Baxalta Completes Oncaspar Portfolio Acquisition, Aims To Broaden Patient Access To Leading Treatment For Leukemia

• Baxalta to bolster its oncology footprint with marketed biologic and investigational treatment in leukemia, consistent with company focus on addressing underserved cancers
• Company plans to expand patient access by increasing geographic reach as well as pursuing new indications and formulations
• ONCASPAR clinical and commercial teams in the U.S. and Europe to join the growing Baxalta oncology organization, strengthening readiness for successful near-term launches

DEERFIELD, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that the company 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.

“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”

ONCASPAR is a biologic cancer therapy used as a component of multi-agent chemotherapeutic regimens to treat acute lymphoblastic leukemia (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 percent of pediatric ALL patients in the United States.¹

ONCASPAR is primarily marketed in the United States, Germany, Poland and certain other countries and is currently under centralized marketing authorization 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 authorizations in additional countries.

“As the first commercial product in our growing oncology portfolio, ONCASPAR aligns well with our other liquid tumor 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.”

About ONCASPAR

ONCASPAR (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the first–line treatment of patients with acute lymphoblastic leukemia (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.

Important Safety Information

ONCASPAR is contraindicated in patients with a history of serious allergic reactions to ONCASPAR, and in patients with a history of serious thrombosis, pancreatitis, or serious hemorrhagic events with prior L-asparaginase therapy.

Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions. ONCASPAR with abdominal pain should be evaluated for evidence of pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. ONCASPAR should also be discontinued in patients with serious thrombotic events.

Glucose intolerance, in some cases irreversible, can occur; serum glucose should be monitored. Coagulopathy and hepatotoxicity can occur; appropriate monitoring should be performed.

The most common adverse reactions with ONCASPAR (=2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) events, thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases.

Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.

Please click here to review full Product Information:
http://oncaspar.com/pdf/OncasparPI.pdf.

About Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia (ALL) 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.¹

About Baxalta

Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.

Forward-Looking Statements

This release includes forward-looking statements concerning ONCASPAR and its related product portfolio as acquired by Baxalta, including expectations with regard to future sales, the development of the product pipeline and pending and future regulatory actions. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta’s control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: clinical trial results; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta’s Registration Statement on Form 10 and other Securities and Exchange Commission filings, all of which are available on Baxalta’s website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.

1. Dinndorf P, Gootenberg J, Cohen M, Keegan P, Pazdur R. FDA Drug Approval Summary: Pegaspargase (Oncaspar®) for the First-Line Treatment of Children with Acute Lymphoblastic Leukemia (ALL). The Oncologist 2007, 12:991-998. doi: 10.1634/theoncologist.12-8-991

2. Acute lymphoblastic leukemia. Medline Plus. 2014. Available at:
www.nlm.nih.gov/medlineplus/ency/article/000541.htm.