On December 11, 2015 Takeda reported that NINLARO (ixazomib) capsules, the first and only oral proteasome inhibitor, are now available in the United States (Press release, Takeda, DEC 11, 2015, View Source [SID:1234508541]). NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Takeda Pharmaceutical Company Limited (TSE: 4502) recently received U.S. Food and Drug Administration (FDA) approval for NINLARO, four months prior to its Priority Review PDUFA date. NINLARO is a once-weekly pill for three weeks of a four week cycle. More information is available at www.NINLARO.com.

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"With NINLARO now available in the U.S., we have taken our extensive research and turned it into a reality. In addition to the clinical investigators and patients, I would like to extend our thanks to the FDA for its expedited review of NINLARO. The need for new and differentiated treatment options is urgent, and their commitment allowed us to bring NINLARO to market within a rapid timeframe," said Christophe Bianchi, M.D., President, Takeda Oncology. "In the short time since receiving FDA approval of NINLARO, we have seen an enthusiastic reception from providers and patients alike; in fact, prescriptions have already been written by physicians and approved by insurers. We are excited to realize our commitment to the multiple myeloma community as we bring NINLARO to patients."

NINLARO is a pill that can be taken at home which may reduce some of the logistical burden for patients, because administration does not require an infusion or injection at a hospital, clinic or physician’s office. For patients prescribed NINLARO, Takeda is offering NINLARO 1Point, a comprehensive support program offering an array of access and coverage services. More information about NINLARO 1Point is available through www.NINLARO.com or by calling 1-844-N1POINT (1-844-617-6468).

"Access to therapy for patients in need is our first and foremost priority," said Ryan Cohlhepp, Vice President of U.S. Marketing at Takeda. "And with NINLARO 1Point, we have created a robust suite of support services to help patients access NINLARO."

NINLARO is available through an open distribution model that includes physician in-office dispensing. Additionally, there is a specialty pharmacy network to assist patients and healthcare providers.

To arrange for in-office dispensing, offices may call their normal distributor/wholesaler. If unavailable, please call 1-844-N1POINT (1-844-617-6468) for options to arrange for immediate access to product as distribution channels open up.

About NINLARO (ixazomib) capsules
NINLARO (ixazomib) is the first and only oral proteasome inhibitor indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. NINLARO is administered orally, once-weekly on days 1, 8, and 15 of a 28-day treatment cycle. NINLARO is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP). NINLARO also received Breakthrough Therapy status by the U.S. FDA for relapsed or refractory systemic light-chain (AL) amyloidosis, a related ultra orphan disease, in 2014.

The TOURMALINE clinical development program further reinforces Takeda’s ongoing commitment to developing innovative therapies for people living with multiple myeloma worldwide and the healthcare professionals who treat them. Five global Phase 3 trials are ongoing:

TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in relapsed and/or refractory multiple myeloma

TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination with lenalidomide and dexamethasone in patients with newly diagnosed multiple myeloma

TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma following induction therapy and autologous stem cell transplant (ASCT)

TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance therapy in patients with newly diagnosed multiple myeloma who have not undergone ASCT

TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs. physician choice of selected regimens in patients with relapsed or refractory AL amyloidosis

In addition to the TOURMALINE program, a large number of investigator initiated studies are evaluating ixazomib for patients globally.

For additional information on the ongoing Phase 3 studies please visit www.clinicaltrials.gov. To learn more about NINLARO, please visit www.NINLARO.com or call 1-844-N1POINT (1-844-617-6468).

Important Safety Information

WARNINGS AND PRECAUTIONS

Thrombocytopenia has been reported with NINLARO. During treatment, monitor platelet counts at least monthly, and consider more frequent monitoring during the first three cycles. Adjust dosing as needed. Platelet nadirs occurred between Days 14-21 of each 28-day cycle and recovered to baseline by the start of the next cycle.

Gastrointestinal Toxicities, including diarrhea, constipation, nausea and vomiting, were reported with NINLARO and may occasionally require the use of antidiarrheal and antiemetic medications, and supportive care. Adjust dosing for severe symptoms.

Peripheral Neuropathy (predominantly sensory) was reported with NINLARO. Monitor patients for symptoms of peripheral neuropathy and adjust dosing as needed.

Peripheral Edema was reported with NINLARO. Monitor for fluid retention. Investigate for underlying causes when appropriate and provide supportive care as necessary. Adjust dosing as needed.

Cutaneous Reactions: Rash, most commonly maculo-papular and macular rash, was reported with NINLARO. Manage rash with supportive care or with dose modification.

Hepatotoxicity has been reported with NINLARO. Monitor hepatic enzymes regularly during treatment and adjust dosing as needed.

Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women should be advised of the potential risk to a fetus, to avoid becoming pregnant, and to use contraception during treatment and for an additional 90 days after the final dose of NINLARO.

ADVERSE REACTIONS

The most common adverse reactions occurring in greater than or equal to 20% of patients treated with NINLARO were diarrhea, constipation, thrombocytopenia, peripheral neuropathy, nausea, peripheral edema, vomiting and back pain.

SPECIAL POPULATIONS

Hepatic Impairment: Reduce the NINLARO starting dose to 3mg in patients with moderate or severe hepatic impairment.
Renal Impairment: Reduce the NINLARO starting dose to 3 mg in patients with severe renal impairment or end-stage renal disease requiring dialysis. NINLARO is not dialyzable.
Lactation: Advise women to discontinue nursing while on NINLARO.

DRUG INTERACTIONS: Avoid concomitant administration of NINLARO with strong CYP3A inducers.

Please see the full Prescribing Information for NINLARO.

About Multiple Myeloma

Multiple myeloma is a cancer of the plasma cells, which are found in the bone marrow. In multiple myeloma, a group of plasma cells, or myeloma cells, becomes cancerous and multiplies, increasing the number of plasma cells to a higher than normal level. Because plasma cells circulate widely in the body, they have the potential to affect many bones in the body, possibly resulting in compression fractures, lytic bone lesions and related pain. Multiple myeloma can cause a number of serious health problems affecting the bones, immune system, kidneys and red blood cell count, with some of the more common symptoms including bone pain and fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer, with more than 26,000 new cases in the U.S. and 114,000 new cases globally per year.

On December 11, 2015 BioTime, Inc. (NYSE MKT and TASE: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, reported that its Board of Directors has set the record date, the distribution ratio, and expected distribution date for the distribution of a portion of the shares of common stock of BioTime’s subsidiary OncoCyte Corporation ("OncoCyte") to BioTime shareholders (Press release, BioTime, DEC 11, 2015, View Source;p=RssLanding&cat=news&id=2122004 [SID:1234508538]). The record date for determining holders of BioTime common shares entitled to receive shares of OncoCyte common stock in the distribution will be the close of business on December 21, 2015.

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BioTime shareholders will receive one share of OncoCyte common stock for every 20 BioTime common shares held as of the close of business on the record date. The distribution will be made in book-entry form. BioTime expects the distribution to occur on December 31, 2015. BioTime shareholders will not be required to do anything to receive the OncoCyte distribution, meaning that they will not have to surrender or exchange BioTime common shares in order to receive their OncoCyte shares.

Any holder of record who sells their shares of BioTime on or before the distribution date of December 31st will be selling their entitlement of OncoCyte shares to the buyer of their BioTime shares. Holders are encouraged to talk to their financial advisor before selling their shares of BioTime.

After this distribution of OncoCyte shares, BioTime’s ownership will be reduced from approximately 76.4% to approximately 58.6%.

Currently, there is no trading market for OncoCyte common stock. However, OncoCyte plans to apply to list its common stock for trading on the NYSE MKT under the symbol OCX. In the event that a listing application is not approved, OncoCyte plans to arrange for the trading of its common stock on the OTC Bulletin Board market no later than the completion of the distribution.

Completion of the distribution of OncoCyte shares to BioTime shareholders is subject to the satisfaction of certain conditions, including that a Registration Statement on Form 10 filed by OncoCyte with the Securities and Exchange Commission is declared effective.

OncoCyte is engaged in the development of new "liquid biopsy" diagnostic tests for cancer based on analyzing patient blood or urine samples for specific gene or protein markers indicative of the presence of particular types of cancer. OncoCyte is presently developing diagnostic tests for lung cancer, breast cancer, and bladder cancer. For more information about OncoCyte, please visit www.OncoCyte.com.

More information about OncoCyte and the planned share distribution can be found in the Information Statement filed as an exhibit to OncoCyte’s Form 10 Registration Statement filed with the SEC on November 23, 2015, which is available on the Investor Relations page of BioTime’s website: www.biotimeinc.com and the website maintained by the SEC at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy any OncoCyte securities. The distribution of OncoCyte common stock by BioTime will be made only in those states and other jurisdictions where permitted or not prohibited by law.

On December 11, 2015 OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) reported new data related to the development of a novel predictive biomarker for vantictumab (anti-Fzd7, OMP-18R5) at the San Antonio Breast Cancer Symposium (SABCS) (Press release, OncoMed, DEC 11, 2015, View Source [SID:1234508537]). The presentation at SABCS detailed the identification and validation of a novel six-gene signature assay being evaluated as a predictive biomarker of response to vantictumab plus paclitaxel in the treatment of breast cancer. Vantictumab is being studied in three Phase 1b combination clinical trials, including one with paclitaxel in patients with Her2-negative breast cancer.

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"The research presented today is one example of OncoMed’s efforts to identify biomarkers early and aggressively that can be evaluated alongside our therapeutic candidates in order to optimize treatment regimens and patient outcomes," said John Lewicki, Ph.D. Executive Vice President and Chief Scientific Officer of OncoMed. "In preclinical testing, the six-gene biomarker assay has been strongly predictive of anti-tumor responses to treatment with vantictumab in Her2-negative breast cancers. If these results are corroborated in our ongoing clinical study of vantictumab in breast cancer, it will provide an excellent opportunity to develop a companion diagnostic and tailor vantictumab use to patients with the highest likelihood of benefit."

The six-gene Wnt pathway-related biomarker was identified by using gene expression data from breast cancer xenografts in OncoMed’s patient-derived tumor bank with established in vivo response to vantictumab plus standard-of-care. The six-gene signature was tested in 18 xenograft models and effectively predicted anti-tumor responses to treatment. The biomarker was developed as a robust qPCR assay and validated with repeatability studies conducted across different days and in different labs. Prevalence of the six-gene signature is estimated to be approximately 43 percent in Her2-negative patients. In collaboration with Almac Diagnostics, the assay has been successfully developed and is being deployed in OncoMed’s ongoing Phase 1b study of vantictumab in Her2-negative breast cancer.

These data were presented today in a poster titled Development of a 6-gene qPCR RUO-validated assay as a predictive biomarker for response of vantictumab (OMP-18R5; anti-frizzled) in HER2- breast cancer patients (# P3-07-57) during the "Prognostic and Predictive Factors: Response Predictions — Biomarkers and Other Factors" poster session.

About Vantictumab (anti-Fzd7, OMP-18R5)
Vantictumab is a first-in-class antibody that inhibits a key signaling pathway in cancer, the Wnt pathway by selectively targeting Frizzled receptors 1, 2, 5, 7 and 8. In patient-derived xenograft models, vantictumab has shown broad anti-cancer stem cell and anti-tumor activity. Vantictumab is now being tested in combination with standard-of-care chemotherapy in three Phase 1b clinical trials in: 1) advanced NSCLC (vantictumab + docetaxel); 2) advanced HER2-negative breast cancer (vantictumab + paclitaxel); and 3) advanced pancreatic cancer (vantictumab + gemcitabine + Abraxane). Vantictumab is part of OncoMed’s collaboration with Bayer Pharma AG.

Vantictumab is a novel investigational therapeutics currently being evaluated in ongoing clinical trials. Patients interested in participating in one of OncoMed’s many clinical trials may learn more by calling 1-866-914-7347 or emailing [email protected].

On December 11, 2015 Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) reported important progress in its collaboration with NEC Corporation and Yamaguchi University in Japan (Filing, 6-K, Prima Biomed, DEC 11, 2015, View Source [SID:1234508536]). In this collaboration, first announced in May 2015, Prima’s IMP321 Antigen Presenting Cell activator (APC) is being combined with a therapeutic vaccine for different carcinoma types that was developed at Yamaguchi University.

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The Yamaguchi/Prima collaboration resulted from evidence that IMP321 at low doses can be used as a T cell adjuvant for cancer vaccines because of IMP321’s ability to activate dendritic cells1. Under the original May 2015 agreement, scientists at Yamaguchi University and NEC have designed and conducted in vivo studies of the combination, in work supported by NEC Corporation.
Favourable safety data from these studies has now resulted in a decision to progress the vaccine into clinical research. Under a new Material Transfer Agreement (MTA), Yamaguchi University will now work towards clinical research in cancer patients, which will be initiated in Japan in the first quarter of 2016. As with the in vivo work, this proof-of-concept research will be supported by NEC Corporation.

Marc Voigt, Chief Executive of Prima, welcomed the signing of the new MTA: "We are very pleased with the progress our collaborators at Yamaguchi University have made in just six months of work. We see significant upside from this work for cancer patients, given the current limited treatment options for many tumour types and the ease with which we think IMP321 can be used in combination with other therapies".

Yamaguchi University President Dr Masaaki Oka commented, "I am proud of our teams’ work in cancer vaccines, given the increasing importance of immuno-oncology to the future of cancer medicine. We thank Prima BioMed and NEC Corporation for their support and look forward to continued progress".

About IMP321
IMP321, a first-in-class Antigen Presenting Cell (APC) activator based on the immune checkpoint LAG-3, represents one of the first proposed active immunotherapy drugs in which the patient’s own immune system is harnessed to respond to tumour antigenic debris created by chemotherapy. As an APC activator IMP321 boosts the network of dendritic cells in the body that can respond to tumour antigens for a better anti-tumour CD8 T cell response. IMP321 has been shown in an open-label Phase I study to be able to double the expected six-month response rate in HER-2 negative metastatic breast cancer patients receiving standard-of-care paclitaxel, from a 25% historic response rate (RECIST criteria)2 to 50% when combined with IMP3213.

On December 11, 2015 ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) reported that it will continue negotiations with the Economic Committee on Health Care Products in France regarding pricing and reimbursement for Iclusig (ponatinib) into 2016 (Press release, Ariad, DEC 11, 2015, View Source;p=RssLanding&cat=news&id=2121970 [SID:1234508534]). The Company had previously anticipated reaching agreement by year-end 2015. As a result, ARIAD now expects its global product revenue for Iclusig in 2015 to be $110 million to $115 million, excluding France, compared to our previous guidance of $130 million to $140 million. The Company estimates shipments of Iclusig to patients in France for 2015 to be approximately $9 million, and the cumulative value of shipments through year-end 2015 to be approximately $26 million.

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"We are pleased with the continued growth of our business in France as evidenced by increasing product shipments and look forward to successful resolution of price," stated Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "We continue to promote and sell Iclusig in France with the objective of helping patients and driving long-term brand value for key stakeholders."

ARIAD’s previously stated revenue guidance for 2015 assumed the completion of pricing and reimbursement negotiations in France by year-end. ARIAD will record revenue related to cumulative shipments in France upon completion of pricing and reimbursement negotiations, net of any amounts that will be refunded to the French health authorities as a result of these negotiations, which we now anticipate will be completed in 2016.

About Iclusig (ponatinib) tablets

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug-design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

Iclusig is approved in the U.S., EU, Australia, Switzerland, Israel and Canada.

In the U.S., Iclusig is a kinase inhibitor indicated for the:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.
These indications are based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.

IMPORTANT SAFETY INFORMATION, INCLUDING THE BOXED WARNING

WARNING: VASCULAR OCCLUSION, HEART FAILURE, and HEPATOTOXICITY

See full prescribing information for complete boxed warning

Vascular Occlusion: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Monitor for evidence of thromboembolism and vascular occlusion. Interrupt or stop Iclusig immediately for vascular occlusion. A benefit risk consideration should guide a decision to restart Iclusig therapy.
Heart Failure, including fatalities, occurred in 8% of Iclusig-treated patients. Monitor cardiac function. Interrupt or stop Iclusig for new or worsening heart failure.

Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients. Monitor hepatic function. Interrupt Iclusig if hepatotoxicity is suspected.

Please see the full U.S. Prescribing Information for Iclusig, including the Boxed Warning, for additional important safety information.

About ARIAD