Costa Mesa-based Valeant Pharmaceuticals International said Tuesday that it’s completed two safety studies for a key drug in its pipeline.
The drug candidate,Zelapar,is a pill that could be used in combination with other drugs to treat patients with Parkinson’s disease.
Valeant said the company submitted the safety test results to the Food and Drug Administration, which is expected to complete its review in the next six months.
“Zelapar is an important pipeline candidate for Valeant, which we expect to make available to the market by mid-2005,” said Chief Executive Timothy C. Tyson.
Tyson, who came to Valeant in 2002, took over as chief executive at the start of the year from Robert O’Leary. He’s expected to continue the drug maker’s focus on developing new products. Building up sales in North America also is a goal.
Key drug milestones for Valeant include a third-phase clinical study data for viramidine, a next-generation version of Valeant’s core ribavirin hepatitis C drug, and the advancement of remofovir, a drug that’s aimed at treating hepatitis B, into third-phase development, assuming ongoing successful second-phase clinical studies.
As part of its bid to focus on new drugs, Valeant has been shedding its far-flung manufacturing plants acquired under the leadership of controversial founder and former chief Milan Panic, who left the company in 2002.
The plan to sell a number of its plants started in 2003. The goal: reducing the company’s operations from 33 sites to five sites by the end of 2006.
When a recent sale of a plant in Mexico is completed, Valeant will have 12 sites remaining in its manufacturing network.
