ERYTECH Pharma, a late stage biopharmaceuticals company focused on orphan oncology and rare diseases, announced today that it has entered into a definitive agreement with Orphan Europe, part of the Recordati Group, granting Orphan Europe exclusive rights for the commercialization and distribution of GRASPA® in Acute Lymphoblastic Leukemia (ALL) and Acute Myeloid Leukemia (AML) in Europe.
GRASPA®, L-asparaginase encapsulated into human erythrocytes, for the treatment of hematological malignancies, is in pivotal Phase II/III clinical trial for ALL and will enter a Phase IIb trial in AML in Europe. The product holds orphan designation in Europe and the US for ALL. GRASPA® is intended to satisfy the important unmet medical needs of frail cancer patients, patients suffering relapses and other patient groups for whom the current treatments are not suitable.
“We are very pleased to announce this agreement with Orphan Europe” said Pierre-Olivier Goineau, Chief Executive Officer of Erytech. “We believe we have found in Orphan Europe a partner that is uniquely positioned to ensure market access and commercial success of our lead product in ALL, and to advance the product in AML. Erytech will manufacture the product. This agreement is a major milestone for Erytech, and a clear recognition of the potential of our technology. It will allow us to focus on our developments in the US, in solid tumors and in other rare disease indications.”
Marco Liguori, CEO of Orphan Europe, is delighted with this new partnership. “The Orphan Europe team has considerable experience in the orphan drug field and the special requirements of rare diseases. We are committed and prepared to ensure that these treatments become available for patients in Europe rapidly.”
Erytech Pharma SA is a late-stage French biopharmaceutical company developing medicinal products for orphan oncology and rare diseases. The company’s proprietary core technology is based on the use of human red blood cells (RBCs) to improve the pharmacokinetic (PK) and pharmacodynamic (PD) properties of therapeutic molecules. Its lead product, GRASPA® is in pivotal Phase II/III clinical trial for ALL and will enter a Phase IIb trial in AML in Europe. The product holds orphan designation in Europe and the US for ALL.
The company is expanding the use of its technology in oncology to Acute Myeloid Leukemia and solid tumors, and outside oncology in rare immunology and haematology indications.
About Orphan Europe
Orphan Europe was founded in 1990 and acquired by Recordati in 2007. For the past two decades Orphan Europe has developed and marketed orphan drugs for patients with rare diseases. In 2000 orphan drugs were defined by the European Drug Regulation as a treatment for a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons. The parameters involved in the development of an orphan drug are very different to the development of conventional drugs, for example there is a limited number of patients and a scarcity of expertise. Therefore Orphan Europe’s approach is based on combined efforts between the company, patients and the medical community with the overall aim to improve the life of affected persons. Orphan Europe has also built the Orphan Europe Academy with the aim to further the understanding of rare diseases and provide a forum for sharing knowledge and developing new ideas.
Recordati, established in 1926, is a European pharmaceutical group, listed on the Italian Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT 0003828271), with a total staff of over 3,200, dedicated to the research, development, manufacturing and marketing of pharmaceuticals. Headquartered in Milan, Italy, Recordati has operations in the main European countries, in Central and Eastern Europe, and in Turkey. A field force of around 1,700 medical representatives promotes a wide range of innovative pharmaceuticals, both proprietary and under license, in a number of therapeutic areas including a specialized business dedicated to treatments for rare diseases. Recordati is a partner of choice for new product licenses from companies which do not have a European presence. Recordati is committed to the research and development of new drug entities within the cardiovascular and urogenital therapeutic areas and of treatments for rare diseases. Consolidated revenue for 2011 was € 762.0 million, operating income was € 163.5 million and net income was € 116.4 million.