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Mithra Pharmaceuticals SA (MITRA.BR)

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Latest Key Developments (Source: Significant Developments)

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

Mithra Announces Valorization Of French Subsidiary
Thursday, 7 Dec 2017 01:37am EST 

Dec 7 (Reuters) - Mithra Pharmaceuticals Sa ::MITHRA ANNOUNCES VALORIZATION OF FRENCH SUBSIDIARY.SUCCESSFULLY DIVESTED ITS FRENCH AFFILIATE, MITHRA FRANCE‍​.SALE CONSISTS OF TWO AGREEMENTS.FIRST CONTRACT IS CLOSED WITH LABORATOIRE CCD.ON CONTRACT LABORATOIRE CCD: CONCERNS TRANSFER OF MARKETING AUTHORIZATIONS FOR 4 PRODUCTS.LABORATOIRE CCD CONTRACT: HAS 10-YEAR EXCLUSIVE TIBELIA LICENSE&SUPPLY AGREEMENT IN FRANCE.LABORATOIRE CCD CONTRACT: MITHRA ELIGIBLE FOR UPFRONT PAYMENT AND FUTURE ROYALTIES FOR 4 PRODUCTS OVER 5 YRS.COMMERCIAL LAUNCH OF TIBELIA IN FRANCE IS EXPECTED IN H2 2018.OTHER CONTRACT: SHARE PURCHASE AGREEMENT FOR MITHRA FRANCE WITH THERAMEX.THERAMEX WILL TAKE OVER SUBSIDIARY INCLUDING ITS PHARMACEUTICAL LICENSE.FINANCIAL DETAILS OF AGREEMENTS WERE NOT DISCLOSED.  Full Article

Mithra Pharmaceuticals Announces Update On Clinical Study Progress For Estelle And Donesta‍​
Thursday, 30 Nov 2017 01:39am EST 

Nov 30 (Reuters) - MITHRA PHARMACEUTICALS SA ::ANNOUNCES AN UPDATE ON THE CLINICAL STUDY PROGRESS FOR ESTELLE AND DONESTA‍​.‍ESTELLE IS CURRENTLY IN PHASE III STUDIES IN EUROPE/RUSSIA AND IN US/CANADA​.‍RECRUITMENT HAS NOW BEEN COMPLETED FOR BOTH STUDIES​.‍CURRENTLY OVER 50% OF SUBJECTS HAVE COMPLETED MORE THAN HALF OF 13 TREATMENT CYCLES​.‍20% HAVE COMPLETED FULL 13 CYCLES IN EUROPEAN STUDY, AND OVER 4% IN US STUDY​.‍TO REPORT TOP LINE DATA FOR EUROPE/RUSSIA IN Q3 2018.‍TO REPORT TOP LINE DATA FOR US/CANADA IN Q1 2019.‍RECRUITMENT ALSO COMPLETED FOR DONESTA, CURRENTLY IN PHASE IIB DOSE-FINDING STUDY.‍ALMOST 80% OF 260 SUBJECTS HAVE SUCCESSFULLY FINISHED 12-WEEK PROTOCOL​.‍TOP-LINE RESULTS FOR DONESTA ARE EXPECTED TOWARDS END OF Q1 2018​.  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