Novo Nordisk provides update on corporate strategy at its Capital
Markets Day
At its Capital Markets Day today, Novo Nordisk will present robust
progress in both the diabetes care and biopharmaceuticals pipelines,
an update on productivity improvements in manufacturing and an
overview of the company's current strategic position in core therapy
areas and markets.
Key highlights presented today will include:
* Plans for how to sustain and expand Novo Nordisk's current
protein franchises: insulin, GLP-1, NovoSeven® and Norditropin®
* New data from a 14-week extension of the LEAD(TM) 6 study
confirms promising profile of liraglutide
* Announcement of the intended brand name for liraglutide:
Victoza®
* Update on the general haemophilia strategy including
clinical activities with recombinant clotting factors VIII, IX and
XIII.
Lars Rebien Sørensen, president and CEO: "With the pipeline progress
we have achieved over the last couple of years, we are confident that
we have secured the long-term sustainability of our key franchises
within diabetes, the haemophilia inhibitor segment and growth
hormone. Importantly, we are also developing liraglutide for the
treatment of obesity, new coagulation factors for general
haemophilia, as well as new protein therapeutics within the area of
inflammation."
R&D highlights
Diabetes care and obesity
New data from a 14-week extension of the LEAD(TM) 6 phase 3b study
will be presented in addition to data from the entire phase 3a
programme on liraglutide (LEAD(TM) studies 1-5). After the initial 26
weeks of treatment with either liraglutide or exenatide in the
LEAD(TM) 6 study, 376 patients with type 2 diabetes entered a 14-week
non-randomised extension study where all patients received
liraglutide. Patients from the initial liraglutide treatment arm
continued previous treatment at an unchanged dose while patients from
the initial exenatide treatment arm were switched to liraglutide 1.8
mg once daily, following a two-week dose escalation period. Headline
data from the study showed that patients who switched from exenatide
to liraglutide experienced the following benefits which were all
statistically significant:
* reduction in HbA1c of 0.3 percentage points
* decrease in fasting plasma glucose of 0.9 mmol/L
* weight loss of approximately 1 kg
* reduction in systolic blood pressure of close to 4 mmHg
The tolerability profile of liraglutide was confirmed in the 14-week
extension.
The design of the phase 3b study comparing the effect of liraglutide
with sitagliptin, both in combination with metformin, will also be
presented. The study was initiated in June 2008 and headline results
from the first 26 weeks of the study are expected in the third
quarter of 2009.
The phase 3 programme for liraglutide in obesity is expected to be
initiated before the end of 2008 and will include 4,500-5,000
patients. One-year data from the study is expected in early 2011. The
phase 3 programme will, in accordance with US and European guidelines
for development of obesity drugs, investigate weight management in
obese subjects, but also explore a potential delay in onset of
diabetes, weight management in type 2 diabetes as well as prevention
of weight regain.
In addition, Novo Nordisk will provide an update on the clinical
development of the next-generation insulins. Phase 2 programmes in
both type 1 and type 2 diabetes for the next-generation insulins,
NN1250 and NN5401, are now expected to be finalised before the end of
2008. Results from the phase 2 studies are expected to be presented
in the first quarter of 2009.
Biopharmaceuticals
An updated strategy for haemophilia A and B will be presented and the
clinical highlights are:
* A phase 1 study with a recombinant factor VIII compound is
expected to be initiated before the end of 2008
* A phase 1 study with a long-acting recombinant factor IX compound
is expected to be initiated in 2009
* Novo Nordisk has a longer-term aspiration to develop a
long-acting recombinant factor VIII compound.
An update of Novo Nordisk's strategy for NovoSeven® and recombinant
factor VIIa (rFVIIa) analogues will also be presented. The key
clinical highlights are:
* The phase 2 study with NN1731, a fast-acting rFVIIa analogue, is
still expected to be completed in the second half of 2009
* The phase 1 study with a long-acting rFVIIa derivative, NN7128,
has completed phase 1 and a phase 2 study is expected to be
initiated in 2009
* A subcutaneous version of rFVIIa is currently in phase 1 and a
new phase 1 study is planned for subcutaneous administration of
NN7128
* No further activities for rFVIIa within critical bleedings are
currently planned.
In relation to factor XIII, Novo Nordisk will present:
* The design of a phase 3 study investigating recombinant factor
XIII within congenital factor XIII deficiency. This study was
initiated in August 2008
* A phase 2 study with recombinant factor XIII within prevention of
bleeding in cardiac surgery, expected to be initiated in 2009.
Within the area of human growth hormone, Novo Nordisk will present
its plans for label expansions as well as the clinical progress for a
long-acting human growth hormone compound which is currently in phase
2 clinical development. The phase 3 study for the use of Norditropin®
for the treatment of dialysis patients is now expected to be
completed in 2012 due to slower than anticipated recruitment of
patients.
Novo Nordisk will provide an update on the progress within the area
of inflammation research. The update will include an overview of Novo
Nordisk's core capabilities within inflammation as well as an
announcement of the two first phase 1 studies within inflammation.
Operations highlights
Novo Nordisk will present key productivity improvements within global
manufacturing and give an update on globalisation of production. The
presentation will include examples of productivity improvements in
upstream production of insulin crystals in Denmark and downstream
manufacturing at key production sites in Denmark, France, Brazil and
the United States. The update will also include information on a new
set-up for device production with a focus on globalisation and
sourcing of production.
The update on global sales and market dynamics for Novo Nordisk's key
products will include details on the market performance of the modern
insulins, NovoSeven® and Norditropin® as well as a review of the
potential for the strategic products. Focus will be on the following
areas:
* Modern insulin performance
* Next Generation FlexPen® launch
* Review of the GLP-1 market potential and high-level launch plan
for liraglutide including the intended brand name: Victoza®
* Strategy for market entry into general haemophilia
Finally, Novo Nordisk will give an update on the market potential in
the US and in International Operations with a special focus on China.
The above communication does not impact Novo Nordisk's expectations
for the company's financial results for 2008, which were provided on
7 August in connection with the release of the financial results for
the first six months of 2008.
Novo Nordisk is a healthcare company and a world leader in diabetes
care. 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 26,550
employees in 80 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.
Further information:
Media: Investors:
Mike Rulis Mads Veggerby Lausten
Tel: (+45) 4442 3573 Tel: (+45) 4443 7919
E-mail: mike@novonordisk.com E-mail: mlau@novonordisk.com
Hans Rommer
Tel: (+45) 4442 4765
E-mail: hrmm@novonordisk.com
In North America:
Sean Clements
Tel: (+1) 609 514 8316
E-mail: secl@novonordisk.com
Company Announcement no 61 / 2008