Dexamethasone Acetate

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

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 transforaminal epidural injection [TF-EI] for the management of sciatica pain) today announced United States Patent and Trademark Office (USPTO) has issued Patent No. 11,771,707 related to its micro-suspension platform technology. Patent No. 11,771,707 provides additional protection for SX600 and complements previously issued U.S. Patent Nos. 8,927,529, 9,572,771, 10,350,222, 10,925,883, and 11,058,692. The newly granted ‘707’ patent underscores SpineThera’s ongoing dedication to developing novel medical technologies that enhance spinal health and improve patients' quality of life. The invention covered by this patent is a result of years of research and development by SpineThera’s team of skilled scientists, engineers, and medical professionals. “Our lead asset, SX600, is built on our micro-suspension platform technology, which is clinically proven to provide sustained-release of the active pharmaceutical ingredient for 90 days. This 6th US Patent provides additional depth and breadth to our patent portfolio covering our micro-suspension technology. We will continue to vigorously pursue development of SX600 with the aim of offering patients a non-opioid treatment for chronic sciatica pain,” said Jeff Missling, CEO of SpineThera. Recently SpineThera announced successful market research results for its lead asset SX600 showing a potential 70% adoption rate by physicians to treat patients suffering with lumbar radicular pain (sciatica). “This news, paired with strong clinical trial results in the phase-2 SALIENT trial, leads us to believe SX600 holds great potential to be a more effective sciatica pain management option for patients, and a leading drug in the non-opioid category,” Missling said. 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 is based in Medical Alley, Minnesota, the global epicenter of health innovation and care. View source version on businesswire.com: Contacts Jeff Missling, CEO jmissling@spinethera.com 612-508-4795 Source: SpineThera, Inc. View this news release online at: