Lipsovir® – all patients in the phase III program now enrolled
13-Sep-07 Medivir’s phase III project Lipsovir® has now enrolled and issued study drug to all of the intended patients. In two of the studies, the final patient has commenced treatment.
The phase III program consists of three studies. The first study, which enrolled children and adolescents, commenced in January 2007 and is being performed in Sweden and Russia. The aim of the study is to confirm the safety profile of Lipsovir® in this age group. The study embraces 240 patients, of which 130 are to be treated with Lipsovir®. The final patient has now started treatment, which is ahead of schedule.
The second study is being performed on immunocompromised patients with cold sores. This also started in January 2007 and is being carried out in Russia and the Ukraine. The primary aim of the study is to compare lesion healing time between Lipsovir® and acyclovir. The study embraces 200 patients, of which 105 are to be treated with Lipsovir® or acyclovir. The final patient has now started treatment, which is also ahead of schedule.
The third study is the pivotal clinical trial and has enrolled patients with recurrent cold sores. It is being performed in North America at over 50 clinical sites. The primary aim of the study is to demonstrate that early treatment with Lipsovir® can prevent a cold sore arising. All 2400 patients have now been enrolled in the study and 1400 will commence treatment. The number of patients being treated has been increased by around 100, relative to the original plan, in order to ensure a satisfactory number of evaluable patients. The augmented patient numbers have been crosschecked with the US regulatory authority FDA. This pivotal study is divided into three treatment arms, one with placebo, one with acyclovir and one with Lipsovir®. Thus far, 94% of the patients intended to be treated have undergone treatment.
During the summer, Medivir has also carried out a photosensitization study and a phototoxicity study, which is standard in the development of many topical drugs.
The increase in patient numbers in the pivotal clinical trial has only a marginal impact on the timing of the regulatory filing (New Drug Application, NDA). The two smaller phase III studies have been performed more rapidly than planned, meaning that the results from all three studies can now be compiled simultaneously for evaluation.
Medivir will have access to the results and conclusions from the whole development program during Q1 of 2008, which will be communicated. The NDA will be filed during spring/summer 2008 and Medivir anticipates grant of a marketing authorization at the beginning of 2009.
Activities in relation to identifying a suitable partner or partners for the global marketing rights to Lipsovir® have been underway since the spring. As previously communicated, Medivirs ambition is to enter one or several agreements after the phase III results are available.
For additional information, please contact
Rein Piir, CFO & Vice President Investor Relations, Medivir AB. +46 8 5468 3123, +46 708 537292
For more information on Medivir, please see the company website www.medivir.se