Strides Pharma Science’s wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore has entered into an exclusive product development, licensing and supply agreement with SUDA Pharmaceuticals for its novel drug SUD-001H, an oral spray of sumatriptan to treat migraine headache for the US market.
Execution of Strides’ generic product pipeline for the US is nearing completion and is expected to have 150+ ANDA filings by 2021. The company is now focusing on developing a portfolio of complex and specialty products including products filed under the 505B (2) regulatory pathway. The company through in-house development and partnerships will build a portfolio of limited competition products offering exclusivity for a sustainable period. The partnership with SUDA is part of company’s specialty portfolio build out for the US market.
Sumatriptan is one of the most widely used drugs for the treatment of acute migraine in adults. SUD-001H is a first-in-class mint-flavoured oral spray formulation of sumatriptan (marketed in tablet form and in a nasal spray by GlaxoSmithKline under the brand name Imitrex). The product will be filed with the USFDA under the 505B (2) regulatory pathway and on approval is expected to be the first fast-acting oral spray of sumatriptan in the US market. The product will utilize SUDA’s recently developed proprietary OroMist hydrotrope technology that significantly improves the rate of absorption and the quantity of drug that is absorbed across the mucosal membranes. A primary market assessment on the potential for SUD-001H for the treatment of adult migraine confirmed the need for a product that could demonstrate a faster onset of action and the same was supported by medical practitioners.
Terms of the agreement are that SUDA will provide product development services for SUD-001H funded by Strides. Further, SUDA will work with Strides team through joint committees to achieve successful USFDA approval for the product. In addition, SUDA will receive an upfront cash payment of US$ 0.4 million and a further payment of US$ 0.6 million on reaching certain milestones including the pilot first-in-man clinical study, submission and approval of the product in the US. On commercial sales, SUDA will receive royalties plus a handling fee. Strides to have a right of first refusal for additional territories including the European Union, Australia and New Zealand, Canada, South Africa and Japan.