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Biotech / Medical : HuMAB companies
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To: nigel bates who started this subject4/22/2002 8:51:58 AM
From: nigel bates   of 1022
 
Danish Genmab/CEO Sees HuMax-CD4 On Sale in 2004
COPENHAGEN -(Dow Jones)- Danish biotechnology company Genmab A/S (K.GEM) expects to launch its rheumatoid arthritis drug HuMax-CD4 in late 2004, Chief Executive Lisa Drakeman said Monday.
In an interview with Dow Jones Newswires, Drakeman said she expects Genmab to file an application for HuMax-CD4 with the U.S. Food & Drug Administration in 2004.
HuMax-CD4 will be given to patients with rheumatoid arthritis who fail to respond to standard treatments.
"An approval would allow Genmab to start selling HuMax-CD4 later that year," she said.
In February, the FDA granted HuMax-CD4 Fast Track Product status, allowing the application priority and cutting the review process to six months.
Drakeman also said she expects Genmab to ask the FDA in 2005 to aprove the use of HuMax-CD4 in other rheumatoid arthritis patients.
But she said the initial approval of HuMax-CD4 will probably lead doctors in the U.S. to prescribe the product to other patients on a so-called off-label basis even before the broader approval is received.
Drakeman also said Genmab is forecast to generate a revenue in 2002, the first time since its establishment in 1999.
"We expect revenue in the form of small milestone payments from Roche," she said.
Switzerland 's Roche Holding AG (Z.ROC) and Genmab are collaborating to develop human antibodies for disease targets identified by Roche.
Company Web site genmab.dk
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