바이오스펙테이터

바이오스펙테이터 Jongwon Jang 기자

license agreement HL 161, anti-FcRn monoclonal antibody

HanAll Biopharma has signed again a large-scale technology transfer agreement. In September, following the Chinese Harbour BioMed, this time is the Swiss pharmaceutical company, Roivant Sciences. This contract on HL 161, autoimmune antibody, is worth up to 500 million dollars.

HanAll Biopharma announced on Tuesday that they have transferred technology for the treatment of autoimmune disease antibody to Roivant Sciences. Under the terms of agreement, Roivant Sciences will now have exclusive rights to clinical development, production, and product licensing in North America, Latin America, the EU, the UK, Switzerland, the Middle East and North Africa.

The fixed-term technology fee is a total of $502.5 million, with $30 million in non-refundable contracts, research fees limited to $20 million, (five-year split), and $452.5 million dollars in each milestones. It is also a condition to receive the ordinary technical fee separately.

Swiss pharmaceutical company Roivant Sciences is also well known as a company that has received investment $1.1 billion, the largest ever in the biotechnology and pharmaceutical industry, from Vision fund led by Softbank in August.

Roivant has a model to develop and commercialize by taking over the late clinical pipeline through its subsidiary company.

The technology transferred this time is HL 161, which is being developed as an autoimmune disease antibody drug. Technology of this substance was transferred at a total of $81 million (including substance HL036), including $4 million contracts fee, to Chinese Harbour Biomed in September.

HL161 is a human antibody derived from a transgenic model. It has a mechanism of inhibiting FcRn receptor that keeps autoimmune antibody staying in our body, entering the cells and degraded in lysosome.

While most of drugs are targeting the factors associated antibodies producing b-cells, this new substance is targeting FcRn receptor as a ‘first-in-class’ drug. HanAll Biopharma targets optic neuropathy, a rare neurological disorder, and plans to expand its indications to other rare diseases such as myasthenia gravis and pemphigus vulgaris.

HanAll Biopharma has recently received phase 1 approval from the Austrailian FDA for clinical trials for HL 161 autoimmune disease therapeutic antibody drug and started phase 1 clinical trial. Phase 1 clinical trial is processed under Quintiles, a global CRO, and to be completed by third quarter of 2018.