25th Jun 2015 07:40
LONDON (Alliance News) - Allergy Therapeutics PLC Thursday said it is to resume its US clinical development programme for its Pollinex Quattro Grass product, with trials scheduled for September.
In a statement, the pharmaceutical company said its move follows "productive discussions" with the US Food and Drug Administration, an agency within the US Department of Health and Human Services, which is responsible for ensuring that drugs and vaccines are safe for humans.
Pollinex Quatro is a subcutaneous seasonal allergy treatment. It is injected into people with an allergy to grass pollen.
"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 USD2 billion," Chief Executive Manuel Llobet said in a statement.
"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," Llobet said.
Allergy Therapeutics expects to submit a Biological Licence Application for Pollinex Quattro Grass for US regulatory approval in 2018, if the clinical development programme is a success.
Allergy Therapeutics shares were up 5.2% at 21.70 pence on Thursday morning.
By Samuel Agini; [email protected]; @samuelagini
Copyright 2015 Alliance News Limited. All Rights Reserved.
Related Shares:
Allergy Thera.