HUDDINGE, Sweden--(BUSINESS WIRE)--Regulatory News:
Medivir AB (STO:MVIR), the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced that it has renegotiated the terms of its commercial partnership with Meda (OMX: MEDA A) for Xerese™, its unique marketed product for cold sores (herpes labialis). Xerese™ is FDA-approved and available in the US as a prescription medicine. Meda launched the product in the US in February 2011 and Medivir currently receives a double digit royalty on Meda’s sales in this market.
Under the terms of the renegotiated agreement, Medivir will now receive a USD 45 million payment from Meda in return for the transfer of all rights to the product in US, Canada and Mexico. This agreement will trigger a payment to AstraZeneca, the patent originator, according to agreed terms.
The amended agreement also provides Meda with the exclusive US rights to Xerese™ for the genital herpes indication. Meda is responsible for the development of this indication for which Medivir will be eligible to receive a USD 10 million development milestone if the product is approved by the US Food and Drug Administration. Medivir will also receive single digit royalties on sales in the US and full commercial rights outside US. Medivir will pay Meda a single digit royalty on these sales.
Other agreements that Medivir has for Xerclear with GSK, Daewoong Pharmaceuticals and Luxemburg Pharmaceutical will remain unchanged by the transaction with Meda for North America.
Ron Long, CEO of Medivir, commented: “We are following the performance of Xerese™ with great interest since the US launch by our partner Meda in February. However both we and Meda recognize that it will take time and require considerable marketing resources to achieve successful penetration of this important market. The revised agreement fairly reflects our view of the market potential and provides us with cash proceeds that we can devote both to our R&D projects in the infectious disease area and to other product in licensing opportunities to take advantage of the commercial platform acquired through the acquisition of Biophausia”
Medivir and Meda’s collaboration on Xerese™ dates back to February 2010 when Medivir licensed the rights to market, sell and distribute Xerese™ to Meda in the US, Canada and Mexico.
About Xerese™
(Xerclear® in Europe) Xerese™ consists of a combination of the antiviral aciclovir with the corticosteroid hydrocortisone in a proprietary formulation. It is available as an over-the-counter product or as a prescription-only product in certain markets. It is the first and only cold sore treatment 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[3] 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)[4], 50% greater reduction in cumulative lesion area with Xerese™ vs. vehicle placebo and greater relief of symptoms, such as tenderness vs. vehicle placebo.[3],[4]
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.
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.
References: [1] US Food and Drug Administration, 31/07/2009. www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
[2] US Food and Drug Administration, 5/12/2010. www.accessdata.fda.gov/drugsatfda_docs/label/2010/022436s001lbl.pdf
[3] 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].
[4] Xerese™ (package insert). Somerset, NJ:Meda Pharmaceuticals Inc.; 2010
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 novel protease inhibitor is in phase 3 clinical development for hepatitis C and is partnered with Tibotec Pharmaceuticals. In June 2011, Medivir acquired the specialty pharmaceutical company BioPhausia to ensure timely commercialisation of TMC435 in the Nordic markets, once approved.
Medivir’s first product, the unique cold sore product Xerese™/Xerclear® was launched on the US market in February 2011. Xerese™/Xerclear®, which has been approved in both the US and 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® in Sweden and Finland.
For more information about Medivir, please visit the Company’s website: www.medivir.se.
About Meda
Meda is an international specialty pharma company with its own operations in 50 countries. Meda has approximately 1,700 employees in sales and marketing of which 300 are in the US. Meda’s worldwide sales exceeded SEK 11 billion in 2010 and the Company is now the 50th largest pharmaceutical company in the world with products sold in more than 120 countries.
Meda AB is the Group’s parent company; its head office is in Solna, outside of Stockholm. Meda is listed under Large Cap on the NASDAQ OMX Nordic Exchange in Stockholm.
For more information about Meda, please visit the Company’s website: www.meda.se
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