Xspray Pharma AB

STOCKHOLM--( BUSINESS WIRE )-- Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY), a pharmaceutical company leveraging its proprietary HyNap™ technology to develop enhanced cancer therapies, today announced significant progress following a productive meeting with the U.S. Food and Drug Administration (FDA). The company plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, incorporating feedback from the Complete Response Letter (CRL) issued by FDA in July 2024. If the FDA sets a two-month review period upon resubmission, the launch of Dasynoc could be expected as early as Q1 2025. The FDA recommends adjustments to Dasynoc's tablet strengths to reduce the risk of medication errors. Although these changes are minor (within normal variability), the FDA has requested new batches to be produced before submission. Xspray Pharma has already initiated production of these batches. The company will also provide further clarification on the manufacturing process to ensure full alignment with the FDA’s requirements. Per Andersson, CEO of Xspray Pharma, commented: “We are very encouraged by the positive and collaborative discussions with the FDA. The new tablet strengths will enhance patient safety by reducing the potential for dosing errors, and we are working diligently to meet all the necessary requirements. Our production process is well underway, and we are on track to resubmit the NDA in Q4 2024.” He continued: “Xspray Pharma is particularly eager to bring Dasynoc to market because of the critical need we have identified in our research. Many patients, especially those relying on pH-altering medications like antacids, face challenges with existing cancer treatments due to inconsistent absorption. Dasynoc’s innovative pH-independent formulation directly addresses this issue, which minimizes the risks associated with fluctuating drug absorption ensuring that patients can receive consistent treatments. We believe this solution will be welcomed by healthcare providers and patients alike, who are in need of more reliable treatment options.” Upon resubmission, Xspray Pharma expects the FDA to assign a new Prescription Drug User Fee Act (PDUFA) date, with a final decision anticipated within two or six months of the resubmission, depending on the review timeline set by the FDA. About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com .

STOCKHOLM--( BUSINESS WIRE )-- A new scientific article, published in the US journal Clinical Pharmacology in Drug Development, shows how Xspray Pharma's HyNap™ technology improves the bioavailability and reduces variability of two important tyrosine kinase inhibitors (TKIs), Dasynoc™ (XS004, dasatinib) and XS005 (sorafenib). Reduced variability generally leads to better safety and can potentially increase treatment effectiveness for patients, ensuring prescribers that their seriously ill patients consistently receive the prescribed dose. The article, entitled “Enhanced Oral Bioavailability and Reduced Pharmacokinetic Variability of Dasatinib and Sorafenib through Hybrid Nanoparticle-Amorphous Solid Dispersion Technology,” highlights that Xspray's amorphous drug formulations achieve bioequivalence at lower doses and with less variability in uptake and thus plasma exposure compared to crystalline reference products. These new data in several hundred people, together with a previous study showing that Xspray's amorphous dasatinib products are not affected by gastric acid-reducing agents, are major improvements for clinical use. Key findings presented in the article: Dasynoc™ (XS004, dasatinib): Bioequivalence at 30% lower dose, with up to 4.8 times less variation in plasma exposure compared to the reference product. XS005 (sorafenib): 45% increase in absorption and up to 2.8 times less variability in plasma exposure compared to the reference product. The publication in a peer-reviewed journal confirms the HyNap technology's potential to improve both efficacy and safety in the treatment of cancer patients. Per Andersson, CEO of Xspray Pharma, comments: “It is significant that our research is recognized in a leading American scientific journal. The publication confirms HyNap technology's ability to improve drug solubility and bioavailability, which we believe will lead to better treatment outcomes and fewer side effects especially for chronically medicated cancer patients.” https://doi-org.libproxy1.nus.edu.sg/10.1002/cpdd.1416 About Xspray Pharma Xspray Pharma AB (publ) is a pharmaceutical company focused on the development of improved PKIs for cancer treatment, leveraging its proprietary HyNap™ technology platform. The company aims to enhance clinical outcomes for cancer patients by improving the efficacy, safety, and patient experience of existing cancer therapies. Xspray Pharma’s shares are traded at Nasdaq Stockholm (Nasdaq Stockholm: XSPRAY). For more information about Xspray Pharma AB and its innovative approach to cancer treatment, please visit www.xspraypharma.com .

Pharmaceutical companies face a looming patent cliff over the next several years, as generic rivals could erode sales of some of the industrys best-selling medicines. For some drugmakers, copycat competitors are already on the doorstep.Bristol Myers Squibb, for one, could soon hit headwinds for its blockbuster Sprycel as the first generic of the leukemia drug is expected to hit the market in September.Sprycel, or dasitinib, is a kinase inhibitor that was approved in 2006 to treat chronic myeloid leukemia, a type of blood cancer thats diagnosed in about 10,000 people in the U.S. each year. The tablet has been a reliable blockbuster for Bristol Myers over the years, reaching $1.9 billion in global sales in 2023. Sales topped $2.1 billion in both 2022 and 2021.Bristol Myers has faced several challenges to Sprycels patents, and filed a patent infringement lawsuit again Swedish biopharma company XSpray Pharma in 2022, as well as a handful of other companies that were challenging two patents listed in the Food and Drug Administrations Orange Book that expire in 2025 and 2026.Bristol Myers settled with XSpray last year, clearing the way for the challenger to launch a generic dasatinib as soon as Sept. 1, 2024. XSpray has an FDA decision date of July 31 for its optimized version of dasatinib, Dasynoc.If Dasynoc is approved, it will join dozens of new generics cleared by the FDA this year, including several copies of cancer drugs. Their entry could lead to price declines in oncology, according to IDP Analytics. Sprycel has a list price of more than $18,000 per month. CML mostly affects adults 65 and older, and Sprycel treatment is therefore often covered under Medicare.Biocon, Teva Pharmaceutical and several other companies also have developed dasitinib generics and secured tentative FDA approval.Sprycels patent expiration isnt the only generic threat Bristol Myers faces. Copycat competitors to Revlimid are available in limited fashion already, while protection for top-sellers Eliquis and Opdivo run out in 2026 and 2028 in the U.S., respectively.In oncology, Bristol Myers is focused on expanding the market for Breyanzi, a CAR-T cell therapy for different types of lymphoma and leukemia, as well as for Abecma, for multiple myeloma. Opdualag, a combination immunotherapy for melanoma, also figures heavily in the companys plans.Elsewhere in Bristol Myers pipeline are two candidates for acute myeloid leukemia, or AML, that are in early clinical stages. The company co-markets with Servier Idhifa for AML, which is considered a hard-to-treat disease, '