Stock in Trimeris jumped nearly 3 percent on Tuesday on news that the European Commission has granted formal approval for sale of the new HIV drug Fuzeon.
Trimeris (Nasdaq: TRMS) closed at $48.51, up $1.34.
The European Commission blessing comes after approval by the FDA in the United States in March and by Switzerland just last week. Trimeris stock is up some 10 percent since it won FDA approval. The price had dipped under $39 a share due in part to concerns about pricing ($20,000 a year per patient) and production concerns but the stock has rallied sharply in the past month.
In a statement, Trimeris and its partner Roche said that Fuzeon should be made available in European markets “over the next several months.”
“The rapid European approval reflects the efficacy and safety of Fuzeon shown in the two pivotal phase III studies, as well as the compelling need for this new therapy,” said Dr. Dani Bolognesi, chief executive officer of Trimeris, in a statement.
The companies said that the European approval covers use of Fuzeon “in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens” of other drugs. They added that the approval calls for “careful consideration” to be given to individual case histories and patterns of HIV mutation development.