Under this agreement, Dr Reddy’s is given exclusive rights for India and grants both Dr Reddy’s and GRA the rights to develop, sell and distribute Avigan in all countries other than Japan, China, and Russia.
An upfront license fee and royalties on sales would be given by Dr Reddy’s and GRA to Fujifilm.
Earlier in 2011, Dr Reddy’s had formed a joint venture with Fujifilm for generic drugs business in the Japanese market, but both the companies called off the venture after two years as the venture did not take off.
In 2014, Fujifilm Toyama Chemical received approval for manufacturing and selling Avigan tablet as an influenza antiviral drug in Japan. This 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. The Japanese government decided to use the drug as a countermeasure against such influenza viruses.
Fujifilm developed Avigan and is presently under trail in several parts of globe targeting COVID-19 patients and a large trial result is expected this month. A clinical study in Japan and the US is currently being conducted by Fujifilm group and it has been partnering with both the Japanese and overseas drug makers.
According to a statement released by Dr Reddy’s, GRA and it will obtain from Fujifilm an array of data on Avigan’s preclinical and clinical studies accumulated so far. Dr Reddy’s and GRA will use this data for clinical studies, targeting COVID-19 in regions where the infection was spreading.
“Dr Reddy’s and GRA shall introduce the product in the market post all applicable approvals in the respective countries,” said the statement.
It will also obtain rights from Fujifilm to use Avigan’s patents of formulation and manufacturing method, added the statement. The Hyderabad-headquartered drug maker will establish a setup for manufacturing drugs of the same quality as Avigan. Moreover, Dr Reddy’s said it will use GRA’s global sales network to supply the manufactured drugs swiftly and in a stable manner.
Recently, Glenmark has received emergency approval for the generic favipiravir from India’s drug controller to manufacture the drug but the drug is yet to be part of the treatment protocol reviewed last week by the Indian Council of Medical Research.
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