GlaxoSmithKline enters agreement with Medivir for exclusive rights to cold sore treatment Xerclear™

​GlaxoSmithKline (GSK) and Medivir (STO: MVIR-B) today announced an exclusive agreement for the commercialization of cold sore treatment, Xerclear™ (acyclovir and hydrocortisone) for non-prescription use (OTC) in key global markets. Xerclear™ is the first and only topical herpes labialis (cold sores) treatment clinically proven to help prevent cold sore lesions appearing. 1)

Under the terms of the agreement, GSK gains exclusive rights to commercialize and distribute non-prescription Xerclear™ as part of the Zovirax™ franchise, across multiple markets, including Europe, Russia, Japan, India, Australia and New Zealand. The agreement excludes North and South America, China, South Korea and Israel. 

GSK will assume responsibility for funding ongoing and future commercial development of Xerclear™ in all territories covered by the agreement. In addition to funding the commercial development of Xerclear™, GSK will pay up to Euro 3 million in up-front and pre-launch milestones and up to double-digit royalties on sales to Medivir for the exclusive rights. 

John Clarke, President, Consumer Healthcare GSK, said: “This alliance demonstrates GSK’s ongoing commitment to invest in and expand our OTC business.  It will help strengthen our dermatology portfolio across multiple territories including several key emerging markets. ”  

“We are pleased to have partnered Xerclear™ with GlaxoSmithKline Consumer Healthcare – one of the world’s largest OTC consumer healthcare products companies, said Ron Long, Medivir’s CEO, and concluded, “This represents a major step in the global commercialization of our cold sore product."  

Xerclear™, a combination product of acyclovir and hydrocortisone - was granted marketing approval in 14 European countries in October 2009. Based on strong clinical data, Xerclear™ was given a unique label, which differentiates it from other topical cold sore products currently on the market. 2) 

GlaxoSmithKline
One of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com 

Medivir
Based on its world class expertise in protease and polymerase inhibition technology, Medivir develops drugs with primary focus on infectious diseases. Its objective is to become a sustainable and profitable specialty pharmaceutical company with a strong research base. 

Medivir’s first pharmaceutical product - for the topical treatment of cold sores - has recently been approved by the US FDA (trademark "Xerese™") and in Europe (trademark "Xerclear™"). The product will be commercialized through partners outside the Nordic region, where Medivir intends to market and sell the product.


For additional information, please contact
Rein Piir, CFO & VP Investor Relations, Medivir;
Office phone +46 8 54683123
Cell phone +46 708 537 292. 

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


Referenses

1) Hull, C. Episodic treatment with topical ACV/Hydrocortisone prevents cold sores: A randomized, double-blind, patient-initated clinical trial. Poster presentation 49th ICAAC meeting in San Fransisco, USA (2009) and data on file.
2) Xerclear™ SPC, approved 2009-10-14, www.mpa.se

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