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Ligand’s Partner Jazz Pharmaceuticals Receives European Commission Approval for Enrylaze® (a recombinant Erwinia asparaginase or crisantaspase) for the Treatment of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ), (“Jazz”)
About this update from Ligand Pharmaceuticals Incorporated
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nLigand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ), (“Jazz”) has been granted marketing authorization by the European Commission (EC) for Enrylaze® (JZP458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients (one month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. Enrylaze, approved as Rylaze® in the United States and Canada, is a new Erwinia-derived asparaginase developed using a next-generation recombinant technology with a safety profile consistent with that of other asparaginase preparations.\n\n\n“We congratulate our partner Jazz on its receipt of approval for Enrylaze® from the European Commission, expanding the market opportunity for one of our key commercial-stage products,” said Todd Davis, CEO of Ligand Pharmaceuticals. “Jazz has executed on a successful launch of the product in the U.S., and we look forward to contributions from sales in the European Union.”\n\n\nLigand is eligible to receive milestone payments and tiered low- to mid-single digit royalties based on worldwide net sales of any products resulting from its collaboration with Jazz, including Rylaze.\n\n\nEnrylaze may be given by both intravenous infusion (IV) and intramuscular injection (IM) and is dosed either on alternate days (every 48 hours) or via a Monday/Wednesday/Friday (MWF) dosing schedule. The use of recombinant technology to manufacture Enrylaze delivers a scalable supply – able to meet global demand, and a ready-to-use solution that avoids the need for reconstitution in the clinic.\n\n\nThe EC approval is based on data from a Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group (COG) in a cohort of 228 pediatric and adult patients with ALL and LBL who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. The study was conducted in two parts to assess the IV and IM routes of administration. The determination of efficacy was based on demonstration of the achievement and maintenance of nadir serum asparaginase activity (NSAA) levels ≥ 0.1 U/mL.\n\n\nTh...