April 24, 2024

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[THE INVESTOR] SK Biopharmaceuticals’ US$10 million-plus license-out deal with US Acorda Therapeutics is on the verge of collapsing as the Korean firm’s investigational epilepsy drug Plumiaz has failed to show expected results in late-stage studies.

“We are discussing the cancellation of the contract,” an SK Biopharmaceuticals told The Investor on Aug. 11. 

It won’t be surprising if the US partner decides to abandon the deal, analysts say. In May 2016, Acorda Therapeutics had announced that it would discontinue the development of Plumiaz, saying it was “very disappointed” by the clinical study results.

Plumiaz is a nasal spray for the treatment of people with epilepsy who experience cluster seizures.

Acorda said Plumiaz failed to demonstrate its bioequivalence to its reference product Diastat during clinical trials conducted by the New York-based firm.

Passing the bioequivalence test is a requirement if Acorda is to refile the new drug application of Plumiaz with the US Food and Drug Administration which was previously planned for the first quarter of 2017 after a failed attempt in 2013.

SK Biopharmaceuticals signed the license deal with Neuronex, acquired by Acorda in 2012, to give the US biotech firm worldwide rights to the compound except for some Asian countries. Under the agreement, Neuronex had to pay SK Biopharmaceuticals up to US$8 million upon reaching development milestones, plus another US$3 million in sales milestones.

Still, SK plans to push the development of the drug candidate. “If the deal collapses, we will start discussing whether we should look for new overseas partners or initiate clinical trials for a new indication of the drug candidate,” the SK Biopharmaceuticals official said.

By Park Han-na (hnpark@heraldcorp.com)