Genmab A/S, a Danish therapeutic human antibody development firm, continued its progress toward the front rank of European biotechnology companies by receiving FDA clearance to commence its first Phase III clinical trial, in patients with active rheumatoid arthritis who have failed to respond to treatment with methotrexate and TNF-alpha blocking agents.
¿It is a huge step,¿ Genmab CEO Lisa Drakeman told BioWorld International. ¿It accelerates our development timetable by at least a year.¿ Analysts originally forecasted market approval for Genmab¿s first product in 2005 or 2006, she said. ¿We are now targeting 2004.¿
The Copenhagen-based company now has a product pipeline extending from the preclinical through Phase III stages. It joins an ¿elite¿ band of just five or six European firms with a similar position, Drakeman said. ¿None of them has done it in two and a half years,¿ she added. By next year, Genmab will have five programs in the clinic, 10 more at the preclinical stage and additional projects under evaluation. HuMax-CD4 also is undergoing Phase II trials for psoriasis.
The company is moving immediately to its Phase III study, which will take place in 50 centers across the U.S. and Europe. ¿We plan to initiate centers in December and start enrolling patients this month,¿ Drakeman said.
Genmab plans to recruit 400 patients between now and the end of next year, each of whom will receive either 80 mg or 160 mg of HuMax-CD4, or placebo, over 26 weeks. This is the first long-term study of the antibody product. The majority of the 200 participants in earlier trials received multiple doses, but over shorter time frames.
Genmab will perform an interim analysis of the efficacy data, which will feed into the design of an additional Phase III trial of the broader indication of moderately to severely diseased RA patients. The company plans to commence this study early in 2003.
But the refractory RA marketplace is itself substantial. According to Genmab estimates, based on clinical trial data and information from clinical practice, around half of RA patients fail to respond to TNF-alpha inhibitors. ¿I think the FDA was interested in this study because there is such an urgent medical need,¿ Drakeman said.
Genmab has yet to find a partner for this program, but is in no particular hurry to do so. ¿Because we are so well funded we can definitely afford the cost of this study,¿ Drakeman said. The company had US$203.6 million in cash at the end of the third quarter. It is examining all its options, however. ¿We will consider what the partnering universe looks like,¿ she said. But it has not ruled out a solo strategy, either. ¿This is a specialty product. We could market this in the U.S. with 200 to 300 salespeople,¿ she said.