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Xspray Pharma (Nasdaq Stockholm: XSPRAY) has submitted a New Drug Application (NDA) to the FDA for XS003, its improved nilotinib formulation for chronic myeloid leukemia treatment. The product, developed using proprietary HyNap™ technology, demonstrates superior characteristics compared to reference drug Tasigna®.
Key advantages include significantly reduced food interaction (28% vs 82% for Tasigna®), improved dose linearity, and bioequivalence achieved at less than half the reference dose. The company aims to eliminate the three-hour fasting requirement currently mandated for Tasigna®. The target market represents USD 850 million in U.S. sales, part of global nilotinib sales of USD 1.67 billion in 2024.
Xspray Pharma (XSPRAY) has signed a significant non-exclusive license agreement with Handa Therapeutics for patents related to dasatinib product commercialization in the US and select Asian markets. Under the agreement, Xspray will receive up to double-digit royalties on Handa's net proceeds.
This marks Xspray's first patent portfolio out-licensing while maintaining focus on its core strategy of developing PKI-drugs using HyNap technology. The company's lead product, Dasynoc, awaits FDA approval with a PDUFA date of October 7, 2025. The agreement ensures Dasynoc's launch won't be affected by potential US regulatory exclusivities associated with Handa's yet-to-be-launched product.
Xspray Pharma (Nasdaq Stockholm: XSPRAY) has announced plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024 following a positive FDA meeting. The company is addressing feedback from the Complete Response Letter (CRL) issued in July 2024. Key points include:
1. Potential launch of Dasynoc as early as Q1 2025 if FDA sets a two-month review period.
2. FDA recommends minor adjustments to tablet strengths to reduce medication error risks.
3. New batches with adjusted strengths are already in production.
4. Xspray will provide further clarification on the manufacturing process.
5. Dasynoc's pH-independent formulation addresses challenges faced by patients using pH-altering medications.
A new scientific article in the US journal Clinical Pharmacology in Drug Development validates Xspray Pharma's HyNap™ technology. The study shows improved bioavailability and reduced variability for two tyrosine kinase inhibitors (TKIs): Dasynoc™ (XS004, dasatinib) and XS005 (sorafenib).
Key findings include:
- Dasynoc™: Bioequivalence at 30% lower dose, with up to 4.8 times less variation in plasma exposure
- XS005: 45% increase in absorption and up to 2.8 times less variability in plasma exposure
These improvements could lead to better safety and potentially increased treatment effectiveness for cancer patients. The publication in a peer-reviewed journal confirms the HyNap technology's potential to enhance both efficacy and safety in cancer treatment.
Xspray Pharma has released new clinical data for its second product candidate, XS003, which shows matching bioavailability to Tasigna at more than a 50% lower dose.
XS003 is designed to overcome limitations of current crystalline formulations of nilotinib, a protein kinase inhibitor used in cancer treatment.
The new data suggests that XS003 may reduce the risk of sudden death caused by QTc interval prolongation, a known complication with Tasigna, by minimizing food interactions.
The company aims to complete the pivotal clinical program within this year and submit an FDA approval application by the first half of 2025, despite a slight delay in the study's processing time.
XS003's amorphous formulation could also reduce environmental impact by decreasing the amount of unabsorbed drug excreted.
CEO Per Andersson expressed satisfaction with the progress, emphasizing the potential safety benefits of using a reduced dose.
Xspray Pharma presented compelling data at the ASCO Annual Meeting, highlighting significant issues in the co-medication of Proton Pump Inhibitors (PPIs) with Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia (CML) patients. The study revealed that 54% of CML patients treated with TKIs also received a PPI, with 66% of these comedications prescribed by different healthcare providers. The bioavailability of crystalline dasatinib was significantly affected, with a 96% reduction in Cmax and an 88% reduction in AUC24 when co-medicated with a PPI. To address this, Xspray plans to launch Dasynoc®, an optimized version of dasatinib, by September 2024.
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.
