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 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.

On December 22, 2015 Merck KGaA, Darmstadt, Germany and Pfizer reported the opening of trial sites for an international Phase III study of avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in patients with platinum-resistant/refractory ovarian cancer (Press release, Pfizer, DEC 22, 2015, View Source [SID:1234508627]). The JAVELIN Ovarian 200 trial is the first Phase III study of a PD-L1 inhibitor investigated as a treatment for platinum-resistant/refractory ovarian cancer. The alliance also announced that the US Food and Drug Administration has provided approval to move forward with a Phase III study of avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. The first trial sites are expected to open shortly.

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"There are limited treatment options for women with ovarian cancer, and the prognosis for women with platinum-resistant ovarian cancer is especially poor," said Chris Boshoff, Vice President and Head of Early Development, Translational and Immuno-Oncology at Pfizer Oncology. "We have observed encouraging signs of early clinical activity of avelumab in patients with platinum-resistant or platinum-refractory ovarian cancer, and we hope to build on these results next year through a planned Phase III study of avelumab in combination with platinum therapy in patients with previously untreated ovarian cancer."

This Phase III, randomized (1:1:1), open-label, parallel, multicenter, global study (JAVELIN Ovarian 200) is designed to evaluate the superiority of avelumab as a monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, in treating patients with platinum-resistant/refractory ovarian cancer. The primary endpoint is overall survival (OS). Study investigators anticipate enrolling approximately 550 patients across more than 190 sites in Asia, Europe and North America.

Merck KGaA, Darmstadt, Germany, and Pfizer have also initiated a Phase III study (JAVELIN Bladder 100) investigating avelumab as a maintenance treatment, in the first-line setting, in patients with locally advanced or metastatic urothelial cancer. This is currently the only Phase III trial designed to evaluate an immunotherapy agent as a maintenance treatment, in the first-line setting, in patients with urothelial cancer.

"Locally advanced or metastatic urothelial cancer is another aggressive cancer, with the disease often progressing quickly following first-line treatment," said Dr. Alise Reicin, Head of Global Clinical Development at Merck KGaA, Darmstadt, Germany’s biopharma business. "It’s an exciting time for the Merck KGaA, Darmstadt, Germany, and Pfizer Alliance as we continue to accelerate our clinical development program, and now into urothelial cancer. This disease has an exceptionally high unmet need and we believe there is potential for our anti-PD-L1 antibody to be part of future treatment strategies."

This open-label, multicenter, randomized, global, Phase III study is designed to evaluate the safety and efficacy of avelumab plus best supportive care (BSC), compared with BSC alone, in patients with unresectable locally advanced or metastatic urothelial cancer whose disease did not progress on (or following) completion of first-line treatment with a platinum-containing chemotherapy. The primary endpoint of the study is OS, which will be assessed in two urothelial cancer patient populations: patients with PD-L1 positivity and all randomized patients.

JAVELIN Bladder 100 is expected to enroll 668 patients across more than 200 sites in 38 countries. PD-L1 expression status will be determined by retrospective analysis of mandatory tumor samples collected from patients enrolled in the trial. It is estimated that at least half of those patients randomized to treatment will be PD-L1-positive.

The clinical development program for avelumab now includes more than 1,500 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. The alliance has initiated six pivotal trials, reaching its goal for 2015, with additional trials expected to initiate in 2016.

*Avelumab is the proposed International Non-proprietary Name for the anti-PD-L1 monoclonal antibody (MSB0010718C). Avelumab is under clinical investigation and has not been proven to be safe and effective. There is no guarantee any product will be approved in the sought-after indication by any health authority worldwide.

References

1. Ferlay J, et al. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: View Source (link is external). Accessed December 2015.

2. World Cancer Research Fund International. Ovarian Cancer Statistics. Available from: View Source (link is external). Accessed November 2015.

3. NICE. Ovarian Cancer: Recognition and Initial Management. View Source (link is external). Accessed November 2015.

4. National Cancer Institute. Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ). Available from: View Source (link is external)Accessed November 2015.

5. Lederman JA, et al. Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO (Free ESMO Whitepaper) clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol (link is external) 2013; 24 Suppl 6: vi24–32.

6. Ojavo LS, et al. Emerging immunotherapies in ovarian cancer. Discov Med 2015; 20: 97–109.

7. NCCN Clinical Practice Guidelines in Oncology. Bladder Cancer Version 2. 2015. Available at:View Source (link is external). Accessed December 2015.

8. Malats N, Real FX. Epidemiology of Bladder Cancer. Hematol Oncol Clin North Am 2015; 29(2): 177-89.

About Ovarian Cancer

Globally, ovarian cancer is the seventh most common cancer in women.1 Annually, nearly 239,000 cases are diagnosed worldwide.2 Ovarian cancer may be difficult to diagnose, as symptoms may appear only in the later stages, when the disease has spread beyond the ovaries.2 Outcomes for women with ovarian cancer are generally poor due to most patients presenting with advanced disease.3 The 5-year prevalence of women globally living with ovarian cancer is 22.6 per 100,000.2 Current treatment options for epithelial ovarian cancer may include surgery, radiotherapy, chemotherapy and targeted therapies.4Women who are unable to undergo treatment with platinum-based chemotherapy, due to resistance or refractory disease, currently have very limited treatment options. Platinum-resistant ovarian cancer is defined as ovarian cancer that recurs within six months of completing primary chemotherapy with a platinum-based medication.5 Platinum-refractory ovarian cancer is defined as ovarian cancer that progresses during treatment with a platinum-based chemotherapy regimen.5 There is still a clear unmet need in ovarian cancer in relation to general disease awareness,2 improving initial investigations in primary and secondary care and novel therapies with demonstrable efficacy.6

About Urothelial Cancer

Urothelial cancer includes several tumors originating from the urothelial cells lining the bladder, renal pelvis and urethra.7 Bladder cancer accounts for 90% of urothelial cancers,7 and is the ninth most common cancer globally. Approximately 400,000 new cases of bladder cancer are diagnosed and 150,000 deaths are attributed to this disease each year.8 The incidence and mortality of bladder cancer have remained unchanged over the past 25 years.8

About Avelumab

Avelumab (also known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. By inhibiting PD-L1 interactions, avelumab is thought to enable the activation of T-cells and the adaptive immune system. By retaining a native Fc-region, avelumab is thought to engage the innate immune system and induce antibody-dependent cell-mediated cytotoxicity (ADCC). In November 2014, Merck, KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

On December 22, 2015 Celgene Corporation (NASDAQ: CELG) reported the settlement of litigation with Natco Pharma Ltd. of India, Natco’s U.S. partner, Arrow International Limited, and Arrow’s parent company, Watson Laboratories, Inc. (a wholly-owned subsidiary of Allergan plc) relating to patents for REVLIMID (lenalidomide) (Press release, Celgene, DEC 22, 2015, View Source [SID:1234508630]).

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As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Natco from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene will permit entry of generic lenalidomide before the April 2027 expiration of Celgene’s last-to-expire patent listed in the Orange Book for REVLIMID. Celgene has agreed to provide Natco with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total lenalidomide capsules dispensed in the U.S. in the final year of the volume-limited license under this agreement. Natco’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

"We believe strongly in our patent estate for REVLIMID, and that this settlement appropriately recognizes the strength of our patents. This settlement provides clarity around the future of REVLIMID, and we will continue to focus on developing our many important pipeline assets, which provide great potential promise to patients with unmet medical needs," said Bob Hugin, Chairman and CEO of Celgene Corporation. "We remain confident in the strength of our patents, and will continue to vigorously defend them."

On December 21, 2015 Array BioPharma Inc. (NASDAQ: ARRY) reported the closing of its definitive agreement with Pierre Fabre following approval of the agreement by the European Commission on Competition (ECC) (Filing, 8-K, Array BioPharma, DEC 21, 2015, View Source [SID:1234508616]). The definitive agreement, announced on November 16, 2015, relates to globally developing and commercializing Array’s late-stage novel oncology products, binimetinib and encorafenib. Binimetinib, a MEK inhibitor, and encorafenib, a BRAF inhibitor, are currently advancing in three, global Phase 3 trials for melanoma and ovarian cancer.

About the Array / Pierre Fabre Agreement
Under the terms of the agreement, Array will receive an upfront payment of $30 million and retains exclusive commercialization rights for binimetinib and encorafenib in the United States, Canada, Japan, Korea and Israel. Pierre Fabre will have exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Array is entitled to receive up to $425 million if certain development and commercialization milestones are achieved, and is eligible for robust, tiered double-digit royalties. Array and Pierre Fabre have agreed to split future development costs on a 60:40 basis (Array:Pierre Fabre) with initial funding committed for new clinical trials in colorectal cancer and melanoma. All ongoing binimetinib and encorafenib clinical trials remain substantially funded through completion by Novartis.

About Binimetinib and Encorafenib
RAF and MEK are key protein kinases in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor and encorafenib is a small molecule BRAF inhibitor, both of which target key enzymes in this pathway. Three Phase 3 trials in advanced cancer patients continue to advance: NRAS-mutant melanoma (NEMO, with binimetinib), low-grade serous ovarian cancer (MILO, with binimetinib) and BRAF-mutant melanoma (COLUMBUS, with binimetinib and encorafenib). Array announced on December 16, 2015 that NEMO met its primary endpoint of improving progression-free survival compared with dacarbazine treatment. Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Array also projects a regulatory filing of binimetinib in combination with encorafenib in BRAF melanoma in 2016.

About Pierre Fabre and Pierre Fabre Oncology
Pierre Fabre is a French privately-owned health and beauty care company created in 1961 by Mr. Pierre Fabre. In 2014, global sales reached €2.1 billion across 130 countries. The company is structured around two divisions: Pharmaceuticals (Prescription drugs, Consumer Health Care) and Dermo-cosmetics (including the European and Asian market-leader Eau Thermale Avene brand). Pierre Fabre employs some 10,000 people worldwide and owns subsidiary in 43 countries. In 2014, the company allocated 17 percent of its pharmaceuticals sales to R&D with a focus on 4 therapeutic areas: oncology, dermatology, CNS and consumer health care.
Pierre Fabre Oncology, a business unit of the Pierre Fabre company, is supported by over 1,000 employees with a strong focus on European markets. In 2014, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands. In addition, Pierre Fabre has a significant commitment and track record in pharmaceutical R&D, developing products for patients afflicted with lung, breast and other solid tumors and hematological cancers.

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