LYON, France, and PORTON DOWN, England, August 30 /PRNewswire/ -- OPi SA, Pharmaceuticals for Rare Diseases and the UK Health Protection Agency (HPA) announce today that they have entered into a world-wide licensing and supply agreement on Erwinase(R) (crisantaspase), L-asparaginase derived from Erwinia chrysanthemi. Erwinase(R) is indicated for the treatment of acute lymphoblastic leukaemia and may also be used in some other malignant hemopathies. Under the terms of the agreement, OPi is being granted worldwide exclusive rights to market the product, which is manufactured by the HPA in its recently upgraded Porton Down facility.
"We are very proud to work closely with the HPA, a highly respected institution, as their exclusive partner on this important drug." said Gilles Alberici, PhD, President and Founder of OPi Group. "Erwinase(R) is a great and logical addition to our existing portfolio in onco-haematology , and will allow us to accelerate our international expansion in Europe and North America, which was commenced with Kidrolase(R) (E. coli-derived L-asparaginase) acquired last year".
"Partnering with OPi is a great opportunity for Erwinase(R)." commented Roger Gilmour, PhD, HPA Director. "Over the last few years, we have made significant investments in our manufacturing facilities, in order to meet the highest standards of quality on a long-term basis. We strongly believe that our joint efforts, combining our expertise with the proven track record of OPi, its medical approach and its global network, will make Erwinase(R) a success".
Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children, representing nearly one third of all paediatric cancers. It also affects adults, with an overall yearly incidence of approximately 80,000 patients. L-asparaginases have been used in combination with other chemotherapeutic agents as a mainstay of the ALL treatment for many years. L-asparaginases are used to deprive cells from L-asparagine, an essential amino-acid for lymphoblasts, the cancer cells involved in ALL. Kidrolase(R), as well as all L-asparaginases currently on the market are from Escherichia coli sources. However, a significant proportion of patients treated with these L-asparaginases develop allergic reactions or neutralizing antibodies that could require modification of the dosage, or treatment cessation, and may decrease the effectiveness of the treatment. There is thus a need for a structurally unrelated L-asparaginase to manage patients sensitized to Escherichia coli L-asparaginase.
"Since Erwinase(R)'s primary sequence differs from those of all available L-asparaginase preparations, we consider Erwinase(R) as the most appropriate therapeutic option for the significant proportion of patients who develop allergic reactions or neutralizing antibodies against E. coli L-asparaginases", indicated Thierry Abribat, PhD, Chief Executive Officer of OPi. "Erwinase(R), together with Kidrolase(R), will allow OPi to offer a unique source of complementary L-asparaginase treatments to the clinical teams and ultimately to the patients for an optimised management of Acute Lymphoblastic Leukemia".
Erwinase(R) (crisantaspase) has been registered in 22 countries and commercialised in more than 60 countries, but its availability was voluntarily suspended in 2003 following manufacturing issues encountered at the HPA manufacturing site. Over the last two years, HPA has conducted the necessary studies and made significant investments to upgrade its manufacturing processes and facilities. The manufacturing changes were recently approved by the UK regulatory authorities. OPi and the HPA are undertaking a rolling programme to bring the product back to market.
For full prescribing information about Erwinase(R), please refer to locally approved 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(R) (E.coli-derived L-asparaginase), approved and marketed internationally, 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.
Health 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.
Health Protection Agency & OPi SA