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Valeant Pharmaceuticals International, Inc.

Drug Names(s): 5% acyclovir and 1% hydrocortisone, ME-609, Lipsovir, Xerclear (EU), Zoviduo/Zovirax Duo (EU OTC)

Description: ME-609 is a combination of acyclovir and hydrocortisone cream.

Acyclovir is a nucleotide analogue. Its inhibitory activity is highly selective due to its affinity for the enzyme thymidine kinase encoded by herpes simplex and varicella-zoster viruses. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted by other enzymes to acyclovir triphosphate, which stops replication of herpes viral DNA through competitive inhibition of viral DNA polymerase, incorporation into and termination of the growing viral DNA chain, and inactivation of the viral DNA polymerase.

Hydrocortisone is a steroid that suppresses inflammation and the immune response, which may help symptoms of herpes.

Deal Structure: AstraZeneca
In February 1998, Medivir initiated analliance with AstraZeneca relating toresearch and development of pharmaceuticalsactive against recurring herpessimplex viral infections in the skin andmucus membranes. In order to achievefaster and improved treatment resultsthan with existing pharmaceuticals, antiviraldrugs are be combined with animmunomodulator, in order to reducethe bodys over-reaction. Medivir's subsidiary, CCS' formulationexpertise has contributed to thedevelopment of a new cream, ME-609.

The agreement stipulates that Medivir(in partnership with AstraZeneca) has theprimary responsibility for developing anew pharmaceutical in cream form employingthis new treatment principle, upto and including Phase II. AstraZenecasubsequently has the possibility ofbringing the project to the global registration,launch and marketing stage. In conjunctionwith AstraZeneca assuming fullresponsibility for the further developmentof ME-609, Medivir will receivea smaller...See full deal structure in Biomedtracker

Partners: Medivir AB GlaxoSmithKline plc Mylan Inc.


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