May 23, 2012 -- Allergy Therapeutics plc (AIM: AGY), the fully integrated specialty pharmaceutical company, announces that it has been notified by Lincoln Medical Limited, the producer of Anapen® (adrenaline for injection), that they are undertaking a voluntary drug recall for all unexpired units of Anapen® in the UK, as a precautionary measure. Allergy Therapeutics has distribution rights for Anapen® in a number of countries.
Lincoln Medical has informed the UK MHRA that it has received no reports of defects or adverse events which may be associated with this issue.
The voluntary recall affects all doses of Anapen® and relates to a potential problem with delivery time and delivery volume of the dosage following activation of the auto-injector which has been identified during development work by Lincoln.
Allergy Therapeutics has so far launched the product in the UK & Ireland (in November 2011), The Netherlands (in July 2011) and Poland (in October 2011). Allergy Therapeutics recorded sales of Anapen® for the half year across all territories to December 2011 of £845,000, while total revenues for that period were £28.5m. Lincoln Medical is contractually required to reimburse the reasonable costs incurred by Allergy Therapeutics in assisting in a recall of Anapen®.
This recall will impact Allergy Therapeutics’ expected sales for the financial year ending June 2013. Lincoln is working closely with the MHRA to resolve the issues with a view to reinstating sales of the product as soon as possible. However at this time the Company is uncertain of the exact timing of such a reintroduction. The Company will continue to monitor the regulatory situation and confer with its local distributors in relevant jurisdictions.
Further updates will be provided when available from Lincoln.
No other Allergy Therapeutic products are affected by this notice.
For further information
Allergy Therapeutics +44 (0) 1903 845 820
Manuel Llobet, Chief Executive Officer
Ian Postlethwaite, Finance Director
Nomura Code Securities +44 (0) 207 776 1200
Clare Terlouw/Jonathan Senior
FTI Consulting +44 (0) 207 831 3113
Simon Conway /Jonathan Birt/ Susan Quigley/
About Allergy Therapeutics
Allergy Therapeutics is a specialty pharmaceutical company focused on allergy vaccination. It has a growing business achieving sales in the prior financial year of £42 million mainly in Europe through its own sales and marketing infrastructure and further afield through distributors. The Company is expanding its infrastructure into the Emerging Markets.