Presentation on theme: "This is MEDIVIR OUR research is based on the know how of proteases and polymerases. The aim is to have a steady flow of CDs into clinical development."— Presentation transcript:
This is MEDIVIR OUR research is based on the know how of proteases and polymerases. The aim is to have a steady flow of CDs into clinical development. WE focus on mainly two therapeutic areas; infectious and immunological diseases. OUR pipeline is balancing commercial opportunities and development risks. WE are one of the largest biotech companies in Europe in terms of pipeline and employees, located in Cambridge (UK) and Huddinge (SE). WE own CCS, a specialty pharma company. Most likely to have one product to launch in 2005.
Medivir has a broad know how in these enzymes, enabling a variety of research options and still be focused. Proteases and polymerases represent major pharmaceutical opportunities
CD = Candidate DrugNNRTI = Non Nucleoside Reverse IND = Investigational New Drug Transcriptase Inhibitor SBDD = Structured Based Drug Design PI = Protease Inhibitor Pre-clinical Discovery in Medivir Infectious and immunological diseases Target Identification Hit Identification Lead Identification Lead Optimisation CD NominationCD IND IND X-ray Structure Protease & polymerase compound libraries Prodrugs RAPiD TM Hits Robust Leads CD SBDD Combinatorial Chemistry DMPK FOCUS TM XED n Improved capacity and shorter time to CD Validation - protease gene family polymerases - polymerases Screening Identification RAPiD TM FOCUS TM
High activity in operations 2002-09-30: Positive results for Medivir’s HIV and hepatitis B antiviral MIV-210 presented at ICAAC. 2002-09-10: Change of CEO at Medivir 2002-05-31: A phase IIa clinical study with Medivir’s compound MIV-310 shows a major antiviral effect in patients with multi drug resistant HIV. 2002-05-29: Proof of principle in research on treatment of multiple sclerosis (MS). 2002-04-25: Change in the Medivir HIV program. 2002-04-15: Medivir signs agreement to out-license its novel HIV/AIDS treatment to Roche. 2002-02-26: Medivir and Reliant Pharmaceuticals form strategic alliance. 2001-12-20: Medivir and Peptimmune announce break-trough research on treatment of rheumatoid arthritis. 2001-12-06: Medivir’s HIV research programme designates Candidate Drug.
Status October 2002 Partnership and deal values Partnership and deal values Deal values for existing partnerships amounts to SEK 700 million (refers to 3 deals) of which SEK 100 million is down payments to be accounted as revenues during 2002. Cash wise, Medivir has received SEK 80 million of these during H1 2002. Medivir has retained the Nordic marketing rights for RP-606 and MV026048. Corporate Peptimmune 50/50 ”joint venture” for Cathepsin S in late pre-clinical research. Chiron for Hepatitis C in pre-clinical discovery. Roche for HIV-NNRTI in late pre-clinical development. Reliant in RP-606 (Shingles) on its way to phase III. University University of Dundee – AEP, autoimmune disorders, in early pre-clinical discovery. St:George (London, UK) – Cathepsin K, osteoporosis, in pre-clinical lead identification phase. MRC (London, UK) – broad anti-bacterial program, in early pre-clinical discovery. Karolinska Institute – Alzheimer disease, in pre-clinical discovery. Agrivir – Joint venture med BioAgri. And several other universities in Sweden, US and UK.
Status October 2002 Financial The group, period ending 30 June Profit after financial items amounted to SEK 4,3 (-68,0) million. Cash SEK 195 million. Going forward, the R&D expenditure will be in the range of 150- 160 MSEK on a rolling 12 month average. CCS, a strategic and financial asset to Medivir Net sales SEK 76,7 (63,8) million during H1 (2002); SEK 9,7 (9,7) million profit. Cash positive operations. CCS had extraordinary costs amounting to MSEK 4,5 during H1 (2002) for investments for the coming AstraZeneca production. Significant increase in sales, profit and “market cap” predicted over next years from both internal activities and by aggressive acquisition strategy.
Status October 2002 Pipeline Varity of projects focusing on; HIV, Hepatitis, Cold sores, Shingles, MS, RA and Osteoporosis of which; »4 projects in clinical development »4 late stage pre-clinical projects »More than 10 discovery activities
Status clinical projects RP-606 - Shingles: Licensed to reliant in February. Transfer of project completed in May. Planning and development work ongoing towards phase III studies. Waiting for the end of phase II meeting with FDA. ME-609 - Cold sores: Seeking partnership in order to conduct phase III studies. MIV-310 - HIV: Phase IIa results reported during summer. Planning for phase IIb studies and seeking partnership in parallel. MIV-210 – Hepatitis B and HIV: Results from pre-clinical studies reported at ICAAC in September. Ongoing phase I trails and planning for phase IIa studies, both for Hepatitis B and HIV. (MV026048 – Licensed to Roche in April. Transfer of project completed in June. Now in late pre-clinical development towards clinical trails during 2003.)
Late Pre-clinical projects October 2002 Hit Identification Lead Identification Lead Optimisation Project Indication NNRTI -polymerase inhibitor HIV-protease inhibitor Cathepsin S -protease inhibitor Cathepsin K -protease inhibitor CD HIV-AIDS e.g. astma, MS, RA, GVHD Osteoporosis 20002002
Strategy going forward 2003 Mainly two internal clinical programs ongoing, MIV-310 and MIV-210. The aim is to find partners for all clinical projects. The aim is to balance risk/benefit in an optimal way. Secure the Nordic rights in future partnerships. Use CCS as a financial asset and develop it accordingly. Continue aggressive “Key Account Management”. Continue the focusing process in order to increase research capacity to speed up several promising pre-clinical activities and projects. Add pre-clinical collaborations and partners. Add new targets. Expand size and coverage of protease and polymerase inhibitor libraries by building up of matrix metallo & serine protease inhibitor library. Position Medivir as the preferred partner in protease and polymerase research.
Medivir as an investment ”Well positioned for success and value creation” Medivir is one of the largest biotech companies in Europe in terms of pipeline and personnel. Is establishing itself as the research driven small pharmaceutical company. CCS is a strategic asset in this process. Large scientific and commercial opportunities in pipeline. Solid financial position including opportunities in late stage clinical projects. Existing and future partnerships will secure speed of development adding value to the shareholders. Most likely to have one product to launch in 2005.