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Lipsovir

Lipsovir. Many people suffer from cold sores. Medivir develops a new unique treatment. Lipsovir cream can prevent the development of a cold sore. No other drug treatment has shown this effect. Lipsovir. Avoid your next cold sore. Well proven and brand new.

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Lipsovir

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  1. Lipsovir

  2. Many people suffer from cold sores Medivir develops a new unique treatment Lipsovir cream can prevent the development of a cold sore No other drug treatment has shown this effect Lipsovir Avoid your next cold sore

  3. Well proven and brand new The ingredients of Lipsovirhave been used safely for decades. The trick was bringing them together. hydrocortisone aciclovir formulation patent protection The Lipsovir concept is a completely new way of managing the life long infection of the cold sore virus Lipsovir Avoid your next cold sore

  4. HERPES VIRUS Ow! IMMUNE RESPONSE

  5. HERPES VIRUS Ow! Current drugs IMMUNE RESPONSE

  6. HERPES VIRUS Ow! Lipsovir IMMUNE RESPONSE

  7. A scientific break through Lipsovir Avoid your next cold sore

  8. The difference in treatment efficacy Lipsovir Current drugs Lipsovir Avoid your next cold sore

  9. Many people suffer from cold sores Only about 1-2% of all cold sore episodes are currently treated Even so this represents an SEK 3 billion market just in the USA An effective pharmaceutical like Lipsovir is expected to expand this market Lipsovir Avoid your next cold sore

  10. A large market which can expand NB! Only 1-2% of all cold sore episodes are currently treated Total USD 383 miljon, current growth 17% (IMS) Lipsovir Avoid your next cold sore

  11. Other treatments under development • Famvir (famciclovir) tablets from Novartis- Clinical trials on cold sores performed, but no regulatory approval yet - Probably no more effective than other antiviral treatments - Does not prevent development of cold sores • Transport Pharmaceuticals- developing apparatus which provides high local dosages of acyclovir via a mild electric current- appears only to shorten episode duration (phase II data) • interceptCS™- thermal treatment of herpes episodes- approved in Canada- large, clumsy and expensive Lipsovir Avoid your next cold sore

  12. Low risk of generic competition • Patents protect Lipsovir from generic competition until 2016 • The formulation technology (cream) is patented to 2019 (2020 in USA) • Uncommonly difficult and time-consuming for competitors to register a Lipsovir-copy • Systemic drugs – relationship exists between drug concentration in the plasma and therapeutic activity – quick and easy to do bioequivalance studies • Topical drugs – no relationship between plasma concetration and therapeutic activity – harder to prove that the copy has the same efficacy as the original • Topical drugs for cold sores – the indication has no surrogate markers – enormous clinical trials are needed to prove that the copy is not worse than the orginal • “Unusually high regulatory hurdles for topical herpes drugs” Robert W. Pollock, Lachman Consultant Services, f d Acting Deputy Director, FDA’s Office of Generic Drugs News! Lipsovir Avoid your next cold sore

  13. A solid platform for phase III • Lipsovir phase II data showed a unique therapeutic activity • The results for antiviral drugs in this kind of clinical trial are predictive for efficacy in phase III • Discussions with FDA have evolved an attractive development programme för Lipsovir Lipsovir Avoid your next cold sore

  14. Phase II data are convincing • All trial participants (n=380) irradiated with UV light on the lips in order to induce a cold sore episode • Two days later treatment was commenced with either Lipsovir or placebo cream • Results with antivirals in this type of clinical trial are predictive of efficacy in phase III Lipsovir Undvik ditt nästa munsår

  15. Phase II data are convincing • In the phase II trial1 (n=380) the number of cold sores in the Lipsovir-group were 29% lower than the placebo group; the difference is statistically significant (p=0.02) • Independent studies of Spruance et al2 (n=49) • Trail participants treated with oral famciclovir + steroid cream; or oral famciclovir + placebo cream • The number of cold sores was 36% lower in those receiving famciclovir + steroid cream than in the other group (p=0.09, dvs trend) • Preclinical data3 show that Lipsovir gives a 50% better therapeutic efficacy than acyclovir cream alone These results support the phase II trails Lipsovir 1) Evans et al, Antimicrobial Agents & Chemotherapy 2002 2) Journal of Infectious Diseases 2000 3) Harmenberg et al, Antiviral Chemistry & Chemotherapy 2003 Avoid your next cold sore

  16. Previous phase III trials on the same indication • * Field study: • Patients are given clinical trial material • Patients self-initiates treatment as soon as they feel the symptoms of a cold sore episode Lipsovir Avoid your next cold sore

  17. The clinical development campaign is approved by the DA... • A pharmaceutical with two active ingredients must usually show therapeutic superiority over • Each active ingredient on their own • Placebo • Issues which have been discussed with authorities: • Can we avoid the hydrocortisone-alone comparison? • Which is the most relevant acyclovir cream for the trial? • Is it sufficient with one pivotal trial? • An agreement on the phase III programme has been reached at the End-of-Phase II meeting at the FDA • The programme has been checked with authorities in the EU Yes Same cream base as Lipsovir Yes! Lipsovir Avid your next cold sore

  18. A large clinical study starts autumn 2006 The purpose of the study is to show that Lipsovir prevents development of ulcerative lesions 1270 subjects with recurrent cold sores will be treated with one of the following Lipsovir Aciclovir cream Placebo cream Treatment is started as soon as the subjects feel the first symptoms of a cold sore (herpes). Lipsovir Avoid your next cold sore

  19. Potential product launch in 2.5 years Clinical trials begin July 2006 Clinical trials complete Autumn 2007 Application to authorities Spring 2008 Marketing Approval End of 2008 Find partner(s) for marketing News! Lipsovir Avoid your next cold sore

  20. A competent organisation A handful of experienced consultants in close collaboration with Medivir Scientific Board CRO companies in USA Clinical centres in USA and Canada

  21. 50 clinical centres will participate

  22. Our collaborators CRO för Phase III trails Manufacturor Clinical trial packaging 1 project manager 1 project assistant 6 monitors medical advisor data management statistician safety monitoring report drafting 1 project manager manufacturing personnel analytical chemists quality assurance 1 project manager quality assurance programmers Lipsovir Undvik Avoid your next cold sore

  23. Masses of preparations... • Manufacture and packaging of study drug • Applications to ethical committees and authorities • Contracting of 50 clinical centres • Designation of central laboratories for sample analysis • Drafting and printing of informational material e.g. Patient diaries and trial questionnaires (CRF) • Investigator meetings with >100 participants (training ahead of the studies) • Systems for monitoring inclusion rates Preparations July Rectruitment of > 2000 patients Lipsovir The trial starts Avoid your next cold sore

  24. How will the trial be performed? • People with 3 or more herpes episodes per year recruited to selected clinical centres • The participants are questioned on their cold sores • is the description consistent with herpes? • can the participant feel the early symptoms of a cold sore episode? • is the participant willing to live up to the trial rules? • Approved participants receive a tube with clinical trial material + a key ring container anc can return home and await their next herpes episode recruitment Waiting... It can take months symptoms 5 days treatment Clinic visits until symptom-free Patient receives their tube Treatment commences within an hour Lipsovir Reminders Avoid your next cold sore

  25. Other studies during phase III • An open study on 100 teenagers (12-17 years) starts in Sweden this autumn • The aim is to get approval to treat all patients over 12 years • Only recording of potential side effects • A study of 75 immunocompromised subjects starts in Russia/Ukraine this autumn • The aim is to see if the therapeutic efficacy is any different in this patient group • Both studies performed by av CRO-companies Lipsovir Avoid your next cold sore

  26. Many people suffer from cold sores Medivir develops a new unique treatment Lipsovir cream can prevent the development of a cold sore No other drug treatment has shown this effect Lipsovir Avoid your next cold sore

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