Handa Pharmaceuticals announced that its subsidiary Handa Neuroscience's new 505(b)(2) drug Tascenso ODT, 0.5mg, for the treatment of multiple sclerosis, has passed the US Food and Drug Administration (FDA) New Drug Application review and has officially received Final Approval. Handa's General Manager Toshiyo Chen recently revealed that the drug is expected to be officially launched in the first quarter of next year through its licensing partner.

Handa Pharmaceuticals said that Handa Neuroscience, its 100% indirectly owned subsidiary, was notified by the US FDA on December 9 that Tascenso ODT, 0.5mg (i.e. HND-020, 0.5mg), a new 505(b)(2) drug for the treatment of multiple sclerosis, had passed the US FDA's New Drug Application review.

On March 4 this year, Clcle Pharmaceuticals Ltd. was granted the exclusive rights to market Tascenso ODT in the United States, and will be responsible for the subsequent sale of Tascenso ODT in the United States. Mr. Chan recently disclosed that Handa will receive up to US$56 million in royalties and that Clcle expects to launch Tascenso ODT in the US in the first quarter of next year.

Tascenso ODT is a new and improved dosage form of the drug developed by Handa Pharmaceuticals. The original developer of the drug is Novartis' best-selling "Gilenya Capsules". It is an easy-to-swallow, non-bitter, fast-dissolving dosage form with better stability.

According to Novartis' 2021 Annual Report, global sales of Gilenya in 2021 were US$2,787 million, including US$1,427 million in the US and US$1,360 million outside the US.

Handa indicated that it entered into a settlement agreement with Novartis on 24 October in relation to the 0.5mg patent litigation against Tascenso ODT and Novartis has withdrawn all related litigation and closed the case.

In addition, another dose of Tascenso ODT, 0.25mg, was finally approved by the US FDA on 23 December, and is also marketed through Cycle.