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® 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™”), 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 £20 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.”
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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 £42 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors.
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