On January 11, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported key program updates and its Annual financial guidance at the 34th annual JP Morgan Healthcare Conference (Press release, Halozyme, JAN 11, 2016, View Source [SID:1234508747]).

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"We enter the year with great momentum in our expanded PEGPH20 clinical program and with our collaboration partners, including achieving targeted enrollment in our Phase 2 study in pancreatic cancer patients and signing our sixth ENHANZE global collaboration and licensing agreement through the Lilly relationship we announced last month," said Dr. Helen Torley, president and chief executive officer. "In 2016, we will continue to invest to advance our study of the pan-tumor potential of PEGPH20, and to further expand the value of our growing ENHANZE franchise."

Program updates and recent highlights include:

Achieving target enrollment in Stage 2 of Halozyme Study 202 of investigational new drug PEGPH20 in metastatic pancreatic ductal adenocarcinoma patients. Halozyme has enrolled approximately 120 patients through the end of 2015. The company remains blinded to the efficacy results and projects presentation of mature progression-free survival data in the event driven study in the fourth quarter of 2016.

Reporting a continued reduction in the rate of thromboembolic (TE) events in the PEGPH20 treatment arm in Stage 2 of Study 202. With patient data through Dec. 15, 2015, Halozyme reported a TE event rate in the PEGPH20 arm of 12 percent (9 out of 73 patients) compared to the previously reported 42 percent (31 out of 74 patients) in Stage 1 of the study. Halozyme amended the study protocol in 2014, including the addition of prophylactic administration of low molecular weight heparin (enoxaparin) in both treatment arms based on a reported potential imbalance of TE events in the study.

The TE event rate in both stages and arms of the study are:

Progressing toward HALO-301 | Pancreatic study start, the company provided an update on the Phase 3 trial design selecting approximately 200 sites in 20 countries concentrated in North America, Europe, South America and Asia Pacific. The protocol and statistical design have been reviewed by the majority of participating countries, including the U.S. and multiple E.U. member states through the voluntary harmonization procedure (VHP).

The trial is powered for two primary endpoints, progression-free survival (PFS) and overall survival. Statistical powering to support PFS is based on achieving a hazard ratio of 0.59

Advancing development of the companion diagnostic test to prospectively identify patients with high levels of hyaluronan, or HA.
Halozyme has partnered with Ventana to develop the companion diagnostic and reported the methodology and scoring algorithm have been finalized. Based on the cutpoint for the Ventana diagnostic, Halozyme now expects approximately 35 to 40 percent of metastatic pancreatic cancer patients to have high-HA tumors, similar to the previously reported interim results from Stage 1 of its Phase 2 study using the Halozyme prototype assay.

Analysis of biopsy samples from patients in Stage 1 of Study 202 with the new diagnostic show a PFS benefit in the PEGPH20 arm with a hazard ratio of 0.48.

Signing last month a global collaboration and licensing agreement with Eli Lilly and Company to develop and commercialize products combining proprietary Lilly compounds with Halozyme’s ENHANZE platform. The agreement – Halozyme’s third in 12 months – is for up to 5 collaboration targets using Halozyme’s proprietary ENHANZE technology platform and is valued at up to $160 million for each target. The agreement included an upfront payment of $25 million.

Securing $150 million in non-dilutive financing through a royalty-backed debt transaction announced January 4.

Halozyme also provided financial guidance today for 2016, including:

Revenue of $110 million to $125 million, excluding revenue from any new ENHANZE global collaboration and licensing agreements that may be signed during the year. In 2015, Halozyme recorded $48 million for new ENHANZE partner upfront payments that was not included in 2015 guidance issued at the beginning of the year from initiation of agreements with AbbVie in June and Lilly in December.

Operating Expenses of $240 million to $260 million, supporting the initiation of the Phase 3 study in metastatic pancreatic cancer patients and the continued execution of clinical programs to study the pan-tumor potential of PEGPH20 in non-small cell lung cancer, gastric and breast cancers.

Cash flow of $35 million to $55 million, which assumes receipt in January of $25 million upfront payment from Lilly and $150M from the Royalty Backed Debt Financing.

Year-end cash balance of $140 million to $160 million.

Halozyme will present at 4 p.m. PST on Tuesday, Jan. 12 at the JP Morgan Healthcare Conference. The presentation will be webcast through the "Investors" section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately fifteen minutes prior to the presentation to register and download any necessary audio software.

About Study 202

Study 202 (Halo 109-202) is a phase 2 multi-center, randomized clinical trial evaluating investigational new drug PEGPH20 as a first-line therapy for potential treatment of patients with metastatic pancreatic cancer. The primary outcome of the trial is to measure improvement in progression-free survival in patients receiving investigational new drug PEGPH20 in combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared to gemcitabine and ABRAXANE alone. A second primary endpoint will assess the TE event rate in the PEGPH20 treatment arm. Secondary endpoints also include objective response rate and overall survival. More information may be found at: View Source

About PEGPH20

PEGPH20 is an investigational PEGylated form of Halozyme’s proprietary recombinant human hyaluronidase under clinical development for the potential systemic treatment of tumors that accumulate hyaluronan.

FDA granted orphan drug designation to PEGPH20 for treatment of pancreatic cancer and fast track for PEGPH20 in combination with gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer. Additionally, the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency, designated investigational drug PEGPH20 an orphan medicinal product for the treatment of pancreatic cancer.

About ENHANZE

ENHANZE is Halozyme’s proprietary drug delivery platform based on its patented, FDA-approved recombinant human hyaluronidase enzyme (rHuPH20) injection. The ENHANZE platform enables rHuPH20 to be co-administered with other biologics for both research and commercialization purposes. The combination of ENHANZE with some intravenously administered biologics and compounds offers the potential benefit of enabling subcutaneous delivery. In other cases, combining with ENHANZE may reduce the number of injections required for some subcutaneously administered biologics. For approved prescribing information for approved rHuPH20, visit www.hylenex.com.

On January 11, 2016 Foundation Medicine (NASDAQ:FMI) reported preliminary unaudited total revenue of approximately $26.1 million in the fourth quarter of 2015 and $93.2 million for the full year ended December 31, 2015, a 39% and 53% increase from the $18.7 million and $61.1 million recorded in the fourth quarter and full year ended December 31, 2014, respectively (Press release, Foundation Medicine, JAN 11, 2016, View Source [SID:1234508744]). The company reported 8,286 clinical tests to ordering physicians in the fourth quarter of 2015, compared to a total of 7,233 tests reported during the fourth quarter of 2014. A total of 32,998 clinical tests were reported to ordering physicians for the full year ended December 31, 2015, compared to 24,271 clinical tests reported in 2014. Cash, cash equivalents and marketable securities at December 31, 2015, was approximately $232 million.

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"Foundation Medicine achieved significant strategic and operational advances across all aspects of our molecular information business in 2015 that position the Company for continued growth in 2016 and beyond," stated Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "Specifically, we grew our commercial business and our molecular information platform to more than 68,000 cases, expanded our biopharmaceutical business both in terms of the number of partners and revenue, strengthened our leadership position through our collaboration with Roche, and secured our first national payer contract for metastatic non-small cell lung cancer with United Healthcare."

2015 Enterprise Highlights:

Completed a strategic transaction with Roche to further advance Foundation Medicine’s market-leading position in molecular information and expand access to the company’s products globally.

Grew biopharmaceutical revenue by approximately 80% in 2015 and added new molecular information and companion diagnostic collaborations with Roche, H3 Biomedicine, Mirati Therapeutics, and several other partners.

Improved patient access to comprehensive genomic profiling by signing a national agreement with United Healthcare for FoundationOne in metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a Medicare Administrative Contractor (MAC), announced a final local coverage determination for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer.

Expanded its molecular information platform to more than 68,000 cases.

Advanced its circulating tumor DNA (ctDNA) assay program by initiating a large, multi-center clinical study to support the anticipated commercial launch of the assay in 2016. The ctDNA assay was launched to biopharmaceutical partners in 2015, as planned.

Launched the Precision Medicine Exchange Consortium (PMEC) with leading academic medical centers and community oncology networks to advance the integration of molecular information into clinical oncology and accelerate the adoption of precision care.
Launched decision support tools to help improve utilization of molecular information by oncologists and pathologists, including enhancements to FoundationICE, such as PatientMatchTM and the introduction of GeneKitTM, a genomics solutions portal for pathologists.

Published 56 peer-reviewed manuscripts in top medical and scientific journals and presented 101 podium talks and posters at scientific and medical meetings.

2016 Outlook

The company expects revenue in 2016 will be in the range of $110 to $120 million and operating expenses will be in the range of $175 and $185 million. The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016. The company also expects to expand upon progress made in 2015 with Palmetto and commercial payers and drive additional coverage decisions.

As part of its commitment to providing healthcare practitioners with a full suite of analytically validated genomic profiling assays to support precision medicine in oncology, the company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016. The assay is being rigorously evaluated as part of an ongoing, multi-center study to identify patients who are most likely to benefit from liquid-based genomic profiling. The study will also provide the analytic validation mandated for clinical use of a commercial ctDNA assay. To further support the commercial launch of the assay, the laboratory will have expansion capability for a QSR-compliant version of the assay to support companion diagnostics for potential FDA approval.

Complete quarterly and full year financial results will be announced during the company’s fourth quarter and fiscal year 2015 financial results conference call in February. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company’s management and its independent auditors.

Dr. Pellini is scheduled to present at the 34th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2016, at 9:30 a.m. PST, in San Francisco. A live, listen-only webcast of the presentation and breakout session may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the presentation and breakout session and will be archived on the company’s website for two weeks.

On January 11, 2016 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company) reported 2015 achievements and provided an outline of the Company’s key business objectives for 2016 (Press release, Cyclacel, JAN 11, 2016, View Source [SID:1234508742]). These will be highlighted at the Company’s presentation during the Biotech Showcase 2016 Conference at 9:30 a.m. PST, Monday, January 11, 2016, at the Parc 55 Wyndham Hotel – Union Square at 55 Cyril Magnin Street in San Francisco.

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"During 2015, we continued to follow-up patients in SEAMLESS, our Phase 3 clinical trial evaluating sapacitabine in the front-line treatment setting of elderly patients with acute myeloid leukemia, or AML," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Approximately 7% of prespecified events remain to be observed before we can unblind the randomization code and report top-line results. We anticipate this happening by the end of the first half of 2016. At that point, we will analyze available data and determine submissibility to regulatory authorities. We also continued to follow patients in our Phase 1 trial of sapacitabine and seliciclib in patients with advanced solid tumors. Based on observations to date, we are extending the trial into a selected population of patients with breast cancer who are positive for BRCA mutations. Finally, we advanced CYC065, our second-generation CDK2/9 inhibitor, into a Phase 1, first-in-human study. Based on our preclinical data, we have determined the mechanistic rationale for the clinical development of CYC065 in certain hematological and solid tumor indications. We believe that 2016 may prove to be an important year for Cyclacel and we look forward to keeping you apprised of developments as the year unfolds."

2015 Achievements

Drug Development

Sapacitabine in SEAMLESS, pivotal Phase 3 study as first-line treatment in elderly patients with AML:

Continued follow-up and treatment of patients of this fully enrolled study.
7% of events remain before reporting topline results and mature data analysis.
Submitted to the European Medicines Agency (EMA) a Paediatric Investigation Plan application for sapacitabine.

Sapacitabine and seliciclib in Phase 1 study in patients with advanced solid tumors

Continued to follow patients treated with the all-oral combination of the CDK2/9 inhibitor seliciclib and sapacitabine in a Phase 1 trial in patients with advanced solid tumors. A breast cancer patient with BRCA mutations has been administered more than 70 cycles of the combination and continues on treatment.

Cyclin Dependent Kinase (CDK) Inhibitor Programs

Dosed the first patients in a Phase 1 trial of CYC065, the Company’s second-generation CDK2/9 inhibitor, to evaluate the safety, tolerability and pharmacokinetic profile of CYC065 in solid tumor and lymphoma patients.

Presented preclinical data on the molecular rationale and therapeutic potential in both hematologic and solid tumors of CYC065 at several medical conferences including the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2015, the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting, the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference and the San Antonio Breast Cancer Symposium (SABCS). The data show that:
CYC065 may reverse drug resistance associated with addiction of cancer cells to cyclin E, the partner protein of CDK2.
CYC065 may also inhibit CDK9-dependent oncogenic and leukemogenic pathways, including malignancies driven by certain oncogene and MLL rearrangements. MLL gene status and levels of Bcl-2 family proteins correlated with sensitivity of AML cell lines to CYC065.

CYC065’s anticancer activity presents an opportunity for patient stratification and combinations with anti-leukemic agents.
CYC065 was also effective against uterine cancer cells including those resistant to chemotherapy and was especially potent in uterine cancer cells in which cyclin E was amplified or overexpressed.

CYC065 could be active in triple-negative breast cancer.

First patients dosed in a Phase 2 investigator-sponsored trial (IST) evaluating seliciclib in patients with Cushing’s disease.
Presented preclinical data at the 4th Neuroblastoma Symposium in Newcastle Upon Tyne, UK demonstrating that CYC065 prolongs survival in MYCN-addicted neuroblastoma models.

Corporate Developments

Raised gross proceeds of $10 million from a public offering of common stock.
Entered into a Controlled Equity OfferingSM Sales Agreement with Cantor Fitzgerald & Co., as sales agent ("Cantor"), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to $8.35 million through Cantor.

Entered into a license and supply agreement with ManRos Therapeutics regarding the development of oral seliciclib for the treatment of cystic fibrosis.

2016 Key Upcoming Business Objectives

Sapacitabine in SEAMLESS:

Continue follow-up of patients until the requisite number of events occur, which is anticipated by the end of the first half of 2016.
Report top-line results.

Following analysis of the mature data set determine submissibility to regulatory authorities for marketing approval.
Progress a Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
Sapacitabine in myelodysplastic syndromes (MDS):

Initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.

Sapacitabine and seliciclib in Phase 1 study in patients with advanced solid tumors:

Initiate expansion of the Phase 1 study in a breast cancer patient population enriched for BRCA mutations.
Report updated Phase 1 data.

Cyclin Dependent Kinase (CDK) Inhibitor Programs

Report top-line results of the CYC065 Phase 1 trial in solid tumor and lymphoma patients.

Report data from seliciclib ISTs when available.

For the live and archived webcast of the Company’s presentation at the Biotech Showcase 2016 San Francisco conference, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for seven days.

On January 11, 2015 Celgene Corporation (NASDAQ:CELG) reported a business update as well as its preliminary 2015 results and financial outlook for 2016 at the 34th Annual J.P. Morgan Healthcare Conference (Press release, Celgene, JAN 11, 2016, View Source [SID:1234508741]). In 2016, net product sales are expected to be approximately $10.5 billion to $11.0 billion, a 17 percent increase year-over-year, based on the mid-point of the range. The negative impact of foreign exchange on net product sales is expected to be approximately $120 million in 2016. For the full-year 2016, REVLIMID net sales are expected to be in the range of $6.6 billion to $6.7 billion. Adjusted diluted earnings per share (EPS) for the full-year 2016 is expected to be in the range of $5.50 to $5.70, a 19 percent increase year-over-year, based on the mid-point of the range. Based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected to be in the range of $4.26 to $4.64.

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"In 2015, we delivered a strong year operationally and commercially with eight regulatory approvals, the acquisition of Receptos and significant acceleration of our pipeline," said Bob Hugin, Celgene’s Chairman and Chief Executive Officer. "The momentum in our operations and the advancement of our pipeline gives us confidence in our 2020 targets and beyond."

Preliminary 2015 Financial Results Year-Over-Year (Unaudited)

Total net product sales are expected to be approximately $9,160 million, up 21 percent year-over-year. Fourth quarter of 2015 net product sales are expected to be approximately $2,540 million.
REVLIMID: $5,801 million, 16 percent year-over-year increase
ABRAXANE: $967 million, 14 percent year-over-year increase

POMALYST/IMNOVID: $983 million, 45 percent year-over-year increase
OTEZLA: $472 million in the first full year of sales

Adjusted operating margin is expected to be approximately 52 percent for the full year, up 140 basis points (bps) year-over-year. GAAP operating margin is expected to be approximately 24 percent, a decrease from 33 percent in the prior year, primarily due to increased upfront payments to collaboration partners in 2015

Adjusted diluted EPS is expected to be approximately $4.71, a 27 percent year-over-year increase, and reflects $0.14 dilution associated with the Receptos Inc. transaction. GAAP diluted EPS is expected to be in the range of $1.89 to $1.99, and reflects $0.40 dilution associated with the Receptos Inc. transaction

For the fourth quarter of 2015 adjusted diluted EPS is expected to be approximately $1.18, including a $0.07 impact from a $70 million milestone achieved by OncoMed Pharmaceuticals Inc. during the quarter. GAAP diluted EPS is expected to be in the range of $0.63 to $0.73

Certain activities involved in determining the audited results for the fiscal year ended December 31, 2015 are in process and could result in the final reported audited results being different from the unaudited results noted in this press release. Please see the attached Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Measures for further information.

Celgene Expects Strong Product Sales and Earnings Growth in 2016

Total net product sales of $10.5 billion to $11.0 billion, an increase of 17 percent year-over-year based on the mid-point of the range and includes a negative impact from foreign exchange of approximately $120 million
REVLIMID net sales in the range of $6.6 billion to $6.7 billion, an increase of 15 percent year-over-year based on the mid-point of the range

Adjusted operating margin of approximately 53.5 percent after investments across the entire organization, a 150 bps improvement over 2015. GAAP operating margin is expected to be approximately 42 percent

Adjusted diluted EPS in the range of $5.50 to $5.70, an increase of approximately 19 percent year-over-year based on the mid-point of the range. GAAP diluted EPS is expected to be in the range of $4.26 to $4.64
Fully diluted share count in 2016 of approximately 825 million

Please see the attached Reconciliation of Estimated/Projected GAAP to Adjusted (Non-GAAP) Measures for further information.

Affirming Expected 2020 Long-term Financial Targets

2020 total net product sales to exceed $21 billion
Hematology franchise to exceed $14.8 billion
Oncology franchise to exceed $2.2 billion
I&I franchise to exceed $4 billion
Adjusted diluted EPS to exceed $13.00
Fully diluted share count of approximately 830 million
2016 Expected Operational Milestones

Hematology/Oncology

Regulatory Submissions/Decisions

Submission for REVLIMID as maintenance after stem-cell transplant in newly diagnosed multiple myeloma (NDMM) in the U.S. and Europe
Submission of renal impairment data for label update for POMALYST/IMNOVID in relapsed/refractory multiple myeloma (RRMM) in the U.S. and Europe
Submission of ABRAXANE for early-stage breast cancer in Europe
Decision by the Committee for Medicinal Products for Human Use (CHMP) on the submission of REVLIMID for relapsed/refractory mantle cell lymphoma in Europe

Clinical Data

Data from the phase III REMARC trial with REVLIMID as maintenance in diffuse large B-cell lymphoma (DLBCL)
Data from the phase III cooperative group ETNA trial with ABRAXANE as neoadjuvant therapy in HER2-negative high-risk breast cancer
Data from the CLL-002 CONTINUUM trial with REVLIMID as maintenance in relapsed/refractory chronic lymphocytic leukemia (CLL)

Data from a phase II trial with CC-122 in non-Hodgkin’s lymphoma (NHL)
Data from phase II trials with motolimod (VTX-2337) in squamous cell carcinoma of the head and neck and ovarian cancer in collaboration with partner VentiRx
Data from the phase II tnAcity trial with ABRAXANE in triple-negative breast cancer

Trial Enrollment

Complete enrollment in the phase III AUGMENT trial with REVLIMID in relapsed/refractory follicular lymphoma
Complete enrollment in the phase III apact (PANC-003) trial with ABRAXANE as adjuvant therapy in surgically resected pancreatic cancer
Complete enrollment in a phase II trial with CC-486 in combination with pembrolizumab in locally advanced or metastatic non-small cell lung cancer

Trial Initiations

Initiate enrollment in a phase I trial of B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy in RRMM in collaboration with partner bluebird bio
Initiate enrollment in six trials in the FUSIONTM program with durvalumab in NDMM, RRMM, NHL, myelodysplastic syndromes and acute myeloid leukemia with partner AstraZeneca/MedImmune
Initiate phase II combination studies with AG-221 and AG-120 in frontline AML in collaboration with partner Agios

I&I

Regulatory Submissions/Decisions

Submission of OTEZLA for psoriasis in Japan

Clinical Data

Long-term radiographic data from the POSTURE (AS-001) trial with OTEZLA in ankylosing spondylitis
Data from the phase III PSA-006 trial with OTEZLA in patients with active psoriatic arthritis who are biologic-naïve
Data from the phase III PSOR-011 trial with OTEZLA in Japanese patients with psoriasis
Data from a pharmacokinetic comparability study to support registration of the OTEZLA once-daily formulation
Data from a phase II trial with OTEZLA in atopic dermatitis
Data from a phase II trial with CC-220 in systemic lupus erythematosus
Data from a phase II trial with RPC-4046 in eosinophilic esophagitis

Trial Enrollment

Complete enrollment in the phase III RELIEFTM (BCT-002) trial with OTEZLA in active Behçet’s disease
Complete enrollment in a phase II trial with OTEZLA in ulcerative colitis
Complete enrollment in the phase II STEPSTONE trial with ozanimod in Crohn’s disease
Research and Early Development

File eight Investigational New Drug (IND) applications
Advance at least two compounds to mid-to-late stage development

Management Changes

On January 8, the Company announced changes to our Research & Early Development organizational structure, which will leverage our strong foundation and drive the rapid advancement of next generation landmark therapies. Tom Daniel, MD, President, Research and Early Development is appointed to Chairman of Celgene Research. Tom, who has been instrumental in building our broad and deep development engine, will oversee strategic initiatives and investments in our research and collaboration portfolio. Rupert Vessey, MA, BM BCh, FRCP, DPhil succeeds Tom Daniel as President, Research and Early Development. Rupert joined Celgene a year ago bringing great insight and leadership to the evolution of our discovery and development strategies in inflammation and immunology as well as in hematology and oncology. Rupert is responsible for leading the execution of discovery and development programs across our portfolio ensuring Celgene capitalizes on the potential of its internal and partnered opportunities. Rob Hershberg, MD, PhD is promoted to Chief Scientific Officer (CSO) and will lead the expansion of our scientific platforms and discovery capabilities. Rob joined Celgene in August 2014 and has led the development of our immuno-oncology efforts, helping to engineer several key collaborations and partnerships.

Q4 and Full year 2015 Conference Call and Webcast Information

Celgene will host a conference call to discuss the fourth quarter and full-year of 2015 operational and financial performance on Thursday, January 28, 2016, at 9 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from noon January 28, 2016, until midnight ET February 4, 2016. To access the replay in the U.S., dial 1-855-859-2056; outside the U.S. dial 404-537-3406. The participant passcode is 11177982.

On January 11, 2016 Celator Pharmaceuticals, Inc. (Nasdaq:CPXX) reported that CPX-351 (also known as VYXEOS) has been selected for participation in a Cardiff University-sponsored clinical trial in adult patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) (Press release, Celator Pharmaceuticals, JAN 11, 2016, View Source [SID:1234508740]).

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"This study is designed to use a risk-based approach to treat younger patients with AML," said Professor Nigel Russell, Centre for Clinical Haematology, Nottingham University Hospital, the trial’s chief investigator. "CPX-351 has demonstrated encouraging activity in high-risk patients. We are excited to study the product in those patients with the highest risk disease."

Some of the anticipated findings from the trial related to CPX-351:

Evaluating CPX-351 in younger patients ( < 60 years of age) in a front line setting
For poor risk patients, to compare CPX-351 versus FLAG-Ida
In patients who fail following FLAG-Ida (two courses) to evaluate a combination of CPX-351 and fludarabine
Evaluating the clinical activity of CPX-351 in patients following treatment with an immunoconjugate
Evaluating the relevance of detecting minimal residual disease using one of two methods (molecular and immunophenotypic)
Health resource utilization
Clinical trials with CPX-351 have shown improved efficacy and reduced early mortality in the majority of patients studied directly supporting evaluating CPX-351 in these patient populations.

"We are pleased that Professor Russell and the trial sponsors chose to study CPX-351 in these patient populations," said Arthur Louie, Chief Medical Officer of Celator Pharmaceuticals. "As we await overall survival data from our CPX-351 Phase 3 trial in patients with high-risk AML, we believe there is significant potential for CPX-351 in other AML populations as well as other blood cancers such as high-risk MDS, and we believe it important to continue to evaluate these opportunities."

About the AML 19 clinical trial

The trial is open to all patients aged 18 to 60 years, and also to patients aged 60 years or over for whom intensive therapy is considered appropriate. In total, across all arms of the study, approximately 3,000 patients are expected to be recruited. The clinical trial has started enrolling patients.

Patients with known adverse cytogenetics will be randomized to receive either FLAG-Ida (fludarabine/cytarabine/G-CSF and idarubicin) or CPX-351 (cytarabine:daunorubicin) liposome injection as induction. Non-adverse cytogenetic patients will be randomized to compare two courses of FLAG-Ida with DA (daunorubicin/cytarabine) chemotherapy each in combination with one of two doses of the immunoconjugate Mylotarg (gemtuzumab ozogamicin).

After one course of treatment, patients who are at high risk of relapse based on the AML Risk Score, or who are deemed refractory ( < 50% reduction in blast percentage, and resistant disease) will be eligible to enter a randomized study of FLAG-Ida compared to CPX-351, with the aim of allowing patients to proceed to allogeneic transplant.

Patients who are not in remission after two courses of FLAG-Ida or in relapse within 6 months after FLAG-Ida, are eligible to receive CPX-351 in combination with fludarabine, for induction and consolidation.