Genmab to Focused on Key Development Programs
Projects 2003 Cash Burn of DKK 345 Million
Copenhagen,
Denmark; November 13,
2002 – Genmab A/S (CSE: GEN and FSE: GE9D)
announced today a strategy update including financial guidance for 2003.
The company’s strategy update meeting will be webcast live today at 1530 CET/0930 Eastern on the Genmab
website www.genmab.com
Strategy
As a strategy to build its business, Genmab plans to access the value of
its human antibody portfolio through a combination of in-house clinical
development as well as outlicensing of both
early and late stage programs. In 2003, Genmab plans to advance six key
development programs through clinical trials. The company will also
identify some programs for strategic outlicensing. Genmab will continue to balance risk by
pursuing numerous opportunities to succeed, both by developing its own
products and through existing and potential partnerships. As part of this
strategy, the company will continue to focus on cost controls and work to
maximize the value of its existing products, technology and development
organization.
Financial Guidance
For 2003, Genmab’s board has approved an
operating budget of DKK 438 million (approximately $58 million US) compared
to an operating budget in 2002 of DKK 500 million (approximately $66
million US) and projects a cash burn of DKK 345 million (approximately $45
million US) for 2003. Based on this budget and the projected 2002 year end
cash figure of DKK 1.35-1.38 billion (approximately $178-182 million US),
the company expects to have approximately DKK 1.020 billion (approximately
$134 million US) at the end of 2003. Research and Development will make up
83% of the costs compared to 80% in 2002, with General and Administration
accounting for around 17% of the costs compared to 20% in 2002.
Focus Programs 2003
The following six programs will be the focus of in-house product
development activities during 2003 and Genmab projects reaching the
development stage indicated.
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Phase II for rheumatoid arthritis (RA).
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Phase IIb for psoriasis.
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Phase II for T-cell lymphoma.
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Phase I/II for head and neck cancer.
Production of
this
antibody is underway and clinical
material is expected to be delivered in 2003.
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Phase I/II for an autoimmune disease.
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Phase I/II for Non Hodgkin’s Lymphoma
(NHL).
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HuMax-IL15
Genmab has filed an Investigational New Drug application (IND) in Denmark
in order to start a Phase II trial using HuMax-IL15 for the treatment of
RA. The study will be a multi dose, double-blind, placebo-controlled trial
in patients with active RA who have previously failed one or more disease
modifying anti-rheumatic drugs (DMARDs).
Patients will receive doses of 40 mg, 80 mg, 160 mg or 280 mg of HuMax-IL15
or placebo once every two weeks for 12 weeks and will be followed for three
months after the final dose. The objective of the study is to demonstrate
efficacy as measured by the industry recognized ACR score as well as
safety.
Manufacturing
The lack of contract manufacturing capacity in the industry has eased
recently and Genmab has obtained access to manufacturing resources through
relationships with existing and new manufacturing partners. Planning and
building a facility would require a significant commitment to fixed costs
and, as the company wishes to maintain flexibility for future budget
planning, any plans to build a manufacturing facility in Hillerød, north of Copenhagen are postponed indefinitely.