Du är här

2015-08-26

Novo Nordisk A/S: Novo Nordisk to initiate phase 3a development of oral semaglutide, a once-daily oral GLP-1 analogue

Bagsværd, Denmark, 26 August 2015
- Novo Nordisk today announced the decision to initiate a phase 3a programme
with oral semaglutide; a once-daily oral formulation of the long-acting GLP-1
analogue semaglutide. The decision follows the encouraging results of the
proof-of-concept phase 2 trial announced on 20 February 2015 and the
subsequent consultations with regulatory authorities.

Novo Nordisk intends to initiate a global phase 3a programme, named PIONEER,
comprising seven trials with approximately 8,000 people with type 2 diabetes.
The PIONEER programme will include six safety and efficacy trials and one
trial for evaluating the cardio-vascular safety of oral semaglutide. The
first trial in the programme is planned for initiation in first quarter of
2016 and will investigate the efficacy and safety of once-daily oral
semaglutide doses of 3 mg, 7 mg and 14 mg, compared to once-daily oral
anti-diabetic sitagliptin dose of 100 mg. The remaining six trials of the
PIONEER programme are all expected to be initiated during 2016.

In order to meet capacity requirements for current and future diabetes care
products, including oral semaglutide, Novo Nordisk expects to invest an
estimated 2 billion US dollars over the coming five years in two new
production facilities; a new production facility for a range of active
pharmaceutical ingredients in Clayton, North Carolina, US and a new
drug-product facility in Måløv, Denmark. The final design and cost of the new
production facilities will be presented for approval by the company's board
of directors in 2016.

"Delivering protein-based medicine like semaglutide in the form of a tablet
and producing it on a large scale is a major challenge, and with the
announcement today we have reached a significant milestone towards achieving
that goal", said Mads Krogsgaard Thomsen, executive vice president and chief
science officer of Novo Nordisk. "We are excited about the opportunities oral
semaglutide represents as a new oral anti-diabetic agent to further improve
type 2 diabetes treatment".

About semaglutide Semaglutide (NN9924) is a new glucagon-like peptide-1 (GLP-1) analogue that
can help people with type 2 diabetes achieve substantial lowering of blood
glucose with a low risk of hypoglycaemia. In addition, semaglutide induces
weight loss by decreasing appetite and food intake. The oral formulation of
semaglutide is provided in a tablet formulation with SNAC, an
absorption-enhancing excipient included in the Eligen®Carrier Concept. The
Eligen®technology is licenced from Emisphere Technologies, Inc.

Further information

---------------------------------------------------------------------
| Media: |
| Katrine Sperling +45 3079 6718 krsp@novonordisk.com |
| Ken Inchausti (US) +1 609 514 8316 kiau@novonordisk.com |
| Investors: |
| Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com |
| Daniel Bohsen +45 3079 6376 dabo@novonordisk.com |
| Melanie Raouzeos +45 3075 3479 mrz@novonordisk.com |
| Frank Daniel Mersebach (US) +1 609 235 8567 fdni@novonordisk.com |
---------------------------------------------------------------------
Company announcement No 52 / 2015

Company announcement No 52 / 2015
http://hugin.info/2013/R/1947638/707250.pdf

---------------------------------------

This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novo Nordisk A/S via Globenewswire

HUG#1947638

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.