About Sunshine Biopharma

Sunshine Biopharma, Inc. operates as a pharmaceutical company. The company offers and researches life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals. In addition to its own drug development operations, the company operates three wholly owned subsidiaries, including Nora Pharma Inc. (Nora Pharma), a Canadian corporation with a portfolio consisting of 49 prescription drugs on the market in Canada and 28 additional drugs scheduled to be launched in 2023 and 2024; Sunshine Biopharma Canada Inc. (Sunshine Canada), a Canadian corporation, which develops and sells OTC supplements; and NOX Pharmaceuticals, Inc., a Colorado corporation, which is inactive and is scheduled to be dissolved later. Products on the Market As a result of the acquisition of Nora Pharma, the company has various generic prescription drugs on the market in Canada, including Alendronate, Amlodipine, Apixaban, Atorvastatin, Azithromycin, Candesartan, Candesartan HCTZ, Celecoxib, Cetirizine, Ciprofloxacin, Citalopram, Clindamycin, Clopidogrel, Donepezil, Duloxetine, Dutasteride, Escitalopram, Ezetimibe, Finasteride, Flecainide, Fluconazole, Fluoxetine, Hydroxychloroquine, Lacosamide, Letrozole, Levetiracetam, Mirtazapine, Montelukast, Olanzapine ODT, Olmesartan, Olmesartan HCTZ, Pantoprazole, Paroxetine, Perindopril, Pravastatin, Pregabalin, Quetiapine, Quetiapine XR, Ramipril, Rizatriptan ODT, Rosuvastatin, Sertraline, Sildenafil, Tadalafil, Telmisartan, Telmisartan HCTZ, Tramadol Acetaminophen, Zolmitriptan, and Zopiclone. In addition, the company has various nonprescription OTC products on the market in Canada and partially in the U.S., including Essential 9, L-Arginine, L-Carnitine, Extreme-Mass, Iso-Whey, BCAA 2:1:1, L-Creatine, Nora B12-1000, Nora Calcium, Nora Cal-D 400, Nora Cal-D 1000, Nora D-400, Nora D-1000, Nora Senna, Nora Sennosides, NRA-ASA, NRA-Docusate Sodium, and NRA K-20. Products in Development The company's generic drugs in development include Group A (5 Products), Group B (3 Products), Group C (1 Product), Group D (8 Products), Group E (5 Products), and Group F (6 Products); and proprietary drugs in development include Adva-27a (Small Molecule), K1.1 (mRNA LNP), and SBFM-PL4 (Small Molecule). Proprietary Drugs in Development Adva-27a Anticancer Compound In the area of oncology, the company's proprietary drug development activities have been focused on the development of a small molecule called Adva-27a for the treatment of aggressive forms of cancer. A Topoisomerase II inhibitor, Adva-27a has been shown to be effective at destroying Multidrug Resistant Cancer cells, including Pancreatic Cancer cells, Breast Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). The company is the direct owner of all issued patents pertaining to Adva-27a, including the U.S. Patents Number 8,236,935 and 10,272,065. Adva-27a is a GEM-difluorinated C-glycoside derivative of Podophyllotoxin. Adva-27a and Etoposide are similar in that they both attack the same target in cancer cells, namely the DNA unwinding enzyme, Topoisomerase II. Unlike Etoposide however, Adva-27a is able to penetrate and destroy Multidrug Resistant Cancer cells. In addition, Adva-27a has been shown to have distinct and more desirable biological and pharmacological properties compared to Etoposide. In side-by-side studies using Multidrug Resistant Breast Cancer cells and Etoposide as a reference, Adva-27a showed markedly greater cell killing activity. In February 2023, the company signed a research agreement with the Jewish General Hospital (JGH) to complete the IND-enabling studies. The JGH has also agreed to negotiate with the company the terms for Phase I Clinical Trials. Adva-27a's initial indication will be pancreatic cancer for which there are little or no treatment options available. All aspects of the clinical trials in Canada will employ the U.S. Food and Drug Administration (FDA) standards at all levels. K1.1 Anticancer Messenger Ribonucleic Acid (mRNA) In June 2021, the company initiated a new research project in which it sets out to determine if certain mRNA molecules can be used as anti-cancer agents. As of December 31, 2022, the data collected have shown that a selected group of mRNA molecules are capable of destroying cancer cells in vitro, including multidrug resistant breast cancer cells (MCF-7/MDR), ovarian adenocarcinoma cells (OVCAR-3), and pancreatic cancer cells (SUIT-2). In April 2022, the company filed a provisional patent application in the United States covering the subject mRNA molecules. The company recently concluded an agreement with a specialized partner for the purposes of formulating its K1.1 mRNA molecules into lipid nanoparticles, ready for use to conduct studies in xenograft mice. The company anticipates commencing such studies within approximately the next twelve months. SBFM-PL4 COVID-19 Treatment The company's COVID-19 research effort has been focused on developing an inhibitor of PLpro, the viral enzyme that mediates suppression of the human immune system. On May 22, 2020, the company filed a patent application in the United States for a new treatment for Coronavirus infections. Its patent application covers composition subject matter pertaining to small molecules for inhibition of the Coronavirus main protease (Mpro) and papain-like protease (PLpro). In February 2022, the company expanded its PLpro inhibitors research effort by entering into a research agreement with the University of Arizona for the purposes of conducting research focused on determining the in vivo safety, pharmacokinetics, and dose selection properties of three University of Arizona owned PLpro inhibitors, to be followed by efficacy testing in mice infected with SARS-CoV-2 (the 'Research Project'). Under the agreement, the University of Arizona granted the company a first option to negotiate a commercial, royalty-bearing license for all intellectual property developed by University of Arizona personnel under the Research Project. In addition, the company and the University of Arizona entered into an option agreement whereby the company was granted a first option to negotiate a royalty-bearing commercial license for the underlying technology of the Research Project. Encouraged by the results obtained as of December 31, 2022, the company submitted a Notice of Option Exercise to the University of Arizona on September 13, 2022. Intellectual Property The company is the sole owner of all worldwide rights pertaining to Adva-27a. These patent rights are covered by PCT/FR2007/000697 and PCT/CA2014/000029. The patent applications filed under these two PCTs have been issued in the United States (U.S. Patent Number 8,236,935 and 10,272,065), Europe, and Canada. On May 22, 2020, the company filed a provisional patent application in the United States for a new treatment for Coronavirus infections. Its patent application covers composition subject matter pertaining to small molecules for inhibition of the main Coronavirus protease, Mpro, an enzyme that is essential for viral replication. The patent application has a priority date of May 22, 2020. On April 30, 2021, the company filed a PCT application containing new research results and extending coverage to include the Coronavirus Papain-Like protease, PLpro. The priority date of May 22, 2020 has been maintained in the newly filed PCT application. On April 20, 2022, the company filed a provisional patent application in the United States covering mRNA molecules capable of destroying cancer cells in vitro. The patent application contains composition and utility subject matter pertaining to the structure and sequence of the relevant mRNA molecules. The company's recently acquired wholly owned subsidiary, Nora Pharma, owns 152 DINs issued by Health Canada for prescription drugs on the market in Canada. These DINs were secured through in-licenses or cross-licenses from international manufacturers of generic pharmaceutical products. In addition, the company is the owner of two NPNs issued by Health Canada: NPN 80089663 authorizes it to manufacture and sell its in-house developed OTC product, Essential 9; and NPN 80093432 authorizes it to manufacture and sell the OTC product, Calcium-Vitamin D under the brand name Essential Calcium-Vitamin D. Manufacturing The company's generic drugs are manufactured by several different international partners under long-term contracts. Research quantities of the company's proprietary drug candidates are manufactured at the University of Arizona located in Tucson, Arizona (Anti-Coronavirus compounds); WuXi App Tech located in Hong Kong, China (Adva-27a compound); and Arranta Bio MA LLC located in Watertown, Massachusetts (K1.1 mRNA). The company's OTC products are manufactured under contract by INOV Pharma Inc. located in Montreal, Canada. Marketing and Sales The company's generic drugs are being sold across Canada. All of its generic drug sales are conducted by Nora Pharma's sales representatives based in key provinces across Canada. In addition, a segment of the company's marketing team offers human resources and commercial assistance to pharmacies and pharmacy owners by providing experienced pharmacists and technical assistant recruitment services, as well as training and education support. The company's OTC products are sold in the U.S. and Canada through Amazon.com and Amazon.ca, respectively. The company's personnel together with outside consultants develop and place ads on Google, YouTube, Amazon, and other media outlets. The same team manages the company's accounts with Amazon. Acquisitions On October 20, 2022, the company acquired Nora Pharma Inc. (Nora Pharma), a Canadian generic pharmaceuticals company based in the greater Montreal area. Nora Pharma offers 49 generic prescription drugs and 11 nonprescription OTC products. Competition Most of the company's pharmaceutical company competitors include Merck, Bristol-Myers Squibb, Pfizer, Amgen, and others. Government Regulations The company's generic prescription medicines are produced following the same Good Manufacturing Practices (GMP) guidelines as for brand-name drugs. In the case of Nora Pharma's products, Nora Pharma secures cross-licenses from supply partners holding Notice of Compliance's (NOC) and in turn applies to Health Canada to obtain DINs issued in Nora Pharma's name in order to commercialize in Canada. The company is committed to meeting or exceeding the standards set by the FDA and the FTC. The company is operating within both the FDA and Federal Trade Commission (FTC) mandates.