HUDDINGE, Sweden, Dec. 9, 2005 (PRIMEZONE) -- Medivir announced today that all rights relating to the development of RP-606 (MIV-606), an oral antiviral being developed for the treatment of herpes zoster (shingles) and post-herpetic neuralgia (PHN), the chronic pain which is associated with shingles, have been reverted to Medivir. The reversion is effected by way of a mutual termination of the license agreement with Reliant Pharmaceuticals, Inc., which is now focusing on the marketing and development of its portfolio of cardiovascular products.
"During the autumn Medivir has intensified its efforts to find an appropriate way forward for its shingles project MIV-606. With the termination of the Medivir-Reliant licensing agreement for MIV-606, all rights as well as all clinical and other data developed during the term of the agreement will be reverted to Medivir," says Medivir's CEO Lars Adlersson.
"Since the undertaking of the development of MIV-606, Reliant has committed substantial resources to synthesis development and new tablet formulations. Additionally, they have carried out six (6) phase I clinical trials with positive results, which has increased the data bank and the value of the project. Several of these trials have been carried out at the same dose as the earlier phase II clinical trial which showed a clear trend towards efficacy on PHN. Higher doses have also been evaluated, without observing any significant side-effects that would preclude further clinical evaluation of higher doses. Medivir intends to continue discussions with the FDA, and investigate the possibility of performing a combined phase II/III clinical trial as a way to expedite the progress of the project," says Medivir's VP, Development Johan Harmenberg.
'Medivir's project portfolio is currently dominated by protease inhibitors. It is, however, important that the older antiviral polymerase projects are also supported in the best possible way. A potential go ahead for a combined phase II/III clinical trial makes the conditions favorable for being able to take the project to the market, together with a new partner," says Medivir's CEO Lars Adlersson.
Shingles causes severe pain
About 95% of the population are carriers of the virus which causes shingles. During the initial infection, the varicella zoster virus (VZV) causes chicken-pox. After the chicken-pox episode, the VZV remains latent in particular nerve cells. In around 50% of these people, the VZV will reactivate and cause shingles.
Shingles manifests itself, inter alia, as vesicles which develop into open lesions. The lesions heal in a couple of weeks, but in some individuals the viral replication in the nerve cells and the resultant nerve damage causes severe and protracted pain, PHN. The risk of getting shingles increases with age, as does the risk of PHN.
The majority of shingles patients over the age of 60 are afflicted with PHN. Up to half of all patients over 70 still have the pain after one year. Early treatment of shingles patients with acyclovir to some extent reduces the duration of post-herpetic neuralgia. MIV-606 has 50-100 times greater antiviral activity than acyclovir. It is likely that a pharmaceutical with a much better antiviral potency should additionally lessen the duration of PHN.
The Medivir Group
Medivir is an innovative, specialist research company that develops drugs with the objective of becoming a sustaining, profitable pharmaceuticals company. Medivir is located in Huddinge, Sweden and at Chesterford Research Park, Essex, UK.
Medivir's research is oriented on developing new drug compounds based on polymerases and proteases as target enzymes. The group consists of Medivir AB, its subsidiary Medivir UK Ltd. and Medivir Personal AB. As of 30 September 2005, the group had 129 employees. Medivir was listed on the Stockholm Exchange O-list in 1996.
Medivir's research portfolio includes projects against HIV, jaundice, shingles, cold sores, osteoporosis, RA (rheumatoid arthritis), asthma and MS (multiple sclerosis). Medivir has five projects in clinical development phases, each with a unique clinical profile. The company's broad-based preclinical research portfolio houses six defined projects and nearly ten activities in various preclinical phases.
Medivir AB (publ), Lunastigen 7, 141 44 Huddinge, Sweden, tel (switchboard): +46 (0)8 546 83100
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