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FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions
Date : 02/09/2010 @ 1:30AM
Source : PR Newswire
Stock : (CTIC)
http://ih.advfn.com/p.php?pid=nmona&cb=1265734404&article=41447059&symbol=N^CTIC
SEATTLE, Feb. 9 /PRNewswire-FirstCall/ --
Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the United States Food and Drug Administration (the "FDA") informed CTI that due to severe weather conditions in the Washington, D.C. area, the FDA is postponing the Oncologic Drugs Advisory Committee ("ODAC") meeting that was to be held on Wednesday, February 10, 2010 to discuss the pixantrone New Drug Application ("NDA"). The FDA indicated that it intends to reschedule the meeting as soon as the FDA can determine a schedule that will allow them to reconvene the advisory panel.
This meeting is an open public forum for the presentation and discussion of safety and efficacy information contained in the pixantrone NDA for the treatment of relapsed/refractory aggressive non-Hodgkin's lymphoma (NHL).
According to its usual practice the FDA has posted on its website briefing documents for the ODAC meeting that will be held to discuss the pixantrone NDA. The briefing information can be accessed on the FDA website at: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Oncolog icDrugsAdvisoryCommittee/ucm195226.htm
"We are pleased with the time that the FDA has invested in connection with its review of our application for pixantrone. We believe that many of the key issues they identified are addressed in our own briefing material which is now publically available as well," said James A. Bianco, M.D., CEO of Cell Therapeutics. "We are disappointed that the meeting was not able to take place as originally scheduled but understand that the severe weather conditions made travel safety an issue. We look forward to the ODAC meeting where our lymphoma expert physicians will discuss the clinical benefits of pixantrone with the advisory panel."
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA (including ODAC), that the FDA may postpone the ODAC meeting again, that CTI's briefing materials do not address all of the key issues the FDA may have with the pixantrone NDA, CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
Media Contact: Dan Eramian T: 206.272.4343 C: 206.854.1200 F: 206.272.4434 E: http://www.celltherapeutics.com/press_room
Investors Contact: Ed Bell T: 206.272.4345 Lindsey Jesch Logan T: 206.272.4347 F: 206.272.4434 E: http://www.celltherapeutics.com/investors
DATASOURCE: Cell Therapeutics, Inc.
CONTACT: Media, Dan Eramian, +1-206-272-4343, cell, +1-206-854-1200,
fax, +1-206-272-4434, ,
http://www.celltherapeutics.com/press_room, or Investors, Ed Bell, +1-206-272-4345,
or Lindsey Jesch Logan, +1-206-272-4347, fax, +1-206-272-4434,
, http://www.celltherapeutics.com/investors
Web Site: http://www.celltherapeutics.com/
Hartford CEO: Seeing Signs Of 'Gradual Economic Recovery'
Date : 02/09/2010 @ 10:07AM
Source : Dow Jones News
Stock : Hartford Financial Services Group Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&cb=1265731761&article=41456876&symbol=NY^HIG
Hartford Financial Services Group Inc. (HIG) is seeing signs of a gradual economic recovery, as midterm policy cancellations have stabilized and, if the trends hold, could see a "modest top-line benefit in 2010," said Liam McGee, Hartford's chief executive, during the company's earnings conference call Tuesday.
He said in April, at its investors meeting, the company will outline its capital plan for repaying the $3.4 billion in government assistance it received through the Capital Purchase Program.
"We recognize that the government's preferred stock is not permanent capital, and we will repay it," McGee said. "But as I have said previously, we will be prudent" in repaying it.
He said the company would balance the company's capital resources, shareholder dilution, the future impact on its business and the views of regulators.
Hartford posted a fourth-quarter profit of $557 million, or $1.19 a share, compared with a year-earlier loss of $806 million, or $2.71 a share.
Core earnings, excluding net realized and unrealized investment gains and losses, were $1.51 a share, compared with a year-earlier loss of 72 cents. Last month, Hartford said it expected $1.45 to $1.60, up from its November view.
The company said its guidance doesn't include potential changes in reserves from previous years, or changes in charges related to acquisition costs.
The Hartford Reports Fourth Quarter 2009 Net Income of $557 Million, or $1.19 Per Diluted Share
Date : 02/08/2010 @ 4:24PM
Source : Business Wire
Stock : The Hartford Financial Services Group, Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&article=41444843&symbol=HIG
Liberty Analytics Co. Initiates Independent Research Coverage on NexMed, Inc.
Date : 02/09/2010 @ 1:00AM
Source : globe
Stock : (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1265731761&article=41457740&symbol=N^NEXM
Liberty Analytics Co. Initiates Independent Research Coverage on NexMed, Inc.
CALGARY, Alberta, Feb. 9, 2010
GLOBE NEWSWIRE
Liberty Analytics Co., a leading provider of large, small - and micro-cap independent investment research, today initiated coverage on NexMed, Inc. (Nasdaq:NEXM).
Liberty Analytics is currently offering a complimentary trial subscription. To view our research go to: www.libertyanalyticsco.com
About LAC:
Liberty Analytics Co. is a leading provider of independent investment research in North America. Our services include research analysis on the large, small- and micro-cap markets, real-time news and financial data, market commentary and the LAC newsletter. Liberty Analytics' staff of large and small-cap investment professionals is dedicated to providing the market's investment community with the tools and avenues necessary to make the important investment decisions. To view our research reports on a complimentary trial basis and take advantage of our other services, go to www.libertyanalyticsco.com and click on the complimentary trial subscription button on our home page, or go directly to our registration page at www.libertyanalyticsco.com/signup.php
About NexMed, Inc. (Nasdaq:NEXM)
NexMed, Inc. (Nasdaq:NEXM) is the largest specialty contract research organization ("CRO") based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. NexMed has a proprietary product pipeline based on its NexACT drug delivery technology, including a late stage terbinafine treatment for onychomycosis, a late stage alprostadil treatment for erectile dysfunction, a Phase 2 alprostadil treatment for female sexual arousal disorder, and an early stage treatment for psoriasis and wound healing.
LAC Disclosure:
Libertyanalyticsco.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. Liberty Analytics has not been compensated by any of the above-mentioned companies. Please read our report and visit our Web site, www.libertyanalyticsco.com, for complete risks and disclosures.
CONTACT: Liberty Analytics
Kevin Mix
480-626-1850
info@libertyanalyticsco.com
Goldman Small Cap Research rates NewCardio (NWCI:OB) a speculative buy
Written by BioMedReports.Com
Tuesday, 09 February 2010 04:50
http://biomedreports.com/articles/most-popular/28128-goldman-small-cap-research-rates-newcardio-nwciob-a-speculative-buy.html
Goldman Small Cap Research share some interesting insights as they initiate coverage of NewCardio (NWCI:OB) with a Speculative Buy recommendation. In his report, analyst Rob Goldman cites several factors for his $4.00 price target.
“With a combined $5 billion annual market for the Company’s first three solutions, NewCardio is well-positioned to capture maket share in the cardiac safety, urgent care and chronic care markets. The Company is led by a first-class management team with a history of success. Now, with NewCardio, they have launched a blockbuster technology platform. As investors become more familiar with the NewCardio story, and management continues to execute, the stock could reach $4.00, said Goldman..”
NewCardio's offerings are used to determine the cardiac toxicity of new drugs in clinical trials and development, and to evaluate cardiac status during acute and chronic patient management. NewCardio's unique 3D ECG approach enables faster, more accurate and less expensive assessment of cardiac status than products/services currently in use, and can provide diagnosis of previously difficult or undiagnosable conditions.
According to Goldman, “NewCardio recently began marketing marketing its flagship cardiac safety product QTinno™, and it has already signed several Master Service Agreements, with more likely in the offing.”
A free copy of the report is available at the Company’s website, www.goldmanresearch.com.
About Goldman Small Cap Research: Led by former Piper Jaffray analyst and mutual fund manager Rob Goldman, Goldman Small Cap Research produces stock market research reports. The Firm produces research via two formats: Goldman Select Research and Goldman Opportunity Research. The Select product reflects the Firm’s internally generated stock ideas while the Opportunity product reflects sponsored research reports. It is important to note that while performance maybe tracked separately, the same coverage criteria is utilized in determining coverage of all stocks in both research formats.
A Goldman Small Cap Research report is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed. Please read the report’s full disclosures and analyst background fund on our website before investing. To download our research or for more information, visit www.goldmanresearch.com.
NewCardio, Inc. NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). Â NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. Â NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com.
UPDATE 5-Cell Therapeutics drug draws US FDA staff concerns
09.02.2010 01:59
By Lisa Richwine
http://www.finanznachrichten.de/nachrichten-2010-02/16093661-update-5-cell-therapeutics-drug-draws-us-fda-staff-concerns-020.htm
WASHINGTON, Feb 8 (Reuters) - U.S. drug reviewers questioned effectiveness data from Cell Therapeutics Inc for an experimental lymphoma drug and said the medicine had substantial side effects, according to documents released on Monday.
Cell Therapeutics shares fell 42 cents to close at 64 cents on Nasdaq.
A Food and Drug Administration advisory panel review of the drug, originally scheduled for Wednesday, was postponed due to weather. The Washington region is digging out from a storm that dumped two feet (half-meter) of snow, and more snow was forecast for Tuesday and Wednesday.
Seattle-based Cell Therapeutics is seeking approval to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.
FDA reviewers, in an analysis prepared for the advisory committee, said issues raised in their review included 'the reliability of (the efficacy) conclusions' and 'substantial hematologic and cardiac toxicity.'
The company's main study tested 140 patients whose cancer worsened after at least two chemotherapy regimens, FDA staff said. That was less than half the 320 originally planned. Cell Therapeutics told the FDA it had trouble attracting patients because doctors preferred multiple chemotherapy drugs or supportive care, the FDA staff summary said.
FDA reviewers also said they had concerns about re-readings of patient results by independent experts.
The agency said it would ask the advisory panel if the company has provided enough evidence that pixantrone worked and if benefits outweighed risks.
The FDA usually follows panel recommendations when deciding whether to approve drugs. A final decision is due by April 23.
Cell Therapeutics spokesman Dan Eramian said many of the key issues raised by FDA staff were addressed in a company summary prepared for the panel.
In the summary, the company said pixantrone worked better than other drugs with 'manageable toxicities.' Twenty percent of patients treated with pixantrone met the study's main goal of having a major decrease in their disease, compared with about 6 percent with a different medicine.
Non-hodgkin's lymphoma is a blood cancer that affects about 66,000 U.S. patients annually. Patients who have relapsed following two prior regimens often live less than six months.
'Pixantrone fulfills an unmet medical need in multiply relapsed patients with aggressive NHL,' Cell Therapeutics said.
FDA reviewers said data suggested pixantrone could be toxic to the heart, 'but no conclusions can be drawn' about how the risks compared with cancer drugs called anthracyclines or anthracenediones, which are known to cause cardiac damage.
In the company study, deaths and serious complications from heart damage and bone marrow suppression 'were all more common' in patients treated with pixantrone versus other cancer drugs, FDA staff said.
Swiss drugmaker Novartis has an option for a worldwide license to develop and sell pixantrone.
The FDA has not set a new date for the panel meeting, FDA spokeswoman Karen Riley said.
(Reporting by Lisa Richwine; Editing by Gerald E. McCormick; Steve Orlofsky; and Carol Bishopric)
((lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx) Keywords: CELLTHERAPEUTICS FDA/
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
EMCORE Corporation to Report Fiscal 2010 First Quarter Results on Tuesday, February 9, 2010
Date : 02/08/2010 @ 9:07PM
Source : MarketWire
Stock : EMCORE (EMKR)
http://ih.advfn.com/p.php?pid=nmona&article=41446778&symbol=EMKR
ALBUQUERQUE, NM -- (Marketwire) -- 02/08/10 --
EMCORE Corporation (NASDAQ: EMKR), a leading provider of compound semiconductor-based components, subsystems and systems for the fiber optics and solar power markets, will announce its fiscal 2010 first quarter results for the period ended December 31, 2009 on Tuesday, February 9, 2010 after market close. A conference call discussing the results will be held at 4:30 p.m. EST on Wednesday, February 10, 2010
Conference Call Information:
To participate in the conference call, U.S. callers should dial (toll free) 888-587-0613 and international callers should dial 719-325-2352. The access code for the call is 7863504. A replay of the call will be available beginning Wednesday, February 10, 2010 at 8:00 p.m. EST until February 17, 2010 at 11:59 p.m. EST. The replay call-in number for U.S
callers is 888-203-1112, for international callers it is 719-457-0820 and the access code is 7863504. The call also will be web cast via the Company's web site at http://www.emcore.com. Please go to the site beforehand to download any necessary software
About EMCORE:
EMCORE Corporation is a leading provider of compound semiconductor-based components and subsystems for the fiber optics and solar power markets
EMCORE's Fiber Optics segment offers optical components, subsystems and systems that enable the transmission of video, voice and data over high-capacity fiber optic cables for high-speed data and telecommunications, cable television (CATV) and fiber-to-the-premises (FTTP) networks. EMCORE's Solar Power segment provides solar products for satellite and terrestrial applications. For satellite applications, EMCORE offers high-efficiency compound semiconductor-based gallium arsenide (GaAs) solar cells, covered interconnect cells and fully integrated solar panels
For terrestrial applications, EMCORE offers concentrating photovoltaic (CPV) systems for utility scale solar applications as well as offering its high-efficiency GaAs solar cells and CPV components for use in solar power concentrator systems. For specific information about our company, our products or the markets we serve, please visit our website at http://www.emcore.com
NexMed Receives over $2.7 Million Cash Infusion
Date : 02/08/2010 @ 1:41PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1265654747&article=41442756&symbol=N^NEXM
UPDATE 3-Cell Therapeutics drug draws US FDA staff concerns
08.02.2010 19:03
By Lisa Richwine
http://www.finanznachrichten.de/nachrichten-2010-02/16091510-update-3-cell-therapeutics-drug-draws-us-fda-staff-concerns-020.htm
WASHINGTON, Feb 8 (Reuters) - U.S. drug reviewers questioned effectiveness data from Cell Therapeutics Inc for an experimental lymphoma drug and said the medicine had substantial side effects, according to documents released on Monday.
Cell Therapeutics shares fell 28 cents, or 26.6 percent on the Nasdaq to 78 cents.
The Seattle-based biotechnology company is seeking approval to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.
Food and Drug Administration reviewers, in an analysis prepared for an advisory committee, said issues raised in their review included 'the reliability of (efficacy) conclusions' and 'substantial hematologic and cardiac toxicity.'
The company's main study tested 140 patients whose cancer worsened after at least two chemotherapy regimens, FDA staff said. That was less than half the 320 originally planned. Cell Therapeutics told the FDA it had trouble attracting patients because doctors preferred multiple chemotherapy drugs or supportive care, the FDA staff summary said.
FDA reviewers also said they had concerns about re-readings of patient results by independent experts.
The agency will ask the advisory panel on Wednesday if the company has provided enough evidence that pixantrone worked and if benefits outweighed risks. The FDA usually follows panel recommendations when deciding whether to approve drugs. A final decision is due by April 23.
Cell Therapeutics spokesman Dan Eramian said many of the key issues raised by FDA staff were addressed in a company summary prepared for the panel.
In the summary, the company said pixantrone worked better than other drugs with 'manageable toxicities.' Twenty percent of patients treated with pixantrone met the study's main goal of having a major decrease in their disease, compared with about 6 percent with a different medicine.
Non-hodgkin's lymphoma is a blood cancer that affects about 66,000 U.S. patients annually. Patients who have relapsed following two prior regimens often live less than six months.
'Pixantrone fulfills an unmet medical need in multiply relapsed patients with aggressive NHL,' Cell Therapeutics said.
FDA reviewers said data suggested pixantrone could be toxic to the heart, 'but no conclusions can be drawn' about how the risks compared with cancer drugs called anthracyclines or anthracenediones, which are known to cause cardiac damage.
In the company study, deaths and serious complications from heart damage and bone marrow suppression 'were all more common' in patients treated with pixantrone versus other cancer drugs, FDA staff said.
(Reporting by Lisa Richwine; Editing by Gerald E. McCormick and Steve Orlofsky) Keywords: CELLTHERAPEUTICS FDA/
(lisa.richwine@thomsonreuters.com; + 1 202 310 5691; www.twitter.com/ReutersLisaRx)
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
ROTH Capital Partners to Hold 22nd Annual OC Growth Stock Conference March 15-17, 2010
Monday, February 8, 2010
By Paul DeRiso
http://www.roth.com
http://techstocks.techinvestmentnews.com/2010/02/roth-capital-partners-to-hold-22nd-annual-oc-growth-stock-conference-march-15-17-2010/
List of Confirmed Presenting Companies at time of this announcement: (Please visit ROTH website for updates and agenda)
...
Cell Therapeutics, Inc. (CTIC): Biotechnology & Healthcare
ROTH Capital Partners to Hold 22nd Annual OC Growth Stock Conference March 15-17, 2010
Monday, February 8, 2010
By Paul DeRiso
http://www.roth.com
http://techstocks.techinvestmentnews.com/2010/02/roth-capital-partners-to-hold-22nd-annual-oc-growth-stock-conference-march-15-17-2010/
List of Confirmed Presenting Companies at time of this announcement: (Please visit ROTH website for updates and agenda)
...
NexMed Inc. (NEXM): Pharmaceuticals
ROTH Capital Partners to Hold 22nd Annual OC Growth Stock Conference March 15-17, 2010
Monday, February 8, 2010
By Paul DeRiso
http://www.roth.com
http://techstocks.techinvestmentnews.com/2010/02/roth-capital-partners-to-hold-22nd-annual-oc-growth-stock-conference-march-15-17-2010/
February 08, 2010 11:27 AM Eastern Time
Over 350 Companies Scheduled To Present in Biotechnology, Medical Devices, Pharmaceuticals, Media & Internet, Enterprise Software, Gaming, Semiconductors, Global Energy and Industrials, Industrials and Retail & Consumer
NEWPORT BEACH, Calif.–(BUSINESS WIRE)–ROTH Capital Partners (ROTH), www.roth.com, a full service investment bank recognized for providing financing and advisory services to emerging growth companies worldwide, today announced that their 22nd Annual OC Growth Stock Conference will be held March 15-17, 2010 at The Ritz Carlton, located at 1 Ritz Carlton Drive, Dana Point, California.
“As 2009 progressed, investors demonstrated a renewed interest in investment opportunities with emerging growth stocks”
The three-day, institutional investor conference will be the largest ROTH conference ever and will feature management presentations from over 350 small cap public companies–100 of those companies are based in China. The broad spectrum of presenting companies will represent the following sectors: Healthcare (Biotech, Medical Devices and Pharmaceuticals), Media & Internet, Enterprise Software, Gaming, Semiconductors, Global Energy and Industrials and Retail & Consumer.
This event is designed to provide investors with a unique chance to gain insight into small- and mid-cap growth companies and is expected to attract 2,500 attendees, including over 1,500 institutional investors. The conference is formatted to maximize investor/company interaction through a combination of company presentations, Q&A sessions, expert panels and management one-on-one meetings.
“This is a conference that our clients look forward to each year,” commented Byron Roth, CEO of ROTH. “We believe that destination conferences are much more effective in getting the institutional investors to focus on our presenting companies without distractions. It also provides investors with an opportunity to discover new ideas and share ideas with each other versus just doing maintenance work on names they already know.”
Small-cap equities posted strong gains during 2009, and investor interest in emerging growth companies remains high, according to Mark Tobin, ROTH Director of Research.
“As 2009 progressed, investors demonstrated a renewed interest in investment opportunities with emerging growth stocks,” said Tobin. “The performance of our research coverage universe highlights this, with our BUY-rated stocks returning 66% during 2009, compared to 25% for the Russell 2000, 44% for the Nasdaq, 23% for the S&P500, and 19% for the Dow.* We are optimistic that this momentum will continue into 2010 and strong early interest in this year’s conference supports this view.”
The presenting companies were carefully selected by ROTH’s research team and represent a median market cap of approximately $300 million. More than 185 of the presenting companies are covered by ROTH’s team of 21 publishing analysts.
A partial list of supporting conference sponsors at time of this announcement includes:
PLATINUM: AFH Holding & Advisory; Friedman LLP; DLA Piper; Loeb & Loeb LLP; Lowenstein Sandler; Pillsbury Winthrop Shaw Pittman LLP, and Thomson Reuters.
GOLD: Bullivant, Houser, Bailey PC; Capital IQ; K&L Gates; Rothstein Kass; The Piacente Group, Inc.; and Winston & Strawn LLP.
SILVER: Anslow & Jaclin; Avant Air, Inc.; Belmont Accounting & Bookkeeping Services, LLC; Bernstein & Pinchuck LLP; Business Wire, a Berkshire Hathaway Company; CCG Investor Relations; Dorsey & Whitney LLP; Goodwin Procter; Junior Achievement; KPMG, LLP; Lambert, Edwards & Associates; Mayer Hoffman McCann P.C.; Moss Adams, LLP; NYSE Euronext; PrivateRaise – A Dealflow Media Service; Samuel H. Wong & Co. LLP, CPAs; SingerLewak; Sichenzia Ross Friedman Ference LLP; Stradling, Yocca, Carlson & Rauth; Stroock; Toronto Stock Exchange; Vintage Filings; and Weinberg & Company, P.A.
BDO is a Participant Sponsor.
For more information about this invitation-only event, please visit the conference website at: www.roth.com or contact your ROTH representative at 800-933-6830.
Media inquiries and press credentials only — please call 818-904-0500.
*Past Performance is not indicative of future returns
About Roth Capital Partners, LLC:
ROTH Capital Partners is a full service investment banking firm dedicated to the small-cap public market. Since its inception in 1984, ROTH has been an innovator in this space. ROTH has participated in underwriting IPOs for small-cap companies, has helped develop the PIPE financing structure, and more recently in underwriting offerings from shelf registration statements. ROTH was one of the first U.S. investment banks to focus on financing small-cap Chinese companies, and established a Representative Office in Shanghai in 2007.
ROTH’s experience and capabilities in raising capital for public companies are the hallmarks of the firm. It has raised over $12.6 billion for public companies and completed approximately 160 merger, acquisition and advisory assignments. During 2009, ROTH assisted public companies in raising over $1.8 billion.
Visit the Roth Capital Partners website at www.roth.com. Member FINRA/SIPC.
List of Confirmed Presenting Companies at time of this announcement: (Please visit ROTH website for updates and agenda)
**Huifeng Group (HFGB): Healthcare: China Track
3SBio Inc. (SSRX): Healthcare: China Track
7 Days Group Holdings Limited (SVN): Leisure: China Track
A.T. Cross Co. (ATX): Retail & Consumer Products
Achillion Pharmaceuticals (ACHN): Biotechnology & Healthcare
Acorn International, Inc. (ATV): Advertising, Media & Internet: China Track
Actuate Corporation (ACTU): Enterprise Software
Administaff Inc. (ASF): Business Services
Akeena Solar, Inc. (AKNS): Cleantech
Align Technology Inc. (ALGN): Medical Devices
Alloy Inc. (ALOY): Advertising, Media & Internet
Alnylam Pharmaceuticals, Inc. (ALNY): Biotechnology & Healthcare
Alphatec Holdings, Inc. (ATEC): Medical Devices
American Dairy Inc. (ADY): Retail & Consumer Products: China Track
Amerigon Inc. (ARGN): Industrials
Anadys Pharmaceuticals (ANDS): Biotechnology & Healthcare
Antares Pharma Inc. (AIS): Biotechnology & Healthcare
Arabian American Development Company (ARSD): Industrials
Ardea Biosciences, Inc. (RDEA): Biotechnology & Healthcare
Ariba Inc. (ARBA): Enterprise Software
Art Technology Group Inc. (ARTG): Enterprise Software
Asia Entertainment & Resources Ltd. (CSAQF): Leisure: China Track
Atheros Communications Inc. (ATHR): Semiconductor
AtriCure, Inc. (ATRC): Medical Devices
AutoChina International Ltd. (AUTC): Automotive: China Track
Avantair, Inc. (AAIR): Business Services
Bally Technologies, Inc. (BYI): Gaming
Balqon Corporation (BLQN): Cleantech
Barrett Business Services Inc. (BBSI): Business Services
BioDelivery Sciences International (BDSI): Pharmaceuticals
BioSante Pharmaceuticals, Inc. (BPAX): Pharmaceuticals
BioSphere Medical Inc. (BSMD): Medical Devices
BluePhoenix Solutions Ltd. (BPHX): Enterprise Software
Broadcom Corp. (BRCM): Semiconductor
Cambium Learning Group (ABCD): Business Services
CardioNet, Inc. (BEAT): Medical Devices
Cash America International, Inc. (CSH): Financials
Cash Store Financial (TSX:CSF): Financials
Casual Male Retail Group, Inc. (CMRG): Retail & Consumer Products
Cavium Networks, Inc. (CAVM): Semiconductor
CDC Corporation(CHINA): Leisure: China Track
Cell Therapeutics, Inc. (CTIC): Biotechnology & Healthcare
Celldex Therapeutics Inc (CLDX): Biotechnology & Healthcare
Century Casinos, Inc. (CNTY): Gaming
Chelsea Therapeutics International Ltd. (CHTP): Biotechnology & Healthcare
China Advanced Construction Materials Group, Inc. (CADC): Industrials: China Track
China Aoxing Pharmaceutical Co., Inc. (CAXG): Healthcare: China Track
China Automation Group Ltd. (569.HK): Global Energy & Industrials: China Track
China Automotive Systems, Inc. (CAAS): Industrials: China Track
China Cord Blood Corporation (CO): Healthcare: China Track
China Distance Education Holdings Limited (DL): Education: China Track
China Education Alliance, Inc. (CEU): Education: China Track
China Electric Motor, Inc. (CELM): Automotive: China Track
China Finance Online Co. Ltd. (JRJC): Financials: China Track
China Fire & Security Group, Inc. (CFSG): Industrials: China Track
China Gengsheng Mineral (CHGS): Industrials: China Track
China Gerui Advanced Materials Group Ltd. (CHOP): Healthcare: China Track
China Green Agriculture, Inc. (CGA): Agricultural Products: China Track
China Housing and Land Development, Inc. (CHLN): Real Estate: China Track
China Integrated Energy, Inc. (CBEH): Global Energy & Industrials: China Track
China Interactive Education, Inc. (FNDW): Education: China Track
China MediaExpress Holdings, Inc. (CCME): Advertising, Media & Internet: China Track
China Natural Gas, Inc. (CHNG): Global Energy & Industrials: China Track
China Nepstar Chain Drugstore Ltd. (NPD): Healthcare: China Track
China Nutrifruit Group Ltd. (CNGL): Retail & Consumer Products: China Track
China Pharma Holdings, Inc. (CPHI): Healthcare: China Track
China Recycling Energy Corporation (CREG): Global Energy & Industrials: China Track
China Ritar Power Corp. (CRTP): Global Energy & Industrials: China Track
China RuiTai International Holding, Co. (CRUI): Industrials: China Track
China TransInfo Technology Corp. (CTFO): Technology: China Track
China Valves Technology, Inc. (CVVT): Global Energy & Industrials: China Track
China Wind Systems, Inc. (CWS): Global Energy & Industrials: China Track
China XD Plastics Company Ltd. (CXDC): Industrials: China Track
China Yida Holding, Co. (CNYD): Leisure: China Track
China-Biotics, Inc. (CHBT): Healthcare: China Track
ChinaCast Education Corporation (CAST): Education: China Track
ChinaEdu Corporation (CEDU): Education: China Track
ChinaNet Online Holdings, Inc. (CHNT): Advertising, Media & Internet: China Track
CIBER, Inc. (CBR): Business Services
City Telecom (H.K.) Limited (CTEL): Advertising, Media & Internet: China Track
CKE Restaurants Inc. (CKR): Retail & Consumer Products
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NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenza (VLP) Vaccine Clinical Study in Healthy Adults / Data show significant Neuraminidase Inhibition Antibody Titers in VLP vaccine recipients
08.02.2010 18:43
http://www.finanznachrichten.de/nachrichten-2010-02/16091384-novavax-reports-additional-positive-data-from-its-trivalent-seasonal-influenza-vlp-vaccine-clinical-study-in-healthy-adults-data-show-significant-008.htm
NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenza...
08.02.2010 18:43
http://www.finanznachrichten.de/nachrichten-2010-02/16091384-novavax-reports-additional-positive-data-from-its-trivalent-seasonal-influenza-vlp-vaccine-clinical-study-in-healthy-adults-data-show-significant-008.htm
NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenza (VLP) Vaccine Clinical Study in Healthy Adults / Data show significant Neuraminidase Inhibition Antibody Titers in VLP vaccine recipients
ROCKVILLE, Md., Feb. 8 /PRNewswire-FirstCall/ -- Novavax, Inc. announced today new data from a clinical study that began in May of 2009 among healthy adults 18 to 49 years of age with Novavax's trivalent seasonal influenza Virus-like Particle (VLP) vaccine. The vaccine matched the influenza strains recommended for the 2008-2009 influenza season including H1N1 A/Brisbane/59/2007, H3N2 A/Brisbane/10/2007, and B/Florida/04/2006 strains. The study enrolled 241 subjects, including 221 who were randomized to receive either VLP vaccine at 15 mcg or 60 mcg doses or a placebo and 20 subjects who received a licensed inactivated influenza vaccine (TIV).
Novavax reported safety and hemagglutination inhibition (HAI) antibody titers from this study in a poster presentation at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA). In addition to the HAI titers, functional antibody against the Neuraminidase enzyme was measured in the sera of immunized subjects using a neuraminidase inhibition assay (NAI) developed by Novavax scientists. Inhibition of neuraminidase activity may be important in reducing the spread of influenza virus down the respiratory tract and severe influenza disease. Since neuraminidase mutates less rapidly than hemagglutinin(HA), the antibody against neuraminidase may be more effective in protecting against drifted seasonal strains or new, emerging strains of influenza virus.
In continued evaluation of the May 2009 clinical study, Novavax tested volunteers for NAI against H3N2/Brisbane and B/Florida components of the vaccine before and after immunization. The results showed that 50 to 73% of the volunteers immunized with the Novavax VLP vaccine had a 4-fold increase in the antibody that blocks neuraminidase activity. In contrast, only 1 of 19 volunteers that received the TIV showed a 4-fold rise for NAI. There was no 4-fold rise in volunteers that received placebo.
"These are very exciting results which not only support continued development of novel VLP vaccines against influenza but also provides a cornerstone to potentially differentiate our vaccine from the current standard of care," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "We will continue to evaluate NAI responses in additional clinical trials particularly in the ongoing study in the elderly and work to optimize the NA activity required in our vaccine to maximize NAI responses. We believe these new data reinforce our long standing thesis that VLP influenza vaccines have the potential to induce broad immunity that could lead to meaningful reduction in the burden of disease," said Dr. Singhvi.
Dr Singhvi presented these new data today in New York city at the BIO CEO Conference. Further details can be found on the corporate website at http://www.novavax.com/.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: http://www.novavax.com/.
Forward-looking Statements
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding revenues, operating expenses, cash burn, and clinical developments and anticipated milestones are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Novavax cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the Company's ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; clinical trial results; current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, the product may not prove to be safe and efficacious; Novavax's pilot plant facility is subject to extensive validation and FDA inspections, which may result in delays and increased costs; our ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; our ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; our ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise;general business conditions; competition; business abilities and judgment of personnel; and the availability of qualified personnel. Further information on the factors and risks that could affect Novavax's business, financial conditions and results of operations, is contained in Novavax's filings with the U.S. Securities and Exchange Commission, which are available at http://www.sec.gov/. These forward-looking statements speak only as of the date of this press release, and Novavax assumes no duty to update forward-looking statements.
Novavax, Inc.
CONTACT: Tricia J. Richardson, Senior Manager, Investor Relations,
Novavax, Inc., +1-240-268-2031
Web Site: http://www.novavax.com/
© 2010 PR Newswire
About Sepsis -
Sepsis is a condition that results from the immune system’s response to severe infection leading to cardiovascular collapse and multiple organ failure. It is one of the top-ten causes of death in the U.S., killing over 225,000 Americans each year, more than lung and breast cancer combined. Severe sepsis has reported mortality rates ranging from 30 to 60 percent, and an average cost of $22,100 per case. Over three quarters of a million new cases of sepsis are identified in the U.S. annually, with an equally large case population in Europe and Asia. The disease typically attacks the elderly and its incidence is expected to increase with the aging population, and as more pathogens develop resistance to antibiotics. A research study performed at Emory University and the Centers for Disease Control concluded that the incidence of sepsis increased an average of 8.7 percent a year over the past two decades. Patients with severe sepsis require intensive care and account for a large proportion of ICU resource allocation.
February 8, 2010, 9:00 am EST
http://finance.yahoo.com/news/Study-at-the-Karolinska-bw-584817367.html?x=0&.v=1
Study at the Karolinska Institute suggests potential for reducing the high death rate from sepsis, one of the top-10 causes of death in the U.S.
BERKELEY, Calif.--(BUSINESS WIRE)--ExThera Medical announced today that the results of a preliminary study (“Cytokines in blood from septic patients interact with surface immobilized heparin”) of its proprietary medical device, Seraph™ extracorporeal affinity therapy, have been published in the current issue of the Journal of the American Society for Artificial Organs (Jan.-Feb. 2010).
One very important clinical application of Seraph (Selective Removal by Apheresis) is expected to be the treatment of sepsis within intensive care units. Seraph consists of a specially designed cartridge packed with a novel bioactive polymer substrate that acts as a hemofilter. By incorporating immobilized heparin, the cartridge’s high-surface-area can safely and selectively reduce cytokine levels and remove certain pathogens from a patient’s blood before the blood is (re)infused.
In the study conducted at the Karolinska Institute in Stockholm, Sweden, when blood from septic patients was passed through a miniature version of the Seraph cartridge, concentrations of pro-inflammatory cytokine tumor necrosis factor-a (TNF-a) were “significantly reduced from initially very high levels.” In the control group, passage of blood from septic patients over non-heparinized beads did not affect the TNF-a levels. “We conclude that surface heparinization may be a useful technique for selectively regulating the levels of heparin-binding cytokines from whole blood. This may have implications for the treatment of hyper-inflammatory conditions such as severe sepsis,” said principal investigator Jonas Axelsson, M.D., Ph.D., of Karolinska Institute’s Department of Renal Medicine.
“The removal of blood-borne pathogens by adsorption onto heparinized surfaces such as Seraph may become a viable method for treating sepsis patients at both the onset and advanced stage of the disease,” said George Pitarra, President and Managing Director of Emergence LLC. “Although a considerable amount of clinical work remains to be done, we are extremely encouraged by the results of the Karolinska study.”
“It is well-established that heparin can bind an enormous variety of peptides with high specificity at the appropriate binding sites,” added Olle Larm, Ph.D., CEO of ExThera AB. “In addition to the affinity of heparin for cytokines, heparin also is capable of binding the pathogens responsible for the onset of sepsis as previously demonstrated during our earlier in vitro experiments and now in this ex vivo study at the Karolinska Institute. Apheresis based on a bioactive heparinized polymer surface such as Seraph avoids the constraints of drugs, which typically target only one pathogen and do not affect the cytokine level. The combination of specific removal of cytokines and the removal of pathogens from the blood stream may give clinicians a new paradigm for treating septic patients.”
“The use of bioactive synthetic polymers to treat or even cure disease may open a whole new area of application for biomaterials—which have previously been used after the fact—to rebuild, replace or augment body parts already damaged by disease and trauma,” added Bob Ward, Chairman of Emergence LLC. “I am very happy to be working on this project with Professor Olle Larm and his team, as Dr. Larm pioneered the surface heparinization of biomaterials in blood contacting medical devices.”
About Seraph™
Selective Removal by Apheresis (Seraph™) is based on the unique binding capacity of the immobilized, naturally occurring heparin molecule. Disease-causing microorganisms use cell surface glycoconjugates such as heparin as receptor molecules for cell attachment, e.g., to facilitate their invasion and colonization of tissue. Similar receptors can be built into a polymer surface for selective removal of these microorganisms from blood. ExThera Medical is investigating the clinical impact of the ability of immobilized heparin to bind viruses, bacteria, parasites and excess cytokines in blood, while developing both therapeutic products to treat patients in the clinic, and devices that purify blood prophylactically before (re)perfusion. Both product types treat blood in a flow-through Heparin Affinity Apheresis™ column or cartridge, using heparin that has been chemically bonded to a novel polymer with precisely controlled surface chemistry and nano-structure. Smaller cartridge-type devices may also be effective in reducing iatrogenic disease associated with conventional extracorporeal blood-handling, including kidney dialysis, cardio-pulmonary bypass, and even blood-banking. In these circuits the inflammatory cascade is initiated when blood contacts a man-made surface, releasing proteins and cell aggregates into the circulating blood. This can lead to brain damage and other complications related to the activation of the inflammatory system. ExThera Medical’s Seraph™ cartridge may be used in-line to treat the activated blood just before it is returned to the patient.
About Sepsis
Sepsis is a condition that results from the immune system’s response to severe infection leading to cardiovascular collapse and multiple organ failure. It is one of the top-ten causes of death in the U.S., killing over 225,000 Americans each year, more than lung and breast cancer combined. Severe sepsis has reported mortality rates ranging from 30 to 60 percent, and an average cost of $22,100 per case. Over three quarters of a million new cases of sepsis are identified in the U.S. annually, with an equally large case population in Europe and Asia. The disease typically attacks the elderly and its incidence is expected to increase with the aging population, and as more pathogens develop resistance to antibiotics. A research study performed at Emory University and the Centers for Disease Control concluded that the incidence of sepsis increased an average of 8.7 percent a year over the past two decades. Patients with severe sepsis require intensive care and account for a large proportion of ICU resource allocation.
About ExThera Medical
Privately held ExThera Medical, based in Berkeley, Calif., is a joint venture company formed in 2007 by Emergence LLC, a life science incubator headquartered in Berkeley, Calif., and ExThera AB, a technology transfer partner of Karolinska Institute based in Stockholm, Sweden. ExThera Medical is targeting the clinical treatment of blood-borne diseases including sepsis and autoimmune disease, as well as the removal of harmful substances present in banked human blood and/or caused by contact with man-made materials during cardiopulmonary bypass, dialysis and other extracorporeal procedures.
Study results published in current issue of ASAIO Journal
US FDA staff questions Cell Therapeutics drug data
Mon Feb 8, 2010 10:00am EST
http://www.reuters.com/article/idCNN0515749720100208?rpc=44
* FDA staff raise issues with safety, effectiveness
* Pixantrone to be reviewed by advisory panel Wednesday
* Company says drug works, side effects manageable
* Shares drop 36 pct (Adds FDA staff comments, shares)
By Lisa Richwine
WASHINGTON, Feb 8 (Reuters) - U.S. drug reviewers questioned effectiveness data from Cell Therapeutics Inc (CTIC.O) for an experimental lymphoma drug and said the medicine carried substantial side effects, according to documents released on Monday.
Cell Therapeutics shares fell 36 percent on Nasdaq to 68 cents.
The Seattle-based biotechnology company is seeking approval to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.
Food and Drug Administration reviewers, in an analysis prepared for an advisory committee, said issues raised in their review included "the reliability of (efficacy) conclusions" and "substantial hematologic and cardiac toxicity."
The company's main study enrolled less than 50 percent of the number of patients originally planned, FDA reviewers said. Cell Therapeutics told the FDA it had trouble enrolling patients because doctors preferred to use multiple chemotherapy drugs or supportive care, the FDA staff summary said.
FDA reviewers also said data suggested pixantrone was toxic to the heart, "but no conclusions can be drawn concerning its toxicity relative to" other cancer drugs known as anthracyclines or anthracenediones.
The FDA reviewers said they would ask the advisory panel at a meeting on Wednesday whether the company had provided enough evidence that pixantrone worked and whether the benefits outweighed risks. The agency usually follows panel recommendations when deciding whether to approve drugs. A final decision is due by April 23.
Cell Therapeutics, in a separate summary prepared for the panel, said its data showed pixantrone worked better than comparison drugs with "manageable toxicities." (Reporting by Lisa Richwine, editing by Gerald E. McCormick)
US FDA staff questions Cell Therapeutics drug data
Mon Feb 8, 2010 10:00am EST
http://www.reuters.com/article/idCNN0515749720100208?rpc=44
* FDA staff raise issues with safety, effectiveness
* Pixantrone to be reviewed by advisory panel Wednesday
* Company says drug works, side effects manageable
* Shares drop 36 pct (Adds FDA staff comments, shares)
By Lisa Richwine
WASHINGTON, Feb 8 (Reuters) - U.S. drug reviewers questioned effectiveness data from Cell Therapeutics Inc (CTIC.O) for an experimental lymphoma drug and said the medicine carried substantial side effects, according to documents released on Monday.
Cell Therapeutics shares fell 36 percent on Nasdaq to 68 cents.
The Seattle-based biotechnology company is seeking approval to sell pixantrone under the brand name Pixuvri for treating non-Hodgkin's lymphoma that has stopped responding to other treatments.
Food and Drug Administration reviewers, in an analysis prepared for an advisory committee, said issues raised in their review included "the reliability of (efficacy) conclusions" and "substantial hematologic and cardiac toxicity."
The company's main study enrolled less than 50 percent of the number of patients originally planned, FDA reviewers said. Cell Therapeutics told the FDA it had trouble enrolling patients because doctors preferred to use multiple chemotherapy drugs or supportive care, the FDA staff summary said.
FDA reviewers also said data suggested pixantrone was toxic to the heart, "but no conclusions can be drawn concerning its toxicity relative to" other cancer drugs known as anthracyclines or anthracenediones.
The FDA reviewers said they would ask the advisory panel at a meeting on Wednesday whether the company had provided enough evidence that pixantrone worked and whether the benefits outweighed risks. The agency usually follows panel recommendations when deciding whether to approve drugs. A final decision is due by April 23.
Cell Therapeutics, in a separate summary prepared for the panel, said its data showed pixantrone worked better than comparison drugs with "manageable toxicities." (Reporting by Lisa Richwine, editing by Gerald E. McCormick)
Novavax Terminates Negotiations with ROVI Pharmaceuticals for Influenza Vaccine Collaboration
Date : 02/08/2010 @ 2:00AM
Source : PR Newswire
Stock : (NVAX)
http://ih.advfn.com/p.php?pid=nmona&cb=1265642933&article=41430432&symbol=N^NVAX
REASON : Adam Feuerstein AGAIN!
FDA Raises Concerns About Cell Therapeutics' Cancer Drug
02/08/10 - 09:46 AM EST
http://www.thestreet.com/_yahoo/story/10676284/1/fda-raises-concerns-about-cell-therapeutics-cancer-drug.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA
MedaSorb's (MSBT.OB) Answer to Unmet Medical Need Could Be Commercialized This Year
Date : 02/08/2010 @ 8:13AM
Source : MarketWire
Stock : BioMedReports (MSBT)
http://ih.advfn.com/p.php?pid=nmona&cb=1265642432&article=41436372&symbol=NB^MSBT
LOS ANGELES, CA -- (Marketwire) -- 02/08/10 --
BioMedReports.Com, the news portal which covers Wall Street's biomedical sector and delivers financial and investment intelligence to a community of highly informed investors, is reporting that MedaSorb Technologies' (OTCBB: MSBT) flagship product CytoSorb? -- a therapeutic device, may be a Holy Grail which has eluded medicine for decades
Severe sepsis is a life-threatening condition, which affects over 18 million people each year
"Unfortunately, most know someone who had developed a severe infection. It could have been something as catastrophic as a ruptured appendix, or something more common as pneumonia, maybe a bad urinary tract infection or even influenza -- where the infection got out of hand and sent that person to the intensive care unit on life support, with failing critical organs like the hearts, lungs, and kidneys," says Dr. Phillip Chan, MD, PhD, the Chief Executive Officer of the company
"Despite the best medical care here in the United States, one in every three patients die of this disease, and in fact, more people die of severe sepsis in the United States than from either heart attacks or strokes or any single form of cancer. It remains a major unmet medical need."
While massive resources have been invested in developing and evaluating potential therapies, MedaSorb is conducting human trials in Europe and has already announced preliminary positive proof of concept in humans, using CytoSorb? to treat severe sepsis patients
"Our major goal (for 2010) is the successful completion of our trial, which will hopefully lead to CE Mark approval," Chan said
The complete report is available now at BioMedReports.Com:
http://biomedreports.com/articles/most-popular/27800-has-medasorb-found-the-holy-grail-to-treat-severe-infections.html
Biotech investors interested in accessing the news portal's complete database of clinical trials and upcoming FDA decisions can access that information here:
http://biomedreports.com/fda-calendar/fda-calendar.html
About BioMedReports.Com
BioMedReports.com is a news portal covering the biomedical news and financial sector. BioMedReports is not paid or compensated to report news and developments about publicly traded companies. See our complete disclosure statements at BioMedReports
For more biomedical sector and investment news go to http://BioMedReports.com
Media Contact: Mary Davila Assistant Editor BioMedReports.Com e-mail: Email Contact Tel: +1 323 472 4480 Fax: +1 888 210 3556
IBOX updated! ...'UNIS'-Ticker/Chart "not activated"//wrong !
Yingli Green Energy Announces Global Sponsorship of 2010 FIFA World Cup(TM)
Date : 02/03/2010 @ 3:00AM
Source : PR Newswire
Stock : Yingli Grn Engy Adr (YGE)
http://ih.advfn.com/p.php?pid=nmona&cb=1265536465&article=41370669&symbol=NY^YGE
Yingli Green Energy Announces Global Sponsorship of 2010 FIFA World Cup(TM)
The first renewable energy company in history to sponsor the FIFA World Cup(TM)
BEIJING, and ZURICH, Switzerland, Feb. 3 /PRNewswire-Asia-FirstCall/ --
Yingli Green Energy Holding Company Limited (NYSE:YGE) ("Yingli Green Energy" or the "Company"), who holds the brand Yingli Solar, is a leading solar energy company and one of the world's largest vertically integrated photovoltaic ("PV") manufacturers. In a statement released jointly with world football's governing body FIFA, the Company today announced that it had become the first renewable energy company to sponsor the FIFA World Cup(TM). This year's tournament will be held in South Africa from June 11 to July 11, 2010. Yingli Green Energy is also the first Chinese company to seal a global sponsorship deal with FIFA
By joining the list of prestigious FIFA World Cup(TM) sponsors, Yingli Green Energy is answering FIFA's call to make the world's most popular sport not only a celebration of the game but also a sign of respect for the planet that we inhabit
The announcement was made at the Yingli 2010 FIFA World Cup(TM) sponsorship-signing ceremony and press conference hosted in Beijing, with video messages from FIFA headquarters in Zurich. By establishing this alliance with FIFA, Yingli Green Energy is aiming to further its strategic marketing initiatives worldwide in conjunction with the FIFA World Cup(TM)
FIFA President Joseph S. Blatter congratulated Yingli Green Energy from Zurich and indicated that FIFA had selected Yingli Green Energy to become one of its international sponsors because of Yingli's track record of success in the field of renewable energy and the Company's clear commitment to the environment
"The announcement of Yingli Green Energy as the first Chinese company to be a global sponsor of the FIFA World Cup(TM) marks a historical moment," said Mr. Blatter. "Furthermore, I am extremely pleased that Yingli has chosen to support 20 Centres for 2010, the Official Campaign of the 2010 FIFA World Cup(TM), by providing solar panels and committing to our efforts to create a better environment, as embodied by our 'Green Goal' concept. I want to commend Mr. Liansheng Miao and his team at Yingli Green Energy on this sponsorship and their commitment to helping us build a better future, which is one of our most important missions."
Mr. Jerome Valcke, Secretary General of FIFA, added: "I am very excited to welcome such a world-leading renewable energy company and the first Chinese company to the FIFA family. We are looking forward to sharing ideas on how to go about making the world greener and cleaner through the love of football."
Mr. Liansheng Miao, Chairman and Chief Executive Officer of Yingli Green Energy, commented: "As one of the world's leading solar companies, we are excited to be joining other world-class brands as an international sponsor of the FIFA World Cup(TM). This sponsorship links Yingli Green Energy to the world's most popular and passionately followed sport. We feel privileged to have this opportunity, and look forward to offering our expertise to help FIFA leverage this much-loved sport to promote a better, greener environment. This sponsorship also signifies our response to the growing global demand to create a greener world through renewable energy. We are proud of our mission and the steps we are taking to make solar power an enduring and cost-effective technology for all humankind."
Mr. Miao noted that Yingli Green Energy had long been dedicated to a vision of a world powered by clean, renewable energy. In pursuing this vision, the Company strives to create a healthy, safe and supportive working environment for all of its employees. In late 2009, Yingli Green Energy was proud to receive the SA 8000 certification, which is testament to its ongoing commitment to social responsibility. This commitment complements FIFA's mission to help create a better future
Yingli Green Energy's sponsorship agreement for the 2010 FIFA World Cup(TM) gives the Company global marketing rights, including certain ticket, perimeter-board advertising and media rights as well as the right to showcase its solar products at the fan zones in the FIFA World Cup(TM) stadiums. Additionally, the agreement gives Yingli the right to place its company logo next to the FIFA World Cup(TM) Official Emblem and advertise or promote its products and services at each step of the distribution process. Yingli will have access to extensive on-site opportunities at FIFA World Cup(TM) stadiums for marketing and promotion purposes
About Yingli Green Energy
Yingli Green Energy Holding Company Limited (NYSE:YGE), who holds the brand Yingli Solar, is a leading solar energy company and one of the world's largest vertically integrated photovoltaic manufacturers. Yingli Green Energy develops, manufactures and sells photovoltaic modules to a wide range of markets, including Germany, Spain, Italy, Greece, France, South Korea, China, and the United States. Headquartered in Baoding, China, Yingli Green Energy has more than 6000 employees and more than 10 branch offices worldwide. Yingli Green Energy is publicly listed on New York Stock Exchange (NYSE:YGE). For more information, please visit http://www.yinglisolar.com/
About FIFA
The Federation Internationale de Football Association (FIFA) is world football's governing body and as such is responsible for many aspects of the game, ranging from publishing the Laws of the Game to organising major international tournaments like the FIFA World Cup(TM). FIFA was founded in 1904 by seven associations representing Belgium, Denmark, France, the Netherlands, Spain, Sweden and Switzerland. It now boasts over 200 member associations, divided between six continental confederations: Asia (AFC), Africa (CAF), Europe (UEFA), Oceania (OFC), North and Central America and the Caribbean (CONCACAF), and South America (CONMEBOL). FIFA is based in Zurich, Switzerland. As world football's governing body, FIFA is responsible for the core values of the game
For further information, please contact:
Yingli Green Energy
In China: Qing Miao Director, Investor Relations Yingli Green Energy Holding Company Limited Phone: +86-312-3100502 Email:
In the Americas: Judy Tzeng Lee Director of Corporate Development Yingli Green Energy Holding Company Limited Phone: +1-510-847-3920 Email:
In Europe: Rebecca Jarschel Brand Manager Yingli Green Energy Europe GmbH Phone: +49-89-540303412 Email:
Fleishman-Hillard International Communications
China: Riomma Zhou / Daniel Ye Phone: +86-10-5869-1666 x2113/2105 Email:
FIFA Media Department Zurich: Phone: +41-43-2227272 Fax: +41-43-2227373 Email:
DATASOURCE: Yingli Green Energy Holding Company Limited
CONTACT: in China, Qing Miao, Director, Investor Relations, +86-312-
3100502, , or in the Americas, Judy Tzeng Lee, Director of
Corporate Development, +1-510-847-3920, , both of Yingli
Green Energy Holding Company Limited; or in Europe, Rebecca Jarschel, Brand
Manager of Yingli Green Energy Europe GmbH, +49-89-540303412,
; or Fleishman-Hillard International Communications in China,
Riomma Zhou, +86-10-5869-1666 x2113, , or Daniel Ye,
+86-10-5869-1666 x2105, ; or FIFA Media Department
Zurich:, +41-43-2227272, +41-43-2227373 (fax),
Web site: http://www.yinglisolar.com/
Yingli Green Energy to Announce Fourth Quarter and Full Year 2009 Financial Results on March 8, 2010
Date : 01/26/2010 @ 4:40AM
Source : PR Newswire
Stock : Yingli Grn Engy Adr (YGE)
http://ih.advfn.com/p.php?pid=nmona&cb=1265536465&article=41254186&symbol=NY^YGE
BAODING, China, Jan. 26 /PRNewswire-Asia-FirstCall/ --
Yingli Green Energy Holding Company Limited (NYSE:YGE) ("Yingli Green Energy" or the "Company"), a leading solar energy company and one of the world's largest vertically integrated photovoltaic ("PV") product manufacturers, today announced that it plans to release its unaudited financial results for the fourth quarter and full year ended December 31, 2009 before the U.S. market opens on Monday, March 8, 2010
The Company has scheduled a corresponding conference call and live webcast to discuss the results at 8:00 AM Eastern Standard Time (EST) on March 8, 2010, which corresponds to 9:00 PM Beijing/Hong Kong time the same day
The dial-in details for the live conference call are as follows: -- U.S. Toll Free Number: +1-866-356-4281 -- International dial-in number: +1-617-597-5395 -- Passcode: 50414803
A live and archived webcast of the conference call will be available on the Investors section of Yingli Green Energy's website at http://www.yinglisolar.com/ . A replay will be available shortly after the call on Yingli Green Energy's website for 90 days
A replay of the conference call will be available until March 22, 2010 by dialing:
-- U.S. Toll Free Number: + 1-888-286-8010 -- International dial-in number: + 1-617-801-6888 -- Passcode: 90317348
About Yingli Green Energy
Yingli Green Energy Holding Company Limited is a leading solar energy company and one of the world's largest vertically integrated photovoltaic product manufacturers. Yingli Green Energy develops, manufactures and sells photovoltaic modules to a wide range of markets, including Germany, Spain, Italy, Greece, France, South Korea, China, and the United States. Headquartered in Baoding, China, Yingli Green Energy has more than 6,000 employees and more than 10 branch offices worldwide. Yingli Green Energy is publicly listed on New York Stock Exchange (NYSE:YGE). For more information, please visit http://www.yinglisolar.com/
For further information, please contact:
In China: Qing Miao Director, Investor Relations Yingli Green Energy Holding Company Limited Tel: +86-312-3100-502 Email:
Courtney Shike Brunswick Group LLC Tel: +86-10-6566-2256 Email:
In the United States: Katie Cralle Brunswick Group LLC Tel: +1-212-333-3810 Email:
DATASOURCE: Yingli Green Energy Holding Company Limited
CONTACT: In China: Qing Miao, Director, Investor Relations of Yingli
Green Energy Holding Company Limited, +86-312-3100-502, or ;
Or Courtney Shike of Brunswick Group LLC, +86-10-6566-2256, or
; Or In the United States: Katie Cralle of Brunswick
Group LLC, +1-212-333-3810, or
Web site: http://www.yinglisolar.com/
State Key Laboratory of PV Technology to be Established at Yingli Green Energy's Manufacturing Base
Date : 01/15/2010 @ 5:00AM
Source : PR Newswire
Stock : Yingli Grn Engy Adr (YGE)
http://ih.advfn.com/p.php?pid=nmona&cb=1265536465&article=41120550&symbol=NY^YGE
BAODING, China, Jan. 15 /PRNewswire-Asia-FirstCall/ --
Yingli Green Energy Holding Company Limited (NYSE:YGE) ("Yingli Green Energy" or the "Company"), one of the world's leading vertically integrated photovoltaic ("PV") product manufacturers, today announced the Ministry of Science and Technology of China has approved the application to establish the first national-level key laboratory in the field of PV technology development, the State Key Laboratory of PV Technology (the "Laboratory"), at Yingli Green Energy's manufacturing base in Baoding
Yingli Green Energy has actively devoted technology and management resources to facilitate both the application and the initial set-up of the Laboratory. The State Key Laboratory will be established with the mission of driving the Chinese development of world-class PV technology in China. Yingli Green Energy expects to enjoy priority rights to commercialize technologies developed in the Laboratory at the Company's production lines. The Laboratory, as an independent research entity, has had the support of Baoding Yingli Group Company Limited, an affiliate of the Company, throughout the application process to satisfy relevant application criteria
"We are pleased to announce the establishment of the State Key Laboratory at our manufacturing base in Baoding," commented Mr. Liansheng Miao, chairman and chief executive officer of Yingli Green Energy. "We believe technological innovation is essential to our position as a global leader in sustainable energy solutions and key to the quality and cost structure of our products. With increasing support from both the public and private sectors, we believe the Laboratory has the potential to positively contribute to the development of the PV industry as a platform for the commercialization of cutting-edge PV technologies, as well as a center for academic and professional training."
About Yingli Green Energy
Yingli Green Energy Holding Company Limited (NYSE:YGE) is one of the world's leading vertically integrated PV product manufacturers. Yingli Green Energy designs, manufactures and sells PV modules and designs, assembles, sells and installs PV systems that are connected to an electricity transmission grid or operate on a stand-alone basis. Based in Baoding, China, Yingli Green Energy sells its PV modules to system integrators and distributors located in various markets around the world, including Germany, Spain, Italy, South Korea, Belgium, France, China and the United States. For more information, please visit http://www.yinglisolar.com/
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Such statements are based upon management's current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Yingli Green Energy's control, which may cause Yingli Green Energy's actual results, performance or achievements to differ materially from those in the forward- looking statements. Further information regarding these and other risks, uncertainties or factors is included in Yingli Green Energy's filings with the U.S. Securities and Exchange Commission. Yingli Green Energy does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law
For further information, please contact:
In China: Qing Miao Director, Investor Relations Yingli Green Energy Holding Company Limited Tel: +86-312-3100-502 Email:
Courtney Shike Brunswick Group LLC Tel: +86-10-6566-2256 Email:
In the United States: Katie Cralle Brunswick Group LLC Tel: +1-212-333-3810 Email:
DATASOURCE: Yingli Green Energy Holding Company Limited
CONTACT: In China: Qing Miao, Director, Investor Relations of Yingli
Green Energy Holding Company Limited, +86-312-3100-502, or ;
Or Courtney Shike of Brunswick Group LLC, +86-10-6566-2256, or
; Or In the United States: Katie Cralle of Brunswick
Group LLC, +1-212-333-3810, or
Web site: http://www.yinglisolar.com/
Yingli Green Energy Receives $4.5 Million Tax Credit for Planned Establishment of Manufacturing Operations in the United States
Date : 01/13/2010 @ 6:35AM
Source : PR Newswire
Stock : Yingli Grn Engy Adr (YGE)
http://ih.advfn.com/p.php?pid=nmona&cb=1265536465&article=41084695&symbol=NY^YGE
BAODING, China, Jan. 13 /PRNewswire-Asia-FirstCall/ --
Yingli Green Energy Holding Company Limited (NYSE:YGE) ("Yingli Green Energy" or the "Company"), one of the world's leading vertically integrated photovoltaic ("PV") product manufacturers, today announced it has received through its US subsidiary, Yingli Green Energy Americas, Inc. ("Yingli Americas"), a tax credit of US$4.5 million from the United States Treasury Department, as part of its Recovery Act Advanced Manufacturing Tax Credit program ("MITC program"), for the Company's planned establishment of manufacturing operations in the United States. According to the U.S. Department of Energy, tax credits under the MITC program are focused on putting Americans back to work by building a robust domestic manufacturing capacity to supply clean and renewable energy projects with American-made parts and equipment
Yingli Green Energy is currently evaluating several potential sites for its planned 100 MW module manufacturing facility, which will also serve as its North American headquarters for operations and research and development. The Company expects to select a location in the following weeks and begin production later this year. Much of the manufacturing equipment used for production and testing will be procured from US companies and assembled in the United States
"We are pleased to have been selected as a recipient of tax credits under the MITC program," commented Mr. Liansheng Miao, Chairman and Chief Executive Officer of Yingli Green Energy. "Establishing a manufacturing presence in the United States will enable our company to better serve our local customers and build upon our existing commercial relationships. The tax credits we received will positively contribute towards making these domestic operations sustainable for our customers, employees and community."
"The tax credits we received will accelerate our momentum in the US market," added Mr. Robert Petrina, Managing Director of Yingli Americas. "Our North America Center of Excellence will serve to facilitate the collaboration we enjoy with our commercial partners and reduce time-to-market for newly developed innovative products designed to drive down the cost of solar power generation. We look forward to advancing our contribution to the growth of the domestic green economy."
About Yingli Green Energy
Yingli Green Energy Holding Company Limited (NYSE:YGE) is one of the world's leading vertically integrated PV product manufacturers. Yingli Green Energy designs, manufactures and sells PV modules and designs, assembles, sells and installs PV systems that are connected to an electricity transmission grid or operate on a stand-alone basis. Based in Baoding, China, Yingli Green Energy sells its PV modules to system integrators and distributors located in various markets around the world, including Germany, Spain, Italy, South Korea, Belgium, France, China and the United States. For more information, please visit http://www.yinglisolar.com/
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute "forward-looking" statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates" and similar statements. Such statements are based upon management's current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Yingli Green Energy's control, which may cause Yingli Green Energy's actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in Yingli Green Energy's filings with the U.S. Securities and Exchange Commission. Yingli Green Energy does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law
For further information, please contact:
In China: Qing Miao Director, Investor Relations Yingli Green Energy Holding Company Limited Tel: +86-312-3100-502 Email:
Courtney Shike Brunswick Group LLC Tel: +86-10-6566-2256 Email:
In the United States: Katie Cralle Brunswick Group LLC Tel: +1-212-333-3810 Email:
DATASOURCE: Yingli Green Energy Holding Company Limited
CONTACT: In China: Qing Miao, Director, Investor Relations, Yingli Green
Energy Holding Company Limited, +86-312-3100-502, ; Courtney
Shike, Brunswick Group LLC, +86-10-6566-2256, ; In
the United States: Katie Cralle, Brunswick Group LLC, +1-212-333-3810,
Web site: http://www.yinglisolar.com/
Cytori Receives Stem Cell Order from Japanese Cosmetic Surgery Center
Posted by Cosmetic Surgery Review on February 6, 2010
http://cosmeticsurgerytoday.wordpress.com/2010/02/06/cytori-receives-stem-cell-order-from-japanese-cosmetic-surgery-center/
Stem cell surgery options and procedures continue to evolve at a rapid rate, and companies such as Cytori Therapeutics are making preparations to serve more medical centers and cosmetic surgery facilities with stem cell orders in the oncoming years. Most recently, Cytori has received an order for a StemSource Cell Bank from Cosmetic Surgery Seishin in Japan.
The order request is for the patented Cell Bank which includes a complete StemSource processing system, equipment, software, a database, and protocols needed to freeze and preserve patient’s adipose-derived stem cells. Since stem cell and regenerative cell preservation is such a delicate process, it is critical that the cells are stored under the perfect temperature and extracted using very special techniques and tool.
Chief Medical Officer of Cosmetic Surgery Seishin Dr. Tatsuro Kamakura reports, “I have been using Cytori’s products for over three years and they have become an integral part of my practice…I have seen an increasing demand among my patients for the ability to bank their cells on their own future use. Having a StemSource Cell Bank will further distinguish our growing practice.” (Source: TradingMarkets.com)
Cytori is one of the world leaders in regenerative medicine and has been providing hundreds of physicians with the latest innovations in medical technology and stem cell resources such as the StemSource Cell Bank. The bank allows doctors to use adult regenerative cells that are extracted directly from the patient’s adipose tissue, and use them in procedures such as stem cell breast augmentation, skin resurfacing procedures, and facial plastic surgery procedures that demand rapid regeneration of cells and skin tissue.
The Cell Bank will be installed at Cosmetic Surgery Seishin within the next few months, and the center will be using the stem cells derived from liposuction procedures that are performed at the practice on a regular basis.
Cardiac Electrophysiology Conference in Tokyo - February_8,_2010
Date : 02/04/2010 @ 8:00AM
Source : PR Newswire
Stock : (NWCI)
http://ih.advfn.com/p.php?pid=nmona&article=41396179&symbol=NWCI
NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to Present at Prestigious Cardiac Electrophysiology Conference in Tokyo
Dr. Gussak to Provide Special Lecture at the Japanese Idiopathic Ventricular Fibrillation (J-IVFS) Annual Meeting on February 8, 2010
SAN JOSE, Calif., Feb. 4 /PRNewswire-FirstCall/ --
NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that its Chief Medical Officer, Ihor Gussak MD, PhD, FACC, world-recognized expert in electrocardiology and cardiac safety, will provide a special lecture at the prestigious Japanese Idiopathic Ventricular Fibrillation (J-IVFS) Annual Meeting at the Sankei Plaza convention center in Tokyo, Japan on February 8, 2010. Dr. Gussak's presentation, Early Ventricular Repolarization: ECG Phenomena and Arrhythmogenic Potentials" will be Chaired by Prof. Kaoru Sugi (Toho University Ohashi Medical Center)
The 45-minute presentation will show how a three-dimensional (3D) ECG analysis, made possible by NewCardio's technology, provides additional information on subtle or non-conclusive changes, which clinicians can use to assess risk of sudden cardiac arrest more appropriately and effectively. NewCardio's platform technology, which applies advanced 3D techniques and modern computer software, can help clinicians to identify patients at risk of fatal arrhythmias by providing clinicians a deeper look and additional information compared to traditional techniques
"NewCardio remains committed to deploying state-of-the-art science and technology to enable more accurate diagnosis and risk stratification of serious cardiac conditions and to advance the prevention and treatment of life-threatening conditions, including electrical diseases of the heart," commented Dr. Gussak. "I am excited to share our latest developments and discuss the far-reaching potential of our platform technology at the J-IVFS."
The J-IVFS is one of the most prestigious Cardiac Electrophysiology events in the world, covering areas of particular focus in Japan where idiopathic sudden cardiac arrest is endemic and very problematic. Distinguished attendees at the event include Dr. Masakazu Hiraoka (Ministry of Health, Labor and Welfare, Labor Health Appeal Committee), Professor Kazutaka Aonuma (University of Tsukuba), Naohiko Aihara (National Cardiovascular Center), Dr. Masahiko Takagi (Osaka City University Graduate School of Medicine), Dr. Yukio Sekiguchi (University of Tsukuba), Dr.Yasuhiro Yokyama (National Disaster Medical Center), Professor Hirotsugu Atarashi (Nihon Medical University Tama Nagayama Hospital) and Dr. Akihiko Nogami (Yokohama Rosai Hospital), and Dr. Sami Viskin (Israel)
Dr. Gussak is a Fellow of the American College of Cardiology, and serves on the Clinical Cardiology Council of the American Heart Association. He is a member of the American Academy of Pharmaceutical Physicians, the International Cardiac Electrophysiology Society, the International Society for Holter and Noninvasive Electrocardiology, the Drug Information Association, and the International Scientific Committee on Arrhythmogenic Right Ventricular Dysplasia-Cardiomyopathy. He has published several textbooks and numerous peer-reviewed articles on these and other subjects in clinical cardiology
NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno(TM), a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno(TM), software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development
About NewCardio, Inc
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit http://www.newcardio.com/
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2008 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements
To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0
Investor Contact: Hayden IR Jeff Stanlis, Partner (602) 476-1821
DATASOURCE: NewCardio, Inc
CONTACT: Investors, Jeff Stanlis, Partner at Hayden IR, +1-602-476-1821,
, for NewCardio, Inc
Web Site: http://www.newcardio.com/
1.ALERT: Unilife Medical Solutions - Update_on_NASDAQ_listing
NEWSROOM : http://www.proactivenewsroom.com/unilife/
January 15, 2010: 05:18 PM ET
http://money.cnn.com/news/newsfeeds/articles/marketwire/0577518.htm
The Company is now in the process of completing the final steps necessary for the listing of Unilife Corporation on NASDAQ. Subject to the Form 10 registration statement being declared effective by the SEC and Unilife Corporation's NASDAQ listing application being approved, Unilife Corporation expects its common stock to commence trading on NASDAQ on or around 10 February 2010.
The reserved NASDAQ ticker code for Unilife Corporation is "UNIS."
Comment from Unilife Chief Executive Officer, Alan Shortall
"Unilife has now received the final green light needed to complete our redomiciliation from Australia to the United States of America and move to finalising our listing on NASDAQ.
"During this transition period, which will result in Unilife Corporation becoming the trading entity for the Unilife Group, shareholders will need to be conscious of upcoming changes to our ticker codes. On 18 January 2010, our ASX code will change from 'UNI' to 'UNS' and Unilife Corporation CDIs will commence trading on ASX on a deferred settlement basis. From 2 February 2010, CDI trading should commence on a normal T+3 settlement basis.
"For those shareholders electing to retain their Unilife shares on the ASX as CDIs, there will be little apparent change apart from our Australian ticker code. Shareholders choosing to transfer their holdings to shares of Unilife Corporation common stock that will be tradeable on NASDAQ (subject to the application to list on NASDAQ being approved) will have their shares consolidated on a six to one basis. Following the NASDAQ listing, should shareholders wish to trade their shares of Unilife Corporation common stock, they may choose to either convert it back to CDIs or appoint a qualified broker with the capacity to trade in Unilife Corporation common stock on NASDAQ on their behalf."
Timetable to implementation
The Company would also like to take this opportunity to set out the timetable for completion of the redomiciliation:
Event Date
------------------------------------------------------ -----------------
Federal Court hearing for approval of the Schemes 14 January 2010
------------------------------------------------------ -----------------
Effective Date of the Schemes 15 January 2010
------------------------------------------------------ -----------------
Suspension of the Company's shares from trading on ASX 15 January 2010
------------------------------------------------------ -----------------
Unilife Corporation CDIs commence trading on ASX on a
deferred settlement basis 18 January 2010
------------------------------------------------------ -----------------
Record Date for the Schemes 22 January 2010
------------------------------------------------------ -----------------
Implementation Date for the Schemes 27 January 2010
------------------------------------------------------ -----------------
Despatch of holding statements and transmittal letters 1 February 2010
------------------------------------------------------ -----------------
CDIs commence trading on normal T+3 basis 2 February 2010
------------------------------------------------------ -----------------
Expected commencement date for listing on NASDAQ 10 February 2010
(subject to SEC
review of Form 10
and approval of
NASDAQ listing
application)
------------------------------------------------------ -----------------
All dates and times are indicative only and are subject to change.
All dates and times are Australian Eastern Daylight Time
About Unilife
Unilife Medical Solutions Ltd. is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.
Shareholder / Analyst Enquiries:
Australia
Jeff Carter
Phone: + 61 2 8346 6500
United States
Stuart Fine
Phone: + 1 908 469 1788
###########################################################
IHUB: http://investorshub.advfn.com/boards/board.aspx?board_id=15924
Unilife Medical Solutions Update on NASDAQ listing
NEWSROOM : http://www.proactivenewsroom.com/unilife/
January 15, 2010: 05:18 PM ET
http://money.cnn.com/news/newsfeeds/articles/marketwire/0577518.htm
The Company is now in the process of completing the final steps necessary for the listing of Unilife Corporation on NASDAQ. Subject to the Form 10 registration statement being declared effective by the SEC and Unilife Corporation's NASDAQ listing application being approved, Unilife Corporation expects its common stock to commence trading on NASDAQ on or around 10 February 2010.
The reserved NASDAQ ticker code for Unilife Corporation is "UNIS."
Comment from Unilife Chief Executive Officer, Alan Shortall
"Unilife has now received the final green light needed to complete our redomiciliation from Australia to the United States of America and move to finalising our listing on NASDAQ.
"During this transition period, which will result in Unilife Corporation becoming the trading entity for the Unilife Group, shareholders will need to be conscious of upcoming changes to our ticker codes. On 18 January 2010, our ASX code will change from 'UNI' to 'UNS' and Unilife Corporation CDIs will commence trading on ASX on a deferred settlement basis. From 2 February 2010, CDI trading should commence on a normal T+3 settlement basis.
"For those shareholders electing to retain their Unilife shares on the ASX as CDIs, there will be little apparent change apart from our Australian ticker code. Shareholders choosing to transfer their holdings to shares of Unilife Corporation common stock that will be tradeable on NASDAQ (subject to the application to list on NASDAQ being approved) will have their shares consolidated on a six to one basis. Following the NASDAQ listing, should shareholders wish to trade their shares of Unilife Corporation common stock, they may choose to either convert it back to CDIs or appoint a qualified broker with the capacity to trade in Unilife Corporation common stock on NASDAQ on their behalf."
Timetable to implementation
The Company would also like to take this opportunity to set out the timetable for completion of the redomiciliation:
Event Date
------------------------------------------------------ -----------------
Federal Court hearing for approval of the Schemes 14 January 2010
------------------------------------------------------ -----------------
Effective Date of the Schemes 15 January 2010
------------------------------------------------------ -----------------
Suspension of the Company's shares from trading on ASX 15 January 2010
------------------------------------------------------ -----------------
Unilife Corporation CDIs commence trading on ASX on a
deferred settlement basis 18 January 2010
------------------------------------------------------ -----------------
Record Date for the Schemes 22 January 2010
------------------------------------------------------ -----------------
Implementation Date for the Schemes 27 January 2010
------------------------------------------------------ -----------------
Despatch of holding statements and transmittal letters 1 February 2010
------------------------------------------------------ -----------------
CDIs commence trading on normal T+3 basis 2 February 2010
------------------------------------------------------ -----------------
Expected commencement date for listing on NASDAQ 10 February 2010
(subject to SEC
review of Form 10
and approval of
NASDAQ listing
application)
------------------------------------------------------ -----------------
All dates and times are indicative only and are subject to change.
All dates and times are Australian Eastern Daylight Time
About Unilife
Unilife Medical Solutions Ltd. is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.
Shareholder / Analyst Enquiries:
Australia
Jeff Carter
Phone: + 61 2 8346 6500
United States
Stuart Fine
Phone: + 1 908 469 1788
###########################################################
IHUB: http://investorshub.advfn.com/boards/board.aspx?board_id=15924
Update on NASDAQ listing
January 15, 2010: 05:18 PM ET
http://money.cnn.com/news/newsfeeds/articles/marketwire/0577518.htm
The Company is now in the process of completing the final steps necessary for the listing of Unilife Corporation on NASDAQ. Subject to the Form 10 registration statement being declared effective by the SEC and Unilife Corporation's NASDAQ listing application being approved, Unilife Corporation expects its common stock to commence trading on NASDAQ on or around 10 February 2010.
The reserved NASDAQ ticker code for Unilife Corporation is "UNIS."
Comment from Unilife Chief Executive Officer, Alan Shortall
"Unilife has now received the final green light needed to complete our redomiciliation from Australia to the United States of America and move to finalising our listing on NASDAQ.
"During this transition period, which will result in Unilife Corporation becoming the trading entity for the Unilife Group, shareholders will need to be conscious of upcoming changes to our ticker codes. On 18 January 2010, our ASX code will change from 'UNI' to 'UNS' and Unilife Corporation CDIs will commence trading on ASX on a deferred settlement basis. From 2 February 2010, CDI trading should commence on a normal T+3 settlement basis.
"For those shareholders electing to retain their Unilife shares on the ASX as CDIs, there will be little apparent change apart from our Australian ticker code. Shareholders choosing to transfer their holdings to shares of Unilife Corporation common stock that will be tradeable on NASDAQ (subject to the application to list on NASDAQ being approved) will have their shares consolidated on a six to one basis. Following the NASDAQ listing, should shareholders wish to trade their shares of Unilife Corporation common stock, they may choose to either convert it back to CDIs or appoint a qualified broker with the capacity to trade in Unilife Corporation common stock on NASDAQ on their behalf."
Timetable to implementation
The Company would also like to take this opportunity to set out the timetable for completion of the redomiciliation:
Event Date
------------------------------------------------------ -----------------
Federal Court hearing for approval of the Schemes 14 January 2010
------------------------------------------------------ -----------------
Effective Date of the Schemes 15 January 2010
------------------------------------------------------ -----------------
Suspension of the Company's shares from trading on ASX 15 January 2010
------------------------------------------------------ -----------------
Unilife Corporation CDIs commence trading on ASX on a
deferred settlement basis 18 January 2010
------------------------------------------------------ -----------------
Record Date for the Schemes 22 January 2010
------------------------------------------------------ -----------------
Implementation Date for the Schemes 27 January 2010
------------------------------------------------------ -----------------
Despatch of holding statements and transmittal letters 1 February 2010
------------------------------------------------------ -----------------
CDIs commence trading on normal T+3 basis 2 February 2010
------------------------------------------------------ -----------------
Expected commencement date for listing on NASDAQ 10 February 2010
(subject to SEC
review of Form 10
and approval of
NASDAQ listing
application)
------------------------------------------------------ -----------------
All dates and times are indicative only and are subject to change.
All dates and times are Australian Eastern Daylight Time
About Unilife
Unilife Medical Solutions Ltd. is an ISO 13485 certified company that designs, develops and supplies innovative safety medical devices. Listed on the Australian Securities Exchange (ASX: UNI) since 2002, Unilife has FDA-registered manufacturing facilities in the US State of Pennsylvania and a proprietary portfolio of clinical and prefilled safety syringes designed for use within healthcare and pharmaceutical markets.
Shareholder / Analyst Enquiries:
Australia
Jeff Carter
Phone: + 61 2 8346 6500
United States
Stuart Fine
Phone: + 1 908 469 1788
WAMUQ Technical Chart_ 2/5/2010 @ClayTrader
Cantwell reveals another WaMu inquiry
Friday, February 5, 2010, 2:50pm PST
http://www.bizjournals.com/seattle/stories/2010/02/01/daily48.html?surround=lfn
In her first extensive interview about Washington Mutual since right after its closure, Sen. Maria Cantwell revealed there is an additional investigation ongoing into the bank’s seizure by the government in September 2008.
Cantwell, D-Wash., declined to release details of the investigation, or even say whether a government agency is involved. In an interview with the Puget Sound Business Journal this week, she said only that “we’ve pushed the people who are looking into it and they are working with us.”
More than a year after government regulators seized Seattle-based WaMu and sold it to JPMorgan Chase & Co., the number of parties investigating the seizure is growing. Among the agencies involved in WaMu investigations:
- The Inspector General offices of the Federal Deposit Insurance Corp. (FDIC) and the Office of Thrift Supervision (OTS), WaMu’s chief federal regulators
- The Senate Permanent Subcommittee on Investigations
- The Federal Bureau of Investigation (FBI) ,which is heading up a larger task force.
Cantwell said she is aware of all the ongoing investigations and decided not to launch her own in the wake of the WaMu fallout because of the other parties involved. Still, she said that an additional investigation is taking place, but she declined to elaborate.
WaMu, in light of more than 170 other banking failures across the country, remains a “critically important” issue, Cantwell said.
“WaMu represents the challenges and the moral hazards that exist when you’re trying to pick winners and losers,” Cantwell said. “That’s not what’s going to give people faith in our system.”
Cantwell’s comments about WaMu come as the senator has increasingly positioned herself as critical of the federal government’s actions during the financial crisis. She voted against the Troubled Asset Relief Program (TARP) in 2008, the government’s billion-dollar plan to help banks, and recently voted against a second term for Federal Reserve Chairman Ben Bernanke.
She also recently lobbied Treasury Secretary Timothy Geithner for billions of dollars in additional capital for community banks nationwide in a push to unplug the flow of credit to small businesses.
“It’s a battle against this large institution conglomerate taking over and then being set up so they can be bailed out by taxpayers again,” Cantwell said.
In WaMu’s case, Cantwell said she tried on several occasions to get answers from former Treasury Secretary Hank Paulson and FDIC Chairman Sheila Bair about how the government was handling WaMu in the frantic days before the bank was closed in September 2008. At one point, she said, after Paulson didn't return her phone calls, she cornered him before a congressional hearing to ask about the bank. After she told him that WaMu had adequate capital and liquitity, he hurriedly answered, “I know all this.”
Cantwell said she told Bair before the bank’s closure that she didn’t understand why regulators would take action against WaMu when the government was anticipating passing legislation that would help all banks.
Cantwell said she told Bair that “whatever she did better be clear and transparent.”
After WaMu was shut down on Sept. 25, 2008, Cantwell said federal regulators explained to her that a $16.7 billion bank run was the reason for its closure. That information was also released to the general public.
Cantwell reveals another WaMu inquiry
Friday, February 5, 2010, 2:50pm PST
http://www.bizjournals.com/seattle/stories/2010/02/01/daily48.html?surround=lfn
In her first extensive interview about Washington Mutual since right after its closure, Sen. Maria Cantwell revealed there is an additional investigation ongoing into the bank’s seizure by the government in September 2008.
Cantwell, D-Wash., declined to release details of the investigation, or even say whether a government agency is involved. In an interview with the Puget Sound Business Journal this week, she said only that “we’ve pushed the people who are looking into it and they are working with us.”
More than a year after government regulators seized Seattle-based WaMu and sold it to JPMorgan Chase & Co., the number of parties investigating the seizure is growing. Among the agencies involved in WaMu investigations:
- The Inspector General offices of the Federal Deposit Insurance Corp. (FDIC) and the Office of Thrift Supervision (OTS), WaMu’s chief federal regulators
- The Senate Permanent Subcommittee on Investigations
- The Federal Bureau of Investigation (FBI) ,which is heading up a larger task force.
Cantwell said she is aware of all the ongoing investigations and decided not to launch her own in the wake of the WaMu fallout because of the other parties involved. Still, she said that an additional investigation is taking place, but she declined to elaborate.
WaMu, in light of more than 170 other banking failures across the country, remains a “critically important” issue, Cantwell said.
“WaMu represents the challenges and the moral hazards that exist when you’re trying to pick winners and losers,” Cantwell said. “That’s not what’s going to give people faith in our system.”
Cantwell’s comments about WaMu come as the senator has increasingly positioned herself as critical of the federal government’s actions during the financial crisis. She voted against the Troubled Asset Relief Program (TARP) in 2008, the government’s billion-dollar plan to help banks, and recently voted against a second term for Federal Reserve Chairman Ben Bernanke.
She also recently lobbied Treasury Secretary Timothy Geithner for billions of dollars in additional capital for community banks nationwide in a push to unplug the flow of credit to small businesses.
“It’s a battle against this large institution conglomerate taking over and then being set up so they can be bailed out by taxpayers again,” Cantwell said.
In WaMu’s case, Cantwell said she tried on several occasions to get answers from former Treasury Secretary Hank Paulson and FDIC Chairman Sheila Bair about how the government was handling WaMu in the frantic days before the bank was closed in September 2008. At one point, she said, after Paulson didn't return her phone calls, she cornered him before a congressional hearing to ask about the bank. After she told him that WaMu had adequate capital and liquitity, he hurriedly answered, “I know all this.”
Cantwell said she told Bair before the bank’s closure that she didn’t understand why regulators would take action against WaMu when the government was anticipating passing legislation that would help all banks.
Cantwell said she told Bair that “whatever she did better be clear and transparent.”
After WaMu was shut down on Sept. 25, 2008, Cantwell said federal regulators explained to her that a $16.7 billion bank run was the reason for its closure. That information was also released to the general public.
Yingli Green Energy becomes FIFA World Cup sponsor
Published: 04 Feb 2010 23:55:14 PST
http://news.alibaba.com/article/detail/business-in-china/100245482-1-yingli-green-energy-becomes-fifa.html
Feb. 5, 2010 (China Knowledge) - New York-listed Chinese solar energy company Yingli Green Energy Holding Co Ltd<YGE> on Wednesday signed an agreement with FIFA in Beijing, becoming an official sponsor of the upcoming FIFA Word Cup, sources reported.
The Baoding-based Yingli is the first renewable energy company to sponsor the FIFA World Cup and also the first Chinese company to ink a global sponsorship deal with FIFA.
This year's tournament will be held in South Africa from Jun. 11 to Jul. 11.
Yingli Green Energy, which owns the Yingli Solar brand, is a leading solar energy company and one of the world's largest vertically integrated photovoltaic manufacturers. It develops, manufactures and sells photovoltaic modules to a wide range of markets. It has more than 6,000 employees and over 10 branch offices worldwide, according to the firm's website.
Copyright © 2009 www.chinaknowledge.com
...will do IBOX-update next weekend!
at this moment: Ticker/Chart "not available" !!
http://www.finviz.com/quote.ashx?t=unis&ty=c&ta=0&p=d
Unilife Medical Solutions (NASDAQ: UNIS) /// NEWSROOM
NEWSROOM : http://www.proactivenewsroom.com/unilife/
Keryx Biopharmaceuticals (NASDAQ: KERX) responds to erroneous report about planned Phase III study for patients with Colorectal Cancer
Written by Mike Havrilla
Friday, 05 February 2010 12:37
http://biomedreports.com/articles/most-popular/27884-keryx-biopharmaceuticals-nasdaq-kerx-responds-to-erroneous-report-about-planned-phase-iii-study-for-patients-with-colorectal-cancer.html
Keryx Biopharmaceuticals (NASDAQ: KERX) was mentioned in a published article which contained an inaccurate statement regarding the design of a pending Phase III study for patients with metastatic colorectal cancer (mCRC) that is summarized in quotes below.
". . . The only point of concern I see is that the phase III study will enroll patients who failed treatment with either Erbitux or Vectibix, which makes them a bit sicker than half the patients in the phase II study who were never treated with either commonly-used colon cancer drug. . ."
BioMedReports reached out to Keryx for their comment on the concern noted in the TheStreet.com article today and spoke with the Keryx CEO, Ron Bentsur. Mr. Bentsur noted it is estimated that approximately 50% to 60% of mCRC patients are KRAS positive, so that only this sub-group would potentially benefit from receiving an EGFR antibody such as Erbitux or Vectibix, while the remaining 40% to 50% of mCRC patients do not receive EGFR inhibitors.
Based on these statistics, Keryx estimates that only 50% to 60% of the patients to be enrolled in its upcoming Phase 3 trial for perifosine in metastatic colorectal cancer will have received and failed treatment by either Erbitux or Vectibix, which is similar to the patient population in the Keryx Phase 2 study, as well as the general population.
In addition, the data reported in the Keryx Phase 2 study for the sub-set of 5-FU refractory patients indicated that 60% of those patients had failed prior EGFR antibody, underscoring the fact that the Phase 2 population mimics the targeted Phase 3 patient population, and both of the studies represent true snapshots of the general patient population. In summary, the pending Phase 3 study and the Phase 2 study populations will be virtually the same.
On 2/3/10, Keryx announced that it had reached agreement with the FDA regarding a SPA on the design of a Phase 3 trial for perifosine in patients with refractory mCRC. The Phase 3 X-PECT trial will be a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda) vs. placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer. The primary endpoint is overall survival (OS), with secondary endpoints including overall response rate (ORR: complete responses + partial responses), progression-free survival (PFS) and safety.
The median OS for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in OS, with an assumed median OS for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study. Approximately 40-50 U.S. sites will participate in the study, which is expected to begin during 2Q10 while enrollment is expected to take approximately 12 months, with study completion expected in 2H11.
Keryx Biopharmaceuticals (NASDAQ: KERX) responds to erroneous report about planned Phase III study for patients with Colorectal Cancer
Written by Mike Havrilla
Friday, 05 February 2010 12:37
http://biomedreports.com/articles/most-popular/27884-keryx-biopharmaceuticals-nasdaq-kerx-responds-to-erroneous-report-about-planned-phase-iii-study-for-patients-with-colorectal-cancer.html
Keryx Biopharmaceuticals (NASDAQ: KERX) was mentioned in a published article which contained an inaccurate statement regarding the design of a pending Phase III study for patients with metastatic colorectal cancer (mCRC) that is summarized in quotes below.
". . . The only point of concern I see is that the phase III study will enroll patients who failed treatment with either Erbitux or Vectibix, which makes them a bit sicker than half the patients in the phase II study who were never treated with either commonly-used colon cancer drug. . ."
BioMedReports reached out to Keryx for their comment on the concern noted in the TheStreet.com article today and spoke with the Keryx CEO, Ron Bentsur. Mr. Bentsur noted it is estimated that approximately 50% to 60% of mCRC patients are KRAS positive, so that only this sub-group would potentially benefit from receiving an EGFR antibody such as Erbitux or Vectibix, while the remaining 40% to 50% of mCRC patients do not receive EGFR inhibitors.
Based on these statistics, Keryx estimates that only 50% to 60% of the patients to be enrolled in its upcoming Phase 3 trial for perifosine in metastatic colorectal cancer will have received and failed treatment by either Erbitux or Vectibix, which is similar to the patient population in the Keryx Phase 2 study, as well as the general population.
In addition, the data reported in the Keryx Phase 2 study for the sub-set of 5-FU refractory patients indicated that 60% of those patients had failed prior EGFR antibody, underscoring the fact that the Phase 2 population mimics the targeted Phase 3 patient population, and both of the studies represent true snapshots of the general patient population. In summary, the pending Phase 3 study and the Phase 2 study populations will be virtually the same.
On 2/3/10, Keryx announced that it had reached agreement with the FDA regarding a SPA on the design of a Phase 3 trial for perifosine in patients with refractory mCRC. The Phase 3 X-PECT trial will be a randomized, double-blind trial comparing the efficacy and safety of perifosine + capecitabine (capecitabine is a chemotherapy marketed by Roche as Xeloda) vs. placebo + capecitabine in approximately 430 patients with refractory metastatic colorectal cancer. The primary endpoint is overall survival (OS), with secondary endpoints including overall response rate (ORR: complete responses + partial responses), progression-free survival (PFS) and safety.
The median OS for the X-PECT study's targeted patient population, that has failed prior therapies as described above, is approximately 5 months. The X-PECT study will be powered at 90% to detect a statistically significant difference in OS, with an assumed median OS for the control arm of 5-6 months and 7-8 months for the perifosine arm. Approximately 360 events of death will trigger the un-blinding of the study. Approximately 40-50 U.S. sites will participate in the study, which is expected to begin during 2Q10 while enrollment is expected to take approximately 12 months, with study completion expected in 2H11.