UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 6-K
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REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
September 26, 2008
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NOVO NORDISK A/S
(Exact name of Registrant as specified in its charter)
NOVO ALLE
DK-2880, BAGSVAERD
DENMARK
(Address of principal executive offices)
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Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F
Form 20-F [X] Form 40-F [ ]
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes [ ] No [X]
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g-32(b):82-_____________________
RESEARCH UPDATE
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(R) and Norditropin(R)
* 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(R)
* Update on the general haemophilia strategy including clinical activities
with recombinant clotting factors VIII, IX and XIII.
Lars Rebien S0rensen, 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(R) 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(R) 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(R) and Norditropin(R) 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(R) launch
* Review of the GLP-1 market potential and high-level launch plan for
liraglutide including the intended brand name: Victoza(R)
* 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
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf of the
undersigned, thereunto duly authorized.
Date: September 26, 2008 NOVO NORDISK A/S
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Lars Rebien Sorensen,
President and Chief Executive Officer