|Anadys Pharma reports positive Hep C study results. ZioPharm trial hits survival goal|
|By BioMedReports.com Staff|
|Friday, 21 May 2010 18:08|
Below is a list of the companies that made news in the healthcare sector on Friday, May 21, 2010.
Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced completed 12-week results from an ongoing Phase II study, which demonstrated that 75% of hepatitis C patients treated with 400 mg ANA598 twice daily in combination with the current standard of care, pegylated interferon and ribavirin, achieved undetectable levels of virus at week 12, known as complete Early Virological Response or cEVR.
"We are very pleased with the comparable antiviral potency and favorable safety profile demonstrated through 12 weeks for both doses investigated in this study," said Steve Worland, Ph.D., President and CEO of Anadys. "Coupled with the favorable tolerability profile seen at 200 mg bid, we believe that these results establish ANA598 at 200 mg bid as one of the most attractive agents in Phase 2 HCV development today."
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) reported that a mid stage study of its experimental cancer treatment, palifosfamide in combination with the chemotherapy drug doxorubicin resulted in patients living a median of 7.8 months before their cancer progressed as compared with 4.4 months for a group that was treated withdoxorubicin alone. The trial consisted of 62 patients with a cancer of the connective and soft tissues known as soft tissue sarcoma.
The treatment resulted in a delay by 77 percent of the time that it normally took for sarcoma tumors to grow and showed no significant side effects between the two groups. Ziopharm has decided to end the trial early as it has become apparent that the drug has reached its goal of extending patient survival time.
The company also announced that its abstract "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)" has been selected as part of 2010 Best of ASCO. Best of ASCO sessions with be held in both San Francisco and Boston and in several countries around the world in the months following the ASCO meetings. Best of ASCO represents high impact abstracts that represent the most relevant and cutting edge science in oncology.
In other news Friday:
Abbott (NYSE:ABT) announced a definitive agreement with Piramal Healthcare Limited to acquire full ownership of Piramal's Healthcare Solutions business (Domestic Formulations), a leader in the Indian branded generics market, for an up-front payment of $2.12 billion, plus $400 million annually for the next four years, giving Abbott the No. 1 position in the Indian pharmaceutical market. This further accelerates Abbott's emerging markets growth following the recent acquisition of Solvay Pharmaceuticals and announcements last week of Abbott's collaboration with Zydus Cadila as well as the creation of a new stand-alone Established Products Division to focus on expanding the global markets for its leading branded generics portfolio.
"This strategic action will advance Abbott into the leading market position in India, one of the world's most attractive and rapidly growing markets," said Miles D. White, chairman and chief executive officer, Abbott. "Our strong position in branded generics and growing presence in emerging markets is part of our ongoing diversified pharmaceutical strategy, complementing our market-leading proprietary pharmaceutical offerings and pipeline in developed markets."
"Emerging markets represent one of the greatest opportunities in health care – not only in pharmaceuticals – but across all of our business segments. Today, emerging markets represent more than 20 percent of Abbott's total business," said Mr. White.
Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) announced that data on two of its lead anticancer compounds, perifosine and AEZS-108, will be presented at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO), which will be held June 4 through 8, 2010 at McCormick Place in Chicago. Two posters on perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented in pediatric solid tumors and colorectal cancer. A poster will also be presented on the Company's doxorubicin targeted conjugate compound, AEZS-108, in ovarian cancer.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) announced that new data on AP24534, its investigational pan-BCR-ABL inhibitor, and ridaforolimus, its investigational mTOR inhibitor being developed by Merck, Sharpe & Dohme Corp., have been accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) announced that new interim data from an ongoing, multicenter, Phase 2 clinical trial of oral sapacitabine, the Company's lead product candidate, will be presented at an oral poster discussion during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois on Monday, June 7, 2010.
The Phase 2 study is evaluating sapacitabine administered as a single agent in older patients with myelodysplastic syndromes, or MDS, after treatment with hypomethylating agents.
Echo Therapeutics, Inc. (OTC Bulletin Board:ECTE.ob), a company developing its needle-free Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude SkinPrep System for transdermal drug delivery, announced today that the Chairman of its Scientific Advisory Board, Dr. Robert Langer, a world-renowned engineer at Massachusetts Institute of Technology (MIT) discussed his opinions of the Company's products and technology in an audio interview with LifeTech Capital institutional research analyst, Steven M. Dunn.
EpiCept Corporation (Nasdaq and Nasdaq OMX Stockholm Exchange: EPCT) announced the commercial launch of Ceplene (R) (histamine dihydrochloride) in Germany. The launch is being conducted by Meda AB, (OMX Nordic Exchange: MEDA-A-ST) as part of an exclusive commercialization agreement for Ceplene signed by the two companies in January 2010. Meda is a leading international specialty pharmaceutical company with products sold in 120 countries worldwide and a marketing organization of about 1,200 people throughout Europe.Germany is the second country in the European Union in which Ceplene has become commercially available, following the product’s launch in the United Kingdom in April, 2010.
Health Discovery Corporation (OTCBB: HDVY) announced that Support Vector Machine technology was used to take first place in solving a complex marketing problem in the recent Active Learning Challenge. The results of the Active Learning Challenge were presented this past week at the 13th International Conference on Artificial Intelligence and Statistics, in Sardinia, Italy.
ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) a biotechnology company focused on the development of novel immune-based cancer therapies, today announced that it will be presenting results from its clinical trial of ICT-107 at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I) announced that it has achieved a significant advance in its program to develop and manufacture drugs incorporating abuse-deterrent characteristics. The Company advises that it has taken delivery of and fully qualified its primary manufacturing equipment for the manufacture of an abuse-deterrent formulation of controlled-release oxycodone hydrochloride, and that the manufacture of clinical batches using that equipment has commenced. The successful manufacture of clinical batches is required to make the drug eligible for Phase I studies, and to establish a clinical program in cooperation with the FDA in order to facilitate advancement of the drug through the application process.
Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that it has purchased from the Genaera Liquidating Trust certain intellectual property and interests in future milestones and royalties for MEDI-528, an IL-9 antibody program under development by AstraZeneca’s subsidiary, MedImmune. MEDI-528 is currently in a 320-patient Phase II study for moderate-to-severe asthma.
Ligand paid $2.75 million to the Genaera Liquidating Trust in connection with the purchase. This opportunity arose from initial diligence and work conducted by Biotechnology Value Fund, L.P. (BVF). As part of this transaction and a result of BVF's contributions, Ligand entered into a separate agreement with BVF and certain of its affiliates, whereby BVF and Ligand will share the purchase price and any proceeds from the deal equally. Accordingly, BVF has paid Ligand $1.375 million.
Masimo (Nasdaq:MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced that a new clinical study published in the May 2010 issue of Acta Anaesthesiologica Scandinavica shows that Masimo pleth variability index (PVI) can be used to help clinicians assess risk for mean arterial pressure (MAP) decreases and subsequent hypotension during anesthesia administration. Researchers concluded that PVI may be "useful to identify patients at high risk for developing severe hypotension during anesthesia induction", allowing "anesthesiologists to adopt preventive measures to ensure greater patient safety."
MEDI-528 is an example of a new generation of asthma medicines designed to target underlying interleukin signaling pathways. "We believe the IL-9 antibody program could provide a significant revenue stream, if MedImmune’s development and commercialization efforts are successful, as it is potentially a blockbuster drug being developed by a premier pharmaceutical company," said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals.
OccuLogix, Inc. (Nasdaq:TEAR) (TSX:TLB) announced that the Company has officially changed its corporate name to TearLab Corporation. "The name change is intended to better align our corporate brand with our vision to become the leader in tear testing and biomarker analysis at the point-of-care," said Elias Vamvakas, TearLab's Chief Executive Officer.
Oncothyreon Inc. (Nasdaq:ONTY) announced that data highlighting the Company's two small molecule programs will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting being held June 4 through 8, 2010 in Chicago.
Positron Corporation (OTCBB:POSC) stated today that over the first 4 months of 2010 that it has seen tremendous interest in its Attrius dedicated cardiac PET scanner. The Attrius™ was introduced in the 4th quarter of 2009 and has been met with critical acclaim throughout the molecular imaging industry.
Patrick G. Rooney, Positron Corporation’s CEO states, "The Nuclear Cardiology industry is experiencing a shift from SPECT to PET as a result of molly shortages combined with changes in reimbursement. Positron is in an ideal position to capitalize on this shift more so than any other imaging company. The Attrius™ is a state of the art, Frost & Sullivan New Product Innovation Award winning, device that was designed to be optimized for Cardiac imaging allowing physicians an easy transition to PET. Our pipeline for PET systems has had significant increases each month since we launched the Attrius™ late last year. Our current pipeline has over 55 potential and/or pending sales with the second half on the year still too follow. We have done a very good job of positioning Positron to meet this new demand. Based on the current interest we believe we will meet or exceed our projected system sales moving forward. Positron’s objective is to be the leader in cardiac PET solutions. We believe we will continue to see substantial growth from both devices and radiopharmaceuticals."
Seattle Genetics, Inc. (Nasdaq: SGEN) and Millennium: The Takeda Oncology Company announced that data regarding retreatment experiences with brentuximab vedotin in phase I and phase II clinical trials will be presented during a poster session at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 4-8, 2010 in Chicago, Illinois. The presentation will highlight data from Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL) patients who have been retreated upon relapse after discontinuing previous brentuximab vedotin therapy.
Shire plc (LSE: SHP, Nasdaq: SHPGY) announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), at a major psychiatric meeting. The primary objective of this study was to evaluate the efficacy of INTUNIV, dosed either in the morning or evening compared with placebo, when co-administered with stimulant medications used to treat ADHD in children and adolescents ages 6 to 17 with ADHD and suboptimal response to stimulant alone. The study met its primary end point, which was the change from baseline to end point in the ADHD Rating Scale-IV (ADHD RS-IV) total score.
USANA Health Sciences, Inc. (NASDAQ: USNA) announced that it will add two new products, USANA Calming Tea and Sensé Blanc Balance, to the company’s nutrition and skin-care product lines in the Asia Pacific market. The announcement was made in Hong Kong at the company’s Asia Pacific Convention.
YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced that three poster presentations and a published abstract will report results from several global nimotuzumab trials in adults with Glioblastoma Multiforma and in patients with head and neck cancer at the American Society of Clinical Oncology annual meeting.
AstraZeneca (NYSE:AZN) contributed $1 million to Wilmington Hospital today to support the expansion and renovation of the hospital as a vital part of the Christiana Care Health System.
Biogen Idec Inc. (NASDAQ: BIIB) announced today that its presentation at the 2010 Citi Investment Research Global Healthcare Conference will be webcast live, via the internet, on Wednesday, May 26, 2010 at 1:30 p.m. EDT.
BioTime, Inc. (AMEX:BTIM) Chief Executive Officer Michael West, Ph.D. will give a presentation next week at the GTCbio 6th Annual Stem Cell Research & Therapeutics Conference, which will be held May 27-28, 2010 in Boston, Massachusetts.
Bristol-Myers Squibb Company (NYSE: BMY) today announced positive results from a randomized Phase 2 study evaluating ipilimumab in combination with standard chemotherapy in previously untreated patients with advanced non-small cell lung cancer (NSCLC).
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc., will present at the Citi 2010 Investment Research Global Health Care Conference at the Hilton New York in New York City on Thursday, May 27, 2010 at 2:30 pm EDT.
China Pediatric Pharmaceuticals, Inc. (OTC Bulletin Board: CPDU), announced its first quarter 2010 financial results.
Dr. Reddy's Laboratories (NYSE:RDY) today announced that it has launched tacrolimus capsules, (0.5mg, 1mg, 5mg), a bioequivalent generic version of Prograf® capsules, in the US market on May 20, 2010.
Exelixis, Inc. (NASDAQ:EXEL) today reported promising interim data from an ongoing phase 2 trial of XL184 in patients with recurrent glioblastoma (GB), the most common and aggressive form of brain cancer. In addition, the company today reported interim data from an ongoing adaptive randomized discontinuation trial (RDT) of single agent XL184 in patients with melanoma, non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), hepatocellular carcinoma (HCC), pancreatic, gastric/GE junctional, prostate, ovarian, or breast cancer who have measurable disease and had undergone up to 3 prior lines of systemic therapy.
FutureFuel Corp. (OTC Bulletin Board: FTFL) filed a Form 8K with the Securities and Exchange Commission on May 21, 2010, declaring a special cash dividend of $0.20 per share.
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that two presentations on clinical data from KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be made at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO).
Marshall Edwards, Inc., (NASDAQ: MSHL) An abstract titled "A phase II study of oral phenoxodiol in castrate and non-castrate prostate cancer patients with associated cytokine changes" by Dr Kevin Kelly at the Yale School of Medicine Department of Medical Oncology, is now available at www.asco.org (abstract # 4661).
Provectus Pharmaceuticals, Inc. (OTCBB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has announced further positive data on the first forty subjects in its Phase 2 clinical trial of PV-10 for metastatic melanoma, with an objective response ("OR") observed in 61% of subjects and a mean Progression Free Survival ("PFS") of at least 11.1 months among those subjects achieving an OR.
SOHM, Inc. (PINKSHEETS: SHMN), a generic pharmaceutical manufacturer that produces and markets generic drugs covering all major treatment categories, announced today that its branded generic pharmaceutical line has expanded to 280 products.
Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial stage biotechnology company with a primary focus in hematology and oncology, today announced that clinical data on belinostat will be presented at the 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held June 4-8, 2010 at the McCormick Place Convention Center in Chicago, Illinois.
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