Copenhagen, Denmark; December 16, 2004 – Genmab A/S (CSE:
GEN) announced today that HuMax™-CD20 has been designated a Fast Track
Product by the US Food and Drug Administration (FDA). This designation
covers patients with chronic lymphocytic leukemia (CLL) who have failed
fludarabine therapy. This patient group includes those who are
refractory to available treatment. HuMax-CD20 is currently in two Phase
I/II studies to treat CLL and Non-Hodgkin’s Lymphoma (NHL).
Fast Track Product status allows the FDA to facilitate the development and
expedite the review of a drug if it is intended for the treatment of a
serious or life-threatening condition, and if it demonstrates the potential
to address unmet medical needs for such a condition.
This fast track designation gives Genmab the opportunity to submit a
Biologics License Application (BLA) in sequential sections, and have these
sections reviewed as they are submitted, thus saving development time. A
BLA is the biologic products’ equivalent to a New Drug Application and is
the final stage before a drug is approved for the market by the FDA. Fast
track status also opens the possibility for receiving a priority review or
accelerated approval of the BLA where the review time would be halved to
just 6 months.
“The designation of HuMax-CD20 as a Fast Track Product recognizes the need
for new forms of treatment for patients suffering from CLL,” said Lisa N.
Drakeman, Ph.D., Chief Executive Officer at Genmab.
About HuMax-CD20
HuMax-CD20 is a human antibody which is effective at binding to the disease
target, and releases only very slowly from the target over time. In December 2004 Genmab presented
positive data from a Phase I/II trial with patients with relapsed or
refractory follicular lymphoma showing 55% of patients treated with
HuMax™-CD20 achieved a clinical response in the Phase I/II study, including
two complete responses and one unconfirmed complete response for a 27%
complete response rate. These responses were observed in 11 evaluable
patients among the first 15 of the 40 patients included in this study at
the week 11 evaluation point. Further details can be found in the press
release from December 4, 2004 on the press center site at www.genmab.com
About Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia is the most common leukemia in adults in the
US and most of Western Europe. The incidence is 8,100 to 12,500 new
cases in the US per year and 85-95% of the cases are of B-cell
origin. CLL is a subgroup of Non-Hodgkin’s lymphoma (NHL) and
together with small lymphocytic lymphoma (SLL) corresponds to around 20% of
all NHL cases.
Conference Call
A conference call will be held to discuss this news on Thursday, December
16 at
3:00 pm CET
2:00 pm GMT
9:00 am EST
The conference call will be held in English.
The dial in numbers are as follows:
+1 800 474 8920 (in the US) and ask for the Genmab conference call
+1 719 457 2727 (outside the US) and ask for the Genmab conference call