GlaxoSmithKline enters agreement with Medivir for exclusive rights to cold sore treatment Xerclear™
London UK & Huddinge, Sweden - GlaxoSmithKline (GSK) and Medivir (STO: MVIR-B) today announced an exclusive agreement for the commercialisation 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.[i]
Under the terms of the agreement, GSK gains exclusive rights to commercialise 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 commercialisation 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.[ii]
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 speciality pharmaceutical company with a strong research base. For more information on Medivir, please see the company’s website: www.medivir.se
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under ’Risk Factors’ in the ’Business Review’ in the company’ s Annual Report on Form 20-F for 2009.
[i] 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 Francisco, USA (2009) and data on file .
[ii] Xerclear SPC, approved 2009-10-14, www.mpa.se
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