BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Novo Nordisk A/S (NVO) Halts Development of Hemophilia Drug


9/28/2012 9:44:26 AM

September 28, 2012 - Novo Nordisk today announced the decision to discontinue the development ofvatreptacog alfa, a fast-acting recombinant factor VIIa analogue for haemophilia patients with inhibitors. The decision follows analysis of the data from the phase 3a trial adeptTM 2. On 9 August, Novo Nordisk announced that a few patients in the trial had developed anti-drug antibodies to vatreptacog alfa, one patient with a potentially neutralising effect.

In the blinded adept™2 trial, 72 haemophilia patients with inhibitors were treated. Patients were treated on demand with either vatreptacog alfa or NovoSeven® in random sequence as bleedings occurred. In total, 567 bleeding episodes were treated.

The trial demonstrated that both vatreptacog alfa and NovoSeven® can stop a very high percentage of bleeding episodes, 93%, with three doses or less. However, a few patients developed anti-drug antibodies to vatreptacog alfa, including one patient with a potentially neutralising effect in one sample. Some of these patients also developed cross-binding antibodies to NovoSeven®. None of the antibodies were inhibitory and the patients responded well to treatment during the course of the trial.

In contrast to the findings for vatreptacog alfa, anti-drug antibodies have not previously been reported for NovoSeven® when used for haemophilia patients with inhibitors to factor VIII and IX. Consequently, the observation of anti-drug antibodies and the potential risks hereof for haemophilia patients with inhibitors has led Novo Nordisk to discontinue further development of vatreptacog alfa.

About vatreptacog alfa and adeptTM 2

Vatreptacog alfa is a fast-acting recombinant FVIIa analogue discovered and developed by Novo Nordisk. Vatreptacog alfa was intended as an improved bypassing agent providing safe, rapid and sustained resolution of bleeds in patients with haemophilia and inhibitors.

Structurally, three amino acid substitutions have been made to vatreptacog alfa compared with native FVIIa, to enhance platelet-dependent enzymatic activity, which makes vatreptacog alfa more than 99% homologous with native FVIIa.

Adept™2 is the largest double-blinded, randomised, controlled trial ever conducted with bypassing agents in haemophilia patients with inhibitors to FVIII or FIX. The trial was a global trial with participating haemophilia treatment centres from Africa, Asia, Europe, North and South America.

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries. Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com.

Media:

Investors:

Mike Rulis

Kasper Roseeuw Poulsen

Tel: (+45) 3079 3573

Tel: (+45) 4442 4303

mike@novonordisk.com

krop@novonordisk.com

Frank Daniel Mersebach

Tel: (+45) 4442 0604

fdni@novonordisk.com

Lars Borup Jacobsen

Tel: (+45) 3075 3479

lbpj@novonordisk.com

In North America:

Ken Inchausti

Jannick Lindegaard

Tel: (+1) 609 514 8316

Tel: (+1) 609 786 4575

kiau@novonordisk.com

jlis@novonordisk.com



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES