Avastin - Anti-Angiogenic or Vascular Permeability Factor

1. <br />ONCOLOGYWeek of March 14, 2011By Scott Jordan, Partner -- scott@sjordanassociates.com News & Events: Avastin - Anti-Angiogenic or Vascular Permeability FactorNews SummaryNews & Events: Avastin - Anti-Angiogenic or Vascular Permeability Factor The theory that Avastin kills tumors by cutting of blood supply is open to question because there is little evidence it works on its own. Prior to being classified as an anti-angiogenesis agent (tumor growth can be stopped by turning off a cancer cell’s access to blood by deactivating a chemical known as vascular endothelial growth factor or VEGF, which spurs blood-vessel growth) Avastin was referred to as a Vascular Permeability Factor (VPF) agent. Recent studies have added credence to the VPF mechanism of action (MoA) argument. Adding Avastin to a weak chemotherapy backbone results in pronounced efficacy versus when added to a strong chemotherapy backbone like modern combination regimens wherein the added benefit of Avastin is modest. Follow-up studies of Avastin in colorectal cancer with newer types of chemotherapy, Folfox and Xelox, increased progression free survival for just 1.4 months and offered no significant improvement in survival (versus registration approval study using older chemotherapy regimen – added five months of survival). Tests with two types of chemotherapy against lung cancer resulted in an outcome similar to that of later performed colorectal cancer studies. When combined with slightly more powerful Cisplatin chemotherapy (widely prescribed in Europe), Avastin did not improve overall survival and had a smaller effect on progression-free survival.Building upon the validity of the Vascular Permeability Factor theory in cancer therapy, recent studies including JNCI’s “Stromal Depletion Goes on Trial in Pancreatic Cancer” (Vol. 102, Issue 7, April 7, 2010) and Cancer Cell’s “Pancreatic Cancer – Could It Be that Simple? A Different Context of Vulnerability” postulate stroma blocks drug penetration contributing to cancer survival. Several combination therapies are now in clinical trials to test the “stromal depletion hypothesis” including Abraxane (nab-paclitaxel) in pancreatic cancer (30% of those diagnosed with pancreatic cancer have stroma-rich hypovascular tumors that cannot be resected because the tumor encases the superior mesenteric artery). Tumor stromal inflammatory cells (lymphocytes, macrophages, mast cells) and stromal fibroblasts oftentimes comprise up to 50-70% of tumor mass. Tumor cells co-evolve with stromal cells and there is active biodirectional communication between stromal and tumor cells. Ability of tumor-associated stromal cells to induce EMT (Epithelial-mesenchymal transition or transformation – program of development of biological cells characterized by loss of cell adhesion, repression of E-cadherin expression, and increased cell mobility) in tumor cells has been well established. Additional evidence strongly suggests that tumor-associated stromal cells provide paracrine stimuli for mesenchymal cell growth and survival. Primary epithelial tumor cells can undergo EMT and become mesenchymal in order to metastasize and in the process lose sensitivity to many drugs that target epithelial tumors; drug and drug combinations that target EMT form the basis of rational selection of therapies to enhance EGFR responsiveness. Abraxis (company that developed and markets Abraxane/nab-paclitaxel) reported in the Journal National Cancer Institute (2004; 96:90-1) that albumin in nab-paclitaxel actively binds to the protein SPARC in pancreatic tumors further concentrating the drug in the tumor. The effect leads to a “stromal collapse. ” The SPARC protein is highly concentrated in the stroma and positive SPARC expression predicts poor clinical outcome. In response, leading clinical oncologist, Dr. Daniel Von Hoff, launched a Phase I/II trial of nab-paclitaxel in combination with gemcitabine in metastatic pancreatic cancer. Results presented at the 2009 American Society of Clinical Oncology (ASCO) meeting detailed of 58 evaluable patients treated with Stage IV (metastatic) disease, 23 achieved a partial response, and 22 stable disease. Median time to progression-free survival was 6.9 months and overall survival was 10.3 months. For the 44 patients treated at the best dose of nab-paclitaxel, the median progression-free survival was 7.9 months, and the median survival had not been reached. By comparison, median survival for patients treated with gemcitabine alone is 5.9 months, and combining it with erlotinib (Tarceva) gives only 2 more weeks. A Phase III trial launched in March 2009 in metastatic pancreatic cancer enrolling 630 patients with a primary endpoint of survival.The debate over Avastin’s mechanism of action (MoA) will be debated for some time given the failure of Avastin in combination with modern chemotherapy regimens (pointing toward a hypothesis that in weaker chemotherapy regimens, Avastin depletes the stromal layer and allows more chemotherapy to reach the tumor) and recent positive outcomes in treating cancer with stromal depletion agents. In the next issue of “Vital Signs” we will explore the role of EMT/CTGF (Connective Tissue Growth Factor) in the maintenance of cancer stem cells (CSCs) and explore promising emerging growth companies with therapeutic programs targeting CSCs. Clinical & Regulatory:Helix BioPharma Corp. announced that it has filed a clinical trial application with the Central Register of Clinical Trials at the Polish Ministry of Health seeking approval to perform its planned Phase I/II clinical safety, tolerability and preliminary efficacy study of its lung cancer drug candidate L-DOS47. L-DOS47 is Helix’s first therapeutic immunoconjugate drug candidate under development based upon the Company’s novel DOS47 technology, which is designed to modify the microenvironmental conditions of cancer cells in a manner that leads to their destruction. L-DOS47 is intended to offer an innovative approach to the first-line treatment of inoperable, locally advanced, recurrent or metastatic, non-small cell lung cancer. The CTA review process in Poland typically requires 60 days, during which the reviewers will decide if an applicant is permitted to proceed with its proposed clinical trial. Additional information may be requested from the applicant, which could extend the review period. About the Planned Phase I/II Study: The proposed Phase I/II study is planned to be an open-label, non-randomized study to evaluate the safety, tolerability and preliminary efficacy of L-DOS47 alone and in combination with chemotherapy or radiation therapy. The study is planned to be conducted in patients with inoperable, locally advanced, recurrent or metastatic non-squamous NSCLC, using a multi-arm design whereby patients will be recruited into one of four treatment arms: (1) L-DOS47 monotherapy; (2) L-DOS47 + vinorelbine; (3) L-DOS47 + vinorelbine + cisplatin; or (4) L-DOS47 + radiation therapy. Vinorelbine, cisplatin and radiation therapy are all common treatments used for NSCLC.Oncolytics Biotech Inc. announced that enrollment has been completed in a U.K. translational clinical trial investigating intravenous administration of REOLYSIN in patients with metastatic colorectal cancer prior to surgical resection of liver metastases (REO 013). The principal investigator is Professor Alan Melcher of St. James's University Hospital and the trial is sponsored by the University of Leeds, UK. The trial was an open-label, non-randomized, single centre study of REOLYSIN given intravenously to patients for five consecutive days in advance of their scheduled operations to remove colorectal cancer deposits metastatic to the liver. After surgery, the tumour and surrounding liver tissue were assessed for viral status and anti-tumour effects. The primary objectives of the trial are to assess the presence, replication and anti-cancer effects of reovirus within liver metastases after intravenous administration of REOLYSIN by examination of the resected tumour. Secondary objectives include assessing the anti-tumour activity and safety profile of REOLYSIN, and monitoring the humoral and cellular immune response to REOLYSIN. Eligible patients included those with histologically proven colorectal cancer, planned for potentially curative surgical resection of liver metastases. A total of 10 patients were treated in the study. The results are expected to be fully reported in 2011.Amgen Inc. announced the publication of results from a pivotal Phase 3 study of 1,776 advanced cancer patients with different types of solid tumors (not including breast and prostate cancer) or multiple myeloma, which compared XGEVA(TM) (denosumab) to Zometa(R) (zoledronic acid) in preventing skeletal-related events (SREs). The study, which appeared in the Journal of Clinical Oncology, found that XGEVA was non-inferior to Zometa in delaying or preventing SREs. XGEVA, the first and only RANK Ligand inhibitor indicated for the prevention of SREs in patients with bone metastases from solid tumors was approved by the U.S. Food and Drug Administration (FDA) on Nov. 18, 2010. The approval was based in part on results described in this publication. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma. For the primary endpoint of this study, the median time to first on-study SRE (defined as fracture, radiation to bone, surgery to bone, or spinal cord compression) was 20.6 months for patients receiving XGEVA and 16.3 months for patients receiving Zometa (hazard ratio 0.84, 95% CI: 0.71-0.98), which is statistically significant for non-inferiority (p=0.0007). Although numerically greater, the delay in the time to first SRE associated with XGEVA was not statistically superior compared to Zometa based upon the statistical testing strategy (adjusted p=0.06) (secondary endpoint). The time to first- and subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95% CI: 0.77-1.04, p=0.14) (secondary endpoint). In a subgroup analysis of patients with multiple myeloma, mortality appeared to be higher for denosumab-treated patients compared to those in the control arm (hazard ratio [95% CI] of 2.26 [1.13, 4.50]; n = 180). The limited number of patients in this subgroup, however, precludes definitive conclusions regarding the effects of XGEVA in multiple myeloma patients.Fate Therapeutics, Inc. reported preliminary data from an ongoing Phase 1b clinical trial of FT1050 at the 2011 BMT Tandem Meetings in Honolulu, Hawaii. The goal of the Phase 1b trial, which is being conducted at the Dana-Farber Cancer Institute and Massachusetts General Hospital, is to determine the safety and tolerability of introducing FT1050 during the standard course of dual umbilical cord blood transplant in adult patients with hematologic malignancies, such as leukemia and lymphoma, who have undergone nonmyeloablative conditioning therapy. Fate Therapeutics is developing FT1050 to improve the overall efficiency of hematopoietic stem cell (HSC) support by enhancing HSC homing to and proliferation in the bone marrow. In the ongoing Phase 1b clinical trial, after a reduced-intensity conditioning regimen, each patient receives two umbilical cord blood units for hematopoietic reconstitution: one treated ex vivo at the point-of-care with FT1050 and one untreated. Fifteen subjects of an anticipated 21 have been enrolled to date, with the last six having received an umbilical cord blood unit using the current FT1050 treatment protocol designed to enhance activity; the first nine patients received an umbilical cord blood unit using an earlier version of the FT1050 treatment protocol designed to assess safety. The investigators evaluated the safety of FT1050 as well as the time to initial hematopoietic reconstitution, and which cord blood unit ultimately contributed most to blood count recovery. The average time to engraftment for the six patients who were treated under the current protocol was 18.5 days compared to a historic average of approximately 21 days. In addition, five of these six patients engrafted with the FT1050 treated cord blood unit, suggesting that FT1050 may confer preferential engraftment. In all 15 patients, the safety profile did not appear to differ from that of a standard double umbilical cord transplant. To date, only one patient has experienced Grade 2 or higher acute graft versus host disease. Ten of 15 patients remain alive and disease-free. Accrual is ongoing. In addition, Fate Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to FT1050 for the ex vivo treatment of human allogeneic hematopoietic stem cells to enhance stem cell engraftment by treating neutropenia, thrombocytopenia, lymphopenia and anemia. The Company has also received a positive recommendation by the Committee for Orphan Medicinal Products for orphan designation in the European Union.AB Science S.A. announced publication in The Veterinary Journal of results from a preclinical study showing that masitinib has potential as a chemosensitizer. This study, conducted by Dr. Douglas Thamm (VMD, Diplomate ACVIM Oncology; Colorado State University) and colleagues, investigated the ability of masitinib to sensitize different canine cancer cell lines to various chemotherapeutic agents. Results showed that masitinib sensitized numerous tumor cell lines from different origins (breast, bladder, melanoma, lymphoma, etc.) to chemotherapeutic drugs such as doxorubicin, gemcitabine and vinblastine. These data also provide additional weight to findings from studies showing that masitinib can enhance the antiproliferative effects of gemcitabine in human pancreatic cancer, including gemcitabine-resistant cell lines, which is a property not seen with other tyrosine kinase inhibitors (Humbert et al. PLoS One, 2010). Masitinib was the first ever approved anticancer drug in veterinary medicine, receiving approval from the European Medicines Agency (EMA) under the trade name Masivet. Masitinib has also recently become obtainable in the United States under the trade name Kinavet CA-1, having received conditional approval in December 2010 from the US Food and Drug Administration (FDA) for treatment of recurrent or nonresectable Grade II and Grade II cutaneous mast cell tumors in dogs that have not previously received radiotherapy and/or chemotherapy except corticosteroids. AB Science is developing masitinib in veterinary medicine in oncology, including several studies to further investigate masitinib's potential as a chemosensitizer, as well as in non-oncology diseases, such as canine atopic dermatitis or asthma in cats. A summary of masitinib's veterinary clinical development program is provided below (note that this list of indications reflects the development program of masitinib in veterinary medicine and should not be interpreted as a list of indications for which masitinib has demonstrated efficacy). Besides using the animal health segment as a source of revenues to finance its clinical development program in human medicine, AB Science is also using veterinary medicine as a platform to discover new indications for its lead compound masitinib and translate this use into human medicine.ImmuPharma Plc announced encouraging results from its ongoing phase I/IIa clinical trial in cancer patients: around half of the cancer patients that have undergone treatment with ImmuPharma's drug candidate IPP-204106 are in stable condition (their disease has stopped progressing) without any other drug treatment. All the patients that enrolled in the study were suffering from advanced cancer with metastases and had all failed their previous treatments with other existing cancer drugs. The third dose level of IPP-204106 has just begun in the next group of patients. ImmuPharma's clinical trial began last summer and up to now two lower dose levels have been tested. The initial dose level of 1 mg/kg did not show any drug-related side effects. The first patient to be treated in this study is still alive and with stable disease 8 months after starting treatment with ImmuPharma's cancer compound. The second dose level of 2 mg/kg also did not show any drug-related side effects. ImmuPharma has already begun development of the next generation of IPP-204106, the 'micro Nucants'. This improved formulation comprising of small particles of the drug candidate has shown an even more impressive efficacy in cancer models. The clinical trial is taking place in two hospitals in Paris and one hospital in Dijon, in France and is expected to complete in the coming months. ImmuPharma hopes to start a Phase IIb programme later in 2011 in patients with glioblastoma (brain tumour), hormone-resistant prostate cancer and pancreatic cancer.Prima Biomed Ltd. - Special call to provide updates and commentary around the phase III study of CVac(TM), the unmet medical need of ovarian cancer patients and relevance for the medical oncology professionCorporate Finance:Thallion Pharmaceuticals, Inc. announced consolidated earnings results for the fourth quarter and full year ended November 30, 2010. Net loss for the quarter was $1,128,252 or $0.04 per basic and diluted share compared to $4,685,447 or $0.15 per basic and diluted share for the three-month period ended November 30, 2009. Net loss for the year was $4,880,232 or $0.15 per basic and diluted share compared to $13,948,305 or $0.43 per basic and diluted share for the corresponding period in 2009. Revenues were $3,911,772 against $78,247 reported last year. The changes in net loss were mainly attributable to collaboration and licensing revenues beginning in 2010, as well as reductions in R&D expenses, lease exit costs, stock-based compensation expenses and the write-off of capital assets, partially offset by the 2009 gain on the settlement of note receivable with Caprion Proteomics Inc. Net cash flows from operating activities were $932,072 against net cash used in operating activities of $10,715,638 and additions to capital assets were $16,721 against $22,215 reported last year.GTX Inc. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2010. For the quarter, the company reported total revenue was $1,805,000 against $3,677,000 for the same period a year earlier. Loss from operations was $8,756,000 against $10,937,000 for the same period a year earlier. Loss before income tax was $7,529,000 against $10,919,000 for the same period a year earlier. Net loss was $7,529,000 or $0.16 per basic and diluted share against $10,875,000 or $0.30 per basic and diluted share for the same period a year earlier.For the year, the company reported total revenue was $60,613,000 against $14,730,000 for the same period a year earlier. Income from operations was $13,931,000 against loss from operations of $46,682,000 for the same period a year earlier. Income before income tax was $15,294,000 against loss before income tax of $46,494,000 for the same period a year earlier. Net income was $15,294,000 or $0.39 per basic and diluted share against net loss of $46,256,000 or $1.27 per basic and diluted share for the same period a year earlier.Progen Pharmaceuticals Limited reported consolidated earnings results for the half year ended December 31, 2010. For the period, net loss decreased 61.2% to AUD 3,176,000 or 12.85 cents basic and diluted loss per share compared to a loss of AUD 8,192,000 or 33.16 cents basic and diluted loss per share for the six months ended December 31, 2009. The variance is primarily due to reduced costs of AUD 1.8 million as a result of the settlement with Medigen in 2009, a decrease in research and development expenditure of AUD 1.1 million, a reduction in legal expenses of AUD 826,000 and administrative savings of AUD 516,000. Increased profitability of the company’s manufacturing operations also contributed a AUD 453,000 improvement to the result. Revenue was AUD 1,494,000 against AUD 1,120,000 corresponding period of 2009. Interest income decreased 20.1% from the previous corresponding period to AUD 298,000. This is due to the reduced cash equivalents available for investment due to operating losses sustained during 2010. Net loss from operations was AUD 3,097,000 versus AUD 7,725,000 for the same period last year. Net cash flows used in operating activities were AUD 2,216,000 against AUD 7,640,000 of previous year period. Purchase of property, equipment and other assets was AUD 36,000 versus AUD 21,000 for the same period last year.Caliper Life Sciences, Inc. reported unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2010. For the quarter, the company reported net loss of $1,434,000 or $0.03 per diluted share and operating loss of $1,000,000 on total revenue of $36,249,000 compared to net income of $5,851,000 or $0.11 per diluted share and operating income of $959,000 on total revenue of $37,656,000 for the same period a year ago. Adjusted earnings was $1,313,000 or $0.02 per diluted share compared to adjusted earnings of $2,479,000 or $0.05 per diluted share for the same period a year ago. The decrease in non-GAAP net income resulted primarily from the impact of a non-recurring significant microfluidic license and settlement agreement in the fourth quarter of 2009. GAAP revenue decreased 4% compared to 2009, due to the impact of divestitures. For the year, the company reported net income of $4,276,000 or $0.08 per diluted share and operating loss of $6,044,000 on total revenue of $123,696,000 compared to net loss of $8,225,000 or $0.17 per diluted share and operating loss of $12,204,000 on total revenue of $130,412,000 for the same period a year ago. Adjusted earnings was $960,000 or $0.02 per diluted share compared to adjusted loss of $5,839,000 or $0.12 per diluted share for the same period a year ago. The increase in non-GAAP net income over 2009 resulted primarily from gross margin improvements achieved in 2010. The company reported positive cash flows from operations of $4.3 million. EBITDA more than tripled to $6.7 million. Non-GAAP EBITDA was $4 million.The company is currently projecting 2011 full year GAAP revenue in the range of $135 million to $145 million including approximately 1% point of anticipated currency benefit. The company expects gross margins 52%-plus. The company is projecting about $4 million to $6 million of EBITDA in 2011. The company expects to report non-GAAP adjusted net loss per share of between $0.03 and $0.05 in 2011. The company is looking at CapEx of roughly $3.5 million.For the first quarter of 2011, the company is projecting GAAP revenues in the range of $32 million to $34.5 million.Exelixis, Inc. reported consolidated unaudited earnings results for the fourth quarter and full year ended December 31, 2010. For the quarter, the company reported total revenues of $40,777,000 against $44,079,000 for the same period a year ago. Loss from operations was $14,109,000 against $30,303,000 a year ago. Consolidated loss before taxes was $17,865,000 against $36,133,000 a year ago. Consolidated net loss was $17,865,000 against $28,833,000 a year ago. Net loss attributable to the company was $17,865,000 or $0.16 per basic and diluted share against $28,833,000 or $0.27 per basic and diluted share a year ago. For the full year, the company reported total revenues of $185,047,000 against $151,759,000 for the same period a year ago. Loss from operations was $91,397,000 against $121,907,000 a year ago. Consolidated loss before taxes was $92,402,000 against $140,843,000 a year ago. Consolidated net loss was $92,330,000 against $139,557,000 a year ago. Net loss attributable to the company was $92,330,000 or $0.85 per basic and diluted share against $135,220,000 or $1.26 per basic and diluted share a year ago. The decrease in net loss attributable to the company from 2009 to 2010 for both the quarter and the full year was primarily due to decreases in operating expenses relating to 2010 restructuring plans and other cost containment measures.For the full year 2011, the company expects revenues in the range of $145 million to $160 million.Telik Inc. reported unaudited earnings results for the fourth quarter and full year ended December 31, 2010. For the quarter, the company has posted net loss of $9.8 million, or $0.18 basic and diluted per share, compared with a net loss of $4.2 million, or $0.08 basic and diluted per share, for the comparable period in 2009. Loss from operations was $10.99 million against $4.26 million a year ago.For the year, net loss was $24.7 million or $0.46 basic and diluted per share, compared with a net loss of $23.7 million, or $0.44 basic and diluted per share, for the year ended December 31, 2009. Loss from operations was $26.05 million against $24.48 million a year ago.For the full year 2011, the company anticipates cash utilization to be in the range of $14.0 million to $15.0 million. Total operating costs and expenses to be in the range of $13.0 million to $15.0 million, which includes stock-based compensation expense of approximately $1.3 million.The shareholders of Novartis AG approved all proposed resolutions at the group's Annual General Meeting. The shareholders approved a dividend payment of CHF 2.20 per share for 2010 compared to CHF 2.10 in 2009, representing a payout ratio of approximately 55% of net income from continuing operations. Payment for the 2010 dividend will be made with effect from March 1, 2011.The Group confirmed expectations for 2011 to be a year of continued progress in delivering its strategic priorities continuing to drive innovation, growth and productivity across its businesses implementing its strategy to meet the growing needs of patients and aging societies worldwide through its healthcare portfolio. The company further confirmed its guidance for the year and barring unforeseen events, expects to maintain momentum in 2011 and increase group constant currency sales growth around the double-digit mark. With the continuing drive to generate productivity improvements across the Group, Novartis aims to improve constant currency core operating income margin while investing for the future. In addition, in 2011, the company expects the full effect of Alcon acquisition accounting to result in amortization of intangible assets of approximately USD 2.0 billion. Reported sales growth will be lower as a result of the combined effect of price reductions seen in 2010, the full impact of healthcare reform in the US and generic competition. The Shareholders of the company elected Dr. Enrico Vanni to the Board of Directors for a three year term. He is an independent consultant and member of three company boards of directors, including Alcon Inc. The company also announced that Alexandre Jetzer-Chung and Hans-Joerg Rudloff will retire from the Board as they have reached the statutory age limit.ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) announced a private placement of 5,200,000 units at a price of $1.55 per unit for gross proceeds of $8,060,000 on February 23, 2011. The transaction will see participation from certain institutional and other investors. Each unit consists of one common share and one warrant to purchase one-half share. Each warrant entitles the holder to purchase one common share at a price of $2.25 per share for a period of five years from closing. Summer Street Research Partners and Dawson James Securities, Inc. will serve as the exclusive placement agents to the company in connection with this transaction. Exelixis, Inc. is looking to raise additional funds. It stated, “We have incurred cumulative net losses of $1,182.1 million through December 31, 2010 and expect to incur losses for the next several years. Our ultimate success depends on the outcome of our research and development activities. We may seek to raise funds through the sale of equity or debt securities or through external borrowings. In addition, we may enter into additional strategic partnerships or collaborative arrangements for the development and commercialization of our compounds. If adequate funds are not available, we will be required to delay, reduce the scope of, or eliminate one or more of our development programs.Leadership Review:Spectrum Pharmaceuticals, Inc. announced the appointment of Steven M. Fruchtman, MD, to the position of Vice President of Clinical Development. Dr. Fruchtman will report directly to George Tidmarsh, MD, PhD, the company's Chief Scientific Officer and Head of Research and Development Operations, and will provide the strategic planning and leadership necessary for managing the Company's clinical development of belinostat, ZEVALIN(R) and its other pipeline products. Dr. Fruchtman comes to the company from Allos Therapeutics, where he led the development of pralatrexate for Hematologic and Oncologic indications. After a successful academic career at Mount Sinai Hospital and Medical School in New York, where he was Chief of the Stem Cell Transplantation Program, and prior to joining Allos, Dr. Fruchtman was Senior Director of U.S. Clinical Development and Medical Affairs for Novartis Pharmaceuticals. Dr. Fruchtman has served as an external reviewer for the New England Journal of Medicine, Mayo Clinic Proceedings, Experimental Hematology, European Journal of Hematology, Leukemia, and served on the editorial board of The Mount Sinai Journal of Medicine. Dr. Fruchtman is an author of more than 170 lectures, presentations, books, chapters, and abstracts. Dr. Fruchtman received his Bachelor of Arts with Honors from Cornell University, and his MD from New York Medical College.Legal & Litigation:Elan Corporation plc and Celgene Corporation announced that Elan Pharma International Ltd. has entered into a settlement and license agreement with Celgene Corporation resolving the patent infringement litigation involving ABRAXANE(R). Elan initiated legal action in 2006 against Abraxis BioScience Inc. Abraxis was acquired by Celgene in October, 2010. In consideration of the terms of the settlement and license agreement, Celgene will pay Elan a one-time fee of $78 million. Elan will not receive any additional payments for sales of ABRAXANE(R), or any other nab(R)-Paclitaxel product in the United States or globally. Celgene will acquire a fully-paid up, exclusive, world-wide license to select Elan U.S. and foreign patents for ABRAXANE(R).Mergers & Acquisitions:Several private equity companies intend to place bids for Astra Tech AB, people familiar with matter said. Permira Advisers Ltd, Advent International Corp, Bain Capital LLC and Warburg Pincus LLC are among the private equity companies that are interested in the company. Other potential bidders include Cinven Group Limited and Apax Partners Worldwide LLP. JPMorgan Chase & Co. is handling the sale process. First round bids are due in mid-March, people said. According to media reports, AstraZeneca PLC intend to divest Astra Tech for about $2 billion.News & Events:AstraZeneca PLC opened the new global headquarters in Paddington. AstraZeneca will employ around 350 people over three floors in its new headquarter. This includes 90 staff from its global marketing and sales divisions, some of whom are relocating from its US and Brussels operations.Bio-Bridge Science Inc.’s common stock has been deleted from OTC Bulletin Board (OTCBB) effective February 23, 2011, on account of its failure to comply with Rule 15c2-11.Hospira Inc. announced the unveiling of the Hospira MedNet(TM) Portal at the Healthcare Information and Management Systems Society (HIMSS) Annual Conference and Exhibition in Orlando. This web-based application will provide healthcare institutions with advanced medication error reporting and patient safety benchmarking capabilities. It will be available as an add-on feature to the award-winning Hospira MedNet safety software. Hospira MedNet Portal, on demonstration at HIMSS booth 6449, improves a hospital's ability to monitor, benchmark and evaluate intravenous (I.V.) drug administration practices. With this new technology, healthcare institutions will have access to side-by-side, blinded comparisons of their own safety software drug libraries and infusion performance data with the same information from other institutions. Users can look at data by hospital size, institution type or specific clinical care areas to help them develop and refine their drug library. The software system also allows clinicians and hospital staff to view internal and external peer benchmarking reports to drive improved I.V. medication safety and to help enhance clinical and operational outcomes. Hospira MedNet Portal supports continuous quality improvement efforts by helping users analyze key aspects of their drug administration process against best practices and by providing a more complete picture of clinical performance indicators. Hospira MedNet Portal will be available as a value-added feature for healthcare institutions using Hospira MedNet safety software with their Hospira infusion technologies, such as the Plum A+(TM) with Hospira MedNet safety software, a proven and scaleable infusion pump system; the technologically advanced Symbiq(TM) infusion system with built-in Hospira MedNet; and the market-leading LifeCare PCA(TM) pump with Hospira MedNet. Hospira is also the U.S. leader in I.V. clinical integration of infusion pumps with electronic health record systems. The company is targeting mid-year for making Hospira MedNet Portal available to Hospira MedNet customers.Strategy & Strategic Alliances:Yakult Honsha Co. Ltd. signed a development and commercialisation agreement with Proacta, Inc. for anti-cancer drug candidate PR509. Under the agreement, Yakult will conduct preclinical studies and early-Phase clinical trials for PR509 in the United States with Proacta. The terms of the agreement will see the Japanese development and commercialisation rights now belonging to Yakult. No financial detail is disclosed. This co-development agreement in the US and license in Japan are expected to extend Yakult's current oncology products pipeline such as Campto (irinotecan), Elplat (oxaliplatin) and Opeprim (mitotane) in the long term. PR509 is a pro-drug activated in low oxygen environment, specific for solid tumour cells and targeted for Genentech (US)'s erlotinib and AstraZeneca's Irressa (geftinib) tolerated in non-small-cell lung cancer, with an eye to widen to stomach cancer, breast cancer and pancreatic cancer in the long run. With Yakult's support, Proacta will be able to move forward the development of PR509 in the US.Caliper Life Sciences, Inc. and Covaris, Inc. announced a co-marketing agreement which will leverage Covaris' acoustic DNA shearing platforms and Caliper's automation and microfluidics technologies to develop automated workflows for next generation sequencing experiments. Caliper has developed a complete suite of solutions for library construction, sample analysis, and nucleic acid fractionation, which significantly reduces manual manipulations, increases throughput and improves sample-to-sample consistency. Covaris sample preparation technology, which is based on its industry-standard Adaptive Focused Acoustic(TM) (AFA) technology, brings quality, speed, and efficiency to biological and chemical sample preparation with the single-sample S220, the multi-sample E220 and high throughput parallel-processing LE220. The isothermal and non-contact Covaris method accelerates next-generation DNA sequencing sample preparation by providing a highly predictable and reproducible DNA shearing instrumentation, consumables, and applications to the next-gen workflow. Caliper's portfolio of microfluidic and automation solutions that uniquely enable sample preparation for high throughput sequencing. Caliper's sequencing tools include the LabChip XT for nucleic acid fractionation, the LabChip GX for library quantification and sizing, the recently launched LabChip DS for purity and quality control, the Zephyr(R) Genomics Workstation for automated nucleic acid extraction and reaction setup, and the Sciclone(R) NGS Workstation, which includes validated protocols for library preparation, sequence capture, and sample normalization.MedTrust Online, LLC and Avantra Biosciences Corporation announced a novel collaboration to involve clinicians in the earliest stages of molecular diagnostic assay development for Avantra Biosciences' revolutionary QPDx(TM) multiplex immunoassay system. The two companies will provide a global community of over 10,000 cancer care professionals with early access to the latest panels of protein biomarkers implicated in different cancers. Avantra, based in Woburn, MA, is a leading innovator in protein diagnostics and recently announced the commercialization of the new Q400 Biomarker Workstation and innovative AngioGenQx(TM) BioChip immunoassay. The system provides quantitative protein biomarker results for ten analytes in less than an hour, requiring only five minutes for sample preparation. As Avantra's scientific development team identifies biomarkers of interest for its QPDx(TM) system, MedTrust will use its Knowledge Medicine(TM) platform to engage oncologists in online discussions that will validate the role of different panels in diagnosis, prognosis, and treatment efficacy in cancer care. The first of several multiplex assays to be evaluated include an upcoming panel developed in the recently announced collaboration between Avantra and TGen Drug Development. Avantra intends to develop additional panels that may target ovarian, pancreatic, lung, prostate, breast, and colorectal cancers to uncover associations between protein marker levels and patient drug responses that can positively impact clinical decisions. Currently available for research use only (RUO), Avantra intends to seek regulatory approval for its assay technologies as the clinical utility of the molecular information becomes evident. In addition to oncology, Avantra is exploring opportunities in other areas such as infectious disease through its upcoming panel for sepsis.Harris Corp. is teaming with Cancer Treatment Services International L.P. to bring high quality, cost-effective cancer care to patients in regions worldwide. Under the agreement, Harris will serve as the exclusive technology provider for CTSI's growing network of oncology clinics, including a state-of-the-art facility currently under construction in Hyderabad, India. Harris and CTSI will collaborate to develop and integrate advanced healthcare IT and clinical approaches. <br />