Allergy Therapeutics PLC Company to resume US clinical programme (1578R)
June 25 2015 - 2:00AM
UK Regulatory
TIDMAGY
RNS Number : 1578R
Allergy Therapeutics PLC
25 June 2015
25 June 2015
Allergy Therapeutics plc
("Allergy Therapeutics" or "the Company")
Company to resume US clinical development programme
Allergy Therapeutics, the fully integrated specialty
pharmaceutical company specialising in allergy immunotherapy, today
announces that following productive discussions with the US Food
and Drug Administration ("FDA") regarding the US clinical
development of Pollinex(R) Quattro Grass MATA MPL, the Company has
submitted its clinical trial protocols to the FDA. The trials are
scheduled to start in September 2015. In addition, the Company has
engaged Inflamax Research Inc., the contract research organisation
specialising in mobile environmental exposure chambers ("mECC(TM)
"), to run the studies. Pollinex Quattro Grass could be the first
subcutaneous seasonal allergy treatment to receive regulatory
approval in the US, as well as being the Company's first product to
be approved for the US market. The US allergy immunotherapy market
is estimated to be c$2 billion.
The Company is resuming its clinical development programme of
Pollinex Quattro Grass in the US following successful Phase I, II
and III programmes, having invested US$100 million to date in its
Pollinex Quattro product pipeline. In March 2015, Allergy
Therapeutics raised GBP20 million to fund the final phase of US
clinical development of Pollinex Quattro Grass through to FDA
regulatory approval.
The Company anticipates that it will submit a Biological Licence
Application ("BLA") for Pollinex Quattro Grass for US regulatory
approval in 2018, assuming the successful completion of the
remaining clinical development programme. Following input on trial
design from the FDA, the Company will initially conduct a small
safety study, immediately followed by a Phase IIb study this year,
before progressing into a pivotal Phase III study in 2016.
Manuel Llobet, Chief Executive Officer, commented:
"This is an important and long-awaited milestone for Allergy
Therapeutics and I want to thank our investors for their continued
support and patience.
"Pollinex Quattro Grass could be the first licensed seasonal
subcutaneous immunotherapy allergy treatment, authorised for sale
in the US, with the US allergy immunotherapy market estimated at $2
billion. We therefore view the prospects for Pollinex Quattro as
transformational for the Company and we look forward to making a
significant contribution to improving the lives of millions of US
allergy sufferers."
-Ends-
For further information:
Allergy Therapeutics +44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Ian Postlethwaite, Finance Director
Panmure Gordon +44 (0) 20 7886 2500
Freddy Crossley / Peter Steel / Duncan Monteith,
Corporate Finance
Tom Salvesen, Corporate Broking
FTI Consulting +44 (0) 20 3727 1000
Simon Conway
Victoria Foster Mitchell
Note to editors
About Allergy Therapeutics
Allergy Therapeutics is a specialty pharmaceutical company
focused on allergy vaccination. It has a growing business achieving
revenue in the last financial year of GBP42 million mainly in
Europe through its own sales and marketing infrastructure and
further afield through distributors.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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