BioWorld International Correspondent
Despite receiving fast-track status from the FDA, Danish firm Genmab A/S is sticking to current projections for its HuMax-CD4 treatment for patients with active rheumatoid arthritis who do not respond to current treatment.
“We would say we would hold to our timescale that we will be on the market in 2004,” Rachel Gravesen, vice president for investor relations and public relations at Genmab, told BioWorld International.
However, depending on progress of Phase III trials, the Copenhagen-based company could cut in half the time required for review of its biologics license application. “It opens up the possibility that the BLA may be accelerated,” Gravesen said. The company, it stated, will be permitted to file its BLA in sequential sections and have them reviewed as they are submitted, thereby saving development time.
HuMax-CD4 is a fully human monoclonal antibody, developed using the HuMab-Mouse system Genmab licensed from parent firm Medarex Inc., of Princeton, N.J. It targets the CD4 receptor on T lymphocytes, which is linked to the inflammatory cascade that leads to rheumatoid arthritis.
The drug entered Phase III trials in December in patients with active rheumatoid arthritis who do not respond to treatment with methotrexate and TNF-alpha blocking agents. (See BioWorld International, Dec. 19, 2001.)
“We expect to end the recruitment process for 400 patients in December of this year,” Gravesen said, but she would not outline the expected time for initiating the BLA.
HuMax-CD4 is Genmab’s lead program. In addition to the current study, a Phase III trial of the drug in the broader indication of moderately to severely diseased RA patients is slated to begin early next year. The company is keeping its options open with respect to finding a partner for HuMax-CD4. “We have not finalized our strategy about what we are going to do with HuMax-CD4 yet,” Gravesen said.
Earlier this month, Genmab reported a net loss of DKK168.7 million (US$20.1 million) and revenues of DKK81.9 million for 2001. The company exited the year with DKK1.6 billion in cash.