Danish biotech company ups outlook after cancer drug approval by U.S. FDA

The Danish biotech company Genmab on Tuesday raised its financial guidance for the year 2015 after having received approval for its cancer drug Darzalex by the U.S. Food and Drug Administration (FDA).

In a statement released on Tuesday, Genmab announced the FDA approved Darzalex for heavily pre-treated or double refractory multiple myeloma, an incurable blood cancer that starts in the bone marrow.

It added Darzalex was the first monoclonal antibody approved anywhere in the world and the first therapeutic antibody ever approved to treat multiple myeloma.

Data shows that multiple myeloma is the third most common blood cancer in the United States, where approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in 2015.

"This is an important day for patients in the United States with double refractory multiple myeloma, who will now have Darzalex as a new treatment option for this incurable disease," said Genmab CEO Jan van de Winkel.

The approval also raises Genmab's financial expectations for 2015, due to the inclusion of a milestone payment from its partner Janssen of 45 million U.S. dollars associated with the first commercial sale of the product in the United States.

The company now expects its revenue to be between 1.025 to 1.1 billion Danish kroner (160 million U.S. dollars), as against the earlier forecast of 725-800 million kroner.

Operating profits are expected to be in the range of 625 to 700 million kroner, up from the previously forecast of 325 to 400 million kroner.

Genmab's share price on Tuesday morning skyrocketed 11.2 percent after the first minutes of trading at the Copenhagen Stock Exchange following the announcement.

Founded in 1999, Genmab specializes in the creation and development of differentiated antibody therapeutics for the treatment of cancer. (1 U.S. dollar = 6.98 Danish kroner) Endit