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. HyNap-Dasa is named Dasynoc. The application for US market approval of the first product candidate Dasynoc (dasatinib) is submitted to the Food and Drug Administration (FDA) under the 505(b)(2) NDA procedure, which is the registration path that applies to improved drugs.
The company decides to focus entirely on improved PKIs, since the value of generics in the calculating models has gradually decreased, while the value of improved drugs has instead increased.
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.