Medivir signs agreement with Daewoong to distribute Xerclear® in China and Hong Kong

Huddinge, Sweden, - Medivir AB (OMX: MVIR), a research-based specialty pharmaceutical company focused on infectious diseases, today announced that it has signed an agreement with Daewoong Pharmaceutical Co. Ltd. to exclusively distribute Medivir’s unique cold sore treatment Xerclear^® in China and Hong Kong.  

Under the terms of the agreement, Daewoong will be responsible for conducting clinical studies for obtaining the regulatory approvals, and for marketing, sales and distribution of Medivir’s cold sore product in the territory. In return, Medivir will receive royalties on all product sales.

Daewoong is also responsible for the commercialisation of Xerclear^® inSouth Korea.  Daewoong has recently filed for registration with the South Korean authorities and expects the regulatory approval later this year.

Ron Long, President and CEO of Medivir commented, “We are pleased to expand our collaboration for Xerclear^® with Daewoong and to have them as our commercial partner in this high growth emerging market where there is a growing demand for high quality treatments such as Xerclear^®. We look forward to continuing to work closely with Daewoong and the launch of Xerclear^® in South Korea early next year.”

Mr. Ji-Hyung Kim, Vice President of Daewoong Pharmaceutical Co. Ltd. Commented, “We are very delightful to announce this collaboration with Medivir. Taking this opportunity, we are ready to strengthen and expand our dermatology portfolio in China and Hong Kong. From MIV-210 collaboration to this Xerclear^® distribution agreement, we are sure that this will provide us more potential to strengthen the relationship between companies.”

For more information about Medivir, please contact;

Rein Piir, CFO & VP Investor Relations, Medivir, at  +46 708 537 292

Eva Arlander, VP Pharma, +46 702 556 855

Johan Inborr, Head of Business Development (Pharma), +46 708 853 893

M:Communications:

Mary-Jane Elliott / Amber Bielecka / Katja Toon

Medivir@mcomgroup.com

+44(0)20 7920 2330

About Xerclear^®

Xerclear^® (Xerese™ in the USA) – a patented combination of 5% acyclovir and 1% hydrocortisone in Medivir’s proprietary cream formulation - is a topical product for the treatment of recurrent herpes labialis. The indication text as approved by FDA, states “Xerclear^® is indicated for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time in adults and adolecents (12 years of age and older)”. Xerclear^® is the first topical product that in controlled clinical trials has been shown to significantly (P<0.0001 vs. placebo) reduce the development of ulcerative lesions during a cold sore episode.

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.

Today only 1-2% of the episodes are treated. 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 South Korea is estimated at USD 5 million, and in the USA and Europe at USD 230 million and USD 170 million, respectively.

About Daewoong

Daewoong Pharmaceutical Co. Ltd. is a leading Korean pharmaceutical company with annual turnover of nearly $680 millionU.S.in 2010. Daewoong Pharmaceutical Co. Ltd. was ranked in the first position in South Korean pharmaceutical market in terms of requested reimbursement totals, according to Health Insurance Review Agency (HIRA). Daewoong has expanded global business operations throughoutAsiaand is currently developing strategies for the global market.

Daewoong Pharmaceutical Co. Ltd. engages in the research, development, manufacturing and marketing of healthcare products. It provides a full spectrum of healthcare products for various therapeutic areas that include infectious diseases, cardiovascular diseases, metabolic disorders, disorder of central nervous system, digestive disorders, oncology and vaccines.

Daewoong's R&D activity explores a broad spectrum of innovative approaches and has developed new

products in key therapeutic area such as EGF for mucositis and wound healings and DWP05195 for Neuropathic Pain.

In particular, Daewoong Pharmaceutical Co. Ltd. has made numerous successful partnerships with multinational pharmaceutical companies launching number of blockbuster products on the Korean market, and its strong growth is attributable to its dedication to excellence in sales and marketing, which is backed by a comprehensive portfolio of both innovative and generic prescription drugs.

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™/Xerclear^® which has recently been launched on the US market. Xerclear^®/Xerese™ which is also approved in 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^® inSweden andFinland.

For more information about Medivir, please visit the Company’s website: www.medivir.com.