Medivir's Cold Sore Treatment Xerese™ Now Launched in the United States


Medivir's Cold Sore Treatment Xerese™ Now Launched in the United States

Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based
specialty pharmaceutical company focused on infectious diseases, today
announces that the Company's commercialization partner, Meda AB, has
launched Medivir's unique cold sore treatment Xerese™ in the United
States.

Xerese™ is the first topical combination product of five per cent
acyclovir and one per cent hydrocortisone in a unique cream vehicle for
the treatment of recurrent herpes simplex labialis.  Xerese™ was granted
FDA marketing approval [1] and based on strong clinical data, Xerese™
was given a label, which differentiates it from other topical cold sore
products currently on the market.[2]  Xerese™ will be sold in the U.S.
as a prescription medicine.

Medivir estimates that the U.S. market for cold sore products is valued
at USD 230 million (EUR 168 million) and with Meda's strong commercial
presence and deep understanding of U.S. market dynamics, combined with
Xerese's™ differentiated profile, it is anticipated that Xerese™ will be
a successful entrant to the cold sore treatment market. Medivir granted
Meda the exclusive rights to market, sell and distribute Xerese™ in the
United States, Canada and Mexico for the treatment of cold sores (herpes
labialis) in February 2010. In addition to funding the commercial
development of Xerese™ and up-front and pre-launch milestones totaling
USD 5 million, Medivir will also receive double-digit royalties on
sales.

Ron Long, CEO of Medivir, commented: “We are delighted that Xerese™ has
been launched on the U.S. market today. Our partner Meda has a strong
commercial presence in the US and has demonstrated great success in
marketing products in the U.S., specifically in dermatology. We very
much look forward to the further launches of Xerese™ by our partner Meda
in Canada and Mexico and also the launch later this year in Europe by
our partner GlaxoSmithKline.”

About Xerese™ (Xerclear®  in Europe)
Xerese™ is the first and only cold sore treatment 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 [3] and 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) [4], 50%
greater reduction in cumulative lesion area with Xerese™ vs. vehicle
placebo and greater relief of symptoms, such as tenderness vs. vehicle
placebo [3],[4].

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 aciclovir, 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. 

References:
[1] US Food and Drug Administration, 31/07/2009.
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Sear
ch.Label_ApprovalHistory#apphist (http://www.accessdata.fda.gov/scripts/
cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphis
t)

[2] US Food And Drug Administration, 5/12/2010.
www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf (htt
p://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf)

[3] 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].

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

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

Medivir (www.medivir.com)
Rein Piir, CFO & VP Investor Relations                                  
                       Mobile: +46 708 537 292
Eva Arlander, VP Marketing                                              
                       Mobile: +46 (70) 25 56 855
M:Communications:                                                       
                       +44(0)20 7920 2330
Mary-Jane Elliott / Amber Bielecka / Katja Toon 
Medivir@mcomgroup.com (Medivir@mcomgroup.com)

About Medivir
Medivir is an emerging 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 which has resulted in a strong
infectious disease R&D portfolio. The Company's key pipeline asset is
TMC435, a protease inhibitor which has recently entered phase 3 clinical
development for hepatitis C and is partnered with Tibotec
Pharmaceuticals. 

Medivir is also marketing its first product, the unique cold sore
product Xerese™/Xerclear® which has recently been launched on the US
market. Xerese™/Xerclear®, which has been approved in both the US and
Europe. is partnered with GlaxoSmithKline to be sold OTC in Europe,
Japan and Russia and with Meda AB in North America, Canada and Mexico.
Medivir has retained the Rx rights for Xerclear® in Sweden and Finland.

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

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