Date: 2015-05-12
Type of information: Product acquisition
Compound: Oncaspar® (pegaspargase), calaspargase pegol
Company: Baxter (USA - IL) Baxalta (USA - IL) Sigma-Tau Finanziaria (Italy)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: product acquisition
Action mechanism:
- enzyme/protein. Oncaspar® (pegaspargase) is composed of E. coli derived L-asparaginase, which is synthetically modified by covalently conjugating units of monomethoxypolyethylene glycol (PEG) to the enzyme. The mechanism of action of Oncaspar® is based on selective killing of leukemic cells due to depletion of plasma asparagine. Normal cells, however, are less affected by the depletion due to their ability to synthesize asparagine. It is given to patients with ALL as part of a multi-agent chemotherapeutic treatment regimen.
Disease: acute lymphoblastic leukemia (ALL)
Details:
- • On May 12, 2015, Baxter International 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.
- Oncaspar® is a first-line biologic used as part of a multi-agent chemotherapy regimen to treat acute lymphoblastic leukemia (ALL). It is currently marketed in the United States, Germany, Poland and certain other countries and has approximately $100 million in annual sales. 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).
- The acquisition is expected to accelerate the company\'s efforts to capitalize on the rapidly growing oncology market, with an estimated $10 billion total market potential across current oncology indications for Baxter\'s pipeline assets. It also complements recent momentum on several partnerships within the oncology pipeline, including positive Phase III results for the investigational treatment pacritinib for myelofibrosis as well as the recent regulatory filings of MM-398 for metastatic pancreatic cancer.
Financial terms:
- Under the terms of the agreement, Baxter will purchase the portfolio for $900 million before working capital and other transaction adjustments. The company expects to finance the transaction through a combination of foreign cash and debt. This transaction is expected to be accretive to adjusted earnings on a cash basis in the first full year and increasingly accretive thereafter. The closing of the transaction, expected in the third quarter, is subject to regulatory approvals and other customary closing conditions.
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