PERTH, AUSTRALIA – 6 December 2017: SUDA Pharmaceuticals Ltd...

PERTH, AUSTRALIA – 6 December 2017: SUDA Pharmaceuticals Ltd (ASX: SUD), a leader in oro-mucosal drug delivery, today announced that its licensee, Teva Pharmaceutical Industries Ltd., has submitted its first Marketing Authorization Application for ZolpiMist
 in the licensed territory. In July 2017, SUDA and Teva entered a licence and supply agreement for ZolpiMist covering multiple countries.
The regulatory review process is expected to take 12 months with approval of ZolpiMist anticipated in Q4 2018. Under the terms of the agreement with Teva, the approval of ZolpiMist triggers a milestone payment to SUDA

12 months up 12 days ago - looks like its going to be late.



This deal announced over two years ago and no progress by the looks of it

PERTH, AUSTRALIA – 9 November 2016: SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, and Eddingpharm (Asia) Macao Commercial Offshore Limited (Eddingpharm), a leading Chinese pharmaceutical company, today announce that the companies have entered into an exclusive license agreement for the development and commercialisation of SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate to treat insomnia in China.
Once approved by the Chinese Food and Drug Administration (CFDA), ZolpiMist would be the first imported fast-acting oral spray of zolpidem tartrate available in China.
Under the terms of the agreement, SUDA receives an upfront cash payment of US$300,000 (approx. A$400,000) and is entitled to receive a further milestone payment of US$200,000 (approx. A$260,000) following registration of the product in China.
In addition, once Zolpimist is registered for sale in China, SUDA will receive escalating tiered royalties on net sales in the territory. The total value of the deal could exceed US$26 million (approx. A$34 million) based on Eddingpharm’s forecast sales for the first 15 years from launch.
Under the terms of the agreement, Eddingpharm will assume responsibility for development, regulatory and commercialisation activities for ZolpiMist in China. SUDA will supply the product to Eddingpharm and both parties will work together through a Joint Governance Committee to maximise the commercial opportunity for ZolpiMist in China.