Baxalta Incorporated, a $6 billion global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, has completed the acquisition of the Oncaspar (pegaspargase) portfolio from Sigma-Tau Finanziaria S.p.A.
The acquisition includes Oncaspar, an important biologic treatment for patients with acute lymphoblastic leukemia (ALL), the novel investigational biologic calaspargase pegol, and established global clinical and commercial resources. Baxalta previously announced plans to acquire the portfolio for approximately $900 million.
Oncaspar is a biologic cancer therapy used as a component of multi-agent chemotherapeutic regimens to treat ALL, a rapidly progressing cancer of the white blood cells responsible for more than 80 percent of childhood leukemia cases. Standard of care regimens are highly effective in treating more than 80 per cent of paediatric ALL patients in the United States.
Oncaspar is primarily marketed in the United States, Germany, Poland and certain other countries and is currently under centralised marketing authorisation review with the European Medicines Agency. Today, annual sales of Oncaspar are estimated at $100 million, with significant growth potential starting in 2016. The product portfolio has peak sales potential of at least $500 million.
“Our focus at Baxalta is building on our rich expertise and capabilities in orphan diseases and complex therapeutics to address significant unmet needs for patients with a variety of challenging diseases, including leukemia,” said Ludwig Hantson, chief executive officer and president, Baxalta.
“With the addition of Oncaspar, a very well recognized and effective component of standard chemotherapy, we’re now positioned to introduce innovation in areas where the community is still seeking meaningful new solutions.”
Baxalta will pursue a number of opportunities to expand the value of the Oncaspar portfolio for the oncology community, including the development of new formulations and new indications, as well as calaspargase pegol. Baxalta will also leverage its global presence to seek marketing authorisations in additional countries.
“As the first commercial product in our growing oncology portfolio, Oncaspar aligns well with our other liquid tumour products and strengthens our capabilities to introduce new and innovative oncology treatments, including our late-stage pipeline candidates MM-398 (nal-IRI) for metastatic pancreatic cancer and pacritinib for myelofibrosis,” added David Meek, president of oncology at Baxalta.
“By harnessing our infrastructure and expertise, it is our goal to make ONCASPAR accessible to more patients than ever before.”
Oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the first–line treatment of patients with ALL and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase. Oncaspar is currently approved in the United States as a first line treatment and select European countries as a second line option.
Acute lymphoblastic leukemia is a rare, fast-growing cancer of the white blood cells, with approximately 5,000 new cases each year in the United States, and 4,000 in Europe. The disease is the most common childhood cancer and is responsible for more than 80 percent of childhood leukemia cases.2 The five-year pediatric survival rate has climbed to 80 percent with modern therapies.