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“I’d like to get him [Icahn] back in the black again.”
Once Destined for Bankruptcy, Adventrx Pharmaceuticals Sets New Course With Reformulated Drugs
Bruce V. Bigelow 1/13/10
http://www.xconomy.com/san-diego/2010/01/13/once-destined-for-bankruptcy-adventrx-pharmaceuticals-sets-new-course-with-reformulated-drugs/
NEXM ...also as previously announced, NexMed remains subject to a grace period through January 25, 2010 to evidence compliance with the $1.00 bid price requirement for continued listing on NASDAQ.
http://ih.advfn.com/p.php?pid=nmona&cb=1263325022&article=41031116&symbol=N^NEXM
ProLogis Announces 4.0 Million Square Feet of Fourth Quarter Global Development Portfolio Leasing Activity
Date : 01/12/2010 @ 7:00AM
Source : PR Newswire
Stock : Prologis (PLD)
Quote : 13.73 -0.36 (-2.56%) @ 1:47PM
http://ih.advfn.com/p.php?pid=nmona&article=41067513&symbol=PLD
ProLogis Announces 4.0 Million Square Feet of Fourth Quarter Global Development Portfolio Leasing Activity
- Global Static Development Portfolio Now 68.2 Percent Leased -
DENVER, Jan. 12 /PRNewswire-FirstCall/ --
ProLogis (NYSE:PLD), a leading global provider of distribution facilities, announced today that its static global development portfolio was 68.2 percent leased as of year-end 2009
"Roughly one year ago, we set a goal to achieve a leased percentage of 60 - 70 percent by year-end 2009 for our development portfolio properties in place as of the end of 2008, or what we have called our static portfolio," said Walt Rakowich, chief executive officer. "We are pleased to have reached the upper end of that goal and are encouraged by continued leasing activity and customer demand. At a time when little development is coming online, ProLogis' best-in-class development inventory provides immediate solutions for our customers' distribution space needs."
ProLogis signed 56 leases in its static development portfolio during the fourth quarter, which increased leased space in this portfolio by approximately 4.0 million square feet (372,000 square meters) in locations worldwide
Recent development portfolio leasing transactions included:
-- Asia: A new, 381,000-square-foot (35,400-square-meter) lease agreement in Japan with Hitachi Transport System, Ltd., a leading third-party logistics provider. Hitachi Transport System will operate the space on behalf of its customer at ProLogis' newly developed facility in the Tokyo market. New development leases in Asia during the fourth quarter totaled 1,130,000 square feet (105,000 square meters)
-- Europe: A new, 237,000-square-foot (22,000-square-meter) lease agreement in the United Kingdom with Biffa, a leading integrated waste management business. Biffa will occupy the space in Building Three at ProLogis Park Midpoint, located in the West Midlands, and will use it as a materials recycling facility for non-hazardous recyclable materials. New development leases in Europe during the fourth quarter totaled 1,937,000 square feet (180,000 square meters)
-- North America: A new, 255,000-square-foot (23,700-square-meter) lease agreement signed in Atlanta with Viega LLC, a manufacturer of plumbing, heating, gas and potable water products. Occupying space at ProLogis Park Greenwood, the customer will use the space as a new distribution hub to serve its customers in the southeastern United States. New development leases in North America during the fourth quarter totaled 877,300 square feet (81,500 square meters)
About ProLogis
ProLogis is a leading global provider of distribution facilities, with more than 475 million square feet of industrial space (44 million square meters) in markets across North America, Europe and Asia. The company leases its industrial facilities to more than 4,500 customers, including manufacturers, retailers, transportation companies, third-party logistics providers and other enterprises with large-scale distribution needs. For additional information about the company, go to http://www.prologis.com/.
DATASOURCE: ProLogis
CONTACT: media, Mo Sheahan, +1-303-567-5434, , or
investors, Melissa Marsden, +1-303-567-5622, , both of
ProLogis; or Suzanne Dawson of Linden Alschuler & Kaplan, Inc.,
+1-212-329-1420, , for ProLogis
Web Site: http://www.prologis.com/
NexMed Announces the Ability of the NexACT® Technology to Deliver Drugs Orally and with Enhanced Bioavailability
Date : 01/12/2010 @ 1:51PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=41075942&symbol=NEXM
NexMed Announces the Ability of the NexACT® Technology to Deliver Drugs Orally and with Enhanced Bioavailability
Date : 01/12/2010 @ 1:51PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&article=41075942&symbol=NEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today announced that pre-clinical results from its research and development group at Bio-Quant successfully demonstrated the ability of the NexACT technology to deliver an oral formulation of Taxol® (paclitaxel) and to enhance the drug’s bioavailability by approximately ten-fold through this oral administration. Taxol, a first line chemotherapy drug used to treat breast, lung and ovarian cancers, is currently administered through an intravenous infusion that can take up to 24 hours to complete
Dr. Bassam Damaj, NexMed’s Chief Executive Officer stated, “The results from these proof of concept studies are exciting and support our belief that NexACT can be successfully used to enhance oral bioavailability of a broad range of drugs, which could include our proprietary drug candidates, generic drugs and proprietary drugs owned by others who are developing second-generation formulations to provide extended patent protection with increased convenience and bioavailability. Our ability to leverage our proprietary NexACT technology in this way is expected to provide exciting new development opportunities and will no longer restrict us to the topical delivery of dermal drugs. Additional studies are ongoing to extend the validation of the technology into other classes of oral drugs.” About NexMed NexMed, due to its recent acquisition of Bio-Quant, 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. For further information, go to www.nexmed.com and www.bio-quant.com
Taxol® is a registered trademark of Bristol-Myers Squibb Company
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. For example, and without limitation, there can be no assurance that the Company will be able to achieve or will continue to pursue its product development goals, that initial pre-clinical findings will be supported by later studies, or that the Company will be able to integrate its business following the Bio-Quant acquisition in a successful manner
Unilife Medical Poised for NASDAQ: UNIS Trading Debut
Written by Mike Havrilla
Tuesday, 12 January 2010 07:22
http://biomedreports.com/articles/most-popular/24289-unilife-medical-poised-for-nasdaq-unis-trading-debut.html
During the second week of January, Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) shareholders overwhelmingly voted in favor of the Company's U.S. relocation. Unilife is now in the final stages of preparation for a NASDAQ: UNIS stock market trading debut, which is expected to occur by the end of February in conjunction with the Company's re-domiciliation to Central Pennsylvania.
Unilife is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injected medications, sharps safety devices for healthcare facilities, and contract manufacturing services.
Unilife USA will replace Unilife Australia as the entity which is listed on the ASX. Unilife Australia shareholders will receive common stock or CHESS Depositary Interests (CDIs) in Unilife USA. The CDIs will trade on the ASX and are analogous to American Depository Receipts (ADRs), which represent ownership stakes in foreign companies that trade on U.S. financial exchanges. Unilife USA will trade on the NASDAQ with ticker ‘UNIS' and six CDIs will be equivalent to one ordinary share in Unilife USA.
Last December, Unilife announced the construction of a 165,000 square foot development that will house the Company's new global headquarters and a commercial production facility at 250 Cross Farm Lane in York, PA. The new facility will also include a 54,000 square foot office space for administrative, marketing, research / development, and quality control. The first stage of the new manufacturing facility will include automated assembly lines with annual capacity of 360 million units per year for Unifill, in addition to other assembly lines for Unitract 1mL safety syringes and other medical device contract manufacturing systems. There is a built-in option and strategy to allow for future expansion, including an additional 100,000 square foot in connected production space that would provide Unifill manufacturing capacity of 1 billion syringes per year.
The new facility is expected to be operational by late 2010 and is being developed on a 38 acre parcel of land at a projected cost of $26 million, which included favorable terms for Unilife in terms of acquiring the land and the project development / contractor expense because of the overall economic conditions in the region which make this situation a buyer's market (construction costs are down an estimated 25-30% from two years ago). However, Unilife has contracted with Keystone Redevelopment Group and HSC Builders and Constructions Managers, which are top tier organizations that serve Fortune 500 companies for economic development projects and specialize in the construction of customized facilities for leading life science / healthcare companies, respectively. The projected timeline for construction of the new facility includes the following milestones:
1.) the completion of clean rooms for equipment installation and a temporary occupancy permit for manufacturing / warehouse by the end of October 2010;
2.) an unrestricted occupancy permits for manufacturing / warehouse and office space by the end of December 2010;
3.) transfer and consolidation of all US-based staff / manufacturing systems from Lewisberry facilities (approximately five miles apart) beginning in early 2011.
In addition, the centralization of production activities within Central PA will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply its safety syringes to all of its anticipated customers while leveraging upon the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs. In late October, Unilife announced the acceptance of a US$5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County as part of the Company's relocation of its global headquarters and manufacturing facilities to Central PA.
Unilife plans to finance development of the new facility from a combination of existing cash reserves ($9 million) and external financing ($17 million), which may include a commercial bank loan, government agencies, and / or other lending institutions. The Company estimates that it saved $2-3 million in upfront development costs and will save approximately $400,000 annually in estimated loan financing payments for the new facility compared to lease payments at the current facility. The following are some key milestones that Unilife expects to achieve during 2010:
1.) the commercial release of Unitract 1mL plastic safety syringes in early 2010;
2.) complete negotiations with Sanofi-Aventis (NYSE: SNY) by end of February for Unifill therapeutic class exclusivity;
3.) subject to the SEC declaring registration statement effective and NASDAQ approval for listing application, Unilife expects NASDAQ: UNIS trading to begin in mid-February
4.) complete the Unifill industrialization program by the end of 2010 (one year ahead of original plan) with initial production goal of 60 million units per year and a projected increases to approximately 150 million units annually by 2012; and
5.) agreement(s) are possible as early as mid-2010 with additional pharmaceutical companies for Unifill pre-filled syringes outside of the exclusive therapeutic categories that are pending final negotiations with SNY.
More than 2 billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000) in the U.S. (enforced by OSHA) with Europe expected to follow with similar regulations by 2012 based on the model that is currently enforced in Germany. The Unitract product line-up includes plastic safety syringes as 1mL fixed-needle + 3mL and 5mL attachable needles while the Unifill product line-up includes a glass ready-to-fill solution with both fixed needle and attachable options for medications delivered by pre-filled syringes.
A strong resistance to change and high barrier to entry exists for competitors in the medical device / safety syringe market because once supply contracts are agreed upon and products receive marketing clearance; there is little incentive to change components (e.g. a pre-filled syringe) since this would require a new approval process to certify the new components being utilized.
The unique features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes are outlined below and the Company has a major advantage and pending customer in the form of SNY along with a strategic plan that targets companies with new products in development that are designed for delivery through pre-filled syringes.
1.) a passive needle retraction system that is activated inside the body
2.) healthcare providers / shot administrators control the speed of needle retraction
3.) auto-disabling prevents the re-use or tampering of used syringes
The market opportunity for prefilled syringes includes over 50 medications (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including a projected 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features, adding to the manufacturing and shipping costs while significantly increasing the overall packaging size (i.e. Unifill reduces packaging volume for drug products by 60% without the need for ancillary safety instruments that must be attached / assembled as with standard prefilled syringes), resulting in both waste disposal and marketing issues.
The key strategic business partner for Unilife is Sanofi-Aventis, which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). This key partnership provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of initial commercial demand for Unifill in 2011 with an initial production target of 60 million units per year.
In July, Unilife and SNY agreed to a five-year exclusive licensing agreement for Unifill. SNY is paying A$46M for the right to negotiate purchase of the Unifill RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class. While the therapeutic exclusivity agreement (expected by February) will not be disclosed to the public to protect Sanofi's R&D pipeline; blood thinners and vaccines are two major product segments for SNY that are obvious inclusions and agreements that are announced with other companies will provide this information over time.
The industrialization program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of Unifill RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system, and the design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011.
Given the current foreign exchange ratio for the Australian / U.S. dollar, a share price of $1 for the ASX stock listing ‘UNI' would correspond to roughly $5.50 per share for Unilife USA when it begins trading on the NASDAQ. The share price above $5 and NASDAQ listing will be key elements to increasing the Company's U.S. shareholder base and attracting institutional investors. In addition, the strong commitment to building a new facility in Central PA and over-delivering on strategic objectives adds to the bullish case for Unilife in 2010 and beyond.
Click here for the ProActive News Room website for Unilife, which includes an updated compilation of digital media coverage links for the Company such as a recent CNBC video interview with CEO Alan Shortall, research reports (including an update report published yesterday by Crystal Research Associates), corporate presentations, news feeds, market data, and more.
Disclosure: No positions
XL Capital Ltd Announces Proposed Redomestication to Ireland From the Cayman Islands
Date : 01/12/2010 @ 6:26AM
Source : PR Newswire
Stock : (XL)
http://ih.advfn.com/p.php?pid=nmona&cb=1263310817&article=41065985&symbol=NY^XL
HAMILTON, Bermuda, Jan. 12 /PRNewswire-FirstCall/ --
XL Capital Ltd ("XL" or "the Company") (NYSE:XL) announced today that it proposes to change the parent holding company's place of incorporation to Ireland from the Cayman Islands, with the parent holding company to be renamed "XL Group plc"
XL's Chief Executive Officer, Michael S. McGavick, said: "We believe that changing XL's place of incorporation from the Caymans to Ireland is in the best interests of XL and our shareholders. Among other benefits, we believe the proposed move will reduce certain risks that may impact us and offer us the opportunity to reinforce our reputation, which is one of our key assets, and to better support our global business platforms. The new "XL Group" name is desirable to reflect our exclusive focus on providing property, casualty and specialty insurance and reinsurance products for our customers' complex risks."
To effect the redomestication, a new Irish public limited company, XL Group plc, would replace XL Capital Ltd as the ultimate holding company of the XL group of companies, and the Company's ordinary shareholders would receive one ordinary share of the new Irish company in lieu of each ordinary share of the Company held by them. XL expects to submit the proposal for redomestication, along with related proposals, to its shareholders in the next several months and complete the transaction on July 1, 2010. The proposed redomestication will be subject to approval by the Company's ordinary shareholders and the Grand Court of the Cayman Islands, as well as satisfaction of other conditions
XL has operated in Ireland for most of its corporate history and is very familiar with its regulatory and legal environment. Ireland has strong international relationships as a member of the Organisation for Economic Co-Operation and Development (OECD) and the European Union, a long history of international investment, and long-established commercial relationships, trade agreements and tax treaties with the other European Union member states, the United States and other countries around the world. As a result, XL believes Ireland offers a stable long-term legal and regulatory environment with the financial sophistication to meet the needs of XL's global business
XL does not expect the redomestication will have any material impact on its financial results. XL will continue to be registered with the U.S. Securities and Exchange Commission ("SEC") and be subject to SEC reporting requirements. Further, the Company will continue to be subject to the mandates of the Sarbanes-Oxley Act of 2002 and the applicable corporate governance rules of the New York Stock Exchange ("NYSE"), and will continue to report its financial results in U.S. dollars and under U.S. generally accepted accounting principles, in addition to any reporting requirements under Irish law. The Company's shares will continue to trade on the NYSE under the ticker symbol "XL"
This communication is being made in respect of the proposed redomestication. In connection with the proposed redomestication, XL has today filed a proxy statement in preliminary form with the SEC, and XL will mail the definitive proxy statement to its shareholders when available. Security holders are urged to read the definitive proxy statement regarding the proposed redomestication when it becomes available because it will contain important information. You may obtain a free copy of the definitive proxy statement (when available) and other related documents filed by XL with the SEC at the SEC's website at http://www.sec.gov/. The definitive proxy statement (when it is available) and the other documents may also be obtained for free by accessing XL's website at http://www.xlcapital.com/ by clicking on the link for "Investor Relations" and then clicking on the link for "SEC Filings"
XL and its directors, executive officers and certain other members of management and employees may be soliciting proxies from shareholders in favor of the redomestication. You can obtain information about XL's executive officers and directors in XL's proxy statement for the 2009 annual general meeting filed with the SEC on March 9, 2009. You can obtain free copies of this document from XL using the contact information in this press release
This press release contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Statements that are not historical facts, including statements about XL's beliefs, plans or expectations, are forward-looking statements. Such statements include forward-looking statements both with respect to us in general, and to the insurance and reinsurance sectors (both as to underwriting and investment matters). These statements are based on current plans, estimates and expectations, all of which involve risk and uncertainty. Actual results may differ materially from those included in such forward-looking statements and therefore you should not place undue reliance on them. The factors that could cause actual results to differ materially from current expectations include, but are not limited to, our ability to obtain approval of XL's ordinary shareholders and the Grand Court of the Cayman Islands for, and to satisfy the other conditions to, the redomestication within the expected time frame or at all, our ability to realize the expected benefits from the redomestication, the occurrence of difficulties in connection with the redomestication, any unanticipated costs in connection with the redomestication and changes in tax laws, tax treaties or tax regulations or the interpretation or enforcement thereof by the tax authorities in Ireland, the United States and other jurisdictions following the redomestication. The foregoing factors are in addition to those factors included in the "Risk Factors" section and elsewhere in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents on file with the SEC (including the proxy statement filed with the SEC in connection with the redomestication). There may be other risks and uncertainties that we are unable to predict at this time. XL expressly disclaims any obligation to update or revise these forward-looking statements, whether as a result of new information, future developments or otherwise
Contact: David R. Radulski Investor Relations (441) 294 7460
Carol Parker-Trott Media Relations (441) 294 7290
DATASOURCE: XL Capital Ltd
CONTACT: Investor Relations, David Radulski, +1-441-294-7460, or Media
Relations, Carol Parker-Trott, +1-441-294-7290, both of XL Capital
Web site: http://www.xlcapital.com/
NOVAVAX Announces Positive Preclinical Results for its Respiratory Syncytial Virus (RSV) Vaccine Candidate
Date : 01/12/2010 @ 8:05AM
Source : PR Newswire
Stock : (NVAX)
http://ih.advfn.com/p.php?pid=nmona&cb=1263310817&article=41069050&symbol=N^NVAX
The Hartford Announces Estimated Fourth Quarter 2009 Core Earnings of Between $1.45 and $1.60 Per Diluted Share
Date : 01/12/2010 @ 8:34AM
Source : Business Wire
Stock : The Hartford Financial Services Group, Inc. (HIG)
http://ih.advfn.com/p.php?pid=nmona&cb=1263310817&article=41069405&symbol=NY^HIG
The Hartford Financial Services Group, Inc. (NYSE: HIG) today announced estimated fourth quarter 2009 core earnings per diluted share of between $1.45 and $1.60, as compared to the company’s previous guidance of $0.65 to $0.80. The company’s estimated fourth quarter 2009 financial results are preliminary and subject to change
“The core businesses of The Hartford performed well in the fourth quarter,” said Liam E. McGee, The Hartford’s Chairman, President and Chief Executive Officer. “This is our third consecutive quarter of improving core earnings results, demonstrating the underlying strength of The Hartford’s franchise.” During the fourth quarter, the company’s property and casualty operations continued to see strong current accident year underwriting profitability, driven by disciplined risk selection and light catastrophe losses. In addition, the preliminary results reflect favorable net prior year reserve development of approximately $85 million, after-tax, or $0.20 per diluted share, as reserves developed positively across multiple lines
The company’s life results benefited from improving margins in its more equity-sensitive businesses, driven by rising account values and reduced expense levels. The fourth quarter preliminary estimate of core earnings also includes an after-tax DAC unlock benefit of $110 million, or $0.26 per diluted share, driven primarily by strong equity market returns. This is a preliminary estimate and is subject to change
The company’s preliminary estimate of fourth quarter losses on limited partnerships and other alternative investments is approximately $5 million, after-tax, or $0.01 per diluted share. The better than expected performance was due to strong hedge fund and private equity results and smaller losses on real estate-oriented funds
The Hartford intends to release its fourth quarter and full year 2009 financial results on Monday, February 8, 2010, following the close of the market. The company’s conference call to discuss its fourth quarter and full year 2009 financial results will take place on Tuesday, February 9, 2010, at 9 a.m. EST and will be simultaneously webcast at http://ir.thehartford.com
About The Hartford Celebrating nearly 200 years, The Hartford (NYSE: HIG) is an insurance-based financial services company that serves households, businesses and employees by helping to protect their assets and income from risks, and by managing wealth and retirement needs. A Fortune 500 company, The Hartford is recognized widely for its service expertise and as one of the world’s most ethical companies. More information on the company and its financial performance is available at www.thehartford.com
DISCUSSION OF NON-GAAP AND OTHER FINANCIAL MEASURES The Hartford uses non-GAAP and other financial measures in this press release to assist investors in analyzing the company’s operating performance for the periods presented herein. Because The Hartford’s calculation of these measures may differ from similar measures used by other companies, investors should be careful when comparing The Hartford’s non-GAAP and other financial measures to those of other companies
The Hartford uses the non-GAAP financial measure core earnings (loss) as an important measure of the company's operating performance. The Hartford believes that the measure core earnings provides investors with a valuable measure of the performance of the company's ongoing businesses because it reveals trends in the company’s insurance and financial services businesses that may be obscured by the net effect of certain realized capital gains and losses. Some realized capital gains and losses are primarily driven by investment decisions and external economic developments, the nature and timing of which are unrelated to the insurance and underwriting aspects of the company’s business
Accordingly, core earnings (loss) excludes the effect of all realized gains and losses (net of tax and the effects of deferred policy acquisition costs) that tend to be highly variable from period to period based on capital market conditions. The Hartford believes, however, that some realized capital gains and losses are integrally related to the company’s insurance operations, so core earnings (loss) includes net realized gains and losses such as net periodic settlements on credit derivatives and net periodic settlements on the Japan fixed annuity cross-currency swap. These net realized gains and losses are directly related to an offsetting item included in the statement of operations such as net investment income (loss). Core earnings (loss) is also used by management to assess the company’s operating performance and is one of the measures considered in determining incentive compensation for the company’s managers. Net income (loss) is the most directly comparable GAAP measure. Core earnings (loss) should not be considered as a substitute for net income (loss) and does not reflect the overall profitability of the company’s business. Therefore, The Hartford believes that it is useful for investors to evaluate both net income (loss) and core earnings (loss) when reviewing the company’s performance. The fourth quarter 2009 earnings estimate presented in this release is calculated based on core earnings (loss). A quantitative reconciliation of The Hartford’s net income (loss) to core earnings (loss) for the fourth quarter of 2009 is not calculable because it is not yet possible to provide a reliable estimate of the effect of realized capital gains and losses on net income
Core earnings (loss) per share is calculated based on the non-GAAP financial measure core earnings (loss). The Hartford believes that the measure core earnings (loss) per share provides investors with a valuable measure of the company’s operating performance for many of the same reasons applicable to its underlying measure, core earnings (loss). Net income (loss) per share is the most directly comparable GAAP measure. Core earnings (loss) per share should not be considered as a substitute for net income (loss) per share and does not reflect the overall profitability of the company’s business. Therefore, The Hartford believes that it is useful for investors to evaluate both net income (loss) per share and core earnings (loss) per share when reviewing the company’s performance
Some of the statements in this release should be considered forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. These include statements about The Hartford’s future results of operations and The Hartford’s estimated fourth quarter 2009 financial results. The Hartford cautions investors that these forward-looking statements are not guarantees of future performance, and actual results may differ materially. Investors should consider the important risks and uncertainties that may cause actual results to differ. These important risks and uncertainties include, without limitation, uncertainties related to the current recession and financial market conditions, which have pressured the Company’s capital position and have adversely affected the Company’s business and results, the extent of the impact on the Company’s results and prospects of downgrades in 2009 to the Company’s financial strength and credit ratings; the success of management’s initiatives to mitigate and reduce risks associated with various business lines; the oversight, costs and other potential consequences of the Company’s participation in the Capital Purchase Program under the Emergency Economic Stabilization Act of 2008; changes in financial and capital markets, including changes in interest rates, credit spreads, equity prices and foreign exchange rates; the inability to effectively mitigate the impact of equity market volatility on the company’s financial position and results of operations arising from obligations under annuity product guarantees; the amount of statutory capital that the company has, changes to the statutory reserves and/or risk based capital requirements, and the company’s ability to hold and protect sufficient statutory capital to maintain financial strength and credit ratings; the possibility of general economic and business conditions that are less favorable than anticipated; the potential for differing interpretations of the methodologies, estimations and assumptions that underlie the valuation of the company’s financial instruments that could result in changes to investment valuations; the subjective determinations that underlie the company’s evaluation of other-than-temporary impairments on available-for-sale securities; losses due to defaults by others; the potential for further acceleration of DAC amortization; the potential for further impairments of our goodwill; the difficulty in predicting the company’s potential exposure for asbestos and environmental claims; the possible occurrence of terrorist attacks; the response of reinsurance companies under reinsurance contracts and the availability, pricing and adequacy of reinsurance to protect the company against losses; the possibility of unfavorable loss development; the incidence and severity of catastrophes, both natural and man-made; stronger than anticipated competitive activity; unfavorable judicial or legislative developments; the potential effect of domestic and foreign regulatory developments, including those which could increase the company’s business costs and required capital levels; the company’s ability to distribute its products through distribution channels, both current and future; the uncertain effects of emerging claim and coverage issues; the ability of the company’s subsidiaries to pay dividends to the company; the company’s ability to adequately price its property and casualty policies; the ability to recover the company’s systems and information in the event of a disaster or other unanticipated event; potential for difficulties arising from outsourcing relationships; potential changes in federal or state tax laws, including changes impacting the availability of the separate account dividend received deduction; the company’s ability to protect its intellectual property and defend against claims of infringement; and other risks and uncertainties discussed in The Hartford’s Quarterly Reports on Form 10-Q, the 2008 Annual Report on Form 10-K and other filings The Hartford makes with the Securities and Exchange Commission. The Hartford assumes no obligation to update this release, which speaks as of the date issued
XL Insurance and American Wholesalers Underwriting Announce New Underwriting Agreement to Service Wholesale Distribution Industr
Date : 01/11/2010 @ 12:00PM
Source : PR Newswire
Stock : XL Capital Ltd. (XL)
http://ih.advfn.com/p.php?pid=nmona&cb=1263231707&article=41055576&symbol=NY^XL
XTON, Pa. and STAMFORD, Conn., Jan. 11 /PRNewswire-FirstCall/ --
XL Insurance, the global underwriting operations of XL Capital Ltd (NYSE:XL), and American Wholesalers Underwriting, Ltd., a specialized program administrator, today announced a new joint underwriting agreement to provide the Wholesalers' Insurance Program(R) the WIP(R), a comprehensive insurance program for the durable and non-durable goods wholesale distribution industry
John Hartman, XL Insurance's Chief Underwriting Officer of Programs, said: "XL Insurance values industry expertise. In this new underwriting agreement, that is exactly what American Wholesalers Underwriting brings to the table. With their experienced staff and thorough industry knowledge, they have carved out a 'best in class' approach to service the wholesale distributors' insurance needs. We are looking forward to a long-term relationship that will yield strong results for us as well as the customers we'll serve together."
"We are very excited to be working with XL Insurance," said American Wholesalers Underwriting President Ken Lewis. "We both value technical underwriting expertise and loss prevention that can help our clients manage their risk exposures effectively."
"WIP is a recognized program in this industry. Over the years, we have tailored and streamlined the underwriting, policy servicing, accounting and claims processing to specifically address issues that are unique to wholesalers," explained Mr. Lewis
"Technology is the cornerstone of our underwriting operation. AWUL's advanced automated management system allows us to efficiently and consistently process our policies while providing our clients with quick and efficient quotes and policy turnaround," said John Shea, AWUL's Chief Operating Officer,
WIP is a national insurance program designed to meet the needs of the durable, non - durable, and food distribution industries. These industries encompass a broad scope of Standard Industrial Classifications ranging from 5000-5199. (visit http://www.awul.com/) including motor vehicle supplies, industrial supplies and equipment, material handling equipment, metal services, electrical and plumbing, hardware, and food and beverage distributors
The program provides property, inland marine, auto, general liability, workers comp and umbrella coverage with numerous industry specific extensions. Available in all 50 states, coverages and limits are tailored to meet individual distributor's specific risk management needs. The program will be provided by XL's Greenwich Insurance Company and its affiliates, licensed to write property and casualty insurance throughout the United States
American Wholesalers Underwriting, Ltd. is a nationally recognized program administrator, underwriter and wholesaler serving retail insurance agencies. More information about American Wholesalers Underwriting is available at http://www.awul.com/
"XL Insurance" is the global brand used by member insurers of the XL Capital Ltd (NYSE:XL) group of companies. More information about XL Insurance is available at http://www.xlinsurance.com/. Through its operating subsidiaries, XL Capital Ltd is a leading provider of global insurance and reinsurance coverage and services to industrial, commercial and professional service firms, insurance companies, and other enterprises on a worldwide basis. More information about XL Capital Ltd is available at http://www.xlcapital.com/.
DATASOURCE: XL Insurance
CONTACT: Christine M. Weirsky, XL Insurance Media Relations, +1-610-968-
9395
Web site: http://www.xlcapital.com/
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make sure you have boardmarked us (added to favorites)!
Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing
Posted : Fri, 08 Jan 2010 20:23:29 GMT
Author : Oxygen Biotherapeutics, Inc.
http://www.earthtimes.org/articles/show/oxygen-biotherapeutics-inc-announces-approval-for-nasdaq-listing,1112965.shtml
URHAM, N.C., Jan. 8 /PRNewswire-FirstCall/ -- Oxygen Biotherapeutics, Inc. (OTC Bulletin Board: OXBT) announced today that its common stock has been approved for listing on the NASDAQ Capital Market.
"Moving up from the OTC Bulletin Board to the NASDAQ is a very important milestone for our company," said company chairman and CEO Chris J. Stern. "Being listed on the NASDAQ provides us with greater visibility for our company, more liquidity for our stock and the opportunity to further expand our investor base. I believe that this move will deliver increased value for our shareholders now and down the road."
Trading on the NASDAQ is excepted to begin next week. The company will announce further details in due course. Prior to the listing change, Oxygen Biotherapeutics, Inc. shares will continue to trade on the Over-the-Counter (OTC) Bulletin Board.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and Defense Medicine?. The company has developed a perfluorocarbon (PFC) therapeutic oxygen carrier and liquid ventilation product (Oxycyte?) and has out-licensed an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for PFCs as well as medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including traumatic brain injury, sickle cell crisis, trauma, wound care, decompression sickness, acute respiratory distress syndrome, stroke, myocardial infarction, surgery, diabetes wounds and ulcers, and cosmetic applications which are being marketed under the Dermacyte name. More information is available at www.oxybiomed.com.
SOURCE Oxygen Biotherapeutics, Inc.
CEL-SCI Completes Validation of Manufacturing Facility Allowing It To Commence Manufacturing of Multikine
Date : 01/11/2010 @ 9:30AM
Source : PR Newswire
Stock : (CVM)
http://ih.advfn.com/p.php?pid=nmona&cb=1263227552&article=41052136&symbol=A^CVM
China a rising star in regenerative medicine despite world skepticism of stem cell therapies
January 11, 2010
http://swegene.com/blog/china-a-rising-star-in-regenerative-medicine-despite-world-skepticism-of-stem-cell-therapies.html
@ locksflooring: OK!
http://daytradingstockblog.blogspot.com/2010/01/hot-penny-stocks-11110-january-11-2010.html
OTC - Pink Sheets Stock Gainers - 1/11/10
...
Stem Cell Innovations, Inc. (SCLL.PK)
...
LINK back to currently Stem Cell MOMO play!?
REUTERS Research Reports (9-Jan-2010)
https://commerce.us.reuters.com/purchase/showReportDetail.do?docid=31590300
...old one(2): Stem Cell Innovations' C3A Human Liver Cell Line is Capable of Producing Biosimilar Serum Proteins for Follow-On Biologics
Tuesday February 24, 2009 - 08:00 AM EST
http://studio-5.financialcontent.com/genpublishing/news/read?GUID=8075902
Blood clotting proteins factor 8 and 9 are first target indications
HOUSTON, Feb. 24 /PRNewswire-FirstCall/ -- Stem Cell Innovations' (Pink Sheets: SCLL) liver assist device program has additional application in the production of biosimilar and novel proteins. "Many of the commercially important therapeutic proteins are liver products and comprise a multibillion dollar market in the US," said James H. Kelly, CEO of SCLL. "Albumin, the clotting factors and alpha-1-antitrypsin are all produced naturally in the liver. Our C3A cell line produces each of these proteins at levels comparable to the natural liver cell. We already have the capability for large scale culture of the C3A cell line and expect that our PluriCell(TM) derived hepatocytes will have similar production capabilities. In addition, the C3A line provides an excellent host for the production of recombinant proteins due to the liver's massive synthetic capability."
In a sign that major pharmaceutical companies are becoming more aggressive about the biosimilar business, Merck is buying Insmed's portfolio of follow-on biologics for $130 million in cash. "We are exploring ways to fund our activities in this area through a spin out or an acquisition," said Kelly.
About Stem Cell Innovations, Inc.
SCLL is a cell biology company based in Houston, TX. The Company's ACTIVTox system is a human liver based model for high throughput toxicity testing. Stem Cell Innovations' proprietary, human pluripotent stem cells, known as PluriCells, have the potential to aid in drug discovery, toxicology, and cell therapy.
Additional information is available at www.stemcellinnovations.com and at www.activtox.com.
ACTIVTox and PluriCells are Trademarks of Stem Cell Innovations, Inc.
...old one: Stem Cell Innovations' PluriCells(TM) To Form The Basis Of A Liver Assist Device To Support Patients Waiting For Transplant
Main Category: Liver Disease / Hepatitis
Also Included In: Medical Devices / Diagnostics; Transplants / Organ Donations
Article Date: 06 Feb 2009 - 1:00 PDT
http://www.medicalnewstoday.com/articles/138071.php
In a paper published in the most recent issue of Current Gastroenterology Reports, Drs. Norman L. Sussman, Brendan M. McGuire and James H. Kelly describe the need and requirements for a successful liver assist device. "There are currently three times as many patients on the waiting list for liver transplantation as there are organs available and few ways to stabilize them if they enter an acute phase of their disease," said Kelly, CEO of Stem Cell Innovations, Inc. (OTC Pink Sheets: SCLL).
This second generation device, based on the PluriCells, "combines the safety of primary hepatocytes (normal liver cells) with the standardization of a cell line," continued Kelly. "We're building on what we learned from our earlier device which utilizes the C3A cells that form the basis of Stem Cell Innovations' ACTIVTox(R) drug discovery products. We are one of the few companies that can approach this problem from both sides: from the stem cell and from the adult liver cell. We are using our PluriCell(TM) system to understand the requirements of the liver stem cell and our ACTIVTox system to understand the requirements of the mature cell."
Liver disease is a serious problem in the United States and worldwide. There are about 6,500 liver transplantations performed each year in the US, with about 16,000 on the waiting list, about 1,800 of whom will die each year without receiving an organ. A liver assist device would be expected to first find use in such acute cases but could be used more widely as experience grows.
Dr. Norman L. Sussman, MD is currently Director of Hepatology at the University of Utah School of Medicine and is also a Director of Stem Cell Innovations. Dr. Brendan M. McGuire, MD is an Associate Professor of Medicine at the University of Alabama School of Medicine and is not affiliated with SCLL.
ACTIVTox® (Powerpoint Presentation [2004])
http://www.toxicology.org/isot/RC/ncac/symposia_files/Spring2004Kelly.pps
********************************************************************
Company details > Stem Cell Innovations
Founding mode:
Merger of Amphioxus Cell Technologies with Interferon Sciences.
http://www.ccls.nl/bestanden/company_detail.php?com_id=114
For more information on Amphioxus Cell Technologies and ACTIVTox® please visit http://www.amphioxus.com/ / http://www.activtox.com/
Application of ACTIVTox® screening results to evaluate toxic profiles
Liver toxicity is a common cause of failure in new drug development. A system for predictive hepatotoxicology for use in the design of new screening campaigns and optimizing leads could dramatically reduce the time and cost of drug development.
Any such system consists of three essential parts: a reliable human hepatotoxicity model, a database of compounds that have been screened in the system and software to collate the data, find similarities and make predictions. ACTIVTox® is an hepatocyte-based system coupling a human liver cell line with simple, rugged assays for hepatotoxicity, such as LDH release. MDL software provides a series of modules, such as MDL® Assay Explorer, that can be used to manage screening campaigns as well as visualize the results.
Together, MDL and Amphioxus Cell Technologies are creating a database of compounds tested in a variety of toxicity assays providing a framework in which to examine the structural basis of liver toxicity. This tool has the unique attribute that proprietary compounds can be screened in the same experimental system and added to the database, creating a customized environment for lead optimization.
For more information on Amphioxus Cell Technologies and ACTIVTox® please visit http://www.amphioxus.com/
To read the complete case study, click the Download Document link near the top of the this article.
( http://www.symyx.com/solutions/case_studies/downloads/public/mdl_activtox_case_study.pdf )
Stem cell projects under way
The California Institute for Regenerative Medicine recently awarded 14 grants to stem cell-based projects that are close to being ready for clinical trials.
Copyright © 2010, The Los Angeles Times
http://www.latimes.com/news/science/la-sci-stem-cells-box10-2010jan10,0,878458.story?track=rss&utm_source=feedburner&utm_medium=feedutm_campaign=Feed%3A+latimes%2Fnews%2Fscience+%28L.A.+Times+-+Science%29
Grant money could speed stem cell cures
State money from 2004's Proposition 71 is being channeled toward research with the most potential for near-term benefits.
Copyright © 2010, The Los Angeles Times
http://www.latimes.com/news/nationworld/nation/la-sci-stem-cells10-2010jan10,0,2536499.story
LINK back...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=38011711
FDA's Hydroxycut Recall Highlights the Need for Stem Cell Innovations' ACTIVTox Human Liver Testing
HOUSTON, May 21 /PRNewswire-FirstCall/ -- Stem Cell Innovations' (Pink Sheets: SCLL) ACTIVTox(R) human liver toxicity tests are the only products on the market using a standardized human liver cell line to identify potential toxicities associated with nutraceuticals and dietary supplements. This system is available now and can be used to help prevent future liver-related damage and death.
"The use of our ACTIVTox testing system could help prevent recalls associated with liver toxicity," said James H. Kelly, PhD, CEO of Stem Cell Innovations, Inc. "ACTIVTox allows manufacturers to evaluate potential liver issues before release. This can be particularly important in the use of botanical extracts where both growing conditions and the extraction procedure can have dramatic effects on the composition of the final product."
ACTIVTox is designed to identify human liver toxicities associated with drugs, nutraceuticals and food supplements. "Consumers often have the impression that plant-based products are totally benign where, in fact, many of the most potent chemicals ever identified are plant products," said Kelly. "Particularly with the complex manufacturing challenges associated with the use of crude plant extracts, cell-based testing can give an extra measure of comfort to both the consumer and the producer. Considering the cost of developing, manufacturing and marketing new products, ACTIVTox testing protects your investment."
Upcoming 'scientific' Conferences 2010
http://www.selectbiosciences.com/
...upcoming Stem Cell Conferences - 2010 (generally)
Stem Cells World Congress
20-21 January 2010, South San Francisco, CA, USA
http://www.selectbiosciences.com/conferences/scwc2010/
-Stem Cells in Drug Discovery and Development
-Regenerative Medicine
Stem Cells Europe
24-25 August 2010, Edinburgh, Scotland
http://www.selectbiosciences.com/conferences/SCE2010/
Source: http://www.selectbiosciences.com/
Company details > Stem cell innovations
http://www.ccls.nl/bestanden/company_detail.php?com_id=114
...Stem Cell Innovations (SCI) is headquartered in Houston, Texas and has a European office based in The Hague, The Netherlands. The company currently employs 10 people in its Houston facilities; the European team consists of 8 people.
Stem Cell Innovations (SCI) intends to become...
http://www.stemcellinnovations.com/about/index.php?about
...the global leader in human cell based drug discovery & development. SCI has laboratories and offices in Scotch Plains, N.J., Houston, TX and in Leiden, the Netherlands.
SCI's core technology focuses on developing, growing, and manipulating human cells in the laboratory using proprietary technology. By growing pure cultures of individual cell types, SCI is currently developing a broad array of human primary cell models as powerful research tools that can form the basis of therapeutic breakthroughs.
SCI has established several human pluripotent stem cell lines from fetal gonadal tissue using defined conditions. These PluriCellTM lines have been established directly onto tissue culture plastic without the use of feeder layers or conditioned medium. In addition to the PluriCell technology SCI has already established in vitro hepatocyte screening, kits, compositions, and services for compound toxicity testing, ACTIVTox® and PREDICTIVToxTM.
ACTIVTox®: http://activtox.com/
ACTIVTox products are readily available, high-throughput, in vitro human liver assay kits that measure liver toxicity or P450 CYP1A induction. ACTIVTox is a logical alternative to expensive and variable human primary hepatocytes and can effectively replace the in vivo animal testing that is discouraged by the REACH mandate. This system is perfect for early drug discovery and product development as well as the testing of botanical supplements, potentially dangerous chemical substances, and hazardous waste.
Unlike other human liver cell lines, ACTIVTox is built around a stable, highly characterized, patented human liver cell line possessing the functions of an adult liver cell. Capable of gluconeogenesis, it produces liver-specific proteins such as apolipoprotein and albumin, and exhibits Phase II metabolism as well as the appropriate p450 enzymes. The ACTIVTox cells are robust, reproducible, and adaptable to high-throughput assays. These features make ACTIVTox an excellent tool for studying human liver biology.
Keryx Biopharma : Well-Funded Comeback Story with Multiple Catalysts
Written by Mike Havrilla
Saturday, 09 January 2010 08:46
http://biomedreports.com/articles/most-popular/23944-keryx-biopharma-nasdaq-kerx-well-funded-comeback-story-with-multiple-catalysts.html
EEE - K-Fuel® Plants
http://www.evgenergy.com/k_fuel.php
VIDEO: http://www.evgenergy.com/flash/kfxcoalanim.swf
Evergreen Energy produces K-Fuel®, a cleaner, more efficient refined coal, using a patented pre-combustion refining process. With abundant low-grade coal as a raw material, the K-Fuel® process employs heat and pressure to transform the coal into a cleaner, more efficient fuel by removing water and polluting impurities, thus increasing combustion efficiency.
When applied to different lower-rank sub-bituminous and lignite coals, the K-Fuel process removes, on average, almost 70 percent of the coal's elemental mercury. That is mercury that will not go into the atmosphere when the coal is burned. Across that same range of coals, the K-Fuel process raised Btu levels by almost 30 percent and removed, on average, 61 percent of the coal's moisture.
K-Fuel® can provide a lower-cost alternative to installing expensive, space consuming post-combustion pollution control systems or make plants with existing emissions control systems operate more efficiently and cleaner.
Process treatments reduce dust and K-Fuel® can be handled, transported and stored using the same equipment and methods as raw coal.
K-Fuel® can be blended with other coals to meet customer-specific needs. Fly ash characteristics depend on the original feedstock coal, but because a significant amount of mercury is removed before K-Fuel® is burned, the resulting fly ash has a lower mercury content when compared to raw coals, making it especially appealing to cement manufacturers..
Evergreen Energy to form clean coal company
Evergreen Energy spins clean coal unit into separate company; anticipates Chinese investment
Thursday January 7, 2010, 1:42 pm EST
http://finance.yahoo.com/news/Evergreen-Energy-to-form-apf-3851061114.html?x=0&.v=1
NEW YORK (AP) -- Evergreen Energy Inc. shares jumped by a third Thursday after the company said it would spin off a cleantech unit into a subsidiary that would help Chinese coal producers cut carbon emissions.
Evergreen, a coal producer and refiner with headquarters in Denver, said the new company would be called Clean Coal China.
The new company is expected to receive investment from one of China's "largest conglomerates" and its affiliates, Evergreen said. Afterward, Evergreen's shareholders and the Chinese conglomerate would own Clean Coal China. Evergreen did not disclose the name of the conglomerate or the amount of the investment.
Evergreen's clean coal technology, known as K-Fuel, makes coal burn more efficiently and release smaller amounts of greenhouse gases.
Annual Report (10-K) For_the_fiscal_year_ended _September_30,_2009
Date : 12/29/2009 @ 3:46PM
Source : Edgar (US Regulatory)
Stock : (EMKR)
http://ih.advfn.com/p.php?pid=nmona&cb=1263044540&article=40910347&symbol=N^EMKR
...
The number of shares outstanding of the registrant’s no par value common stock as of December 21, 2009 was 81,123,911.
NexMed Provides Corporate Update
Date : 01/08/2010 @ 12:00PM
Source : Business Wire
Stock : NexMed, Inc. (NEXM)
http://ih.advfn.com/p.php?pid=nmona&cb=1262970500&article=41031116&symbol=N^NEXM
NexMed, Inc. (Nasdaq: NEXM), a specialty CRO and a developer of products based on the NexACT® technology, today provided an update on ongoing corporate activities and the status of the Company’s NASDAQ listing
Product Pipeline Topical Alprostadil Treatments NexMed expects to hear from Health Canada concerning the approvability of its New Drug Submission (NDS) for Vitaros®, its topical treatment for erectile dysfunction, sometime in February 2010. As such, management has postponed negotiations with its potential partner until an approval decision from Health Canada is received, as partnering negotiations with a marketing approval would be expected to yield more favorable terms for the Company
In the U.S., NexMed is awaiting a response from the Food and Drug Administration (FDA) regarding the carcinogenicity (CAC) assessment package, which it expects to occur within the next two months. Partnering efforts for Femprox®, NexMed’s topical treatment for female sexual dysfunction, are on hold pending the final decision by the FDA
Outside of North America, NexMed is awaiting Health Canada or the FDA’s response to accelerate partnering efforts and/or filing for marketing approvals. To date, NexMed has received multiple indications of interest from international pharmaceutical companies that might be interested in partnering with NexMed.
In addition, through its Bio-Quant research and development team, NexMed is running new efficacy studies on the Vitaros formulation to assess the potential of the compound for other indications such as wound healing and Raynaud’s Syndrome. NexMed’s strategy is to take advantage of the development work already completed for Vitaros and bolster the existing database with new data and apply it to potentially shorten the path of approval. The goal includes commencing partnering discussions in mid-2010 for the new indications, if the pre-clinical data are positive
NM100060 Onychomycosis Treatment NexMed is actively engaged in efforts to re-license this product for the treatment of nail fungus. In the meantime, Novartis continues to transfer the clinical and regulatory dossiers to the Company and the data are being shared with potential partners
Topical Psoriasis Treatment NexMed’s Bio-Quant R&D team is also proceeding with extensive pre-clinical efficacy studies to strengthen its psoriasis candidate while actively engaging in partnering discussions
Topical NSAID Program NexMed is also exploring the opportunity to license an early stage NSAID program, which includes an issued U.S. patent. This program was not pursued when NexMed chose to focus its resources on its sexual dysfunction programs. Preclinical data of the NexACT-based ketoprofen cream has shown more rapid and efficient delivery of the drug as compared to the currently marketed products
NexACT technology, Partnering as a Service NexMed has initiated discussions with potential partners regarding the application of its NexACT technology to drugs that will soon be going off-patent to help create a second-generation drug that has patent protection through the mechanism of delivery. The NexACT platform technology has demonstrated the potential to improve the topical absorption of active therapeutic ingredients and/or to develop new patient-friendlier routes of administration. Incorporating older drugs with the NexACT proprietary delivery system can create new products that not only provide patients with added therapeutic benefits, but can also extend the product life for up to an additional 20 years. As such, the Company intends to aggressively pursue these types of potential partnering arrangements going forward
NexACT technology, New Applications In addition to developing innovative topical treatments, NexMed’s new scientific team is evaluating the ability of the NexACT technology to deliver biologics, such as humanized or fully human antibodies, via transdermal application. The delivery of such biologics through the skin represents a novel approach to delivering antibodies to specific areas of the body with limited systemic exposure – potentially reducing side effects and toxicity. We are also evaluating the ability of the NexACT technology to deliver drugs orally, including various first-line oral chemotherapeutics, which currently have poor bioavailability and thus require high doses and result in certain toxic side effects
NASDAQ Listing On January 4, 2010, NexMed received an expected notice of non-compliance from The NASDAQ Stock Market LLC based upon its failure to solicit proxies and hold an annual meeting for fiscal 2008 by December 31, 2009, as required by NASDAQ Listing Rules 5620(a) and 5620(b), which could serve as an additional basis for the delisting of the Company’s securities from The NASDAQ Capital Market. NexMed had discussed this matter with the NASDAQ Listing Qualifications Panel (the “Panel”) at the hearing on November 12, 2009, and explained that it planned to postpone the 2008 annual meeting due to the ongoing acquisition of Bio-Quant and would not be able to incorporate all of the relevant acquisition related materials in the meeting proxy in a timely manner
As NexMed previously announced on December 18, 2009, the Panel granted its request to remain listed on The NASDAQ Capital Market, subject to the condition that it evidence stockholders’ equity of at least $2.5 million or a market value of listed securities of at least $35 million on or before March 31, 2010. The determination followed the hearing before the Panel on November 12, 2009, at which time NexMed presented its plan to evidence compliance with all requirements for continued listing on The NASDAQ Capital Market, including the proxy solicitation/annual meeting and bid price requirements (notwithstanding the fact that NexMed was not yet deficient with respect to those standards)
As provided by NASDAQ’s most recent notice, NexMed plans to timely make a formal written submission to the Panel presenting its plan to evidence compliance with the proxy solicitation and annual meeting requirements. While it intends to file a proxy statement for a special meeting of shareholders to be held within the next sixty days to consider amending its Articles of Incorporation to authorize more common stock for issuance, that meeting may not be conducted as an annual meeting since the proxy statement will not incorporate audited financial statements for the fiscal year ended December 31, 2009. As a result, in order to satisfy NASDAQ’s annual meeting requirement, NexMed plans to file a proxy statement for a joint 2008/2009 annual meeting promptly following the filing of its Annual Report on Form 10-K for fiscal 2009 in March 2010. Accordingly, the Company is asking the Panel to modify its previously issued decision in accordance with the Company’s revised plan of compliance. However, there can be no assurance that the Panel will grant the Company’s request
Also as previously announced, NexMed remains subject to a grace period through January 25, 2010 to evidence compliance with the $1.00 bid price requirement for continued listing on NASDAQ. In the event NexMed does not evidence compliance with the bid price requirement by that date, NexMed expects to receive an additional formal notice of non-compliance and to be afforded an opportunity to request an exception from the Panel to evidence compliance with the minimum bid price requirement. In that regard, NexMed will implement a reverse stock split, if necessary, to evidence compliance with NASDAQ’s minimum bid price requirement, which action may be taken at any time at the discretion of the NexMed Board of Directors
Corporate Integration Subsequent to the December 17, 2009 announcement of the lease of its manufacturing building in New Jersey, NexMed has completed the relocation of its headquarters to 6330 Nancy Ridge Drive, San Diego, CA 92121. NexMed now has 34 full time employees, of whom eight employees hold either Ph.D or MD degrees. NexMed will include the pro forma financial statements for the combined entity in an amendment to its December 17, 2009 Current Report on Form 8-K, to be filed on or before February 26, 2010
About NexMed NexMed, due to its recent acquisition of Bio-Quant, 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. For further information, go to www.nexmed.com and 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. For example, and without limitation, there can be no assurance that the Company will receive favorable approvability decisions from Health Canada or the FDA within the anticipated time frames or at all, the Company’s research and development activities will yield the desired results, the Company will be able to achieve or will continue to pursue its product development goals, the Company will be able to execute on its partnering strategies, the Company will be able to satisfy NASDAQ continued listing standards, and that the Company will be able to integrate its business following the Bio-Quant acquisition in a successful manner
...thanks for sharing!