Medivir AB a research-based specialty pharmaceutical company focused on infectious diseases, 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 in South 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.”

Ji-Hyung Kim, vice president of Daewoong Pharmaceutical Co. Ltd. Commented, “We are very delighted to announce this collaboration with Medivir. Using this opportunity, we are ready to strengthen and expand our dermatology portfolio in China and Hong Kong. From our MIV-210 collaboration with Medivir to this Xerclear distribution agreement, we are sure that this will provide us a further opportunity to strengthen the relationship between our two companies.”

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.

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 US$ 5 million, and in the USA and Europe at US$ 230 million and US$ 170 million, respectively.

Daewoong Pharmaceutical Co. Ltd. ranked in the first position in South Korean pharmaceutical market in terms of requested reimbursement totals, according to Health Insurance Review Agency (HIRA). It engages in the research, development, manufacturing and marketing of healthcare products.

Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases.