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

   

Allergy Therapeutics plc: FDA Clinical Hold Lifted


8/3/2012 10:28:01 AM

August 03, 2012 -- Allergy Therapeutics plc, (AIM: Allergy or the “Company”), the specialist pharmaceutical company focused on allergy vaccination, today announces that the FDA has confirmed that the clinical hold in the US dated 2007 has now been lifted on the Company’s grass pollen allergy vaccine (Grass MATA MPL/ Pollinex® Quattro Grass 0.5ml) clinical development programme, with immediate effect. Allergy has gained approval to progress with a Phase III efficacy study, to be conducted in an Environmental Exposure Chamber (“EEC”). The Company is now focused on securing a partner to commercialise Pollinex Quattro in the US.

Allergy is planning to progress phase III development of their ultra short course allergy vaccines in the US. These ‘four shot’ products are based on the adjuvant MPL®, the Company's innovative TLR4-agonist which acts to stimulate and re-direct the immune response. The Pollinex Quattro allergy vaccines, which are already commercialised in a number of European countries under a named patient basis, require only four injections per year and have the potential to transform allergy treatment in the US, providing a convenient, safe, and effective vaccination to allergic rhinitis sufferers.

The FDA’s decision to lift the clinical hold marks an important step in the development of Pollinex Quattro for the treatment of grass allergy in the US.

Manuel Llobet, Chief Executive Officer, commented:

“We are pleased that the FDA has decided to lift the clinical hold on our Pollinex Quattro programme. This product has the potential to greatly benefit allergy sufferers in the US in the absence of registered products by being the first subcutaneous immunotherapy vaccine to reach the US market. Additionally, lifting of the hold will allow for discussions with potential partners with whom we will finalise the clinical development and start the commercialisation of Pollinex Quattro in a market estimated to be around US$ 2 billion.”

Lawrence DuBuske MD, Clinical Professor of Medicine at George Washington University School of Medicine, Washington, DC, principal investigator for the previous phase III study (G301) of the Company’s Grass MATA MPL product, the largest ever allergy immunotherapy study to be undertaken, commented:

“Grass MATA MPL could revolutionise treatment for grass related allergic rhinitis in the US by providing effective, fast-acting treatment to allergy sufferers. The product involves four pre-seasonal allergy vaccine injections administered over a month, making it an attractive alternative to the prolonged course of weekly to monthly injections over three years that is currently available with the allergen extract vaccines used in the United States. There are many patients who decline injections offered by allergists, due to the time commitment and safety concerns when using the typical allergen vaccines

For further information

Allergy Therapeutics

+44 (0) 1903 845 820

Manuel Llobet, Chief Executive Officer

Ian Postlethwaite, Finance Director

www.allergytherapeutics.com

Nomura Code Securities

+44 (0) 207 776 1200

Juliet Thompson/ Clare Terlouw

FTI Consulting

+44 (0) 207 831 3113

Simon Conway/ Susan Stuart/ Victoria Foster-Mitchell



Read at BioSpace.com

   

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