SubscribeErwinase® (crisantaspase), the L-asparaginase derived from Erwinia chrysanthemi, approved and available in UK for the treatment of acute lymphoblastic leukaemia.
OPi, Pharmaceuticals for Rare Diseases, and the Health Protection Agency (HPA) announce today that Erwinase® (crisantaspase), L-asparaginase derived from Erwinia chrysanthemi, has been launched in the UK for the treatment of acute lymphoblastic leukaemia and of some other malignant haemopathies. The commercialisation of Erwinase® in the UK is managed by OPi Ltd, OPi’s wholly owned and newly created subsidiary.
This follows the announcement on August 30, 2005 of a world-wide licensing agreement between OPi and the HPA, whereby OPi was being granted world-wide exclusive rights to market Erwinase®, manufactured by the HPA in its recently upgraded Porton Down facility.
Since then, the HPA and OPi have actively collaborated to obtain regulatory approval from the Medicines and Healthcare products Regulatory Agency (MHRA) and to prepare commercialisation in the UK.
“We are very pleased to have achieved our goal to make Erwinase® available to UK medical teams and patients before the end of 2005 as planned. This product is intended to fulfil an important medical need, especially in patients suffering from acute lymphoblastic leukaemia who are sensitized to currently available L-asparaginases” said Gilles Alberici, PhD, President and Founder of OPi Group. “We also welcome Tim Brady on board as General Manager of OPi Ltd, and wish our UK subsidiary the best success in its mission” he added.
All L-asparaginases currently used as front-line therapy for the treatment of acute lymphoblastic leukemia are derived fromEscherichia coli. However, 15 to 30% of patients treated with these E. coli-derived L-asparaginases develop allergic reactions and several medical and scientific reports have demonstrated that a significant proportion of patients develop neutralizing antibodies that may decrease the effectiveness of the treatment.
Since crisantaspase primary sequence differs from that of all other available L-asparaginase preparations, Erwinase® appears to be the most appropriate therapeutic option for the significant proportion of patients sensitised to Escherichia coliL-asparaginases.
“This Erwinase® UK launch is the first step of our rolling program to make this and other OPi products available internationally” indicated Thierry Abribat, PhD, Chief Executive Officer of OPi. “We are notably looking forward to extending Erwinase® commercialisation in the other European countries and in North America as next steps, in parallel to the ongoing expansion of OPi’s international presence”.
Roger Hinton, PhD, Business Development Manager for the HPA commented “We are delighted that our partners have moved swiftly to bring the product to market and we believe that our joint efforts will make Erwinase® a success”.
Erwinase® (crisantaspase) is an enzymatic anti-neoplastic agent indicated in the treatment of acute lymphoblastic leukemia and of some other malignant haemopathies. It exerts its hydrolytic action on L-asparagine, an amino acid which cannot be synthesized by certain types of cells, in particular blast cells, resulting in the death of the tumour cells.
Used in combination with other cytostatic drugs, L-asparaginases are a key part of the therapeutic strategy for acute lymphoblastic leukemia, a haematological malignancy affecting both adults and children with a world-wide incidence of approximately 80,000 patients.
For complete information on Erwinase® (crisantaspase), please refer to the British Summary of Product Characteristics.
OPi, Pharmaceuticals for Rare Diseases
Founded in 1999, OPi is a European integrated biopharmaceutical company whose mission is to develop and market pharmaceuticals (small molecules and biologicals) aimed at treating patients suffering from rare and severe diseases. OPi’s primary focus is onco-haematology, with Kidrolase® (E. coli-derived L-asparaginase), and Erwinase® (E. chrysanthemi-derived L-asparaginase), and with a R&D portfolio of monoclonal antibodies at various stages of preclinical and clinical development.
OPi is also active in other therapeutic areas, with commercialised hospital products targeting rare and severe diseases in neurology, metabolic diseases and clinical toxicology. Innovation and medical needs are the mainstays of OPi’s approach.
OPi Ltd
OPi Ltd is OPi’s newly created UK subsidiary and is located in Hatfield, Hertfordshire, in the vicinity of London. It is managed by Tim Brady, a seasoned pharmaceutical executive, with a prior successful experience of having implemented and developed a UK subsidiary for a European pharmaceutical company.
Health and Protection Agency
The Health Protection Agency (HPA) is an independent body formed in 2003 to protect the health and well-being of everyone in England and Wales. As well as providing a co-ordinated response to emerging chemical, radiological and biological health threats, including the threat of bioterrorism, the Agency also undertakes contract research, manufacture and service activities for industry.
The HPA’s core business areas are contract research and development of vaccines against infectious diseases, process development and GMP manufacture of biologics derived from microbial fermentation. In addition, a wide range of support services are offered from bio safety, through GLP immunoassay testing to in-vivo studies and the supply of cell cultures.
Lyon, France, and Salisbury, UK, November 22, 2005.
For more information:
OPi - Elisabeth Guichard: tel: + 33 (0)4 37 49 85 97; fax: + 33 (0)4 37 49 85 99
opi@orphan-opi.com –opi.uk@orphan-opi.comwww.orphan-opi.com
HPA - Roger Hinton PhD: tel: +44 (0) 198 061 23 93 ; fax: +44 (0) 198 061 22 41
roger.hinton@hpa.org.uk,www.hpa.org.uk/business