is the ex-US trade name for AMPYRA (dalfampridine) extended release tablets, 10mg, which is being developed and marketed in the United States by Acorda. AMPYRA is an oral medication approved by the US Food and Drug Administration as a treatment to improve walking in patients with MS. This was demonstrated by an increase in walking speed.
In the United States, AMPYRA is covered by multiple patents providing coverage through 2027. In addition, AMPYRA has Orphan drug status providing market exclusivity through January 22, 2017.
Fampyra is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). Fampyra is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7). In clinical trials the highest incidence of adverse reactions identified with Fampyra given at the recommended dose was urinary tract infection, although infection was often not proven by culture. Other adverse drug reactions identified were mainly divided between neurological disorders, such as insomnia, balance disorder, dizziness, paraesthesia, headache and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Confounding factors may have contributed to the occurrence of seizure in some patients.
Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological conditions.