On February 23, 2023, Xspray Pharma AB announced that it has signed an agreement with EVERSANA to aid the launch and commercialization of its innovative cancer therapy Dasynoc for treating chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL) in the United States. Xspray Pharma will maintain financial and strategic control while granting EVERSANA exclusive commercialization access to support the second-half 2023 launch of Dasynoc. Dasynoc, if FDA approved, will be a new treatment option for CML and ALL patients that will enter the $3.5 billion commercial market for Tyrosine Kinase Inhibitors in the United States.
Under the agreement, EVERSANA will provide Xspray with a dedicated commercialization team with expertise in the successful commercialization of cancer drugs, including TKI products, and offer support in areas such as agency services, market access, clinical and commercial field teams, patient services, medical science liaisons, and compliance. In addition, this agreement gives Xspray access to EVERSANA's experienced commercial leaders and enables a quick launch while optimizing the launch budget.
Dasynoc is expected to bring significant benefits to CML patients as it is bioequivalent to Sprycel® at a 30% lower dose with significantly better variability, enabling better precision and predictability of dosing. Dasynoc is granted ODD by FDA for the treatment of CML and ALL.
The product offers an important improvement for CML patients, as retrospective registry data presented at ASH 2022 show that patients on concomitant tyrosine kinase inhibitor (TKI) and proton pump inhibitor (PPI) treatment (e.g., omeprazole) of 79% have low 5-year overall survival rates compared to 94% for patients on TKI only. Dasynoc uptake is unaffected by PPIs, hence offering an essential benefit to CML patients.
Xspray plans to launch the product in the second half of 2023, subject to FDA approval and ongoing litigation processes pertaining to patents for crystalline dasatinib forms that Xspray believes are not present in its product.
About EVERSANA
EVERSANA is a prominent global services provider to the life sciences industry, offering integrated solutions that focus on the patient experience and cover all stages of the product life cycle. The company aims to create long-term, sustainable value for patients, prescribers, channel partners, and payers. It works with over 670 organizations, including established pharmaceutical companies and start-ups, to advance life sciences solutions and contribute to creating a healthier world.