Lipsovir
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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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Lipsovir

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


Lipsovir

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


Lipsovir

HERPES VIRUS

Ow!

IMMUNE RESPONSE


Lipsovir

HERPES VIRUS

Ow!

Current drugs

IMMUNE RESPONSE


Lipsovir

HERPES VIRUS

Ow!

Lipsovir

IMMUNE RESPONSE


Lipsovir

A scientific break through

Lipsovir

Avoid your next cold sore


Lipsovir

The difference in treatment efficacy

Lipsovir

Current drugs

Lipsovir

Avoid your next cold sore


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

Potential product launch in 2.5 years

Clinical trials beginJuly 2006

Clinical trials completeAutumn 2007

Application to authorities Spring 2008

Marketing ApprovalEnd of 2008

Find partner(s) for marketing

News!

Lipsovir

Avoid your next cold sore


Lipsovir

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


Lipsovir

50 clinical centres will participate


Lipsovir

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


Lipsovir

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


Lipsovir

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


Lipsovir

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


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


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