Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Sweden
  4. Nasdaq Stockholm
  5. Xspray Pharma AB (publ)
  6. News
  7. Summary
    XSPRAY   SE0009973563

XSPRAY PHARMA AB (PUBL)

(XSPRAY)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancials 
SummaryMost relevantAll NewsOther languagesPress ReleasesOfficial PublicationsSector news

Xspray Pharma : announces update of its improved version of dasatinib

04/08/2021 | 04:51pm EDT

Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) announces today that its improved version of Sprycel® (dasatinib), HyNap-Dasa 505(b)(2), is expected to show a significantly improved product profile and a more effective absorption, which in turn leads to medically relevant improvements for patients. This version is based on the thoroughly tested “A” formulation and will be tested in a pivotal bioequivalent study during Q2.

The current formulation has undergone scale-up in the manufacturing process, stability testing, and has been tested in four clinical studies. External experienced pharmacokinetic experts have, with existing clinical data, calculated that with a 30 percent reduction in dose, the product should be bioequivalent to Sprycel®. Human bioequivalence studies confirms that the formulation:

  • can be used simultaneous with omeprazole without affecting the absorption of dasatinib, which enables treatment of ulcer at the same time as the patient receives cancer treatment
  • gives an even absorption of dasatinib without the number of low uptake outliers related to previous studies with Sprycel®
  • can be administrated with a lower dose, which could lead to fewer side effects

“Our product is designed to improve the quality of life for patients with acute lymphocytic leukemia (ALL) and chronic myeloid leukemia (CML). I am convinced that our version, which is more soluble, bioavailable, gastric pH independent, and has a lower variability will lead to oncology physicians seeing improvements to both safety and efficacy. The application for market approval for our product will be submitted in accordance with the 505(b)(2) regulatory pathway”, says Per Andersson, CEO of Xspray Pharma.

HyNap-Dasa 505(b)(2) will be tested against Sprycel® at a 30% lower dose in a pivotal bioequivalence study. If results are positive, a 505(b)(2) NDA submission is expected during H2 2021.

In 2020 Sprycel® sold worldwide for USD 2.14 billion, of which USD 1.295 billion in the US. Xspray Pharma is working to obtain market approval for the improved version of dasatinib in the US, Europe, and all other major markets.

© Modular Finance, source Nordic Press Releases

All news about XSPRAY PHARMA AB (PUBL)
11:51aXSPRAY PHARMA  : Notice of annual general meeting of Xspray Pharma AB (publ)
AQ
04/08XSPRAY PHARMA  : announces update of its improved version of dasatinib
AQ
04/08XSPRAY PHARMA  : announces the results of two bioequivalence studies with adjust..
AQ
03/19XSPRAY PHARMA  : publishes its annual report for 2020
AQ
03/18XSPRAY PHARMA  : aims to submit its improved version of dasatinib for market app..
AQ
03/05XSPRAY PHARMA  : Both groups in the two ongoing bioequivalence studies with Xspr..
AQ
02/25XSPRAY PHARMA  : publishes Interim report Q4, January – December 2020
AQ
02/17XSPRAY PHARMA  : Nomination Committee proposes Anders Ekblom as new Chairman of ..
AQ
02/01XSPRAY PHARMA  : Number of shares and votes in Xspray Pharma
AQ
01/29XSPRAY PHARMA  : Number of shares and votes in Xspray Pharma
AQ
More news
Financials
Sales 2020 - - -
Net income 2020 -52,4 M -6,21 M -6,21 M
Net cash 2020 321 M 38,0 M 38,0 M
P/E ratio 2020 -63,6x
Yield 2020 -
Capitalization 1 592 M 189 M 189 M
EV / Sales 2019 -
EV / Sales 2020 -
Nbr of Employees 20
Free-Float 70,8%
Chart XSPRAY PHARMA AB (PUBL)
Duration : Period :
Xspray Pharma AB (publ) Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends XSPRAY PHARMA AB (PUBL)
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Managers and Directors
NameTitle
Per Andersson Chief Executive Officer & Media Contact
Kerstin Hasselgren Chief Financial Officer
Michael Wolff Jensen Chairman
Charlotta Liljebris Vice President-Research & Development
Gunnar Gårdemyr Independent Director
Sector and Competitors
1st jan.Capitalization (M$)
XSPRAY PHARMA AB (PUBL)-55.98%194
GILEAD SCIENCES, INC.14.78%83 035
VERTEX PHARMACEUTICALS-7.26%56 728
REGENERON PHARMACEUTICALS4.03%52 040
WUXI APPTEC CO., LTD.3.92%51 089
BIONTECH SE83.37%36 103