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 BioTime, Inc. (NYSE MKT: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported that the common stock of its subsidiary OncoCyte Corporation ("OncoCyte") will begin trading today on a "when-issued" basis on the NYSE MKT under the symbol OCX WI. "Regular-way" trading of OncoCyte common stock on the NYSE MKT is expected to begin on January 4, 2016 under the symbol OCX (Press release, BioTime, DEC 30, 2015, View Source;p=RssLanding&cat=news&id=2125391 [SID:1234508644]).

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As previously announced, the Board of Directors of BioTime declared a pro rata distribution of shares of OncoCyte common stock to BioTime shareholders of record as of the close of business on December 21, 2015, the record date. As a result, on December 31, 2015, BioTime shareholders will receive one share of common stock of OncoCyte for every twenty BioTime common shares they held on the record date. Fractional shares of OncoCyte common stock will not be distributed to BioTime shareholders. Instead, the fractional shares of OncoCyte common stock will be aggregated and sold in the open market, with the net cash proceeds distributed pro rata to the BioTime shareholders who otherwise would have received fractional shares of OncoCyte common stock.

No action is required by BioTime shareholders to receive the distributed shares of OncoCyte common stock. BioTime shareholders who held BioTime common shares on the record date and do not sell those shares prior to December 31, 2015 will receive a book-entry account statement reflecting their ownership of OncoCyte common stock or their brokerage account will be credited with OncoCyte shares.

OncoCyte is primarily focused on the development of novel, non-invasive liquid biopsy diagnostic tests for the early detection of cancer. After the distribution of OncoCyte shares, BioTime’s ownership of OncoCyte will be reduced from approximately 76.4% to approximately 58.55%. An "Information Statement" containing details regarding the distribution of OncoCyte common stock and OncoCyte’s business and management is being mailed to BioTime shareholders. 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.

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.

This press release does not constitute any offer to sell or a solicitation of an offer to buy OncoCyte common stock.

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.

On December 24, 2015 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported that the U.S. Food and Drug Administration ("FDA") has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer (Press release, Eagle Pharmaceuticals, DEC 24, 2015, View Source [SID:1234508639]). Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S.

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Docetaxel Injection is the first alcohol-free formulation approved in the U.S. Additional features of this product are:

presents as one, pre-filled vial that does not require mixing;
is available in three different dosages: 20mg/1ml, 80mg/4mL, and 160mg/8mL; and
24 hours of stability at final dilution strength.1
The need for an alcohol-free docetaxel gained visibility in June 2014 when the FDA issued a Drug Safety Communication warning patients that docetaxel may cause symptoms of alcohol intoxication after treatment. Manufacturers of docetaxel formulations for domestic use were subsequently required to revise their product labels to reflect alcohol content and include a drug safety warning. Some U.S. hospitals and clinics require patients to wait two or more hours after treatment with docetaxel before they can be released. This formulation of docetaxel was specifically developed to address these concerns.

"Docetaxel Injection addresses a compelling need in the docetaxel market. As the first alcohol-free formulation approved in the U.S., we believe the benefits of this novel formulation will provide an option for patients with alcohol sensitivity or a preference for an alcohol-free treatment. We are excited to add alcohol-free docetaxel to our growing portfolio of differentiated injectable products and believe it has the potential to improve the lives of patients, resolve concerns among health care professionals at hospitals and infusion centers, and ultimately drive value for Eagle stakeholders," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Eagle expects to begin shipping Docetaxel Injection in January 2016. Eagle estimates that annual sales of generic docetaxel are approximately $75 million.

About Docetaxel

Docetaxel is a taxane product indicated for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Docetaxel was originally developed by Sanofi and marketed under the Taxotere brand. Since its patent expiration in 2011, several generics entered the market. The alcohol content of these docetaxel formulations, including Taxotere, ranges from 2.0 to 6.4 grams in a 200 mg dose2.