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Regular-article-logo Monday, 23 December 2024

Strides Pharma in pact with Australia’s SUDA

Bangalore-based company to sell migraine drug SUD-001H in US market

Our Special Correspondent Mumbai Published 09.11.18, 09:03 PM
Strides Pharma Science said the product will be filed with the US Food and Drug Administration (USFDA) and, on approval, is expected to be the first fast-acting oral spray of Sumatriptan in the US market.

Strides Pharma Science said the product will be filed with the US Food and Drug Administration (USFDA) and, on approval, is expected to be the first fast-acting oral spray of Sumatriptan in the US market. Shutterstock

Strides Pharma Science (formally Strides Shasun) on Friday said its step-down subsidiary has entered into an exclusive product development, licensing and supply agreement with Australia’s SUDA Pharmaceuticals for its drug SUD-001H used to treat migraine.

The Bangalore-based firm said this partnership with SUDA is part of its speciality portfolio for the US market.

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Under the terms of agreement, SUDA will receive an upfront cash payment of $0.4 million and a further payment of $0.6 million on reaching certain milestones, the company said in a filing with stock exchanges.

Further, on commercial sales, SUDA will receive royalties and a “handling fee”.

SUD-001H is an oral spray of Sumatriptan to treat migraine.

“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),” it added.

Strides Pharma Science said the product will be filed with the US Food and Drug Administration (USFDA) and, on approval, is expected to be the first fast-acting oral spray of Sumatriptan in the US market.

Strides added that the company will have the right of first refusal for additional territories, including the European Union, Australia and New Zealand, Canada, South Africa and Japan.

“Execution of Strides' generic product pipeline for the US is nearing completion and is expected to have over 150 abbreviated new drug application (ANDA) filings by 2021. The company is now focusing on developing a portfolio of complex and speciality products,” the company said.

An ANDA is an application for a generic drug.

The stock markets reacted positively to the development with shares of Strides Pharma Science surging over 11 per cent to Rs 476.65 on the BSE.

The plan

  • Product development, licensing and supply agreement with Australia’s SUDA Pharma
  • Tieup is for SUD-001H used to treat migraine
  • SUDA will receive an upfront cash payment of $0.4 million and $0.6 million on reaching certain milestones plus royalties and a handling fee
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