About us – a timeline
Xspray Pharma has developed today’s technology and refined the business model for a long time.
Bioequivalence is achieved in pivotal bioequivalence study with HyNap-Dasa 505(b)(2) compared with the reference product Sprycel®. The result demonstrate that the dose strength can be reduced by 30% but still yield the same uptake in the body as the reference product.
The essential supply chain for the commercial production of HyNap-Dasa from supply of the active substance to the final product is secured. Study demonstrates that solubility and absorbtion of HyNap-Dasa is not dependent on the gastric acidity (pH level), and is not affected during proton pump inhibitor treatment, like Omeprazol. 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 (nilotinib). The FDA’s Orphan Drug Designation (ODD) is granted to Xspray Pharma for nilotinib oral formulation intended for the treatment of chronic myeloid leukemia. Planning for a manufacturing facility in Malta started.
2017 – 2019
Start of the scale up of the HyNap technology begins. Development of a new GMP-classified production facility with the Italian partner NerPharMa. First GMP batch of HyNap-Dasa amorphous material manufactured on a commercial scale. Development of final tablet of HyNap-Dasa and manufacture of GMP batches on a commercial scale of final tablets at a US supplier.
2011 – 2016
The Company’s HyNap technology is developed with a focus on protein kinase inhibitors (PKIs). Positive results are shown from three clinical studies of an improved and generic version of HyNap-Dasa, respectively. The FDA confirms that the Company’s clinical trials with HyNap-Dasa can be performed in healthy subjects and that no studies on cancer patients are required for approval.
2003 – 2010
Xspray Pharma was founded, based on the development of a new nozzle that enables a unique upscaling of particle technology. Scale-up of technology proven in a new pilot plant ten times larger than the lab system.