Medivir AB the emerging research-based specialty pharmaceutical company focused on infectious diseases, announces that the company’s commercialization partner, Meda AB, has launched Medivir’s unique cold sore treatment Xerese in the United States.
Xerese is the first topical combination product of five per cent acyclovir and one per cent hydrocortisone in a unique cream vehicle for the treatment of recurrent herpes simplex labialis. Xerese was granted FDA marketing approval and based on strong clinical data Xerese was given a label, which differentiates it from other topical cold sore products currently on the market. Xerese will be sold in the US as a prescription medicine.
Medivir estimates that the US market for cold sore products is valued at USD 230 million (EUR 168 million) and with Meda’s strong commercial presence and deep understanding of US market dynamics, combined with Xerese’s differentiated profile, it is anticipated that Xerese will be a successful entrant to the cold sore treatment market.
Medivir granted Meda the exclusive rights to market sell and distribute Xerese in the United States, Canada and Mexico for the treatment of cold sores (herpes labialis) in February 2010. In addition to funding the commercial development of Xerese™ and up-front and pre-launch milestones totaling USD 5 million, Medivir will also receive double-digit royalties on sales.
Ron Long, CEO of Medivir, commented: “We are delighted that Xerese has been launched on the US market today. Our partner Meda has a strong commercial presence in the US and has demonstrated great success in marketing products in the US, specifically in dermatology. We very much look forward to the further launches of Xerese by our partner Meda in Canada and Mexico and also the launch later this year in Europe by our partner GlaxoSmithKline.”
Xerese is the first and only cold sore treatment that demonstrated greater efficacy vs. 5 per cent acyclovir in the same cream vehicle (with early treatment), reduced the likelihood of progression to ulceration with early treatment and combines an antiviral and an anti-inflammatory.
Xerese also provided faster healing time vs. vehicle placebo (mean time to skin normalization was approximately 1.6 days shorter) 50 per cent greater reduction in cumulative lesion area with Xerese vs. vehicle placebo and greater relief of symptoms, such as tenderness vs. vehicle placebo.
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 the USA and Europe is estimated at USD 230 million and USD 170 million, respectively.
Medivir is an emerging research-based specialty pharmaceutical company focused on the development of high-value treatments for infectious diseases. Its 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.