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Apricus Biosciences Appoints Manufacturer for Vitaros®, Its Newly Approved Drug to Treat Erectile Dysfunction in Canada
Date : 12/01/2010 @ 10:59AM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45469150
Apricus Biosciences, Inc. (“Apricus Bio”) (NASDAQ: APRI), announced today that it has appointed a manufacturer for Vitaros®, its new treatment for erectile dysfunction (ED), which was approved for marketing by Health Canada on November 12, 2010. Specifically, the Therapex Division (www.therapex.com/corporate.html) of E-Z-EM Canada, Inc., a wholly-owned subsidiary of Bracco Pharma in Italy, will manufacture the product for Apricus Bio. Therapex will also be the designated manufacturer when Apricus Bio files for marketing approval in Europe for Vitaros, which is expected in the first half of 2011. The Company intends to move forward with production of Vitaros in parallel to ongoing partnering discussions, in order to accelerate the planned commercial launch of the drug.
Vitaros differs from other existing ED drugs like Viagra®, Cialis® and Levitra® in two ways. First, it is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. “Its topical application helps to reduce side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative. Vitaros is the first topical ED treatment that clinically works with an excellent side effect profile,” said Dr. Bassam Damaj, Apricus Biosciences’ President and Chief Executive Officer.
Second, Vitaros operates by a different biochemical mechanism than oral ED medications and causes erections to occur in a more localized fashion and more quickly when compared to oral treatments. Vitaros contains a previously marketed ED drug, known by the chemical name of alprostadil. When absorbed through the skin, alprostadil, a vasodilator, directly boosts blood flow, thereby causing an erection. Clinical studies have shown that Vitaros works in a matter of minutes, compared to a reported onset time of 30 minutes or more for oral medications indicated for the treatment of ED.
Alprostadil is a well recognized drug for treating ED, and is currently marketed as an injectable drug or as a suppository inserted into the urethra. Apricus Bio incorporated alprostadil with its NexACT delivery technology, resulting in a rapid and efficient topical delivery of the drug into the penis. In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to Viagra®.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Viagra® is a registered trademark of Pfizer, Inc, Cialis® is a registered trademark of Lilly, USA and Levitra® is a registered trademark of Bayer A.G. Vitaros® is a registered trademark in Canada held by Apricus Bio; Vitaros® is a registered trademark in the U.S., held by Warner Chilcott 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, including, but not limited to, timing for seeking foreign approvals for Vitaros and the timing and success of the commercial launch of Vitaros in Canada. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Cardium Announces Market Launch of Linee(TM) - A Scientific Approach to Weight Management
http://www.finanznachrichten.de/nachrichten-2010-11/18684320-cardium-announces-market-launch-of-linee-tm-a-scientific-approach-to-weight-management-008.htm
SAN DIEGO, Nov. 29, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced the addition of Linee(TM) to its MedPodium product line. Linee is a plant-derived non-prescription dietary supplement in the form of easy-to-use capsules designed to help promote healthy weight management. Cardium launched its MedPodium modern lifestyle brand in early November and the addition of Linee represents an important step toward broadening the line to include additional products designed to promote personal health and wellness.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
Linee is a nutritional supplement intended to be taken before meals to help manage appetite and control hunger as part of a comprehensive weight management program. The key ingredient of Linee is a potato-based protein extract (Appexium(TM) 150 mg) having Proteinase Inhibitor-II (PI-2) activity. Multiple scientific studies have shown that PI-2 can promote the release of a naturally-occurring peptide called cholecystokinin or CCK into the bloodstream. By increasing feelings of fullness or satiation, CCK can help to reduce the amount of daily food intake.* Linee's custom formulation contains a blend of Appexium PI-2, vitamin D3 and vitamin B12, which is filled into small, easy-to-swallow, pharmaceutical-quality capsules. As part of an overall weight management program, Linee may also be integrated into exercise, yoga and other fitness programs, or used in concert with popular weight-loss and dietary meal plan programs to enhance plan compliance and improve results.
"We are pleased to announce the addition of Linee to our MedPodium modern lifestyle brand initiative. We recently announced a co-development and strategic licensing agreement with BioZone Laboratories for the formulation, manufacture and licensing of a portfolio of up to 20 products to further broaden and expand our MedPodium brand initiative to encompass other healthy lifestyle formulations including novel metabolics, neurologics and aesthetics designed to address emerging health and well-being issues that are increasingly important in modern society. In addition to the MedPodium web boutique, we plan to market and sell certain products through various select distributors or retailers in the United States," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
About Linee
Linee(TM) is a dietary supplement based on the use of Proteinase Inhibitor-II (PI-2), a naturally-occurring protein derived from white potato that is a commonly consumed food and generally recognized as safe. While extracted and concentrated from white potato in the form of Appexium, the PI-2 protein is not altered chemically and it does not rely on absorbing fat or causing gastrointestinal (GI) tract fullness as in many other weight loss aids and dietary supplements that are sometimes not well tolerated due to discomfort, GI bloating and irregular bowel discharge. Based on multiple scientific studies, PI-2 appears to promote the release of a small peptide called cholecystokinin (CCK) that is naturally produced in the GI tract and can increase feelings of fullness and therefore help to reduce the amount of food eaten daily.*(1)(2) While exercise is important, years of research has suggested that the most effective means of ensuring weight loss in the average healthy person is by reducing total daily caloric intake. In a multi-site double-blind, placebo-controlled clinical study, patients receiving PI-2 twice daily before the two largest meals had statistically significant reductions in overall weight as well as in waist and hip measurements, as compared to placebo.*(3)
About MedPodium
MedPodium(TM) is a portfolio of premium, science-based, easy to use nutraceuticals, metabolics and aesthetics designed to promote health and well-being for today's active and professional lifestyles. MedPodium products are based on key ingredients that have been well characterized scientifically and shown to be capable of promoting healthy lifestyle interests such as enhancing energy, cognition, mood, sleep, weight management, fitness and aesthetics. The MedPodium brand also features improved product formulations including easy to use pills and capsules, novel, fast-acting oral drops and sprays, and innovative transdermal delivery systems. Additional information about MedPodium is located at http://www.medpodium.com/
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium modern lifestyle brand. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx(R), a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward-looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that Linee can be effectively commercialized as a dietary supplement for promoting weight management, that the clinical studies cited in this release will be regarded as substantiation for corresponding product claims or that the product will be accepted as being sufficiently safe, improved or cost-effective compared to other products for weight management; that the MedPodium product line can be successfully broadened to include additional healthy lifestyle opportunities and that these products will be commercially successful or will effectively enhance our businesses or their market value; that results or trends observed in clinical studies or other observations will be reproduced in subsequent studies or in broader use; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that the Food and Drug Administration, the Federal Trade Commission or other regulatory agencies will not introduce additional or more restrictive regulations covering naturally-derived products such as those in our MedPodium product line; that our in-house or external product commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our co-development and strategic licensing arrangements with BioZone and others will successfully and timely lead to the development, formulation, manufacture and licensing of products for Cardium's MedPodium healthy lifestyle line; or that these or any other third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of biologics and in the development and commercialization of new products, the conduct of human clinical trials and other product development efforts, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and qualifications and to maintain our listing on a national stock exchange, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition and regulation, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
1. Badman, MK, Flier, JS. The Gut and Energy Balance: Visceral Allies in the Obesity Wars. (2005) Science. 307: 1909-1914 2. Hu, J, Edmonson B, Radosevich J. The effectiveness of potato proteinase inhibitor II in promoting satiety in healthy human subjects: VAS summary. Kemin Consumer Care White Paper. 2004 3. Dana, S. A randomized, double-blind, placebo-controlled clinical study demonstrates Slendesta potato extract is a safe and effective tool for promoting weight reduction. Kemin Consumer Literature
* Note: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company. (Other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
Cardium Therapeutics; MedPodium
CONTACT: investors, Bonnie Ortega, Director, Investor/Public Relations,
+1-858-436-1018, InvestorRelations@cardiumthx.com, or media /sales, Hanna
Wagari, Director of Marketing, +1-858-436-1042, hwagari@cardiumthx.com, both
of Cardium Therapeutics, Inc.
Web Site: http://www.cardiumthx.com/
http://www.medpodium.com/
© 2010 PR Newswire
OK @ KarinCA ...update it!!!
Chart ( daily / weekly ) >>> LINK back
Apricus rockets on liver cancer drug update
Nov. 22, 2010, 10:27 a.m. EST
http://www.marketwatch.com/story/apricus-rockets-on-liver-cancer-drug-update-2010-11-22
BOSTON (MarketWatch) -- Apricus Biosciences shares were on fire early Monday, rocketing on news that it has filed with U.S. regulators to conduct a Phase III clinical trial for its liver cancer medication PrevOnco. Shares of Apricus were up almost 40% at $3.77. PrevOnco is being tested on patients who are no longer responding to the widely-used liver cancer agent Nexavar, which is marketed by Bayer AG and Onyx Pharmaceuticals.
Apricus Biosciences Files Phase 3 Registration Protocol for PrevOnco™ for Special Protocol Assessment Consideration by the FDA
Date : 11/22/2010 @ 4:13PM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45344446&symbol=APRI
Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) today announced that it has filed the protocol for a proposed Phase 3 clinical trial of PrevOnco™, its proprietary treatment for hepatocellular carcinoma (liver cancer), with the U.S. Food and Drug Administration (FDA). The FDA will review the protocol under its Special Protocol Assessment (SPA) program, under which the FDA would give approval for the trial’s design, clinical endpoints and statistical analysis. The Phase 3 study is expected to take about 12-24 months depending on the recruitment of patients. If the trial shows positive results within the parameters agreed upon in the SPA, the data would then be expected to provide the basis for the filing of a New Drug Application for marketing approval of PrevOnco in the U.S.
The FDA granted PrevOnco Orphan Drug status in August 2008. The product incorporates lansoprazole, a commonly marketed anti-ulcer compound which has shown strong anti-cancer activity in mice bearing human liver tumors. The Phase 3 study will enroll up to 218 patients who have advanced, unresectable hepatocellular carcinoma who no longer respond to Nexavar® (the currently marketed first-line anti-cancer treatment for patients with this type of liver cancer). The subjects will receive Nexavar and doxorubicin (the widely used chemotherapy anti-cancer drug), plus either PrevOnco or a placebo. Nexavar is marketed in the U.S. by Onyx Pharmaceuticals, Inc. and Bayer HealthCare Pharmaceuticals, Inc., with close to $1 billion in sales, and is approved in more than 90 countries for the treatment of patients with hepatocellular carcinoma.
Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, noted, "Fifteen years worth of experience using lansoprazol to treat ulcers has shown that the drug is safe for human use. We have also seen strong anti-cancer activity in mice bearing human liver tumors. As a result, we are optimistic that PrevOnco to do well in the clinic.”
In addition, the Company has developed a new, oral lansoprazole formulation incorporating its clinically validated, proprietary NexACT® drug delivery technology, which is designed to potentially reduce the lansoprazole dose needed in humans by seven times, based on data generated in non-human primate studies. The Company may seek FDA approval to switch the current lansoprazole formulation with the NexACT formulation of lansoprazole following a Phase I human pharmacokinetic equivalency bridging study.
About Special Protocol Assessment
The FDA's Special Protocol Assessment process was implemented under the Prescription Drug User Fee Act (PDUFA) in November 1997. The SPA process provides for review and a binding agreement that the Phase III trial protocol design, clinical endpoints, planned conduct and statistical analyses are acceptable to support regulatory approval.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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, approval of the proposed SPA, the Company’s capital resources needed to fund any clinical trials, the Company’s ability to replicate pre-clinical study results in subsequent human clinical studies and the rate of patient enrollment in any clinical studies. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Vitaros® -
http://seekingalpha.com/article/237770-groundbreaking-drug-solid-management-make-apricus-bio-a-compelling-buy?source=yahoo
The drug is even safe for use by patients with hypertension, diabetes, cardiac problems, and many others who are often unable to safely use traditional oral treatments. Vitaros® has been shown to work within a couple of minutes, compared to the typical 30 minutes to two hour delay from oral medications. This is quite a remarkable medical feat and one that is sure to pique the interest of patients. Company market research also indicates that urologists would prescribe the drug to up to 30% of their patients diagnosed with erectile dysfunction—not a bad number in a $2 billion ex-US market. The company plans to use the recent approval to move forward in getting Vitaros® into over 100 international markets.
SNSS Corporate Presentation 11/16/10
@ $heff's $tation http://investorshub.advfn.com/boards/read_msg.aspx?message_id=56969736
...nice!
FDA_Guidance on Phase 3 Study - LINK back
Chart ( daily / weekly ) >>> LINK back
Apricus Bio Announces Pre-Clinical Data Showing Significant Improvement in Solubility & Absorption of NexACT®-Based Small Mo...
Date : 11/19/2010 @ 10:03AM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45321193&symbol=APRI
Apricus Biosciences, Inc., (“Apricus Bio”) (Nasdaq: APRI) today announced data from animal studies showing that the NexACT® technology significantly improved the oral delivery of five small molecule drugs tested, with the best improvements up to 20-fold, in terms of improvement in absorption. A total of 10 small molecule therapeutic drugs with known low solubility and/or permeability, according to the Biopharmaceuticals (“BCS”) Classification System, were selected for these studies, and represented the following classes: anti-inflammatory drugs, diuretics, anti-hypertensives, antibiotics, anti-psychotics, anti-Parkinson agents and proton pump inhibitors.
The BCS, developed by Professor Gordon L. Amidon from the College of Pharmacy at the University of Michigan, separates drugs into four quadrants depending on their solubility and permeability. Class 1 drugs are high solubility and high permeability, Class 2 low solubility and high permeability, Class 3 high solubility and low permeability, and Class 4 low solubility and low permeability. In the Apricus Bio studies, the compounds that showed the most improvement when formulated with the NEXACT technology were in Classes 2 and 4, where solubility is a determining factor.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, “Drugs are classified according to their solubility and permeability. This early data shows that the inclusion of NexACT can significantly improve the oral delivery of some small molecules by positively affecting their solubility, which affects absorption. Over time, this could open up exciting new partnership opportunities, especially for promising drug candidates that did not reach, or successfully pass through clinical development, because of poor solubility. Our goal is to make a major breakthrough in the utilization of NexACT to improve and/or enable the delivery of difficult-to-absorb compounds.”
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros®, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 replicate pre-clinical study results in subsequent human clinical studies, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
ANNUAL MEETING OF STOCKHOLDERS - December 21, 2010
PROXY STATEMENT: http://ih.advfn.com/p.php?pid=nmona&article=45248503
Quarterly Report (10-Q)
Date : 11/15/2010 @ 5:06PM
Source : Edgar (US Regulatory)
Stock : (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45248636
...As of November 12, 2010, 206,652,815 shares of the registrant’s common stock, par value $0.001 per share, were outstanding.
Cardium Announces Co-Development and Strategic Licensing Agreement with BioZone Laboratories for Expansion of MedPodium Portfolio
http://www.finanznachrichten.de/nachrichten-2010-11/18595945-cardium-announces-co-development-and-strategic-licensing-agreement-with-biozone-laboratories-for-expansion-of-medpodium-portfolio-008.htm
SAN DIEGO, Nov. 18, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced a co-development and strategic licensing agreement with BioZone Laboratories, Inc. ("BioZone") for the formulation, manufacture and licensing of a portfolio of up to 20 aesthetics, advanced skin care formulations and other products for Cardium's MedPodium(TM) product line. Under terms of the agreement, Cardium will identify a line of products applying BioZone technology such as that incorporated into its QuSome(TM), Inflacin(TM), LipoCeutical(TM), LipoSpray(TM) and other formulation and delivery technologies.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO)
"We are pleased to partner with BioZone and look forward to expanding our MedPodium product platform to potentially encompass aesthetics, metabolics, neurologics and nutraceuticals based on BioZone's technology and extensive experience and know-how. Our MedPodium product line initially includes seven podiatry-focused advanced skin care products and our recently announced weight management product, Linee. Under our agreement with BioZone, we plan to develop a portfolio of up to 20 products that will be designed to address the emerging lifestyle issues that are increasingly important in our technology-driven society. Our products will initially be available through Cardium's MedPodium web-based boutique with future plans to market and sell certain product lines through various select distributors or retailers in the United States," stated Christopher J. Reinhard, Chairman and Chief Executive Officer of Cardium.
Under the terms of the agreement, Cardium will receive a royalty-free license for a portfolio of 20 products selected by Cardium using BioZone technology in exchange for total consideration of $1.0 million through the issuance of shares of Cardium common stock priced at the greater of (i) the closing price of Cardium common stock on the date of closing, or (ii) $0.50 per share. The purchased stock will be in the form of unregistered shares of common stock transferred to and held in an escrow account, to be released to BioZone beginning six months following the closing date of the transaction with such shares being released in five equal monthly installments. Under the terms of the agreement, product manufactured for Cardium by BioZone will be supplied at agreed-upon pricing terms and Cardium has a right of first refusal with respect to any potential sale of BioZone or BioZone assets, under which Cardium would be entitled to acquire BioZone or BioZone assets as applicable on the same terms and conditions as negotiated to mutual acceptability with any third party.
About BioZone Laboratories
BioZone Laboratories is a custom product manufacturer that provides cost-effective, high quality formulations and products to a number of private-label customers. BioZone operates a cGMP manufacturing facility in Pittsburg, California, and is registered with the U.S. Food and Drug Administration (FDA) as a drug manufacturer. BioZone has several novel drug delivery technology platforms and corresponding products and drug candidates that are broadly applicable to multiple medicinals, therapeutics and dosage forms, including topical and oral applications. The development of products with BioZone's technology and formulation platforms may result in products having better effectiveness or marketability, an improved safety or product use profile, or more convenient or cost-effective formulation. Additional information about BioZone is located at http://www.biozonelabs.com/.
About MedPodium
MedPodium is being developed as a portfolio of premium, science-based nutraceuticals, medicinals, metabolics, neurologics and aesthetics designed to promote optimal health and wellness for today's active and professional lifestyles. MedPodium delivers customized nutritional supplements and other products featuring easy to use pills and capsules, novel, fast-acting oral drops and sprays, and innovative transdermal delivery systems. Additional information about MedPodium is located at http://www.medpodium.com/.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium lifestyle medicinals brand platform. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx®, a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that the co-development and strategic licensing agreement with BioZone will successfully and timely lead to the development, formulation, manufacture and licensing of products for Cardium's MedPodium healthy lifestyle medicinals line, that any products that are developed under the BioZone agreement or other products in the MedPodium product platform will be commercially successful or will effectively enhance our businesses or their market value, that the MedPodium product line can be successfully broadened to include additional healthy lifestyle opportunities, that our products will prove to be sufficiently safe and effective after introduction into a broader patient population; that results or trends observed in clinical studies or other observations will be reproduced in subsequent studies or in broader use, that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive, that FDA or other health regulatory agencies will not introduce additional or more restrictive regulations covering naturally-derived products such as those in our MedPodium product line, that our in-house or external product commercialization efforts will be successful or will effectively enhance our businesses or their market value, that Cardium can maintain its exchange listing compliance with NYSE Amex and continue to support its business and operations, that any of the third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of biologics and other new products and in the conduct of human clinical trials and other product development efforts, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition and regulation, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/.
Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.
Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company.
(Any other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
CONTACT: Investor Contact: Bonnie Ortega, Director, Investor/Public
Relations, Cardium Therapeutics, Inc., +1-858-436-1018,
InvestorRelations@cardiumthx.com; Media /Sales Contact: Hanna Wagari, Director
of Marketing, Cardium Therapeutics, Inc., +1-858-436-1042,
hwagari@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
Zoom Technologies Closes on Private Placement of $7.9M
Date : 11/16/2010 @ 12:56PM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=45265307
Zoom Technologies, Inc. (NASDAQ: ZOOM) ("Zoom") is pleased to announce the closing of a private placement for gross proceeds of $7,926,240. In the private placement, Zoom sold 2,113,664 units at a price of $3.75 per unit. Each unit is comprised of one share of common stock of Zoom and three-quarters of one common stock purchase warrant. Each whole warrant entitles the holder to purchase an additional common share at a price of $4.71 for a period of five years following the closing date.
Global Hunter Securities LLC acted as the lead placement agent in the transaction and Ladenburg Thalmann & Company Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE Amex: LTS), acted as co-placement agent. Ellenoff Grossman & Schole LLP served as legal advisor to Zoom in the transaction. Proceeds from this financing will be used for capacity expansion purposes.
This press release does not and shall not constitute an offer to sell or the solicitation of any offer to buy any of the securities. For additional information, please refer to Zoom's current report on Form 8-K to be filed with the Securities and Exchange Commission in conjunction to this transaction.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. Zoom's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward-Looking Statements
This release contains forward-looking information relating to Zoom's plans, expectations, and intentions. Actual results may be materially different from expectations as a result of known and unknown risks, including the risks set forth in Zoom's filings with the Securities and Exchange Commission. Zoom cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Zoom expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Zoom's expectations or any change in events, conditions or circumstance on which any such statement is based.
Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966
Apricus Biosciences’ CEO Bassam Damaj, Ph.D., Interviewed by the Financial Network CDTV.net
Date : 11/17/2010 @ 10:00AM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45281291
Apricus Biosciences, Inc. (“Apricus Bio”) (Nasdaq: APRI) ( www.apricusbio.com ), announced today that President and Chief Executive Officer Bassam Damaj, Ph.D., has been interviewed by CDTV.net, a New York-based financial network ( www.cdtv.net ). The interview is currently available at CDTV.net or directly at http://www.cdtv.net/users/content/apricus-biosciences-nasdaq-apri-receives-canadian-approval-vitaros-first-line-therapy-erecti .
Apricus Bio announced on November 15, 2010 that Health Canada has granted marketing approval for Vitaros®, the Company’s proprietary, topically applied, on-demand treatment for erectile dysfunction. In the interview at CDTV.net, Dr. Damaj explained that Apricus Bio decided to research, develop, and seek approval for Vitaros for several reasons, including addressing the unmet medical need for a patient-friendly, on-demand topical treatment suitable for patients with erectile dysfunction of different severity. Dr. Damaj said that now, with Vitaros, patients with cardiac disease, hypertension, diabetes, and patients who are obese or who are not successful or contraindicated for currently available oral erectile dysfunction drugs, will have a fast-acting and non-painful alternative.
Apricus Bio developed the Vitaros cream by incorporating its proprietary NexACT® permeation enhancer technology with alprostadil, a well-recognized vasodilator and treatment for erectile dysfunction that is currently marketed as an injectable product or an intraurethral insert product. The NexACT delivery technology has been clinically validated by Health Canada’s approval and the Vitaros cream treatment will be available to patients in Canada. Apricus Bio also intends to use the Canadian approval as the basis for seeking registration of the product for potential marketing in more than 100 international markets.
In the CDTV.net interview, Dr. Damaj noted that there is currently a $3 billion market worldwide for erectile dysfunction treatments, with oral medication dominating the marketplace. Some urologists have said that a prescribed topical erectile dysfunction treatment has the potential to capture up to 20-30 percent of their patients, once approval is granted.
Now that its NexACT technology has been validated in an approved prescription product, Apricus Bio intends to continue moving forward with the development of the 12 other drugs in its pipeline, including potential treatments for liver cancer, female sexual arousal disorder, Raynaud’s syndrome secondary to scleroderma, psoriasis, oral cancer and pain.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 successfully commercialize Vitaros in Canada, receive registration of Vitaros in other countries, replicate pre-clinical study results in subsequent human clinical studies, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Discovery Labs to Present at the Lazard Capital Markets Healthcare Conference
Date : 11/15/2010 @ 7:30AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45234844&symbol=DSCO
Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing its novel, synthetic, peptide-containing surfactant and related aerosolization technologies as first-in-class therapies for severe respiratory diseases, announced today that Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, will present at the Lazard Capital Markets 7th Annual Healthcare Conference on November 17, 2010 in New York. The conference will be simultaneously webcast over the Internet.
Dr. Miller is scheduled to present at 9:00 AM EST on Wednesday, November 17, 2010. The presentation will be available through a live audio webcast at http://www.wsw.com/webcast/lz8/dsco/ or Discovery Labs' web site, www.discoverylabs.com. A replay of the audio webcast will be available on both websites for ninety days.
About Discovery Labs
Discovery Laboratories, Inc. is a biotechnology company developing KL4 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 and 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.
CONTACT: Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and
Chief Financial Officer
215-488-9490
Sunesis Issued Important U.S. Patent Covering Vosaroxin Clinical Formulation
Date : 11/15/2010 @ 7:30AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=45234816&symbol=SNSS
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 7,829,577, claiming the Company's pharmaceutical compositions of lead drug candidate vosaroxin. This patent is scheduled to expire on March 14, 2025, and could be eligible for patent term extension beyond this date. Corresponding patent applications are pending in major markets throughout the world including Europe, Japan, Australia and Canada.
"This patent is an important new addition to our intellectual property estate, as it covers the formulation currently used in our clinical trials," stated Daniel Swisher, Chief Executive Officer of Sunesis. "Vosaroxin's extended patent life to 2025 increases not only the value of our AML franchise but also provides sufficient time for lifecycle evaluation of vosaroxin in other indications. We are pursuing a sophisticated and deliberate strategy to extend exclusive coverage in the vosaroxin patent estate beyond 2025. In addition to our granted patents, we have filed patent applications covering additional formulations, combination uses, dosing, manufacturing processes and composition of matter claims. We look forward to the successful prosecution of these patent applications in multiple territories around the world."
About Vosaroxin
Vosaroxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Vosaroxin is currently being evaluated in a fully enrolled single agent Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a fully enrolled Phase 2 clinical trial combining vosaroxin with cytarabine for the treatment of patients with relapsed/refractory AML. A Phase 2 single agent clinical trial in platinum-resistant ovarian cancer has also been completed. Sunesis plans to initiate the VALOR trial, a multinational, randomized, double-blind, placebo-controlled, pivotal Phase 3 clinical trial of vosaroxin in combination with cytarabine in a relapsed/refractory AML patient population, in the fourth quarter of this year.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, vosaroxin, in multiple indications to improve the lives of people with cancer.
For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including without limitation statements related to the prosecution of patent applications and Sunesis' plans to initiate a pivotal Phase 3 clinical trial of vosaroxin in the fourth quarter of this year. Words such as "evaluate," "planned," "will," "look forward" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Sunesis' current expectations. Forward-looking statements involve risks and uncertainties. Sunesis' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include without limitation, risks related to Sunesis' need for additional funding to fully finance the planned vosaroxin pivotal trial, the risk that Sunesis' development activities for vosaroxin could be halted or significantly delayed for various reasons, the risk that Sunesis' clinical studies for vosaroxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical studies may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, risks related to the manufacturing of vosaroxin, and the risk that Sunesis' proprietary rights may not adequately protect vosaroxin. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
Apricus Biosciences Receives Canadian Approval for Vitaros® as First Line Therapy for Erectile Dysfunction
Date : 11/15/2010 @ 12:21PM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45242778&symbol=APRI
Apricus Biosciences, Inc. (“Apricus Bio”) (Nasdaq: APRI), announced today that Health Canada has granted marketing approval for Vitaros® as a first-line therapy for erectile dysfunction. Vitaros® is Apricus Bio’s proprietary, topically-applied, on-demand treatment for erectile dysfunction.
Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, “We at Apricus Bio are thrilled to have received this approval from Health Canada. The achievement of this milestone is a testament to the focus and dedication of the Apricus Bio team and our success in executing on our stated growth strategy.”
Dr. Damaj continued, “Data from our clinical trials showed that patients responded to treatment within minutes of applying Vitaros. Now, for the first time, men suffering from erectile dysfunction will have access to a patient-friendly, on-demand topical treatment. We view this Canadian approval as a validation of the NexACT technology as a transdermal delivery mechanism that is safe and effective. We intend to quickly finalize our marketing strategy to bring the product to the Canadian patient population. In addition, we will use this approval as the basis for seeking registration of the product for marketing in over 100 international markets.”
Vitaros® incorporates alprostadil, a well-recognized vasodilator that is currently marketed as an injectable product or an intra-urethral insert product for patients with erectile dysfunction. Apricus Bio incorporated its proprietary NexACT drug delivery technology in the development of Vitaros as a patient-friendly topically-applied treatment for erectile dysfunction.
The product has been studied in over 3,300 patients including difficult to treat populations (diabetes, cardiac problems, sildenafil (Viagra®) failures and post prostatectomy patients). Vitaros demonstrated clinical efficacy and excellent safety profile versus the currently approved oral therapies, and is not contraindicated for patients taking alpha blockers or nitrate medication. Viagra® is a registered trademark of Pfizer.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 successfully commercialize Vitaros in Canada, receive registration of Vitaros in other countries, replicate pre-clinical study results in subsequent human clinical studies, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Apricus Biosciences Receives Canadian Approval for Vitaros® as First Line Therapy for Erectile Dysfunction
Date : 11/15/2010 @ 12:21PM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45242778&symbol=APRI
Apricus Biosciences, Inc. (“Apricus Bio”) (Nasdaq: APRI), announced today that Health Canada has granted marketing approval for Vitaros® as a first-line therapy for erectile dysfunction. Vitaros® is Apricus Bio’s proprietary, topically-applied, on-demand treatment for erectile dysfunction.
Commenting on today’s news, Bassam Damaj, Ph.D., President and Chief Executive Officer of Apricus Bio, stated, “We at Apricus Bio are thrilled to have received this approval from Health Canada. The achievement of this milestone is a testament to the focus and dedication of the Apricus Bio team and our success in executing on our stated growth strategy.”
Dr. Damaj continued, “Data from our clinical trials showed that patients responded to treatment within minutes of applying Vitaros. Now, for the first time, men suffering from erectile dysfunction will have access to a patient-friendly, on-demand topical treatment. We view this Canadian approval as a validation of the NexACT technology as a transdermal delivery mechanism that is safe and effective. We intend to quickly finalize our marketing strategy to bring the product to the Canadian patient population. In addition, we will use this approval as the basis for seeking registration of the product for marketing in over 100 international markets.”
Vitaros® incorporates alprostadil, a well-recognized vasodilator that is currently marketed as an injectable product or an intra-urethral insert product for patients with erectile dysfunction. Apricus Bio incorporated its proprietary NexACT drug delivery technology in the development of Vitaros as a patient-friendly topically-applied treatment for erectile dysfunction.
The product has been studied in over 3,300 patients including difficult to treat populations (diabetes, cardiac problems, sildenafil (Viagra®) failures and post prostatectomy patients). Vitaros demonstrated clinical efficacy and excellent safety profile versus the currently approved oral therapies, and is not contraindicated for patients taking alpha blockers or nitrate medication. Viagra® is a registered trademark of Pfizer.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including its approved drug erectile dysfunction treatment, Vitaros, as well as compounds in development from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 successfully commercialize Vitaros in Canada, receive registration of Vitaros in other countries, replicate pre-clinical study results in subsequent human clinical studies, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Quarterly Report (10-Q)
Date : 11/12/2010 @ 6:23AM
Source : Edgar (US Regulatory)
Stock : (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45206333
...as of November 10, 2010, 12,853,994 shares of Common Stock, par value $0.001 per share, were outstanding.
Cardium Reports on Presentation at American Heart Association Meeting Relating to Gene Delivery to the Heart and Generx Clinical Development
http://www.finanznachrichten.de/nachrichten-2010-11/18554762-cardium-reports-on-presentation-at-american-heart-association-meeting-relating-to-gene-delivery-to-the-heart-and-generx-clinical-development-008.htm
SAN DIEGO, Nov. 15, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) reported on the presentation of results from the Company's sponsored preclinical research at the American Heart Association 2010 Annual Meeting Scientific Sessions being held November 13 - 17, 2010 in Chicago, IL. The new findings showed that coronary artery occlusion and reperfusion can substantially increase adenovector-mediated gene delivery to the heart, which is used in the Company's Generx product candidate.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO ) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO )
Cardium's Generx (Ad5FGF-4) clinical development program, including four completed clinical studies enrolling over 650 patients worldwide, has generated data indicating that the level of myocardial ischemia in patients with severe coronary artery disease may affect the angiogenic response in patients. These new findings indicate that induced myocardial ischemia and reperfusion can increase adenovector uptake by heart muscle which could potentially be applied to enhance the delivery of DNA encoding growth factors to the heart as used in the Company's Generx product candidate. Generx is designed for potential use by interventional cardiologists as a one-time treatment to promote and stimulate the growth of collateral circulation in the hearts of patients with ischemic conditions, such as recurrent angina, due to coronary artery disease. A new presentation entitled New Cardiovascular Therapeutic Paradigm: Development and Commercialization of Cost-Effective DNA-Based Angiogenic Therapeutic for International Markets, is now available for viewing at the Investors Section of Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.
New Preclinical Study Results
The preclinical study undertaken at the Carlyle Cardiothoracic Surgery Center at Emory University, Atlanta, GA, evaluated the effect of ischemia-reperfusion (IR), induced by balloon occlusion of the left anterior descending (LAD) coronary artery for 75 minutes, followed by reperfusion (balloon deflation) on myocardial expression of luciferase (Luc, a reporter gene easily measured and quantified in the heart) after intracoronary infusion of Ad5Luc (10e11 viral particles). The study results showed that intracoronary infusion of Ad5Luc to normal (non-ischemic) pig heart caused no or very little Luc expression (0.2+/- 0.6 pg Luc/g tissue), measured 3 days after administration. In contrast, intracoronary infusion of Ad5Luc after ischemia and reperfusion resulted in statistically significantly higher Luc expression in the ischemic region of the heart (90.4+/- 26.5 pg Luc/g tissue; p<0.05). Another important outcome of the study was the demonstration that intracoronary infusion of Ad5Luc directly to the ischemic region of the left ventricle caused no myocardial inflammation or any other untoward effects.
"These important preclinical findings suggest that induced myocardial ischemia can increase the heart muscle uptake of the adenovector that is used to deliver DNA into cells. As a result of these new insights we may consider modifications to future clinical studies and clinical trial protocols in order to potentially enhance patients' angiogenic response and therapeutic effect and reduce response variability," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
Reinhard added, "We look forward to receiving clearance from the Russian Health Authority to initiate our Generx clinical study at three leading medical centers in Moscow. We believe there is a growing need for innovative and cost-effective cardiovascular care to meet the increasing levels of cardiovascular disease in emerging market countries. Our Generx product candidate could potentially be developed as a front-line therapy for patients with coronary artery disease who often do not have access to costly advanced care procedures such as coronary angioplasty and stenting, or cardiac bypass surgery."
About Generx
The Generx(TM) (alferminogene tadenovec, Ad5FGF-4) product candidate represents a new class of cardiovascular biologics that is being developed to leverage the body's natural healing processes in response to repeated ischemic stress (insufficient blood flow and myocardial oxygen supply due to coronary heart disease). The natural biologic response to repeated transient ischemia is angiogenesis, the growth of new collateral blood vessels, which is orchestrated by a complex and incompletely understood cascade involving many myocardial-derived growth factors. These newly-formed vessels can effectively augment blood flow and oxygen delivery to parts of the patient's heart downstream from a blockage in a coronary artery. In many patients however, including those with recurrent angina, coronary collateral vessel formation is insufficient to meet the heart's needs during stress. Currently available anti-anginal drugs, which may provide symptomatic relief, are generally designed to alter the oxygen demand of the heart muscle or dilate vessels to temporarily relieve angina. Generx is an angiogenic therapeutic product candidate that is designed to promote the heart's natural response of collateral growth and to increase blood flow in the microcirculation. In contrast to the transient symptomatic relief by marketed anti-anginal medicines, usually taken several times a day for years, a single administration of Generx aims at modifying the disease by permanent or long-lasting structural changes in the heart.
Researchers believe that central to the biological activity and potential therapeutic benefit of Generx is the effective capture of the Ad5 delivery vector in the coronary micro-circulation, subsequent vector uptake, and FGF-4 protein expression (preferentially in myocytes and endothelial cells). The formation of new blood vessels (angiogenesis) and remodeling of existing collateral vessels (arteriogenesis) are the two main mechanisms contributing to the therapeutic effect of an angiogenic growth factor. New micro-vessel development naturally occurs in the embryo, but in the adult organism it requires tissue injury (such as ischemia) to initiate a regenerative process, including collateral vessel formation. Research shows that FGF-4 is one of the key regulatory growth-factor proteins that orchestrates micro-vascular and collateral vessel regeneration in the heart. After the FGF-4 protein is secreted or transported out of the myocyte, it acts via high affinity FGF receptors on neighboring endothelial cells to signal the initiation of cardiac angiogenic activity and enhancement of the arteriogenesis processes.
These actions of FGF-4 are believed to require an ischemic/hypoxic milieu to proceed efficiently. The structure of the FGF-stimulated vessels may promote stability and produce more mature vessels, which, combined with appropriate blood flow, should contribute to the long term persistence of these newly formed collateral vessels. Once the beneficial blood vessel growth or vascular remodeling has been accomplished, and provided there is sustained blood flow through the newly-formed vessels, continued FGF-4 growth factor secretion is no longer needed. Indeed, preclinical studies demonstrated that a single intracoronary infusion of Generx was capable of stimulating new vessel formation in the heart that was associated with improved blood flow and ventricular contractile function, an effect which lasted for at least 3 months.
About Generx Clinical Development Program
Generx (alferminogene tadenovec, Ad5FGF-4) is a DNA-based angiogenic growth factor therapeutic product candidate representing a new class of cardiovascular biologics as a treatment for patients with advanced coronary artery disease. Generx is designed to stimulate and promote the growth of collateral vessels to enhance myocardial blood flow (perfusion) following a one-time intracoronary administration from a standard cardiac infusion catheter in patients who have insufficient blood flow due to atherosclerotic plaque build-up in the coronary arteries. Generx has progressed through four randomized, placebo controlled clinical studies at over 100 medical centers in the United States and Western Europe that have enrolled over 650 patients.
In June 2010, Cardium announced that it had entered into a Master Services Agreement with bioRASI, an international contract research organization, to assist in the conduct of a late-stage clinical study (ASPIRE) designed to support regulatory approval and commercialization activities for Generx in Russia and affiliated jurisdictions, as well as in other newly industrializing markets. The Generx clinical study will be conducted at three leading medical centers in Moscow and will be a randomized, controlled, parallel-group, multi-center study to evaluate the safety and efficacy of Generx using SPECT imaging of myocardial blood flow in patients with stable angina pectoris. The primary endpoint will be the change in reversible perfusion defect size as measured by SPECT imaging, which is directly analogous to that successfully used in a Phase 2a clinical study of Generx in the United States.
Positive results from the prior Phase 2a clinical study (Grines et al., J Am Coll Cardiol 2003; 42:1339-47) showed that Generx improved myocardial blood flow in the ischemic region of the hearts of men and women following a single intracoronary infusion as measured by the objective efficacy endpoint of SPECT imaging. As noted in the publication, the mean change observed in Generx-treated patients was a 4.2% absolute reduction (which represents a 20% relative reduction) in the reversible perfusion defect size from baseline at eight weeks (p<0.001), while the placebo group showed only a 1.6% absolute reduction from baseline (not significant) at eight weeks following treatment. The observed treatment effect for patients receiving Generx was similar in magnitude to that reported in the literature for patients undergoing angioplasty/stent or revascularization procedures with reversible perfusion defects of comparable size at one year following these procedures.
About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's current investment portfolio includes the Tissue Repair Company, Cardium Biologics, and the Company's in-house MedPodium lifestyle medicinals brand platform. The Company's lead product candidates include: (1) Excellagen(TM) topical gel, for wound care management, which Cardium plans to market launch in the fourth quarter subject to pending FDA 510(k) clearance; and (2) Generx®, a DNA-based angiogenic cardiovascular biologic for patients in international markets with coronary artery disease. In addition, consistent with its capital-efficient business model, Cardium continues to actively evaluate new technologies and business opportunities. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Forward-Looking Statements
Except for statements of historical fact, the matters discussed in this press release are forward looking and reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond our control and may cause actual results to differ materially from stated expectations. For example, there can be no assurance that enhancements in the uptake of adenovectors can be successfully applied to improve the uptake or therapeutic effects of Generx in human patients; that Generx can be successfully advanced in clinical studies outside of the U.S.; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures, or that clinical studies even if successful will lead to product advancement or partnering; that improvements in the formulation or use of Generx will be commercially practicable, or that Generx could be successfully advanced as a therapeutic in developing markets or that the results of studies in such markets could be used to advance or broaden the regulatory or commercialization activities of Generx in the U.S. or other markets; that our products or product candidates will not be unfavorably compared to competitive products that may be regarded as safer, more effective, easier to use or less expensive; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or their market value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; or that third parties on whom we depend will perform as anticipated.
Actual results may also differ substantially from those described in or contemplated by this press release due to risks and uncertainties that exist in our operations and business environment, including, without limitation, risks and uncertainties that are inherent in the development of complex biologics and in the conduct of human clinical trials, including the timing, costs and outcomes of such trials, our ability to obtain necessary funding, regulatory approvals and expected qualifications, our dependence upon proprietary technology, our history of operating losses and accumulated deficits, our reliance on collaborative relationships and critical personnel, and current and future competition, as well as other risks described from time to time in filings we make with the Securities and Exchange Commission. We undertake no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/. Cardium Therapeutics(TM) Generx(R) and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc. Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company. (Other trademarks belong to their respective owners)
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CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
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Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
Zoom Technologies Executed Definitive Agreement With Investors for $7.9 Million Raise
Date : 11/10/2010 @ 9:25AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=45171441&symbol=ZOOM
Zoom Technologies, Inc. (NASDAQ: ZOOM) today announced it has executed definitive agreements with institutional and accredited investors for gross proceeds of $7,926,240 in connection with the Company's private placement of common stock and warrants.
The transaction involves the sale of 2,113,664 newly-issued shares of the company's common stock at the price of $3.75 per share and warrants to purchase an additional 1,585,248 shares of the company's common stock at $4.71 per share.
The transaction will close pending satisfaction of certain closing procedures. Proceeds from this financing will be used for capacity expansion purposes.
Global Hunter Securities LLC acted as the lead placement agent in the transaction and Ladenburg Thalmann & Company Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc. (NYSE Amex: LTS), acted as co-placement agent. Ellenoff Grossman & Schole LLP served as legal advisor to Zoom Technologies in the transaction.
This press release does not and shall not constitute an offer to sell or the solicitation of any offer to buy any of the securities. For additional information, please refer to Zoom's current report on Form 8-K to be filed with the Securities and Exchange Commission in conjunction to this transaction.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward Looking Statements
This release contains forward-looking information relating to Zoom's plans, expectations, and intentions. Actual results may be materially different from expectations as a result of known and unknown risks, including the risks set forth in Zoom's filings with the Securities and Exchange Commission. Zoom cautions readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Zoom expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Zoom's expectations or any change in events, conditions or circumstance on which any such statement is based.
Contacts:
Cynthia Hiponia
The Blueshirt Group
+1 415-217-4966
Apricus Biosciences Announces 2010 Third Quarter Financial Results Conference Call
Date : 11/10/2010 @ 10:39AM
Source : Business Wire
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45173226
Apricus Biosciences, Inc. (“Apricus Bio”) (Nasdaq: APRI), announced today that management will hold a conference call to discuss 2010 third quarter financial results and ongoing corporate activities, on Friday, November 12, 2010 at 12:00 p.m. ET. The Company will file its Form 10-Q by the open of business on Friday, November 12, 2010.
The call can be accessed in the U.S. by dialing (877) 407-8031 and outside of the U.S. by dialing (201) 689-8031 and asking the conference operator for the Apricus Bio Conference Call. The teleconference replay will be available for one week by dialing in the U.S. (877) 660-6853 and outside of the U.S. by dialing (201) 612-7415. Replay pass codes 286 and 360911 are both required for playback. The conference call will also be Webcast live at http://www.investorcalendar.com/IC/CEPage.asp?ID=162504. The Webcast replay will be available for three months.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.com.
Discovery Labs Provides a Third Quarter 2010 Business and Financial Update
Date : 11/09/2010 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45144596&symbol=DSCO
Discovery Laboratories, Inc. (Nasdaq:DSCO), a biotechnology company developing its novel, synthetic, peptide-containing surfactant and related aerosolization technologies as first in class therapies for severe respiratory diseases, today provides an update on key pipeline and business initiatives and a financial update for the third quarter ended September 30, 2010. The Company will host a conference call this morning at 10:00 AM EST. The call-in number is 866-332-5218.
Selected highlights, discussed in greater detail below, include:
* Surfaxin® (lucinactant) – Discovery Labs has now completed studies proposed to the FDA relating to its comprehensive preclinical program intended to gain regulatory approval for Surfaxin for the prevention of respiratory distress syndrome (RDS) in premature infants. In conducting the preclinical program, Discovery Labs has taken into account guidance from the U.S. FDA and anticipates further FDA feedback in advance of filing a complete response. The Company believes it remains on track for the potential filing of a complete response in the first quarter of 2011.
* Surfaxin Phase 2 Acute Respiratory Failure (ARF) Trial – New analyses from this trial demonstrate that, based on patient stratification by severity of lung injury, Surfaxin treatment significantly reduced time on mechanical ventilation in the least severe patient segment (p < 0.01). Furthermore, the data demonstrated that Surfaxin intervention reduced the need for a second dose (p < 0.05), suggesting a decrease in disease severity following surfactant treatment.
* Aerosolized KL4 Surfactant (lucinactant) for Cystic Fibrosis (CF) – results from the recently-completed Phase 2a, investigator-initiated trial concluded that aerosolized KL4 surfactant delivery to CF patients was feasible, generally safe and well tolerated, and demonstrated evidence of pharmacologic response via improvement in mucociliary clearance (MCC) versus patient baseline. Additionally, the FDA recently granted orphan drug designation to Discovery Labs' KL4 surfactant for the treatment of CF.
* 3Q10 Financial Update - cash burn from operations was $5.0 million, before financings and debt service. Additionally, the Company paid $4.0 million to fully satisfy its loan obligations with PharmaBio. Discovery Labs ended the third quarter of 2010 with cash and cash equivalents of $14.7 million. In addition, the Company's 2010 Committed Equity Financing Facility (2010 CEFF) may, subject to certain conditions and limitations, allow the Company to raise additional capital. For the fourth quarter of 2010, Discovery projects a net cash burn of $4.0 million. The Company recently received a non-dilutive grant to advance the aerosolized KL4 surfactant program for prevention of neonatal RDS awarded under the Patient Protection and Affordable Care Act of 2010.
W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs commented, "We are at an important transition point for our Company and the third quarter has been very productive for Discovery Labs. We have solidified our Company's leadership, significantly progressed the Surfaxin complete response initiative and have begun to understand the potential role of KL4 surfactant in two new disease targets – cystic fibrosis and acute respiratory failure. As we move towards the end of 2010, Discovery Labs will be focused on remaining activities to support the Surfaxin complete response filing and ongoing strategic alliance initiatives while diligently managing our financial resources."
Selected Updates on KL4 Surfactant Pipeline Development
Surfaxin for Neonatal RDS: If approved, Surfaxin would become the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine. The safety and efficacy of Surfaxin for neonatal RDS has been previously demonstrated in a large, multinational Phase 3 clinical program. Discovery Labs believes that the last remaining step necessary to potentially gain FDA marketing approval for Surfaxin for the prevention of RDS is to satisfy the FDA as to the final validation of an important quality control release and stability test for Surfaxin, the fetal rabbit biological activity test (BAT).
In this respect, Discovery Labs conducted a comprehensive preclinical program intended to satisfy the FDA. The comprehensive preclinical program, as proposed to the FDA, involved the optimization and subsequent revalidation of the BAT, which was then employed in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS. Discovery Labs has taken into account the FDA's guidance in conducting its comprehensive program. These proposed studies were recently completed. The resulting dataset is undergoing final review and compilation in preparation for submission to the FDA.
Throughout this process, Discovery Labs has had multiple interactions with the FDA intended to ensure that the comprehensive preclinical program satisfies the FDA as to the final validation of the BAT and its ultimate appropriateness as a release and stability test for Surfaxin, upon potential approval. Previously, Discovery Labs provided additional analysis to the FDA regarding the revalidation of the BAT intended to aid the FDA in its final determination of whether the BAT is appropriately validated for use as an ongoing quality control release and stability test for Surfaxin, if approved. Discovery Labs is awaiting FDA feedback regarding this analysis and anticipates further interactions in advance of the pending complete response. Such interactions with the FDA could affect the ultimate timing, conduct and outcomes of remaining steps necessary to gain Surfaxin approval, including the potential filing of the complete response. Discovery Labs believes it remains on track to submit a complete response to the FDA in the first quarter of 2011, potentially leading to Surfaxin approval later in the year.
Surfaxin LS and Aerosurf Neonatal RDS Programs: Surfaxin LS (lyophilized lucinactant) is an important life-cycle initiative, intended to further improve on the Surfaxin product profile and provide access to international markets. Discovery Labs has contracted with a leading pharmaceutical contract manufacturing organization to establish a Surfaxin LS clinical supply manufacturing capability that is compliant with current good manufacturing practices (cGMP). Preparation for the manufacture of process validation lots of lyophilized lucinactant has initiated in the fourth quarter of 2010. Additionally, the Company intends to seek regulatory guidance for its planned development program, first with the FDA in the fourth quarter of 2010 and then with the EMA in early 2011.
Aerosurf is a novel drug/device combination therapy intended to allow early administration of aerosolized surfactant to address neonatal RDS. Aerosurf holds the promise to significantly expand the use of surfactant therapy by providing neonatologists with a less invasive means of delivering KL4 surfactant without the current requirement of invasive endotracheal intubation and mechanical ventilation. The Company is preparing to engage the FDA and EMA in the first half of 2011 for regulatory guidance with respect to the planned Aerosurf development program. Discovery Labs, working with a leading technology company with expertise in biomedical device development, is optimizing the design of the capillary aerosolization device to potentially reduce development risk and satisfy regulatory and development requirements for Aerosurf.
Surfaxin Phase 2 trial for ARF: Discovery Labs recently completed a comprehensive analysis of its Phase 2 clinical trial of Surfaxin in children with ARF, a critical condition often caused in children by severe respiratory infections. The study was a multicenter, randomized, masked trial that enrolled 165 children under the age of two and compared Surfaxin treatment to standard of care alone. The objective was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF. The trial was designed as an estimation trial, intended to evaluate multiple, potentially clinically-relevant endpoints, as this was the first ever exposure of Surfaxin in a pediatric ARF patient population. The previously reported preliminary analysis indicated that Surfaxin treatment was generally safe and well tolerated in the ARF patient population in this trial. Additionally, Surfaxin treatment reduced time on mechanical ventilation by approximately 10% compared with standard of care alone, although this observation was not statistically significantly.
The recently completed comprehensive analysis demonstrated that, based on patient stratification by severity of lung injury, Surfaxin treatment significantly reduced time on mechanical ventilation in the least severe patient segment (p<0.01) when compared with standard of care alone. Furthermore, the data demonstrated that Surfaxin intervention reduced the need for a second dose (p<0.05), suggesting a decrease in disease severity following surfactant treatment. The comprehensive analysis of the ARF trial has been submitted for presentation at several medical congresses in 2011.
Data from this trial are supportive of Discovery Labs belief that intervention with aerosolized KL4 surfactant earlier in the disease progression may provide for a better clinical outcome in patients at risk for severe respiratory compromise. As a next step in development, Discovery Labs has entered into a collaboration with a leading academic center to evaluate the potential advantage of aerosolized KL4 surfactant intervention in a pre-clinical model of acute lung injury and expects this study to conclude in early 2011.
Aerosolized KL4 Surfactant (lucinactant) for CF: Aerosolized KL4 surfactant was evaluated in a Phase 2a investigator-initiated clinical trial as a single center, pilot study to evaluate the effect of aerosolized KL4 surfactant in patients with mild to moderate CF. The study was designed to assess the safety, tolerability and preliminary effectiveness of short term administration of aerosolized KL4 surfactant on MCC.
Discovery recently announced the completion of this study and that the trial was presented at the 2010 North American Cystic Fibrosis Conference. Dr. Scott H. Donaldson (University of North Carolina), the study's principle investigator, concluded that aerosolized KL4 surfactant delivery to CF patients was feasible, generally safe and well tolerated, was not associated with serious adverse events, and demonstrated evidence of pharmacologic response via improvement in MCC versus patient baseline. Discovery Labs believes that this Phase 2a trial supports the rationale for further development of aerosolized KL4 surfactant in CF and other diseases associated with mucociliary compromise and also represents the first meaningful assessment of feasibility relating to the therapeutic use of aerosolized KL4 surfactant in an ambulatory setting.
Recently, the Office of Orphan Products Development of the FDA granted orphan drug designation to Discovery Labs' KL4 surfactant for the treatment of CF. Orphan designation provides for up to seven years of U.S. market drug product exclusivity for the designated indication following marketing authorization.
Surfaxin, Surfaxin LS, Aerosurf and the Company's other Aerosolized KL4 surfactant drug product candidates are investigational products and are not approved by the FDA or any other world health regulatory authority for use in humans.
Selected Financial Results for the Quarter Ended September 30, 2010
For the quarter ended September 30, 2010, the Company reported a net operating loss of $6.2 million (or $0.03 per share) on 194.2 million weighted average common shares outstanding. For the nine months ended September 30, 2010, the Company reported a net operating loss of $19.5 million (or $0.12 per share) on 164.3 million weighted average common shares outstanding. As of September 30, 2010, the Company had 198.9 million common shares outstanding.
For the third quarter of 2010, net cash burn from ongoing operating activities (before financing and debt service activities) was $5.0 million. Additionally, the Company made $4.0 million of repayments under its previously restructured $10.6 million loan with PharmaBio Development Inc. (PharmaBio), the former strategic investing subsidiary of Quintiles Transnational Corp. (Quintiles). As of September 30, 2010, all amounts owed under this loan obligation have been paid in full. During September 2010, the Company received aggregate proceeds of $0.6 million from the issuance of 3.1 million shares of common stock pursuant to a financing under the 2010 CEFF.
As of September 30, 2010, the Company had cash and cash equivalents of $14.7 million. Additionally, under the 2010 CEFF, there were approximately 28.5 million shares (not to exceed an aggregate of $34.4 million) available for issuance, (subject to certain conditions and limitations, including a minimum share price requirement of $0.20) which may allow the Company to raise additional capital to support its business plans.
The Company anticipates that its net cash burn for the fourth quarter of 2010 will be approximately $4.0 million consisting of $5.5 million of cash used primarily for operating activities offset by cash inflows to date in the fourth quarter from the following financing activities:
* The Company has been awarded a grant of $244,479, administered through the U.S. Internal Revenue Service's Qualifying Therapeutic Discovery Project, to advance its project for aerosolized KL4 surfactant for prevention of neonatal RDS. The award payments are expected in the fourth quarter of 2010 and will provide non-dilutive capital to support the program based on expenditures made in 2009.
* PharmaBio invested an incremental $0.5 million to advance Surfaxin LS and Aerosurf regulatory and development activities. Discovery issued to PharmaBio approximately 2.4 million shares of the Company's common stock and warrants to purchase approximately 1.2 million shares of common stock.
* The Company received aggregate proceeds of approximately $0.8 million from the issuance of 4.7 million shares of common stock pursuant to financings under the 2010 CEFF.
Restatement of Financial Statements
In connection with a review of our Annual Report on 2009 Form 10-K by the Audit Committee of the Company's Board of Directors (the "Audit Committee"), and the Company's management, conducted with the assistance of Ernst & Young LLP ("Ernst & Young"), the Company's independent registered public accounting firm, and the Company's outside legal advisors, the Audit Committee has reassessed the accounting classification of certain warrants issued by the Company in May 2009 and February 2010 with respect to ASC 815 "Derivatives and Hedging — Contracts in Entity's Own Equity" ("ASC 815," formerly known as Emerging Issues Task Force Issue 00-19, "Accounting for Derivative Financial Instruments Indexed to, and Potentially Settled in, a Company's Own Stock"). The review was conducted to respond to certain comments raised by the Staff of the Securities and Exchange Commission ("SEC") following its periodic review of the Company's Annual Report on Form 10-K for the year ended December 31, 2009.
The warrants under review are:
* Warrants to purchase 7,000,000 shares of common stock issued in May 2009 in connection with a registered equity offering. The warrants expire in May 2014 and are exercisable, subject to an aggregate share ownership limitation, at an exercise price of $1.15 per share; and
* Warrants to purchase 13,750,000 shares of our common stock issued in February 2010 in connection with a registered equity offering. The warrants expire in February 2015 and are exercisable, subject to an aggregate share ownership limitation, at a price of $0.85 per share.
The Company has historically accounted for its warrants, which prior to May 2009 were issued in private transactions, as equity instruments. The Company's warrants generally provide that, in the event the related registration statement or an exemption from registration is not available for the issuance or resale of the warrant shares, the holder may exercise the warrant on a cashless basis. However, notwithstanding the availability of cashless exercise, ASC 815, as interpreted, appears to establish a presumption that, in the absence of express language to the contrary, registered warrants may be subject to net cash settlement, as it is not within the absolute control of the Company to provide freely-tradable shares in all circumstances. After extensive discussion, the Company's management, Ernst & Young, and the Company's outside legal advisors concluded that, although the interpretation and applicability of ASC 815 as it relates to registered warrants is complex and subject to varying interpretations, it should be applied based on a strict reading of the authoritative literature without respect to any evaluation of remoteness or probability.
Applying such a strict reading, the Audit Committee, together with management and in consultation with Ernst & Young and the Company's outside legal advisors, determined that, notwithstanding the highly–remote and theoretical possibility of net cash settlement, the warrants identified above should have been recorded as liabilities, measured at fair value on the date of issue, with changes in the fair values recognized in the Company's quarterly statement of operations in its quarterly financial reports. Accordingly, the Audit Committee has also concluded on November 8, 2010 that the Company's previously-filed consolidated financial statements for the fiscal year ended December 31, 2009 on Form 10-K; Ernst & Young's reports on the financial statements and the effectiveness of internal control over financial reporting for the fiscal year ended December 31, 2009; each of the consolidated financial statements included in the Company's Quarterly Reports on Form 10-Q for the periods ended June 30, 2009, September 30, 2009, March 31, 2010 and June 30, 2010; and all related earnings releases and similar communications issued by the Company with respect to the foregoing, should no longer be relied upon. The Company's management and the Audit Committee are assessing the effect of the pending restatements on the Company's internal control over financial reporting and its disclosure controls and procedures.
On or before November 15, 2010, the Company anticipates filing an amended Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and amended Quarterly Reports on Form 10-Q for the quarterly periods ended March 31, 2010 and June 30, 2010, each with restated financial statements reflecting the reclassification of the warrants identified above, together with the Quarterly Report on Form 10-Q for the period ended September 30, 2010. The Company does not expect to amend its previously-filed Quarterly Reports on Form 10-Q for the periods ended June 30, 2009 and September 30, 2009.
The restatements that are being implemented will reflect the reclassification of the warrants from equity to a liability in an amount equal to the fair value of the warrants, as of the dates of issuance, calculated using the Black Scholes option pricing model. The restatements will have no impact on amounts previously reported for Assets; Revenues; Operating Expenses; Cash Flows; Loans, Equipment Loan and Accounts Payables; and Contractual Obligations. The restatements will have no effect on the Company's development programs, including Surfaxin, anticipated development milestones, or business strategy.
Readers are referred to, and encouraged to read in their entirety, the Forms 8-K regarding the matters referred to herein, including any exhibits attached thereto, and the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 to be filed with the Securities and Exchange Commission, which includes further detail on above-referenced transactions and the Company's business plans and operations, financial condition and results of operations.
Conference Call Details
Discovery Labs will hold a conference call on Tuesday November 9, 2010 at 10:00 AM EST to further discuss the foregoing. The call in number is 866-332-5218. The international call in number is 706-679-3237. This audio webcast will be available through a live broadcast on the Internet at http://us.meeting-stream.com/discoverylabs_110910 and www.discoverylabs.com. The replay number to hear the conference call is 800-642-1687 or 706-645-9291. The passcode is 22279770.
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 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 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 Capital Market listing requirements prior to the expiration of the additional grace period currently in effect, which could 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.
CONTACT: Linnden Communications
Media relations:
Michelle Linn
508-362-3087
Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
Discovery Laboratories
Apricus Bio's VP of Investor Relations, Edward Cox, Interviewed by Steve Crowley's American Scene
http://www.finanznachrichten.de/nachrichten-2010-11/18497861-apricus-bio-s-vp-of-investor-relations-edward-cox-interviewed-by-steve-crowley-s-american-scene-004.htm
Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq: APRI) today announced today that Edward Cox, Vice President of Investor Relations, was recently interviewed by "Steve Crowley's American Scene," a radio broadcast on the Money Channel produced by IRNUSA News. To access the interview, go to: http://www.youtube.com/user/Apricusbio#p/u/0/cbybcr3IAmg
During the interview, Mr. Cox highlighted Apricus Bio's latest achievements, including the recent securities offering which raised over $9.3 million in gross proceeds, intended for product and technology development, and general corporate purposes. According to Mr. Cox, the offering put Apricus Bio in a strong operating position to execute on its growth strategy, including the out-licensing of its NexACT® technology and partnering of Apricus Bio's 13 product candidates, which are in various stages of pre-clinical and clinical development.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 successfully execute on its business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Contacts:
Apricus Biosciences
Edward Cox, 858-848-4249
V.P. Investor Relations
ecox@apricusbio.com
or
Rx Communications Group, LLC
Paula Schwartz, 917-322-2216
pschwartz@rxir.com
© 2010 Business Wire
Cardium Reports on Third Quarter 2010 Financial Results and Recent Developments
SAN DIEGO, Nov. 9, 2010 /PRNewswire-FirstCall/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported highlights and financial results for its third quarter ended September 30, 2010. Highlights of the quarter and recent developments include:
-- Website and market launch of Cardium's MedPodium product line, a portfolio of premium science-based, easy to use medicinals, neurologics, metabolics, nutraceuticals and aesthetics designed to promote and manage personal health. The MedPodium product portfolio, which initially includes seven podiatry-focused advanced skin care products to promote foot health and comfort, are currently available MedPodium's web-based boutique at http://www.medpodium.com/. In the future, the Company plans to expand distribution and sell certain MedPodium products through various select distributors or retailers in the United States.
-- Planned addition of the new weight management product, Appexium(TM), to Cardium's MedPodium(TM) product line. Appexium, a plant-derived non-prescription dietary supplement to be marketed under the trade name Linee(TM), is designed to facilitate healthy weight management. Linee is expected to be launched and available for purchase at the MedPodium web boutique in mid-November.
-- Exclusive commercial development rights for certain novel supramacromolecular polymer complexes, which represent a potentially novel and practical way to integrate the use of Nitric Oxide into a variety of wound healing products, and that appear to be compatible with Cardium's Excellagen formulated collagen topical gel wound care dressing, which is currently the subject of a pending FDA 510(k) clearance application for marketing and sales in the United States.
-- New preclinical research findings demonstrating that the Company's Excellagen collagen wound management gel product candidate activates platelet release of platelet-derived growth factor (PDGF) locally at the wound site. This growth factor has been shown to play an essential role in the wound healing process.
-- Cash grant award of approximately $245,000 under the U.S. Government's Qualifying Therapeutic Discovery Project ("QTDP") program to further the Company's Generx clinical development program. The funds are immediately available and the Company will recognize the full award that was authorized on October 29, 2010 as revenue during the fourth quarter 2010.
-- Presentations at two investor conferences - the Rodman&Renshaw 12th Annual Healthcare Investment Conference and the 10th Annual Biotech in Europe Investor Forum, Zurich. In addition, Cardium will be presenting at the LifeTech Capital Miami Medical Investors Conference on November 12, 2010 at 2:00 p.m. Eastern in Miami. Although this presentation will not be webcast, investors can access the Company's presentation slides now available at Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations .
-- Continued identification and evaluation of innovative and capital-efficient product opportunities and strategic partnership opportunities for the Company's current product candidates as they are advanced and corresponding valuations are established. Financial Report
For the third quarter ended September 30, 2010, the Company reported a net loss of $3.4 million, or $(0.04) per share, compared to net income of $4.9 million, or $.10 per share for the same period in 2009. For the nine months ended September 30, 2010, net loss was $5.2 million, or $(0.07) per share, compared to a net loss of $20.1 million, or $(0.44) per share, for the same nine-month period in 2009. Financial results for the three months ended September 30, 2009 included a $6.4 million gain on the sale of our InnerCool business unit. For the nine months ended September 30, 2009 the decrease in net loss was due to a $5.9 million decrease in interest expense related to notes that were paid off in the fourth quarter of 2009 as well as a $12.5 million positive adjustment to the non-cash change in fair market value of certain common stock warrants we recorded as derivative liabilities upon the adoption of ASC 815 (formerly Emerging Issues Task Force EITF 07-05), recorded in "Change in Fair Value of Derivative Liabilities" when comparing year over year. Research and development costs for the three months ended September 30, 2010 totaled $0.7 million and general and administrative expenses were $1.1 million, compared to $1.2 million and $1.3 million, respectively, for the same period last year. As of September 30, 2010, the Company had a total of $9.1 million in cash ($7.7 million in cash and $1.4 million in restricted cash) compared to total cash of $4.8 million ($3.4 million in cash and $1.4 million in restricted cash) for the same period last year.
As of November 5, 2010, approximately 78.6 million shares of Cardium's common stock were outstanding.
http://www.finanznachrichten.de/nachrichten-2010-11/18495064-cardium-reports-on-third-quarter-2010-financial-results-and-recent-developments-008.htm
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(HGSI) Human Genome: Benlysta FDA Panel Preview
http://www.thestreet.com/story/10914942/1/human-genome-benlysta-fda-panel-preview.html?puc=_tscrss
Investor Presentation – LifeTech Capital Miami Medical Investors Conference
11/12/10
http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9Mzk2ODc4fENoaWxkSUQ9NDExMTQyfFR5cGU9MQ==&t=1
Cardium to Present at the LifeTech Capital Miami Medical Investors Conference
http://www.finanznachrichten.de/nachrichten-2010-11/18480362-cardium-to-present-at-the-lifetech-capital-miami-medical-investors-conference-008.htm
SAN DIEGO, Nov. 8, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) announced today that Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer will present at the LifeTech Capital Miami Medical Investors Conference on November 12, 2010 at 2:00 p.m. Eastern. The conference will take place at the JW Marriott Marquis in Miami. Although this presentation will not be webcast, investors can access the Company's presentation slides now available at Cardium's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations .
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO) (Logo: http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO) About Cardium
Cardium is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses that have the potential to address significant unmet medical needs and definable pathways to commercialization, partnering and other economic monetizations. Cardium's investment portfolio includes the Tissue Repair Company and Cardium Biologics, medical technology companies primarily focused on the development of innovative therapeutic products for wound healing, bone repair, and cardiovascular indications. In July 2009, Cardium completed the sale of its InnerCool Therapies medical device business to Royal Philips Electronics, the first asset monetization from the Company's biomedical investment portfolio. News from Cardium is located at http://www.cardiumthx.com/.
Copyright 2010 Cardium Therapeutics, Inc. All rights reserved. For Terms of Use Privacy Policy, please visit http://www.cardiumthx.com/. Cardium Therapeutics(TM) Generx® and MedPodium(TM) are trademarks of Cardium Therapeutics, Inc.Tissue Repair(TM), Gene Activated Matrix(TM), GAM(TM), Excellagen(TM), Excellarate(TM), Osteorate(TM), Appexium(TM) and Linee(TM) are trademarks of Tissue Repair Company. (Other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
http://www.newscom.com/cgi-bin/prnh/20051018/CARDIUMLOGO
AP Archive: http://photoarchive.ap.org/
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
Therapeutics, Inc., +1-858-436-1018, InvestorRelations@cardiumthx.com
Web Site: http://www.cardiumthx.com/
© 2010 PR Newswire
YRC Worldwide CEO Discusses Q3 2010 Results - Earnings Call Transcript
November 05, 2010
http://seekingalpha.com/article/235092-yrc-worldwide-ceo-discusses-q3-2010-results-earnings-call-transcript?source=feed
Vitaros® - final approval decision expected November 2010
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52848632
Apricus Bio Awarded Three Qualifying Therapeutic Discovery Project Grants
05.11.2010 17:36
http://www.finanznachrichten.de/nachrichten-2010-11/18466234-apricus-bio-awarded-three-qualifying-therapeutic-discovery-project-grants-004.htm
-Federal Grants Further Bolster Company's Cash Reserves-
Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq: APRI) today announced the award of three grants totaling $733,437 under the Qualifying Therapeutic Discovery Project program for PrevOncoTM, RayVaTM and Femprox® which are the Company's development programs in cancer, autoimmune/cardiovascular and female sexual dysfunction, respectively. The credit is a tax benefit for 2010 expenditures awarded to therapeutic discovery projects that show a reasonable potential to result in new therapies that treat areas of unmet medical need or prevent, detect or treat chronic or acute diseases and conditions. Apricus Bio will use the proceeds of the grant funds to continue development of PrevOnco™, RayVa™ and Femprox®.
Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased to be one of the California companies that received more than one grant of the maximum 2010 credit allowed. The U.S. government, relying on the National Institutes of Health peer review process, has acknowledged the scientific merit of our three projects and deemed them worthy of financial support. The receipt of this grant award further bolsters our cash reserves as we continue the development of these three important pipeline product candidates."
PrevOnco, based on a marketed anti-ulcer compound, lansoprazole, is indicated for the treatment of solid tumors. Apricus Bio has filed an Investigational New Drug Application with the U.S. Food&Drug Administration (FDA) to begin testing in humans. Based on input from the FDA, the Company expects to submit before the end of 2010, the Special Protocol Assessment Phase 3 registration protocol for a comparator study against doxorubicin in Nexavar® failure, which would be expected to support the filing of a New Drug Application for marketing approval in the U.S. and Europe, subject to positive data.
RayVa is a topical alprostadil-based treatment for Raynaud's syndrome, and Apricus Bio expects to submit to the FDA the Phase 3 protocol for Special Protocol Assessment for review before the end of 2010. Raynaud's is a disorder in which the fingers or toes (digits) suddenly experience decreased blood circulation, and is characterized by color changes of the skin of the digits upon exposure to cold or emotional stress.
Femprox is an alprostadil-based cream intended for the treatment of female sexual arousal disorder. The Company has completed nine clinical studies to date, including one, 98-patient Phase 2 study in the U.S. and a 400-patient proof-of-concept Phase 2/3 study in China. The Phase 2/3 study results showed that primary efficacy endpoint was statistically significant and patients showed demonstrable improvement in sexual arousal over the course of therapy.
About the Qualifying Therapeutic Discovery Project Tax Credit
The Qualifying Therapeutic Discovery Project tax credit was enacted as part of the Patient Protection and Affordable Care Act of 2010. Allocation of the credit took into consideration which projects showed the greatest potential to create and sustain high-quality, high-paying U.S. jobs and to advance U.S. competitiveness in life, biological and medical sciences.
About Apricus Biosciences
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its proven NexACT® drug delivery technology to enable multi-route administration of new and improved compounds across numerous therapeutic classes. Future growth is expected to be driven primarily through out-licensing of this technology for the development and commercialization of such compounds to pharmaceutical and biotechnology companies, worldwide. Concurrently, the Company is seeking to monetize its existing product pipeline, including compounds from pre-clinical through Phase 3, currently focused on dermatology, sexual dysfunction and cancer. For further information on Apricus Bio and its subsidiaries, visit http://www.apricusbio.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 replicate pre-clinical study results in subsequent human clinical studies, meet projected regulatory timelines, enter into partnership agreements and successfully execute business plans. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K and subsequent quarterly reports filed on Form 10-Q. Copies of these reports are available from the SEC's website or without charge from the Company.
Contacts:
Apricus Biosciences
Edward Cox, V.P. Investor Relations
(858) 848-4249
ecox@apricusbio.com
or
Investor Relations:
Rx Communications Group, LLC
Paula Schwartz
(917) 322-2216
pschwartz@rxir.com
© 2010 Business Wire
Zoom Technologies Launches New Branding Initiatives
Date : 11/05/2010 @ 7:00AM
Source : MarketWire
Stock : Zoom Technologies (ZOOM)
http://ih.advfn.com/p.php?pid=nmona&article=45095951
Zoom Technologies, Inc. (NASDAQ: ZOOM), a leading China based manufacturer of mobile phones and related products, is solidifying its ZOOM brand by acquiring the URL domain name of zoom.com and significant Zoom Telephonics rights to the ZOOM logo and registered trademarks for China, and rebranding its growing and highly popular LEIMONE mobile phones to the ZOOM brand.
Mr. Leo Gu, Chairman and Chief Executive Officer of Zoom Technologies, stated, "We are very excited about our ZOOM brand initiative with our ownership of the URL domain of zoom.com and uniformly branding our mobile phones. We believe Zoom Technologies will benefit from the domain name and trademark rights it has acquired. All new mobile phones manufactured by Zoom Technologies will now be branded ZOOM mobile phones. The transition will have no impact on customers, and we are committed to providing the same quality mobile phones that we have built our reputation on. Since Zoom Technologies' listing on the NASDAQ over a year ago, our LEIMONE mobile phones have evolved significantly into popular 3G models. We feel that our new ZOOM mobile devices will directly reflect our mission and position in the robust China market. We are proud of our continued expansion in the rapidly growing China 3G market and our ability to produce mobile products for top tier Chinese mobile phone companies. Under the ZOOM name, we are confident our mobile phones will continue to enjoy strong growth and continue to be popular with the growing number of young people in China who seek feature-rich, mid-priced and sleek designed mobile phones."
Zoom Technologies acquired all rights to the zoom.com URL domain and significant trademark rights for China from Zoom Telephonics in exchange for 80,000 shares of Zoom Technologies common stock. During a four-month transitional period both companies will share the zoom.com home page, and a single click will transfer the visitor to the home page of either Zoom Technologies or Zoom Telephonics. The companies have agreed to cooperate in order to effect a smooth transition of email addresses.
For areas outside of China, Zoom Technologies has been granted a perpetual, royalty-free license to use Zoom's logo and trademarks for Zoom Technologies' products, services and corporate purposes to the full extent that Zoom Telephonics is able to grant this license given its current trademark position.
About Zoom Technologies, Inc.
Zoom Technologies is a holding company with subsidiaries that engage in the manufacturing, research and development, and sale of electronic and telecommunication products for the latest generation mobile phones, wireless communication circuitry, and related software products. Zoom Technologies' subsidiary, Jiangsu Leimone, owns a majority stake of TCB Digital, which offers highly customized and high quality Electronic Manufacturing Service (EMS) for Original Equipment Manufacturer (OEM) customers as well as its own brand under the brand name of Leimone. The company's products are both exported and sold domestically. For more information about Zoom Technologies please visit Zoom's corporate website at http://www.zoomleimone.com.
Forward-Looking Statements
This information and other statements by the Company in this press release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to, among other items: projections and estimates of earnings, revenues, or other financial items, statements regarding future economic, industry or market conditions or performance. Forward-looking statements are typically identified by words or phrases such as "believe," "expect," "anticipate," "preliminary" and similar expressions. You should not place undue reliance on these forward-looking statements because actual performance or results could differ materially from that anticipated by these forward-looking statements, and such forward-looking statements speak only as of the date they are made, and the Company undertakes no obligation to update or revise any forward-looking statement. If the Company does update any forward-looking statement, no inference should be drawn that the Company will make additional updates with respect to that statement or any other forward-looking statements. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission which are available to the public at www.sec.gov.
Investor Relations Contact:
Cynthia Hiponia
The Blueshirt Group
415-217-4966
Positron Announces Completion of Cardio-Assist™; Set for Early 2011 Deployment
http://www.finanznachrichten.de/nachrichten-2010-11/18450873-positron-announces-completion-of-cardio-assist-set-for-early-2011-deployment-004.htm
Positron Corporation (OTCBB:POSC), a leading molecular imaging company specializing in the field of nuclear cardiology, announced today it has completed development of its proprietary automated compounding and unit dose dispensing device, Cardio-Assist™, which will be installed in coming weeks at a functioning clinical site for final acceptance. The Company expects to commence commercial deployment during the first quarter of 2011.
"Today marks an important milestone for Positron - since acquiring Dose Shield in 2008, we've worked diligently to get this product to market with precision, speed and efficiency. We have successfully delivered on our pharmaceutical projects that have exceeded both internal and external development requirements as well as timing targets which is a true testament to the entire team. With our current product mix, the Attrius® PET scanner, Cardio-Assist™ and our state-of-the-art radiopharmaceutical manufacturing facility, we have positioned Positron to be a unique and true leader in the nuclear cardiology marketplace," said Patrick G. Rooney, chief executive officer of Positron.
Commensurate with the Company's acquisition of Dose Shield in June of 2008, Positron and Dose Shield set a 36-month timeline to reach its goals of developing an automated virtual nuclear pharmacy and a fully functional radiopharmaceutical manufacturing facility. These developmental milestones mark the completion of the Company's objectives; approximately 7 months ahead of schedule. Mr. Zehner who joined the Company in the acquisition of Dose Shield has successfully executed the Company's objectives per terms of his employment agreement; as such he has resigned as Positron's COO and will continue to serve the Company as a pharmaceutical consultant.
About Positron: Positron is a molecular imaging company focused on Nuclear Cardiology. Positron utilizes its proprietary product line to provide unique solutions to the Nuclear Medicine community ranging from imaging to radiopharmaceutical distribution. Positron products include: the Attrius®, a PET imaging device; the Pulse®, a SPECT imaging device; the Nuclear Pharm-Assist®, an automated radiopharmaceutical distribution device; and the Tech-Assist™, a radiopharmaceutical injection shield. More information about Positron is available at www.positron.com.
Forward Looking Statements: Statements in this document contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on many assumptions and estimates and are not guarantees of future performance and may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Positron Corporation to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Positron assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation those set forth as "Risk Factors" in our filings with the Securities and Exchange Commission.
For further information please contact Positron Corporation at (317)576-0183.
Contacts:
Positron Corporation
Patrick Rooney, (317)576-0183
© 2010 Business Wire