Medivir Receives $45 million from Meda for US rights for Xerese™


Medivir Receives $45 million from Meda for US rights for Xerese™

Huddinge, Sweden - Medivir AB (OMX: MVIR), the emerging research-based
specialty pharmaceutical company focused on infectious diseases, today
announced that it has renegotiated the terms of its commercial
partnership with Meda (OMX: MEDA A) for Xerese™, its unique marketed
product for cold sores (herpes labialis). Xerese™ is FDA-approved and
available in the US as a prescription medicine. Meda launched the
product in the US in February 2011 and Medivir currently receives a
double digit royalty on Meda's sales in this market.

Under the terms of the renegotiated agreement, Medivir will now receive
a USD 45 million payment from Meda in return for the transfer of all
rights to the product in US, Canada and Mexico. This agreement will
trigger a payment to AstraZeneca, the patent originator, according to
agreed terms.

The amended agreement also provides Meda with the exclusive US rights to
Xerese™ for the genital herpes indication. Meda is responsible for the
development of this indication for which Medivir will be eligible to
receive a USD 10 million development milestone if the product is
approved by the US Food and Drug Administration. Medivir will also
receive single digit royalties on sales in the US and full commercial
rights outside US. Medivir will pay Meda a single digit royalty on these
sales.

Other agreements that Medivir has for Xerclear with GSK, Daewoong
Pharmaceuticals and Luxemburg Pharmaceutical will remain unchanged by
the transaction with Meda for North America.

Ron Long, CEO of Medivir, commented: “We are following the performance
of Xerese™ with great interest since the US launch by our partner Meda
in February. However both we and Meda recognize that it will take time
and require considerable marketing resources to achieve successful
penetration of this important market. The revised agreement fairly
reflects our view of the market potential and provides us with cash
proceeds that we can devote both to our R&D projects in the infectious
disease area and to other product in licensing opportunities to take
advantage of the commercial platform acquired through the acquisition of
Biophausia”

Medivir and Meda's collaboration on Xerese™ dates back to February 2010
when Medivir licensed the rights to market, sell and distribute Xerese™
to Meda in the US, Canada and Mexico.

About Xerese™ (Xerclear® in Europe)
Xerese™ consists of a combination of the antiviral aciclovir with the
corticosteroid hydrocortisone in a proprietary formulation. It is
available as an over-the-counter product or as a prescription-only
product in certain markets. It 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 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.  

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 Xerese™, please contact:

Medivir (www.medivir.com)                      Mobile: +46 708 537 292
Rein Piir, CFO & VP Investor Relations
M:Communications:                              +44(0)20 7920 2330
Peter Laing / Amber Bielecka / Katja Toon                    +1
212-232-2356
Medivir@mcomgroup.com (Medivir@mcomgroup.com)
USA: Roland Tomforde

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 novel protease inhibitor is in phase 3 clinical development
for hepatitis C and is partnered with Tibotec Pharmaceuticals. In June
2011, Medivir acquired the specialty pharmaceutical company BioPhausia
to ensure timely commercialisation of TMC435 in the Nordic markets, once
approved.

Medivir's first product, the unique cold sore product Xerese™/Xerclear®
was launched on the US market in February 2011. 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.se (http://www.medivir.com/).

About Meda
Meda is an international specialty pharma company with its own
operations in 50 countries. Meda has approximately 1,700 employees in
sales and marketing of which 300 are in the US. Meda's worldwide sales
exceeded SEK 11 billion in 2010 and the Company is now the 50th largest
pharmaceutical company in the world with products sold in more than 120
countries.

Meda AB is the Group's parent company; its head office is in Solna,
outside of Stockholm. Meda is listed under Large Cap on the NASDAQ OMX
Nordic Exchange in Stockholm.

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

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