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Mithra Pharmaceuticals SA (MITRA.BR)

MITRA.BR on Brussels Stock Exchange

13.32EUR
23 Jan 2018
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Latest Key Developments (Source: Significant Developments)

Mithra Pharmaceuticals And Adamed Sign Commercialization Agreement For Myring™ In The Czech Republic
Wednesday, 27 Dec 2017 

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 

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 

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 

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 

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

Mithra Pharmaceuticals: ‍positive outcome of Myring commercial batch bioequivalence study​
Friday, 17 Nov 2017 

Nov 17 (Reuters) - MITHRA PHARMACEUTICALS SA ::‍POSITIVE OUTCOME OF MYRING COMMERCIAL BATCH BIOEQUIVALENCE STUDY.DATA WILL FORM PART OF PLANNED MYRING FDA FILING BY US PARTNER MAYNE PHARMA‍​​.  Full Article

Mithra Pharmaceuticals ‍completes recruitment for Estelle Phase III study in US and Canada​
Monday, 30 Oct 2017 

Oct 30 (Reuters) - MITHRA PHARMACEUTICALS SA ::‍COMPLETES RECRUITMENT FOR ESTELLE® PHASE III STUDY IN US AND CANADA​.‍ESTELLE® PHASE III STUDY IN US/CANADA REMAINS ON TRACK TO REPORT TOP LINE DATA IN Q1 2019​.STUDY RECRUITED 2148 WOMEN; 57% OF SUBJECTS COMPLETED OVER HALF OF 13 TREATMENT CYCLES‍​.FIRST SUBJECT COMPLETED THE 13 CYCLE TREATMENT.EXPECTS OUTCOME OF PHASE III TRIAL IN Q1 2019.‍STUDY TAKES PLACE IN AROUND 77 CENTRES ACROSS US AND CANADA, AND WILL INVOLVE SUBJECT TREATMENT FOR A PERIOD OF 12 MONTHS​.  Full Article

Mithra Pharmaceuticals' application for Tibelia marketing authorization accepted by Health Canada‍​
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA’S MARKETING AUTHORIZATION APPLICATION FOR TIBELIA ACCEPTED BY HEALTH CANADA‍​.‍MITHRA IS ON TRACK TO RECEIVE POTENTIAL TIBELIA® APPROVAL AS OF Q4 2018​.MITHRA ANNOUNCED AN EXCLUSIVE LICENSE AND SUPPLY AGREEMENT FOR TIBELIA® WITH AN UNDISCLOSED CANADIAN PARTNER.‍CANADIAN MENOPAUSAL HEALTH MARKET IS WORTH EUR 80 MILLION WITH GROWTH POTENTIAL, OFFERING OPPORTUNITY FOR TIBELIA.SEES ‍CANADA AS IMPORTANT CONTRIBUTOR TO GROWING REVENUES FROM TIBELIA​.  Full Article

Mithra Pharmaceuticals receives GMP approval for Myring production
Tuesday, 23 May 2017 

May 23 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA RECEIVES GMP APPROVAL FOR MYRING PRODUCTION.APPROVAL ENSURES MITHRA FULLY PREPARED TO SHIP FIRST COMMERCIAL BATCHES IN EUROPE.ON TRACK TO FILE FOR MARKETING APPROVAL OF HORMONAL CONTRACEPTIVE MYRING IN EU AND US IN Q2 2017.MYRING’S ORIGINATOR PRODUCT, NUVARING, WILL GO OFF PATENT IN APRIL 2018, ALLOWING OTHER PRODUCTS, SUCH AS MYRING, TO ENTER US AND EUROPEAN MARKET.  Full Article

Mithra Pharmaceuticals H1 net loss widens to 19.6 million euros
Thursday, 1 Sep 2016 

Mithra Pharmaceuticals SA : H1 revenue of the group decrease by 53,000 euros from 8.42 million euros to 8.36 million euros . H1 EBIT loss of 21.5 million euros ($23.97 million) versus loss of 6.8 million euros year ago . H1 net loss 19.6 million euros versus loss of 6.3 million euros year ago .H1 cash position 65.9 million euros versus 96.8 million euros year ago.  Full Article