● Roivant Sciences is a global biotechnology company founded by US and Israeli investor groups
● Granting the exclusive business in North America, Central and South America, EU and MENA region, HanAll acquires separate upfront payment, research funds, milestones and sales royalties. (MENA, Middle East Asia and North Africa)
● This contract is the first large-scale technology export case of domestically developed new antibody drug
HanAll Biopharma (CEO Park Seung-kook and CEO Yoon Jae-chun) announced that it licensed rights to HL161BKN, the new antibody drug for autoimmune disease, which is undergoing phase 1 clinical study, North America, Central and Latin America, the European Union, including the U.K. and Switzerland, the Middle East, and North Africa, to a US company, Roivant Sciences.
With this agreement, Roivant can exclusively develop, manufacture, receive approval and sell HL161BKN, the antibody drug, in the region. HanAll Biopharma will receive upfront payment, research funds, stage-by-stage milestone payments, as well as double-digit royalties on sales. The deal is the first large-scale technology export case for new target first-in-class antibody drugs developed in Korea.
HL161BKN is an antibody drug that is currently attracting attention as a treatment for severe autoimmune diseases such as myasthenia gravis, pemphigus, chronic thrombocytopenia, neuromyelitis optica, polyneuropathy and lupus nephritis that have no distinct therapeutic agent. Under normal conditions, the antibody acts to neutralize and eliminate external intruders such as pathogens or viruses. In autoimmune disease patients, some of the antibodies in the body may attack the patient’s body rather than defend it from external substances. Antibodies that attack themselves are called pathogenic autoantibodies. The pathogenic autoantibody concentration and disease symptoms are closely related to each other, and if you lower the concentration of the autoantibody, the symptoms will also be alleviated.
Currently, the treatments for autoimmune diseases caused by autoantibody include the plasmapheresis, a process of taking blood out of a patient’s body to filter and remove autoantibodies and returning it to the patient, and the intravenous administration of antibody molecules (immunoglobulin) collected from a large amount of blood to dilute autoantibodies and prevent them from causing problems. Last year, the US market reached US $ 7.5 billion (about KRW 8 trillion) and is steadily increasing. The problem of the existing treatment is that it can be used selectively only in an emergency where the symptoms rapidly deteriorate because of its serious side effect, a great deal of patient suffering, and the high costs of treatment. It cannot be used at all as a preventative measure to prevent chronic autoimmune diseases or symptoms from rapidly worsening.
HanAll has developed a novel antibody drug, HL161BKN, which eliminates autoantibodies by inhibiting Fc receptor (FcRn) that accumulate autoantibodies, a cause of various autoimmune diseases, in the body. It is expected that HL161BKN, which has a mechanism to directly promote the degradation of autoantibodies, will bring about dramatic improvements in terms of efficacy, price and safety compared with the existing treatment methods such as plasmapheresis or high-dose intravenous immunoglobulin (IVIG) therapy. HanAll is currently conducting phase 1 clinical study in Australia for HL161BKN.
“The HL161BKN is a first-in-class new drug that aims a novel target, of which no therapy has been developed, and we are pleased to give hope to patients who are suffering from severe intractable autoimmune diseases,” said Park Seung-kook, CEO of HanAll Biopharma. “We selected Roivant as a partner because we liked the company’s business model, corporate structure and innovative management that can focus on our product and develop it quickly,” he added.
Roivant Sciences (http://roivant.com/) is a global biotechnology company based in Basel, Switzerland and the largest NRDO (No Research Development Only) business model in New York. Six subsidiaries have been established for each disease area and commercialize more than 10 pipelines acquired from major pharmaceutical companies such as GSK, Merck, AstraZeneca, Takeda, Eisai and Vertex. Roivant is expected to establish another subsidiary specialized in autoimmune diseases in order to commercialize HL161BKN licensed from HanAll.
Roivant has received USD 2.6 billion of investment since its establishment in 2014, and in August this year, it made the headlines for receiving USD 1.1 billion from SoftBank’s Vision Fund, the largest investment for a single venture in the world. Vivek Ramaswamy, Founder and Chief Executive Officer of Roivant, was named one of five risk-takers among health-innovation leaders changing the healthcare industry in July 2017 by Fortune magazine. In addition, the global clinical development of HL161BKN is expected to accelerate because Roivant's executives include a number of specialists who have led the clinical development of the hepatitis C treatment drugs, Sovaldi AND Harvoni, AND the Alzheimer's drug Aricept.
HanAll received KRW 3.2 billion in research funding for the HL161BKN antibody drug from the Korea Drug Development Fund (KDDF) from September 2012 to June 2017.