Hier ein Update meines Postings auf WOanders aus 2010. MediGene hat sich nach den Phase II Daten in der Indikation TNBC entschieden EndoTAG-1 zuerst in dieser Indikation weiter zu entwickeln. Mögliche Gründe: ORPHAN Wettbewerb in BSDK, Höherer Umsatz in TNBC / Her2- BC, favorisierte Zielidikation pot. Partner. Aus meiner Sicht hat FM die aufgestellte Planung bisher ganz vernünftig umgesetzt. Verzögerungen bei der Pipelineentwicklung zugunsten der Qualität und die Entscheidung für eine neue EndoTAG-Lead-Indikation mit einem Partner sind für mich akzeptabel, da erst einmal die Basis der Entwicklung stimmen muss. Wenn es FM im nächsten Jahr gelingt EndoTAG-1 Partner für US und EU zu finden, dann ist MediGene wieder ganz vernünftig aufgestellt. Eine gesunde risikoarme Finanzplanung ist sicherlich der Schlüssel zum Erfolg. Eine kompakte Zusammenfassung aus Präsentationen im Jahr 2010 zur Validierung des Fortschritts:
Strategy: Leverage liposomal know-how and complement portfolio with selective partnering
- Step-wise,value-optimized focus on Oncology (2012: AAVLP HLV-L2 + EndoTAG-1)
- Spin-out of all non-core technologies (2012: Immunocore, Catherex done)
- EndoTAG-1 Partnering partly done Änderung der Strategie - BSDK Phase III Studie vorerst zurückgestellt: - Phase III in pancreatic cancer will be launched in H1/2011 using new spray-dried material.
- BSDK Phase III development of EndoTAG-1 with partner for launch in 2015
- BSDK Phase III study design finalized and accepted by EMEA & FDA
- BSDK Phase III Network of clinical opinion leaders and research organization - High medical need, attractive market potential
- Positive phase II data in pancreatic cancer are a solid base for phase III trial
- Good tolerability for palliative setting
- Favorable time-to-market
- Orphan drug designation
- Feasibility study demonstrated little competition and high interest EndoTag-1 Phase III setup of the pivotal BSDK trial:
- Study design defined
- Medical steering committee established
- Country / site feasibility study completed
- Scientific advice from BfArM, MPA, EMEA, FDA completed
- Study design accepted by EMEA and FDA
- FDA Orphan drug designation for panreatic cancer granted - Option: Start einer BSDK Studie in einem neo-adjuvanten Setting (?) Neu in 2012 Partner for EndoTAG-1 Switch to Lead IndikationTNBC: - TNBC Phase III development of EndoTAG-1 with partners planed
- TNBC Phase III study design already discussed with EMEA. - TNBC Phase II study started - Investigator Initiated Trial (phase II neoadjuvant study) with EndoTAG®-1/paclitaxel combination in HER2-negative breast cancer. (Results now expected in Q1 2013) - Perform small explorative phase I/II trials in selected indications and patient populations (planed)
- Leveraging of liposomal technology in other indications (SCLC, Ovarian, esophageal, pancreatic ca - neoadjuvant - Orphan, little competition, high medical need, highly vascularized, chemo-sensitive, fast read-out, check additional combinations p.e. platinium analogue (?) - Selective additions to oncology pipeline through strategic transactions (outstanding) - M&A with complementary Biotech companies (outstanding) - New RhuDex Formulation successfully developed in 2012 - Start additional non-clinical studies will be started to support clinical development in RA - Start prove-of-concept PBC trial end of 2012 with new RhuDex formulation - Outlicensing RhuDex after proof of concept in PBC Indication (?)
- Adaption of structures - rigorous cost control - reach break even. (ongoing)
- Focus expenses on strategic objectives, i.e. key programs and assets (ongoing)
- Assure sufficient cash to maintain key programs development (Eligard - completely done in 2012)
Adapt and restructure operations:
- Focus on clinical development and CMC (Phase I and Phase II)(proposed)
- Focus expenses to reduced project portfolio
- Adapt headcount to reduced project portfolio
- Streamline processes and reporting lines
- Reduce external spending (Spin-Out, Studies, ongoing process)
Focus on EndoTAG-1, Prerequisite to achive attractive deal parameters with potential partner(s)
- Evaluation of spray-drying for commercial process (done)
- TNBC to provide second proof of concept (done)
- Prepare commercial manufactoring (CMC) process (done)
Deal after second proof of concept
Front-loaded
- Higher upfront payment
- Limited MDG role in development
- lower royalty share
Back-loaded
- Lower upfront payment
- MDG role in development, co-investment
- Higher royalties share
EndoTAG new applications (possibly suspended ?):
- Explore new product opportunities in further cancer indications
- Combination with novel (IP-protected, high potency) actives having shown clinical proof of concept in oncology
- "Enhancement" of existing activities
- Improve anti-tumor efficacy and safety (improved benefit/risk profile based on more efficient liposomal carrier)
- Expand application Interval (>= two weeks)
- Reduce amount of liposomes per application (Improved API loading capacity)
- Reduce interaction with serum components
- Develop high capacity, robust manufacturing process
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Webcast Verkauf der Eligard Rechte:
In naher Zukunft wird es Entscheidungen geben, die eine signifikante Reduzierung der Kosten bringt und die es erlaubt, den Eligard Verkaufserlös zur Stärkung der Pipeline zu verwenden.
Ziel ist es den nachhaltigen Break Even möglichst früh zu erreichen.
Die nächsten Meilensteine stehen an:
- Anpassung Head-Count (done)
- Meilenstein CMC - Sprühtrocknung (done)
- Meilenstein EndoTAG-1 Deal (done)
- Selective additions to oncology pipeline through strategic transactions (planed)
- M&A with complementary Biotech companies (planed)
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