Medivir's U.S. commercialisation partner Meda presents positive Xerese™ data at ASHP

Medivir's U.S. commercialisation partner Meda presents positive Xerese™
data at ASHP  

Medivir AB (OMX: MVIR), the emerging research-based specialty
pharmaceutical company focused on infectious diseases, today announced
that its U.S. commercialisation partner, Meda, has presented virolology
data from the phase 3 programme on Xerese™/Xerclear®, Medivir's unique
cold sore treatment, at the 45th American Society of Health System
Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition, Anaheim, USA,
5-9 December 2010.  

The poster[1] summarised the results of virology assessments from two
phase 3 two-arm, randomised, multicenter, subject-initiated studies.
These studies included immunocompetent adults and HIV-positive patients
and examined the topical administration of the combination of five
percent acyclovir and one percent hydrocortisone in a unique cream
vehicle (Xerese™/Xerclear®) for the treatment of recurrent herpes
simplex labialis. The data showed that Xerese™/ Xerclear® was well
tolerated and did not give rise to acyclovir resistant virus. 

Medivir sponsored and executed the studies and the poster was presented
by Dr. Larry N. Gever from Meda. The poster can be accessed via
Medivir's website www.medivir.se (http://www.medivir.se/). 

About Xerese™ (Xerclear® in Europe)
Xerese™ is the first and only cold sore agent that demonstrated greater
efficacy vs. 5% acyclovir in the same cream vehicle (with early
treatment), reduced the likelihood of progression to ulceration with
early treatment[2].  Xerese™ combines an antiviral and an
anti-inflammatory. 

Xerese™ also provided faster healing time vs. vehicle placebo (mean time
to skin normalization was approximately 1.6 days shorter)[2], 50%
greater reduction in cumulative area for all lesions with Xerese™ (78
mm2) vs. vehicle placebo (155 mm2) and greater relief of symptoms, such
as tenderness vs. vehicle placebo[2, 3]. 

Indication (US label)
XERESE™ (acyclovir 5% and hydrocortisone 1%) cream is indicated for the
early treatment of recurrent herpes labialis (cold sores) in adults and
adolescents (12 years of age and older)

  · To reduce the likelihood of ulcerative cold sores
  · To shorten the lesion healing time

Important Risk Information

  · Use topically for herpes labialis of the lips and around the mouth.
  · Do not use in the eye, inside the mouth or nose, or on the genitals.
  · Encourage patients to seek medical advice when a cold sore fails to
heal within 2 weeks. Other orofacial lesions, including bacterial and
fungal infections, may be difficult to distinguish from a cold sore.
  · Do not apply under an occlusive dressing; contact dermatitis has
been observed  
  · The most common adverse reactions (< 1%) were local skin reactions:
Drying or flaking of the skin; burning or tingling, erythema;
pigmentation changes.

For US; available by prescription only. Full prescribing information
available at www.medapharma.us (http://www.medapharma.us/).  

 

For more information about Medivir or Xerclear®, please contact;

                                                                        
                         
Medivir (www.medivir.se)                                                
                         
Rein Piir, CFO & VP Investor Relations                                  
                        Office: +46 8 546 831 23
                                                                        
                        Mobile: +46 708 537 292
Eva Arlander, VP Marketing                                              
                        Office: +46 (8) 5468 3121
                                                                        
                        Mobile: +46 (70) 25 56 855
M:Communications                                                        
                         +44(0)20 7920 2330
Mary-Jane Elliott / Amber Bielecka / Nick Francis
Medivir@mcomgroup.com (Medivir@mcomgroup.com)

 

About Medivir
Medivir is a research-based specialty pharmaceutical company focused on
the development of high-value treatments for infectious diseases.
Medivir has world-class expertise in polymerase and protease drug
targets and drug development. Medivir has a strong R&D portfolio and has
recently launched its first product, an innovative treatment for cold
sores. 

Xerese™/Xerclear® is a treatment for cold sores, which has been approved
in both the US and Europe. It is partnered with GSK to be sold OTC in
Europe, Japan, Australia and Russia and by prescription sold by Meda in
North America. Medivir has retained the Rx rights for Xerclear® in
Sweden and Finland.  

Medivir's key pipeline asset, TMC435, a protease inhibitor, is in phase
2b clinical development for Hepatitis C and is partnered with Tibotec
Pharmaceuticals. 

For more information about Medivir, please visit the Company's website:
www.medivir.se (http://www.medivir.se/)   

About cold sores
Recurrent herpes labialis (cold sores) is a common infection that
affects one-third of the population in the Western world resulting in
around 600 million episodes per year with 57 million people having 3 or
more episodes per year. The great majority of cases are caused by herpes
simplex virus type 1 (HSV-1). Unlike most viruses, the cold sore virus
is not completely eliminated by the body's immune response. Instead it
establishes a chronic, latent and life-long infection in sensory
ganglia. At a later date, the virus may be reactivated and travel back
to the skin - often around the mouth and nose - to trigger a clinical
episode of recurrent herpes labialis. The virus is reactivated by
factors like sunlight and stress. 

Products based on antiviral substances such as acyclovir, penciclovir,
famciclovir and valaciclovir are the most commonly used treatment
options. The market for topical treatment of herpes infections in the
USA and Europe is estimated at USD 230 million and USD 170 million,
respectively.

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[1]The topical application of acyclovir five percent and hydrocortisone
one percent cream in subjects with recurrent herpes labialisis not
associated with acyclovir resistance. Authors: Mia Brytting, Eva
Arlander, Larry N Gever, William Wheeler. Affiliations: Swedish
Institute of Infectious Disease Control, Stockholm, Sweden, Medivir AB,
Huddinge, Sweden, Meda Pharmaceuticals, Inc., Somerset, NJ 

[2] Hull CM, Harmenberg J, Arlander E, et al. Early treatment of cold
sores with topical ME-609 decreases the frequency
of ulcerative lesions: a randomized, double-blind, placebo-controlled,
patient-initiated clinical trial . [published online ahead of print
September 17, 2010]. J Am Acad Dematol. Doi:10.1016/j.jaad 2010.08.012.

[3] Xerese™ (package insert). Somerset, NJ:Meda Pharmaceuticals Inc.;
2010