Medivir HIV Franchise AB by xkp52206


									Medivir HIV Franchise AB
    Professor Bo Öberg, CEO
Medivir HIV Franchise AB Portfolio 2007
                                    date of                                                        Explorative Optimiz Preclinic         Phase   Phase
Project          Indication(s)      agreement       Terms                   Medivir's markets        phase      ation al dev.* Phase I     II     III    NDA

Valomaciklovir Shingles,herpes-     Epiphany Bio- USD 24.5 m + royalties    Nordic region
(MIV-606,      viruses, HIV         sciences /2006 Epiphany shares
Alovudine      HIV                  Presidio/2006   USD 75.25 m+royalties   Nordic region and UK
 (MIV-310)                                          Presidio shares         option on Europe

MIV-210          HIV, Hepatitis B   Hainan Noken/ USD 7 m + royalties       World exc. Asia
MIV-150          HIV                Population                              Option of 50% of
(PC815)                             Council / 2003                          Western world

MIV-160          HIV                Mefuvir/ 2007   Mefuvir shares and      World exc. China,
                                                    royalties               Taiwan and Macao

MIV-410          HIV, CMV           Presidio/2006   See above, MIV-310      See above, MIV-310
MIV-170          HIV

Polymerase inhibitor

All projects actively driven by partners except MIV-170

Valomaciclovir (MIV-606,EPB-348)
• NRTI with potent effect against varicella zoster virus and
  other herpesviruses. Phase IIa study showed better
  effect (PHN reduction) than present therapies.

2006                      2007
Licensed to               Phase IIb study in zoster
Epiphany Biosience        patients started
                          Other viral infections
                          considered as targets (HHV-6,
                          EBV, etc,)
                          New patent application filed

Valomaciclovir (MIV-606, EPB 348) – Shingles
Phase IIb trials recently started by Epiphany

• Once daily valomaciclovir at different doses compared to
  Valtrex given 3 times per day

• Adequately powered to assess a number of pivotal outcomes

• Prof Stephen Tyring at Texas Health Science Centre in
  Houston is Principal Investigator

The zoster market and unmet need
• 95% of adult population chronically infected with VZV

• 50% of population will have one attack of zoster by the age of 85

• Prevalence increasing by 3.5% p.a.

• Post herpetic neuralgia (PHN) – the major unmet need
    − 25% of all patients; 65% of all patients >60 years

    − Pain persists for as long as 1 year in 50% of patients >70 year

    − Very severe: physical, occupational and social disability; often

       refractory to treatment

    − No drug licensed for prevention of PHN

• NNRTI with activity superior to that of Sustiva and
  other NNRTIs against HIV and HIV mutants. Preclinical.

2006                     2007
Licensed to Lantai       License transferred to Mefuvir
Pharmaceuticals          (Wuhan Humanwell)
                         Development started for use as
                         condome coating, microbicide,
                         vaginal ring, oral use
                         Superior inactivation of HIV
                         determined by university groups

MIV-160 vaginal ring
• All HIV vaccines have failed, the most recent from Merck. It is
  unlikely that there will be any vaccine on the market the next 20
  years, if ever.

• MIV-160 is bound faster and stronger to HIV RT than any other
  compound described, thus inactivating HIV and blocking

• 5-20 mg MIV-160 in a vaginal ring could be slowly released to
  inactivate both free and cell bound HIV during 21days (+ hormone)
  to 90 days (-hormone) and thereby prevent HIV transmission.


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