Japanese drug development: Where is the innovation? 

Lu Rahman looks at how opportunities are growing in Japanese drug development and where innovation is coming from.

Japan is a fascinating drug discovery and development market. A strong pharmaceutical sector (some reports place it second globally behind the US), an ageing population and a tranche of expertise, put the country in a good position. But these advantages come at a point when pre-COVID-19, Japan was already facing economic uncertainty. Add to this the fact that pricing and regulatory barriers have not always been as kind to its drug development sector and it’s clear the country has had hurdles to innovation to clear. A low birth rate and a shrinking tax pot due to a growing number of retired has led to a rise in the cost of healthcare. The pharmaceutical sector has also been faced with the challenges of patents expiring and a growing generics market. However, regulatory change has taken place in recent years and the country has become increasingly attractive to drug development and biotech companies.

According to CPhI PharmaInsights: “The Japanese pharma industry has long been a sizable presence in the innovative part of the global market. Anti-cancer drugs have been at the forefront of Japanese development of biopharmaceutical products, as well as enhanced immune class drugs, including cutting edge technologies such as checkpoint inhibitors (e.g. PD1), chimeric antigen receptor (CAR)-T-cell therapies, antibody- drug conjugates (ADCs) and monoclonal antibodies (mAbs). However, focus on generics and biosimilars is increasing.”

The country’s ability to innovate in drug development is clear. The report highlights that, “biosimilars are experiencing the fastest growth in the Japanese pharma industry,” and adds that one of the segments that will grow fastest will be biologics.

Despites its size, accessing the Japanese pharma market has proved tricky. However, innovation is ongoing. The report highlighted a desire by Japanese companies to work internationally. It is hoped this collaboration will boost innovation and development opportunities.

Looking to innovate

One company that had continued to push the boundaries is Fujifilm Toyama Chemical. Back in March this year, the company was making headlines such as “Japanese flu drug ‘clearly effective’ in treating coronavirus”. This story in the UK’s Guardian newspaper referred to the flu drug favipiravir (Avigan).

It was of course, early on in the COVID-19 story but months later and the company is still innovating. It recently partnered with Dr Reddy’s Laboratories and Global Response Aid (GRA) for the development, manufacture and sale of Avigan Tablets, a potential treatment for COVID-19. Under the agreement Fujifilm Toyama Chemical will provide Dr Reddy’s and GRA with an array of data on Avigan’s preclinical and clinical studies that Fujifilm Toyama Chemical has accumulated. Dr Reddy’s and GRA, will use this data to implement clinical studies, targeting COVID-19 patients in India, the Middle East, among other regions.

Avigan was approved for manufacture and sale in Japan as an anti-influenza virus drug. Because it has a mechanism of action that selectively inhibits viral RNA polymerase, preventing viral proliferation, the drug may have an antiviral effect on the novel coronavirus, as it is classified into the same type of RNA virus as influenza viruses. At the time of writing, the Fujifilm Group was conducting a clinical study on Avigan targeting COVID-19 patients in Japan and the US and working to increase the drug’s production by partnering with domestic and overseas companies.

Such collaboration is key within the drug development sector. Takeda recently partnered with Novavax for its COVID-19 Vaccine Candidate in Japan. Under the agreement, Novavax will license COVID-19 vaccine technology to Takeda for local production and commercialisation in Japan.

NVX CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix M adjuvant. Takeda will receive funding from the government of Japan’s Ministry of Health, Labour and Welfare (MHLW) to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.

“Takeda’s leading position in Japan, technical expertise, regulatory know-how and manufacturing capacity make the company an ideal partner to further expand the global availability of NVX CoV2373,” said Stanley Erck, President and Chief Executive Officer of Novavax. “We look forward to collaborating with Takeda to rapidly develop, produce and commercialise the vaccine in Japan.”

COVID-19

There is much work being carried out in Japan around COVID-19. Recently the University of Tokyo and a range of partners including Daiichi Sankyo agreed to work collaboratively on R&D on a Nafamostat inhalation formulation for the treatment of novel coronavirus infection.

In the first stage of infection by the causative virus of COVID-19, SARS-CoV-2, the outer envelope of the virus fuses with the host cell surface membrane. Professor Junichiro Inoue, Institute of Medical Science, The University of Tokyo and others discovered that by preventing this fusion, Nafamostat could efficiently inhibit the viral entry process. Nafamostat is an injectable that has been prescribed mainly as a treatment for acute pancreatitis and disseminated intravascular coagulation for many years in Japan and adequate safety-related clinical data has been accumulated.

Separately, Daiichi Sankyo announced that it has been selected by the Japan Agency for Medical Research and Development (AMED) to be a company for the AMED’s Drug Discovery Support Program Development of a Vaccine for COVID-19 Vaccines (Second Round) in relation to its genetic (mRNA) vaccine (DS-5670) for COVID-19.

DS-5670 is a gene (mRNA) vaccine for COVID-19 using a novel nucleic acid delivery technology discovered by Daiichi Sankyo. Daiichi Sankyo will proceed with preparations for the start of clinical studies around March 2021 in collaboration with the University of Tokyo’s Institute of Medical Science.

There is a clear mood for innovation within the Japanese drug development market. Despite past challenges around pricing and regulation, the future looks strong for this country which is keen to bring new products to market, to work internationally, and to collaborate.

PeptiDream

PeptiDream a Kanagawa-based biopharmaceutical company has hit the headlines recently. In 2019 it announced a new Peptide Drug Conjugate (PDC) collaboration agreement with Novartis. Under the agreement, PeptiDream would use its proprietary Peptide Discovery Platform System (PDPS) technology for the identification of novel macrocyclic/constrained peptides for use as PDCs against multiple targets of interest selected by Novartis.

Patrick Reid, CEO of PeptiDream commented: “We are extremely excited to be working with Novartis on peptide drug conjugates, specifically on peptide-radionuclide conjugates, in which Novartis is one of the leading companies in the space. Our macrocyclic/constrained peptides are ideal for the delivery of conjugated payloads, either therapeutic or diagnostic, specifically to the targeted cells/tissues and we believe this partnership has the potential to bring a number of first-in-class and best-in-class therapeutics and their companion diagnostics to patients worldwide.”

PeptiDream is a biopharmaceutical company using its PDPS discovery platform which enables the production of highly diverse (trillions) non-standard peptide libraries with high efficiency, for the identification of highly potent and selective hit candidates, which then can be developed into peptide-based or small molecule-based therapeutics. The company says it aspires to be a world leader in drug discovery and development to address unmet medical needs and improve the quality of life of patients worldwide.

Volume 21, Issue 4 – Fall 2020

 

 

 

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