Sumatriptan is one of the most widely used drugs for the treatment of an 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)
New Delhi: Strides Pharma Science has recently announced its step-down subsidiary has entered into an exclusive product development, licensing and supply agreement with Australia’s SUDA Pharmaceuticals for its novel drug SUD-001H, used in the treatment of a migraine. Strides Pharma Science said this partnership with SUDA is part of its speciality portfolio for the US market.
Under the terms of an agreement, SUDA will receive an upfront cash payment of USD 0.4 million and a further payment of USD 0.6 million on reaching certain milestones including the pilot first-in-man clinical study, submission and approval of the product in the US,” Strides Pharma Science said in a BSE filing.
On commercial sales, SUDA will also receive royalties plus a handling fee.
SUD-001H is an oral spray of sumatriptan to treat a migraine headache.
“Sumatriptan is one of the most widely used drugs for the treatment of an 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 said the company will have a 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.
The company through in-house development and partnerships will build a portfolio of limited competition products offering exclusivity for a sustainable period, it added.