|Javelin sues Hospira. FDA clears Abbott ovarian cancer test. After the bell: SCOLR Pharma tumbles on revenue forecast|
|By BioMedReports.com Staff|
|Thursday, 03 June 2010 18:25|
Below is a list of the companies that made news in the healthcare sector on Thursday, June 3, 2010.
SCOLR Pharma, Inc. (NYSE AMEX: DDD) after the bell today announced that it will be unable to meet its previously-issued 2010 revenue expectations with respect to sales of its new line of extended-release nutritional products. The revenue outlook for 2010 was based on the expected shipment of SCOLR products to certain large accounts which place orders three times a year based on a shelf planning cycle. Due to delays in product availability, SCOLR will be unable to meet the second of these scheduled review cycles and will not be able to ship products to these large accounts in 2010.
Stephen J. Turner, SCOLR’s President and CEO, stated, "We are disappointed that we missed the mid-year purchasing cycle for several large national retailers as a result of product availability. These issues have been, or will be, resolved in advance of the next purchasing cycle and we look forward to a successful launch of our branded nutritional products business. We are confident that our potential customer base remains unchanged and that demand for these novel products is expected to remain high. We are gratified that our customers remain enthused and we look forward to building on this interest as we grow this proprietary franchise of extended release supplements."
Mr. Turner continued, "The company’s goal is to focus on successfully launching these new products and utilize the revenues to fund our other product development programs. We continue to be encouraged about the opportunity our extended-release nutritional supplements will provide."
Shares of SCOLR Pharma dropped sharply in the extended session, falling 26 cents or nearly 30%.
Also after the bell:
Illumina, Inc. (NASDAQ: ILMN) today announced a new price of $19,500 for its individual genome sequencing service. In addition, the company announced a price of $14,500 per genome for groups of five or more participants using the same physician. Individuals with serious medical conditions for whom whole-genome sequencing could provide potential direct clinical value will be eligible for special pricing of $9,500 per genome. In all cases, the service requires individuals to follow Illumina’s physician-mediated process, which involves pre-service consultation, consent, and a seven-day cooling off period, with final genome data returned to the physician."We are very excited to be able to offer improved pricing for our individual genome sequencing service, as technological advancements continue to drive down costs," said Jay Flatley, president and chief executive officer of Illumina.
Kendle (Nasdaq:KNDL), a leading, global full-service clinical research organization (CRO), today announced it is ranked a top CRO to work with in the 2010 CenterWatch European Investigative Site Survey. Kendle is the only CRO to be ranked consistently among the top three providers for each of the past four years in the annual U.S. and European site surveys conducted by CenterWatch, a leading publishing and information services company focusing on the clinical trials industry.
Oculus Innovative Sciences, Inc. (Nasdaq: OCLS) today announced financial and operating results for the fourth quarter of fiscal year 2010, ended March 31, 2010. During the quarter the company increased product revenue by 65% with increases in the United States, Mexico, India, China and Middle East. Operating expenses for the quarter were down 9% from the same period last year and in line with previous guidance.
Oculus reported total revenue of $2.2 million in the fourth quarter of fiscal 2010, an increase of 51% over $1.5 million in the fourth quarter of fiscal 2009. Product revenue was $2.0 million, up 65% from $1.2 in the prior fourth quarter primarily due to higher sales in the United States, Mexico, China, India and the Middle East.
"A year ago we had a single product offering in the United States. Now, along with our partner Vetericyn, we have over a dozen products and formulations introduced in the U.S. and our portfolio continues to expand, including recent U.S. launches of the Microcyn Solution for post-surgical irrigation, the Microcyn Dermatology HydroGel and just earlier this week, the launch of the Microcyn Negative-Pressure Wound Therapy Solution," said Hoji Alimi, founder and CEO of Oculus. "Pursuant to our two-year strategic plan, we multiplied our single shot on goal to many shots on goal with five more expected FDA clearances and product launches in the U.S. in 2010 alone. These are significant market opportunities that are at the foundation for our targeted annual global revenue growth rate of 50% to 100% and guidance of annual revenue of $45 to $60 million by calendar year 2013 with operating profitability of 20%.
Trubion Pharmaceuticals, Inc. (Nasdaq:TRBN), jumped after the bell today after the company reported that the Board of Appeal for the European Patent Office (EPO) has upheld the Opposition Division's original decision (announced Sept. 11, 2008) to revoke Genentech and Biogen Idec's European Patent 1176981, generally directed to the use of an anti-CD20 antibody for the treatment of rheumatoid arthritis (RA). The revocation of the patent claims as originally granted is now final. Shares of Trubion moved up 26 cents in the extended session.
In news from earlier in the day:
Javelin Pharmaceuticals, Inc. (NYSE -- Amex: JAV) today announced that it has filed a lawsuit against Hospira, Inc. and Discus Acquisition Corporation, a wholly owned subsidiary of Hospira formed to acquire Javelin. The complaint, filed in the Delaware Court of Chancery by Javelin, seeks to compel Hospira and Discus to complete the agreed-upon merger pursuant to the definitive merger agreement among Javelin, Hospira and Discus dated April 17, 2010. Javelin also has filed a motion seeking expedited proceedings in Delaware court to allow for an early trial at which it will seek an order requiring Hospira to fulfill its obligations under the merger agreement and under the loan agreement dated April 17, 2010 among Javelin, Hospira and Innovative Drug Delivery Systems, Inc., a wholly-owned subsidiary of Javelin.
Hospira last month extended its $145-million tender offer for Javelin to June 2, but today, Hospira said the offer had been extended once again, this time set to expire at midnight, EST, on June 16.
Hospira stated that conditions of the offer had not been satisfied pointing out that Javelin's licensee for the pain treatment Dyloject has withdrawn all batches of the drug from the United Kingdom after finding the presence of a "white particulate matter" in some vials.
Shares of Javelin fell 19 cents, or nearly 13 percent, to $1.33 in Thursday trading.
Abbott (NYSE:ABT) reported today that the U.S. Food and Drug Administration has cleared a new diagnostic test to monitor ovarian cancer, a disease that will strike an estimated one out of every 71 women in the United States in their lifetimes. Abbott's new ARCHITECT HE4 (human epididymis protein 4) assay, the first automated test of its kind available in the United States, uses a simple blood test to aid in monitoring for the recurrence or progression of this disease.
"Disease monitoring in ovarian cancer is crucial. Seventy-five percent of all ovarian cancer patients will have a recurrence," said Cara Tenenbaum, vice president of policy and external affairs, Ovarian Cancer National Alliance. "New monitoring tools may provide patients and physicians with critical disease information to help make important treatment and care decisions."
Arena Pharmaceuticals, Inc. (Nasdaq:ARNA) announced today that it has entered into an agreement with Deerfield Management, a leading healthcare investment organization, to provide Arena with approximately $35.5 million through an equity investment.Under the terms of this financing, Arena will receive gross proceeds of approximately $35.5 million from the sale of 11 million shares of its common stock to Deerfield at a price of $3.23 per share.
Biovail Corporation (NYSE, TSX: BVF) today announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a license agreement with Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin). BLS has acquired the U.S. and Canadian rights to commercialize products containing istradefylline – a new chemical entity targeted for the treatment of Parkinson’s disease.
"This transaction again highlights our focus on late-stage specialty central nervous system products," said Bill Wells, Biovail’s Chief Executive Officer. "Istradefylline represents a novel approach for the treatment of Parkinson’s disease and provides another building block within our development pipeline, which now has four programs targeting unmet medical needs in Parkinson’s disease."
iBio, Inc. (OTCBB: IBPM) and the Fraunhofer USA Center for Molecular Biotechnology (CMB) announced today an agreement which provides a license of iBio’s proprietary technology to CMB for the development and manufacture of Global Health Vaccines for, and financed by, the Bill & Melinda Gates Foundation. Under the terms of the Agreement, CMB will use iBio’s technology under a non-exclusive, non-royalty bearing grant to develop and test new Global Health Vaccines funded by the Bill & Melinda Gates Foundation. The Agreement establishes iBio as the preferred manufacturer of Global Health Vaccines and provides a right of first refusal to iBio to provide technology transfer and vaccine manufacturing services to achieve Global Access Objectives on a commercially reasonable, competitive and sustainable cost basis. In accordance with prior agreements, iBio will own commercial rights to new technology and improvements arising during the course of the programs.
Intellect Neurosciences, Inc. (OTCBB:ILNS) announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a new patent related to the Company's humanized monoclonal antibody, IN-N01, being developed as a disease-modifying treatment for Alzheimer's disease and other related indications. The antibody's intended use is to promote clearance of the amyloid beta toxin from the brain, which leads to Alzheimer's disease.
Kinetic Concepts, Inc. (NYSE: KCI) today announced it is the first manufacturer to commit to submitting labeling for its products used in the home to the Food and Drug Administration as part of the agency’s medical device Home Use Initiative. KCI will voluntarily submit labeling for its products cleared by FDA for home use for inclusion in the home use device labeling repository on the FDA’s website.
Masimo (Nasdaq:MASI), the inventor of Pulse CO-Oximetry and Measure-Through Motion and Low Perfusion pulse oximetry, announced today that a new clinical study published online in the German pediatric journal, Klinische Padiatrie, showed that adding Masimo SET pulse oximetry screening to the physical examination of newborns was an effective method to achieve early diagnosis of critical congenital heart disease.
Oxygen Biotherapeutics, Inc. (Nasdaq:OXBT) today reported on the results of two University of Miami Miller School of Medicine studies involving the Company's third-generation perfluorocarbon, Oxycyte(R) perfluorocarbon emulsion. Both study reports showed that Oxycyte(R) has a marked neuroprotective effect in a rat model of spinal cord injury.
"Having proof-of-concept is a first step toward moving Oxycyte down the spinal cord injury track. The positive results observed in both studies may warrant efforts to pursue partnerships to conduct clinical studies of Oxycyte in spinal cord injury in the future," said Gerald Klein, Chief Medical Officer for Oxygen Biotherapeutics.
Exelixis, Inc. (Nasdaq:EXEL) today announced that it has entered into agreements providing for two separate financing transactions with Silicon Valley Bank and Deerfield Management for an aggregate of $160.0 million in capital. Exelixis expects to use the proceeds from these transactions to finance the repayment of the remaining obligations under its loan from GlaxoSmithKline and to fund development activities related to its lead compound XL184.
Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat -1 Combination Pack. Perrigo expects to begin shipping immediately. Monistat -1 has annual retail sales of approximately $90 million dollars.
PolyMedix, Inc. (OTC BB: PYMX),reported today that the company has successfully completed a second Phase 1B clinical safety and pilot efficacy study with PMX-60056, a small synthetic molecule designed to reverse heparin and low molecular weight heparin (LMWH) anticoagulants. The data from this study show that PMX-60056 met the study safety and efficacy endpoints regarding the reversal of the anticoagulant activity of the LMWH tinzaparin.
Radient Pharmaceuticals Corporation (RPC) (AMEX:RPC) announced today it is attending and presenting at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago June 4-8, 2010.
According to Douglas MacLellan, Chairman and CEO of Radient Pharmaceuticals, "RPC is excited to be an active participant at ASCO, an event that represents the largest gathering of physicians, scientists and oncology experts. This year's event serves as an ideal venue for RPC to share its latest scientific and product developments, company progress and market developments."
Rosetta Genomics (NASDAQ: ROSG) announced today the legal formation of Rosetta Green as a majority-owned subsidiary with Rosetta Genomics holding a 76% ownership position in the new company. Rosetta Genomics has signed a license agreement with Rosetta Green providing for the use of its microRNAs by Rosetta Green in agricultural and clean technology applications, with a particular focus on improving feedstocks for biofuels and crops for agriculture. Rosetta Green in-licensed three patent-pending applications covering the use of microRNAs in these areas.
RXi Pharmaceuticals Corporation (Nasdaq: RXII) and Royal Philips Electronics (NYSE: PHG, AEX: PHI) today announced that they have entered into a joint research agreement to explore the benefits of combining proprietary technologies from both companies for the targeted delivery of experimental therapeutics based on RNA interference (RNAi).
Compounds based on RNAi represent a promising new class of drugs for the targeted treatment of a number of diseases including cancer and cardiovascular disease. Currently, however, one of the greatest challenges in developing RNAi-based therapeutics is finding ways to deliver them to their target while keeping them fully active. The joint research program between Philips and RXi will address this challenge by exploring, in preclinical studies, the possibility of using RXi’s sd-rxRNA (self-delivering rxRNA) in conjunction with Philips’ ultrasound technology to achieve the targeted delivery and monitoring of RNAi-based compounds in cells.
Wright Medical Group, Inc. (NASDAQ: WMGI), a global orthopaedic medical device company, today announced the full commercial launch of the VALOR® Hindfoot Fusion Nail – the most comprehensive and advanced surgical product for fusion of the ankle joint. The system was designed in conjunction with world-renowned foot and ankle surgeons to facilitate ankle fusion in the treatment of skeletal deformity, late-stage arthritis, or complications resulting from diabetes (neuro-osteoarthropathy). Since its initial pre-market availability announced in November of 2009, the system has been limited to use in a few centers in the U.S. gathering early clinical results.
Advaxis, Inc., (OTCBB: ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, held its annual meeting on June 1st at 10:00 am EDT at Nasdaq MarketSite in Times Square. Audio of the meeting was webcast through the company's website.
AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced today that the company is scheduled to present at the Jefferies 2010 Global Life Sciences Conference on Thursday, June 10, 2010, at 9:00 a.m., Eastern Time, in New York City.
Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced that Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics, Inc., will present at the following investor conferences: Jefferies 2010 Global Life Sciences Conference on Tuesday, June 8, 2010 at 3:00 pm ET 9th Annual Needham Healthcare Conference on Wednesday, June 9, 2010 at 9:20 am ET.
Clinical Data, Inc. (NASDAQ: CLDA), today announced that data from a study of the Fc gamma 3A receptor (FCGR3A) in patients with follicular non-Hodgkin's lymphoma (NHL) validates the use of genotyping for genetic variants in the Fc gamma receptors for predicting response to rituximab.
Express Scripts, Inc. (Nasdaq: ESRX), today officially opened its new Technology & Innovation Center, a high-tech facility near its world headquarters campus that brings 300 jobs to the St. Louis region.
Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that Richard Scheller, Ph.D., Executive Vice President, Research and Early Development (gRED), is a winner of the 2010 Kavli Prize in Neuroscience, awarded for outstanding achievement in advancing our knowledge and understanding of the brain and nervous system.
HealthWarehouse.com, Inc. (OTC Bulletin Board: HEWA), a leading retail mail-order pharmacy, announced today the expansion of its discount generic list to include more than 750 medications under $20 for a 30-day supply
ImmunoGen, Inc. (Nasdaq: IMGN) announced today that Daniel Junius, President and CEO, will present at two investor conferences next week.
Martek Biosciences Corporation (Nasdaq: MATK) announced today that it has entered into a multi-year DHA and ARA agreement with Feihe Dairy, a wholly owned subsidiary of American Dairy, Inc.
Millipore Corporation (NYSE:MIL), a leading provider of technologies, tools and services for the global life science industry, today announced that its shareholders voted at a Special Meeting of Shareholders to approve the previously-announced acquisition of all outstanding shares of common stock of Millipore by Merck KGaA of Germany, the global pharmaceutical and chemical company.
PerkinElmer, Inc. (NYSE: PKI), a global leader focused on improving the health and safety of people and their environment, today announced that the Company will present at the Jefferies 2010 Global Life Sciences Conference on Thursday, June 10, at 1:30 pm Eastern Time at the Grand Hyatt Hotel in New York.
Sigma-Aldrich (Nasdaq: SIAL) will be presenting at the Jefferies 2010 Global Life Sciences Conference on Wednesday, June 9th at 3:00 PM Eastern Time in New York, NY.
ULURU Inc. (NYSE Alternext: ULU) announced today that advanced applications of the Nanoflex™ technology, related to future products in drug delivery and tissue engineering, will be presented at the 11th annual New Cardiovascular Horizons Meeting to be held in New Orleans, Louisiana on June 2-5, 2010.
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.