Strides enters into a strategic partnership with SUDA Pharmaceuticals for the US market
Deepthi | Myequity news | Date : 09-11-2018 10:25:00 IST
Strides Pharma Global Pte Limited, Singapore has entered into an exclusive product development, licensing and supply agreement with SUDA Pharmaceuticals Ltd for its novel drug SUD-001H, an oral spray of sumatriptan to treat migraine headache 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
-SUDA will provide product development services for SUD-001H funded by Strides
-SUDA to work with Strides team through joint committees to achieve successful USFDA approval for the product
-SUDA to receive an upfront cash payment of US$ 0.4 Mn and a further payment of US$ 0.6 Mn 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. About Strides
Strides is global pharmaceutical Company headquartered in Bangalore. The Company has two business verticals, viz., Regulated Markets and Emerging Markets. The Company has a global manufacturing footprint with 7 manufacturing facilities spread across three continents including 5 facilities for Regulated Markets and 2 facilities for the Emerging Markets. The Company has strong R&D infrastructure in India with global filing capabilities and a strong commercial footprint across100 countries.