Indevus shares rise on Nebido, cost-cutting plan

Tag : injection site
NEW YORK -
Shares of Indevus Pharmaceuticals Inc. rose Monday after drug developer said the Food and DrugAdministration gave it clear recommendations to put an experimentaltestosterone drug back on the path toward approval.
Still, the company plans to cut 12 percent of its staff, mainly atthe Lexington, Mass., headquarters, and aggressively pursue otherprograms because of the regulatory delays with Nebido. Indevusexpects restructuring charges between $3 million and $4 million inthe third quarter.
Shares rose 1 cent, or 0.6 percent, to $1.57 Monday. The stock hastraded between $1.19 and $8.22 over the past 52 weeks.
In a June 27 letter, the FDA indicated that Nebido could beapproved if the company addresses certain safety concerns. Theagency had expressed concern over a small number of patients in aEuropean post-marketing study who have had respiratory problemsfollowing intramuscular injection of the drug. Those issues,though, were with a 1,000-milligram dose and not the 750-milligramdose up for review in the U.S.
The FDA wants the company to provide detailed safety data todetermine the precise number of post-injection reactions.Specifically, it wants follow-up data from ongoing U.S. andEuropean studies, most of which will be complete within 12 months.
"We believe that Nebido is a safe and effective drug for itsintended use and continue to be disappointed that the FDA was notwilling to approve the drug at this time with adequate labeling ofthe oil-based reactions and how to minimize them with properinjection technique," Dr. Glenn L. Cooper, chairman and chiefexecutive, said in a statement. "However, we are encouraged thatthis approvable letter provides a road map for the product'seventual approval."
The company said the reaction is likely the result of a smallamount of the oily solution immediately entering the vascularsystem from the injection site, a known, rare complication ofoil-based depot injections. Symptoms include coughing episodes,shortness of breath, and in rare occasions, dizziness. There wasonly one such coughing reaction in U.S. studies as opposed toseveral in European studies.
On June 4, Indevus said it might have to perform additional studieson the drug, triggering a 69 percent drop in the stock. Indevusstill may need to conduct an additional study, it said.
The company said its revised plan is expected to drop its operatingcash burn in fiscal 2009 to about $10 million per quarter onrevenue of about $88 million to $95 million. It's recent averageoperating cash burn was between $18 million and $20 million perquarter, with 2008 revenue expected to be about $70 million.

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