Xspray Pharma CEO: "Hope to launch end of 2025"

Xspray Pharmas HyNaptechnology is designed to improve the solubility and bioavailability of protein kinase inhibitors (PKIs). The amorphous technology enables pH-independent drug uptake and reduced variability, resulting in easier dosing and fewer side effects compared to crystalline reference products.

The company's lead product candidate, Dasynoc, is an independent and improved version of BMS Sprycel (dasatinib), with documented benefits in the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). It is targeting the US dasatinib market, where sales of existing products crossed the 10 billion mark in July and are expected to exceed 15 billion SEK in 2025.

One problem with the original is that its absorption in the body varies greatly depending on the patient's stomach pH, ​​which makes it difficult for a doctor to dose. The lower variability for Dasynoc means that it can be given in lower doses and can be combined with stomach acid-suppressing drugs such as omeprazole.

– The use of gastric acid inhibitors is a huge problem for doctors. They often have no idea whether patients are taking, for example, omeprazole, which can mean that current dasatinib products in some cases barely provide any absorption at all, with negative effects on both survival and health economics, comments Per Andersson.

Aiming for premium pricing

Dasynoc has several clear advantages and stands out in a market where generic copies of Sprycel have recently been launched. Sprycel has a list price of $218 per year and despite the generics being available for over a year, the value of total sales of dasatinib products has barely decreased at all.

– The market is still at the same levels as when Sprycel was alone, which shows that pricing is stable. Regardless of whether the average price remains at today's level or follows an expected decline of 10–50 percent, we will be able to charge a price that allows the company to reach break-even one year after launch, Per Andersson tells BioStock.

Alone with large-scale production

The product's advantages lie in a production technology innovation. It is widely known that amorphous pharmaceutical products provide better solubility and lower variability compared to their crystalline form. However, it is important to ensure that the amorphous state of the product is stable over time, otherwise the product tends to revert to a more crystalline state. Manufacturing a stable amorphous product on a large scale using supercritical fluid has proven to be a challenge.

– There are many big players who have ploughed a lot of money into trying to do what we are successful at. Where others have managed to produce a few grams of amorphous pharmaceutical product a day, we can produce several kilos.

Long road to approval

New technology obviously brings benefits to those who reach the market, but for Xspray it has also meant some obstacles along the way. The FDA reviewers have had a hard time relating to the new technology – they have simply never seen anything like it before. The questions to the company have therefore been numerous and unfortunately in many cases ignorant, which has made the journey take longer than desired.

“The regulatory review was challenging, not because our manufacturing technology was flawed, but because the review team lacked experience with our amorphous HyNap methodology. Once we had an inspector with the right expertise in place, even the FDA understood that our process was working as intended – but by then the delay had already been around two years,” says Per Andersson.

Great interest among COPD patients

Finally, a welcome announcement came at the beginning of the summer. After a successful Pre-Approval Inspection of the manufacturing lines, it was confirmed that the FDA inspector had no further questions that needed answering. Final announcement on whether Xspray will be approved for its marketing application in the US is expected on October 7. Although Andersson does not want to take anything out in advance, he is hopeful that it will go well this time.

– We have done what we can and cannot do more at this time as all FDA questions have been answered. The FDA has not come back with new questions, which is a very good sign.

The delay in the launch has of course been stressful, but in the meantime the company has been able to process the market, which is now fully aware of what kind of product is on the way.

– We have had several scientific publications on Dasynoc and we have also had active dialogues with several key opinion leaders in the field. A few years ago, hardly anyone knew who we were, but now I can say that we have eight of the top ten leading doctors in the US in the field on our so-called advisory board at a KML conference already this October.

Getting into the starting blocks with capital raising

In order to gain the best possible starting position for the launch, the company is now conducting a rights issue of SEK 130 million. 83 percent of the rights issue, corresponding to approximately SEK 109 million, is covered by subscription commitments and letters of intent received so far. Upon approval, the company will be ready with the commercialization partner Eversana.

– Eversana is like a sales force that you can hire. Sure, the setup costs a bit in the beginning, but once sales start, we get a share of all the revenue, instead of sharing it with a distributor.