Acorda’s snafu-plagued attempt to get a fast FDA marketing decision on a critically important new drug has just run into a fresh setback — and it’s painful to watch.
Sept 10 (Reuters) - A U.S. appeals court on Monday invalidated Acorda Therapeutics Inc patents covering its multiple sclerosis drug Ampyra, opening the door to generic competition for the company's flagship product.
Shares of Acorda Therapeutics $ACOR tanked mid-day Monday after the biotech put out the word that a federal appeals court voted 2-to-1 to uphold an earlier court ruling invalidating their patents on their sole cash cow Ampyra.
Late last month, a federal court refused to block copies of Acorda’s biggest-selling drug Ampyra leading up to a patent appeal decision. So the New York drugmaker took matters into its own hands.
Over the last 8 months Acorda $ACOR has had to lay off staffers in a painful restructuring as it reacted to the likely loss of patent protection for its sole franchise drug, watched a critical drug application get kicked back as inadequate, scrapped a top pipeline therapy following the death of a slate of patients and adopted a poison pill defense as a key investor pushed for a sale.
With its stock price battered by bad news and its CEO wobbling perilously halfway into a high wire rescue act, Acorda $ACOR has laid out a poison pill plan aimed at scaring off a potential takeover attempt.
With its patent protection crumbling around its mainstay drug, the FDA has refused to file its application for CVT-301, the rescue program that was designated to take the lead drug’s place. The RTF creates an embarrassing and perhaps crippling problem for the biotech, which is fighting a last-ditch battle to maintain patent protection on its one big drug, Ampyra.
Ampyra® (dalfampridine): ACORDA THERAPEUTICS, INC. v. MICRO LABS LIMITED & MICRO LABS USA, INC.,
So far, pharma patent challenger Kyle Bass and his Coalition for Affordable Drugs have met with some failure and some early success. On Friday, it was another mixed bag--but this time it's Acorda Therapeutics ($ACOR) that could face the consequences.