Baxter acquires rights to Oncaspar (pegaspargase) from Sigma Tau.
Baxter International Inc.announced it has signed a definitive agreement to acquire the Oncaspar (pegaspargase) product portfolio from Sigma-Tau Finanziaria S.p.A. The acquisition further accelerates the innovation capabilities and the commercial presence of Baxter BioScience in growing oncology markets for rare and orphan diseases. The company gains the leading marketed biologic treatment Oncaspar, the investigational biologic calaspargase pegol, and an established oncology infrastructure with clinical and sales resources. The Oncaspar transaction is expected to close in the third quarter. By mid-year, Baxter expects to establish the BioScience business as a separate, publicly traded, innovation-oriented biopharmaceutical company, Baxalta Incorporated. In addition to the currently marketed formulation of Oncaspar, Baxter BioScience intends to continue the development of a lyophilized formulation, which is being investigated to enhance product stability to support product supply continuity. As part of the acquisition, Baxter BioScience is also acquiring a related new chemical entity calaspargase pegol, a biologic in development for the treatment of ALL with an increased shelf life that is expected to reduce dosing frequency. Further, the company plans to investigate Oncaspar for potential new indications, including in additional ALL patient populations with significant unmet needs, as well as for acute myeloid leukemia (AML).
Comment:Oncaspar (pegaspargase) is the only FDA-approved pegylated formulation of L-asparaginase, the enzyme that depletes the amino acid asparagine. For the last 25 years, L-asparaginase has been an important component in the treatment of acute lymphoblastic leukemia (ALL). While normal cells can produce asparagine, leukemic cells are unable to produce enough asparagine to survive on their own. L-asparaginase is given to ALL patients to ensure depletion of asparagine that is circulating in the blood.2 Depletion (starving the leukemic cells) of asparagine ultimately results in leukemic cell death. Oncaspar allows patients to gain the full benefits of asparaginase therapy with enhanced patient convenience over native L-asparaginase (nonpegylated form). Through the process of pegylation, the half-life of L-asparaginase is significantly increased and the L-asparaginase activity is sustained.
Related news and insights
NRx Pharmaceuticals announced the publication of peer-reviewed results from a prospective, open-label, administratively controlled trial of aviptadil for the treatment of respiratory failure in patients with Critical COVID-19.
Biogen Inc. announced topline results from its pivotal Phase III VALOR study of tofersen (BIIB 067), an investigational antisense drug being evaluated for people with superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS).
UCB, announced that the FDA has informed the Company that they were unable to complete review of the Biologics License Application (BLA) for bimekizumab for the treatment of moderate to severe plaque psoriasis by the Prescription Drug User Fee Action (PDUFA) date of October 15, 2021.