XSPRAY

Xspray Pharma

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Xspray: Detailed data shows that HyNap-Dasa achieved formal BE

Xspray Pharma today reported detailed data from the previously reported bioequivalence (BE) study, showing that formal BE was achieved for HyNap-Dasa compared to Sprycel (dasatinib).

In early September, Xspray announced preliminary data showing that lead project HyNap-Dasa achieved BE to Sprycel (link). The detailed results reported today confirms that formal BE was achieved. 

Formal BE is achived when the Cmax (concentration in plasma) and AUC (bioavailability) is within 80-125% of the reference drug. In the study, the two HyNap-Dasa formulations showed an AUC of 9% and 8% higher than Sprycel (ratio of 1.09 and 1.08, CI 95-126% and 94-124%, respectively). For Cmax, HyNap-Dasa was 4% lower and 2% higher than Sprycel (ratio of 0.96 and 1.02, CI 81-114% and 86-120%, respectively). While the study was not powered to show formal BE, HyNap-Dasa achieved positive results.

In our update after the positive preliminary data we updated our Base Case valuation to SEK 135 per share. We believe the detailed data supports our positive view on the stock and indicates that a high likelihood of success is warranted, and we re-iterate our valuation and case, which we believe offers a good upside and a good probability of materializing. Further, we believe the results give a good indication that Xspray's technology is working as indicated, laying a good foundation for the continued development. This will allow the company to focus more on the business development of Xspray, which could bring partner negotiations and commercialization efforts.

Next up for the HyNap-Dasa project is a registration trial during 2019, where formal BE will need to be proven to file an ANDA. Updates regarding the HyNap-Sora project is also to be expected in the coming quarters. 

For a more detailed description of the case, the projects, and the generic industry, see our initiation report

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