Wednesday, May 22 2019 | Time 14:08 Hrs(IST)
  • Austrian president consoles public in wake of coalition gov't collapse
  • Stage set for counting of votes in Telangana tomorrow
  • SC stays BJP candidate's arrest till May 28
  • Huge explosion rocks Mogadishu, casualties feared
  • Yemen's Houthi rebels launch fresh drone attack on Saudi Najran airport
  • Local Taliban leader among 16 militants killed in Afghanistan
  • No IED blast on LoC, soldiers injured in training event in Poonch: Army
  • Five militants killed in Eastern Afghan province airstrike
  • 12 Bangladeshi peacekeepers to be honoured by UN on May 29
  • SC to hear Barrackpore BJP candidate petition today
  • Boeing 737 Max: China's top airlines seek compensation
  • EVM result should be verified with VVPATs : Dinesh
  • Indian runner Gomathi fails dope test, suspended provisionally
  • Visva Bharati University students gherao VC and teachers demanding restoration of 2018 fee structure
  • Aurangabad water crisis: 3,163 water tankers supplying water to 50 lakh population
Business Economy

Strides enters into strategic partnership with SUDA Pharmaceuticals for US market

Strides enters into strategic partnership with SUDA Pharmaceuticals for US market

Mumbai, Nov 09(UNI) Pharma Strides Pharma Science Limited today said 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 (ASX: SUD) 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., company said in afiling with BSE.

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.

Under 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.

UNI JS SY 1219

More News

Panacea Biotec receives USFDA approval for manufacture, supply of Azacitidine for US market

22 May 2019 | 12:53 PM

Mumbai, May 22 (UNI) Pharma Major, Panacea Biotec said that company's Oncology Parenteral Formulation Facility at Baddi, Himachal Pradesh has received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection, 100 mg/vial, for the US market.

see more..

Dynamic Cables Ltd bags two orders worth Rs 32 cr

22 May 2019 | 12:35 PM

Mumbai, May 22 (UNI) Dynamic Cables Limited on Wednesday said company has bagged two orders worth Rs 32 crores (inclusive of GST) from one of the largest domestic EPC company of India.

see more..

Chennai Oil Market Rates

22 May 2019 | 11:57 AM

Chennai, May 22 (UNI) Following are the rates in the
Chennai Oil Market here today.

see more..

Wholesale prices of Oils, Sugar, Commodities in APMC

22 May 2019 | 11:57 AM

Bengaluru, May 22 (UNI) Following were the wholesale prices in the
Bengaluru APMC here on Wednesday.

see more..
Major currencies down

Major currencies down

22 May 2019 | 11:47 AM

Mumbai, May 22 (UNI) Following were the indicative currency rates and travellers' cheques buying and selling rates per unit.

see more..