Medivir partners with Meda to commercialize Xerese™ (Lipsovir®) in North America


Medivir partners with Meda to commercialize Xerese™ (Lipsovir®) in North America

Medivir and Meda today announced an agreement for the commercialization of
Medivir's cold sore product which will be marketed in North America under the
trade name Xerese™.  

Under the terms of the agreement, Meda is granted 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 addition to funding the commercial development of Xerese™, Meda will pay USD
5 million in up-front and pre-launch milestones and double-digit royalties on
sales to Medivir for the exclusive rights.

Xerese™ - a combination product of acyclovir and hydrocortisone - was granted
FDA marketing approval in July 2009. Based on strong clinical data, Xerese™ was
given a label, which differentiates it from other topical cold sore products
currently on the market.

“I am pleased to announce this partnership, which is a powerful validation of
the product and represents the first step for the global commercialization of
our cold sore product,” said Ron Long, Medivir's CEO, and continued, “Meda's
demonstrated leadership in marketing pharmaceutical products and understanding
US market dynamics, make them the ideal partner for Xerese™. We are convinced
that Meda will make the new product a success," Ron Long concluded.

“Xerese™ is a very interesting addition to our product portfolio in the US. It's
already registered and has a unique and differentiating claim. When commercial
stock is in place we will launch it. We look forward to the collaboration with
Medivir and that we together can develop new indications for Xerese™”, says
Anders Lönner CEO at Meda.

About Xerese™
Xerese™ (Xerclear™ in Europe) - a patented combination of 5% acyclovir and 1%
hydrocortisone in Medivir's proprietary cream formulation - is a topical product
for the treatment of recurrent herpes labialis. The indication text as approved
by FDA, states “Xerese™ is indicated for the early treatment of recurrent herpes
labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to
shorten the lesion healing time in adults and adolecents (12 years of age and
older)”. Xerese™ is the first topical product that in controlled clinical trials
has been shown to significantly (P<0.0001 vs. placebo) reduce the development of
ulcerative lesions during a cold sore episode.

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 three 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.
 

Today only 1-2% of the episodes are treated. 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 are estimated to USD 230 million and USD 170
million, respectively.

For additional information, please contact
Rein Piir, CFO & VP Investor Relations, Medivir +46 708 537 292.


For more information on Medivir, please see the company website: www.medivir.se 

For more information on Meda, please see the company website: www.meda.se

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