Regulatory News:
Medivir AB (STO:MVIRB), the research-based specialty pharmaceutical
company focused on infectious diseases, announces that its unique cold
sore product Xerclear®, which Medivir developed in-house, is now being
launched for over-the-counter (OTC) use by its partner GlaxoSmithKline
(GSK) in Europe. Xerclear® will be marketed under the trade name Zoviduo
and Zovirax Duo in Europe.
In June 2010, Medivir entered an agreement with GSK, which granted GSK
exclusive rights to market and distribute Xerclear® for non-prescription
(OTC) sales in several markets, including Europe, Russia, Japan, India,
Australia and New Zealand.
GSK has now kicked off the first wave of launches in the five countries
where Zoviduo/Zovirax Duo is approved for OTC sales: Denmark, Czech
Republic, Slovakia, Portugal and Poland. The launches will take place
during the spring, beginning in February. GSK’s goal is to launch the
product in the remaining markets in Europe as the respective regulatory
authorities grant approval for OTC sales.
Maris Hartmanis, CEO of Medivir commented, “Few companies of our size
have experienced the launch of a product, developed in-house, that is
now being introduced in Europe and has also been available in the US
since last spring. This strengthens Medivir in our efforts to develop
new drugs and is yet another step toward our goal of becoming
profitable.”
GSK is responsible for funding commercial development of Xerclear®,
including marketing approval for OTC sales in all territories covered by
the agreement. In addition to funding commercial development of
Xerclear®, GSK will pay Medivir up to double-digit royalties on sales
for the exclusive rights. The remaining Euro 1.9 million in milestones,
according to the agreement, will be due for payment at the time of
future OTC product launches in certain pre-defined countries.
About Xerclear® (Xerese® in the US)
Xerclear® consists of a combination of acyclovir (antiviral) and
hydrocortisone (corticosteroid), in a proprietary formulation. It is
available as an over-the-counter product or as a prescription-only
product in certain markets. Xerclear® is the first and only cold sore
treatment that in clinical trials have shown a reduction in the
likelihood of progression to ulceration with early treatment
initiation.[1] Xerclear® also provided faster healing time vs. placebo
(mean time to skin normalization was approximately 1.6 days shorter)[2],
50% greater reduction in cumulative lesion area vs. placebo and greater
relief of symptoms, such as tenderness vs. placebo.[1],[2]
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 US
and Europe is estimated at USD 230 million and USD 170 million,
respectively.
References:
[1] 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].
[2] Xerese™ (package insert). Somerset, NJ: Meda Pharmaceuticals Inc.;
2010
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 in phase III clinical development for
hepatitis C that is being developed in collaboration 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 being launched in
collaboration with GlaxoSmithKline to be sold OTC in Europe, Japan and
Russia. Rights in North America, Canada and Mexico were sold to Meda AB
in June 2011. 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
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