List of Repurposed/505(b)(2) Drugs Companies with Phase 3 Active Clinical Trial - 6

We are a biopharmaceutical company passionately committed to providing solutions for overlooked and unmet medical needs through patient-focused, innovative products.

Avenue Therapeutics is a specialty pharmaceutical company whose mission is to develop IV tramadol, a potential alternative that could reduce the use of conventional opioids, for patients suffering from acute pain in the U.S. Avenue is headquartered in New York City and was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). FBIO owns a controlling number of voting shares of ATXI. Invagen entered an agreement to purchase ATXI if certain conditions are met, including approval of IV tramadol before April 30, 2021, but Invagen has indicated that due to the Covid epidemic, it can terminate its purchase agreement to acquire ATXI.

Biocon: Enhancing Global Healthcare Biocon Limited, publicly listed in 2004, is India's largest and fully-integrated, innovation-led biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving customers in over 120 countries. Driven by a vision to enhance global healthcare through innovative and affordable biopharmaceuticals, we have enabled access to advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high. The early anticipation of the increasing dominance of biologics in global development pipelines helped us to be ahead of the curve in crafting a differentiated product portfolio based on fermentation and recombinant technologies, which straddles fermentation-derived small molecules and biologics, both novel as well as biosimilars. The significant brand equity that we have built worldwide for our small molecule APIs across statins, immunosuppresants and other specialty products has made us a leading global supplier of these products. We have also built one of the largest and most diverse biosimilar pipelines, spanning insulins, monoclonal antibodies and other recombinant proteins that address critical chronic diseases such as diabetes, cancer and autoimmune disorders. Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in volume terms, we are the first Indian company to launch a biosimilar in Japan with Insulin Glargine, which also has been approved for sale in EU and Australia. Our insulin products have made a difference to the lives of millions of people with diabetes across the globe. We now aim to provide our insulin products to ‘one in five’ people with diabetes in need of insulin-based therapy anywhere in the world within the next 10 years. We are also making a huge impact in the area of cancer care. Our biosimilar Trastuzumab, which was the first to be approved anywhere in the world and launched in India in 2014, has helped treat several thousand HER2-positive metastatic breast cancer patients. We are also the first company from India to get its biosimilar approved by the USFDA; Ogivri™, co-developed by Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition to Trastuzumab, several of our biosimilar assets are on track for anticipated regulatory approvals in developed markets. We are also developing a pipeline of patented biologics to address global unmet medical needs. We have successfully launched a couple of novel biologics in India: Nimotuzumab for the treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, we have a basket of novel assets are under various stages of clinical development, including a high potential oral insulin. Through our subsidiary, Syngene, we offer a suite of integrated, end-to-end discovery and development services for novel molecular entities (NMEs) to the global life sciences sector. Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance access to life-saving therapies and make a significant impact to global healthcare through ‘blockbuster’ drugs with the potential to benefit a billion patients.

Eusol Biotech was founded in March 2005 in Taipei, Taiwan. The company is involved in the R&D and GMP process development of recombinant human acid fibroblast.

KARE Biosciences is a biotechnology company looking to license products and partner with other companies to develop drugs for a wide range of indications. KARE Biosciences is currently focused on repurposing ramatroban for the treatment of acute COVID-19 and long COVID. Ramatroban has great potential in many other indications including sickle cell disease, cardiovascular disease, rhabdomyolysis induced acute kidney injury, community acquired pneumonia, dengue fever, pulmonary fibrosis, Alzheimer's disease and more. Please visit our website for more information about our products.

Privo Technologies is a privately funded, Phase III oncology company that spun out of the world-renowned Langer Laboratory at the Massachusetts Institute of Technology (MIT) in Cambridge, Massachusetts, USA. Privo is developing a novel, nanotechnology-based drug delivery platform capable of local and systemic delivery of a constant, controlled therapeutic dose through the mucosa. This approach eliminates needles, avoids stomach acids, can significantly reduce toxic side effects of drugs and allows for higher dosing where the drugs can be most effective – all of which improve patient outcomes and compliance. Privo was founded by Manijeh Goldberg who is a seasoned executive with over 25 years of experience in the medical industry as an executive leader and a scientist in large and small start-up companies, one of which (Epicon) was acquired for $475M. Her 12 years of large company experience includes working for HP medical and Siemens Medical Systems. Manijeh's MBA from MIT and MS from Harvard Medical School led to her working with Professor Robert Langer. Professor Langer has global expertise in nanotechnology and drug delivery and is now an advisor to Privo. Privo is focused on dramatically improving human health through its novel and proprietary Mucosal Delivery Particle (MDP) platform. Privo's platform has both small and large molecule applications. The technologies used in Privo's platform have won awards and significant grants from the FDA and NIH.