Pharma Focus Asia

Strides enters into strategic partnership with SUDA Pharmaceuticals for the US market

Monday, November 12, 2018

Strides Pharma Science Limited (Strides)  has announced  that  its  step-down  wholly  owned  subsidiary,  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-0001H, 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 inhouse development and partnerships will build  a  portfolio  of  limited  competition  products  offering  exclusivity  for  a  sustainable period. Today's announcement of partnership with SUDA is part of company’s specialty portfolio buildout 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.

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