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Baxter BioScience to Expand Global Oncology Footprint with Acquisition of Oncaspar® Portfolio for Leukemia

On May 12, 2015 Baxter International reported it has signed a definitive agreement to acquire the Oncaspar (pegaspargase) product portfolio from Sigma-Tau Finanziaria S.p.A (Press release, Baxter International, MAY 12, 2015, View Source [SID:1234504264]).

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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 USD $100 million in annual sales. ALL is a rapidly progressing cancer of the white blood cells responsible for more than 80 percent of childhood leukemia cases.

"The Baxter BioScience legacy of delivering solutions for orphan diseases and small patient populations and our global presence positions us well to accelerate the growth of the Oncaspar portfolio globally," said Ludwig Hantson, Ph.D., president of Baxter BioScience. "With Oncaspar, Baxalta will bring an established standard of care therapy to more patients worldwide through the pursuit of additional indications and regulatory approvals across the globe."

"Oncaspar is a strong strategic fit for our rapidly expanding oncology business, as it complements our R&D programs in hematologic cancers," added David Meek, head of oncology for Baxter BioScience. "The acquisition provides an immediate commercial footprint in the United States and Europe with a heritage of expertise in treating this challenging disease."

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).

"We are confident that this transaction provides benefits for patients, our business and our employees. The Oncaspar team will gain beneficial resources by joining forces with Baxter BioScience to bring this valuable treatment to more patients around the world," said Andrea Montevecchi, CEO of Sigma Tau Finanziaria SpA.

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.

Under the terms of the agreement, Baxter will purchase the portfolio for USD $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.

Baxalta Incorporated will host an investor conference on Tuesday, May 19, during which the company’s leadership will address the growing oncology business, strategy and emerging pipeline.

About Oncaspar

ONCASPAR (pegaspargase) is indicated as a component of a multiagent 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. Patients 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) 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: View Source

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. The five-year pediatric survival rate has climbed to 90 percent with modern therapies, though a quarter of patients relapse.1

Takeda Announces Termination of Alisertib Phase 3 Trial in Relapsed or Refractory Peripheral T-cell Lymphoma

On May 13, 2015 Takeda reported that it has decided to discontinue the Phase 3 trial of alisertib (MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) following the results of a pre-specified interim analysis that indicated the study is unlikely to meet the primary endpoint of superior progression-free survival (PFS) over the standard-of-care in this treatment setting (Press release, Takeda, MAY 12, 2015, View Source [SID:1234504253]). Takeda continues to investigate the utility of alisertib in small cell lung cancer (SCLC).

"Takeda has a deep and long-standing commitment to developing innovative cancer therapies. While we are disappointed that alisertib will not be further investigated for relapsed or refractory peripheral T-cell lymphoma, we are optimistic about alisertib’s clinical development program in small cell lung cancer," said Michael Vasconcelles, M.D., Global Head of the Takeda Oncology Therapeutic Unit. "The randomized Phase 2 study of alisertib in small cell lung cancer will continue as planned and is currently underway. Takeda also continues to support investigator initiated research with alisertib and will evaluate its potential use in other oncology indications going forward."

Patients enrolled in the Phase 3 PTCL clinical trial who are being treated with alisertib may continue treatment if they are considered to be benefitting from treatment, and no safety concerns are present. Patients are encouraged to consult their study investigators to address any questions, and before making any changes to their medication. Takeda is working with trial investigators and local regulatory authorities to ensure that patients who participated in the study receive appropriate care. For additional information, please visit www.takeda.com.

Threshold Pharmaceuticals’ Partner Merck KGaA, Darmstadt, Germany, Receives FDA Fast Track Designation for Evofosfamide for the Treatment of Patients Living With Advanced Pancreatic Cancer

On May 12, 2015 Threshold Pharmaceuticals reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s partner Merck KGaA, Darmstadt, Germany, for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer (Press release, Threshold Pharmaceuticals, MAY 12, 2015, View Source [SID:1234504198]). This is the second Fast Track designation for evofosfamide, the first having been granted to Threshold in November 2014 for the development of evofosfamide in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma. Threshold and Merck KGaA, Darmstadt, Germany, are collaborating on the development of evofosfamide, an investigational compound currently in Phase 3 clinical trials.

"We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer," said Barry Selick, Ph.D., Chief Executive Officer of Threshold. "Evofosfamide is currently being studied in two pivotal Phase 3 clinical trials: one in patients with advanced soft tissue sarcoma and the other in patients with advanced pancreatic cancer. Based on current projections, we expect that the number of protocol-specified events for the pivotal Phase 3 trials of evofosfamide may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter."

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"Merck KGaA, Darmstadt, Germany, is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat," said Luciano Rossetti, Head of Global Research and Development for the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. "Many patients with pancreatic cancer present with advanced, inoperable tumors, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer, which is currently being studied in the MAESTRO Phase 3 study, will help to facilitate the timely development of this high-priority program for Merck KGaA, Darmstadt, Germany."

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.

About the Phase 3 Trials of Evofosfamide
In December 2012, Merck KGaA, Darmstadt, Germany, initiated the global pivotal Phase 3 MAESTRO clinical trial assessing the efficacy and safety of evofosfamide in combination with gemcitabine in patients with previously untreated, locally advanced unresectable or metastatic pancreatic adenocarcinoma. MAESTRO stands for evofosfamide in the treatment of MetastAtic or unrESectable pancreaTic adenocaRcinOma. The MAESTRO trial is a randomized, placebo-controlled, international, multi-center, double-blind Phase 3 clinical trial of evofosfamide plus gemcitabine compared with placebo plus gemcitabine. The primary efficacy endpoint is overall survival; the secondary endpoints include efficacy measured by progression-free survival, overall response rate and disease control rate, as well as assessments of safety and tolerability, pharmacokinetics and biomarkers. Patients were randomized to either gemcitabine 1000 mg/m2 plus placebo or to receive evofosfamide 340 mg/m2 administered intravenously with gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle. The trial completed target enrollment of 660 patients in October 2015.

In partnership with the Sarcoma Alliance for Research through Collaboration (SARC), Threshold is conducting an international, randomized pivotal Phase 3 clinical trial designed to investigate the efficacy and safety of evofosfamide in combination with doxorubicin, compared with doxorubicin alone, in previously untreated patients with metastatic or locally advanced unresectable soft tissue sarcoma. The primary endpoint of the trial is overall survival. Secondary endpoints include progression-free survival, overall response rate, pharmacokinetics and safety. Patients were randomized to either doxorubicin alone or to receive evofosfamide 300 mg/m2 administered intravenously on Days 1 and 8 with doxorubicin 75 mg/m2 on Day 1 of each 21-day cycle. After six cycles, patients with stable and/or responding disease could receive evofosfamide according to the same dosing schedule, 300 mg/m2 Days 1 and 8 of each 21-day cycle until progression or undesirable side effects. The trial completed target enrollment of 620 patients in December 2013.

About Pancreatic Cancer
In 2015, it is estimated that there will be 48,960 new cases of pancreatic cancer in the United States and an estimated 40,560 people will die of this disease.1 Ranked as the 12th most common cancer worldwide, it is the 7th most common cause of cancer-related death, accounting for 4% of deaths.1 With 93-95% of patients dying from their disease within 5 years, pancreatic cancer has a low survival rate.2,3 There has been little improvement seen in the survival of patients with this disease over the past 30 years4 and there remain limited treatment options for pancreatic cancer.5 Surgery remains the only curative approach for pancreatic cancer;5 however, many patients (80-85%) present with advanced, inoperable disease.6 For this large group of patients ineligible for surgery, the aim of treatment is prolongation of survival and palliation of symptoms.7

About Soft Tissue Sarcoma
Soft tissue sarcomas are a group of aggressive cancers that form in the soft tissues of the body (e.g., muscles, tendons, fat, blood vessels, lymph vessels, nerves, and tissue around joints) for which currently there are limited treatment options. Tumors may develop at any site, but manifest most often in the extremities and metastasize most often to the lungs and liver. In 2015, it is estimated that there will be 11,930 new cases of soft tissue sarcoma in the United States, and an estimated 4,870 people will die from this disease.7 Chemotherapy is the standard treatment for metastatic or unresectable soft tissue sarcoma. First-line palliative chemotherapy may be beneficial to nearly 50% of patients with advanced soft tissue sarcoma;8 however, prognosis for patients with advanced higher-grade disease is poor with historical median overall survival of 8 to 12 months after developing metastatic disease.9

About Evofosfamide
Evofosfamide (previously known as TH-302), an investigational hypoxia-activated prodrug, is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood supply as a result of aberrant vasculature. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

Evofosfamide is currently under evaluation in two Phase 3 trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (STS), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase 3 trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug Designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase 2 trial designed to support registration for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.

Threshold has a global license and co-development agreement for evofosfamide with Merck KGaA, Darmstadt, Germany, which includes an option for Threshold to co-commercialize in the U.S.

Elasmogen and Almac Discovery join forces to tackle solid tumours

On May 11, 2015 Elasmogen Ltd, the University biologics drug discovery company and Almac Discovery, a pharmaceutical company focused on identifying and developing innovative therapeutics for the treatment of cancer, reported that they have entered into an agreement to co-develop Elasmogen technology for the treatment of solid tumours (Press release, Elasmogen, MAY 11, 2015, View Source [SID1234637767]).

Under the terms of the agreement Elasmogen and Almac will jointly manage the research and development activities aimed at developing a drug candidate to an undisclosed target. Both parties will share costs, with Almac being responsible for commercialisation.

Dr Caroline Barelle CEO and Scientific Officer of Elasmogen, said: "We are very excited about combining the expertise of our two research teams to deliver an effective therapy for patients." Dr Barelle will announce the new collaboration at BioTrinity 2015 in London tonight, 11 May 2015, which is a high profile gathering of Europe’s biotechnology, pharmaceutical and investor community.

Dr Stephen Barr, President Almac Discovery, added: "We are always looking for novel science to drive the next steps in drug development and we feel that the soloMERTM concept could be the next scientific step forward in drug conjugate approaches."

soloMERsTM are humanised versions of antibody-like proteins that were first discovered in sharks. They are chemically robust molecules that tolerate drug conjugation well. It is believed that soloMERsTM bind specifically to the cancer tissue and will penetrate inside the tumour before releasing their war-head of anti-cancer drugs, maximising the damage to the tumour and minimising the toxic effects to healthy tissues.

We are very excited about combining the expertise of our two research teams to deliver an effective therapy for patients."
Dr Caroline Barelle, CEO and CSO of Elasmogen
In February the Elasmogen team, which is part of the Scottish Biologics Drug Discovery Facility at the University of Aberdeen, further strengthened its global intellectual property (IP) position with the granting of a patent in the US, underpinning the generation of its VNAR protein drugs developed from sharks.

Dr Barelle currently leads the team of senior research scientists developing novel biologic therapeutics based on soloMERsTM. Her previous roles include Head of Single-Domain antibody Development at Pfizer and Wyeth where she led the teams isolating and progressing leads through to late pre-clinical assessment. Prior to this she was Programmes Manager at the antibody engineering company, Haptogen Ltd, acquired by Wyeth in 2007.

10-Q – Quarterly report [Sections 13 or 15(d)]

Juno has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Juno, MAY 11, 2015, View Source [SID1234504238]).