|Vivus moves higher on analyst upgrade. Cardiac Science falls on FDA warning. After the bell Discovery Labs surges on positive update|
|By BioMedReports.com Staff|
|Tuesday, 27 April 2010 20:04|
Below is a list of the companies that made news in the healthcare sector on Tuesday, April 27, 2010.
Discovery Laboratories, Inc. (Nasdaq:DSCO), soared in the after hours session today as the company provided an update on Surfaxin and key pipeline and business initiatives. The company also reported financial results for the first quarter ended March 31, 2010.
Discovery Labs reported substantial progress on addressing the sole remaining issue to gain potential FDA approval in 2011 of Surfaxin for Respiratory Distress Syndrome (RDS) in premature infants. The company said re-validation of the optimized fetal rabbit Biological Activity Test (BAT) is 90% complete and currently meeting all pre-specified acceptance criteria. Feedback from the FDA on theproposed Surfaxin preclinical program which employs the optimized and revalidated BAT is expected in May 2010.
In addition, the company expects top line results in June 2010 for its Phase 2 clinical trial to determine whether Surfaxin improves lung function and reduces the duration and related risk-exposure of mechanical ventilation in children up to two years of age diagnosed with Acute Respiratory Failure (ARF).
On heavy volume, shares pushed higher by 8 cents or more than 15% in the after hours market.
Also After the bell:
Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), moved higher after the bell after the company announced that it has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI’s Diamondback 360 System in the coronary arteries. "The unconditional FDA IDE approval continues CSI’s progress toward regulatory approval for a coronary application and potential significant market expansion for our product technology," said David L. Martin, president and CEO of Cardiovascular Systems. "We are optimistic the ORBIT II study will reinforce the safety and effectiveness of removing plaque using the Diamondback 360 System, as already shown in our ORBIT I coronary feasibility study of 50 subjects and in the treatment of more than 25,000 patients to-date with peripheral arterial disease (PAD)."
Dynavax Technologies Corporation (NASDAQ:DVAX ) moved higher after the bell today. The company announced after the close that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV has assessed subject safety data for 1,548 subjects that received their first injection and 1,225 subjects that received a second injection, and determined that the studies may continue without modification of the existing protocols.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
Mesa Laboratories, Inc. (Nasdaq:MLAB ), a Lakewood, Colorado based manufacturer of electronic instruments and disposables, today announced the acquisition of SGM Biotech, Inc., a Montana manufacturer of biological indicator (BI) products.Under the terms of the transaction, Mesa Labs has acquired all of the outstanding shares of SGM for approximately $12 million in cash. The acquisition of SGM by Mesa Labs expands and complements Mesa's existing offering of biological indicators through its Raven Labs division. SGM and Raven are both well established brands in the BI marketplace, with loyal customer followings.
Molecular Insight Pharmaceuticals, Inc. (NASDAQ:MIPI), after the bell today received a letter from The NASDAQ Stock Market notifying the Company it has regained compliance with NASDAQ's minimum market value of listed securities rule.
NexMed, Inc. (Nasdaq: NEXM - News), today announced the appointment of Stephen B. Howell, M.D., as Chairman of its Scientific Advisory Board. Dr. Howell currently serves as a medical oncologist and Professor of Medicine at the University of California, San Diego. He also serves as Associate Director for Clinical Research and Director of the Cancer Therapeutics Training Program at the Moores Comprehensive Cancer Center at the University of California, San Diego, and runs the Clayton Foundation Drug Resistance Laboratory at the Cancer Center. During his career, Dr. Howell has co-founded three pharmaceutical companies, including DepoTech (1989), Beacon Laboratories (1995), and Targa Pharmaceuticals (2003), serving as Medical Director of each.
PPD, Inc. (Nasdaq: PPDI) today announced its contract research facility in Athlone, Ireland, has been awarded manufacturer licenses by the Irish Medicines Board (IMB). The licenses support investigational medicinal products and marketed products and provide laboratory certifications for quality control of medicinal products.
TomoTherapy Incorporated (NASDAQ:TOMO), gained in the after hours session after the producer of products for advanced radiation therapy, released financial results for the first quarter ended March 31, 2010. The company reported a smaller than expected quarterly loss, which was helped by higher product and services revenue. In the first quarter,Tomo reported a net loss of $4.7 million, or 9 cents a share, compared with a loss of $13 million, or 26 cents a share a year ago. Revenue rose 37 percent to $42.1 million. Analysts had expected the company to post a loss of 21 cents a share, on revenue of $34.5 million. The company also reaffirmed its revenue and earnings guidance for full-year 2010, expecting 2010 revenue to be comparable to 2009 revenue of $170 million to $190 million, with a net loss attributable to shareholders in the range of $0.65 to $0.85 per share. In the after hours market, shares of Tomo Therapy shot up more than 7% or 26 cents.
Volcano Corporation (Nasdaq:VOLC), after the bell announced that it has entered into a distribution agreement with AngioScore for its AngioSculpt PTCA Scoring Balloon Catheter for coronary indications in Japan. This is the first of what Volcano believes will be many products distributed by Volcano Japan, which now includes more than 50 direct sales representatives.
Earlier in the day Tuesday:
VIVUS, Inc. (Nasdaq:VVUS) jumped today after a Brean Murray Carret analyst initiated coverage on the stock with a "Buy" rating.
Analyst Jonathan Aschoff placed a $15 price tag on the stock as he expects that the FDA will approve the companies lead drug candidate, Qnexa, in October. An FDA panel of experts is scheduled to make a recommendation on the drug candidate July 15. The FDA is not required to follow the advice of its committees, but it often does.
Aschoff also said he expects Vivus to partner with a large pharmaceutical company to help market Qnexa, post FDA approval.
Shares rose 74 cents or more than 8%, closing the day at $9.56.
Cardiac Science Corporation (Nasdaq:CSCX) fell sharply today after the FDA issued a warning about faulty components in 14 types of external defibrillators made by the company, some of which are sold by other companies including General Electric Co's, GE Healthcare unit. Cardiac Science shares dropped almost 29 percent, or 63 cents, closing the day at $1.57.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that, based on information received from the U.S. Food and Drug Administration (FDA), the Company plans to resubmit its New Drug Application for ANX-530, or Exelbine, in the fourth quarter of 2010.
"We are pleased to have clarified with the FDA certain matters concerning the stability data necessary to file the Exelbine NDA," said Brian M. Culley, Chief Executive Officer of ADVENTRX. "The studies that will generate the stability data from our intended commercial manufacturing site that the FDA wishes to see are ongoing, and we plan to resubmit the NDA in the fourth quarter of this year."
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) announced that it has received a letter from the Nasdaq Stock Market notifying it that the closing price per share of the Company's common stock was above the US$1.00 minimum bid price for 10 consecutive trading days and that, as a result, the Company has regained compliance with the minimum bid price rule as of Friday, April 23, 2010.
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that it has published results from its Phase II GEMINI study.The study showed that treatment with ALN-RSV01 showed statistically significant anti-viral activity, including a decreased RSV infection rate and an increase in the number of subjects who remained free of infection.
Antares Pharma, Inc. (Amex: AIS), a leader in self-injection drug delivery technology and Uman Pharma, a manufacturer of top-quality injectable pharmaceutical products based in Quebec, Canada, today announced the formation of a strategic alliance covering Antares’ VIBEX MTX. Under the terms of the agreement Antares and Uman will invest jointly to develop and commercialize VIBEX MTX, Antares’ novel pressure-assisted, injection device, containing methotrexate (MTX) for rheumatoid arthritis and related autoimmune conditions in the US and Canada.
AstraZeneca (NYSE:AZN) reported today that CRESTOR (rosuvastatin) has been approved in nineteen countries within the EU for the prevention of major cardiovascular events in patients who are at high risk* of having a first cardiovascular event."This new indication is a significant milestone and means that rosuvastatin can now be prescribed to high risk patients to prevent CV events including heart attacks and strokes," said Michael Cressman, Executive Director of Clinical Research for CRESTOR. "Clinical studies have previously shown that rosuvastatin was the most effective statin at lowering LDL-C, had a significant effect on raising HDL-C and slowed the progression of atherosclerosis, an underlying cause of cardiovascular disease."
Bioject Medical Technologies Inc. (OTCBB: BJCT), a leading developer of needle-free injection therapy systems (NFITS), today announced that the US Military Malaria Vaccine Program presented results of its study using the Biojector 2000 with a recombinant DNA vaccine at two recent conferences. A Cooperative Research and Development Agreement was signed with the Navy in April 2009 to work together on the study. On April 12, 2010, the results were presented at the Keystone Conference in Colorado and on April 26, 2010, the results were presented at the 13th Annual Conference on Vaccine Research sponsored by the National Foundation for Infectious Diseases and held in Bethesda, Maryland.
China Biologic Products, Inc. (Nasdaq:CBPO), a leading plasma-based biopharmaceutical company in China, today announced that its majority-owned subsidiary, Shandong Taibang Biological Products Co. Ltd., has been earmarked by the Shandong provincial government, as one of twelve model Shandong-based biopharmaceutical companies, eligible to receive financial subsidies and tax concessions related to new drug research and development in connection with the provincial government's recently announced program to drive growth in the region's biopharmaceutical industry.
ChromaDex Corporation (OTC Bulletin Board:CDXC.ob), a natural products chemistry company which provides novel and innovative ingredients to the dietary supplement, food, beverage and cosmetic markets, announced today The Frost Group, LLC, led by Miami entrepreneur and billionaire Dr. Phillip Frost, has agreed to make an investment in ChromaDex. The amount of the investment was not disclosed.
Curis, Inc. (NASDAQ: CRIS) announced today that its licensee Debiopharm S.A. has treated the first patient in a Phase I clinical trial for small molecule heat shock protein 90 (Hsp90) inhibitor Debio 0932, formerly called CUDC-305.
Under the terms of the August 2009 license agreement between Curis and Debiopharm, Curis will receive a $3 million milestone payment from Debiopharm upon Debiopharm’s treatment of the fifth patient in this Phase I clinical trial.
DARA BioSciences, Inc. (Nasdaq:DARA) announced that on April 26, 2010, DARA Therapeutics, a subsidiary of DARA BioSciences, and the Division of Cancer Prevention, National Cancer Institute (NCI), National Institutes of Health (NIH), entered into a Clinical Trials Agreement to advance the clinical study of KRN5500 for the treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN) in patients with cancer. Under the terms of the collaboration, NCI will fund the studies and DARA will supply KRN5500 and placebo. KRN5500 has successfully completed a Phase 2 clinical trial treating cancer patients for neuropathic pain. In that study, KRN5500 met its primary endpoint and was statistically significantly better than placebo.
GeNOsys, Inc. (OTCBB: GNYS ) announced they are sponsoring a Phase I safety trial in collaboration with Nitric Solutions Inc. GeNOsys will be testing their patented nitric oxide generator and nitric oxide producing formula for safety and effectiveness in treating disease. In a parallel study Nitric Solutions will be testing the efficacy of their prophilactic nitric oxide producing formula Nitrisol. The studies will be conducted in a Canadian government research facility by Dr. Kevin Kane; results are expected to be available within 30 days. GeNOsys will demonstrate that nitric oxide can be safely administered with the generator in compliance with FDA guidelines. Nitric Solutions Inc. will show the antimicrobial effectiveness of Nitrisol in the treatment of H1N1.
Hana Biosciences (OTCBB:HNAB), announced that the Company has completed a pre-New Drug Application meeting with the U.S. Food and Drug Administration related to its lead product candidate, Marqibo for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission.
Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
Icagen, Inc. (Nasdaq:ICGN) provided an update on clinical development plans for ICA-105665, the Company's novel drug candidate for the treatment of epilepsy and pain. The company proposed, and the FDA approved, a study of up to two additional cohorts of photosensitive epilepsy patients at higher doses of ICA-105665. In addition, subject to review of a finalized protocol, the FDA agreed to a second study of higher doses of ICA-105665 in a multiple ascending dose trial of healthy volunteers. The objective of both of these studies is to evaluate higher doses of ICA-105665 in order to optimize dose selection for subsequent larger clinical trials.
Illumina, Inc. (NASDAQ:ILMN) announced shipment of HiScanSQ, the first instrument to integrate microarray analysis and next-generation sequencing in a modular design that can evolve with changing research needs. HiScanSQ is designed for smaller core labs that don’t want to purchase separate platforms to run sequencing and microarray experiments; groups that primarily run arrays but are looking to move into sequencing for the first time; and facilities that run both arrays and capillary electrophoresis sequencing and are looking to add high-throughput sequencing.
NeoStem, Inc. (Amex: NBS) today announced the official launch of the Company's Adult Stem Cell Collection Center and Research & Development laboratory at the Company's 8,000 square foot facility at the Riverside Technology Center in Cambridge, Massachusetts.
Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing Tovaxin®, a personalized T-cell therapy for multiple sclerosis (MS), announced today the hiring of an experienced cell therapy immunologist to lead the Company’s research and development efforts including the further development of Tovaxin. Donald Healey, Ph.D., joins Opexa having developed an international reputation in the area of cellular therapy in both the U.S. and the U.K.
Pluristem Therapeutics Inc. (Nasdaq:PSTI) (DAX:PJT) announced interim top-line results from its Phase I clinical trials utilizing its placenta-derived cell therapy product, PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The interim data demonstrated that PLX-PAD is safe, well tolerated and effective. In a separate release today, the company announced that it has entered into definitive agreements with selected investors to sell restricted common stock and warrants for aggregate gross proceeds of approximately $2.7 million. The offering includes 2,420,293 shares of common stock, warrants to purchase 726,088 shares of common stock at an exercise price of $1.25 per share and warrants to purchase 726,088 shares of common stock at an exercise price of $1.40 per share.
Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today it has submitted validation data regarding the Company's manufacturing process for taliglucerase alfa to the U.S. Food and Drug Administration (FDA). The Company made the submission in response to a request from the FDA for validation data from the Company's upgraded manufacturing facility. The FDA is currently reviewing the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease.
SpectraScience, Inc. (OTC Bulletin Board:SCIE.ob), a San Diego based medical device company, announced today that its senior management team will exhibit at Digestive Disease Week (DDW) in New Orleans, May 2-5. DDW is the world's leading conference for gastrointestinal clinicians and scientists.
RadNet, Inc. (Nasdaq:RDNT), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 185 fully-owned and operated outpatient imaging centers, today reported it has acquired three multi-modality facilities from the Sonix Medical Resources, Inc. bankruptcy proceeding in New York.
RadNet paid $2,250,000 for the three facilities which currently produce approximately $7 million of combined annual revenues. The facilities located in Brooklyn, New York, Chatham, New Jersey and Haddon Heights, New Jersey operate a combination of MRI, CT, mammography, ultrasound, fluoroscopy, x-ray and related modalities.
ViroPharma Incorporated (Nasdaq:VPHM) announced that it has initiated an open-label, multi-dose Phase 2 study to evaluate the safety, and pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous administration of Cinryze in 24 adolescents and adult subjects with hereditary angioedema (HAE). Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.
Cornerstone Therapeutics Inc. (Nasdaq: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that Craig A. Collard, President and Chief Executive Officer, will be presenting a corporate overview at Deutsche Bank's 35th Annual Healthcare Conference at 1:35 PM ET on Wednesday, May 5, 2010, at the InterContinental Hotel in Boston, MA.
Dyax Corp. (NASDAQ:DYAX), a developer of novel biotherapeutics for unmet medical needs, announced today that Gustav A. Christensen, President and Chief Executive Officer of Dyax, will present at the Deutsche Bank 35th Annual Health Care Conference, being held May 3-5th at the InterContinental Hotel in Boston, MA.
Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today that Adrian Adams, President and CEO, will present at the Deutsche Bank 35th Annual Health Care Conference on Tuesday May 4, 2010 at 9:20 am ET in Boston, MA.
Lorus Therapeutics Inc. (TSX:LOR) (OTCBB:LRUSF) abiopharmaceutical company specializing in the research and development of pharmaceutical products and technologies for the management of cancer, today announced that it has received notification that its common stock is now eligible for trading on the Over-the-Counter Bulletin Board ("OTCBB"), under the trading symbol "LRUSF" effective Monday, April 26, 2010.
NEI (Nasdaq: NENG), a leading provider of application platforms, appliances and lifecycle support services for software developers, OEMs and service providers worldwide, today announced that it has become a member of the GE Intelligent Platforms Premier Integration Program, an initiative designed to help customers rapidly design, build and bring to market more complete, qualified and scalable systems with greater competitive advantages.
Renhuang Pharmaceuticals, Inc. (Pink Sheets: RHGP) a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines ("TCM"), today announced the appointment of Mr. Dianjun Pi to its board of directors effective April 26, 2010, and that the Company has established nominating and compensation committees.
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Paragraph IV Notice Letter from Anchen Pharmaceuticals, Inc. advising of the filing of an Abbreviated New Drug Application for a generic version of Shire's 1 mg, 2 mg, 3 mg, and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM).
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