Acorda stumbles with Ampyra patent threat

Ampyra was approved on data whose clinical significance regulators challenged, and once launched the drug failed to live up to early commercial expectations. Now another blow has struck with a challenge to its key US patent.

The threat of an adverse decision shows the perils of the strategy of propping up an old molecule with weaker method-of-use patents and then asking payers to stump up for an orphan-style price. It could also help explain why analysts covering its owner, Acorda Therapeutics, have paid closer attention to R&D lately.

Pharma and biotech has come under increasing price pressure as payers seek to absorb the costs of expensive new speciality drugs. Ampyra, on the other hand, is being tested by a hedge fund manager seeking to cut the intellectual property out from under the $11,000-a-year multiple sclerosis drug. Hayman Capital's founder, Kyle Bass, has been quoted as saying he wants to take an activist position in the industry and "kneecap" companies misusing patent-based lifecycle extensions.

White hat challenge

The challenge comes in the form of an “inter partes review”, a relatively new way of challenging a patent that bypasses the federal courts in favour of a hearing before an administrative judge, speeding a decision. The petitions must be filed by a third party, rather than a direct competitor like a generic drugmaker.

Filed in the name of the “Coalition for Affordable Drugs”, the petition claims that the ‘685 patent protecting the method of use of the active ingredient dalfampridine should be invalidated because of obviousness. The molecule itself has been known since the 1920s, and data on its use in improving MS patients’ walking ability had been published in the early 1990s, according to the petition.

The ‘685 patent is important to protecting the specific dose protocol on the Ampyra label – 10mg twice daily – which was shown to improve patients’ speed over a timed 25-foot walk test. Lack of this protection could knock seven years off the current patent life now estimated to extend to 2025, Leerink analyst Paul Matteis estimates.

How a successful patent challenge would affect one of Acorda’s most immediate strategic moves, its bid to get Ampyra approved for stroke rehabilitation, is an open question. In a note published last month, Mr Matteis wrote that research in this space dated back to 1989 and that a generic MS pill, if it came about as a result of a successful patent challenge, could be used off-label in stroke in any case.

Acorda shares fell 10% yesterday to $36.06.

True innovation a way off

Acorda’s R&D strategy thus takes on much greater importance. Besides Ampyra the group has another MS asset in the early-stage remyelination project rHIgM22. The conclusion of a phase I trial – without full data disclosure – generated excitement last week (Acorda keeps the remyelination dream alive, February 3, 2015).

More immediately, Acorda picked up a Parkinson’s disease programme called CVT-301 with its acquisition of Civitas last year (Acorda plucks Civitas from the jaws of a public listing, September 24, 2014). Other than late-stage stroke data, CVT-301’s phase III readout is probably the company's most immediate catalyst.

The trouble with that project is that it, too, is a reformulation – in this case, an inhalable version of mainstay treatment levodopa. This raises a strategic conundrum for a company whose one money-maker is facing a challenge to a method patent.

Mr Bass has fired a shot across the pharma sector’s bow; repurposing old molecules might not always be a winning strategy in the future, and even in victory legal headaches might multiply.

To contact the writer of this story email Jonathan Gardner in London at [email protected] or follow @JonEPVantage on Twitter

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