Allergy Therapeutics (AGY), the specialist pharmaceutical company focused on allergy vaccination, has submitted its Pollinex Quattro Grass dossier for regulatory approval in the European Union (EU).
The dossier has been submitted to the German Regulatory authority, the Paul Ehrlich Institut (PEI), recognised to be the European authority most expert in the allergy vaccine field. The PEI has agreed to act as 'Reference Member State' for Europe-wide registration under the European Union Mutual Recognition Procedure (MRP). Following the German national phase, which is expected to take approximately one year, the MRP will commence.
In the initial phase of MRP, the company has elected to apply for authorisation in the markets with the greatest revenue potential for Pollinex Quattro and, if the submission to the PEI is successful, approvals could be expected from 2010 with launches taking place in these countries across the following two years.
This is the first submission for an injected therapeutic allergy vaccine aimed at EU-wide approval and marks the culmination of a development programme in which the company has invested more than £20 million over several years. The submission follows the positive outcome, announced last year, of Allergy Therapeutics' Pollinex Quattro Grass phase-III study, G301, the largest controlled allergy vaccine study ever conducted. The study met its primary efficacy endpoint and demonstrated that Pollinex Quattro has significant clinical benefits over placebo.
Keith Carter, chief executive of Allergy Therapeutics, said, "Injected vaccines are the preferred immunotherapy option for allergy specialists because of the excellent compliance levels. As the injections are controlled by the physicians, they can ensure that the patients receive a full course of therapy. This is especially the case with Pollinex Quattro because of the ultra short four-shot dosing course."
Completion of the regulatory process in the EU will open up new markets as well as enabling us to improve pricing and market share in those European countries where named patient sales are currently already possible.
"Pollinex Quattro Grass has already been through the most rigorous clinical evaluation of any allergy vaccine, delivering clear efficacy benefits as well as excellent levels of tolerability. We look forward to progressing the EU mutual recognition process," said Carter.
"The development of a pharmaceutical from the pre-clinical stage to registration application by a single company, unpartnered, is a rare achievement in any market. For a small life sciences company to do so in a major disease is a first ever achievement in the United Kingdom biotech industry and represents a significant milestone for Allergy Therapeutics," Carter added.
Prof Chris Corrigan, Department of Asthma, Allergy & Respiratory Science at King's College London School of Medicine, Guy's Hospital, said, "The submission of Pollinex Quattro Grass brings closer the day when this ultra short course allergy vaccine will become widely available to patients and their physicians."
Pollinex Quattro is a four injection therapeutic vaccine for the treatment of allergic conditions which offers same season relief in as little as three weeks after treatment.
Allergy vaccination or immunotherapy is an effective way of modifying or avoiding disease by influencing the immune system.
Allergy Therapeutics plc is a London Stock Exchange (AIM) listed, integrated specialist pharmaceutical company focused on allergy vaccination.