Gedeon Richter Buys Mycenax's Tocilizumab Biosimilar

A biosimilar under development that is thought to have potential for treating coronavirus disease 2019 (COVID-19)—related pneumonia is changing hands in a $16.5 million deal.

The biosimilar is a tocilizumab version that references Roche’s Actemra. It is intended for the second-line treatment of rheumatoid arthritis, but recent evidence suggests it may have value as an agent in the war on COVID-19.

Taiwan-based Mycenax, a pharmaceutical contract development and manufacturing organization (CDMO), said in a statement it has agreed to sell its tocilizumab biosimilar (LusiNEX) to Hungary-based Gedeon Richter.

LusiNEX is currently being tested in a phase 1 trial and has been in development since 2013. Gedeon Richter aims to launch in the European Union, Canada, Australia, and Japan in 2025. Currently there are no tocilizumab biosimilars on the US market. Roche’s Actemra has global sales estimated at $2.4 billion.

COVID-19 Pneumonia Potential

Meanwhile, the FDA has approved a randomized phase 3 clinical trial to evaluate the safety and efficacy of intravenous tocilizumab (Actemra) plus standard of care in hospitalized adult patients with pneumonia as a complication of COVID-19, according to Genentech, a property of Roche.

The trial will assess whether the agent can reduce uncontrollable inflammation that causes damage to patients’ lungs and heightens risks for ventilation and death. In some cases of COVID-19, the immune system becomes overactive and generates a cytokine storm that can be life threatening. Chinese physicians in Wuhan last year used tocilizumab to treat a small number of patents with COVID-10 with serious lung damage and reported promising results. Tocilizumab is now incorporated into Chinese guidelines for treatment of COVID-19.

“The mechanism of tocilizumab suggests a way to dampen and halt that inflammatory response, which might reduce the need for more extreme medical interventions, such as mechanical ventilation, and greater risk of chronic injury and death,” said Atul Malhotra, MD, research chief of pulmonary, critical care and sleep medicine at UC San Diego Health, which is participating in the trial.

The clinical trial is called COVACTA, and Genentech has also indicated that they will provide 10,000 vials of tocilizumab to the US Strategic National Stockpile for future use at the direction of the HHS to further support the COVID-19 response efforts. Investigators will follow patients for 60 days post-randomization and an interim analysis will be conducted to look for early evidence of efficacy.

According to Genentech, enrollment was expected to start as early as last month, with a target accrual of 330 patients across the United States and other countries.

Several independent clinical trials have already begun globally to evaluate the efficacy and safety of tocilizumab for the treatment of patients with COVID-19 pneumonia. However, there are still no well-controlled studies, and evidence on the safety or efficacy of tocilizumab in the treatment of patients suffering from COVID-19 is limited.

Worldwide Rights for Development

Richter will receive worldwide rights to develop, manufacture, and commercialize LusiNEX. The asset agreement includes the LusiNEX cell lines, intellectual property rights, technology know-how, and data collected by Mycenax.

“Richter, known for its capabilities in drug development and marketing, showed great interest and high confidence in LusiNEX, Pei-Jiun Chen, PhD, chief executive officer of Mycenax, said in the statement..

The company said the successful medical technology transfer demonstrates the viability of its decision in 2019 to focus on biologics and become a leader in the global CDMO market.

The tocilizumab biosimilar will be purchased in 4 installments with the amounts accumulating to $16.5 million. Richter previously made a down payment of $3 million for exclusive negotiation rights and will pay an additional $3 million upon signing as an upfront payment.

More on Biosimilar Tocilizumab

Reference tocilizumab is mostly used in patients with rheumatoid arthritis but also is approved for use in patients with pediatric juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T-cell—induced cytokine release syndrome. It can be administered either subcutaneously or intravenously.

More Details on Richter

Richter is large pharmaceutical company in Central Eastern Europe that also conducts business in Western Europe, China, and Latin America.

Just 1% of the company’s 2019 revenue was from biosimilars, and this derived from Richter’s recent launch of biosimilar teriparatide (Terrosa), their only other biosimilar, for osteoporosis. It was launched on the European market in August of 2019 and generated $9.6 million by the end of the year.

Terrosa was also launched in Japan in November of 2019 in a partnership with Mochida.

Additionally, Richter invested 29% of its research and development (R&D) capital on biosimilars in 2019, suggesting that more biosimilar products are on the way.

"We are thrilled to see our biosimilar portfolio taking shape as we add this highly promising rheumatology project to our biologicals pipeline," said Gábor Orbán, chief executive officer of Richter, in a statement.

The company’s market value reached approximately $4.1 billion in 2019 with a consolidated sales total of $1.7 billion.

More About Mycenax

Besides having developed LusiNEX, Mycenax also has biosimilar versions of bevacizumab (AiNEX), filgrastim (GranNEX), omalizumab, adalimumab and trastuzumab in the works.