NEW YORK - Shares of Indevus Pharmaceuticals Inc. plunged yesterday after the Lexington company said its injectable testosterone drug candidate will face a regulatory delay of up to two years with the Food and Drug Administration because of safety concerns.
Indevus said it expects the FDA to formally request additional safety data on Nebido before considering it for approval. Indevus will likely have to perform another study on the drug to get that data.
The stock fell $2.84, or 69.5 percent, to $1.26, reaching its lowest point in nearly six years.
Indevus said it plans to refile its application with the FDA in about 18 months, followed by a six-month review. The FDA is concerned about a reaction seen in one patient immediately following injection of the drug, which led to coughing episodes and shortness of breath. In rare cases, symptoms from amounts of the oily injectable solution entering the vascular system can include dizziness, flushing, or fainting.
Indevus has 265 employees, including 115 in Massachusetts.
The drug, which treats male hypogonadism, in which the testicles fail to produce enough testosterone, is already approved in Europe. Indevus said safety concerns likely arose from post-marketing studies conducted in Europe.
"We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of Nebido, given the large European experience," Dr. Glenn L. Cooper, chairman and chief executive, said in a prepared statement. "Rare coughing reactions have been well-described in the European product labeling of Nebido."
Indevus expects the official request for more safety data from the FDA by June 27.
Soleil Securities Group analyst Matt Renna downgraded shares of Indevus to "hold" from "buy," saying the drug was a key component to any potential gains for the company's stock.