Acorda aims for leadership in Parkinson's disease with acquisition

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US specialist pharma company Acorda is to acquire Biotie for $363 million, a move which it hopes will make it a leader in Parkinson's disease treatments.

The neurological movement disorder affects an estimated 6.3 million people worldwide, but currently has no treatment to halt its progress, which sees patients decline mentally and physically.

There has been very little progress in the field over the last decade, but now Acorda and others hope to improve treatment of the disease, if not yet actively halt or reverse it.

Based in Turku, Finland, Biotie's lead pipeline drug is tozadenant, an oral adenosine A2a receptor antagonist currently in Phase 3 development for Parkinson's disease (PD).

The current standard treatment is levodopa/carbidopa, but patients often experience 'off' time when the medication doesn't work or is wearing off. A phase 2 study of Biotie's drug showed that when added to levodopa/carbidopa, it was able to reduce this off period.

Acorda will add this to its own pipeline and portfolio of marketed drugs for neurological conditions.

In addition to Parkinson's disease candidates, the New York-based firm's pipeline also includes treatments for chronic post-stroke walking deficits (PSWD), epilepsy, heart failure, MS and spinal cord injury.

It has three products already on the market, most notably Ampyra (dalfampridine, marketed outside the US by Biogen as Fampyra) a treatment to help improve walking in people with MS. Ampyra accounts for most of the firm's revenues, and is forecast to achieve $436 million in 2015, up 15 per cent. However the drug faces legal battles with generic challengers later this year.

Acorda's pipeline includes novel neurological therapies for multiple sclerosis, Parkinson's disease, post-stroke walking deficits, epilepsy and migraine.

The Biotie acquisition includes two other assets, one of them already on the market. BTT1023 is a monoclonal antibody in Phase 2 for primary sclerosing cholangitis (PSC), a chronic liver disease. Meanwhile Selincro is approved in Europe for reduction in alcohol consumption and is marketed by Lundbeck, which pays double digit royalties to Biotie.

"Our acquisition of Biotie positions Acorda as a leader in Parkinson's disease therapeutic development, with three clinical-stage compounds that have the potential to improve the lives of people with Parkinson's," said Ron Cohen, M.D., Acorda's President and CEO.

Commenting on tozadenant, he added: "Adenosine A2a receptor antagonists may be the first new class of drug approved for the treatment of Parkinson's in the US in over 20 years. Approximately 350,000 people with Parkinson's in the US experience off periods, and if approved, tozadenant could provide a much needed treatment option."

The efficacy of Adenosine A2a receptor antagonists is far from proven, however. Merck abandoned its own drug in the class preladenant, after it failed in phase 3 trials in 2013.

There are numerous other approaches being investigated, including gene therapy, such as Oxford BioMedica's ProSavin, currently in phase 1/2 trials.

Acorda already has three late-stage programmes, with major milestone expected in 2016. The firm expects to complete pivotal trials for CVT-301 in Parkinson's disease and PLUMIAZ in seizure clusters - which if successful, will both be filed in 2017. The company forecasts that these two therapies could generate combined peak sales of over $700 million.

Acorda will also perform an interim analysis on its Phase 3 trial of dalfampridine for post-stroke walking deficits, and is developing a once-daily formulation of the molecule.

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Andrew McConaghie

20 January, 2016