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