April 25, 2024

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[THE INVESTOR] HanAll BioPharma, an affiliate of Daewoong Pharmaceutical, said on Dec. 20 it has licensed rights to its drug that blocks pathogenic antibody recycling that causes autoimmune disease to Switzerland-based biotech startup Roivant Sciences in a deal worth US$502.5 million.

Roivant Sciences, which recently attracted US$1.1 billion of investment from SoftBank, will have exclusive rights to develop and commercialize HanAll Biopharma’s drug candidate HL161BKN in North America, Latin America, EU, Middle East and North Africa.

HanAll BioPharma CEO Park Seung-kook

Under the deal, Roivant Sciences is paying the Korean firm US$30 million upfront, US$20 million for drug development expenditure. It has also earmarked US$452.5 million for potential milestone payments, as well as double-digit royalties on sales. Shares of HanAll Biopharma shot up 30 percent following the news.

HL161BKN, which is undergoing phase 1 clinical study in Australia, is a fully human monoclonal antibody targeting neonatal Fc receptor to treat autoimmune diseases such as myasthenia gravis, pemphigus, immune thrombocytopenia purpura.

“HL161BKN is a potential first-in-class drug that challenges novel targets that have not yet been developed,” Park Seung-kook, CEO of HanAll BioPharma, said during a press conference in Seoul.

Autoimmune diseases affect 5 percent of the population in North America and Europe. The US market alone is worth US$7.5 billion.

Park said the company was searching for a partner that will prioritize HL161BKN for fast development and Roivant Sciences was “a perfect fit.” The Seoul-based firm plans to complete the early stage clinical program by September 2018.

He hoped that the potential drug would be commercialized by 2022 and will be granted fast-track designation for approval as the candidate’s indications include rare diseases.

Founded in 1973, HanAll BioPharma was acquired by Daewoong Pharmaceutical in 2015 for 104.6 billion won in 2015.

The company’s pipeline includes two phase 3 hypertension treatment candidates and an ophthalmic solution for dry eyes as well as two immuno-oncology drugs.

By Park Han-na (hnpark@heraldcorp.com)