Date: 2013-01-17
Type of information: Granting of the orphan status in the US
Product name: Graspa®/ERY-ASP®
Compound: L-asparaginase encapsulated in erythrocytes
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism:
Company: ERYtech Pharma (France)
Disease: acute myeloid leukaemia
Latest news:
- • On March 27, 2014, the FDA has granted orphan drug designation for Graspa®/ERY-ASP® for the treatment of acute myeloid leukemia. Graspa®/ERY-ASP® is in Phase III clinical trial for acute lymphoblastic leukemia (ALL) and in Phase IIb trial for AML in Europe. A Phase I study in adult ALL is being launched in the USA as well as a Phase II study in pancreas cancer in Europe. The new Orphan Drug Designation is the seventh ODD for ERYTECH. The dossier was filed after the positive safety review by an independent Data Safety Monitoring Board (DSMB) of the first 30 patients treated in the ongoing Phase IIb study. ERY-ASP now benefits from orphan drug status in all three of its lead indications, ALL, AML and pancreas cancer, both in Europe and the USA.
- • On 8-9 January 2013, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for L-asparaginase encapsulated in erythrocytes for treatment of acute myeloid leukaemia.
Patents:
- • On September 16, 2013, Erytech has announced it received notification of allowance for the granting of its core process patent in the United States with two additional years of exclusivity in the United States. This patent entitled “Lysis/Resealing Process and Device for Incorporating an Active Ingredient, in particular Asparaginase or Inositol Hexaphosphate, in Erythrocytes“ describes and claims the process and methods for preparing erythrocytes which reproducibly contain a well-defined amount of active ingredient for use as a pharmaceutical product. This patent is the core protection of the technology platform and products developed by Erytech, including the Graspa® product used in Phase III clinical trials in Acute Lymphoblastic Leukemia which recruitment was just achieved and Phase IIb in Acute Myeloid Leukemia.
- The patent application was filed in 2004 and had in the mean time been granted in Europe, Australia, China,
- Hong-Kong and Japan. No license fees are due to any third party. Under the US law and the determination of Patent Term Adjustment, the term of this patent has currently been extended for approximately 2 additional years, which means protection until mid 2027 in the United States. This term can possibly be further extended to 2032 on the basis of the patent term extension that may be available based on future marketing authorization.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-03-27
Orphan status UE: 2013-02-08
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
