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Discovery Labs Receives U.S. Patent Covering Pulmonary Surfactant and Protease Inhibitor Combination Products for Pulmonary Conditions Treatments
Date : 01/19/2011 @ 7:30AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCOD)
http://ih.advfn.com/p.php?pid=nmona&article=46081585&symbol=DSCOD
Discovery Laboratories, Inc. (Nasdaq:DSCOD) has been notified that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Number 7,863,241 titled "Compositions for Treatment and Prevention of Pulmonary Conditions." The patent provides broad coverage for compositions that employ a combination of certain pulmonary surfactants with a broad array of protease inhibitors, administered as either a liquid or aerosol, for treating pulmonary inflammation. Dr. Charles Cochrane, the original inventor of Discovery Labs' proprietary surfactant technology and co-founder of The Scripps Research Institute, is the inventor of this newly-issued patent. The Scripps Research Institute has granted Discovery Labs exclusive licensing rights for this patent. The patent term expires in 2023.
Dr. Thomas F. Miller, Chief Operating Officer of Discovery Labs, commented, "We are very pleased with the USPTO's decision to grant our first KL4 surfactant combination product patent. Combining certain protease inhibitors with KL4 surfactant may facilitate more flexible delivery and meaningfully improve the clinical benefit to patients with respiratory disorders. We plan to continue strengthening our patent portfolio around KL4 surfactant and our proprietary aerosol technologies to address a wide range of respiratory disorders."
Several protease inhibitors are approved for use in serious pulmonary conditions. However, while inhaled protease inhibitors are currently under development, no such therapy is believed to be approved for use in aerosolized form for direct delivery to the lung. Discovery's KL4 surfactant may function as an advantaged pulmonary drug delivery system given its novel liposomal structure, completely synthetic composition, and ability to be delivered as an aerosol. Additionally, the immune modulatory properties of KL4 surfactant may complement the pharmacologic activity of protease inhibitors.
Pulmonary inflammation is associated with conditions such as chronic obstructive pulmonary disease (COPD), acute and chronic bronchitis, emphysema, asthma, cystic fibrosis, acute lung injury, and neonatal respiratory disorders.
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.
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, including those related to Discovery Labs' pre-clinical and clinical research and development activities, are 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. Except as otherwise required by law, Discovery Labs undertakes no obligation to update or revise any forward-looking statements.
CONTACT: John G. Cooper, President and Chief Financial Officer
215-488-9490
Discovery Laboratories
Cardium Announces Plans to Introduce Cerex(TM) to Support Cognitive Performance Expanding the MedPodium(TM) Modern Lifestyle Product Line
http://www.finanznachrichten.de/nachrichten-2011-01/19106050-cardium-announces-plans-to-introduce-cerex-tm-to-support-cognitive-performance-expanding-the-medpodium-tm-modern-lifestyle-product-line-008.htm
SAN DIEGO, Jan. 18, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced plans to introduce non-prescription Cerex(TM) (Panax quinquefolius) easy use 200 mg capsules, a plant-based dietary supplement to support cognitive performance for healthy people of all ages.* Cardium is planning to begin marketing Cerex in the first quarter 2011. Cardium launched its MedPodium modern lifestyle brand in early November and the addition of Cerex represents another important step toward broadening MedPodium to address neuro-cognitive function.
(Photo: http://photos.prnewswire.com/prnh/20110118/LA31226) (Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
Cerex(TM) is a ginsenoside-based nutritional supplement intended to support cognitive functions including focus, memory, and attention. Based on data from a recently completed clinical study published in Psychopharmacology 212(3): 345-56 (2010), taking the primary ingredient of a Cerex 200 mg capsule once or twice (approximately six hours following the initial dose) was reported to increase attention, focus and mental alertness.* The key ingredient of Cerex is CereBoost®, a bio-available, standardized, well characterized, North American-sourced ginsenoside, which was developed and clinically-studied by Naturex®, a French-based international manufacturer of natural, specialty ingredients for the food&beverage, nutrition&health and personal care industries. CereBoost® received the dietary supplement industry's 2010 NutrAward for Best New Ingredient. Cerex is expected to be the first CereBoost product available for sale in the U.S.
"Consistent with our strategy, we continue to identify and evaluate many new and established key ingredients and formulations from around the world for Cardium's MedPodium modern lifestyle product portfolio. We are highly selective and require that products in our portfolio be substantiated with scientific data to support an understanding of the mechanism of action, have well-defined manufacturing standardizations, and allow for easy to use formulation and dosage. In short, MedPodium's goal is to design and formulate a portfolio of best-in-class products using innovative and well-tested key ingredients designed to enhance health and wellness concerns for our consumers," stated Christopher J. Reinhard, Cardium's Chairman and Chief Executive Officer.
Continuing, Reinhard noted that, "We recently announced the market launch of our new weight management product, Linee (Appexium 150 mg), designed to help manage appetite and hunger, and Cerex now provides us with an opportunity to address the important and expanding cognitive performance market sector. We plan to initially market Cerex to college students, working professionals and seniors who seek a safe and easy use dietary supplement intended to support cognitive function. In view of widespread press reports about the extensive off-label use of stimulant-based, addictive-prone ADD/ADHD drugs on college campuses throughout the U.S., we believe that MedPodium's Cerex could offer a safe and natural alternative."
About Cerex
Cerex(TM) is a ginsenosides-based dietary supplement formulated to include a standardized powdered extract of North American-sourced Panax quinquefolius root, commonly referred to as American ginseng. This highly characterized plant extract was commercially developed by Naturex® and is standardized to a 10%-12% ginsenoside concentration. As reviewed in detail in the publication cited below, the Panax quinquefolius component of Cerex (200 mg capsule) has recently been evaluated in a randomized, double-blind, placebo-controlled, crossover cognitive assessment clinical study (N=32 healthy young adults), and has been reported to significantly improve cognitive performance using the following computer-based assessments: (i) attention accuracy (p<0.05), (ii) working memory speed (p<0.05), and (iii) working memory capacity (p<0.05) over a six hour period immediately following administration of a 200 mg dosage, as compared to placebo (Reference 1, below).* This is considered to be the first clinical study characterizing the use of American ginseng for cognitive health.
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 healthy lifestyle product platform. The Company's lead product candidates include Excellagen(TM) topical gel for wound care management, and Generx® DNA-based angiogenic biologic for patients 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 Cerex and Linee can be effectively commercialized as a nutritional supplements to support cognitive function and to promote weight management, respectively, 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 cognitive function; 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) Scholey A, Ossoukhova A, Owen L, Ibarra A, Pipingas A, He K, Roller M, Stough C. (2010). Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study. Psychopharmacology. 212(3): 345-56.
*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 2011 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), Linee(TM) and Cerex(TM) are trademarks of Tissue Repair Company.
(Naturex®, Cereboost® and other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
http://photos.prnewswire.com/prnh/20110118/LA31226
PRN Photo Desk, photodesk@prnewswire.com
Cardium Therapeutics
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/
© 2011 PR Newswire
...a long way to go
"Orion MLK Contest Pick" APRI
FORM 10-Q FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2010
http://www.faqs.org/sec-filings/110114/TARA-GOLD-RESOURCES-CORP_10-Q/
Apricus Bio Announces Expansion of Patent Portfolio for Topical Cream to Treat Premature Ejaculation With Issuance of Japanese P
Date : 01/14/2011 @ 12:03PM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=46029054
Apricus Biosciences, Inc., ("Apricus Bio") (Nasdaq:APRI) today announced that the Japanese Patent Office recently issued a Decision to Grant a Patent for the Company's development of a topical cream that utilizes vasoactive prostaglandin E to treat premature ejaculation ("PE"), entitled, "Compositions and Methods for the Treatment of Premature Ejaculation." This patent, when issued, will provide Japanese patent protection until March 2024, and is one in a series of issued patents and pending applications that Apricus Bio owns in the male sexual dysfunction field utilizing its proprietary NexACT® technology, which includes its Vitaros® product to treat erectile dysfunction ("ED"), among others in research and development.
Commenting on today's news, Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio, stated, "We are very pleased with this patent allowance in Japan for the use of vasoactive prostaglandin E to treat PE, which includes the same pharmaceutical composition as Vitaros®, combined with a local anesthetic. While we are aggressively pursuing licensing applications for Vitaros®, we are also developing related products utilizing our NexACT® technology that may add to the value of our existing portfolio of drugs to treat sexual dysfunction. We are very excited about the issuance of this newest patent and we are actively seeking patent protection for this PE application in the U.S. and in other countries."
Currently approved by Health Canada for marketing and sales for patients with ED, Vitaros®, a topical cream, incorporates alprostadil, a well-recognized vasodilator currently marketed by other companies as an injectable product or an intra-urethral insert. Vitaros® has been studied in over 3,300 patients, including difficult to treat populations such as those with diabetes, cardiac problems, sildenafil (Viagra®) failures and post prostatectomy patients. Vitaros® has demonstrated clinical efficacy and an 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, Inc.
Apricus Bio is currently studying the use of vasoactive prostaglandin E, combined with and without local anesthetics, to develop a topical cream to treat premature ejaculation. The Company has completed three clinical studies to date on this application, including two single-blind studies and one double-blind study.
The Company's PE patent portfolio currently consists of three issued patents (Australia, Singapore and soon-to- be Japan) and nine pending applications (the US, Canada, Europe, Mexico, Brazil, China, Hong Kong, South Korea and Israel).
According to Datamonitor 2010, "Premature ejaculation is a commonly yet poorly understood and defined male condition. Prevalence estimates vary greatly from 4% to 29% as stated by a study done by Simons and Carey (2001), according to the different definitions used. The disorder is currently severely undertreated and off-label prescription of selective serontonin reuptake inhibitors("SSRIs") is the most common treatment pathway in the seven major markets."
About Apricus Biosciences, Inc.
Backed by NexMed, USA and Bio-Quant, Inc., its revenue generating CRO business, Apricus Bio has leveraged the flexibility of its clinically-validated 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.
Apricus Bio's Forward-Looking Statement Safe Harbor
Statements under the Private Securities Litigation Reform Act, as amended: 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 obtain and/or enforce patent coverage in major markets, to develop products from its patented technology and to successfully enter into partnership agreements for its product candidates, its Vitaros® product and its NexACT® platform technology. 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, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
CONTACT: Apricus Biosciences, Inc.
Edward Cox,
VP, Investor Relations & Corporate Development
(858) 848-4249
ecox@apricusbio.com
Apricus Bio Investor Relations
Paula Schwartz
Rx Communications Group, LLC
(917) 322-2216
pschwartz@rxir.com
Discovery Labs Provides Update Regarding Its Program for Surfaxin(R) U.S. Marketing Authorization
Date : 01/10/2011 @ 7:30AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCOD)
http://ih.advfn.com/p.php?pid=nmona&article=45946799&symbol=DSCOD
Discovery Laboratories, Inc. (Nasdaq:DSCOD), a biotechnology company developing its novel, synthetic, peptide-containing surfactant, is providing an update regarding its efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization of Surfaxin® for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery Labs has had multiple interactions with the FDA regarding various aspects of the final validation of an important quality control release and stability test for Surfaxin, the fetal rabbit biological activity test (BAT). In response to a proposal submitted by Discovery Labs, the FDA has recently provided detailed, written direction regarding the verification of certain parameters related to final BAT validation. The FDA indicated that several aspects of Discovery Labs' proposed approach to the BAT validation are reasonable; however, with respect to certain parameters, the FDA is requesting additional data to further support ultimate determination of BAT validation.
W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs commented, "We have made considerable progress towards the filing of a Surfaxin Complete Response. The work that we originally proposed to the FDA relating to the comprehensive preclinical program has been completed. We have generated data that demonstrate a meaningful reduction in variability in the optimized BAT and have conducted supportive side-by-side studies with the well-established pre-term lamb model of RDS. We appreciate the FDA's willingness to provide guidance and, based on our preliminary assessment, believe that we could generate the additional data and be in a position to file a Surfaxin Complete Response by early third quarter 2011."
Discovery Labs has conducted a comprehensive pre-clinical program employing an optimized BAT in a series of prospectively-designed, side-by-side preclinical studies with the well-established preterm lamb model of RDS. Discovery Labs engaged in several interactions with the FDA intended to ensure that the comprehensive preclinical program would satisfy the FDA. At the FDA's suggestion, Discovery Labs submitted a proposal seeking clarification regarding specific and detailed aspects of final BAT validation. To address certain technical criteria relating to final BAT validation, the FDA's recent correspondence advises Discovery Labs to increase the sample size of a specific data set by testing additional Surfaxin batches. Discovery Labs currently has data from batches that have already been manufactured and, to be responsive to the FDA's advice, anticipates manufacturing additional batches in January and February of this year.
Later this month, Discovery Labs expects to provide to the public a detailed overview of its program and anticipates holding a conference call.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements relating, among other things, to Discovery Labs' understanding of the recently-received written guidance from the FDA and the remaining questions identified in the FDA's April 2009 Complete Response Letter that must be addressed to gain FDA approval of Surfaxin. Although Discovery Labs currently believes that it may still succeed in submitting a Complete Response and gaining approval of its NDA for Surfaxin for the prevention of RDS in premature infants, anticipated activities will require that Discovery Labs raise significant amounts of additional capital. Discovery Labs has initiated activities relating to this most recent FDA communication and anticipates potential further interactions with the FDA in advance of filing a Complete Response. Such potential 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. In addition, these activities and the ultimate outcomes remain subject to a variety of risks and uncertainties that could cause actual results to be materially different. These risks and uncertainties include, but are not limited to, risks that (i) the FDA may not approve Surfaxin or may subject the marketing of Surfaxin to onerous requirements that significantly impair marketing activities; (ii) Discovery Labs may be unable to complete the manufacture of additional Surfaxin batches within the time frame set forth above, (iii) Discovery Labs may identify unforeseen problems that have not yet been discovered or the FDA could in the future impose additional requirements to gain approval of Surfaxin; and (iv) Discovery Labs may be unable to raise sufficient additional capital, through financings, strategic collaborations, or otherwise. Any failure to satisfy the issues raised by the FDA, in the Complete Response letter or in related discussions, could significantly delay, or preclude outright, gaining approval of Surfaxin, which could potentially delay or prevent the approval of Discovery Labs' other products.
Surfaxin is an investigational drug product and is not approved by the FDA or any other world health regulatory authority for use in humans. If approved, Surfaxin would become the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
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, including those related to the Company's comprehensive non-clinical program, development and manufacturing activities and related regulatory efforts, are 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: John G. Cooper, President and Chief Financial Officer
215-488-9490
Cardium to Present at OneMedForum San Francisco 2011 Conference
http://www.finanznachrichten.de/nachrichten-2011-01/19005913-cardium-to-present-at-onemedforum-san-francisco-2011-conference-008.htm
SAN DIEGO, Jan. 6, 2011 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today announced today that it is scheduled to present at the OneMedForum Finance Conference for Emerging Healthcare and Life Sciences Companies on Tuesday, January 11, 2011 at 3:00 p.m. (PT) at the Sir Francis Drake Hotel in San Francisco, CA. The slide presentation will be available at the company's website at http://phx.corporate-ir.net/phoenix.zhtml?c=77949&p=irol-presentations.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
OneMedForum takes place January 11-13, 2011 in San Francisco, CA during the world's largest gathering of healthcare financiers and executives. The Forum will feature presentations by over 100 of the world's most promising emerging life science public and private companies. In 2010, over 1,000 investors participated in the conference. To learn more about the forum, visit http://www.onemedplace.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 healthy lifestyle product platform. The Company's lead product candidates include Excellagen(TM) topical gel for wound care management, and Generx® DNA-based angiogenic biologic for patients 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 and in the company's presentation 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 company can successfully acquire and develop new and innovative biomedical product opportunities having the potential to address significant unmet medical needs or definable pathways to commercialization, partnering and other economic monetizations, that results observed in one study or using one type of product or procedure will be replicated in subsequent studies or in studies using newly-developed products or procedures, that planned product development efforts and clinical studies can be performed in an efficient and effective manner, that regulatory approvals can be obtained in a timely manner or at all, that partnering, distribution or other commercialization efforts can be achieved, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, 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 results or trends observed in one clinical study will be reproduced in subsequent studies, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. Actual results may also differ substantially from those described in or contemplated by this press release and in the company's presentation 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, testing and marketing of therapeutic hypothermia devices and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new devices and systems and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, 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 2011 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
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/
© 2011 PR Newswire
working closely with the U.S. Food and Drug Administration to evaluate our potential next steps relating to patent foramen ovale (PFO) treatment for the stroke and transient ischemic attack (TIA) indications.
http://ih.advfn.com/p.php?pid=nmona&article=45903874
!! Kabooom !!
NMT Medical Announces New $2 Million Credit Facility
Date : 01/06/2011 @ 7:30AM
Source : MarketWire
Stock : NMT Medical (NMTI)
http://ih.advfn.com/p.php?pid=nmona&article=45903874
NMT Medical, Inc. (NASDAQ: NMTI) today announced that it has entered into a credit agreement with LSQ Funding Group, L.C., a Florida-based firm that specializes in providing financing to small- and medium-sized businesses.
The asset-based credit facility provides for borrowings up to $2 million for working capital requirements and other general corporate purposes. The credit facility has a one-year term and is subject to a borrowing base calculated as a percentage of domestic accounts receivable that are pledged as collateral against the loan.
Richard E. Davis, NMT's Chairman, President and Chief Executive Officer, said, "This non-equity based credit facility, which replaces the credit arrangement with Silicon Valley Bank that we recently terminated, provides NMT with the necessary working capital required to fund its ongoing operations. We continue to tightly manage our expenses while working closely with the U.S. Food and Drug Administration to evaluate our potential next steps relating to patent foramen ovale (PFO) treatment for the stroke and transient ischemic attack (TIA) indications. In addition, we are continuing to evaluate all strategic options."
About NMT Medical, Inc.
NMT Medical is an advanced medical technology company that designs, develops, manufactures and markets proprietary implant technologies that allow interventional cardiologists to treat structural heart disease through minimally invasive, catheter-based procedures. NMT is currently investigating the potential connection between a common heart defect that allows a right-to-left shunt or flow of blood through a defect like a patent foramen ovale (PFO) and brain attacks such as embolic stroke, transient ischemic attacks (TIAs) and migraine headaches. A common right-to-left shunt can allow venous blood, unfiltered and unmanaged by the lungs, to enter the arterial circulation of the brain, possibly triggering a cerebral event or brain attack. More than 34,000 PFOs have been treated globally with NMT's minimally invasive, catheter-based implant technology.
For more information about NMT Medical, please visit www.nmtmedical.com.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including those relating to the Company's cash position and next steps relating to patent foramen ovale (PFO) treatment for the stroke and transient ischemic attack (TIA) indications, involve known and unknown risks, uncertainties or other factors that may cause actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed under the heading "Risk Factors" included in the Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's Annual Report on Form 10-K for the year ended December 31, 2009, Quarterly Report on Form 10-Q for the quarter ended September 30, 2010, and subsequent filings with the U.S. Securities and Exchange Commission.
Contact:
Richard E. Davis
Chief Executive Officer
NMT Medical, Inc.
(617) 737-0930
$ 4.00
Pipeline Overview
http://www.discoverylabs.com/poverview.php
Discovery Labs is developing its novel, fully synthetic KL4 Surfactant platform with the intent to create a completely new therapeutic approach for the treatment of respiratory disease.
Neonatology
Product introduction begins with anticipated US FDA approval of SURFAXIN® (lucinactant), a liquid instillate formulation of KL4 Surfactant, for Respiratory Distress Syndrome (RDS) in premature infants.
Discovery Labs is developing multiple product solutions for RDS, supporting KL4 Surfactant delivery through a variety of dosage forms, including SURFAXIN LSâ„¢, a lyophilized formulation of KL4 Surfactant as well as AEROSURF®, aerosolized KL4 Surfactant. AEROSURF® represents a transformational approach toward neonatal respiratory critical care by potentially reducing or eliminating complications associated with mechanical ventilation.
Additional Respiratory Applications
Discovery Labs is also advancing KL4 Surfactant development in other respiratory disease areas. Key areas of interest include Mucociliary Clearance Dysfunction, a condition which is common to many respiratory diseases; Respiratory Critical Care Spectrum disorders, which include Acute Respiratory Failure (ARF), Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS); and the use of our KL4 Surfactant as an aerosol liposomal system enabling a novel Drug Delivery mechanism for complex pharmaceutical compounds.
Apricus Biosciences and Elis Pharma Sign License Agreement for Vitaros(R) in the Gulf and Part of the Middle East
Date : 01/04/2011 @ 10:13AM
Source : GlobeNewswire Inc.
Stock : Apricus Biosciences, Inc. (APRI)
http://ih.advfn.com/p.php?pid=nmona&article=45866664&symbol=APRI
Apricus Biosciences, Inc. ("Apricus Bio") (Nasdaq:APRI) and Elis Pharmaceuticals ("Elis"), announced today that the two companies have entered into a licensing agreement granting Elis the exclusive rights to market Apricus Bio's new drug for erectile dysfunction, Vitaros®, in the Gulf and part of the Middle East. "This new agreement is the next step in our strategy of seeking to partner Vitaros in more than 100 countries around the world," said Dr. Bassam Damaj, President and Chief Executive Officer of Apricus Bio.
The agreement with Elis follows the December 22 announcement of a similar agreement granting Bracco SpA ("Bracco") the exclusive rights to market Vitaros in Italy.(http://www.apricusbio.com/press_12222010.html)
The drug was approved by Health Canada in November as the first topical treatment for erectile dysfunction ("ED") for marketing in Canada. This validation will also make it possible to register the drug in other countries that recognize Canadian approval. The application for approval to market Vitaros in the territory licensed to Elis is scheduled to be filed in the first half of 2011.
Under the terms of the agreement, Elis has exclusive rights in The Gulf Countries and part of the Middle East (including, Lebanon, Syria, Jordan, Iraq and Yemen) to commercialize and market Vitaros. Apricus Bio is entitled to receive up to $2.1 million in payments for signing, regulatory and sales milestones. Further, Apricus Bio will receive tiered double digit royalties based on Elis's sales of the product. "We are delighted to reach another major milestone in the history of this product," said Dr. Damaj. "This is another partnership in a series of commercialization agreements which we plan to execute for Vitaros. With their proven success in building new markets, Elis is a great partner for launching this product in The Gulf Countries and part of the Middle East."
"This exciting collaboration allows Elis to expand into a complementary therapeutic area utilizing its proven sales and marketing expertise," said Rashed Assouma, Chief Executive Officer of Elis. "We believe that Vitaros has the potential to be an important new therapy for ED in our region."
About the ED Market
According to IMS data, the ED market in The Gulf Countries and part of the Middle East in 2010 (MAT Q3) was estimated to be $103 million (data include Jordan, Kuwait, Lebanon, Saudi Arabia, UAE only, since data are not available for some markets). Despite the availability of today's oral and other therapies, there is still a need for new, safe and effective treatments, especially for those patients who cannot or do not respond well to oral medication.
Vitaros offers potential advantages compared to oral PDE5 drugs like Viagra®, Cialis® and Levitra®. It is applied directly to the penis as a cream, instead of as a pill that is absorbed systemically. The topical application helps to minimize side effects and enables men who cannot take, or do not do well with the existing drugs, to have a patient-friendly alternative.
In addition, Vitaros 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, which directly boosts blood flow, thereby causing an erection.
Alprostadil is currently marketed as an injectable drug or as a pellet 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 and providing a more patient-friendly alternative. In clinical studies, Vitaros worked in patients suffering from mild to severe ED, including men who did not respond to Viagra.
Viagra is a registered trademark of Pfizer, Inc.; Cialis is a registered trademark of Lilly, USA; Levitra, is a registered trademark of Bayer A.G.; Vitaros is a registered trademark of Apricus Bio.
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.
About Elis Pharmaceuticals Limited
Established in the UAE, Elis Pharmaceuticals is one of the region's leading companies dedicated to developing, manufacturing and marketing prescription and generic, pharmaceuticals. The Company markets and distributes products in three main categories: prescription medications, OTC and generics. With over 1000 pharmaceutical products in its portfolio, Elis Pharma is uniquely poised to maximize the market potential of emerging products and is the likely choice for commercializing and marketing any new pharmaceutical products in its territory. The company serves drug wholesalers, distributors of pharmaceuticals, ministries and departments of health; public, private, industry and military hospitals, clinics and healthcare systems and affiliated organizations worldwide. For further information on Elis Pharma and its subsidiaries, visit http://www.elispharmaceuticals.com.
Apricus Bio's 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, timing and success of the commercial launch of Vitaros in The Gulf Countries and part of the Middle East, the ability to receive the potential milestone payments under the license agreement and the ability to execute additional commercialization agreements for other territories. 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.
CONTACT: Apricus Biosciences
Ed Cox, V.P. Investor Relations & Corporate Development
(858) 848-4249
ecox@apricusbio.com
Rx Communications Group, LLC
Apricus Bio Investor Relations:
Paula Schwartz
(917) 322-2216
pschwartz@rxir.com
Elis Pharmaceuticals
Abdul-Khaleq Osman, Public Relations
+9714 2653 844
Pr@elispharmaceuticals.com
Keryx Biopharmaceuticals to Present at 29th Annual J.P. Morgan Healthcare Conference
Date : 01/04/2011 @ 8:30AM
Source : PR Newswire
Stock : Keryx Biopharmaceuticals (MM) (KERX)
http://ih.advfn.com/p.php?pid=nmona&article=45863955&symbol=KERX
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the 29th Annual J.P. Morgan Healthcare Conference, being held January 10-13, 2011 at the Westin St. Francis Hotel in San Francisco. Mr. Bentsur's presentation is scheduled to take place on Tuesday, January 11th, at 4:00 p.m. PST (7:00 p.m. EST).
A live audio webcast of Mr. Bentsur's presentation will be accessible from the Investor Information page of the Company's Website at http://investors.keryx.com. An archived version of the webcast will be available following the conclusion of the live presentation.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 studies is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Keryx is also developing Zerenex (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
SOURCE Keryx Biopharmaceuticals, Inc.
Jiangbo Pharmaceuticals' Hongrui Factory Receives GMP Certificate
http://www.finanznachrichten.de/nachrichten-2011-01/18982487-jiangbo-pharmaceuticals-hongrui-factory-receives-gmp-certificate-008.htm
LAIYANG, China, Jan. 4, 2011 /PRNewswire-Asia-FirstCall/ -- Jiangbo Pharmaceuticals, Inc. ("Jiangbo" or the "Company"), a pharmaceutical company with its principal operations in the People's Republic of China, today announced that its Hongrui factory has been awarded with the Good Manufacturing Practices Certificate for Pharmaceutical Products ("GMP Certificate") by China's State Food and Drug Administration ("SFDA"). The GMP Certificate is valid until the end of 2015. Based on the new GMP Certificate, the Company's Hongrui factory is allowed to manufacture traditional Chinese medicines ("TCMs") in the form of tablet, granule, pill, mixture, syrup, concentrated decoction, and oral intake solution. It is also allowed to produce lactulose concentrate, which is used as a raw material in various medicines.
The Company completed the renovation and upgrade of its Hongrui factory in October 2010. As a result, oral intake solution and lactulose concentrate were newly added to its GMP Certificate. The Company has also re-launched several of the traditional Chinese medicines produced at Honrui, including Laiyang Pear Cough Syrup and Kang Gu Sui Yan Pian (an osteomyelitis treatment tablet).
"We are pleased to have received the GMP Certificate, which has allowed us to re-launch several of the exciting TCMs we obtained in the Hongrui acquisition. We expect the TCMs produced at Hongrui to contribute meaningfully to Jiangbo's revenues and earnings during calendar year 2011," said Mr. Linxian Jin, the Company's Chief Executive Officer.
About Jiangbo Pharmaceuticals, Inc.
Jiangbo Pharmaceuticals is engaged in the research, development, production, marketing and sales of pharmaceutical products in China. The Company's operations are located in Eastern China in an Economic Development Zone in Laiyang City, Shandong Province. Jiangbo produces both western and Chinese herbal-based medical drugs in tablet, capsule, granule, syrup and electuary (sticky syrup) form. For additional information, please visit the Company's website (http://www.jiangbopharma.com/).
Safe Harbor Statement
Certain statements in this press release that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are not guarantees of future performance and are subject to risks and uncertainties that could cause the Company's actual results and financial position to differ materially from those included within the forward-looking statements. Forward-looking statements involve risks and uncertainties, including those relating to the Company's ability to introduce, manufacture and distribute new drugs. Actual results may differ materially from predicted results, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties include, among others, the Company's ability to obtain raw materials needed in manufacturing, the continuing employment of key employees, the failure risks inherent in testing any new drug, the possibility that regulatory approvals may be delayed or become unavailable, patent or licensing concerns that may include litigation, direct competition from other manufacturers, product obsolescence, and risks to the Company's outlook for production at the Hongrui facility. More information about the potential factors that could affect the Company's business and financial results is included in the Company's filings, available via the United States Securities and Exchange Commission.
Contact: Jiangbo Pharmaceuticals, Inc. Ms. Elsa Sung, CFO Phone: +1-954-903-9378 x2 E-mail:elsasung@jiangbo.com http://www.jiangbopharma.com/ CCG Investor Relations Mr. Crocker Coulson, President Phone: +1-646-213-1915 E-mail: crocker.coulson@ccgir.com http://www.ccgirasia.com/
Jiangbo Pharmaceuticals, Inc.
CONTACT: At Jiangbo Pharmaceuticals, Inc., Ms. Elsa Sung, CFO,
+1-954-903-9378 x2, or elsasung@jiangbo.com; or at CCG Investor Relations, Mr.
Crocker Coulson, President, +1-646-213-1915, or crocker.coulson@ccgir.com
Web Site: http://www.jiangbopharma.com/
© 2011 PR Newswire
Registration Statements (SEC - FORM S-3)
01/03/11
http://investors.keryx.com/phoenix.zhtml?c=122201&p=irol-SECText&TEXT=aHR0cDovL2lyLmludC53ZXN0bGF3YnVzaW5lc3MuY29tL2RvY3VtZW50L3YxLzAwMDExNDQyMDQtMTEtMDAwMTkxL3htbA%3d%3d
SmarTrend's Trend Spotter See Continued Upward Momentum on Shares of NMT Medical (NMTI)
Written on Mon, 01/03/2011 - 10:03am
By Chip Brian
http://www.mysmartrend.com/news-briefs/technical-analysis/smartrends-trend-spotter-see-continued-upward-momentum-shares-nmt-med
SmarTrend is monitoring the recent change of momentum in NMT Medical. Please refer to our Company Overview for the results of our proprietary technical indicators that have been scanning shares of NMT Medical in search of a potential trend change.
In the past 52 weeks, shares of NMT Medical have traded between a low of $0.20 and a high of $4.99 and are now at $0.42, which is 109% above that low price.
NMT Medical is currently above its 50-day moving average of $0.28 and should find resistance at its 200-day moving average of $1.43. Look for these moving averages to climb to confirm the company's upward momentum.
In the last five trading sessions, the 50-day MA has fallen 0.56% while the 200-day MA has slid 5.21%.
SmarTrend will continue to scan these moving averages and a number of other proprietary indicators for any shifts in the trajectory of NMT Medical shares.
Chart ( daily / weekly ) >>> LINK back
Quarterly Report (10-Q)
FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2010
http://www.faqs.org/sec-filings/110103/TARA-GOLD-RESOURCES-CORP_10-Q/
...to the board: short-messages are OFFTOPIC
and will be deleted !!
IHUB is not! a BASH or PUSH-board... (like Yahoo)
Discovery Laboratories enters into supply pact with Genzyme
http://www.finanznachrichten.de/nachrichten-2010-12/18951193-brief-discovery-laboratories-enters-into-supply-pact-with-genzyme-020.htm
Dec 29 (Reuters) - Discovery Laboratories Inc:
* Says it and Genzyme Pharmaceuticals llc entered into a supply agreement
* Says Genzyme will provide the co with palmitoyl-oleyl phosphatidylglycerol
* Says the initial term of the agreement is five years
((Bangalore Equities Newsroom; +91 80 4135 5800; within U.S. +1 646 223 8780))
COPYRIGHT
Copyright Thomson Reuters 2010. All rights reserved.
The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
© 2010 AFX News
Cardium Reports Excellagen Matrix Clinical Study Results Accepted for Publication by Peer-Reviewed Journal, and Updates Product Plans
http://www.finanznachrichten.de/nachrichten-2010-12/18940706-cardium-reports-excellagen-matrix-clinical-study-results-accepted-for-publication-by-peer-reviewed-journal-and-updates-product-plans-008.htm
SAN DIEGO, Dec. 28, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) today reported that data from the Company's Matrix Phase 2b clinical study has been accepted for publication in the journal, Wound Repair and Regeneration and provided an update on plans for commercialization of its Excellagen formulated collagen topical wound dressing.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
The clinical paper now accepted for publication is titled, "Formulated Collagen Gel Accelerates Healing Rate Immediately after Application in Patients with Diabetic Neuropathic Foot Ulcers", and was authored by nine investigators who participated in the Matrix study and Cardium researchers and is expected to be published in early 2011. Excellagen formulated collagen topical gel wound care dressing was studied in a controlled, double blind Matrix Phase 2b clinical study of chronic diabetic lower extremity ulcers. Wounds treated with the Excellagen formulated collagen (2.6%) topical gel showed a statistically significant acceleration of wound healing during the first week following a one-time application compared to patients receiving standard of care therapy, a response that was sustained over a 14 day period. The authors suggest that more frequent applications of Cardium's Excellagen product candidate hold promise to significantly improve overall incidence of complete wound closure.
The Company also provided an update with respect to planned commercialization of its Excellagen topical gel wound care dressing, which comprises a specially formulated collagen matrix gel being produced under a supply agreement with Devro Medical Limited, part of Devro PLC, a public limited company registered in Scotland. Certain changes to the manufacturing process for the collagen matrix being prepared at Devro will require modified regulatory submissions under the FDA 510(k) process, which are expected to be filed in first quarter 2011.
About Wound Repair and Regeneration
Wound Repair and Regeneration is the official journal of The Wound Healing Society, The European Tissue Repair Society, The Japanese Society for Wound Healing, and The Australian Wound Management Association. Wound Repair and Regeneration provides extensive international coverage of cellular and molecular biology, connective tissue, and biological mediator studies in the field of tissue repair and regeneration and serves a diverse audience of surgeons, plastic surgeons, dermatologists, biochemists, cell biologists, and others. Additional information about Wound Repair and Regeneration can be found at the following web link: http://onlinelibrary.wiley.com/journal/10.1111/(ISSN)1524-475X.
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 healthy lifestyle product platform. The Company's lead product candidates include Excellagen(TM) topical gel for wound care management, and Generx® DNA-based angiogenic biologic for patients 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 manufacturing changes and modified regulatory submissions will be efficiently and effectively accomplished and that the U.S. Food and Drug Administration will grant marketing clearance of our product candidates; that we or a partner can successfully introduce our products into advanced wound care markets; that results or trends observed in one clinical study or procedure will be reproduced in subsequent studies or procedures; that our product candidates will be perceived as being sufficiently safe and effective to lead to product advancement or partnering; that our product candidates offer the potential for simpler or more cost-effective treatments for physicians and patients than other products that currently are or will be on the market; that FDA or other regulatory clearances or other certifications, or other commercialization efforts will be successful or will effectively enhance our businesses or its perceived value; that our products or product candidates will prove to be sufficiently safe and effective after introduction into a broader patient population; that discussions with potential strategic partners will be successful or that any partner will be able to efficiently and effectively commercialize our products in U.S. or international markets; 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 biologics and other therapeutic products and devices, 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.
(Other trademarks belong to their respective owners)
Photo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO
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
Discovery Labs Announces Reverse Stock Split
Date : 12/27/2010 @ 5:00PM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45796169&symbol=DSCO
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that it has filed a Certificate of Amendment to its Amended and Restated Certificate of Incorporation (the "Amendment") to effect a 1-for-15 share consolidation, or reverse stock split ("reverse split"), effective at 12:01 a.m. on December 28, 2010 (the "Effective Time"). In addition, the Amendment reduces the number of shares of common stock, par value $0.001 per share, authorized under the Certificate of Incorporation from 380 million to 50 million. Because the Amendment does not reduce the number of authorized shares of common stock in the same proportion as the reverse split, the effect of the Amendment is to increase the number of shares of common stock available for issuance relative to the number of shares issued and outstanding. The stockholders of Discovery Labs approved proposals authorizing the Board of Directors, in its discretion, to implement the reverse split and reduce the number of authorized shares of common stock at the Annual Meeting of Stockholders held on December 21, 2010.
The Board of Directors of Discovery Labs has determined to implement the reverse split at this time to enable the market price per-share of its common stock to close above $1.00, which is a continued listing requirement of The NASDAQ Capital Market® ("Nasdaq"). On November 30, 2010, Discovery Labs received a Staff Determination letter from Nasdaq indicating that it had not established compliance with Nasdaq Listing Rule 5550(a)(2) ("Minimum Bid Price Rule") because its common stock had not closed above $1.00 per share over a period of 10 consecutive business days ending on or prior to November 29, 2010, and that its stock is subject to delisting. Discovery Labs has requested a hearing with Nasdaq to review the Staff Determination and believes that implementation of the reverse split will support its continued listing on Nasdaq. Discovery Labs believes that continued listing on Nasdaq, combined with the increase in shares available for issuance, will enhance its ability to secure necessary capital from potential strategic partners and prospective investors to achieve its key business objectives, including potentially gaining U.S. Food and Drug Administration (FDA) approval for its lead product, Surfaxin®, for the prevention of respiratory distress syndrome (RDS) in premature infants.
Details of the Reverse Split
At the Effective Time, immediately and without further action by Discovery Labs' stockholders, every 15 shares of Discovery Labs' pre-split common stock, par value $0.001 per share, will automatically be converted into one share of post-split common stock, par value $0.001 per share. In lieu of fractional shares, stockholders will receive cash in an amount equal to the product obtained by multiplying (i) the closing sale price per share on the business day immediately preceding the Effective Time as reported on Nasdaq by (ii) the number of shares of common stock held by the stockholder that would otherwise have been exchanged for the fractional share interest.
The immediate effect of the reverse split will be to reduce the number of shares of Discovery Labs' common stock that are issued and outstanding to approximately 13.8 million shares (excluding shares reserved for stock options and unexercised warrants), adjusted for fractional interests. The reverse split will affect all stockholders uniformly and will have no effect on the proportionate holdings of any individual stockholder, with the exception of adjustments related to fractional shares. There will be no change in the number of stockholders of record as a result of the reverse split. Following the reverse split, all shares will remain fully paid and non-assessable.
To inform the market of the reverse split, Discovery Labs expects that Nasdaq will append a suffix character, "D," to the Company's trading symbol (DSCO) for approximately 20 days after the Effective Time. After the ~20 trading-day period, the ticker symbol will revert to "DSCO". In addition, Discovery Labs' common stock will also trade under a new CUSIP number beginning on December 28, 2010.
Additional information can be found in Discovery Labs' definitive proxy statement, which was filed with the SEC on November 15, 2010 and is available on the Company's website at www.Discoverylabs.com.
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, including with respect to the potential continued listing of the Company's common stock on the Nasdaq Capital Market, the potential approval in the United States of Surfaxin for the prevention of RDS in premature infants, and the ability of the Company to fund its activities through strategic and financing transactions or otherwise, 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 described in the Company's filings with the Securities and Exchange Commission including the Company's proxy statement on Schedule 14A and the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto.
CONTACT: Discovery Laboratories, Inc.
Investor relations:
John G. Cooper, President and Chief Financial Officer
215-488-9490
Chart (daily/weekly) - LINK back
Zoom Technologies says to acquire Celestial Digital Entertainment
http://www.finanznachrichten.de/nachrichten-2010-12/18899172-brief-zoom-technologies-says-to-acquire-celestial-digital-entertainment-020.htm
Current report filing (8-K)
Date : 12/21/2010 @ 11:02AM
http://ih.advfn.com/p.php?pid=nmona&article=45743270
On December 20, 2010, Zoom Technologies, Inc. (the "Company") executed a share exchange agreement (the "Agreement") to acquire 100% of the shares of Celestial Digital Entertainment, Ltd., ("CDE") a mobile platform video game development company based in Hong Kong (the "Acquisition"). The parties to the Agreement include the Company, CDE, Profit Harvest Company, Ltd. ("Profit Harvest"), the Company's wholly-owned subsidiary organized under the laws of Hong Kong and which is the acquiring entity in the Acquisition, and Everton Development Limited ("Everton") and Hui Pak Kong, who are owners of 100% of the issued and outstanding shares of CDE.
Following the closing of the Acquisition, CDE will be a wholly owned subsidiary of Profit Harvest, as described in the diagram below:
Zoom Technologies, Inc.
?
Profit Harvest Company, Ltd.
?
Celestial Digital Entertainment, Ltd.
Under the terms of the Agreement, Everton and Mr. Hui will sell their combined 100% ownership of CDE to Profit Harvest. The consideration paid for CDE will be US$1,818,000 worth of the Company's common stock at $3.75 per share, or 484,800 shares of the Company's common stock. Closing of the Acquisition is subject to customary closing conditions and deliverables by the Company, Profit Harvest, CDE, Everton and Mr. Hui. The Company expects to close the Acquisition on or about January 3, 2011.
CDE primarily focuses on development of video games and applications for mobile phones and mobile platforms. CDE has developed over 40 titles for the Apple iPhone and is one of the largest developer of iPhone apps in Asia.
Zoom Technologies says to acquire Celestial Digital Entertainment
http://www.finanznachrichten.de/nachrichten-2010-12/18899172-brief-zoom-technologies-says-to-acquire-celestial-digital-entertainment-020.htm
Current report filing (8-K)
Date : 12/21/2010 @ 11:02AM
http://ih.advfn.com/p.php?pid=nmona&article=45743270
On December 20, 2010, Zoom Technologies, Inc. (the "Company") executed a share exchange agreement (the "Agreement") to acquire 100% of the shares of Celestial Digital Entertainment, Ltd., ("CDE") a mobile platform video game development company based in Hong Kong (the "Acquisition"). The parties to the Agreement include the Company, CDE, Profit Harvest Company, Ltd. ("Profit Harvest"), the Company's wholly-owned subsidiary organized under the laws of Hong Kong and which is the acquiring entity in the Acquisition, and Everton Development Limited ("Everton") and Hui Pak Kong, who are owners of 100% of the issued and outstanding shares of CDE.
Following the closing of the Acquisition, CDE will be a wholly owned subsidiary of Profit Harvest, as described in the diagram below:
Zoom Technologies, Inc.
?
Profit Harvest Company, Ltd.
?
Celestial Digital Entertainment, Ltd.
Under the terms of the Agreement, Everton and Mr. Hui will sell their combined 100% ownership of CDE to Profit Harvest. The consideration paid for CDE will be US$1,818,000 worth of the Company's common stock at $3.75 per share, or 484,800 shares of the Company's common stock. Closing of the Acquisition is subject to customary closing conditions and deliverables by the Company, Profit Harvest, CDE, Everton and Mr. Hui. The Company expects to close the Acquisition on or about January 3, 2011.
CDE primarily focuses on development of video games and applications for mobile phones and mobile platforms. CDE has developed over 40 titles for the Apple iPhone and is one of the largest developer of iPhone apps in Asia.
Sunesis Launches Phase 3 VALOR Trial of Vosaroxin in AML
Date : 12/21/2010 @ 8:00AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=45739543
unesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the first patient has been randomized and dosed with blinded study treatment in its pivotal Phase 3 VALOR trial of vosaroxin, the company's lead drug candidate, in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial is a multinational, randomized, double-blind, placebo-controlled, pivotal trial which is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand.
...
Sunesis Launches Phase 3 VALOR Trial of Vosaroxin in AML
Date : 12/21/2010 @ 8:00AM
Source : MarketWire
Stock : Sunesis Pharmaceuticals (SNSS)
http://ih.advfn.com/p.php?pid=nmona&article=45739543
unesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced that the first patient has been randomized and dosed with blinded study treatment in its pivotal Phase 3 VALOR trial of vosaroxin, the company's lead drug candidate, in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemia (AML). The VALOR trial is a multinational, randomized, double-blind, placebo-controlled, pivotal trial which is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand.
"The initiation of VALOR marks the culmination of many years of work and is a gratifying moment for Sunesis in its ongoing efforts to develop a new therapeutic option for AML patients," stated Daniel Swisher, Chief Executive Officer of Sunesis. "AML is a challenging disease, especially for relapsed and refractory patients, yet in our robust Phase 2 program we have shown in this AML setting that vosaroxin plus a leading standard of care, cytarabine, exhibit a combination of efficacy and tolerability that has led to promising results. The support of key opinion leaders, top international trial sites, specialized service providers and a rigorously designed Phase 3 protocol should provide the VALOR trial with a strong foundation for operational success."
"Patients with relapsed or refractory AML have a poor prognosis and are often intolerant of or do not respond to currently available treatment options," said Farhad Ravandi, M.D., Associate Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas M. D. Anderson Cancer Center, and a principal investigator of VALOR. "Despite the unmet medical need, treatment standards have not appreciably changed in more than 30 years. Vosaroxin's differentiated treatment profile from the Phase 2 program is characterized by strong remission rates, low all-cause early mortality and long leukemia free survival, which have led to survival outcomes that compare favorably with published results for current treatment standards. The VALOR trial is a well designed, highly anticipated trial which should provide a clear understanding of vosaroxin's efficacy and safety profile when added to cytarabine in this disease setting."
Patients in the VALOR trial will be randomized one-to-one to receive in a blinded manner either vosaroxin or placebo on days one and four of each treatment cycle in combination with cytarabine daily for five days of each treatment cycle. The trial's primary endpoint is overall survival. The VALOR trial employs an adaptive design that provides for a single interim analysis by an independent Data and Safety Monitoring Board (DSMB) which will meet to examine pre-specified efficacy and safety data sets and decide whether to implement a one-time sample size adjustment of 225 additional evaluable patients to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The interim analysis by the DSMB is expected to take place in mid-2012. For more information on VALOR please visit www.valortrial.com.
About VALOR
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at leading sites in the U.S., Canada, Europe, Australia and New Zealand. VALOR is currently open for enrollment and patients will be randomized one-to-one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The trial's primary endpoint is overall survival. For more information on VALOR please visit www.valortrial.com.
About Vosaroxin
Vosaroxin, formerly known as voreloxin, 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. Sunesis is currently enrolling patients in 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.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The American Cancer Society estimates that 12,330 new cases of AML will be diagnosed and approximately 9,000 deaths from AML will occur in the U.S. in 2010. Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
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, please visit http://www.sunesis.com.
This press release contains forward-looking statements, including statements related to the design, conduct, timing of interim analysis and results of the VALOR trial, and vosaroxin's effects, efficacy and safety profile as a single agent and in combination with cytarabine. Words such as "designed," "expected," "exhibit," "promising," "should," "will" 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 and uncertainties related to Sunesis' need for substantial additional funding to complete the development and commercialization of vosaroxin, the risk that unfavorable economic and market conditions may make it more difficult and costly to raise additional capital, 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. Risk factors related to Sunesis and its business 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
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NIH Awards Discovery Labs Fast Track SBIR Grant to Support Development of Aerosolized KL4 Surfactant
Date : 12/16/2010 @ 7:00AM
Source : GlobeNewswire Inc.
Stock : Discovery Laboratories, Inc. (DSCO)
http://ih.advfn.com/p.php?pid=nmona&article=45679721
Discovery Laboratories, Inc. (Nasdaq:DSCO) today announced that the Company has been awarded Phase I of a Fast Track Small Business Innovation Research Grant (SBIR) from the National Institutes of Health (NIH) to support the development of the Company's program for aerosolizing KL4 surfactant for neonatal respiratory distress syndrome (RDS). The Company submitted a proposal, with a total budget of $2.4 million, for the development of the Company's proprietary capillary aerosol generating (CAG) device technology followed by a Phase 2a clinical trial of aerosolized KL4 surfactant in preterm infants with or at risk for RDS. The Phase I grant provides $580,000 to support development efforts. The Company anticipates the potential awarding of the Phase II grant, up to an additional $1.8 million, following the conclusion of Phase I activities.
Dr. Robert Segal, Discovery Labs' Senior Vice President and the Grant Principal Investigator commented, "We are extremely pleased that the NIH has recognized the importance of our aerosolized KL4 surfactant technology, which has the potential to significantly improve the management of preterm infants with or at risk for RDS and make it possible for many more preterm infants to be treated with surfactant therapy."
RDS is one of the most prevalent medical issues facing premature infants in the neonatal intensive care unit and is a condition in which premature infants are born with a lack of natural lung surfactant and are unable to breathe. Approximately 360,000 low birth weight premature infants are born annually in the United States and at risk for RDS. Premature babies with RDS often require endotracheal intubation and mechanical ventilation. In many cases, currently available animal-derived surfactants are administered while the child is intubated. Neonatologists often try to avoid intubation and mechanical ventilation in preterm infants due to well established medical risks associated with these procedures. As a result, many neonatologists reserve intubation for infants with severe respiratory distress, where the benefits of invasive procedures clearly outweigh the associated risks. The Company believes that the neonatal medical community increasingly recognizes the potential benefits of a synthetic, peptide-containing surfactant, and a less-invasive method of delivering surfactant, such as aerosolized KL4 surfactant.
KL4 surfactant is a completely synthetic, peptide-containing surfactant designed to closely mimic the essential attributes of human lung surfactant. Discovery Labs is developing aerosolized KL4 surfactant for delivery in conjunction with non-invasive nasal continuous positive airway pressure (nCPAP) and other ventilation modalities. Aerosurf®, the Company's initial aerosolized KL4 surfactant product, holds the promise to significantly expand the use of surfactant therapy in at-risk premature infants by potentially providing neonatologists with a means of administering surfactant without the risks currently associated with surfactant administration. The Company believes that Aerosurf, if approved, will allow for a potentially significant increase in the number of infants who will benefit from surfactant therapy.
Discovery Labs' lead KL4 surfactant product, Surfaxin® for neonatal RDS, has been previously demonstrated to be generally safe and effective in a large multi-national Phase 3 clinical program. Surfaxin is the subject of a Complete Response letter from the U.S. Food and Drug Administration (FDA) and Discovery Labs expects to submit a complete response to the FDA in the first quarter of 2011. If approved, Surfaxin would be the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine.
Surfaxin and Aerosurf are investigational drugs that have not been approved by the U.S. FDA or any other world health regulatory authorities.
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, including those related to the Company's pre-clinical and clinical research and development activities and related regulatory efforts, are 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
Cardium Reports on Exchange Listing Deficiency and Compliance Plan
http://www.finanznachrichten.de/nachrichten-2010-12/18725427-cardium-reports-on-exchange-listing-deficiency-and-compliance-plan-008.htm
SAN DIEGO, Dec. 2, 2010 /PRNewswire/ -- Cardium Therapeutics (NYSE Amex: CXM) reported on a communication from the staff of the company's current listing exchange indicating that it considered the company to be noncompliant with one of the listing requirements of the NYSE Amex LLC, based on its quarterly report for the period ended September 30, 2010, and providing that the company should submit a plan that would reestablish compliance with the listing requirement by August 26, 2011. The company reported that it has submitted a plan designed to reestablish compliance with the exchange's requirement in advance of the August 26, 2011 timeframe.
(Logo: http://photos.prnewswire.com/prnh/20051018/CARDIUMLOGO)
Based on the company's quarterly report on Form 10-Q for the period ended September 30, 2010, noncompliance was noted with respect to the requirement for minimum "stockholders' equity" of $6.0 Million pursuant to section 1003(a)(iii) of the exchange's company guide. As reported, the recently revised accounting treatment of certain derivative liabilities that are associated with valuation estimates of unexercised but outstanding variable-priced warrants reduced the calculation of stockholders' equity by $3.5 Million (i.e. to $4.6 Million when it would otherwise have been $8.1 Million without the estimated derivative liability). The exchange indicated that in order to maintain its listing, a plan should be submitted by December 27, 2010 addressing how the company intends to regain compliance with Section 1003(a)(iii) of the exchange's company guide by August 26, 2011. The company reported today that it has submitted a plan designed to reestablish its compliance with the listing requirement.
The communication and compliance plan has no current effect on the listing of the company's shares on the exchange. If the plan is not acceptable or the company does not make sufficient progress under the plan or reestablish compliance by August 26, 2011, then the exchange would be expected to initiate delisting proceedings. If the company's common stock was ultimately delisted from the exchange, it would be expected to trade on the OTC Bulletin Board, a regulated quotation service that provides quotes, sale prices and volume information in over-the-counter equity securities. The company's common stock was traded on the OTC Bulletin Board until July 2007, when the company elected to instead list its shares on the American Stock Exchange.
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 company's plan for regaining compliance with exchange listing requirements will be acceptable or that it will make sufficient progress under the plan or ultimately achieve compliance, that results observed in one study or using one type of product or procedure will be replicated in subsequent studies or in studies using newly-developed products or procedures, that planned product development efforts and clinical studies can be performed in an efficient and effective manner, that regulatory approvals can be obtained in a timely manner or at all, that partnering, distribution or other commercialization efforts can be achieved, that product modifications or launches will be successful or that the resulting products will be favorably received in the marketplace, that our products or proposed products will prove to be sufficiently safe and effective, 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 results or trends observed in one clinical study will be reproduced in subsequent studies, that third parties on whom we depend will behave as anticipated, or that necessary regulatory approvals will be obtained. 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, testing and marketing of biologics, medical devices and other products, and the conduct of human clinical trials, including the timing, costs and outcomes of such trials, whether our efforts to launch new products and expand our markets will be successful or completed within the time frames contemplated, our dependence upon proprietary technology, our ability to obtain necessary funding, regulatory approvals and qualifications, 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.
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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.
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CONTACT: Bonnie Ortega, Director, Investor/Public Relations of Cardium
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