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Mithra Pharmaceuticals SA (MITRA.BR)

MITRA.BR on Brussels Stock Exchange

27.58EUR
23 Aug 2019
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Latest Key Developments (Source: Significant Developments)

Mithra Signs LSA For Commercialization Of Estelle, Myring In Israel
Tuesday, 20 Aug 2019 

Aug 20 (Reuters) - Mithra Pharmaceuticals SA ::MITHRA SIGNS LSA FOR COMMERCIALIZATION OF ESTELLE® AND MYRING™ IN ISRAEL.UNDER TERMS OF THESE AGREEMENTS, DEXCEL WILL DISTRIBUTE ESTELLE® AND MYRING™ IN ISRAEL.MITHRA GRANTS EXCLUSIVE LICENSE TO DEXCEL PHARMA FOR COMMERCIALIZATION OF ITS TWO LEADING CONTRACEPTIVE PRODUCTS IN ISRAEL.  Full Article

Mithra Pharmaceuticals Signs LSA For Commercialization Of Myrin In Germany
Tuesday, 28 May 2019 

May 28 (Reuters) - MITHRA PHARMACEUTICALS SA ::THIS AGREEMENT COULD GENERATE REVENUES OF AT LEAST EUR 2.5 MILLION FOR MITHRA.MITHRA SIGNS LSA FOR COMMERCIALIZATION OF MYRING IN GERMANY, THE BIGGEST MARKET IN EUROPE.UNDER TERMS OF THIS 5-YEAR AGREEMENT, HORMOSAN WILL DISTRIBUTE MYRING IN GERMANY.COMMERCIAL MANUFACTURING PROCESS WILL CONTINUE IN SECOND HALF OF YEAR FOR COMMERCIAL BATCHES FOR EUROPEAN MARKET.MITHRA WILL RECEIVE AN UPFRONT PAYMENT AND WILL BE ELIGIBLE TO RECEIVE MILESTONE PAYMENTS AND RECURRING REVENUES BASED ON MINIMUM ANNUAL QUANTITIES (MAQ).  Full Article

Mithra Pharmaceuticals FY Operating Profit Up At 35.5 Million Euros
Friday, 1 Mar 2019 

March 1 (Reuters) - MITHRA PHARMACEUTICALS SA ::CASH AT DECEMBER 31 2018 WAS EUR 119 MILLION (EUR 36.2 MILLION IN 2017).FY REVENUE EUR 65.5 MILLION VERSUS EUR 46.3 MILLION YEAR AGO.FY OPERATING PROFIT EUR 35.5 MILLION VERSUS LOSS OF EUR 21.1 MILLION YEAR AGO.LOOKING FORWARD TO CONTINUED PROGRESS IN 2019.FOR ESTELLE MITHRA TO FILE FOR MARKET AUTHORIZATION IN EUROPE AND U.S. BY END OF 2019.IN 2019 AND BEYOND, WE EXPECT FURTHER SIGNIFICANT REVENUE GROWTH BASED ON POTENTIAL FOR FURTHER E4 PARTNERSHIPS IN U.S. AND OTHER MARKETS.FOR ESTELLE MITHRA TO FILE FOR MARKET AUTHORIZATION IN EUROPE AND U.S. BY END OF 2019 PHASE III STUDIES OF DONESTA AND PERINESTA COULD BEGIN IN H2 2019.MITHRA IS TARGETING A MARKETING AUTHORIZATION FOR BOTH DONESTA® AND PERINESTA™ PRODUCT CANDIDATES IN 2023.FOR DONESTA AND PERINESTA MITHRA BELIEVES IT COULD ACHIEVE MARKETING AUTHORIZATION FOR BOTH CANDIDATES IN 2023.ONGOING PATENT APPLICATIONS WOULD PROTECT DONESTA AND PERINESTA INTELLECTUAL PROPERTY RIGHTS UNTIL 2039.IN 2019 AND BEYOND, WE EXPECT FURTHER SIGNIFICANT REVENUE GROWTH BASED ON POTENTIAL FOR FURTHER E4 PARTNERSHIPS IN U.S. AND OTHER INTERNATIONAL MARKETS.ESTELLE: ENTERING FINAL STAGES OF CLINICAL DEVELOPMENT, CO INTENDS TO FILE FOR MARKET AUTHORIZATION IN EUROPE AND U.S. BY END OF 2019.IN TERMS OF RESEARCH AND DEVELOPMENT, MITHRA WILL LAUNCH PIVOTAL STUDIES FOR ZORELINE(®) IN 2019 AS WELL AS UNDERTAKE ADDITIONAL RESEARCH PROJECTS..  Full Article

Mithra Announces Positive Top-Line Results Of Estelle Phase III Study In U.S/Canada
Wednesday, 30 Jan 2019 

Jan 30 (Reuters) - MITHRA PHARMACEUTICALS SA ::MITHRA ANNOUNCES POSITIVE TOP-LINE RESULTS OF ESTELLE® PHASE III ORAL CONTRACEPTIVE STUDY IN U.S/CANADA.MITHRA ANNOUNCES POSITIVE TOP-LINE RESULTS OF ESTELLE® PHASE III ORAL CONTRACEPTIVE STUDY IN U.S/CANADA.KEY SECONDARY ENDPOINTS ACHIEVED, INCLUDING EXCELLENT BLEEDING PROFILE, CYCLE CONTROL, QUALITY OF LIFE AND SAFETY AND TOLERABILITY.PRIMARY EFFICACY ENDPOINT INDICATES EXCELLENT CONTRACEPTIVE EFFICACY, WITH A PEARL INDEX (PI) OF 2.41(1) PER 100 WOMEN, IN LINE WITH EXPECTATIONS.DATA IN LINE WITH PREVIOUSLY ANNOUNCED PHASE III TRIAL IN EU / RUSSIA.FILING WITH U.S. AND EU REGULATORY AGENCIES ANTICIPATED BY YEAR END LIÈGE, BELGIUM, 30 JANUARY 2019.  Full Article

Mithra Pharmaceuticals Announces Positive Results From Its Ovarian Function Sub-Study For Estelle
Thursday, 6 Dec 2018 

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 

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 

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 

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 

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 

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