RICHLAND, WA / ACCESSWIRE / September 28, 2023 / GlobeStar Therapeutics Corporation (OTC PINK:GSTC) (GSTC), a clinical-stage pharmaceutical company focused on advancing new therapies for Multiple Sclerosis (MS) and other neurological diseases today announced that it has entered into a definitive agreement with SMI HealthCare LLC (SMIHC) to manage an initial clinical trial, regulatory filings, intellectual property rights filings, manufacturing, sales and distribution in India, Southeast Asia, Africa, and the Middle East, excluding Israel and Iraq, and for government and private aid organizations, for GlobeStar's patented Multiple Sclerosis treatment. GSTC is the exclusive worldwide licensee for Project Amethyst™, including all patents and patent applications relating thereto, including U.S. Patent #10610592.
James C. Katzaroff, President and CEO of GlobeStar Therapeutics Corporation stated: "SMI HealthCare and its affiliates will collaborate closely with GlobeStar to advance our commercialization of Project Amethyst™. Our plan is to utilize the relationships and expertise of SMI HealthCare's professionals in the region to finalize arrangements locally for a clinical trial that meets the requirements for marketing approval by the Drug Controller General of India (DCGI). We then anticipate commencing sales in India and other countries in the region that accept DCGI approvals. Concurrently, we intend to arrange for additional clinical trials and begin the regulatory approval process in the United States, Europe, and elsewhere."
Shekar Tirumalai, Managing Director of Healthcare for SMI Group LLC added: "India has become a leading location for undertaking high quality clinical trials for the FDA and regulators in the UK and EU at a cost that is usually about half of a comparable trial undertaken in the United States. There are substantial opportunities for MS therapeutics and diagnostics in India, and throughout Southeast Asia, the Middle East and parts of Africa. Because of India's priorities for MS products, this is a particularly opportune time to commence an MS trial in India."
The agreement with SMIHC has been approved by the parties' respective boards and is immediately effective. Implementation of the first phase is subject to Globestar arranging financing. The first phase includes formation of Globestar and SMIHC subsidiaries in India, the clinical trial, regulatory and intellectual property rights filings in India, identifying manufacturers, and planning for the commercial launch in India and countries in the region that accept DCGI approvals.
Implementation of the second phase is expected to commence approximately nine months later, and is subject to receipt of DCGI marketing approval and GlobeStar arranging financing. The second phase may continue for the duration of patent validity, and consists initially of sales, marketing and distribution in India and thereafter, countries in SMIHC's territory that will permit sales and distribution based upon DCGI approval. After proof of market in those countries, the intention is to seek regulatory approvals elsewhere in SMIHC's territory in order to expand the sales and distribution of GTC's MS products.
Among other countries, SMIHC's territory includes India, Bangladesh, Indonesia, Saudi Arabia, Singapore, Thailand, the United Arab Emirates, Vietnam, and the members of the African Union.
According to the U.S. National Institutes of Health, between 2013 and 2020, the reported incidence of MS has increased by 50% in the 81 most affected countries. Although the market potential is uncertain in many of the developing countries in SMIHC's territory, in 2020, reported cases of MS in India reached 256,000, and total reported cases in SMIHC's territory exceeded 600,000. According to multiple sources, the reported incidence of MS in the Middle East and Africa is rapidly growing, with treatments in the Middle East (excluding Israel) alone expected to grow from approximately $3.5 billion in 2023 to $4.5 billion in 2032. Within five years after launching sales in each country in which Globestar obtains regulatory approval, GlobeStar's goal is to capture from 20% to 50% of the market for MS therapeutics in that country.
Pursuant to the parties' agreement, GlobeStar retains ownership of its intellectual property rights, and regulatory filings, and approval of SMIHC's services regarding the foregoing, clinical trials, and manufacturing. Subject to the terms of the agreement, SMIHC has final approval over its sales and distribution activities, though with certain limited exceptions, it is required to purchase GTC's MS products from GTC. SMIHC has the first right in its territory to provide similar services for other GTC products and services.
For its consulting and management services, SMIHC will be paid a range of fees that escalate over time and are tied to services rendered. For sales and distribution, SMIHC receives customary commissions and mark-ups. SMIHC is required to rebate to GlobeStar approximately 5% of its profits from certain manufacturing, sales and distribution activities.
SMIHC is an affiliate of SMI Group LLC, a privately-held Los Angeles-based company. The chairman of SMI Group is a Globestar shareholder and consultant, though he did not advise GlobeStar on this transaction and has waived fees payable to an SMI company for introducing SMIHC to Globestar. In India, SMIHC is led by Mr. Tirumalai, who has more than 25 years of experience as an executive and advisor to health care providers, investors and aid organizations worldwide.
Globestar is discussing with Advanced Innovative Partners (AIP) the modification of their non-binding MOU announced on June 14, 2023, with the goal that AIP will focus on advising GlobeStar on opportunities in the United States and Europe, and advising GlobeStar and SMIHC regarding potential clinical partners and design of the clinical trial in India.
About GlobeStar Therapeutics
GlobeStar Therapeutics Corporation (OTC PINK:GSTC) (GSTC)'s mission is to pioneer biotechnology in transformative therapies for the management of chronic neurodegenerative diseases. In an initial study of Project Amethyst™ in Italy of 150 volunteers, 90 between 25 and 65 years of age with MS disease and 60 healthy volunteers, the average Expanded Disability Status Scale (EDSS) score for subjects with MS dropped by at least 1.3 points for pre-treatment and an average of 4.02 points after treatment. After 45 days of treatment, all subjects reported an improvement in balance and motor control of all extremities, and most reported an improvement in bladder control. GSTC is the exclusive global licensee of the Project Amethyst™ patents and patent applications. For additional information see: www.globestartherapeutics.com.
About SMI HealthCare
SMI HealthCare LLC was recently formed by SMI Group LLC to engage in consulting and distribution services regarding health care products and services, with an initial focus on India and developing countries. SMIHC's activities in India, Southeast Asia, and developing countries are led by Shekar Tirumalai, a managing director of SMI Group with more than 25 years of experience as an executive and advisor to health care providers, investors and aid organizations worldwide. SMI Group LLC is a privately-held Los Angeles-based group consisting of management consulting, a licensed investment bank, and a registered investment advisor. Founded by Kenin M. Spivak, SMI Group participates in creating and building companies, joint ventures and other business opportunities. Its professionals have closed more than $50 billion of complex transactions and led multinational businesses with more than 30,000 employees. For additional information about SMI Group see www.SMIGllc.com.
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SOURCE: GlobeStar Therapeutics Corporation