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Medivir develops a new unique treatment Avoid your next cold sore Lipsovir cream can prevent the development of a cold sore No other drug treatment has.

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Presentation on theme: "Medivir develops a new unique treatment Avoid your next cold sore Lipsovir cream can prevent the development of a cold sore No other drug treatment has."— Presentation transcript:

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

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

4 Ow! HERPES VIRUS IMMUNE RESPONSE

5 Ow! HERPES VIRUS IMMUNE RESPONSE Current drugs

6 Ow! HERPES VIRUS IMMUNE RESPONSE Lipsovir

7 Avoid your next cold sore

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9 An effective pharmaceutical like Lipsovir is expected to expand this market Avoid your next cold sore 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

10 Avoid your next cold sore Total USD 383 miljon, current growth 17% (IMS) NB! Only 1-2% of all cold sore episodes are currently treated

11 Avoid your next cold sore oFamvir (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 oTransport Pharmaceuticals - developing apparatus which provides high local dosages of acyclovir via a mild electric current - appears only to shorten episode duration (phase II data) ointerceptCS™ - thermal treatment of herpes episodes - approved in Canada - large, clumsy and expensive

12 oPatents protect Lipsovir from generic competition until 2016 oThe formulation technology (cream) is patented to 2019 (2020 in USA) oUncommonly difficult and time-consuming for competitors to register a Lipsovir-copy oSystemic drugs – relationship exists between drug concentration in the plasma and therapeutic activity – quick and easy to do bioequivalance studies oTopical drugs – no relationship between plasma concetration and therapeutic activity – harder to prove that the copy has the same efficacy as the original oTopical 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 o“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 Avoid your next cold sore

13 1.Lipsovir phase II data showed a unique therapeutic activity 2.The results for antiviral drugs in this kind of clinical trial are predictive for efficacy in phase III 3.Discussions with FDA have evolved an attractive development programme för Lipsovir Avoid your next cold sore

14 oAll trial participants (n=380) irradiated with UV light on the lips in order to induce a cold sore episode oTwo days later treatment was commenced with either Lipsovir or placebo cream oResults with antivirals in this type of clinical trial are predictive of efficacy in phase III Undvik ditt nästa munsår

15 oIn the phase II trial 1 (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) oIndependent studies of Spruance et al 2 (n=49) oTrail participants treated with oral famciclovir + steroid cream; or oral famciclovir + placebo cream oThe number of cold sores was 36% lower in those receiving famciclovir + steroid cream than in the other group (p=0.09, dvs trend) oPreclinical data 3 show that Lipsovir gives a 50% better therapeutic efficacy than acyclovir cream alone Avoid your next cold sore These results support the phase II trails 1) Evans et al, Antimicrobial Agents & Chemotherapy ) Journal of Infectious Diseases ) Harmenberg et al, Antiviral Chemistry & Chemotherapy 2003

16 Avoid your next cold sore * Field study: 1)Patients are given clinical trial material 2)Patients self-initiates treatment as soon as they feel the symptoms of a cold sore episode DrugYear Penciclovir cream Zovirax cream (acyclovir) Valtrex (valaciclovir) Lipsovir Chief Investigator Type of study SpruanceField study* SpruanceField- study* SpruanceField- study* Hull/SpruanceField study* Treatment start < 1 hour after first symptom Directly upon first symptom <1 hour after first symptom Primary endpoint Time to healing Episode duration 1.Episode duration 2. Number of patients who develop cold sores Number of patients who develop cold sores

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

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

19 Clinical trials beginJuly 2006 Clinical trials completeAutumn 2007 Application to authorities Spring 2008 Marketing ApprovalEnd of 2008 Avoid your next cold sore Find partner(s) for marketing

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

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

23 Avoid your next cold sore oManufacture and packaging of study drug oApplications to ethical committees and authorities oContracting of 50 clinical centres oDesignation of central laboratories for sample analysis oDrafting and printing of informational material e.g. Patient diaries and trial questionnaires (CRF) oInvestigator meetings with >100 participants (training ahead of the studies) oSystems for monitoring inclusion rates PreparationsRectruitment of > 2000 patients July

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

25 Avoid your next cold sore oAn open study on 100 teenagers (12-17 years) starts in Sweden this autumn oThe aim is to get approval to treat all patients over 12 years oOnly recording of potential side effects oA study of 75 immunocompromised subjects starts in Russia/Ukraine this autumn oThe aim is to see if the therapeutic efficacy is any different in this patient group oBoth studies performed by av CRO-companies

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


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