Valeant plans to grow base business by 5%-10% per year, save up to $30 million in 2006

By Jennifer Lanning Drey

Eugene, Ore., Sept. 12 - Valeant Pharmaceuticals International expects its base business to grow between 5% and 10% per year and plans to supplement that growth with opportunities in new territories and acquisitions of regional products, Timothy Tyson, Valeant's chief executive officer, said Tuesday at the Bear Stearns health care conference.

In addition, the company plans to seek partnership opportunities for its current pipeline candidates and to continue to add to its pipeline, he said.

"To maintain our growth over the long term, we will continue to select compounds and evaluate additional approaches to diversify our pipeline," Tyson said.

Tyson also told investors that Valeant expects to save between $20 million and $30 million in expenses this year as a result of its restructuring efforts and $50 million to $70 million in 2007.

The company expects the restructuring to be complete by the end of the year with the exception of the sale of its manufacturing plants, which is expected to wrap up in mid-2007, he said.

Valeant, Retigabine development

Valeant is developing Viramidine (taribavirin hydrochloride) for treatment-naive hepatitis C patients and Retigabine as an adjunctive treatment for epilepsy.

On Tuesday, the company announced that its second pivotal phase 3 clinical trial evaluating the safety and efficacy of Viramidine had provided results similar to those found in its first phase 3 trial.

As a result of the data, the company said it will begin a phase 2b program to evaluate the efficacy of Viramidine at higher doses. Valeant will conduct interim reviews of the study at four and 12 weeks and then meet with the Food and Drug Administration to determine whether to continue the trial.

If further results are positive, the company plans to begin an 850-person phase 3 clinical trial.

"If we move into phase 3, we will seek a partner to share the investment and risks of this later development program," Tyson said.

Regarding the development of Retigabine, Tyson said the FDA has qualified the company's phase 2 clinical trial as a well-controlled study for use in the registration process.

Valeant expects to submit data on Retigabine to the FDA in 2008 and, if approved, launch the product in 2009.

The company also plans to file an Investigational New Drug application for Retigabine as a treatment for neuropathic pain, and the company is evaluating a sustained-release version of the drug. Valeant also plans to investigate Retigabine as treatment in a new indication in pain, Tyson said.

"This activity is designed to lengthen the product's lifecycle and increase sales potential," Tyson said.

Valeant is a specialty pharmaceutical company based in Costa Mesa, Calif.

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