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svXspray Pharma Partners with EVERSANA for the U.S. Launch and Commercialization of its Lead Product, Dasynoc (XS004) for the Treatment of Chronic Myeloid Leukemia (CML) and Acute Lymphatic Leukemia (ALL)
Regulatory press release 2023-02-23
Xspray Pharma AB, (NASDAQ Stockholm: XSPRAY) has signed an agreement with EVERSANA® to support the U.S. launch and commercialization of the company’s first innovative cancer therapy Dasynoc for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). While maintaining financial and strategic control, Xspray Pharma will grant EVERSANA exclusive commercialization access to support its Dasynoc launch, aimed at the second half of 2023. Dasynoc, pending FDA-approval and legal conditions, will be a new and differentiated treatment option for CML and ALL patients, entering the $3.5 billion commercial market for Tyrosine Kinase Inhibitors in the United States – a market that has grown by nearly 5% in the last year alone.
Under the agreement, EVERSANA will provide Xspray with a dedicated commercialization team with deep experience in the successful commercialization of cancer drugs including TKI-products. This agreement provides Xspray with access to EVERSANA’s seasoned commercial leaders and allows for a short launch period while optimizing its launch budget. EVERSANA will additionally support Xspray in the areas of market access, agency services, clinical and commercial field teams, medical science liaisons, patient services and compliance.
“As we explored commercialization options to navigate the complexity of bringing new oncology therapies to the U.S., we wanted to find a full-service commercialization partner with vast experience in oncology,” said Per Andersson, CEO of Xspray Pharma. “After a comprehensive evaluation process, EVERSANA met all our selection criteria, and we look forward to their support in bringing Dasynoc to patients in need across the U.S. with chronic myeloid leukemia and acute lymphatic leukemia.”
“The commercialization of every oncology treatment is complex and requires a customized approach led by those with expertise in the space. We are proud to partner with Xspray to bring this much needed therapy to market,” said Jim Lang, CEO, EVERSANA. “Patients deserve easy access to the best options as they fight this dreadful condition, and novel new therapies like Dasynoc may improve the outcome for thousands of patients. As a team, we truly believe in this product and are highly motivated to do everything possible to successfully bring this therapy to the U.S. as quickly as possible.”
Dasynoc brings an important improvement for patients with CML. Retrospective registry data presented at ASH 2022 show inferior 5-year overall survival for patients on concomitant tyrosine kinase inhibitor (TKI) and proton pump inhibitor (PPI) treatment (e.g. omeprazole) of 79% vs. 94% for patients on TKI only. Nearly 50% of the patients in the study used prescribed PPIs during the first 5-year period, many times despite warnings for low TKI absorption when used together. Dasynoc uptake is not affected by PPIs, hence bringing an important benefit to CML patients. Dasynoc is bioequivalent to Sprycel® at a 30% lower dose with significantly better variability allowing for better precision and predictability of dosing. Dasynoc is granted ODD by FDA for the treatment of CML and ALL.
The U.S. launch of the product is planned for the second half of 2023, at which time the company expects to have obtained approval from the FDA. The launch is also conditional on an ongoing litigation process pertaining to patents for crystalline dasatinib forms that Xspray is confident are not present in its product.