Medivir's Cold Sore Treatment Xerese(TM) Now Launched in the United States
By Medivir, Gaea News NetworkMonday, February 28, 2011
HUDDINGE, Sweden, March 1, 2011 - 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(TM) in the United States.
Xerese(TM) 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(TM) was
granted FDA marketing approval [1] and based on strong clinical data,
Xerese(TM) was given a label, which differentiates it from other topical cold
sore products currently on the market.[2] Xerese(TM) 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(TM) differentiated profile, it is anticipated that Xerese(TM)
will be a successful entrant to the cold sore treatment market. Medivir
granted Meda the exclusive rights to market, sell and distribute Xerese(TM)
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(TM) 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(TM) 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(TM) by our partner Meda in
Canada and Mexico and also the launch later this year in Europe by our
partner GlaxoSmithKline."
About Xerese(TM) (Xerclear(R) in Europe)
Xerese(TM) 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(TM) 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(TM) 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=Se
arch.Label_ApprovalHistory#apphist
[2] US Food And Drug Administration, 5/12/2010.
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(TM) (package insert). Somerset, NJ:Meda Pharmaceuticals Inc.;
2010
(Due to the length of these URLs, it may be necessary to copy and paste
the hyperlinks into your Internet browser's URL address field. Remove the
space if one exists.)
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(TM)/Xerclear(R) which has recently been launched on the
US market. Xerese(TM)/Xerclear(R), 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(R) in Sweden and Finland.
For more information about Medivir, please visit the Company's website:
www.medivir.com.
For more information about Medivir or Xerclear(R), 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:
Mary-Jane Elliott / Amber Bielecka / Katja Toon +44(0)20-7920-2330
Medivir@mcomgroup.com
USA: Roland Tomforde +1-212-232-2356
For more information about Medivir or Xerclear(R), 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: Mary-Jane Elliott / Amber Bielecka / Katja Toon, +44(0)20-7920-2330, Medivir at mcomgroup.com ; USA: Roland Tomforde, +1-212-232-2356.
