On January 04, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed refractory acute myeloid leukemia (AML) in patients aged 60 years and older (Press release, Sunesis, JAN 4, 2016, View Source;p=RssLanding&cat=news&id=2125727 [SID:1234508658]). Validation confirms that the submission is complete and initiates the Centralized Review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Under Centralized Review, the CHMP review period is 210 days, excluding question or opinion response periods, after which the CHMP opinion is reviewed by the European Commission, which usually issues a final decision on EU approval within three months. The MAA submission will be reviewed in the Centralized Procedure, which if authorized, provides a marketing license valid in all 28 EU member states.

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"Validation of our vosaroxin MAA begins the EMA review process and brings us another step closer to delivering a new treatment option to patients with relapsed refractory AML," said Deborah Thomas, Ph.D., Vice President, Regulatory Affairs and Medical Writing. "Following encouraging interactions with the agency last summer, we look forward to progressing to the next stage of the review process, which includes the 120-day questions following the assessment report by the CHMP."

"We believe European marketing authorization would represent a significant opportunity both commercially and in providing regulatory validation for other geographies around the world," said Daniel Swisher, Chief Executive Officer of Sunesis. "We look forward to providing more updates in 2016 as we move forward with this regulatory process."

About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer. Preclinical data demonstrate that vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.

The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.

About AML
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. It is estimated that the prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom and Japan) is over 75,000. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.

On January 4, 2016 Theragenics Corporation, a medical device company serving the cancer treatment and surgical product markets, reported it has acquired the U.S. and Canadian seed business of Eckert & Ziegler BEBIG, s.a. ("EZB") (Press release, Theragenics, JAN 4, 2016, View Source [SID:1234508659]). This transaction, which was announced on November 30, 2015, closed on December 31, 2015. Financial terms were not disclosed.

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Theragenics has acquired, among other things, the U.S. and Canadian customers of EZB, the U.S. and Canadian rights to the AnchorSeed, VariStrand and related seed products, and the rights to the SeedLock Needle product. These products will be added to Theragenics’ existing product portfolio. Theragenics will manufacture the products at its current facilities in Buford, Georgia.

"This transaction continues our long-standing commitment to prostate brachytherapy and the physicians and patients who depend on it," stated Frank J. Tarallo, Chief Executive Officer of Theragenics Corporation. "As a leading manufacturer and supplier in this market, our focus has always been on quality and service. Theragenics has a long history of providing physicians with the tools necessary to achieve outstanding results for their patients. We welcome the EZB customers and look forward to working with their programs."

Dr. Edgar Löffler, Managing Director of EZB, stated, "Theragenics has been recognized as a leader in prostate brachytherapy and has been a valued partner of EZB in the United States. I am confident that Theragenics will continue the outstanding quality and service to which the EZB customers and patients they serve have grown accustomed."

Mr. Tarallo concluded, "This transaction enhances our capabilities and expands our product portfolio for brachytherapy. Our legacy is improving lives and curing cancer. This transaction enhances our mission.

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).

On December 31, 2015 BioTime, Inc. (NYSE MKT: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, has completed its previously reported distribution of approximately 4.75 million shares of common stock of its subsidiary OncoCyte Corporation ("OncoCyte") to BioTime shareholders (Press release, BioTime, DEC 31, 2015, View Source;p=RssLanding&cat=news&id=2125490 [SID:1234508648]). Regular way trading of OncoCyte common stock on the NYSE MKT is expected to begin on January 4, 2016 under the symbol OCX. The distributed shares represent approximately 18.69% of the outstanding shares of OncoCyte. As a result of the distribution of the shares, BioTime’s ownership of OncoCyte has been reduced from approximately 76.4% to approximately 58.55%.

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OncoCyte is primarily focused on the development of novel, non-invasive liquid biopsy diagnostic tests for the early detection of cancer. BioTime shareholders receiving OncoCyte stock will receive an Information Statement containing details regarding the distribution of OncoCyte common stock and OncoCyte’s business and management. The Information Statement is part of a Form 10 filed by OncoCyte with the Securities and Exchange Commission that may be found at the Commission’s website www.sec.gov or at OncoCyte’s website at www.oncocyte.com.

"This distribution is another example of the BioTime’s Board of Directors strategy to provide shareholder value from our assets while we focus our operations on the Company’s clinical-stage regenerative therapeutic candidates based on pluripotent stem cell technology," said Adi Mohanty, BioTime’s Co-Chief Executive Officer. "We look forward to participating as a major shareholder in the progress of OncoCyte as the Company’s management advances development of its molecular diagnostic products toward commercialization."

Any BioTime shareholder who sells their BioTime shares on or before December 31, 2015 will be selling their entitlement to receive OncoCyte shares to the buyer of their BioTime shares. BioTime shareholders are encouraged to speak to their financial advisor before making any financial decisions.

On December 30, 2015 KaloBios Pharmaceuticals reported that on December 29, 2015, it filed a voluntary petition for bankruptcy protection under Chapter 11 of Title 11 of the United States Bankruptcy Code (the "Bankruptcy Code") (Press release, KaloBios, DEC 30, 2015, View Source [SID:1234509361]). The filing was made in the United States Bankruptcy Court for the District of Delaware (the "Bankruptcy Court") (Case No. 15-12628).

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The Company will continue to manage and operate its business and assets as a "debtor-in-possession" under the jurisdiction of the Bankruptcy Court and in accordance with the applicable provisions of the Bankruptcy Code and the orders of the Bankruptcy Court.