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Mithra Pharmaceuticals SA (MITRA.BR)

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Latest Key Developments (Source: Significant Developments)

Mithra: Exclusive License And Supply Agreement On Tibelia In Taiwan
Friday, 21 Sep 2018 01:38am EDT 

Sept 21 (Reuters) - MITHRA PHARMACEUTICALS SA ::SIGNS EXCLUSIVE LICENSE AND SUPPLY AGREEMENT FOR COMMERCIALIZATION OF TIBELIA IN TAIWAN.EXCLUSIVE LICENSE AND SUPPLY AGREEMENT WITH PEI LI PHARMACEUTICAL INDUSTRIAL CO, LTD.IN ADDITION TO LICENSE FEES, IS ELIGIBLE TO RECEIVE GUARANTEED ANNUAL RECURRING REVENUES BASED ON MINIMUM ANNUAL QUANTITIES.DURATION OF CONTRACT: 10 YRS.  Full Article

Mithra And Richter Sign License And Supply Agreement For Commercialization Of Estelle
Wednesday, 12 Sep 2018 02:12am EDT 

Sept 12 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA AND RICHTER SIGN LICENSE AND SUPPLY AGREEMENT FOR COMMERCIALIZATION OF ESTELLE.MITHRA PHARMACEUTICALS AND GEDEON RICHTER PLC. ENTERED INTO A LICENSE AND SUPPLY AGREEMENT.UNDER TERMS OF AGREEMENT RICHTER WILL MAKE, UPON SIGNATURE OF CONTRACT, AN UPFRONT PAYMENT TOTALING EUR 35 MILLION..20-YEAR LICENSE FOR ESTELLE.ADDITIONAL MILESTONE PAYMENTS AMOUNTING TO EUR 20 MILLION WILL BE MADE DEPENDING ON PROGRESS OF REGULATORY PROCESS OF PRODUCT.AGREEMENT TO COMMERCIALIZE ESTELLE, IN EUROPE AND RUSSIA..FURTHER SALES-RELATED ROYALTIES WILL BE PAYABLE TO MITHRA SUBSEQUENT TO LAUNCH OF PRODUCT.POTENTIAL FOR ROYALTIES AND REVENUES OVER LIFETIME OF CONTRACT.WILL RECEIVE GUARANTEED ANNUAL RECURRING REVENUES BASED ON MINIMUM ANNUAL QUANTITIES (MAQ).MAQ WILL BE RECEIVED IN ADDITION TO TIERED ROYALTIES ON NET SALES.  Full Article

Mithra Pharmaceuticals To Commercialise Estelle In South Korea With Hyundai Pharm
Tuesday, 5 Jun 2018 01:39am EDT 

June 5 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA SIGNS BINDING HEADS OF TERMS FOR COMMERCIALIZATION OF ESTELLE IN SOUTH KOREA WITH WOMEN'S HEALTH SPECIALIST HYUNDAI PHARM <<<004310.KS>>>.ELIGIBLE FOR MILESTONE PAYMENTS, RECURRING REVENUES AND FURTHER SALES-RELATED ROYALTY PAYMENTS.WILL PRODUCE ESTELLE FOR THE SOUTH KOREAN MARKET AT ITS CDMO..  Full Article

Mithra Pharmaceuticals Updates On Vaginal Contraceptive Ring
Monday, 28 May 2018 01:36am EDT 

May 28 (Reuters) - MITHRA PHARMACEUTICALS SA ::UPDATE ON MITHRA AND MAYNE PHARMA'S VAGINAL CONTRACEPTIVE RING OPPORTUNITY.POTENTIAL FOR APPROVAL AS EARLY AS Q4 2018..BELIEVES THE PLANNED LAUNCH OF THE PRODUCT CANDIDATE REMAINS ON TRACK FOR H1 2019.MARKETING AUTHORIZATION IN EUROPE IS EXPECTED IN Q2/Q3 2018..ELIGIBLE FOR FURTHER MILESTONES OF AT LEAST EUR 7.6 MILLION AFTER US FDA APPROVAL.  Full Article

Mithra Pharmaceuticals Applies For Additional Estelle® Patent Based On Positive Hemostasis Data
Wednesday, 28 Mar 2018 01:41am EDT 

March 28 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA APPLIES FOR ADDITIONAL ESTELLE® PATENT BASED ON POSITIVE HEMOSTASIS DATA.THE PATENT APPLICATION IS FOR EUROPE, CO PLANS TO MAKE FURTHER APPLICATIONS IN MORE REGIONS‍​.‍PATENT WOULD EXTEND EXISTING INTELLECTUAL PROPERTY ESTATE​ OF ESTELLE COMPONENT ESTETROL.  Full Article

Mithra Pharmaceuticals Announces Completion Of Estelle Cycles In Phase III Contraception Studies
Friday, 23 Mar 2018 02:33am EDT 

March 23 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA ANNOUNCES COMPLETION OF ESTELLE® CYCLES REQUIRED IN PHASE III CONTRACEPTION STUDIES.ESTELLE® PHASE III STUDIES REMAIN ON TRACK TO REPORT TOP-LINE RESULTS IN Q3 2018.‍TOP-LINE RESULTS CONTINUE TO BE EXPECTED IN Q3 2018 FOR EUROPE/RUSSIA STUDY AND IN Q1 2019 FOR US/CANADA TRIAL​.  Full Article

Mithra Pharmaceuticals FY Net Loss At 35.0 Million Euros
Friday, 2 Mar 2018 01:51am EST 

March 2 (Reuters) - MITHRA PHARMACEUTICALS SA ::CASH AT DECEMBER 31 2017 WAS EUR 36.2‍​ MILLION VERSUS EUR 45.7 MILLION YEAR AGO.FY REVENUE EUR 46.3 MILLION VERSUS EUR 22.5 MILLION YEAR AGO.FY REBITDA LOSS EUR 18.1 MILLION VERSUS LOSS OF EUR 34.9 MILLION YEAR AGO.LOOKING FORWARD TO SUBSTANTIAL NEWS FLOW IN 2018..FY NET LOSS STABLE AT EUR 35.0 MILLION.TOWARDS END OF Q1/EARLY Q2, TOP-LINE PHASE II DOSE-FINDING RESULTS FOR DONESTA ARE EXPECTED.RESULTS OF THE FIRST PIVOTAL ESTELLE STUDY IN THE EU & RUSSIA TO BE AVAILABLE IN Q3 2018.RESULTS OF ESTELLE STUDY IN US/CANADA PHASE III RESULTS TO BE PUBLISHED IN Q1 2019.EUROPEAN APPROVAL CAN ALREADY BE EXPECTED IN Q2/Q3 2018 FOR MYRING.FOR MYRING MAYNE PHARMA MAKING SIGNIFICANT PROGRESS FOR THE US APPROVAL AND LAUNCH, EXPECTED IN H1 2019.  Full Article

Mithra Pharmaceuticals And Adamed Sign Commercialization Agreement For Myring™ In The Czech Republic
Wednesday, 27 Dec 2017 01:44am EST 

Dec 27 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA AND ADAMED SIGN COMMERCIALIZATION AGREEMENT FOR MYRING™ IN THE CZECH REPUBLIC.GRANTS NON-EXCLUSIVE 10-YEAR LICENSE FOR VAGINAL CONTRACEPTION RING MYRING TM TO ADAMED FOR COMMERCIALIZATION IN CZECH REPUBLIC.AGREEMENT FOLLOWS US AND AUSTRIAN LICENSE GRANTED TO MAYNE PHARMA AND GYNIAL, RESPECTIVELY.MYRING TM TO BE MANUFACTURED AT MITHRA CDMO.FINANCIAL DETAILS OF AGREEMENT WERE NOT DISCLOSED.  Full Article

Mithra Pharmaceuticals Announces Injectables Agreement With GSP
Thursday, 14 Dec 2017 12:44pm EST 

Dec 14 (Reuters) - Mithra Pharmaceuticals Sa ::ANNOUNCES INJECTABLES AGREEMENT WITH GSP.MITHRA CLOSES CONTRACTS WITH LEADING GENERICS PLAYER GSP FOR DEVELOPMENT AND SUPPLY OF 4 HORMONAL INJECTABLES.CONTRACTS SHOULD ALLOW FOR EUROPEAN AND US GMP APPROVAL OF INJECTABLE SECTION AT MITHRA CDMO.EUR 2.4 MILLION DOWNPAYMENT.AGREEMENT SHOULD GENERATE SEVERAL MILLION EUROS IN ANNUAL REVENUE OVER COURSE OF 10-YEAR CONTRACTS.AGREEMENT COMPRISES DEVELOPMENT AND PRODUCTION OF FOUR PRODUCTS.WELL-POSITIONED TO RECEIVE GOOD MANUFACTURING PRACTICE (GMP) APPROVAL FROM EUROPEAN AND AMERICAN AUTHORITIES FOR ITS INJECTABLES SECTION‍​.  Full Article

Mithra Pharmaceuticals Finalizes Estelle Contract With Libbs
Monday, 11 Dec 2017 01:38am EST 

Dec 11 (Reuters) - Mithra Pharmaceuticals Sa ::FINALIZES ESTELLE CONTRACT WITH BRAZILIAN WOMEN’S HEALTH LEADER LIBBS.ESTELLE IS CURRENTLY IN PHASE III TRIALS IN US AND CANADA AND EUROPE AND RUSSIA.ESTELLE TOP LINE RESULTS FOR US AND CANADA EXPECTED IN Q3 2018.ESTELLE TOP LINE RESULTS FOR EUROPE AND RUSSIA EXPECTED IN Q1 2019.  Full Article

BRIEF-Mithra Announces Last Subject Visit In Estelle Phase III Study In EU/Russia

* MITHRA ANNOUNCES LAST SUBJECT VISIT IN ESTELLE® PHASE III STUDY IN EU/RUSSIA AND COMPLETION OF ENDOMETRIAL SUBSTUDY