Medivir appoints Luxembourg Pharmaceuticals as distributor for Xerclear™ in Israel

Medivir AB (OMX: MVIR), the research-based speciality pharmaceutical company focused on  infectious diseases, is today pleased to announce the appointment of Luxembourg Pharmaceuticals Ltd, as the exclusive distributor for Xerclear™, Medivir’s marketed and innovative treatment for recurrent cold sores, in Israel and the Palestinian Authority.

Under the terms of the agreement, Luxembourg Pharmaceuticals Ltd., a subsidiary of The Lapidot Group, a leading healthcare corporation based in Israel, will be responsible for obtaining the regulatory approvals, and for marketing, sales and distribution of Medivir’s cold sore product in the territory. In consideration of the rights granted to Luxembourg Pharmaceuticals Ltd., Medivir will receive revenues from Xerclear™ sales according to an undisclosed profit sharing scheme.

Commenting on the announcement Ron Long, Chief Executive Officer of Medivir AB, said: “We are pleased to announce yet another distribution partner for Xerclear™. We are convinced that Luxembourg Pharmaceuticals Ltd. is an excellent partner for us in this territory.”

“We are pleased to be working with Medivir to distribute this important product in our local market”, added Mr Ilan Lapidot, President and CEO, Luxembourg Pharmaceuticals Ltd.

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 3 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 Israel is estimated at USD 1.5 million, and in the USA and Europe at USD 230 million and USD 170 million, respectively.

About Medivir

Medivir is a 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. Medivir has a strong R&D portfolio and has recently launched its first product, an innovative treatment for cold sores.

Xerese™/Xerclear™ is a treatment for cold sores, which has been approved in both the US and Europe. It is partnered with GSK to be sold OTC in Europe and Russia and by Meda in North America. Medivir have retained the Rx rights for Xerclear™ in Sweden and Finland. 

Medivir’s key pipeline asset, TMC435, a protease inhibitor, is in Phase 2b clinical development for Hepatitis C and is partnered with Tibotec Pharmaceuticals.

About Luxembourg Pharmaceuticals

Luxembourg Pharmaceuticals Ltd., a subsidiary of The Lapidot Group, a privately held corporation based in Caesarea, Israel. Luxembourg Pharmaceuticals has been a leading Israeli health care company since 1930 and exclusive Israeli importer and distributor for major pharmaceutical companies' products including Alcon, B.Braun, ApoPharma, and Piedmont Pharmaceuticals. Luxembourg is active in various healthcare segments such as Ophthalmology, Women’s Health, Haematology, Pediatrics and OTC. Luxembourg maintains valuable relationships with the medical community and operates as a fully integrated company in terms of sales, marketing, logistics and regulatory affairs.  

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