Xspray 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)

Rhea-AI Summary

Xspray Pharma AB (NASDAQ Stockholm: XSPRAY) has partnered with EVERSANA to facilitate the U.S. launch of its innovative cancer therapy, Dasynoc, targeting chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL). Planned for the second half of 2023, Dasynoc is positioned to enter the $3.5 billion Tyrosine Kinase Inhibitor market. EVERSANA will provide a specialized commercialization team, enabling an efficient launch process. Importantly, Dasynoc is designed to be unaffected by proton pump inhibitors, improving dosing precision for patients. The launch hinges on FDA approval and ongoing patent litigation, in which Xspray remains optimistic.

Positive

• Partnership with EVERSANA provides access to experienced commercialization support, optimizing launch budget.
• Dasynoc is bioequivalent to Sprycel at a 30% lower dose, enhancing dosing precision.
• The U.S. market for Tyrosine Kinase Inhibitors is valued at $3.5 billion, indicating significant potential revenue.

Negative

• Launch contingent upon FDA approval and ongoing patent litigation, introducing risk to timelines.

STOCKHOLM, Feb. 23, 2023 /PRNewswire/ -- 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.

For additional information, please contact:
Kerstin Hasselgren, CFO Xspray Pharma AB 
Tel: +46 (0) 70 311 16 83 
E-mail: kerstin.hasselgren@xspray.com

Matt Braun, Director, Corporate Communications, EVERSANA 
Tel: +1 414-434-4830 
E-mail: matt.braun@eversana.com

About XSpray Pharma
Xspray Pharma AB (publ) is a pharmaceutical company with several product candidates in clinical development. Xspray Pharma uses its innovative, patented RightSize™ technology to develop improved versions of marketed drugs, primarily protein kinase inhibitors (PKIs) for the treatment of cancer. The segment is the second largest in oncology, and drug prices are very high. The company´s innovative technology allows Xspray Pharma to gain entry as the first competitor to today's original drugs before the secondary patents expire. Xspray's goal is to become the leader in the development of improved drugs of PKIs already marketed for the treatment of cancer, which numbered to 72 in the end of 2021. To learn more about Xspray, visit xspraypharma.com or connect with the brand on LinkedIn.

About EVERSANA®
EVERSANA® is the leading independent provider of global services to the life sciences industry. The company's integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.

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SOURCE EVERSANA

FAQ

What is Xspray Pharma's lead product, Dasynoc, meant to treat?

Dasynoc is designed for the treatment of chronic myeloid leukemia (CML) and acute lymphatic leukemia (ALL).

When is the planned U.S. launch of Dasynoc?

The U.S. launch of Dasynoc is expected in the second half of 2023, pending FDA approval.

What is the market value for Tyrosine Kinase Inhibitors in the U.S.?

The U.S. market for Tyrosine Kinase Inhibitors is estimated at $3.5 billion.

Who is partnering with Xspray Pharma for the commercialization of Dasynoc?

Xspray Pharma is partnering with EVERSANA for the U.S. launch and commercialization of Dasynoc.

What advantage does Dasynoc offer over traditional treatments for CML?

Dasynoc is unaffected by proton pump inhibitors, allowing for better dosing precision compared to traditional treatments.