On January 4, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, reported a broad strategic immuno-oncology collaboration (Press release, Baxalta, JAN 4, 2016, View Source [SID:1234508653]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, Baxalta and Symphogen will advance novel therapeutics against six checkpoint targets, with the first program to enter clinical studies in 2017. On a product-by-product basis, following successful completion of Phase 1 clinical trials, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Symphogen will receive an upfront payment of $175 million (€160 million) from Baxalta in exchange for the exclusive option rights for six checkpoint therapies. Symphogen will be responsible for performing R&D through Phase 1 clinical trials at its own expense. The agreement holds a total potential value up to €1.4 billion ($1.6 billion) in option fees and milestones over the long-term, in addition to royalties on worldwide sales. Additional terms, including therapeutic targets, were not disclosed.
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"This exciting partnership aligns well to Baxalta’s strategy to invest in immuno-oncology and build an innovative portfolio of immunotherapies," said David Meek, executive vice president and president, Oncology, Baxalta. "With the expertise Symphogen offers in this category and their broad portfolio of early-stage immuno-oncology programs, this collaboration allows us to actively advance one of the most innovative areas of this field. For Baxalta, this is just the beginning of our focus in building world-class capabilities in immuno-oncology."
"Baxalta’s dedication to delivering transformative therapies and its global commercial presence make it an ideal strategic partner for Symphogen, as we complement Baxalta with R&D competencies within the immuno-oncology area," said Kirsten Drejer, Ph.D., Chief Executive Officer, Symphogen. "We look forward to providing Baxalta with innovative immuno-oncology product candidates under this broad collaboration."
Dr. Göran Ando, Chairman of Symphogen’s Board of Directors added, "This collaboration also provides strong validation for Symphogen’s antibody approach and capabilities within the exciting field of immuno-oncology therapy."
Immuno-oncology, a field focusing on activating and directing a patient’s immune system against tumor growth and proliferation, is a highly attractive area of research that is generating promising new therapeutic advances. Recent research indicates that these immunotherapies, both as single agents and as combination therapies, are likely to significantly improve outcomes for a variety of cancers.
Year: 2016
Bevacizumab non-originator biological approved in Russia
On 30 November 2015 Biocad reported that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021 (Press release, Biocad, JAN 1, 2016, View Source [SID1234563674]). The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).
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Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.
The Russian Ministry of Health’s positive opinion on BCD-021 is based on the results of international clinical studies comparing the pharmacokinetics, efficacy, safety and immunogenicity of BCD-021 to Avastin. Biocad’s phase III study, which involved centres in Russia, Belarus and Ukraine was completed in December 2014. The design of the clinical trials was developed with the advice of the European Medicines Agency (EMA) for clinical trials of biosimilars of monoclonal antibodies.
Global sales of Avastin in 2014 amounted to US$7.4 billion. While in Russia, Avastin had sales of more than RUB 3.2 billion in 2014.
Bevacizumab is not the only non-originator biological Biocad has in the pipeline. The company received approval for its rituximab non-originator biological AcellBia (BCD-020) in April 2014 [1]. According to ClinTrials.gov the company is also carrying out a phase III clinical trial for another of its biological candidates, BCD-022, which is a non-originator biological of Roche’s blockbuster cancer drug Herceptin (trastuzumab).