About us – a timeline

Xspray has developed today’s technology and refined the business model for a long time.

2020

  • The essential supply chain for the commercial production of HyNap-Dasa from supply of the active substance to the final product is secured
  • Preparations for submission of Xspray Pharma’s first application for market approval to the FDA completed
  • Development work carried out for the next product candidate HyNap-Nilo
  • Planning for a manufacturing facility in Malta started

2019

  • Positive results from pilot bioequivalence study on HyNap-
    Sora
  • IND application for HyNap-Dasa approved by the FDA
  • First GMP batch of amorphous HyNap-Dasa material
    manufactured on a commercial scale
  • Development and GMP production of final tablet formulation
    of HyNap-Dasa on a commercial scale with US partner

2018

  • Production upscaling – rebuilding and developing new production facility with Italian partner
  • Showing bio equivalency with formula of HyNap-Dasa towards the original drug

2017

  • Positive results from pilot study showed HyNap-Dasa’s bioavailability of dasatinib and achieved the primary purpose of the study which was to provide support the company’s composition of products
  • Xspray Pharma was on the 28th of September listed on Nasdaq First North Growth Market
  • Change of name from Xspray Microparticles to Xspray Pharma in order to highlight the company’s strategy to focus on its own product development

2016

  • Positive results from the clinical trials of an improved as well as generic version of HyNap-Dasa (dasatinib)
  • FDA confirmation that HyNap-Dasa clinical trial programme can be performed on healthy subjects, i.e. no studies on cancer patients will be needed

2015

  • Clinical proof-of-concept (POC) for HyNap-Dasa (dasatinib)
  • Freedom-to-operate (FTO) for HyNap-Dasa confirmed by Swedish and US patent bureaus
  • Sale of Karolinska Developments holding shares to a constorium led by Stiftelsen för Östersjö- och Östeuropastudier (Östersjöstiftelsen) and Recipharm Venture Fund

2014

  • Clinical proof-of-concept (POC) for HyNap-Nilo (nilotinib)

2012

  • Deeper focus on PKI area of study
  • Development of hybrid nanoparticle technology (HyNap)
  • Patent applications on 10 of 18 marketed PKI’s

2011

  • Strategic change of business model from drug delivery to the development of improved anti-cancer drugs, with a patented product portfolio

2009

  • Construction of a GMP-plant for the manufacturing of clinical trial material (CTM) in accordance with GMP legislation which enables CTM deliveries to potential customers

2007 – 2010

  • Cooperation with Roche, Novartis, Lilly and other large and medium-sized pharmaceutical companies in regard to evaluation of the technology in their development programmes

2007

  • Construction of a pilot plant which enables a tenfold uspalcing of the process from gram to kilogram scale

2004 – 2006

  • Development of the RightSize-technology, including basic methodology and design of nozzle

2003

  • Xspray Microparticles is founded. The company is based on the development of a new nozzle which enables upscaling of super critical liquid technology (SCF) that could in the past only be used in non-commercial scale
    Karolinska Development, majority stakeholder in Xspray, finances the technology development of Xspray