Vireo Health Seeks to Develop FDA Approved Cannabinoid-Based Medications
Medical cannabis company with operations in New York and Minnesota signs exclusive Captisol® licensing and supply agreements with Ligand Pharmaceuticals
ALBANY, NY (November 24, 2015) – Vireo Health, LLC announced that it has entered into exclusive license and supply agreements with Ligand Pharmaceuticals, Inc. for Ligand’s patented Captisol®pharmaceutical formulation technology for use by Vireo Health in the development and commercialization of cannabinoid-based medications.
We now embark on our endeavors to bridge the gap between medical cannabis and traditional pharmaceuticals and become the first state-licensed company in the United States to develop proprietary FDA-approved cannabinoid-based medicines. Our operations in state-regulated environments have helped us develop significant in-house expertise with pharmaceutical formulation technologies and we plan to leverage this knowledge in the FDA drug approval process.
Kyle Kingsley, M.D. Chief Executive Officer of Vireo Health
The ability to use Captisol, a patented cyclodextrin solubilizing agent used in numerous FDA-approved prescription medicines, may help scientists and physicians at Vireo Health overcome formulation hurdles unique to cannabinoid-based products. Peer-reviewed scientific literature supports the utility and potential for significant benefits of using cyclodextrins with cannabinoids, illustrating improved solubility, chemical stability and bioavailability. Vireo’s goal is to incorporate Captisol into cannabinoid-based medicines in order to design novel, patent-protected, FDA-approved dosage formats that have been previously unavailable to physicians, caregivers and patients. Possible methods of administration include oral, nasal, topical and nebulized delivery.
“As a board-certified emergency medicine physician I have witnessed, time and again, the adverse impact opiate-based medications have on so many of my patients, including death from overdose and debilitating addiction,” said Laura Bultman, M.D., Chief Medical Officer of Vireo. “Our initial focus will be on developing cannabinoid-based medications for the treatment of chronic pain, a condition that afflicts more than 100 million Americans, as a safe alternative to opiate-based medications.”
“New formulations of these medicines, and potential FDA approval could have a profoundly positive impact on the life of patients suffering from seizures and other neurological diseases,” said Stephen Dahmer, M.D. Chief Medical Officer of Vireo Health of New York. “Captisol formulated cannabinoid medications could be used to treat these patients with administration via a nebulizer, which could help improve their quality of life.”
Unlike other pharmaceutical companies conducting research in this area that oppose state-based medical cannabis programs, Vireo Health has adopted a dual-track approach in which it is committed both to state-based medical cannabis programs and to research and development efforts designed to lead to FDA-approved prescription cannabinoid-based medications.
Vireo Health views its planned research as a potential path to improving patient access to medical cannabinoids by addressing some current limitations. Under the federal Controlled Substance Act (CSA), cannabis is currently classified as a Schedule I drug, which makes medical cannabis ineligible for prescription drug coverage, even in states with approved medical programs. The lack of prescription drug coverage disproportionately impacts some patients, who may have difficulties paying for medical cannabis even at discounted prices. FDA-approved, cannabinoid-based medicines would make medical cannabis eligible for prescription drug coverage and provide patients in all 50 states, even in those states that do not have medical cannabis programs, with access to medicine.
Vireo Health is the parent company of Vireo Health of New York, formerly Empire State Health Solutions, and Minnesota Medical Solutions. Minnesota Medical Solutions has been serving patients since July 1, after winning the competitive process to produce cannabis-based medications there with the highest score of 12 applicants. Vireo Health of New York was awarded one of five medical cannabis licenses in New York, with the second-highest score out of 43 applicants. In accordance with the New York State Compassionate Care Act, Vireo Health of New York will begin serving patients in January of 2016.
Captisol is Ligand Pharmaceuticals’ patent-protected, chemically modified cyclodextrin that has a chemical structure that was specifically engineered to maximize administration safety while improving solubility, stability and bioavailability of active pharmaceutical ingredients (APIs).
Given the well-established contribution of Captisol to the stability and solubility of APIs, it has been an integral part of New Drug Approval submissions for a number of established global companies in the pharmaceutical industry. Captisol has enabled the development of life-saving medicines in a variety of therapy areas including antifungals, CNS disorders, cardiovascular, and oncology. Extensive preclinical and clinical safety studies have been performed relating to Captisol and indicate that it is safe when administered parenterally, orally and in other routes of administration, and that it does not exhibit toxicities commonly associated with other cyclodextrins. Ligand maintains a large safety database for Captisol within Type IV and V Drug Master Files submitted to the FDA that contain over 200 clinical and safety studies, which Ligand’s license partners can reference for their development efforts with new Captisol-enabled medicines. There are more than 45 Captisol-enabled products currently in development.
Captisol’s broad intellectual property estate includes issued patents in over 60 countries with a potential patent term to 2033.
For more information, visit www.captisol.com.
About Vireo Health LLC
Vireo Health, LLC is a physician-led company dedicated to providing best-in-class cannabis-based medications and top quality patient care. The Company provides a wide array of pharmaceutical grade cannabis-based products formulated from the highest quality, organically grown, pesticide-free plants and utilizes its separation chemistry capabilities to create products with novel cannabinoid combinations. As the parent company of Vireo Health of New York, formerly Empire State Health Solutions, and Minnesota Medical Solutions, Vireo has national expertise in providing patients with the safest, most-effective cannabis-based medications for a variety of ailments.
For more information, visit vireohealth.com.
About Ligand Pharmaceuticals
Ligand Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and acquiring technologies that help pharmaceutical companies discover and develop medicines. Over its more than 25 year history, Ligand has employed research technologies such as nuclear receptor assays, high-throughput computer screening, formulation science and liver targeted prodrug technologies to assist companies in their work toward securing prescription drug approvals. Ligand currently has partnerships and license agreements with over 72 pharmaceutical and biotechnology companies, and over 125 different programs under license with Ligand are currently in various stages of development. Ligand has contributed novel research and technologies for approved medicines that treat cancer, osteoporosis, fungal infections, low blood platelets, among others. Ligand’s partners have programs currently in clinical development targeting seizure, coma, cancer, diabetes, cardiovascular disease, muscle wasting, liver disease, and kidney disease, among others. Ligand has over 500 issued patents worldwide, and over 300 currently pending patent applications.
For more information visit www.ligand.com