RESEARCH UPDATE
NOVO NORDISK'S CAPITAL MARKETS DAY 2004
SOLIDIFYING THE POSITION AS A LEADER WITHIN THERAPEUTIC PROTEINS
At its 2004 Capital Markets Day today Novo Nordisk will elaborate on its
biopharmaceuticals businesses, which are focused on attractive market segments,
all characterised by unmet medical needs and growth opportunities.
Highlights from the day will include:
* Insight into a broad range of protein research and development
programmes - focusing on projects within haemostasis management and
immunotherapy of cancer and inflammation.
* Confirmation that Novo Nordisk still expects to file for
approval of rFVIIa for the use in patients experiencing a blunt trauma
in Europe in the first quarter of 2005 - and that a study for the use
of rFVIIa in trauma patients in the US is on track to start early next
year.
* Mentioning that Novo Nordisk still expects to update the
financial market about the regulatory process with regard to the use of
rFVIIa in connection with intracerebral haemorrhage, later this year.
* Announcement of the initiation of a clinical phase 2 study for
the use of rFVIIa in patients undergoing cardiac surgery.
* Announcement of the initiation of an exploratory clinical phase
2 study for the use of rFVIIa in patients with traumatic brain injury.
* Announcement of the initiation of a phase 1/2 study with IL-21
for the use in cancer (malignant melanoma) in Australia.
* Insight into a new in-licensed protein, recombinant factor XIII
(rFXIII). The global rights to the intellectual property portfolio, the
development and the marketing of the protein have been in-licensed from
ZymoGenetics, Inc.
The known mechanism of FXIII for stabilising blood clots indicates that
FXIII alone or in combination with other therapy might become an
interesting new opportunity within haemostasis management.
With the extensive in-house protein experience, Novo Nordisk expects to
be able to bring rFXIII to the market for the benefit of FXIII
deficient patients. However, various settings of critical bleeding in
other patient groups as well as combination therapy with rFXIII and
rFVIIa, add to the rFXIII potential. Novo Nordisk will pay ZymoGenetics
USD 15 million upon signing and up to USD 62 million in milestone
payments as well as pay royalty on potential products containing
rFXIII.
* Details of the preclinical biopharmaceuticals pipeline, where
seven projects within cancer and inflammation are highlighted. Of
these, several are expected to enter clinical trials within the next
1-3 years.
* Further insight into the part of the preclinical
biopharmaceuticals pipeline related to haemostasis - six projects are
highlighted. All six projects are built on the properties of rFVIIa,
and several are expected to enter clinical development within the next
1-3 years.
President and chief executive officer of Novo Nordisk, Lars Rebien
S0rensen said: "The projects we are presenting today provide us with a
robust platform for further strengthening our leadership position
within therapeutic proteins, and are key for the company to continue to
deliver solid growth rates."
At 8:30 CET today, corresponding to 7:30 UK time, the Capital Markets
Day will be webcast. Investors will be able to listen in via a link on
novonordisk.com, which can be found under 'Investors - Investor
Presentations'. Presentation material for the webcast will be made
available on the same page.
The above highlights from the Capital Markets Day do not change Novo
Nordisk's expectations for the financial results for 2004.
About IL-21
The phase 1/2 study, which will be conducted in Melbourne, Australia,
is a dose-escalation study in patients with stage IV malignant
melanoma.
The primary end points in the early clinical development programme are
safety and tolerability. In addition, significant resources will be
allocated to identification of biomarkers that hopefully will allow the
selection of dosing schedule(s) and doses of IL-21 that have
significant anti-tumour effects. The effect of IL-21 on tumour size
will be an important end point in trials following the phase 1/2 study.
About cardiac surgery
Intra-operative and postoperative bleeding, which might result from
inadequate surgical haemostasis, coagulopathic bleeding, or combination
hereof, is a complication in many patients undergoing cardiac surgery
and/or coronary artery bypass graft surgery (CABG). It may result in
increased post-operative morbidity and mortality as transfusion can
alter long-term survival after cardiac operation. Type of surgical
procedure performed and duration of cardiopulmonary bypass (CPB)
influence, for example, the dilution of coagulation factors and
fibrinolytic activity altering the risk of post-operative bleeding and
need for transfusion. Given the limited effectiveness of existing
management options, new therapies are urgently needed.
Novo Nordisk has now initiated a multicentre, multinational,
randomised, double-blind, placebo-controlled, dose escalation trial on
safety and efficacy. The study will have three dosing tiers, 70
patients in each, with the active arms being 40, 80, and 160 ug/kg bw,
respectively, to be administered as a single bolus injection.
About traumatic brain injury
Traumatic brain injury (TBI) occurs as a result of a sudden injury to
the head. TBI is defined as the presence of focal lesions of low, mixed
or high density on CT examination. TBI is most commonly caused by road
traffic accidents and is primarily affecting younger men.
Novo Nordisk has initiated an explorative multi-centre, multi-national,
randomised, double-blind, placebo-controlled, dose escalation trial on
safety and efficacy with patients experiencing a TBI. Injuries from
penetrating objects such as gun shots and knives are not included in
the definition of TBI.
Each subject will receive a single intravenous injection with either
active drug or placebo within 5 hours of injury. The doses are divided
into five dose tiers of 40, 80, 120, 160 and 200 ug/kg.
About recombinant factor FXIII
ZymoGenetics has been developing rFXIII for the prevention and
treatment of bleeding complications and abnormalities in blood clotting
associated with FXIII deficiency. FXIII is the terminal enzyme in the
clotting cascade and is responsible for stabilising blood clots. Its
primary function is to crosslink individual fibrin molecules into a
strong fibrin mesh.
ZymoGenetics has completed phase 1 studies to evaluate the safety and
pharmacokinetics of rFXIII in patients with congenital FXIII
deficiency, a rare disease affecting approximately 100 individuals in
the United States, as well as in healthy volunteers. Individuals who
are born with congenital FXIII deficiency are usually diagnosed within
hours of birth and have a high risk of bleeding into the brain and in
soft tissues. Acquired FXIII deficiencies may occur in people born with
normal levels of FXIII following trauma, various surgical procedures
(such as cardiopulmonary bypass) or as a result of a disease process
(such as graft versus host disease of the gut and ulcerative colitis).
FORWARD-LOOKING STATEMENTS
The above sections contain forward-looking statements as the term is
defined in the US Private Securities Litigation Reform Act of 1995.
Forward-looking statements provide current expectations or forecasts of
events such as new product introductions, product approvals and
financial performance. Such forward-looking statements are subject to
risks, uncertainties and inaccurate assumptions. This may cause actual
results to differ materially from expectations. Factors that may affect
future results include interest rate and currency exchange rate
fluctuations, delay or failure of development projects, production
problems, unexpected contract breaches or terminations,
government-mandated or market-driven price decreases for Novo Nordisk's
products, introduction of competing products, Novo Nordisk's ability to
successfully market both new and existing products, exposure to product
liability and other lawsuits, changes in reimbursement rules and
governmental laws and related interpretation thereof, and unexpected
growth in costs and expenses.
Risks and uncertainties are further described in reports filed by Novo
Nordisk with the US Securities and Exchange Commission (SEC) including
the company's Form 20-F, which was filed on 27 February 2004. Please
also refer to the section 'Management of risk in Novo Nordisk' in the
Annual Financial Report 2003. Novo Nordisk is under no duty to update
any of the forward-looking statements or to conform such statements to
actual results, unless required by law.
Novo Nordisk is a healthcare company and a world leader in diabetes
care. The company has the broadest diabetes product portfolio in the
industry, including the most advanced products within the area of
insulin delivery systems. In addition, Novo Nordisk has a leading
position within areas such as haemostasis management, growth hormone
therapy and hormone replacement therapy. Novo Nordisk manufactures and
markets pharmaceutical products and services that make a significant
difference to patients, the medical profession and society. With
headquarters in Denmark, Novo Nordisk employs approximately 19,600
full-time employees in 69 countries, and markets its products in 179
countries. Novo Nordisk's B shares are listed on the stock exchanges in
Copenhagen and London. Its ADRs are listed on the New York Stock
Exchange under the symbol 'NVO'. For more information, visit
novonordisk.com.
For further information please contact:
Media: Investors:
Outside North America: Outside North America:
Mike Rulis Mogens Thorsager Jensen
Tel (direct): Tel (direct):
(+45) 4442 3573 (+45) 4442 7945
Palle Holm Olesen
Tel (direct):
(+45) 4442 6175
Peter Haahr
Tel: (+45) 3079 1207
In North America: In North America:
Susan T Jackson Christian Kanstrup
Tel (direct): Tel (direct):
(+1) 609 919 7776 (+1) 609 919 7937
Stock Exchange Announcement No 57 / 2004