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Mithra Pharmaceuticals SA (MITRA.BR)

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Latest Key Developments (Source: Significant Developments)

Mithra Pharmaceuticals Announces Positive Results From Its Ovarian Function Sub-Study For Estelle
Thursday, 6 Dec 2018 01:31am EST 

Dec 6 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA ANNOUNCES POSITIVE RESULTS OF OVARIAN FUNCTION SUB-STUDY WHICH STRENGTHENS ESTELLE® CONTRACEPTIVE EFFICACY PROFILE.EFFECTIVE OVULATION INHIBITION WITH NO SINGLE OVULATION AT CYCLES 1 AND 3.ESTELLE® SHOWED NO SINGLE OVULATION AT CYCLES 1 AND 3 AND WAS WELL TOLERATED AND SAFE WHEN TAKEN IN A 24/4 REGIMEN WITH NO SERIOUS ADVERSE EVENTS REPORTED..DATA FURTHER STRENGTHENS THE CONTRACEPTIVE EFFICACY PROFILE OF ESTELLE® PREVIOUSLY SHOWN IN TOP-LINE EU/RUSSIA PHASE III STUDY RESULTS.RESULTS FURTHER SUPPORT ESTELLE® AS A NOVEL, NEXT-GENERATION COMBINED ORAL CONTRACEPTIVE FOR WOMEN.RESULTS CONFIRM CAPACITY OF ESTELLE® TO INHIBIT OVULATION IN 100% OF USERS BY SUPPRESSING HYPOTHALAMIC-PITUITARY STIMULATION OF OVARIAN FOLLICULAR DEVELOPMENT.  Full Article

Mithra Pharmaceuticals EU/Russia Study Reports Positive Results Achieving Primary And Secondary Endpoint
Wednesday, 14 Nov 2018 01:45am EST 

Nov 14 (Reuters) - MITHRA PHARMACEUTICALS SA ::EU/RUSSIA STUDY REPORTED POSITIVE RESULTS ACHIEVING PRIMARY AND SECONDARY ENDPOINT.ESTELLE PHASE III STUDY IN US/CANADA WILL REPORT TOP-LINE RESULTS IN Q1 2019.ESTELLE : A STEP CLOSER TO BECOME NEXT GENERATION COC ON THE MARKET."WE LOOK FORWARD TO REPORTING ADDITIONAL PHASE III TOP-LINE RESULTS IN Q1 2019”- CSO.  Full Article

Mithra Pharmaceuticals Signs Agreement With Adcock Ingram
Tuesday, 30 Oct 2018 12:33pm EDT 

Oct 30 (Reuters) - MITHRA PHARMACEUTICALS SA ::SIGNS EXCLUSIVE LICENSE AND SUPPLY AGREEMENT WITH ADCOCK INGRAM FOR COMMERCIALIZATION OF ESTELLE IN SOUTHERN AFRICA.20-YEAR EXCLUSIVE LICENSE AND SUPPLY AGREEMENT TO GENERATE ANNUAL RECURRING REVENUES AND ROYALTY PAYMENTS.MITHRA IS ELIGIBLE FOR A DOWNPAYMENT OF EUR 1.5 MILLION.TERRITORIES UNDER THE AGREEMENT INCLUDE SOUTH AFRICA, BOTSWANA, LESOTHO, SWAZILAND, MOZAMBIQUE, ZIMBABWE AND NAMIBIA.  Full Article

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

BRIEF- Mithra Pharmaceuticals Provides Update On Its Key Programmes

* US/CANADA PHASE III ARM OF ESTELLE® ORAL CONTRACEPTION DUE TO COMPLETE IN Q4 2018