Dr. Reddy’s Laboratories, one of India’s biggest pharmaceuticals manufacturers, said it has signed a licensing agreement with Japan-based FUJIFILM to manufacture anti-viral drug favipiravir.
Favipiravir is traditionally used to treat infuenza, and is also being tested in COVID-19 patients.
Dr Reddy’s said the tie-up is part of the Japanese company’s efforts to ramp up the manufacturing of the drug, sold under the brand name Avigan, across the world.
The drug, as manufactured by Dr Reddy’s, will be sold in countries other than Japan, China and Russia, where FUJIFILM will sell Avigan directly.
It will be sold via the global sales network of Global Response Aid, a Dubai-based company.
Global Response Aid (GRA) is a Dubai-based unit of Agility, a global logistics provider, established in May this year to procure certified diagnostic, testing and protective products and offer services such as a contact-tracing app and mobile testing used in the detection, treatment and prevention of COVID-19.
The deal with FUJIFILM has been inked as a tripartite agreement involving all three parties, with Dr Reddy’s taking care of the manufacturing part.
Japan has commenced with a phase 3 clinical trial for treating COVID-19 patients with Favipiravir.
In the United States, a phase 2 trial will enroll approximately 50 patients with COVID-19, while in India, a phase 3 trial combining 2 antiviral agents, favipiravir and umifenovir, started in May 2020.
“Under the tripartite agreement signed on 30th June 2020, FUJIFILM grants Dr. Reddy’s the exclusive rights of manufacturing and also grants both Dr. Reddy’s and GRA the rights to develop, sell and distribute Avigan in all countries other than Japan, China and Russia,” the Indian company said.
Dr. Reddy’s would have exclusive rights for development, selling and distribution of Avigan in India.
FUJIFILM would receive an upfront license fee and royalties on sales from Dr. Reddy’s and GRA.
The Japanese company will provide Dr. Reddy’s and GRA with an array of data on Avigan’s preclinical and clinical studies that FUJIFILM has accumulated thus far.
Dr. Reddy’s and GRA will use this data for clinical studies targeting COVID-19 in regions where infection has been spreading, Dr Reddy’s said.
In addition, FUJIFILM will grant Dr.Reddy’s right to use Avigan’s patents of formulation and manufacturing method.
Dr. Reddy’s will herewith establish a setup for manufacturing drugs of the same quality as Avigan.
The FUJIFILM Group is currently conducting a clinical study on Avigan® targeting COVID-19 patients in Japan and the US, and is working to increase the drug’s production by partnering with domestic and overseas companies, Dr Reddy’s said.
Dr. Reddy’s and the Dubai-based company shall introduce the product in the market post all applicable approvals in the respective countries, it said.
Avigan Tablet, developed by FUJIFILM Toyama Chemical, was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug.
The drug is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses.