Pluristem up on heart study. After the bell Alimera gets FDA priority review Print
By BioMedReports.com Staff   
Monday, 30 August 2010 18:13
Alimera Sciences, Inc., (Nasdaq:ALIM) after the market close on Monday, the company announced that the Company's New Drug Application (NDA) for Iluvien(R) (fluocinolone acetonide intravitreal insert) has been accepted for filing and granted Priority Review status by the U.S. Food and Drug Administration (FDA).


Iluvien is Alimera's investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide for the treatment of diabetic macular edema (DME).

Shares rose 40 cents to $8.50 after the bell.

Bionovo, Inc. (Nasdaq: BNVI, BNVID) announced today after the bell that it will effect a 1-for-5 reverse stock split, that will become effective with the opening of trading on August 31, 2010. The primary objective in effecting a reverse stock split at this time is to better enable the company to maintain the listing of its common stock on The NASDAQ Capital Market. The company's common stock will continue trading on The NASDAQ Capital Market and will begin trading on a split-adjusted basis at the opening of trading on Tuesday, August 31, 2010.

SCOLR Pharma, Inc. (NYSE AMEX: DDD) today after the bell announced that it has signed an agreement with The Emerson Group to provide sales support for the Company's new line of extended-release nutritional and over-the-counter drug products.

Earlier in the day:

Pluristem Therapeutics Inc. (NasdaqCM: PSTI) (DAX: PJT) today announced that its PLX cell therapy product, derived from human placenta, a non-controversial, non-embryonic, adult stem cell source, was selected as the only cell therapy product candidate to enter into a study seeking treatments for diastolic heart failure (DHF) in the European Commission’s Seventh Framework Program (FP7). Pluristem is to receive a grant from the FP7 to cover study related R&D expenses.

The study will test the effects of PLX (PLacental eXpanded) cells on various heart cell types under high glucose conditions. Uncontrolled high glucose levels in type 2 diabetes patients can lead to oxidative stress in the heart. This condition can cause local inflammation which can result in fibrosis of the heart muscle and the development of diastolic heart failure (DHF). The properties of Pluristem’s PLX cells may prevent or delay the development of this extremely common but devastating disease.

"There has been a growing interest in the potential of PLX cells to treat a variety of clinical indications following the release of the PLX-PAD clinical study interim results, which demonstrated safety and shows a trend of efficacy. The decision to use our PLX cells in this DHF study is further verification of the uniqueness of Pluristem’s PLX cells as an off-the-shelf product that requires no tissue matching prior to administration," said Zami Aberman, chairman and CEO of Pluristem. "There is a significant unmet medical need for the treatment of DHF, not only in Europe but also globally, and Pluristem’s placenta-derived cell therapy may provide patients and physicians with an effective and safe treatment option for this disease."

Approximately 15 million people worldwide suffer from DHF with the prevalence increasing as the population ages. Heart failure has now become the leading cause of hospitalization among patients over the age of 65 and it has been estimated that the cost of treating the disease in 2010 will exceed $39 Billion in the U.S. alone.

The Study consortium consists of 19 partners from 12 countries. Its objective is to investigate how metabolic derangements contribute to DHF, how diagnostic algorithms for DHF can be improved by assessing metabolic risk and how the correction of metabolic risk or of metabolic risk-induced cardiac abnormalities can open new therapeutic perspectives for DHF.

On heavy volume, shares of Pluristem rose nearly 10% to $1.11.

BMP Sunstone Corporation (Nasdaq:BJGP) today announced that its "Hao Wawa" (Good Baby) brand was ranked first among the top three pediatric medicine brands on China's Pharmaceutical Pediatric Medicine Brand list, under "Healthy China - 2010 China Pharmaceutical Brand Evaluation." The results were based on an extensive evaluation of 20 well-known domestic and international medicine brands, nationally, and officially released on August 28, 2010, in Shanghai.

The evaluation was organized by the China Medicine Retail Development and Research Center (MDC), the China Pharmaceutical Enterprises Cooperation and Development Organization (CPEO) and the China Pharmaceutical Brand Evaluation Committee. Safety and efficacy were the two indicators used to evaluate all domestic and international participants in the evaluation.

David Gao, Chief Executive Officer of BMP Sunstone, stated, "We are honored to receive this award. Safety enhancement is becoming increasingly key to the development of the pharmaceutical industry in China; a trend driven by both government initiatives and competition among manufacturers. The award speaks to the quality and strength of our brand, particularly after our subsidiary, Sunstone (Tangshan) Pharmaceutical Co., Ltd, was listed among the 'Top 100 China Pharmaceutical Enterprises' in 2009."

Shares of BMP Sunstone rose as high as $6.80 before pulling back late in the day to close at $6.53.

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain. The presentation will take place on Friday, September 10, as part of the 7:00 - 9:00 AM podium presentation session.

BDSI previously announced positive top-line results from the study which showed that BEMA Buprenorphine demonstrated a statistically significant improvement compared to placebo in the primary efficacy endpoint, SPID-8 (sum of pain intensity differences at 8 hours; baseline observation carried forward analysis).

In addition, data will be presented which looked at a subset of patients with severe pain, where the analgesic efficacy of BEMA Buprenorphine was more profound.

Bioheart, Inc. (OTC Bulletin Board:BHRT.ob) The mission of the Cell Therapy Foundation is to improve public health through the support of effective adult stem cell research and education. The Foundation aims to promote basic and applied knowledge, processes and cell therapies. As part of this mission Cell Therapy Foundation provides updates concerning advances in adult stem cell research. A recent initiative tabulating clinical trials involving cell therapy identified Bioheart's MyoCell as one of only a few cell therapies that are presently in the Phase III stage of clinical trials in the United States. MyoCell has shown the ability to improve heart function in patients suffering from heart failure.

Dr. Warren Sherman, Lead Investigator of the MARVEL trial and Director of Stem Cell Research and Regenerative Medicine at Columbia University Medical Center stated, "The early positive clinical results from Bioheart's MyoCell are truly an example of how far along adult stem cell research has come. We are very close to proving the value of adult stem cell therapy for a major unmet indication such as heart failure. This is very exciting to all of us in the field."

Bioheart's MyoCell is a composition of immature myoblasts or adult muscle stem cells derived from a biopsy of a patient's thigh muscle. This muscle biopsy is sent to Bioheart's cGMP laboratory where the muscle stem cells are isolated and expanded. The cells are delivered directly into the scar tissue of the heart using Bioheart's MyoCath, a deflecting tip needle catheter. These stem cells may form contractile muscle in the scar tissue of damaged hearts.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for BMN-701, a novel fusion of insulin-like growth factor 2 and alpha glucosidase (IGF2-GAA) in development for the treatment of Pompe disease. An investigational new drug application (IND) for BMN-701 has been submitted, investigational material has been manufactured and a Phase I/II study is expected to start in the first quarter of 2011.

Medicis (NYSE:MRX) today announced that the U.S. Food and Drug Administration (FDA) has approved additional strengths of SOLODYN (minocycline HCl, USP) Extended Release Tablets in 55 mg, 80 mg and 105 mg dosages for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The Company believes all forms of SOLODYN currently approved for use, including the 55 mg, 80 mg and 105 mg dosages, are covered by its patent rights, which include several issued patents and two patent applications for which the U.S. Patent and Trademark Office (USPTO) recently issued Notices of Allowance.

Revolutions Medical Corporation (OTCBB:RMCP) has notified the MDEA that there had been an error in awarding the Free Vac syringe the 2010 Medical Design Excellence Award when in fact Free Vac misrepresented ownership of the syringe. The syringe was actually Revolutions Medical Corporation's RevVac auto retractable safety syringe. This was recently confirmed in a deposition. Ron Wheet, CEO of Revolutions Medical Corporation, states, "The Medical Design Excellence Awards competition, organized and presented by Canon Communications LLC, is the only awards program that exclusively recognizes contributions and advances in the design of medical products. Now in their fourteenth year, the MDEA competition recognizes manufacturers, engineers, scientists designers, and clinicians who are responsible for the leading edge technology that continues to push healthcare to new heights. I am confident that this prestigious organization that prides itself in recognizing the achievements of the workers and companies like ours, will give Revolutions Medical Corporation and the RevVac vacuum operated auto retractable safety syringe the proper recognition that it deserves."

Shares of RMCP shot up nearly 30% on heavy volume.

Also Monday:

Abbott (NYSE:ABT) will present at the Morgan Stanley Global Healthcare Unplugged Conference on Monday, Sept. 13, 2010.

Anavex Life Sciences Corp. ("ANAVEX") (OTCBB: AVXL) is pleased to announce that Dr. Cameron Durrant, the company's Executive Chairman, has been named in this year's "PharmaVOICE 100" as one of the 100 most inspiring people in the life sciences sector.

BioDelivery Sciences International, Inc. (Nasdaq:BDSI) announced today that its abstract showing the results of a Phase 2 clinical study of BEMA Buprenorphine in the treatment of pain has been selected for oral presentation at Pain Week 2010, a national conference educating frontline clinicians who are faced with treating patients with pain.

Biomagnetics Diagnostics Corp., (PINK SHEETS:BMGP) a developer of revolutionary diagnostic systems and technology for HIV, hepatitis, tuberculosis and malaria dete tion, and other innovative technologies, today announced the signing of a Letter of Intent (LOI) with Lanzhou New Sunshine Plastics Industry LTD.

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced the publication of new data supporting the safety and efficacy of Caldolor® (ibuprofen) Injection in pre and post-operative orthopedic surgery patients.

Emerging Healthcare Solutions, Inc. (Pink Sheets:EHSI) disclosed today that their first comprehensive medical iPhone Application module named MedAnywhere HHC has entered the final phase of development.

Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter Plc. today announced preliminary top-line results from an 8-week Phase II clinical trial of the novel, investigational antipsychotic agent cariprazine for the treatment of bipolar depression.

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) announced today that it will present at Rodman & Renshaw's 12th Annual Healthcare Conference in New York on Monday, September 13, 2010, at 2:50 p.m. ET.

Genzyme Corp. (NASDAQ: GENZ) today confirmed that it has received an unsolicited, non-binding proposal from Sanofi-Aventis to acquire all the outstanding shares of Genzyme for $69 per share in cash.

Healthy Coffee International, Inc. (PINKSHEETS: HCEI) announced that it has launched its Founders Club and awards Mercedes cars in Puerto Rico.

Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK) announced that the Company will release results for its first quarter of Fiscal Year 2011 ended July 31, 2010, prior to the market opening on Wednesday September 8, 2010 and will hold a conference call to discuss its financial results at 10 a.m. Eastern Time.

King Pharmaceuticals, Inc. (NYSE: KG) announced today the appointment of Jeffrey A. Bailey to the position of Chief Commercial Officer. Mr. Bailey will be responsible for the Company's commercial activities in the branded pharmaceutical business and will lead all Sales, Marketing, Managed Care, Sales Operations and Business Analytics.

Marina Biotech, Inc. (NASDAQ: MRNA), a leading RNAi-based drug discovery and development company, today announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for patentapplication U.S. 11/745,003 broadly covering amphoteric liposomal formulations, including the Company's proprietary SMARTICLES® technology, for delivery of siRNAs and other compounds with therapeutic application.

New Leaf Brands, Inc. (OTCBB: NLEF) a provider of great tasting, all natural, healthy beverages, today announced the addition of 17 new distributors in California through its agreement with Coast Brands Group, LLC. All 17 distributors, which service the entire state canvassing more than 25,000 retail outlets, will market and sell New Leaf's 11 unique tea flavors sweetened with 100% organic cane sugar, 4 lemonades made with 6%-10% real fruit juice and sweetened with 100% organic cane sugar and 2 diet iced teas sweetened with Splenda™.

Niusule Biotech Corp. (OTCBB: NIUS) (the Company), a fast growing China-based bio-pharmaceutical company focusing on animal-health products and human nutraceutical supplements, today announced they will present at the Rodman & Renshaw 2010 Annual Global Investment Conference.

PharmaGap In . (TSX VENTURE:GAP)(OTCBB:PHRGF) announced today that it has completed the initial tranche of an offering of equity units previously announced on August 11 of up to $3 million.

Santarus, Inc. (NASDAQ: SNTS), a specialty biopharmaceutical company, today announced that it has extended the maturity date of its $25 million revolving line of credit with Comerica Bank from July 11, 2011 to July 11, 2013.

ThermoGenesis Corp. (Nasdaq:KOOLD), a leading supplier of innovative products and services that process and store adult stem cells, said today it has sold two BioArchive® Systems to HealthBanks Biotech Company, Ltd. (HealthBanks).

Yongye International, Inc. (Nasdaq:YONG) a leading manufacturer, developer and distributor of "Shengmingsu" brand plant and animal nutrient products in China, today announced the opening a new production facility in Wuchuan County, Hohhot, Inner Mongolia.

Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.




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