Xspray enters manufacturing collaboration in Malta

Press release 2020-08-03

Xspray Pharma AB (Nasdaq Stockholm: XSPRAY) today announces that Xspray has signed a term sheet with Pharmacare Premium Ltd. for a new manufacturing facility in Malta based on its patented technology platform. The new production lines will be placed within Pharmacare Premium’s existing facility. Apart from increasing Xspray’s manufacturing capacity for amorphous protein kinase inhibitors (PKIs), the location of the manufacturing facility is advantageous from a patent perspective for the development of future products.

The new facility will be built together with Pharmacare Premium Ltd. at their EU-GMP approved site in Malta. Pharmacare Premium is a pharmaceutical manufacturing company and contract development and manufacturing organization (CDMO) focused on high-potency products for oncology therapeutics.

The Malta facility will be used both for development of new product candidates, including production of material for clinical trials, and for the commercial manufacturing of Xspray’s HyNap-products. The facility will allow production of the most highly potent PKIs. Xspray’s existing facility in Italy will remain unchanged.

“We have already succeeded where others have failed during decades with similar technologies. We will now get the final piece in place in order to use our technology platform to repeatedly launch new PKI products. I’m therefore very happy to find a partner that knows manufacturing, has a facility for solid oral dosage forms designed for oncology products and is located in an EU country with a beneficial patent situation. This will increase our manufacturing capacity and allow rapid development of the new product candidates in our growing product portfolio”, says Per Andersson, CEO Xspray.

“An important factor for the choice of country is that Malta joined the European Patent Convention (EPC) first in 2007. Until 2007 Malta was almost never chosen by the large pharmaceutical companies as a country in which to register one’s own patents. This is a considerable advantage for Xspray, as it means that all of our PKI candidates where the substance patent of the original product expires until 2027, can be manufactured there without patent concerns”, Per Andersson concludes.

About Xspray Pharma

Xspray Pharma AB (publ) is a product development company with multiple product candidates in clinical development. Xspray uses its innovative, patented RightSize technology to develop improved and generic versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second largest in oncology, and drug prices are very high.

The company´s innovative technology allows Xspray Pharma to gain entry as the first competitor to today’s original drugs before the secondary patents expire. Xspray’s goal is to become the leader in the development of improved drugs or generic versions of PKIs already marketed for the treatment of cancer, which numbered to 54 in December 2019. The company’s leading product candidates, HyNap-Dasa, HyNap-Sora and HyNap-Nilo, are stable amorphous versions of the three blockbuster cancer drugs Sprycel® (dasatinib), Nexavar® (sorafenib) and Tasigna® (nilotinib), respectively. The launch of the first product candidate, HyNap-Dasa, is planned to take place in 2021. The substance patent for the original drug Sprycel® (dasatinib) expires at the end of 2020, and the secondary patents in 2026, which offers Xspray’s HyNap-Dasa a period of five years of semi-exclusivity before other competitors gain access to the market.

The company has patented manufacturing technology, equipment and the resulting products. The shares in Xspray Pharma are traded on Nasdaq Stockholm.
www.xspraypharma.com