Alize Pharma II, a drug development company focused on oncology and metabolism and part of the Alize Pharma group, announced today the signing of a licensing agreement with EUSA Pharma for ASPAREC(R), a new L-asparaginase product currently in phase I clinical development for the treatment of acute lymphoblastic leukemia.
Pursuant to the agreement, EUSA Pharma will be responsible for the development and worldwide commercialization of ASPAREC. In return, Alize Pharma has received an upfront payment and will be entitled to additional regulatory milestone payments and royalties on sales. The companies have not disclosed further financial information.
ASPAREC is Alize Pharma’s PEGylated recombinant L-asparaginase derived from Erwinia chrysanthemi. It is being developed as a treatment for Acute Lymphoblastic Leukemia (ALL) in patients with hypersensitivity to E. coli-derived L-asparaginase. Preclinical data indicate that ASPAREC is both longer acting and less immunogenic than the currently available Erwinia chrysanthemi derived L-asparaginase product.
“This agreement between Alize Pharma and EUSA Pharma, a worldwide leader in the development and marketing of L-asparaginase products, is excellent news for us, for our investors and for ALL patients,” said Alize Pharma’s president and founder, Thierry Abribat. “It validates our medical approach, emphasizes our drug development capabilities, and fits well with our business strategy, which is to establish partnerships with the pharmaceutical industry early in the development of our programs in order to secure both near-term and long-term revenue streams.”
“We are delighted to reach this agreement with Alize Pharma. ASPAREC fits perfectly with EUSA’s specialty focus on oncology and orphan diseases and builds on our established portfolio in the field of acute lymphoblastic leukemia,” said Bryan Morton, president and chief executive officer of EUSA Pharma. “This agreement follows the approval last year of EUSA’s first internally developed product and further underlines the company’s strategic transition into a fully fledged development as well as commercialization organization.”
About acute lymphoblastic leukemia and L-asparaginase
Acute lymphoblastic leukemia is the most common form of childhood cancer and also affects adults, with approximately 10,000 to 15,000 patients diagnosed in Europe and the USA each year. It is also one of the most curable forms of cancer, with remission rates in treated children of over 95 per cent and 75 to 85 per cent surviving at least five years without recurrence of leukemia. Treatment involves a number of stages and drugs and typically includes L-asparaginase as an essential component of current protocols. L-asparaginase enzymes deplete the level of asparagine in the bloodstream. Asparagine is essential for cell growth and its removal from the blood inhibits the growth of cells associated with acute lymphoblastic leukemia.
L-asparaginase treatments are derived from bacteria and approximately 15 to 20 per cent of patients develop hypersensitivity to modern products derived from E. coli, preventing their continued treatment.
ASPAREC is a proprietary PEGylated recombinant Erwinia chrysantemi-derived L-asparaginase that has significant potential to become a key product for the treatment of Acute Lymphoblastic Leukemia (ALL) in patients with hypersensitivity to E. coli-derived L-asparaginase. Preclinical data indicate that ASPAREC is both longer acting and less immunogenic than the currently available Erwinia chrysanthemi derived L-asparaginase product. ASPAREC is currently in phase I development in France. It is protected by a patent filed internationally, and by orphan drug designations granted both in the US and Europe. The ASPAREC project has been accredited by the LyonBiopole competitive cluster; it has been financially supported in part with a grant contributed both by the European Regional Development Fund (ERDF) and Grand Lyon.
About Alize Pharma
Alize Pharma (http://www.alz-pharma.com) is a group of companies specialized in the development of innovative biopharmaceutical drugs, proteins and peptides, for the treatment of metabolic diseases and cancer. Its management is made up of a team of drug development experts and a board of directors offering wide international experience. Since its inception in 2007, the group has raised EUR five million with private and institutional investors. The first of the two entities of the Group, Alize Pharma SAS, is dedicated to AZP-01, a peptide derived from unacylated ghrelin, currently at the preclinical stage of development for the treatment of type II diabetes and other metabolic and cardiovascular indications. The second entity, Alize Pharma II SAS, is focused on the development of ASPAREC(R) (AZP-02), a new PEGylated recombinant L-asparaginase for the treatment of acute lymphoblastic leukemia, currently in phase I clinical development.
About EUSA Pharma
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on oncology, oncology supportive care and critical care products. The company has an established commercial infrastructure in the US, a pan-European presence and a wider distribution network in numerous additional territories. EUSA currently has a total of ten specialist hospital products, which are sold in over 80 countries globally(1). These include Erwinase(R)/Erwinaze(TM) and Kidrolase(R) for the treatment of acute lymphoblastic leukemia, Caphosol(R) for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high dose chemotherapy, Collatamp(R) G, a surgical implant impregnated with the antibiotic gentamicin, ProstaScint(R) for imaging the extent and spread of prostate cancer and Quadramet(R) for the treatment of pain in patients whose cancer has spread to the bones. The company also has several products in late-stage development.