Dallas TX 9/15/2009 2:22:58 AM
News / Business

KNDR, CHYU, ACCP, SGDH, JAGR, NVSR, PWRM, FHAI, APDN, ALRT, IRSN, DSCO OTCPicks.com Daily Market Movers Digest Midday Report for Monday, September 14th

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover’s Digest Newsletter and Email Stock Watch Alerts.

Our Stocks to Watch today include Kender Energy Inc. (OTC: KNDR), China Youth Media Inc. (OTCBB: CHYU), Access Pharmaceuticals Inc. (OTCBB: ACCP), SGD Holdings Ltd. (OTC: SGDH), Jaguar Mining Enterprises Inc. (OTC: JAGR), NavStar Technologies Inc. (OTC: NVSR), Power3 Medical Products Inc. (OTCBB: PWRM), Fountain Healthy Aging Inc. (OTCBB: FHAI), Applied DNA Sciences Inc. (OTCBB: APDN), ALR Technologies Inc. (OTCBB: ALRT), Irvine Sensors Corp. (Nasdaq: IRSN) and Discovery Laboratories Inc. (Nasdaq: DSCO).

 

Visit http://www.otcpicks.com/microcap.htm to register for our Daily Market Mover’s Digest Newsletter and Email Stock Watch Alerts.

 

KENDER ENERGY INCORPORATED (OTC: KNDR)

 

Detailed Quote: http://www.otcpicks.com/quotes/KNDR.php 

 

Company Profile: http://www.otcpicks.com/kender-energy.htm

 

Kender Energy Inc. is a development phase company active in the field of solar energy. Its present prototypes of solar panels are being developed into a full-scale solar energy production system. The particularity of the Kender solar panel system and technology is to allow, via a closed circuit of gas (usually helium), to create a heat exchange with the sunlight and the air from the environment. The exchange generates the spinning of the helium gas in the closed circuit, propelling a turbine, which produces electricity in a 100% clean and renewable process. The system's main advantages are that it is efficient, cheap in production, and modular. The company is based near Geneva, Switzerland.

 

KNDR News:

 

September 10 - Kender Energy to Distribute Its Solar Technology in Portugal, the Home of the Largest Solar Photovoltaic Farm

 

Kender Energy Inc. (OTC: KNDR) announced that it has signed a distribution agreement for the country of Portugal with Nortfil Lda of San Pedro.

 

Portugal, without its own oil, coal or gas, is leading the European revolution of clean energy with some of the most ambitious objectives for renewable energy. The country is home to the largest solar power station with over 2,520 giant solar panels expected to produce 45MW of electricity each year, enough to power 30,000 homes.

 

"Portugal's objective is to produce 31% of its energy from clean sources by 2020 and Kender Energy's solar technology will tremendously increase the efficiency in the harvest of solar power," said Sean Kelly, President and CEO of Kender Energy. "Portugal's plan to invest more than $1 billion in a series of solar farms to power 450,000 homes makes this market a major focus for our company," further added Mr. Kelly.

 

CHINA YOUTH MEDIA INCORPORATED (OTCBB: CHYU)

 

Detailed Quote: http://www.otcpicks.com/quotes/CHYU.php 

 

Company Profile: http://www.otcpicks.com/china-youth-media/china-youth-media.htm

 

China Youth Media, Inc. is a China-focused youth marketing and media company whose business is to deliver advertising and content to one of the most sought after and fastest growing demographics in the world. Through its wholly owned subsidiary Youth Media (Hong Kong) Limited, CHYU has secured contracts with a term of 20 plus 10 years that provide exclusive rights from the Chinese government controlled corporation, China Youth Interactive, which uniquely position CHYU to market to China’s massive student population with preferred access online, on campus and on mobile. CHYU currently targets China’s campus-based college students, who total more than 30 million and make up a key segment of the largest youth market in the world.

 

CHYU News:

 

September 9 - China Youth Media Launches Converse Ad Campaign on Koobee Network

 

China Youth Media, Inc. (OTCBB: CHYU), a China focused youth marketing and media company, announced that its Koobee Network has launched an advertising campaign for the athletic footwear company Converse, a subsidiary of the world’s leading athletic shoes and apparel company, Nike.

 

Koobee, China Youth Media’s Intranet Television Network and media portal, delivers TV-quality content and advertising directly to China’s 30 million plus college students on a dedicated network targeted to campuses nationwide. The Converse ad campaign is running on Koobee’s recently launched MOGO Music Channel. Produced for and targeted specifically to China’s youth market, the ads feature a nationwide music competition sponsored by Converse that allows young music fans to interact with one of the most popular rock bands in China.

 

“We are very pleased to launch the Converse campaign on Koobee and expect it to become one of many to generate ad revenue for the company,” commented Jay Rifkin, China Youth Media’s CEO. “As more campaigns like this are sold, we believe that Koobee’s highly targeted youth platform will become premium ad inventory for major global brands.”

 

ACCESS PHARMACEUTICALS INCORPORATED (OTCBB: ACCP)

 

Detailed Quote: http://www.otcpicks.com/quotes/ACCP.php 

 

Company Profile: http://www.otcpicks.com/access-pharmaceuticals/access-pharmaceuticals.htm 

 

Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes propriety products for the treatment and supportive care of cancer patients. Access' products include ProLindac™, currently in Phase 2 clinical testing of patients with ovarian cancer, and MuGard™ for the management of patients with mucositis. The company also has other advanced drug delivery technologies including Cobalamin™-mediated targeted delivery and oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism; Angiolix®, a humanized monoclonal antibody which acts as an anti-angiogenesis factor and is targeted to breast cancer; and Thiarabine, a new generation nucleoside analog which has demonstrated both pre-clinical and clinical activity in certain cancers.

 

ACCP News:

 

September 11 - Access Pharmaceuticals Signs Agreement to Manufacture Its FDA-Approved MuGard in the United States

 

Access Pharmaceuticals Inc. (OTCBB: ACCP) has entered into an agreement with a leading commercial manufacturer to produce its FDA-approved MuGard for North American distribution. One or more U.S. market seeding studies could begin as early as Q4 2009, the company says.

 

In a comparison of cancer patients receiving standard oral mucositis care with those patients receiving MuGard , MuGard has been shown to significantly reduce the incidence and severity of the debilitating side effect of radiation treatment and chemotherapy.

 

Access has contracted with Accupac, Inc. to serve as its commercial manufacturer of MuGard in North America. Accupac manufactures, fills and packages a wide range of consumer commodity, over-the-counter (OTC) and prescription (Rx) products for the world's largest pharmaceutical and consumer products companies.

 

"Access is moving forward with the development of MuGard in North America," said Jeffrey B. Davis, Access' President & CEO. "Establishing our relationship with Accupac, a leader in liquid contract manufacturing, is critical to our successful commercialization of MuGard. In addition, Access is currently evaluating potential eMarketing partners as well as potential co-promotion or other licensing opportunities."

 

Access intends to use the initial batches of MuGard in connection with one or more market seeding studies to be conducted in the U.S. pursuant to protocols that are currently being developed. Access hopes to finalize these protocols and begin one or more market seeding studies in Q4 2009.

 

MuGard is a novel, ready-to-use mucoadhesive oral wound rinse for the management of oral mucositis. MuGard forms a protective coating over the oral mucosa when swirled gently around the mouth. Up to 80% of all patients receiving radiotherapy and approximately 40% of all chemotherapy patients develop oral mucositis, and almost all patients receiving radiotherapy for head and neck cancer and those undergoing stem cell transplantation develop symptoms. MuGard is currently being marketed in the United Kingdom, Germany, Italy, Norway and Greece by Access' partner, SpePharm.

 

Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis, expanding to include all patients undergoing chemotherapy and radiotherapy, is estimated to be in excess of $5 billion worldwide.

 

SGD HOLDINGS LIMITED (OTC: SGDH)

 

Detailed Quote: http://www.otcpicks.com/quotes/SGDH.php 

 

Company Profile: http://www.otcpicks.com/sgd-holdings/sgd-holdings.htm

 

SGD Holdings, Ltd. is a holding company which owns and operates through its wholly-owned subsidiary, Ecopaper, Inc. (www.ecopaper.com). Its goal is to acquire new technologies which can positively impact the environment either through internal development or by acquisition.

 

SGDH News:

 

September 9 - SGD Holdings, Ltd. Subsidiary, Ecopaper, Inc. Sells 50% of a Container of Bulk Banana Paper

 

SGD Holdings, Ltd. (OTC: SGDH) announced that its wholly-owned subsidiary, Ecopaper, Inc., pre-sold one half container shipment of bulk banana paper to a wholesale client for $28,000. The balance of the container will go into its retail internet inventory to be sold through www.ecopaper.com.

 

"Increasing consumer demand for our environmentally sustainable tree-free paper products has significantly increased our bulk paper and retail internet sales. Our Central American facility specializes in providing products from the agricultural waste of banana plantations. Increased demand will lower our shipping costs and has improved our overall profit margins," stated Harry Johansing, CEO of SGD Holdings, Ltd.

 

ABOUT ECOPAPER, INC.

 

Ecopaper, Inc. is the first company in the history of the paper industry to create and market treeless paper of a superior quality. Every page of Ecopaper is smooth, acid-free, durable, chemical-free, and made in Costa Rica. Ecopaper, Inc. has developed an innovative and economically feasible option for the removal of 230,000 tons of agro-industrial waste that are dumped yearly in Costa Rica alone. The company's challenge is to invent new processes and create paper from exotic tropical fibers from waste materials in new textures and tones for consumers. The results of processing these exotic tropical fibers are items that both appeal to the consumer and to positively impact the environment.

 

JAGUAR MINING ENTERPRISES INCORPORATED (OTC: JAGR)

 

Detailed Quote: www.otcpicks.com/quotes/JAGR.php

 

Company Profile: http://www.otcpicks.com/jaguar-mining/jaguar-mining.htm 

 

Jaguar Mining Enterprises, Inc. is an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in Mexico. The Company specializes in the exploitation of iron ore mines with proven reserves. The Company's strategy is to locate, acquire and develop mine locations that contain sufficient quantities of iron ore and require minimal start-up costs.

 

JAGR News:

 

September 9 - Jaguar Mining Enterprises Issues Special Letter to Shareholders

 

Jaguar Mining Enterprises, Inc. (OTC: JAGR), an independent mining company engaged in the acquisition, development, and exploitation of iron ore primarily mined in Mexico, announced that it has issued a Special Letter to Shareholders to update existing JAGR investors on the current status of Jaguar Mining, and more importantly, its future growth outlook. Excerpts from the letter follow:

 

"Currently, our primary emphasis is to develop an iron ore reserve containing 20 million metric tons (mt) at our Cascaronal Project in Jalisco, Mexico. We have completed all necessary studies and documentation for permitting and expect commence extraction within the next 45 days. Our plans are to convert the Cascaronal Mine from pre-production to production, with the mine being brought up to full production within 120 days thereafter. Once mining operations have commenced, we believe that over 2,000 tons of iron ore can be mined daily resulting in over $4.5 million in revenues over the next fiscal year with earnings of nearly $1 million."

 

"In spite of recent market volatility, we expect that rising worldwide demand will likely produce a tight market into next year. Iron ore prices are normally set in annual talks between major suppliers and customers. As they have been unable to agree upon a benchmark price, iron ore is being sold on the open market. Prices spiked in early August, but we have seen a decline since then. The company's policy of strict fiscal discipline and cost control will help us weather these up and down prices we're now seeing, and allow us to be profitable as we move forward."

 

The full shareholder letter can be viewed on Jaguar Mining's website at www.jaguarminingenterprises.com.

 

NAVSTAR TECHNOLOGIES INCORPORATED (OTC: NVSR)

 

Detailed Quote: http://www.otcpicks.com/quotes/NVSR.php 

 

Company Profile: http://www.otcpicks.com/navstar-technologies/navstar-technologies.htm

 

NavStar is focused on the creation of GPS products and services that provide wireless tracking of vehicles, equipment, and other valuable and personal assets. The goal is to be a total solutions provider.

 

NVSR News:

 

September 9 - NavStar Technologies, Inc. to Pay 10% Stock Dividend

 

NavStar Technologies, Inc. (OTC: NVSR) announces that the Company's Board of Directors has authorized a 10% (ten percent) dividend of the Company's Common Stock for its Stockholders of Record as of Wednesday, September 30, 2009. The Stock Dividend Pay Date to stockholders will be on Wednesday, October 14, 2009.

 

The Company elected to reward those stockholders who had remained loyal to the Company and have been patient as 2009 has unfolded slower than expected. Each holder with 100 shares of NavStar Technologies, Inc. common stock as of September 30, 2009 shall be entitled to receive ten (10) additional shares of common stock. For example, if a holder owns a round lot of 500 shares he or she shall receive 50 additional shares. The payment date for the common stock dividend is set for October 14, 2009.

 

This Stock Dividend will be electronically credited to stockholders' accounts on the Pay Date. Those stockholders who are not holding their shares with Brokers will receive their Stock Dividends in certificated form.

 

POWER 3 MEDICAL PRODUCTS INCORPORATED (OTCBB: PWRM)

"Up 32.73% in morning trading"

 

Detailed Quote: www.otcpicks.com/quotes/PWRM.php 

 

Power3 Medical Products Inc. is a leading Bio Medical company engaged in the commercialization of cancer and neurodegenerative disease biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets. Power3's patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Power3 operates a state-of-the-art CLIA certified laboratory in The Woodlands (Houston), Texas. The Company continues to evolve and enhance its IP portfolio.

 

PWRM News:

 

September 2 - Transgenomic and Power3 Medical Report Identification of Abnormal Serum Proteins in Parkinson's Disease

 

On-line Publication of Biomarker Panel that Forms Basis for NuroPro®PD Diagnostic Test

 

Transgenomic, Inc. (OTCBB: TBIO) and Power3 Medical Products, Inc. (OTCBB: PWRM) announced the advance on-line publication of a clinical research paper entitled "Abnormal Serum Concentrations of Proteins in Parkinson's Disease" in the scientific journal Biochemical and Biophysical Research Communications. The study demonstrates the usefulness of a protein biomarker panel to distinguish Parkinson's disease (PD) patients from age-matched normal controls independent of the severity of symptoms, using clinical blood serum samples.

 

The analytic technology forms the basis for the NuroProPD test for PD being commercialized by Transgenomic as per a licensing/collaboration agreement with Power3 Medical signed in early 2009. The publication of the peer-reviewed article is a significant validation milestone in the ongoing clinical development of the NuroProPD diagnostic assay.

 

The article describes the use of analytically validated quantitative 2D gel electrophoresis to identify protein biomarkers for diagnosing PD using serum from routinely collected blood samples. 57 protein biomarkers, which had been discovered using retrospective blood serum samples from various neurodegenerative diseases, were then applied specifically to PD in a prospective clinical investigation using freshly collected blood serum from PD patients and age-matched normal controls. A multi-variate statistical method, stepwise linear discriminant analysis, selected a combination of 21 of the biomarkers as optimal to distinguish PD patients from controls. When applied to the PD samples, the 21-protein set had sensitivity of 93.3% (52 of 56 PD correctly classified) and specificity of 92.9% (28 of 30 controls correctly classified); 15 of 15 patients with mild and 28 of 30 with moderate to severe symptoms were correctly classified, as were all 6 PD samples from an independent site.

 

"We are enthusiastic about the acceptance of our paper in this established peer-reviewed scientific journal. It represents independent external validation of the clinical data, and so increases the confidence that we have in NuroProPD to be a meaningful tool for the diagnosis of Parkinson's disease, especially early in its course," said Craig Tuttle, CEO of Transgenomic. "We are completing the clinical validation of the assay in our CLIA-certified molecular testing laboratory and will be launching the assay in the very near future."

 

"In the U.S., there are an estimated 1.5 million individuals with Parkinson's disease. Unfortunately, by the time patients are given a probable diagnosis, many have already suffered substantial and irreparable brain damage, rendering treatment less effective," said Dr. Ira Goldknopf, President and CSO of Power3 Medical and lead author on the paper. "The fact that these results were obtained using fresh blood serum, in the same way that the test will be performed in a clinical diagnostic setting, provides further support for their robustness and their commercial value."

 

Clinical investigators in the study were Dr. Katerina Markopoulou of the University of Thessaly, Greece, Drs. Marwan Sabbagh and Holly Shill of Banner Sun Health Research Institute, Sun City, Arizona, and Dr. Stanley Appel of the Texas Methodist Health System, Houston.

 

ABOUT TRANSGENOMIC, INC.

 

Transgenomic, Inc. (OTCBB: TBIO) is a global biotechnology company specializing in high sensitivity genetic variation and mutation analysis, providing products and services in DNA mutation detection and discovery for clinical research, clinical molecular diagnostics and pharmacogenomics analyses. Its product offerings include the WAVE® Systems and associated consumables specifically designed for use in genetic variation detection and single- and double-strand DNA/RNA analysis and purification. With broad applicability to genetic research, over 1,450 systems have been shipped to customers in more than 30 countries. The SURVEYOR® Mutation Detection Kits and SURVEYOR Check-It Kit provide reagents and protocols for high sensitivity detection of mutations in DNA. In addition, HANABI automated chromosome harvesting systems improve laboratory productivity with consistent quality compared to manual methods for cytogenetic analyses. Service offerings include the Transgenomic Molecular Laboratory, which provides reference laboratory services specializing in molecular diagnostics including Mitochondrial Disorders, Oncology and Hematology, Molecular Pathology and Inherited Diseases. Transgenomic Pharmacogenomic Services is a CRO for pharmacogenomic, translational research and clinical trials.

 

FOUNTAIN HEALTHY AGING INCORPORATED (OTCBB: FHAI)

"Up 22.50% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/FHAI.php 

 

Fountain Healthy Aging is a company specifically focussed in the anti aging industry, which is one of the quickest growing industry sectors worldwide. We have a range of products targeted at the anti-aging market, including our revolutionary flagship product Vitalife, which we believe is ready to make a massive impact in the anti-aging industry. We recognize the importance of the anti-aging sector, an emerging dynamic within the overall health and wellness revolution. We believe that we are uniquely positioned to capitalize on this rapidly growing trend, first with our unique flagship product, rapidly followed by our other products which have been specifically developed for this market. Fountain Healthy Aging's main focus is on the specialty, premium product category, which is a growing segment of the market that provides gross margins significantly higher that the lower-priced, mainstream health products market.

 

FHAI News:

 

September 14 - Fountain Healthy Aging Inc Announces Agreement to Acquire Natural Planet USA

 

Fountain Healthy Aging Inc. (OTCBB: FHAI) announced on September 14, 2009 that it had entered into an agreement to acquire the entire issued stock of Natural Planet USA Inc, a California based developer and distributor of a range of specialist nutraceutical and cosmoceutical products both in the US and across a range of international markets. Fountain has had a relationship with Natural Planet for some months, and has sourced a number of its key products from the Natural Planet product pipeline, as well as engaging Natural Planet as a non exclusive distributor of its flagship product, Vitalife, in the US.

 

Fountain CEO, Paul Hunston, said that "this acquisition not only secures an extensive and highly synergistic pipeline of unique products for Fountain, but also brings a number of important distribution relationships which Natural Planet has established around the world which will enhance Fountain's own distribution capabilities significantly." He continued, "I see this acquisition as a crucial step towards the achievement of our goal to develop Fountain into the leading global player within the anti-aging industry. With Natural Planet comes a huge range of over 50 scientifically developed but completely natural products, which, to use Natural Planet's own motto are specifically designed to help people feel better, look better, live longer ... naturally! That motto fits perfectly with the goals which Fountain has for its own products and, sums up the synergies which form the basis for this acquisition. Add to that the instant additional distribution capabilities which Natural Planet brings to Fountain and it is easy to see why I am so excited about this major development, which is going to form the basis of many further developments for us in the coming weeks and months".

 

APPLIED DNA SCIENCES INCORPORATED (OTCBB: APDN)

"Up 14.73% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/APDN.php 

 

APDN sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied. APDN also provides BioMaterial GenoTyping(TM) by detecting genomic DNA in natural materials to authenticate finished products. Both technologies protect brands and products in a wide range of industries and provide a forensic chain of evidence that can be used to prosecute perpetrators.

 

APDN News:

 

September 9 - Emerging Stock Report Initiates Independent Research Coverage On Applied DNA Sciences, Inc.

 

Emerging Stock Report, a leading provider of sector specific independent investment research, today initiated coverage on Applied DNA Sciences, Inc. (OTCBB: APDN). Emerging Stock Report is currently offering a complimentary trial subscription. To view our research go to www.emergingstockreport.com.

 

ALR TECHNOLOGIES INCORPORATED (OTCBB: ALRT)

"Up 400.00% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/ALRT.php 

 

The ALRT Health-E-Connect Disease Management System is designed to enhance compliance of prescribed therapies and report diagnostic data from a number of devices to health professionals for monitoring of patients. The System facilitates cost effective continued oversight of patients by authorized health professionals in-between visits to their physician.

 

ALRT News:

 

September 14 - Patent Application Approval for Remote Monitoring of Patient's Use of Nebulizer Compressors Facilitates Enhanced Coordination of Care for Patients With Respiratory Disease

 

ALR Technologies (OTCBB: ALRT) announces that it has received notice from the US Patent and Trademark Office that ALRT has been granted approval of its patent application regarding patient compliance and remote monitoring of patient's use of nebulizer compressors. This approval from the US patent office will protect ALRT's Health-E-Connect health management communications system and more importantly, will grant ALRT the exclusive ability to remotely monitor the use of nebulizer compressors in the delivery of medications to patients with COPD, chronic asthma and cystic fibrosis.

 

COPD is one of the leading causes of death in the world. With 16 million people in the US with COPD and 20 million plus with asthma, utilizing ALRT's Health-E-Connect system to monitor their use of nebulizer compressor creates the opportunity to significantly improve quality of life and reduce healthcare costs. Health Professionals will now be able to remotely monitor and evaluate compliance in delivery of aerosolized medications to their patients with respiratory diseases thereby helping these patients to reduce health complications and improve their quality of life.

 

The use of monitoring-ready nebulizer compressors and ALRT's Health-E-Connect health management communications system can become an important new service provided by health professionals. Furthermore, the Health-E-Connect system is on target with the growing recognition in the US to use electronic health records to improve the efficiency and effectiveness of patient care.

 

ALRT announced earlier this year that insurance carriers will reimburse physicians for the remote care of patients with the use of its Health-E-Connect system. This will result in new revenue for physicians as they provide the additional service to their patients with respiratory disease. ALRT's Health-E-Connect and complementary Constant Health Companion is the only system in the US and International markets that allows for remote monitoring of patients' use of nebulizer compressors. This capability will allow for enhanced patient compliance and health professional coordination of care.

 

IRVINE SENSORS CORPORATION (NASDAQ: IRSN)

"Up 76.50% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/IRSN.php

 

Irvine Sensors Corporation, headquartered in Costa Mesa, California, is a vision systems company engaged in the development and sale of miniaturized infrared and electro-optical cameras, image processors and stacked chip assemblies and sale of higher level systems incorporating such products and research and development related to high density electronics, miniaturized sensors, optical interconnection technology, high speed network security, image processing and low-power analog and mixed-signal integrated circuits for diverse systems applications.

 

IRSN News:

 

September 14 - Irvine Sensors Receives Announces $4.6 Million in New Awards

 

Irvine Sensors Corporation (Nasdaq: IRSN) announced that it has received $4.6 million in new development contract awards in approximately the last 30 days. These awards bring the aggregate of new contract and product funding received by Irvine Sensors in the second half of fiscal 2009 to $9.3 million. Much of the recent awards are focused on or related to potential cyber security applications.

 

DISCOVERY LABS INCORPORATED (NASDAQ: DSCO)

"Up 26.79% in morning trading"

 

Detailed Quote: http://www.otcpicks.com/quotes/DSCO.php

 

Discovery Laboratories, Inc. is a biotechnology company developing Surfactant Therapies for respiratory diseases. Surfactants are produced naturally in the lungs and are essential for breathing. Discovery Labs' novel proprietary KL4 Surfactant Technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, aerosol or lyophilized formulations. In addition, Discovery Labs' proprietary Capillary Aerosolization Technology produces a dense aerosol, with a defined particle size that is capable of potentially delivering aerosolized KL4 surfactant to the deep lung without the complications currently associated with liquid surfactant administration. Discovery Labs is focused initially on developing its KL4 surfactant pipeline to build a pediatric franchise that will potentially address several respiratory conditions affecting neonates and young children, beginning with Respiratory Distress Syndrome (RDS).

 

DSCO News:

 

September 10 - Discovery Labs and FDA to Meet On September 29, 2009 to Discuss Potential Path for SURFAXIN Approval

 

Discovery Laboratories, Inc. (Nasdaq: DSCO) has received written notification from the U.S. Food and Drug Administration (FDA) that a meeting has been scheduled for September 29, 2009. This meeting will serve as a follow-up to the June 2 meeting with the FDA and the FDA's April 17 Complete Response letter. The objective of this meeting is to define the options available to Discovery Labs to resolve the remaining primary issue that Discovery Labs must address to gain U.S. marketing approval of Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

 

At the upcoming September 29 meeting, Discovery Labs plans to discuss with the FDA a limited Surfaxin clinical trial design and whether conducting such trial, while simultaneously employing the fetal rabbit Biological Activity Test (BAT, a quality control and stability release test), could potentially address the key remaining requirement for Surfaxin approval. This approach was suggested by the FDA at the June 2 meeting as a way for Discovery Labs to increase the likelihood of gaining Surfaxin approval. In addition, Discovery Labs plans to review its ongoing quality improvement efforts, intended to further refine the BAT in accordance with Discovery Labs' continuing quality improvement initiatives, with the FDA.

 

Background

 

The April 17 Complete Response letter from the FDA and the June 2 meeting focused primarily on certain aspects of the BAT, specifically whether preclinical data generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to the to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.

 

During the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an array of quality control tests, but did not employ the BAT to evaluate biological activity of the Surfaxin clinical drug product. After completing the Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery Labs validated and implemented the BAT as a recurring quality control test to confirm biological activity for Surfaxin release and stability testing. Based on agreements reached in meetings with the FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical experiments to establish comparability between Surfaxin drug product used in Phase 3 clinical trials and the Surfaxin drug product intended to be manufactured for commercial use. Accordingly, Discovery Labs initiated a series of side-by-side studies employing both the preterm lamb model of RDS and the BAT and believes that the correlated results demonstrate comparability and support approval of Surfaxin.

 

At the June 2 meeting with the FDA, Discovery Labs presented data from the preterm lamb model and BAT studies, together with a comprehensive statistical evaluation of such data, intended to establish the comparability of clinical drug product to Surfaxin drug product to be manufactured for commercial use. The comprehensive statistical evaluation was a comparative regression analysis using an accepted FDA statistical method. Discovery Labs believes that the data and related statistical evaluation are highly supportive of the comparability of clinical drug product to commercial Surfaxin.

 

However, the FDA stated at the June 2 meeting, that data generated from the preterm lamb model and BAT studies must demonstrate, in a point-to-point analysis, the same relative changes in respiratory compliance between both models over time. Based on this standard, Discovery Labs believes that establishment of comparability in this manner would be an extremely high hurdle and that, from the FDA's perspective, the data analysis provided by Discovery Labs did not meet that standard.

 

In addition, the FDA suggested that the comparability studies in the preterm lamb model and the BAT would not be necessary if the BAT had been implemented to assess Surfaxin drug product used in the Phase 3 clinical trials. The FDA also suggested that, to increase the likelihood of gaining Surfaxin approval and as an alternative to demonstrating comparability using the preterm lamb model and BAT, Discovery Labs could consider conducting a limited clinical trial, while simultaneously employing the BAT, as a path forward to Surfaxin approval.

 

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Information contained in our report will contain "forward looking statements" as defined under Section 27A of the Securities Act of 1933 and Section 21B of the Securities Exchange Act of 1934. Subscribers are cautioned not to place undue reliance upon these forward looking statements. These forward looking statements are subject to a number of known and unknown risks and uncertainties outside of our control that could cause actual operations or results to differ materially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company's most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating the forward looking statements included in the report and not place undue reliance upon such statements. We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurance as to the accuracy or completeness of the information provided, including information regarding a profiled company's plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company's operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related public information sources which we believe to be reliable but we cannot guarantee the accuracy of the information. To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the report, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to, lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information). We encourage you to invest carefully and read investment information available at the websites of the SEC at http://www.sec.gov/ and FINRA at http://www.finra.org.

 

Disclosure: OTCPicks.com has been compensated two thousand five hundred dollars by a third party (BlueWave Advisors) for KNDR advertising and promotional services. OTCPicks.com has been compensated nine thousand five hundred dollars by the company for CHYU advertising and promotional services. OTCPicks.com has been compensated three thousand five hundred dollars from a third party (Longview Communications Corp.) for ACCP advertising and promotional services. OTCPIcks.com is being compensated eight thousand dollars by a third party (Stock Awareness Group) for SGDH advertising and promotional services. OTCPicks.com has been compensated two hundred thousand free trading shares by a third party (Microcap Management) for JAGR advertising and promotional services. OTCPicks.com has been compensated eight thousand dollars by a third party (Mickey Reno) for NVSR advertising and promotional services. OTCPicks.com has been compensated two thousand five hundred dollars by a third party for APDN advertising and promotional services. Additionally OTCPicks.com has been compensated a total of five thousand dollars by BlueWave Advisors for multiple one week promotions of APDN. OTCPicks.com has been compensated six thousand dollars by a third party (Mercom Capital) for ALRT advertising and promotional services. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. OTCPicks.com is a website partially owned by BlueWave Advisors, LLC, a financial public relations firm. BlueWave Advisors, LLC, its principal and/or its affiliates will hold positions in the company profiled and may buy or sell securities at any time without notice.