STOCKHOLM, Sweden–(BUSINESS WIRE)–Regulatory News:
Medivir AB (OMX: MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced that its U.S. commercialisation partner, Meda, has presented virolology data from the phase 3 programme on Xerese™/Xerclear®, Medivir’s unique cold sore treatment, at the 45th American Society of Health System Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition, Anaheim, USA, 5-9 December 2010.
The poster[1] summarised the results of virology assessments from two phase 3 two-arm, randomised, multicenter, subject-initiated studies. these studies included immunocompetent adults and HIV-positive patients and examined the topical administration of the combination of five percent acyclovir and one percent hydrocortisone in a unique cream vehicle (Xerese™/Xerclear®) for the treatment of recurrent herpes simplex labialis. The data showed that Xerese™/ Xerclear® was well tolerated and did not give rise to acyclovir resistant virus.
Medivir sponsored and executed the studies and the poster was presented by Dr. Larry N. Gever from Meda. The poster can be accessed via Medivir’s website medivir.se.
About Xerese™ (Xerclear® in Europe) Xerese™ is the first and only cold sore agent that demonstrated greater efficacy vs. 5% acyclovir in the same cream vehicle (with early treatment), reduced the likelihood of progression to ulceration with early treatment[2]. Xerese™ 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)[2], 50% greater reduction in cumulative area for all lesions with Xerese™ (78 mm2) vs. vehicle placebo (155 mm2) and greater relief of symptoms, such as tenderness vs. vehicle placebo[2, 3].
Indication (US label)
XERESE™ (acyclovir 5% and hydrocortisone 1%) cream is indicated for the early treatment of recurrent herpes labialis (cold sores) in adults and adolescents (12 years of age and older)
· To reduce the likelihood of ulcerative cold sores
· To shorten the lesion healing time
Important Risk Information
· Use topically for herpes labialis of the lips and around the mouth.
· do not use in the eye, inside the mouth or nose, or on the genitals.
· Encourage patients to seek medical advice when a cold sore fails to heal within 2 weeks. other orofacial lesions, including bacterial and fungal infections, may be difficult to distinguish from a cold sore.
· do not apply under an occlusive dressing; contact dermatitis has been observed
· The most common adverse reactions (< 1%) were local skin reactions: Drying or flaking of the skin; burning or tingling, erythema; pigmentation changes.
For US; available by prescription only. Full prescribing information available at medapharma.us.
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, Japan, Australia and Russia and by prescription sold by Meda in North America. Medivir has 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.
For more information about Medivir, please visit the Company’s website: medivir.se
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 acyclovir, 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.
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[1]The topical application of acyclovir five percent and hydrocortisone one percent cream in subjects with recurrent herpes labialisis not associated with acyclovir resistance. Authors: Mia Brytting, Eva Arlander, Larry N Gever, William Wheeler. Affiliations: Swedish Institute of Infectious Disease Control, Stockholm, Sweden, Medivir AB, Huddinge, Sweden, Meda Pharmaceuticals, inc., Somerset, NJ
[2] Hull CM, Harmenberg J, Arlander E, et al. Early treatment of cold sores with topical ME-609 decreases the frequency of ulcerative lesions: a randomized, double-blind, placebo-controlled, patient-initiated clinical trial . [published online ahead of print September 17, 2010]. J am Acad Dematol. Doi:10.1016/j.jaad 2010.08.012.
[3] Xerese™ (package insert). Somerset, NJ:Meda Pharmaceuticals inc.; 2010
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