BUSINESS INSIGHTS, PHARMACY MARKET
EVERSANA | February 24, 2023
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.
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.
BUSINESS INSIGHTS, PHARMA TECH
XtalPi Inc. | December 29, 2022
One of the pioneering pharmaceutical technology companies - XtalPi, powered by artificial intelligence (AI) and automation, has recently announced a strategic collaboration with Singapore's national platform for drug discovery and development, the Experimental Drug Development Centre (EDDC), which is hosted by the Agency for Science, Technology, and Research of Singapore (A*STAR). The goal of this partnership is to find novel treatment candidates for non-small cell lung cancer (NSCLC).
“According to Research and Markets, the size of the global market for NSCLC treatments will surpass USD 20 billion by 2027”
Lung cancer is the second-most prevalent cancer worldwide and the leading cause of cancer-related mortality. NSCLC accounts for more than 80% of all lung cancer occurrences, while its incidence continues to rise worldwide. Despite growing interest and investment in drug research, there is a substantial unmet demand for effective targeted therapeutic alternatives for NSCLC patients to improve outcomes.
In this partnership, EDDC and XtalPi will work together to find promising candidates against an NSCLC target chosen by EDDC. XtalPi will use its AI technology, automation platform, and expert domain knowledge. It will also use quantum physics and an AI-driven platform to create and test millions of molecules for the De-novo drug design. Iterations will be used in its robotics-powered synthesis and testing lab to confirm and improve the predicted top-performing molecules with desirable drug properties. EDDC will give helpful information and data about the new NSCLC target, which will speed up the process of finding new drugs and carry the program forward.
XtalPi said in a statement that it is delighted to work with EDDC. It intends to help people all over the world by using AI and automation to improve the speed, size, variety, and success rate of drug research and development. In line with this, EDDC stated that it is excited to collaborate with XtalPi to translate science and research into practical and targeted cancer therapies. Furthermore, EDDC is confident that this collaboration will accelerate the development of much-needed targeted therapies for NSCLC patients due to XtalPi's experience in AI and automation technologies.
XtalPi is a quantum physics-based, AI-powered drug R&D firm aiming to improve the speed, scale, novelty, and success rate of drug discovery. To meet the needs of its clients and partners, the company has offices in China and the United States. Frost & Sullivan cites the company as one of the world's first AI-powered drug R&D companies, with an iterative feedback loop between dry and wet lab capabilities.
BUSINESS INSIGHTS, PHARMACY MARKET
Cytel | February 09, 2023
On February 7, 2023, Cytel Inc., a provider of statistical software and advanced analytics in the life sciences industry, announced that GSK, one of the world's top biopharmaceutical firms, signed a three-year strategic agreement to increase GSK’s deployment of the clinical strategy platform Solara (R). This agreement will contribute significantly to the future development of the Solara platform. The platform can help GSK effectively align on trial goals, traverse trial uncertainties, and create pressure-tested clinical trial designs that reduce costs and expedite speed up to the market.
GSK began using Solara in early 2022 and has already profited from the platform in a variety of study design projects. Over 300 users have adopted Solara at the top 20 biopharma firms worldwide since its initial debut in 2021. It is also the recipient of the 2022 Fierce Life Sciences Award for Technology Innovation.
Solara blends Cytel's proprietary algorithms evolved over three decades with enormous cloud computational capacity to overcome limits in clinical trial planning and design. Clinical development teams use Solara to quickly generate thousands of trial models representing thousands of design variants. These are used to pressure-test dozens of trial uncertainties, including treatment effect and enrollment rate. The platform's high-speed processing capabilities simulate tens of millions of modeled events that might occur during trial execution in minutes. In addition, Solara's visualizations make it simple to review results and quantify scientific and business trade-offs.
The user-friendly interface and dynamic visualization of Solara provide a common language and workspace to facilitate a more data-driven and collaborative trial design process across clinical development functions.
Founded in 1987, Cytel is the leading provider of statistical tools and advanced analytics for the design and execution of clinical trials. It helps life sciences decision-makers to realize the full potential of their products. Its 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical firms transform insight into confident decisions, from navigating uncertainty to establishing value. The company has an unwavering dedication to scientific rigor and operational excellence, which is directed via its offices in the United Kingdom, North America, Europe, and Asia.