Globestar Therapeutics Enters into Definitive Agreement with SMI Healthcare to Manage Clinical Trial, Regulatory Filings, Manufacturing and Sales in MEA Region for Multiple Sclerosis Treatment

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.