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Canadian Superior Commits to Rig for Drilling Offshore Tunisia
Apr 30, 2010 08:33 ET
http://www.marketwire.com/press-release/Canadian-Superior-Commits-to-Rig-for-Drilling-Offshore-Tunisia-TSX-SNG-1156641.htm
CALGARY, ALBERTA--(Marketwire - April 30, 2010) - Canadian Superior Energy Inc. ("Canadian Superior" or the "Company") (TSX:SNG)(NYSE Amex:SNG) announces today that it has signed an Assignment and Transfer Agreement with BG Tunisia Limited and ENSCO Offshore International Company related to the ENSCO 105 drilling rig. The ENSCO 105 is a 'jackup' rig (independent leg cantilever) built in 2002 and rated for water depths up to 375 feet and drilling depths down to 30,000 feet. This rig has been in the Mediterranean for the last few years on contract with BG. It is anticipated that Canadian Superior will take operational possession of the rig sometime in the 4th quarter of 2010 for the drilling of the Zarat North appraisal well on the 7th of November Block, offshore Tunisia / Libya.
The well will be drilled to approximately 3000 metres to test the El Gueria Formation. It is anticipated the well will take 45 days to drill and evaluate with a possible testing program to follow.
Canadian Superior is the operator of the 7th of November Block. Under a Participation Agreement, Canadian Superior holds a direct 50% interest in the Block and holds the remaining 50% interest in trust for a third party which is also obligated to pay 50% of project costs.
Canadian Superior Energy Inc. is a Calgary, Alberta, Canada based diversified global energy company engaged in the exploration and production of oil and natural gas and in the development of a liquefied natural gas project. Its operations are located in Western Canada, offshore Trinidad and Tobago, North Africa, offshore Eastern Canada, and offshore Eastern United States.
See Canadian Superior's website at www.cansup.com to review further detail on Canadian Superior's operations.
This news release contains "forward-looking information" (within the meaning of applicable Canadian securities laws) and "forward-looking statements" (within the meaning of the U.S. Private Securities Litigation Reform Act of 1995). Such statements or information are identified with words such as "anticipate", "believe", "expect", "plan", "intend", "estimate", "propose", "project" or similar words suggesting future outcomes or statements regarding an outlook. Such statements include, among others, those relating to the proposed date upon which the Company anticipates taking operational possession of the rig, anticipating drilling results, and anticipated timing for drilling and evaluation of results.
Such forward-looking information or statements are based on a number of risks, uncertainties and assumptions which may cause actual results or other expectations to differ materially from those anticipated and which may prove to be incorrect. Assumptions have been made regarding, among other things, operating conditions, availability of capital, and capital and other expenditures. Actual results could differ materially due to a number of factors, including, without limitation, risks of project delays and unsuccessful drilling results, environmental risks, risks associated with foreign operations and risks in relying on industry partners to comply with their obligations. These and other assumptions and risks are set out in detail in the Company's Annual Information Form, available on SEDAR at www.sedar.com, and the Company's annual reports on Form 40-F or Form 20-F on file with the U.S. Securities and Exchange Commission.
Although the Company believes that the expectations reflected in the forward-looking information or statements are reasonable, prospective investors in the Company's securities should not place undue reliance on forward-looking statements because the Company can provide no assurance that such expectations will prove to be correct. Forward-looking information and statements contained in this news release is as of the date of this news release and the Company assumes no obligation to update or revise this forward-looking information except as required by law.
For more information, please contact
Canadian Superior Energy Inc.
Investor Relations
(403) 294-1411
(403) 216-2374 (FAX)
www.cansup.com
or
Canadian Superior Energy Inc.
Suite 3200, 500 - 4th Avenue S.W.
Calgary, Alberta, Canada
T2P 2V6
The Hartford Reports First Quarter 2010 Net Income Of $319 Million
Date : 04/29/2010 @ 4:10PM
Source : Business Wire
Stock : The Hartford Financial Services Group, Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&article=42598170&symbol=NY%5EHIG
Book value per common share increased to $38.94
29.04.2010 22:34
http://www.finanznachrichten.de/nachrichten-2010-04/16768463-the-hartford-reports-first-quarter-2010-net-income-of-dollar-319-million-004.htm
The Hartford Reports First Quarter 2010 Net Income Of $319 Million
The Hartford Financial Services Group, Inc. (NYSE:HIG):
- Core earnings* of $545 million
- Core earnings per diluted share* of $0.14 includes after-tax charges for CPP repurchase, litigation accrual and new federal healthcare legislation totaling $1.18 per diluted share
- Book value per common share increased 61% over prior year period to $38.94
- With successful capital raise and CPP repurchase, company is focused on execution of go-forward strategy
The Hartford Financial Services Group, Inc. (NYSE:HIG) today reported first quarter 2010 net income of $319 million. Due to the repurchase of the government's CPP preferred shares, the company also recorded a $440 million charge to retained earnings that impacts the calculation of net income per diluted share, contributing to a reported net loss per diluted share of $0.42. In the first quarter of 2009, the company reported a net loss of $1.2 billion, or $3.77 per diluted share.
Core earnings for the first quarter of 2010 were $545 million, or $0.14 per diluted share, compared with a core loss of $1.2 billion, or $3.66 per diluted share, for the prior year period.
"The company's first quarter results reflect building momentum, with year-over-year top-line improvements in many businesses," said Liam E. McGee, The Hartford's Chairman, President and Chief Executive Officer. "We also benefited from capital market improvements, disciplined underwriting and a continued focus on execution across the organization. Our goal is to deliver superior shareholder value by generating sustained, profitable growth over time."
"In the first quarter, we made significant progress on our path forward. We completed a successful capital raise, which enabled us to strengthen the company's balance sheet and return the government's investment in The Hartford. We are now focused on executing our go-forward strategy, which leverages our product breadth, distribution strength and broad customer base," added McGee.
...
Securities Registration Statement (simplified form) (S-3)
Date : 04/29/2010 @ 9:21AM
Source : Edgar (US Regulatory)
Stock : (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=42588543&symbol=N^SNSS
...
Subject to Completion, dated April 29, 2010
The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
PROSPECTUS
LOGO
$60,000,000
Common Stock
Warrants
Units
From time to time, we may offer up to $60,000,000 of any combination of the securities described in this prospectus, either individually or in units. We may also offer common stock upon the exercise of warrants.
We will provide the specific terms of these offerings and securities in one or more supplements to this prospectus. We may also authorize one or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplement and any related free writing prospectus may also add, update or change information contained in this prospectus. You should carefully read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference, before buying any of the securities being offered.
Our common stock is listed on The NASDAQ Capital Market under the symbol “SNSS.” The last reported sale price of our common stock on April 27, 2010 was $1.15 per share. The applicable prospectus supplement will contain information, where applicable, as to any other listing, if any, on The NASDAQ Capital Market or any securities market or other exchange of the securities covered by the applicable prospectus supplement.
Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “ Risk Factors ” contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus.
This prospectus may not be used to consummate a sale of any securities unless accompanied by a prospectus supplement.
The securities may be sold directly by us to investors, through agents designated from time to time or to or through underwriters or dealers, on a continuous or delayed basis. For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus. If any agents or underwriters are involved in the sale of any securities with respect to which this prospectus is being delivered, the names of such agents or underwriters and any applicable fees, commissions, discounts and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
Canadian Superior Energy Releases Details of Upcoming Annual General and Special Meeting of Shareholders
Apr 29, 2010 08:35 ET
http://www.marketwire.com/press-release/Canadian-Superior-Energy-Releases-Details-Upcoming-Annual-General-Special-Meeting-Shareholders-TSX-SNG-1155895.htm
CALGARY, ALBERTA--(Marketwire - April 29, 2010) - Canadian Superior Energy Inc. ("Canadian Superior" or the "Company") (TSX:SNG) (NYSE Alternext US:SNG) advises that its annual and special meeting (the "Meeting") of the holders ("Shareholders") of common shares ("Common Shares") will be held in the McMurray Room, at the Calgary Petroleum Club, 319 - 5th Avenue S.W., Calgary, Alberta, on Thursday, June 3, 2010, at 3:00 p.m. (Calgary time), for the following purposes:
1. to receive the audited financial statements of the Company for the year ended December 31, 2009 and the report of the auditors thereon;
2. to elect the directors of the Company for the ensuing year;
3. to appoint Deloitte & Touche llp as auditors of the Company;
4. to consider and, if thought advisable, pass, with or without variation, a special resolution to amend the articles of the Company to change the name of the Company from "Canadian Superior Energy Inc." to "Sonde Resources Corp.";
5. to consider and, if thought advisable, pass, with or without variation, a special resolution to amend the articles of the Company to consolidate (the "Consolidation") the issued and outstanding Common Shares on the basis of one post-Consolidation Common Share for every five pre-Consolidation Common Shares, or such lesser consolidation ratio as the board of directors (the "Board") of the Company may determine;
6. to consider and, if thought advisable, pass, with or without variation, an ordinary resolution to approve the adoption of a new shareholder rights plan of the Company;
7. to consider and, if thought advisable, pass, with or without variation, an ordinary resolution to confirm the new By-Law Number 1 of the Company; and
8. to transact such further and other business as may properly come before the Meeting or any adjournment or adjournments thereof.
The specific details of the matters proposed to be put before the Meeting will be set forth in an Information Circular to be mailed to the Shareholders and will be made available on the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com and the Electronic Data Gathering, Analysis and Retrieval (EDGAR) system at www.sec.gov.
The proposed Consolidation is also subject to Toronto Stock Exchange and NYSE Amex Equities acceptance and the ultimate discretion of the Board to implement the Consolidation. Subject to these conditions and obtaining Shareholder approval at the Meeting, the 311,481,737 pre-consolidation Common Shares that are currently outstanding would be reduced to approximately 62,296,347 post-Consolidation Common Shares.
If the Consolidation is implemented, fractional post-Consolidation Common Shares will not be issued to Shareholders. Where the Consolidation would otherwise result in a Shareholder being entitled to a fractional Common Share, the number of Common Shares issued to such Shareholder shall be rounded up to the next greater whole number of Common Shares if the fractional entitlement is equal to or greater than 0.5 and shall be rounded down to the next lesser whole number of Common Shares if the fractional entitlement is less than 0.5.
Canadian Superior Energy Inc. is a Calgary, Alberta, Canada based diversified global energy company engaged in the exploration and production of oil and natural gas and in the development of a liquefied natural gas project. Its operations are located in Western Canada, offshore Trinidad and Tobago, North Africa, offshore Eastern Canada, and offshore Eastern United States.
See Canadian Superior's website at www.cansup.com to review further details on Canadian Superior's operations.
This news release contains forward-looking information with respect to the timing of the Meeting, the implementation of the Consolidation and the treatment of fractional post-Consolidation Common Shares. Such forward-looking information is subject to the ability of Canadian Superior to obtain all requisite approvals and accordingly, there can be no assurance that any of the foregoing actions by the Company will be completed as contemplated. The Company assumes no obligation to update and/or revise this forward-looking information except as required by law.
This news release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 relating to the timing of the Meeting, the implementation of the Consolidation and the treatment of fractional post-Consolidation Common Shares. The words "will", "would" and "if" are intended to identify these forward-looking statements. Forward-looking statements are based on estimates and assumptions made by Canadian Superior in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors that Canadian Superior believes are appropriate in the circumstances. Many factors could cause Canadian Superior's actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the ability of Canadian Superior to obtain all requisite approvals. These risk factors and others relating to Canadian Superior are discussed in greater detail in the "Risk Factors" section of Canadian Superior's Annual Information Form, which is included in its Annual Report on Form 40-F (copies of which filings may be obtained at www.sedar.com or www.sec.gov). These factors should be considered carefully, and readers should not place undue reliance on Canadian Superior's forward-looking statements. Canadian Superior has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please contact
Canadian Superior Energy Inc.
Investor Relations
(403) 294-1411
(403) 216-2374 (FAX)
Website: www.cansup.com
or
Canadian Superior Energy Inc.
Suite 3200, 500 - 4th Avenue S.W.
Calgary, Alberta, Canada
T2P 2V6
NewCardio to Perform First Revenue-Generating QT Study Using QTinno / NewCardio Now Has Master Services Agreements (MSAs) in Place with Three of the World's Leading CROs
29.04.2010 14:09
http://www.finanznachrichten.de/nachrichten-2010-04/16762771-newcardio-to-perform-first-revenue-generating-qt-study-using-qtinno-newcardio-now-has-master-services-agreements-msas-in-place-with-three-of-the-w-008.htm
SANTA CLARA, Calif., April 29 /PRNewswire-FirstCall/ -- NewCardio, Inc., (BULLETIN BOARD: NWCI) a cardiac diagnostic technology provider, announced today that a leading global biopharmaceutical services provider has signed a MSA, licensing NewCardio's QTinno(TM) software solution to enhance its delivery of fully automated cardiac safety analyses for early phase QT studies. The CRO is expected to deploy QTinno in several clinical unit locations worldwide.
In addition, the CRO has signed a services work order related to the first study using QTinno, which is scheduled to be initiated this June.
"NewCardio now has agreements with three of the leading CROs in the industry," said Vincent Renz, NewCardio's President and Chief Operating Officer. "We are excited about the prospects of this latest agreement, which will result in initial study-related revenue for NewCardio. We continue to believe the transition from semi-automated to fully automated cardiac safety analysis in early phase QT studies is inevitable and accelerating, and the successful completion of our initial studies is expected to lead the market to shift to more high quality, cost effective fully automated studies in the near future. For the CRO, this agreement expands their scope of services in QT studies, enabling them to enhance delivery of high-quality cardiac safety analyses."
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, 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, 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 ECG. NewCardio's 3-D 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, 2009 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 jeff@haydenir.com
NewCardio, Inc.
CONTACT: Investors, Jeff Stanlis, Partner of Hayden IR, +1-602-476-1821,
jeff@haydenir.com, for NewCardio, Inc.
Web Site: http://www.newcardio.com/
© 2010 PR Newswire
Aeterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement
http://www.finanznachrichten.de/nachrichten-2010-04/16737855-aeterna-zentaris-regains-compliance-with-nasdaq-minimum-bid-price-listing-requirement-008.htm
27.04.2010 16:46
Aeterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement
QUEBEC CITY, April 27 /PRNewswire-FirstCall/ -- Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrinology, announced today that it has received a letter from the Nasdaq Stock Market notifying it that the closing price per share of the Company's common stock was above the US$1.00 minimum bid price for 10 consecutive trading days and that, as a result, the Company has regained compliance with Marketplace Rule 5450(a)(1) (the minimum bid price rule) as of Friday, April 23, 2010.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company specialized in oncology and endocrine therapy News releases and additional information are available at http://www.aezsinc.com/.
AETERNA ZENTARIS INC.
CONTACT: Investor Relations: Ginette Vallieres, Investor Relations
Coordinator, (418) 652-8525 ext. 265, gvallieres@aezsinc.com; Media Relations:
Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406,
pburroughs@aezsinc.com
© 2010 PR Newswire
NexMed Appoints Dr. Stephen B. Howell, World Renowned Key Opinion Leader in Oncology as Chairman of Its Scientific Advisory Board
http://www.finanznachrichten.de/nachrichten-2010-04/16741132-nexmed-appoints-dr-stephen-b-howell-world-renowned-key-opinion-leader-in-oncology-as-chairman-of-its-scientific-advisory-board-004.htm
27.04.2010 22:41
NexMed Appoints Dr. Stephen B. Howell, World Renowned Key Opinion Leader in Oncology as Chairman of Its Scientific Advisory Board
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced the appointment of Stephen B. Howell, M.D., as Chairman of its Scientific Advisory Board.
Commenting on today's news, Dr. Bassam Damaj, Chief Executive Officer of NexMed, noted, "We are very pleased to welcome Steve as Chairman of our Scientific Advisory Board. He is recognized as a world-class, key opinion leader in oncology and his expertise will be especially valuable as we continue the development of our cancer therapies."
Dr. Howell currently serves as a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each.
Dr. Howell holds a number of patents for his innovative work in chemotherapeutics, drug-delivery systems, and diagnostic assays and is the recipient of numerous awards, including the Milken Family Medical Foundation Award for Outstanding Work in the Field of Cancer Research, a presidential citation from the American Head and Neck Society, and a Fogarty Senior International Fellowship. He is currently one of the main organizers of the American Association of Cancer Research.
Dr. Howell is a graduate of Harvard Medical School and is board certified in internal medicine and medical oncology. He completed his internship, residency, and medical oncology training at the Massachusetts General Hospital, the University of California, San Francisco, and the Dana Farber Cancer Institute, respectively. He completed his research training at the National Institutes of Health.
About NexMed
NexMed is the largest specialty 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. The Company's goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed has embarked on a partnering program to pair the NexACT delivery technology with drugs and drug candidates marketed and being developed by others, including NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information, go to www.nexmed.com and www.bio-quant.com.
Contacts:
NexMed, Inc.
Edward Cox, V.P. Investor Relations, 858-926-5811
ecox@nexmed.com
or
Rx Communications Group, LLC
Paula Schwartz, 917-322-1216
pschwartz@rxir.com
© 2010 Business Wire
Discovery Labs Provides Updates on Surfaxin(R), Other Key Programs and First Quarter 2010 Financial Results
http://www.globenewswire.com/newsroom/news.html?ref=rss&d=189974
Discovery Labs Provides Updates on Surfaxin(R), Other Key Programs and First Quarter 2010 Financial Results
Conference Call Wednesday, April 28, 2010 at 10:00 AM EDT
WARRINGTON, Pa., April 27, 2010 (GLOBE NEWSWIRE) -- Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing its novel synthetic surfactant and aerosol technologies for respiratory diseases, today provides an update on Surfaxin® and key pipeline and business initiatives and reports financial results for the first quarter ended March 31, 2010. The Company will host a conference call on Wednesday, April 28, 2010, at 10:00 AM EDT. The call-in number is 866-332-5218.
Highlights, discussed in greater detail below, include:
* Progress on addressing sole remaining issue to gain potential FDA approval in 2011 of Surfaxin for Respiratory Distress Syndrome (RDS) in premature infants. Re-validation of the optimized fetal rabbit Biological Activity Test (BAT) is 90% complete and currently meeting all pre-specified acceptance criteria. Feedback from the FDA on proposed Surfaxin preclinical program which employs the optimized and revalidated BAT is expected this May.
* The $10.6 million loan with PharmaBio Development Inc., the former strategic investment subsidiary of Quintiles Transnational Corp., has been restructured. PharmaBio has agreed to purchase common stock and warrants for $2.2 million. Quintiles, PharmaBio and the Company have also agreed to explore a potential strategic collaboration to develop Surfaxin LS™ and/or Aerosurf®.
* Enrollment completed for Phase 2 clinical trial of Surfaxin for Acute Respiratory Failure (ARF) with top-line results expected in June 2010.
Update on Surfaxin® for the prevention of RDS
In response to written guidance received in February 2010 from the U.S. Food and Drug Administration (FDA), the Company is focused on performing specified preclinical work as the way to potentially address the sole remaining issue necessary for Surfaxin approval, the final validation of a fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test). A key component of the preclinical program is to first satisfactorily optimize and re-validate the BAT. The BAT has been optimized in accordance with previous review and comment from the FDA. Re-validation of the optimized BAT is approximately 90% complete and currently meeting all pre-specified acceptance criteria. The Company anticipates completing its efforts to revalidate the optimized BAT in May 2010.
Additionally, the Company has been interacting with the FDA regarding important aspects of the specified preclinical program, including its proposed study design and success criteria. The program calls for a series of prospectively-designed, side-by-side preclinical studies employing the optimized BAT and a well-established preterm lamb model of RDS to address the sole remaining issue for Surfaxin approval. The Company expects written response from the FDA to its proposed program in May 2010.
Subject to satisfactory BAT revalidation and FDA feedback on the proposed preclinical program, the Company plans to promptly initiate the proposed preclinical protocol to address the sole remaining issue for Surfaxin approval. The Company believes it remains on track to complete the preclinical work and submit its Complete Response to the FDA in the first quarter of 2011.
Financial Update
For the quarter ended March 31, 2010, the Company reported a net loss of $7.3 million (or $0.05 per share) on 137.7 million weighted average common shares outstanding compared to a net loss of $9.0 million (or $0.09 per share) on 102.1 million weighted average common shares outstanding for the same period in 2009. Net cash burn before financings for the first quarter of 2010 consisted of $5.4 million used for ongoing operating activities, a one-time payment of $1.0 million to satisfy certain contractual severance obligations to the Company's former President and Chief Executive Officer, and $0.2 million used for debt service. Also, in February 2010, the Company completed a public offering of common stock and warrants resulting in net proceeds to the Company of $15.1 million.
As of March 31, 2010, the Company had cash and marketable securities of $24.2 million. Additionally, the Company currently has two Committed Equity Financing Facilities (CEFFs) that, subject to certain conditions, may allow the Company to raise additional capital to support its business plans. As the current market price of the Company's common stock is below the minimum price ($0.60 and $1.15) required by the CEFFs, neither CEFF is currently available. The Company had 154.0 million common shares outstanding as of March 31, 2010.
On April 27, 2010, the Company and PharmaBio Development Inc. (PharmaBio), the former strategic investing subsidiary of Quintiles Transnational Corp. (Quintiles), agreed to restructure the Company's $10.6 million outstanding loan due April 30, 2010. The Company will immediately pay PharmaBio $6.6 million of the loan in cash. The remaining $4.0 million balance of the loan will be due in payments of $2.0 million on each of July 30th and September 30th of 2010. PharmaBio has also agreed to the cancellation of warrants held by it to purchase an aggregate of 2,393,612 shares of common stock.
Additionally, on April 27, 2010, PharmaBio agreed to purchase approximately 4.1 million shares of the Company's common stock and warrants to purchase approximately 2.0 million shares of common stock for gross proceeds of $2.2 million. Each common share, together with a related warrant to purchase one half of a share of common stock, was sold at a unit price of $0.5429. The offering is being made solely to PharmaBio. The securities will be issued under a previously filed registration statement that was declared effective by the Securities and Exchange Commission on June 18, 2008. The warrants are exercisable beginning on the date that is 181 days after the date of issuance until the fifth anniversary of such date at an exercise price of $0.7058 per share of common stock. The transaction is expected to close on or about April 30, 2010, subject to satisfaction of customary closing conditions. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Discovery Laboratories, Inc. nor shall there be any sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
Quintiles, PharmaBio and the Company have also agreed to explore a long-term strategic collaboration for the development of Surfaxin LS and Aerosurf. While there can be no assurance regarding the terms of any such strategic collaboration, PharmaBio has, for example, provided other pharmaceutical companies with at-risk funding for product research, development, and commercialization in exchange for anticipated future financial returns, including fees based upon the attainment of success milestones or royalties on net product sales. The companies plan to continue related discussions and activities in connection with the above; however, there can be no assurances that any such arrangements will be entered into.
W. Thomas Amick, Chairman and interim Chief Executive Officer of Discovery Labs, commented, "A key priority for the Company in 2010 is to strengthen our long-term strategic and financial position and secure capital resources to meaningfully advance our promising KL4 surfactant pipeline programs and maximize shareholder value. We continue to engage in discussions with potential strategic and financial partners that, if successful, will provide the financial resources needed to potentially advance our development programs."
Although a key priority for the Company is to secure strategic partners and capital to support its ongoing research and development activities and assure its future growth and financial stability, there can be no assurance that any strategic alliance will be successfully identified or other financing alternatives will be successfully concluded.
Other Key Pipeline Programs
* Discovery Labs is conducting a Phase 2 clinical trial to determine whether Surfaxin improves lung function and reduces the duration and related risk-exposure of mechanical ventilation in children up to two years of age diagnosed with Acute Respiratory Failure (ARF). ARF is a severe respiratory disorder associated with lung injury, often entailing surfactant dysfunction. ARF occurs after patients have been exposed to serious respiratory infections, such as influenza (including the type A serotype referred to as H1N1) or respiratory syncytial virus (RSV). Hospitalization following influenza or other viral infection is associated with high morbidity and significant healthcare costs. Enrollment is now completed and top-line results are expected to be available in June 2010.
* Surfaxin LS™ (lyophilized dry powder formulation of KL4 surfactant) and Aerosurf® (aerosolized formulation of KL4 surfactant) have the potential to greatly improve the management of RDS and represent the opportunity, over time, to expand the current RDS estimated worldwide annual market of $200 million to a $1 billion opportunity. Surfaxin LS is intended to improve product ease of use for healthcare practitioners, eliminate the need for cold-chain storage, and potentially further improve product clinical performance. Aerosurf holds the promise to significantly expand the use of surfactant therapy in pediatric respiratory medicine by providing neonatologists with a means of delivering KL4 surfactant while potentially avoiding the risks associated with invasive endotracheal intubation and mechanical ventilation.
The Company is currently conducting important preclinical activities for both Surfaxin LS and Aerosurf as well as advancing development of its capillary aerosolization device to support regulatory requirements for its planned clinical programs. The Company is preparing to further engage the FDA and international regulatory agencies with respect to its planned Phase 3 clinical program for Surfaxin LS and Phase 2 clinical program for Aerosurf. The Company intends to initiate these clinical programs upon determining final regulatory strategy and after securing appropriate strategic alliances and necessary capital.
* Aerosolized KL4 surfactant is being evaluated in an investigator-initiated Phase 2a clinical trial in Cystic Fibrosis (CF) patients. The trial is being conducted at a leading research center, The University of North Carolina, and is further supported by the Cystic Fibrosis Foundation. The trial has been designed to assess the safety, tolerability and short-term effectiveness (via improvement in mucociliary clearance) of aerosolized KL4 surfactant in CF patients. Enrollment is approximately 70% complete and top-line results are now expected in the third quarter of 2010.
The descriptions of the transactions agreed to with PharmBio are entirely modified by the transaction documents, which are attached as exhibits to the Form 8-K to be filed by the Company with the Securities and Exchange Commission ("SEC"). Readers are referred to, and encouraged to read in their entirety, the Form 8-K, including the exhibits attached thereto, and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2010 to be filed with the SEC, which includes further detail on the Company's business plans and operations, financial condition and results of operations.
Conference Call Details
Discovery Labs will hold a conference call on Wednesday, April 28, 2010 at 10:00 AM EDT to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 71846778.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing surfactant therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary capillary aerosolization technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs believes that its proprietary technology platform makes it possible, for the first time, to develop a significant pipeline of surfactant products to address a variety of respiratory diseases for which there frequently are few or no approved therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties are: risks relating to the rigorous regulatory requirements required for approval of any drug or drug-device combination products that Discovery Labs may develop, including that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or other regulatory authorities will not be able to agree on the matters raised during regulatory reviews, or Discovery Labs may be required to conduct significant additional activities to potentially gain approval of its product candidates, if ever, (b) the FDA or other regulatory authorities may not accept or may withhold or delay consideration of any of Discovery Labs' applications, or may not approve or may limit approval of Discovery Labs' products to particular indications or impose unanticipated label limitations, and (c) changes in the national or international political and regulatory environment may make it more difficult to gain FDA or other regulatory approval; risks relating to Discovery Labs' research and development activities, including (i) time-consuming and expensive pre-clinical studies, clinical trials and other efforts, which may be subject to potentially significant delays or regulatory holds, or fail, and (ii) the need for sophisticated and extensive analytical methodologies, including an acceptable biological activity test, if required, as well as other quality control release and stability tests to satisfy the requirements of the regulatory authorities; risks relating to Discovery Labs' ability to develop and manufacture drug products and capillary aerosolization systems for clinical studies, and, if approved, for commercialization of drug and combination drug-device products, including risks of technology transfers to contract manufacturers and problems or delays encountered by Discovery Labs, its contract manufacturers or suppliers in manufacturing drug products, drug substances and capillary aerosolization systems on a timely basis or in an amount sufficient to support Discovery Labs' development efforts and, if approved, commercialization; the risk that Discovery Labs may be unable to identify potential strategic partners or collaborators to develop and commercialize its products, if approved, in a timely manner, if at all; the risk that Discovery Labs will not be able in a changing financial market to raise additional capital or enter into strategic alliances or collaboration agreements, or that the ongoing credit crisis will adversely affect the ability of Discovery Labs to fund its activities, or that additional financings could result in substantial equity dilution; the risk that Discovery Labs will not be able to access credit from its committed equity financing facilities (CEFFs), or that the minimum share price at which Discovery Labs may access the CEFFs from time to time will prevent Discovery Labs from accessing the full dollar amount potentially available under the CEFFs; the risk that Discovery Labs or its strategic partners or collaborators will not be able to retain, or attract, qualified personnel; the risk that Discovery Labs will be unable to regain compliance with The Nasdaq Global Market listing requirements prior to the expiration of the grace period currently in effect, which could eventually result in delisting of Discovery Labs' common stock and cause the price of Discovery Labs' common stock to decline; the risk that recurring losses, negative cash flows and the inability to raise additional capital could threaten Discovery Labs' ability to continue as a going concern; the risks that Discovery Labs may be unable to maintain and protect the patents and licenses related to its products, or other companies may develop competing therapies and/or technologies, or health care reform may adversely affect Discovery Labs; risks of legal proceedings, including securities actions and product liability claims; risks relating to health care reform; and other risks and uncertainties described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
NexMed Receives FDA Clearance for PrevOnco™ Phase 2 Study as First-Line Therapy for HCC
Date : 04/26/2010 @ 4:45PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1272375892&article=42536383&symbol=N^NEXM
NexMed Receives FDA Clearance for PrevOnco™ Phase 2 Study as First-Line Therapy for HCC
NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.
The Company also noted that in IND review communication, the FDA has given NexMed the opportunity to move PrevOnco™ directly into a Phase 3 trial that would support marketing approval, subject to positive study results. In order to pursue this regulatory path, NexMed would need to expand the proposed Phase 2 study design to use PrevOnco™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR®, the currently marketed first-line anticancer treatment for patients with either HCC or advanced renal cell carcinoma (cancer of the kidney).
PrevOnco™ incorporates lansoprazole, which is the generic anti-ulcer compound approved under the name Prevacid® and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro and in vivo data generated to date has demonstrated the ability of lansoprazole to inhibit tumor cell growth and enhance survival in mouse models of cancer alone, and in combination with Doxorubicin.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “We are very pleased that the FDA agreed with our protocol for the HCC Phase 2 trial for PrevOnco™ as a first-line therapy for HCC. Additionally, we are actively assessing the suggestion made by the FDA to move directly into a Phase 3 trial, by studying PrevOnco™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR® therapy. Following this path could be very advantageous for NexMed since advancing the drug directly into a Phase 3 study would save us at least 12-24 months in development time.”
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world, with a high incidence in China and other Asian countries. Although uncommon in the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year, comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of Chinese descent, a subpopulation which has a high incidence of viral hepatitis – a known risk factor for HCC.
About NexMed, Inc.
NexMed is the largest specialty 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. The Company’s goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: http://www.nexmed.com or http://www.bio-quant.com.
Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company including but not limited to its ability to develop and license PrevOnco™ and the ability to design and commence clinical studies.
As of April 15, 2010 there were 397,933,773shares of the Registrant's common stock, $.01 par value outstanding
http://ih.advfn.com/p.php?pid=nmona&cb=1272211859&article=42402523&symbol=POSC
...Message on 04/22 was written by Garza (he is LONG), message on 04/23 was not written by Garza...
Positron Chariman confirms talks; Partnership or Buy-Out News May Follow
Written by M.E.Garza Disclosure: Long POSC
Thursday, 22 April 2010 00:00
http://biomedreports.com/articles/most-popular/36931-positron-chariman-confirms-talks-partnership-or-buy-out-news-may-follow.html
...he is LONG
#############
Press conference involving POSC and major company may be announced as early as next Monday
Written by Staff and Wire Reports >>> not written by M.E.Garza
Friday, 23 April 2010 05:48
http://biomedreports.com/articles/most-popular/37131-update-posc-rumors.html
Developing...
out now / see all monday!
...once again!
Positron Chariman confirms talks; Partnership or Buy-Out News May Follow
Written by M.E.Garza Disclosure: Long POSC
Thursday, 22 April 2010 00:00
http://biomedreports.com/articles/most-popular/36931-positron-chariman-confirms-talks-partnership-or-buy-out-news-may-follow.html
...he is LONG
#############
Press conference involving POSC and major company may be announced as early as next Monday
Written by Staff and Wire Reports >>> not written by M.E.Garza
Friday, 23 April 2010 05:48
http://biomedreports.com/articles/most-popular/37131-update-posc-rumors.html
Developing...
and therefore NO Disclosure
...good one!
... your next fault! -
Positron Chariman confirms talks; Partnership or Buy-Out News May Follow
Written by M.E.Garza
Thursday, 22 April 2010 00:00
http://biomedreports.com/articles/most-popular/36931-positron-chariman-confirms-talks-partnership-or-buy-out-news-may-follow.html
Disclosure: Long POSC
#############
Press conference involving POSC and major company may be announced as early as next Monday
Written by Staff and Wire Reports
Friday, 23 April 2010 05:48
http://biomedreports.com/articles/most-popular/37131-update-posc-rumors.html
Developing...
WAG 5/04/2010 09:55AM
...good call!
Outstanding at March 31, 2010: 3,388,173
http://ih.advfn.com/p.php?pid=nmona&cb=1271775364&article=42441796&symbol=ENCO
Keryx Biopharmaceuticals Announces Poster Presentation Highlighting Preclinical Activity of Single-Agent KRX-0401 (Perifosine)
Date : 04/20/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&cb=1271773190&article=42450549&symbol=N^KERX
PR Newswire
NEW YORK, April 20
NEW YORK, April 20 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that preclinical data in neuroblastoma for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR), currently being held in Washington, DC.
The following poster will be presented in Exhibit Hall A-C on Wednesday, April 21, 2010, from 8:00am-11:00am:
Abstract Number: 5248
Presentation Title: Neuroblastoma tumors with different ALK
mutations are sensitive to Perifosine
Poster Section: 16
Poster Board Number: 2
Author Block: Zhijie Li, Carol J. Thiele
Cell & Molecular Biology Section
POB/NCI/NIH, Bethesda, MD
Data demonstrating that single agent perifosine targets activation of Akt in neuroblastoma cells and xenografts, significantly inhibited tumor growth in vivo and improved the survival of mice bearing neuroblastoma tumors was originally presented at the 2009 AACR annual meeting by the same group from the Pediatric Oncology Branch of the National Institute of Health.
A Phase I trial exploring the safety and efficacy of single agent perifosine in patients with pediatric tumors, including neuroblastoma, is currently being conducted by Memorial Sloan Kettering Cancer Center.
A copy of the above abstract is currently available and can be viewed on-line through the AACR 2010 Meeting website at: http://www.aacr.org/home/scientists/meetings--workshops/aacr-101st-annual-meeting-2010/abstracts.aspx.
KRX-0401 is currently in Phase 3 clinical development for refractory advanced colorectal cancer and multiple myeloma, both of these Phase 3 programs being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the AACR website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals Announces Poster Presentation Highlighting Preclinical Activity of Single-Agent KRX-0401 (Perifosine)
Date : 04/20/2010 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&cb=1271773190&article=42450549&symbol=N^KERX
PR Newswire
NEW YORK, April 20
NEW YORK, April 20 /PRNewswire-FirstCall/ --
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that preclinical data in neuroblastoma for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, will be presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR), currently being held in Washington, DC.
The following poster will be presented in Exhibit Hall A-C on Wednesday, April 21, 2010, from 8:00am-11:00am:
Abstract Number: 5248
Presentation Title: Neuroblastoma tumors with different ALK
mutations are sensitive to Perifosine
Poster Section: 16
Poster Board Number: 2
Author Block: Zhijie Li, Carol J. Thiele
Cell & Molecular Biology Section
POB/NCI/NIH, Bethesda, MD
Data demonstrating that single agent perifosine targets activation of Akt in neuroblastoma cells and xenografts, significantly inhibited tumor growth in vivo and improved the survival of mice bearing neuroblastoma tumors was originally presented at the 2009 AACR annual meeting by the same group from the Pediatric Oncology Branch of the National Institute of Health.
A Phase I trial exploring the safety and efficacy of single agent perifosine in patients with pediatric tumors, including neuroblastoma, is currently being conducted by Memorial Sloan Kettering Cancer Center.
A copy of the above abstract is currently available and can be viewed on-line through the AACR 2010 Meeting website at: http://www.aacr.org/home/scientists/meetings--workshops/aacr-101st-annual-meeting-2010/abstracts.aspx.
KRX-0401 is currently in Phase 3 clinical development for refractory advanced colorectal cancer and multiple myeloma, both of these Phase 3 programs being conducted under Special Protocol Assessment (SPA) agreements with the FDA, and in Phase 1 and 2 clinical development for several other tumor types.
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is pending commencement under an SPA agreement with the FDA. Keryx is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials and business prospects for KRX-0401 (perifosine), may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete clinical trials for KRX-0401; the risk that the data (both safety and efficacy) from ongoing clinical trials will not coincide with the data analyses from prior pre-clinical and clinical trials previously reported by the Company; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information found on our website and the AACR website is not incorporated by reference into this press release and is included for reference purposes only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Encorium Reports Fourth Quarter and Year End 2009 Financial Results
Date : 04/19/2010 @ 5:15PM
Source : PR Newswire
Stock : Encorium Grp. (MM) (ENCO)
http://ih.advfn.com/p.php?pid=nmona&article=42441954&symbol=ENCO
PR Newswire
WAYNE, Pa., April 19
WAYNE, Pa., April 19 /PRNewswire-FirstCall/ --
Encorium Group, Inc. (Nasdaq: ENCO), a full service multinational clinical research organization (CRO) conducting studies in over 30 countries for many of the world's leading pharmaceutical and biotechnology companies, today announced its financial results for the fourth quarter and year ended December 31, 2009.
As previously announced, on July 16, 2009 the Company sold substantially all of the assets relating to its U.S. line of business to Pierrel Research USA, Inc., the result of which the Company no longer has any employees or significant operations in the United States. Due to this sale, for the three and 12 months ended December 31, 2009 and 2008, the results of the U.S. business have been presented as discontinued operations in the Company's consolidated financial statements.
2009 Fourth Quarter Financial Results
Net revenue for the fourth quarter of 2009 was $4.4 million, a decrease of 21.4% from $5.6 million for the fourth quarter of 2008. The decrease in net revenues was primarily attributable to overall reductions in clinical trial activity, approximately $491 thousand of revenue recognized on contracts that completed in 2008 off set by favorable foreign currency fluctuations of $480 thousand for the three months ended December 31, 2009. The Company had a consolidated backlog at December 31, 2009 from continuing operations of $17.1 million which included approximately $12.3 million of new business wins in 2009 compared to a backlog of $23.8 million at December 31, 2008.
Direct expenses for the fourth quarter of 2009 were $3.3 million, or 74.9% of net revenues, compared to $3.6 million, or 64.4% of net revenues, for the comparable prior year period. The decrease in direct expenses was primarily the result of reductions in staff and subcontractors utilized on active clinical studies being conducted and approximately $341 thousand of unfavorable foreign currency fluctuation.
Selling, general, and administrative expenses (SG&A) was $1.7 million, or 38.5% of net revenue, for the three months ended December 31, 2009, compared to $2.2 million, or 39.2% of net revenue, for the three months ended December 31, 2008.
Loss from continuing operations decreased to $558 thousand or $(0.18) per diluted share for the fourth quarter of 2009, from a net loss of $12.6 million, or $(4.92) per diluted share, in the fourth quarter of 2008.
2009 Full Year Financial Results
Net revenue for the twelve months ended December 31, 2009 decreased to $17.9 million as compared to $22.3 million for the twelve months ended December 31, 2008. The decrease in revenue was primarily due to a decrease in the number of contracts and related contract values of active clinical studies along with $1.1 million of unfavorable currency fluctuations.
Direct expenses for the year ended December 31, 2009 were $12.6 million compared to $14.6 million for the year ended December 31, 2008. Despite reduced staffing and subcontractor costs and a favorable currency fluctuation of $1.1 million, direct expenses as a percent of net revenue increased to 70.3% from 65.6% in the prior year due to lower net revenues. SG&A expenses for 2009 were $8.1 million, or 45.4% of net revenue, compared to $9.0 million, or 40.5% of net revenue, for 2008. Of the $916 thousand decrease in SG&A, approximately $581 thousand was attributable to favorable foreign currency fluctuations, with the remainder a result of reductions in staff and overhead.
Depreciation and amortization expense for 2009 declined to $380 thousand compared to $1.3 million for 2008, primarily as a result of intangibles related to the Encorium OY acquisition becoming fully amortized.
The Company reported a net loss from continuing operations for the twelve months ended December 31, 2009 of $3.1 million, or $(1.16) per diluted share, as compared to a net loss from continuing operations of $16.9 million, or $(6.57) per diluted share for the twelve months ended December 31, 2008. Included in the 2008 results is a non-cash $14.4 million, or ($0.70) per share, asset impairment charge related to the Company's intangible assets, which includes a $1.9 million non-cash interim asset impairment charge recorded by the Company during the third quarter of 2008 as well as the $12.5 million charge taken in the fourth quarter.
Financial Position, Going Concern and Potential Delisting
Encorium's balance sheet at December 31, 2009 reflected cash and cash equivalents of $197 thousand and stockholders' equity of $2.3 million. Our net cash used in operations for the year ended December 31, 2009 was approximately $8.0 million. The Company's latest financials have been prepared on a going concern basis. The report of Encorium's independent registered public accounting firm, included in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 19, 2010, contains a paragraph that indicates that, while the Company's financial statements have been prepared on a going concern basis, there is substantial doubt about its ability to continue as a going concern, and that no adjustments have been made to the financial statements that might result from the outcome of this uncertainty.
We anticipate that will meet our cash requirements at least into March of 2011, assuming we are able to fully implement our current costs cutting initiatives, we are able to win additional contracts and we are able to maintain our current customer contracts. In the event we are unable to do so, in order for the Company to continue as a going concern we will be required to obtain additional capital from external sources or significantly reduce our operating costs, which may include the cessation of operations in some countries.
Encorium currently fails to meet NASDAQ's $2.5 million minimum stockholders' equity requirement for continued listing and may not be able to meet the other listing requirements in the future. The Company anticipates that a delisting action will be brought against it for failure to comply with the requirement. If a delisting action is brought, the Company may request a hearing before the NASDAQ Listing Qualifications Panel. Such request would stay any delisting determination by the NASDAQ Listing Qualifications Staff and the Company's common stock would remain listed on NASDAQ pending a formal determination by the Panel. However, there can be no assurances that the Panel will grant such request.
Dr. Kai Lindevall, executive chairman stated, "We are very pleased with the cost cutting initiatives that we have put in place. While additional financing is likely necessary, we believe our experience and capabilities in the vaccine field coupled with the recent new awards in this area demonstrate the long term potential we have to grow into a leading vaccine franchise with expertise in regulatory consultancy and strategic trial planning."
About Encorium Group, Inc.
Encorium Group, Inc. is a global clinical research organization specializing in the design and management of complex clinical trials and Patient Registries for the pharmaceutical, biotechnology and medical device industries. The Company's mission is to provide its clients with high quality, full-service support for their biopharmaceutical and medical device development programs. Encorium offers therapeutic expertise, experienced team management and advanced technologies. The Company has drug and biologics development as well as clinical trial experience across a wide variety of therapeutic areas such as infectious diseases, cardiovascular, vaccines, oncology, diabetes endocrinology/metabolism, gene therapy, immunology, neurology, gastroenterology, dermatology, hepatology, women's health and respiratory medicine. Encorium believes that its expertise in the design of complex clinical trials, its therapeutic experience and commitment to excellence, and its application of innovative technologies, offer its clients a means to more quickly and cost effectively move products through the clinical development process.
This press release contains forward-looking statements identified by words such as "estimate," "project," "expect," "intend," "believe," "anticipate" and similar expressions. Those statements involve risks and uncertainties, and actual results could differ materially from those discussed. Factors that could cause or contribute to such differences include, but are not limited to: (i) the risk that we may not have sufficient funds to operate our business; (ii) our success in attracting new business and retaining existing clients and projects; (iii) the size, duration and timing of clinical trials we are currently managing may change unexpectedly; (iv) the termination, delay or cancellation of clinical trials we are currently managing could cause revenues and cash-on-hand to decline unexpectedly; (v) the timing difference between our receipt of contract milestone or scheduled payments and our incurring costs to manage these trials; (vi) outsourcing trends in the pharmaceutical, biotechnology industries; (vii) the ability to maintain profit margins in a competitive marketplace; (viii) our ability to attract and retain qualified personnel; (ix) the sensitivity of our business to general economic conditions; (x) other economic, competitive, governmental and technological factors affecting our operations, markets, products, services and prices; (xi) announced awards received from existing and potential customers are not definitive until fully negotiated contracts are executed by the parties; (xii) our backlog may not be indicative of future results and may not generate the revenues expected; (xiii) uncertainties regarding the availability of additional capital; and (xiv) uncertainties regarding the continued listing of our common stock on NASDAQ. You should not place undue reliance on any forward-looking statement. We undertake no obligation to publicly release the result of any revision of these forward-looking statements to reflect events or circumstances after the date they are made or to reflect the occurrence of unanticipated events. Please refer to the section entitled "Risk Factors" in the Company Annual Report on Form 10-K for the year ended December 31, 2009 for a more complete discussion of factors which could cause our actual results and financial position to change.
--financial tables ...
CONGRESS DAY 1 - 19th April: FEDERAL AND GLOBAL IMMUNISATION FOCUS
http://www.terrapinn.com/2010/wvcdc/programme.stm
16.10
How outsourcing can enhance and speed up development towards licensure of vaccines
* What influence will the new emphasis of the World Health Organization have on regional prioritization on immunization program development
* Case Study I: Why is Finland such an excellent choice to conduct pediatric vaccines studies?
* Case Study II: Turkey – a new European country to conduct vaccine studies?
* Case Study III: What are the additional challenges in conducting such studies in emerging countries, e.g. Philippines?
* The vaccine CRO of the Future
Dr Georg Lautscham,
Director Business Development, Encorium, Encorium
Geithner says economy growing faster than expected
Geithner says economy growing faster than expected; nation should see job growth
On Sunday April 18, 2010, 11:01 am EDT
http://finance.yahoo.com/news/Geithner-says-economy-growing-apf-2517964905.html?x=0&sec=topStories&pos=1&asset=&ccode=
WASHINGTON (AP) -- Treasury Secretary Timothy Geithner says the economy is growing faster than the Obama administration expected.
He tells NBC's "Meet the Press" that the country is on the way to sustained job creation. But he acknowledges that unemployment may remain high, close to 10 percent.
Geithner says there's more confidence in the business world, and he says the private sector is growing. He also says people are spending more.
He said he sees encouraging signs that should make Americans confident the country will emerge stronger.
IBOX updated...
...I'll take it!
4/20/2010 09:55AM
...will jointly present data at the 101st Annual Meeting of the American Association for Cancer Research (AACR), in Washington, D.C. from April 17-21, 2010. The poster presentation, entitled, “Å6 peptide binds to CD44 and inhibits migration and metastasis of CD44+ cell lines in in vitro and in vivo studies,” covers pre-clinical work completed by Bio-Quant on Ångstrom’s lead product, Å6, currently in Phase 2 development for ovarian cancer.
NexMed and Ångstrom Pharmaceuticals to Present Data on Å6 Drug at AACR
Tuesday April 13, 2010, 11:00 am EDT
http://finance.yahoo.com/news/NexMed-and-ngstrom-bw-3991454208.html?x=0&.v=1
2010 Milestones to Watch
•Submit complete response to Health Canada by mid-April 2010; approval by end of 2010
•Acquire small/mid size, profitable CRO with compatible services
•Expand facility for growing CRO business
•Out-license pipeline products
•Out-license NexACT technology
http://www.nexmed.com/pdf/CorporatePresentationMar_18_ROTH.pdf
Encorium receives French Research Tax Credit approval
05 February 2010
http://www.encorium.com/news/pdfs/Encorium_French_Research_Tax_Credit_Approval_5-Feb-2010.pdf
The French Ministry for Higher Education and Research has approved Encorium’s application to conduct R&D activities on behalf of private companies.
This approval allows companies subject to the French General Tax Code to take advantage of the research and development tax credit offered by France. As a result, Encorium’s current and future French customers will be able to benefit from the CIR from 2009 to 2011 by which time the approval is up for renewal.
Research and Development (R&D) tax credits have emerged as one of the preferred tools for promoting and expanding R&D spending. In France the pharmaceuticals industry benefits from one of the best R&D tax-credit system in Europe, which reimburses up to 50% of R&D costs in the first year.
Dr. Kai Lindevall, CEO stated, “We are delighted to announce that our application has been successful. This approval will help our existing and future customers to take advantage of the R&D tax credit enabling them to invest more money into the development of their products. This is yet another example of Encorium’s recognition as a high quality CRO and will further strengthen our market position in France.”
http://www.encorium.com
Vulkanausbruch beschäftigt die Formel 1
So 18.Apr. 07:30:00 2010
http://de.eurosport.yahoo.com/18042010/21/vulkanausbruch-beschaeftigt-formel-1.html
Formel 1 Fahrerwertung
Fahrer Mannschaft Pkt.
1 Jenson Button McLaren 60
2 Nico Rosberg Mercedes 50
3 Fernando Alonso Ferrari 49
Konstrukteurswertung
Mannschaft Pkt.
1 McLaren 109
2 Ferrari 90
3 Red Bull 73
...on watch!
(@toucan: if you like, now you can add me)
AACR - 101st Annual Meeting 2010
http://www.aacr.org/home/scientists/meetings--workshops/aacr-101st-annual-meeting-2010.aspx
Impact of volcanic ash surfacing for US businesses
Airlines hit hardest as cloud disrupts air traffic and businesses adjust; not all are losers
Samantha Bomkamp, AP Business Writer
Friday April 16, 2010, 6:10 pm EDT
http://finance.yahoo.com/news/Impact-of-volcanic-ash-apf-1155965958.html?x=0&sec=topStories&pos=6&asset=&ccode=
NEW YORK (AP) -- Overnight shipping, airlines and tourism were just some of the businesses that faced a second day of disruptions as a cloud of volcanic ash emanating from Iceland grounded thousands of flights to and from Europe.
The airline industry is losing an estimated $200 million a day and delays and cancellations are expected to last at least through the weekend. The impact on businesses that depend on air freight to ship products to and from Europe was harder to quantify, but the world's two largest package delivery companies were seeing a growing backlog.
Both UPS and FedEx had their main European air hubs closed down by the cloud of ash. Shipments that are normally transported by air were being delayed by at least a day, according to UPS spokesman Norman Black. Both companies are taking actions that indicate they're worried about falling further behind.
On Friday afternoon, FedEx stopped accepting virtually all its lower-priority international shipments, which can include a wide variety of products from auto parts to clothing, in order to "control any backlog that might occur within the system," spokeswoman Sally Davenport said.
UPS planned to have workers move packages over the weekend -- a time when they don't usually ship -- to catch up. Within Europe, both FedEx and UPS are moving packages by truck instead of air when possible.
"Some businesses will be affected by the inability for freight to get in and out of the country," said Howard Archer, chief European and U.K economist at IHS Global Insight in London. "As long as the disruption is not too long, this should not be a major problem."
Many businesses that rely heavily on air freight because they ship products of high value and small size expressed confidence that current stockpiles would suffice. A spokeswoman for London-based GlaxoSmithKline, the world's fourth largest drug maker by sales, said the company has enough inventory to meet demand until European flights resume.
For now, the most obvious impact is on air travel. At least one airline, Ryanair Holdings PLC, the leading low-cost airline in Europe, has canceled flights through Monday.
Eurocontrol said about 16,000 of Europe's usual 28,000 daily flights were canceled Friday -- twice as many as were canceled a day earlier.
Flight cancelations can have a cascading effect because if a plane is grounded in Europe, it can't get to the United States for a return trip the next day, even if the European airspace is open.
The Air Transport Association says U.S. passenger airlines and cargo carriers cancelled 280 of the more than 330 trans-Atlantic flights on Friday.
Grant Foster, risk consultant for insurance broker Aon Corp., based in Chicago. said issues with travel and products getting delivered "are going to get quite critical over the next couple of days."
But, he added: "As a whole, the impact isn't a show-stopper in the short term."
Sara Johnson, managing director of global macroeconomics at IHS Global Insight, predicts little fallout to the global economy.
"It's just an unfortunate episode that will cause inconvenience but certainly will not derail the global economic recovery," she says.
Not everyone is crying foul over the plume of smoke. The aviation disruption has been a boon to train and bus service in Europe.
And thousands of stranded business travelers need temporary offices and virtual conferencing capabilities. Regus, a company that provides meeting rooms and virtual offices worldwide, said it has seen an unprecedented spike in the use of its more than 2,500 video communication suites. Reservations are up 38 percent in the UK, 12 percent across Europe and 9 percent in the U.S.
Hotels and inns have also held up well as stranded travelers find a place to wait it out.
Rachael Solem, owner of the Irving House at Harvard and Harding House in Cambridge, Mass., has had some cancellations. But a few guests had to stay longer because flights weren't available to Europe.
One guest originally bound for Heathrow returned to stay an extra two days.
"She is visiting a new grandchild, so she has not been too upset over having to extend her visit here," Solem said.
AP writers Jane Wardell in London, Jeannine Aversa and Matthew Perrone in Washington and David Koenig in Dallas contributed to this report.
SEC accuses Goldman Sachs of defrauding investors
Goldman Sachs accused of fraud; SEC says it hid hedge fund's involvement in doomed securities
Marcy Gordon, AP Business Writer
Saturday April 17, 2010, 5:36 am EDT
http://finance.yahoo.com/news/SEC-accuses-Goldman-Sachs-of-apf-20142808.html?x=0&sec=topStories&pos=4&asset=&ccode=
WASHINGTON (AP) -- The government on Friday accused Wall Street's most powerful firm of fraud, saying Goldman Sachs & Co. sold mortgage investments without telling the buyers that the securities were crafted with input from a client who was betting on them to fail.
And fail they did. The securities cost investors close to $1 billion while helping Goldman client Paulson & Co., a hedge fund, capitalize on the housing bust. The Goldman executive accused of shepherding the deal allegedly boasted about the "exotic trades" he created "without necessarily understanding all of the implications of those monstrosities!!!"
The civil charges filed by the Securities and Exchange Commission are the government's most significant legal action related to the mortgage meltdown that ignited the financial crisis and helped plunge the country into recession.
The news sent Goldman Sachs shares and the stock market reeling as the SEC said other financial deals related to the meltdown continue to be investigated. It was a blow to the reputation of a financial giant that had emerged relatively unscathed from the economic crisis.
Goldman Sachs denied the allegations. In a statement, it called the SEC's charges "completely unfounded in law and fact" and said it will contest them.
The SEC is seeking to recoup the money lost by investors and impose unspecified civil fines against Goldman Sachs and the executive, Fabrice Tourre. The SEC could enter into settlement negotiations over the amount if Goldman changed its stance and decided not to fight the charges in a trial.
The SEC said Paulson paid Goldman roughly $15 million in 2007 to devise an investment tied to mortgage-related securities that the hedge fund viewed as likely to decline in value. Separately, Paulson took out a form of insurance that allowed it to make a huge profit when those securities' value plunged.
The fraud allegations focus on how Goldman sold the securities. Goldman told investors that a third party, ACA Management LLC, had selected the pools of subprime mortgages it used to create the securities. The securities are known as synthetic collateralized debt obligations.
The SEC alleges that Goldman misled investors by failing to disclose that Paulson & Co. also played a role in selecting the mortgage pools and stood to profit from their decline in value. Two European banks that bought the securities lost nearly $1 billion, the SEC said.
"Goldman wrongly permitted a client that was betting against the mortgage market to heavily influence which mortgage securities to include in an investment portfolio, while telling other investors that the securities were selected by an independent, objective third party," SEC Enforcement Director Robert Khuzami said in a statement.
But Goldman said in a statement that it never mischaracterized Paulson's strategy in the transaction. It added that it wasn't obliged to "disclose the identities of a buyer to a seller and vice versa."
The charges name only Goldman Sachs and Tourre, who was a vice president in his late 20s when the alleged fraud was orchestrated in 2007. Tourre, the SEC said, boasted to a friend that he was able to put such deals together as the mortgage market was unraveling in early 2007.
In an e-mail to the friend, he described himself as "the fabulous Fab standing in the middle of all these complex, highly leveraged, exotic trades he created without necessarily understanding all of the implications of those monstrosities!!!"
Tourre, 31, has since been promoted to executive director of Goldman Sachs International in London.
Stanford University spokeswoman Elaine Ray said a student by the name of Fabrice Tourre received a master's degree in management science and engineering from the school in 2001.
A call to a lawyer for Tourre, Pamela Chepiga at Allen & Overy LLP, wasn't returned.
Asked why the SEC did not also pursue a case against Paulson, Khuzami said: "It was Goldman that made the representations to investors. Paulson did not."
Paulson & Co. is run by John Paulson, who reaped billions by betting against subprime mortgage securities. He is not related to former Treasury Secretary Henry Paulson, a former Goldman CEO.
John Paulson was among the first on Wall Street to bet heavily against subprime mortgages. His firm earned more than $15 billion in 2007, and he pocketed $3.7 billion. He has since earned billions more, largely by betting against bank stocks and then buying them back after their shares plunged.
In a statement, Paulson & Co. said: "As the SEC said at its press conference, Paulson is not the subject of this complaint, made no misrepresentations and is not the subject of any charges."
Goldman, founded more than 140 years ago, built a reputation as a trusted adviser to investment banking clients and for sending top executives into presidential Cabinet posts.
In recent years, it shifted toward taking more risks with its clients' money and its own. Goldman's trading allowed the firm to weather the financial crisis better than most other big banks. It earned a record $4.79 billion in the last quarter of 2009.
The complaint filed in federal court in Manhattan "undermines their brand," said Simon Johnson, a professor at the Massachusetts Institute of Technology and a Goldman critic. "It undermines their political clout. I don't think anybody really values being connected to Goldman at this point."
He continued: "There are many people who -- until this morning -- thought Goldman Sachs was well-run."
The SEC's enforcement chief said the agency is investigating a wide range of practices related to the crisis. The prospect of possible legal jeopardy for other major financial players roiled the stock market.
Goldman Sachs shares fell more than 12 percent Goldman and lost $14.2 billion in market capitalization. The Dow Jones industrial average finished down more than 125 points.
The SEC appears to be taking a particularly aggressive approach with Goldman. Typically, cases are resolved by firms agreeing to a settlement before the charges are made public, said John Coffee, a securities law professor at Columbia University.
"The SEC has changed its style," Coffee said. "They wanted to tell the world what they thought Goldman had done wrong."
The charges come as lawmakers seek to crack down on Wall Street practices that helped cause the financial crisis. Congress is considering tougher rules for complex investments like those involved in the alleged Goldman fraud.
President Barack Obama vowed Friday to veto a financial overhaul bill that doesn't regulate mortgage-backed securities and other so-called derivatives. Legislation in Congress would for the first time regulate derivatives, whose value depends on an underlying asset, such as mortgages or stocks. Senate Republicans oppose the bill.
Rep. Barney Frank, D-Mass., chairman of the House Financial Services Committee, is "pleased that the SEC is departing from the lax enforcement of the Bush administration and is returning to the SEC's proper role of protecting investors in the marketplace," spokesman Steven Adamske said.
The biggest loser in the alleged fraud was ABN Amro, a major Dutch bank, and the Royal Bank of Scotland, which acquired major portions of it in 2007. The SEC said the Royal Bank of Scotland paid Goldman $841 million to unwind ABN transactions.
IKB Deutsche Industriebank AG, a German commercial bank, lost nearly all its $150 million investment, the agency said. Most of the money the banks lost went to Paulson in a series of transactions between Goldman and the hedge fund, the SEC said.
IKB was an early casualty of the financial crisis. It issued a profit warning in 2007 saying it had been hurt by U.S. subprime mortgage investments. IKB was sold in 2008 to Dallas-based Lone Star Funds.
Ed Trissel, a spokesman for Lone Star Funds, declined to comment on the case.
The SEC charges come after Goldman Sachs denied last week it that bet against clients by selling them mortgage-backed securities while reducing its own exposure to them.
In an annual letter to shareholders, Goldman said it began reducing its exposure to the U.S. mortgage market in late 2006.
AP Business Writers Alan Zibel in Washington, Stevenson Jacobs in New York and Ashley M. Heher in Chicago contributed to this report.
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http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_K/threadview?m=tm&bn=10207&tid=36345&mid=36345&tof=1&frt=2
ASCO Titles Out - PERIFOSINE DATA COMING!
14-Apr-10 08:10 pm
The titles of the ASCO abstracts have been announced.
There will be two poster sessions with Perifosine featured at the early June ASCO Meeting.
1. Most notably, the final results of the randomized phase II trial comparing Xeloda+Perifosine vs. Xeloda alone will be revealed. This study and its findings led to the current large Phase III randomized study designed to explore the same comparison (and lead to a possible FDA approval). Data to be presented Tuesday, June 8th.
2. Pediatric data is now available for recurrent Pediatric solid tumors. This is a new tumor type for Perifosine with brand new, never revealed data. Poster session on Sunday, June 6th.
These two sessions may be located by visiting the "Meeting Planner" section of ASCO. Good luck to all longs!!!
http://chicago2010.asco.org/