Medivir's Partner GSK Initiates OTC Launch of Xerclear® in Europe Under Trade Names Zoviduo and Zovirax Duo

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Feb 08, 2012, 02:30 ET

HUDDINGE, Sweden, February 8, 2012 /PRNewswire/ --

Medivir AB (OMX: MVIR), 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: http://www.medivir.com

For more information about Medivir, please contact:
Medivir
Rein Piir, EVP Corporate Affairs & IR

Mobil: +46-708-537-292

M:Communications
Europe: Mary-Jane Elliott, Amber Bielecka, Hollie Vile

[email protected]
+44(0)20-7920-2330