May 28 (Reuters) - MITHRA PHARMACEUTICALS SA MITRA.BR :
* MITHRA SIGNS LICENSE AND SUPPLY AGREEMENT WITH MAYNE PHARMA FOR COMMERCIALIZATION OF ESTELLE IN AUSTRALIA
* MITHRA ELIGIBLE FOR MILESTONE AND LICENSE FEES OF UP TO EUR 3.5 MILLION
* PREPARATION ONGOING FOR COMMERCIAL LAUNCH OF MITHRA'S ORAL CONTRACEPTIVE IN U.S. AND AUSTRALIA, TARGETED FOR H1 AND H2 2021 RESPECTIVELY
* CONSOLIDATION OF PARTNERSHIP WITH MAYNE PHARMA FOR COMMERCIALIZATION OF THE COMBINED ORAL CONTRACEPTIVE E4/DRSP (ESTELLE®1) IN AUSTRALIA
* PRODUCT IS EXPECTED TO BE FILED WITH AUSTRALIAN AGENCY TGA IN 2020 AND LAUNCHED IN SECOND HALF OF CALENDAR 2021
* WILL ALSO RECEIVE GUARANTEED ANNUAL RECURRING REVENUES BASED ON MINIMUM ANNUAL QUANTITIES IN ADDITION TO OTHER REVENUES ON NET SALES
* ON APPROVAL, PRODUCT IS EXPECTED TO RECEIVE FIVE YEARS OF DATA EXCLUSIVITY FROM TGA AS IT IS A NEW CHEMICAL ENTITY
* MAYNE HAS OPTION TO OBTAIN A LICENSE TO REGISTER AND LAUNCH PRODUCT IN NEW ZEALAND
* BASED ON MARKET ASSUMPTIONS AND MITHRA'S FORECAST, AGREEMENT REPRESENTS DEAL WORTH UP TO EUR 40 MILLION OVER PERIOD