Handa Pharma announced that it has entered into a settlement agreement with Novartis Pharmaceuticals Corporation ("Novartis") in relation to the TASCENSO ODT (i.e. HND-020), 0.5 mg patent infringement lawsuit, whereby the parties will pay a percentage of net sales under certain conditions after the product is marketed in the United States. The parties have entered into a settlement agreement whereby a percentage of the net sales will be paid as royalties upon future sales in the US market under certain conditions. According to Handa, preparations for the commercial launch of TASCENSO ODT continue to be actively pursued and the settlement is aimed at accelerating the pharmaceutical market in order to eliminate direct competition from the generic drug, which will hopefully be available for sale in December this year.

Handa announced that it has received Tentative Approval from the FDA on 18 October 2021 for its new 505(b)(2) drug for multiple sclerosis, TASCENSO ODT, 0.5 mg, and has settled the patent infringement lawsuit with the original manufacturer, Novartis, who will withdraw all related litigation and conclude the case in accordance with the agreement. Novartis will withdraw all related litigation and conclude the case. Upon the launch of TASCENSO ODT in the U.S. market, Handa will pay Novartis royalties based on a percentage of the net sales under certain conditions in accordance with the settlement agreement.

According to Handa, the settlement agreement with Novartis was entered into to expedite the rapid entry of TASCENSO ODT into the market in order to eliminate direct competition from generic drugs, extend the life cycle of the product and ensure product revenues. The Company will apply to the FDA for a switch to Final Approval and will market TASCENSO ODT in the US as soon as possible.

Tascenso ODT, 0.25mg, received Final Approval from the FDA on 23 December 2021 and is expected to be available for sale in December this year at the latest, after more than six months of pre-marketing preparation. According to Handa, the settlement agreement has a positive impact on the exclusive U.S. marketing authorization agreement with Cycle Pharmaceuticals Ltd. for TASCENSO ODT, and preparations for commercial volume production continue to be active.