Dexamethasone Acetate

PLYMOUTH, Minn.--(BUSINESS WIRE)-- SpineThera, Inc., a pharmaceutical company specializing in long-acting injectable technology, has announced it has entered into a know-how agreement with Mayo Clinic. This collaboration aims to develop long-acting injectable drugs to improve treatment outcomes for individuals with substance abuse disorders. The opioid epidemic remains a significant public health crisis, impacting millions worldwide. There is a need to develop treatment options that improve outcomes, increase patient access to supervised treatment, and reduce risk associated with existing treatments. The project will be led by SpineThera CEO, Jeff Missling, and Chair for Addiction Medicine at Mayo Clinic, Tyler Oesterle, M.D. Missling commented on the significance of the collaboration, “SpineThera’s novel, long-acting injectable technology has potential in multiple therapeutic areas. We are honored to move strategically into substance abuse disorder treatment through this collaboration. Despite multiple approved medications for the treatment of opioid use disorder, we are still losing too many people to this crisis every day and seek to make a difference through our contributions." By leveraging SpineThera’s long-acting injectable technology and Mayo Clinic’s expertise in addiction medicine, this collaboration seeks to develop more effective and accessible treatment options. SpineThera is committed to addressing this healthcare challenge and improving the lives of individuals affected by substance abuse disorders. Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research. About SpineThera, Inc.: SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating long-acting injectable drugs utilizing its patented micro-suspension platform technology. SpineThera’s micro-suspension provides months long sustained release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SpineThera's flagship investigational drug product, SX600, is a dexamethasone acetate micro-suspension injection which has been engineered as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk pro to current epidural steroid injections for radicular leg pain. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. For more information visit: .

PLYMOUTH, Minn.--(BUSINESS WIRE)-- SpineThera, Inc., a privately held, clinical-stage pharmaceutical company focused on the development of SX600 (a novel formulation of extended-release dexamethasone microspheres for epidural injection for the management of lumbar radicular pain) and ProMed Pharma LLC, a leading contract manufacturer of polymer-based drug releasing dosage forms and combination device components, announced today that ProMed Pharma has acquired SpineThera’s cGMP manufacturing operational assets. ProMed Pharma also obtained an option to license SpineThera’s microsphere intellectual property with the potential to sub-license to ProMed Pharma’s customers. With this acquisition, ProMed Pharma adds biodegradable microparticle development and manufacturing services to its existing portfolio of polymer-based drug releasing dosage forms by purchasing SpineThera’s controlled environment manufacturing suite and process equipment that provide a robust manufacturing process supported by a cGMP quality management system and a highly experienced CMC team. SpineThera has been developing and manufacturing biodegradable microspheres for 10 years. The sale of its manufacturing operation is consistent with SpineThera’s drug-product asset-development focus. SpineThera’s Chief Executive Officer, Jeff Missling, remarked, “We are focused on improving patients lives by developing innovative injectable drugs based on our proprietary micro-suspension platform technology. Our lead asset, SX600, has shown best-in-class potential for the treatment of lumbar radicular pain. Importantly, SpineThera is maintaining exclusive ownership of intellectual property that enables SX600. With this transaction, our manufacturing team joins a highly capable CDMO, ProMed Pharma, a company we have worked with closely for many years. SpineThera becomes a customer of ProMed, who will manufacture SX600 in the same cleanroom in which we previously developed the technology and manufactured clinical batches. This transaction provides an infusion of working capital and reduces our fixed and recurring expenses.” Missling added, “I thank our employees who have made the transition to ProMed for their years of dedicated service at SpineThera. We look forward to continuing to partner to advance the development of SX600 so that patients suffering from severe lumbar radicular pain may have greatly improved pain management.” “Microparticle formulation capabilities will significantly expand the sustained-release options we can offer our partners,” commented Jim Arps, Director of Business Development at ProMed Pharma. “I’m particularly excited about opportunities to expand our collaborations in Women’s Health, Ophthalmology, and Complex Generics and engage new partners in therapeutic areas such as Oncology, CNS, and Animal Health. Our in-house analytical capabilities are also well-suited to support new projects in these areas from early formulations to clinical trial material testing and release.” The financial terms of the transaction were not disclosed. About SpineThera SpineThera is a clinical stage pharmaceutical company working to improve the lives of patients by creating injectable drugs utilizing its patented micro-suspension platform technology. SpineThera’s micro-suspension provides months long sustained release of the active pharmaceutical ingredient with superior injectability at ultra-high concentrations. Our goal is to develop proprietary drugs that offer patients and physicians new treatment options that reduce risk, improve outcomes, and manage overall treatment costs in markets with few or no approved drugs. SpineThera's flagship investigational drug product, SX600, is a groundbreaking dexamethasone acetate micro-suspension injection which has been meticulously engineered as a targeted, extended-release corticosteroid with the potential to demonstrate a substantially improved benefit-risk pro to current epidural steroid injections for radicular leg pain. SpineThera, Inc., is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. About ProMed Pharma ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early-stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovascular, and ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota