|Novavax up on positive BARDA comments. Acura voted down by advisory panel. Codexis begins trading after IPO|
|By BioMedReports.com Staff|
|Thursday, 22 April 2010 18:18|
Below is a list of the companies that made news in the healthcare sector on Thursday, April 22, 2010.
Novavax, Inc. (Nasdaq:NVAX) announced today that the Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA), has determined the Company's proposal to provide recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness is in the competitive range for award of an advanced development contract. Novavax submitted its proposal in September 2009 in response to Solicitation No. HHS-BARDA-09-32 for development of a new influenza vaccine in a U.S. based manufacturing facility.
The BARDA solicitation states that contracts will be awarded to vaccine manufacturers that satisfy several specific requirements. BARDA's notification indicated that Novavax's proposal is in the competitive range, which consists of the most highly rated proposals. BARDA has proposed to conduct a pre-award site visit to inspect Novavax's manufacturing facility in Rockville, Maryland.
Shares of Novavax soared nearly 14%, moving up 35 cents to $2.86.
Codexis, Inc. (Nasdaq:CDXS) announced today the pricing of its initial public offering of 6,000,000 shares of its common stock, at $13.00 per share. Shares commenced trading today on The NASDAQ Stock Market. The company, which raised $78 Million with its IPO, is a leading provider of optimized biocatalysts that make existing industrial processes faster, cleaner and more efficient than current methods and have the potential to make new industrial processes possible at commercial scale. Shares closed the day at $13.26, up 26 cents on its first day of trading.
Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) and King Pharmaceuticals, Inc. (NYSE:KG) today announced after the market closed that the U.S. Food and Drug Administration's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox.
The panel of Food and Drug Administration experts voted 19-1 against the drug. The addition of niacin to Acurox was central to the deliberations. The additional ingredient is designed to cause irritation and flushing if patients take excessive doses needed to achieve euphoric effects. The panelists said that the negative effects of niacin could be mitigated by eating food or taking aspirin. Some of the experts indicated the drug could be approved if the niacin was removed.
The FDA is not bound by the Advisory Committees' recommendation, but may take its advice into consideration when evaluating the NDA for Acurox Tablets. Acura and King will work with the FDA to determine the next steps for the Acurox development program.
Shares of Acura were hit hard after the bell, dropping more than 43% or $2.57 to $3.33.
In other news Thursday:
Boston Scientific Corporation (NYSE:BSX) today announced the launch of its new Kinetix™ Guidewire for use in percutaneous coronary intervention (PCI) procedures. Guidewires are small flexible wires physicians use to deliver interventional devices such as drug-eluting stents. The Kinetix Guidewire features a unique micro-cut nitinol sleeve designed for significantly improved torque control compared to conventional spring coil guidewires. The Kinetix Guidewire represents the first major advance in coronary guidewire technology in nearly a decade. The Company will begin a phased launch of the Kinetix Guidewire immediately and expand to full product availability by next quarter.
BSD Medical Corporation (NASDAQ:BSDM) today reported clinical study data showing that hyperthermia, using the BSD-2000 Hyperthermia System, combined with chemotherapy has the potential to improve control rate and long-term survival for the treatment of children with high-risk cancer who have a dismal prognosis.The clinical study data will be presented by Rüdiger Wessalowski, M.D., Associate Professor at the Clinic of Pediatric Hematology and Oncology, Heinrich-Heine University, Dusseldorf, Germany, at the annual Society for Thermal Medicine (STM) meeting to be held in Clearwater, Fla. on April 23 to April 26, 2010.
Compugen Ltd. (NASDAQ: CGEN) announced today the development of its Protein-Protein Interaction Blockers (PPI Blockers) Discovery Platform, designed for the prediction of peptides to block disease associated protein-protein interactions. In a pilot validation run, predicted peptides showed positive results for drug targets in two cancer related pathways of interest to the industry.
Corcept Therapeutics Incorporated (NASDAQ:CORT), a pharmaceutical company engaged in the discovery and development of drugs for the treatment of severe metabolic and psychiatric disorders, today announced that certain existing investors exercised the warrants they purchased in Corcept's private placement of securities that closed on October 16, 2009.
Curis, Inc. (NASDAQ: CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that a research paper describing the biological activity of its HDAC, EGFR and HER2 inhibitor, CUDC-101, was published online in the journal Cancer Research and also will be published in an upcoming print version of the journal."We believe that the results described in this publication demonstrate that CUDC-101 may have the potential to increase patient response rates in certain cancers and improve the treatment of drug-resistant tumors that cannot be effectively controlled with single-target EGFR or Her2 inhibitors," stated Dan Passeri, Curis’ President and Chief Executive Officer.
Geron Corporation (Nasdaq:GERN) today announced five presentations by Geron scientists and collaborators on the company’s telomerase inhibitor, imetelstat sodium (GRN163L), including the drug’s activity against cancer stem cells, at the 101st American Association for Cancer Research (AACR) annual meeting held in Washington D.C. Telomerase was a featured topic of over 30 presentations, including two dedicated sessions, underlining, as in previous AACR annual meetings, the importance of telomerase as a cancer target.
Geron plans to initiate four Phase 2 clinical trials of imetelstat in 2010 – two randomized trials in non-small cell lung cancer and breast cancer, and two single arm trials in multiple myeloma and essential thrombocythemia. "The data presented at AACR by Geron and our collaborators once again highlight the importance of telomerase as a cancer stem cell target and the broad anti-cancer stem cell properties of imetelstat in preclinical models," said Stephen M. Kelsey, M.D., Geron’s executive vice president and chief medical officer, oncology. "We are excited about our Phase 2 clinical program for imetelstat, which targets malignancies that are thought to be driven, at least in part, by cancer stem cells and we look forward to initiating our first randomized Phase 2 trial in non-small cell lung cancer in the coming months."
Hana Biosciences (OTCBB:HNAB), edged up as the biopharmaceutical company focused on strengthening the foundation of cancer care, today announced that complete data from its pivotal study of Marqibo(R) in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL), have been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois.
Johnson & Johnson (NYSE:JNJ) today announced that its Board of Directors has declared a 10.2% increase in the quarterly dividend rate, from $0.49 per share to $0.54 per share. The increase was announced this morning at the Annual Meeting of Shareholders in New Brunswick, NJ.
"Given our strong financial position and confidence in our ability to deliver outstanding results now and in the future, the Board has voted to increase the dividend for the 48th consecutive year," said William C. Weldon, Chairman and Chief Executive Officer of the Company.
Milestone Scientific Inc. (OTC Bulletin Board:MLSS.ob), the recognized leader in advanced injection technologies, today announced the appointment of Dale Johnson as Director of International Distribution, responsible for overseeing the Company's network of independent dental distributors operating in the European Union.
Nile Therapeutics, Inc. (Nasdaq:NLTX), a company focused on the development of novel therapeutics for heart failure patients, announced the pricing of its previously announced underwritten public offering of 6,500,000 units of its securities at a public offering price of $0.70 per unit.
NeoStem, Inc. (Amex: NBS), an international biopharmaceutical company with operations in the U.S. and China and ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTC Bulletin Board:IRBS.ob), announced today that they have entered into a Collaborative Research Agreement, focused on the development of an advanced, adult human stem cell product. Under the agreement, NeoStem will investigate the effects of Homspera(R), ImmuneRegen's lead drug candidate, which has been shown to enhance stem cell activity, in combination with NeoStem's VSEL(TM) technology. Very small embryonic-like stem cells are a population of stem cells found in the bone marrow that can be mobilized and subsequently harvested from the peripheral blood of adults. Shares of both companies edged higher on the news.
Optimer Pharmaceuticals, Inc. (Nasdaq:OPTR) announced that data from the second fidaxomicin Phase 3 clinical study will be presented in an oral presentation at Digestive Disease Week (DDW) 2010 in New Orleans.
Radient Pharmaceuticals Corporation (AMEX:RPC) pushed higher today after the company announced that it plans to expand its worldwide commercialization strategy for its Onko-Sure™ in vitro diagnostic (IVD) cancer test to include Clinical Laboratory Improvement Amendments (CLIA) laboratory testing services in the US and Canada through corporate partnerships beginning in the second quarter FY2010.RPC intends to supply Onko-Sure test kits; along with scientific proof tools, marketing support and healthcare advocacy programs to select partners in the US and Canada.
Oncothyreon Inc. (NASDAQ:ONTY) announced today that it has received a staff deficiency notice from the NASDAQ Listing Qualifications Staff stating that it is not currently in compliance with NASDAQ Marketplace Rule 5250(c)(1) because the Company has not timely filed its Annual Report on Form 10-K for the year ended December 31, 2009 (the "2009 Form 10-K"). The delay in filing the 2009 Form 10-K is the result of the Company's anticipated restatement, which was previously disclosed on March 12, 2010.
Orthovita, Inc. (NASDAQ: VITA), a leading orthobiologics and biosurgery company, today announced that product sales for the first quarter of 2010 were $24.1 million, an 11% increase over product sales of $21.7 million in the first quarter of 2009. Product sales for the quarter ended March 31, 2010 included $1.1 million from the sale of Vitomatrix™, a bone graft material used in dental products, and $900,000 from U.S. sales of Cortoss™, the Company’s novel synthetic biomaterial that was cleared by the FDA in June 2009 for the treatment of vertebral compression fractures, and Aliquot, the Company’s Cortoss delivery device. There were no Vitomatrix or U.S. Cortoss sales in the first quarter of 2009. The $1.1 million in Vitomatrix sales occurred in March 2010 as part of an agreement to terminate their supply agreement for this product.
Smith & Nephew (NYSE: SNN, LSE: SN) Orthopaedics Division today announces the results of unprecedented testing on its VERILAST technology for knee replacement implants. After simulating 30 years of physical activity on the company's LEGION knee replacement, VERILAST technology produced an 81-percent reduction* in wear, the leading cause of knee replacement failure.
The Food and Drug Administration has reviewed the results and Smith & Nephew received 510k clearance for claims related to VERILAST technology's ability to "provide wear performance sufficient for 30 years of actual use under typical conditions." The consensus of scientific literature is that knee implants are expected to last 10 to 15 years.
Vical Incorporated (Nasdaq:VICL) announced today that the company's TransVax(TM) cytomegalovirus (CMV) vaccine elicited sustained increases in both cellular and antibody immune responses compared with placebo through the final 12-month follow-up in an ongoing Phase 2 trial in hematopoietic cell transplant (HCT) recipients. "We were excited to see that our TransVax(TM) vaccine was able to enhance both T-cell and antibody responses to the encoded CMV antigens through the final 12-month data point," said Richard T. Kenney, M.D., Vical's Vice President of Clinical Development," and we are excited to see how these responses impact viral control. We also saw an encouraging boost in both T-cell and antibody responses after the fourth injection, which could prove important in controlling late-onset CMV reactivation. We expect to complete our analysis of the final trial data and report on our full evaluation of viral load and clinical endpoints in the third quarter."
Affymax, Inc. (Nasdaq: AFFY) today announced that it has instituted a quiet period to curtail discussions with the investor community and the media in connection with the analysis of Phase 3 results for the investigational drug, Hematide, in four clinical trials (PEARL 1, PEARL 2, EMERALD 1 and EMERALD 2) which evaluated Hematide for the treatment of anemia in chronic renal failure patients.
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON (exenatide for extended-release injectable suspension).
AVEO Pharmaceuticals, Inc. (NASDAQ: AVEO), a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced that financial results for the company's first quarter ended March 31, 2010 will be released before the market opens on Thursday, April 29, 2010.
Biotechcompany Pharming Group NV (NYSE:PHARM) today published its financial report for the first quarter ended March 31, 2010.
China Pediatric Pharmaceuticals, Inc. (OTC Bulletin Board: CPDU) ("China Pediatric Pharmaceuticals" or the "Company"), today announced its financial results for fiscal year ended December 31, 2009.
Columbia Laboratories, Inc. (Nasdaq: CBRX) today announced preliminary results for the quarter ended March 31, 2010.
Depomed, Inc. (NASDAQ:DEPO) announced today that it will release first quarter 2010 financial results after the market closes Thursday, April 29, 2010.
Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced today that its Board of Directors has approved amendments to the Company's certificate of incorporation and bylaws that will declassify the Board of Directors so that all directors will be elected annually.
Kun Run Biotechnology, Inc. (OTC Bulletin Board: KURU), a leading bio-pharmaceutical company in China that focuses on manufacturing and sales of peptides, peptide-based drugs and small molecule drugs, today announced the signing of a private placement agreement totaling approximately US$8 million of preferred stock and warrants with Caduceus Asia Partners, L.P., an investment fund managed by OrbiMed Advisors, LLC, and Mr. Xueyun Cui, the Chairman of the Company's Board of Directors and the majority stockholder of the Company.
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced today that the Company will report its first quarter 2010 financial results after the Nasdaq market closes on Wednesday, April 28, 2010.
OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today its financial results for the first quarter ended March 31, 2010.
Synta Pharmaceuticals Corp. (NASDAQ: SNTA), a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it will release its first-quarter 2010 financial results before the market opens on Tuesday, May 4, 2010.
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that its abstract, "A phase II randomized controlled trial of palifosfamide plus doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)", to be presented at the 2010 ASCO Annual Meeting, has been selected as part of the 2010 Best of ASCO® educational program. Best of ASCO® sessions will be held in both San Francisco and Boston in the United States and in several countries around the world in the months following the ASCO Annual meeting, which is taking place this year June 4th-8th in Chicago.
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