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Apr 30, 2009 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the presentation of preclinical data from its novel Universal Flu vaccine at two medical conferences this week. Through the addition of highly conserved antigens, Dynavax's Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic. The Company currently expects to initiate a Phase 1 clinical trial for its Universal Flu vaccine in the first half of 2010.
"As we see new pandemic threats emerge, we believe that our Universal Flu approach represents a state-of-the-art intervention with the potential to provide broad protection against new strains of the influenza virus," commented Dino Dina, M.D., President and Chief Executive Officer of Dynavax. "We have an urgent need for vaccines that can protect against unpredictable mutations of the influenza virus and reduce mortality and morbidity during pandemic outbreaks."
About Dynavax's Universal Flu Vaccine
Standard annual flu vaccines are designed to provide protection against the three strains of the influenza virus that are predicted to be most prevalent in the upcoming flu season. As such, these vaccines do not provide protection against divergent strains that emerge unexpectedly.
Dynavax's novel Universal Flu vaccine is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine. This unique approach is based on combining two highly conserved antigens and Dynavax's proprietary second-generation TLR9 agonist with standard flu vaccines:
-- Two highly conserved antigens NP and M2e offer protection against divergent strains
Dynavax's Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix 2 protein, is conserved but with some variations among species. NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains.
-- Dynavax's proprietary second-generation TLR9 agonist to enhance efficacy and enable dose-sparing
The conserved antigens NP and M2e are linked to Dynavax's proprietary second-generation TLR9 agonist. This approach has demonstrated the potential to boost the immune response and enable dose sparing, which could extend the quantity of standard flu vaccine available during a pandemic.
-- Standard flu vaccine
Dynavax's Universal Flu vaccine combines the conserved antigens NP and M2e with the Company's proprietary TLR9 agonist and the standard vaccine, which provides neutralizing antibodies. The Company's proprietary component (NP/M2e-ISS) could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV), and emerging strains such as H5N1 or H1N1.
Dynavax's research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has established a worldwide supply and option agreement with Novartis Vaccines and Diagnostics, Inc. for the Company's Universal Flu vaccine program.
Data Presentations at Medical Conferences
Dynavax is presenting data on its Universal Flu vaccine this week at two medical conferences:
-- Third International Conference on Influenza Vaccines for the World in Cannes, France April 27 - 30, 2009
-- Twelfth Annual Conference on Vaccine Research in Baltimore, Maryland April 27 - 29, 2009
These presentations are titled "A Universal Influenza Vaccine: Generating Broad Immunity Using an M2e/NP Fusion Protein" and are posted on Dynavax's website.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified pipeline of novel Toll-like Receptor (TLR) based product candidates. Based on Dynavax's proprietary technologies, these products specifically modify the innate immune response to infectious, respiratory, autoimmune, and inflammatory diseases. Dynavax has partnerships with leading pharmaceutical companies such as GlaxoSmithKline, AstraZeneca, and Novartis as well as funding from Symphony Dynamo, Inc. and the National Institutes of Health.
Apr 30, 2009 -- O.C. Beverages, Inc. (PINKSHEETS: OCBG) has established a health panel to evaluate and guide O.C. Beverages in developing healthy beverages. The Company has already developed Glutathione/Selenium bottled water which will be introduced late spring or early summer and it is in the final stages of packaging design. Glutathione is the body's master anti-oxidant and people cannot live without it. We believe the Glutathione/Selenium Complex will be the strongest, most effective super anti-oxidant health drink ever marketed. Dr. Theodore Hersh and Dr. Julia T. Hunter have been the two professionals guiding our Company through the process. Dr. Hersh is the inventor and patent holder and has provided O.C. Beverages with an exclusive ten year agreement in the U.S. and Canada to market Thione Complex(TM) for beverages. The Thione Complex(TM) is based on Glutathione and Selenium plus its synergistic cellular anti-oxidant partners. Dr. Hunter introduced our Company to Dr. Hersh and has provided guidance in the overall health trends. "We are honored to have these two outstanding doctors as the first two selections on the Company's health panel, which will consist of five panelists," said Lee Danna, President/CEO.
Dr. Hersh stated, "For the past 11 years, my wife, Rebecca, and I have devoted ourselves to unraveling the hidden natural processes by which the body heals itself and how to mimic and optimize this process. This research led to the creation of the "Thione Complex(TM)," based on Glutathione, the body's master anti-oxidant. By combining Glutathione with its synergistic cellular partner, selenium, and adding vitamins B, C, D & E, the Thione Complex(TM) replicates the exact same defense system found in the body, in effect "super-charging" one's own healing powers and allowing the key ingredients to be directly absorbed into the blood stream to repair cells, thereby providing the strongest anti-oxidant complex ever developed. According to Dr. Hersh, "The biggest health benefit for the average consumer is building their immune system and nothing builds it faster or stronger than the body's master anti-oxidant, Glutathione with selenium. This product represents the innovation that results when bio-science and technology are combined and we are very excited to see the product ready and launching here in the U.S."
Dr. Julia T. Hunter, dermatologist and founder of Skin Fitness Plus in Beverly Hills, CA, is well known as an expert on ingredients and "from health comes beauty." "I am delighted that O.C. Beverages is focused on providing healthy beverages to the marketplace and having her as an advisor to accomplish this excellent goal. Glutathione is the master anti-oxidant and for Dr. Theodore Hersh to have developed the technology to place Glutathione in a beverage is very exciting."
About Dr. Theodore Hersh
Born in Mexico City, Dr. Hersh's professional journey began at Harvard University followed by medical school at Columbia University and postgraduate training at Mount Sinai Hospital, the Mayo Clinic, and Harvard Medical School's Division at Boston City Hospital. After two years of private practice in Mexico, he returned to the U.S. to continue his career in research and academia at such esteemed institutions as Yale University, Baylor College of Medicine and Brown University. Dr. Hersh joined Emory University as a professor of Medicine in 1973 and continued there until becoming Emeritus in 1996. For twenty-three years he served as Chairperson of Emory's Institutional Review Board for clinical research. Dr. Hersh, a distinguished clinician, medical innovator and educator, has received awards including the Noble Foundation Award from the Mayo Foundation and Premier Physician Award from the Chrohns and Colitis Foundation of America.
About Dr. Julia T. Hunter
Dr. Julia T. Hunter's primary specialty is Cosmetic Laser and Skin Care Dermatology and is a medical physician with licensure, DEA and MD in the states of California and Alabama. Dr. Hunter's medical education began at the University of South Alabama College of Medicine, Mobile, AL, where she received her M.D.; continuing education and specialized training at Harvard Medical School, Beth Israel Hospital, Boston, MA; Columbia University, College of Physicians and Surgeons, Babies Hospital, New York, NY; Cornell University Medical School, New York Hospital, New York, NY.
About O.C. Beverages, Inc.
Headquartered in Santa Ana, CA, O.C. Beverages is a manufacturer, bottler, and distributor of water, flavored and enhanced waters, teas and spirits for private label. It also has its own unique product mix of trademarked brands of non-alcoholic and alcoholic beverages designed to capture consumer style and taste for unique health benefit beverages and high quality spirits.
April 30, 2009 -- Perceptive Informatics, the industry's leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today announced that it has developed a robust medical imaging methodology for Central Nervous System (CNS) clinical trials involving Alzheimer's disease. The method, based on measuring ventricular size, provides a new approach to monitor brain atrophy in Alzheimer's disease and potential treatment effects. The technique was presented on April 26, 2009 in Seattle, Washington during an invitation-only meeting of the Alzheimer's Disease Neuroimaging Initiative (ADNI).
The advantages of this method include providing higher quality, reproducible, and regulatory compliant assessments with the potential to help clinical trial sponsors make better and faster development decisions about Alzheimer's treatments in development. To develop this method, the Perceptive Informatics team collected Magnetic Resonance Imaging (MRI) scans from the ADNI database using Perceptive's medical imaging system and regulatory compliant processes.
"It is more critical than ever that biopharmaceutical companies have the ability to make accurate go/no go decisions as early as possible for new compounds. Medical imaging is increasingly being used as a surrogate endpoint or biomarker of drug efficacy in all phases of CNS trials. With this new methodology, we believe that Perceptive's therapeutic area experts are able to help sponsors advance neuroimaging and bring important CNS treatments to patients sooner," said Kenneth G. Faulkner, Ph.D., Vice President of Medical Imaging, Perceptive Informatics.
"Based on ADNI data, measuring ventricular change may be one of the most robust outcomes for imaging progression of Alzheimer's disease. Perceptive has developed a novel method of ventricular measurement that accurately reflects brain atrophy," said James Paskavitz, M.D., Medical Director, Perceptive Informatics. "We believe that this method can support sponsors in reducing the time, cost, and risk associated with clinical development of Alzheimer's treatments by providing medical image data that informs early phase decisions and is reproducible for later phase, multi-center trials."
The Perceptive Informatics Medical Imaging Group has helped to develop and validate novel surrogate endpoints for a variety of CNS disorders. Perceptive offers a range of capabilities in the application of imaging techniques from early clinical development through late phase studies. The medical imaging team operates globally and services a wide range of therapeutic areas, including oncology, central nervous system, musculoskeletal, cardiovascular, and metabolism/endocrinology imaging.
ADNI is focused on defining the rate of progress of mild cognitive impairment and Alzheimer's disease, developing improved methods for clinical trials in this area, and providing a large database to improve design of treatment trials. A goal of ADNI is to provide information and methods to help lead to effective treatments for Alzheimer's disease, leading to effective prevention.
About Perceptive Informatics
Perceptive Informatics, a subsidiary of PAREXEL, is the industry's leading eClinical solutions provider. Perceptive Informatics offers unprecedented access to innovative eClinical technologies and resources, providing clinical trial sponsors, CROs, and other service providers with the benefits of an extensive line of products and services throughout the entire clinical development lifecycle. In August, 2008 Perceptive was joined with ClinPhone plc, and the newly combined organization offers eClinical software and services that increase the efficiency and productivity of clinical research. Perceptive's expansive product portfolio includes Interactive Voice and Web Response Systems (IVRS/IWRS), Medical Imaging, Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and Electronic Patient Reported Outcomes (ePRO) solutions, as well as eClinical systems integration and implementation services.
About PAREXEL International
PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, medical communications and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 69 locations throughout 52 countries around the world, and has over 9,400 employees.
Apr 30, 2009 -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial and operating results for the first quarter 2009. The Company reported a net loss of $17.5 million, or $0.22 per share (basic and diluted), for the first quarter of 2009 compared with a net loss of $11.6 million, or $0.15 per share (basic and diluted), for the first quarter of 2008.
At March 31, 2009, cash, restricted cash, and marketable securities totaled $496.0 million compared with $527.5 million at December 31, 2008.
Current Business Highlights
ARCALYST(R) (rilonacept) - Inflammatory Diseases
The Company shipped $4.3 million of ARCALYST(R) (rilonacept) Injection for Subcutaneous Use to its U.S. distributors during the first quarter of 2009, compared to $0.8 million during the first quarter of 2008. Shipments of ARCALYST began in the United States in March 2008 following marketing approval of ARCALYST from the U.S. Food and Drug Administration (FDA) in February 2008 for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. ARCALYST, an interleukin-1 (IL-1) blocker, is the only therapy approved in the United States for patients with CAPS. The Company currently projects shipments of ARCALYST to its distributors to total approximately $15-20 million in 2009.
During the first quarter of 2009, the Company initiated a Phase 3 clinical development program with ARCALYST for the treatment of gout. The program includes four clinical trials, three of which are currently enrolling patients: Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) will evaluate ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) will evaluate treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The Phase 3 program also includes a separate placebo-controlled safety study (RE-SURGE). The Company expects to report initial data from the Phase 3 program in 2010. Regeneron owns worldwide rights to ARCALYST.
Aflibercept (VEGF Trap) - Oncology
At the end of the first quarter of 2009, approximately one-half of the planned number of patients were enrolled in four Phase 3 trials that are evaluating combinations of aflibercept, an investigational anti-angiogenesis agent, with standard chemotherapy regimens for the treatment of cancer. One trial (called VELOUR) is evaluating aflibercept as a 2nd line treatment for metastatic colorectal cancer in combination with FOLFIRI (folinic acid (leucovorin), 5-fluorouracil, and irinotecan). A second trial (VANILLA) is evaluating aflibercept as a 1st line treatment for metastatic pancreatic cancer in combination with gemcitabine. A third trial (VITAL) is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in combination with docetaxel. The fourth trial (VENICE) is evaluating aflibercept as a 1st line treatment for metastatic androgen-independent prostate cancer in combination with docetaxel/prednisone. All four trials are studying the current standard of chemotherapy care for the cancer being studied with and without aflibercept. Initial data from the Phase 3 program are expected in 2010. In addition, a Phase 2 study (AFFIRM) of aflibercept in 1st line metastatic colorectal cancer in combination with folinic acid (leucovorin), 5-fluorouracil, and oxaliplatin began recruiting patients in January 2009.
A Phase 2 single-agent study of aflibercept in advanced ovarian cancer (AOC) patients with symptomatic malignant ascites (SMA) is now fully enrolled, and initial data from this trial are expected by mid-2009. Aflibercept is being developed worldwide by Regeneron and its collaborator, sanofi-aventis.
VEGF Trap-Eye - Ophthalmologic Diseases
VEGF Trap-Eye is a specially purified and formulated form of VEGF Trap for use in intraocular applications that is being developed by Regeneron and its collaborator, Bayer HealthCare, for the treatment of the neovascular form of Age-related Macular Degeneration (wet AMD), Diabetic Macular Edema (DME), Central Retinal Vein Occlusion (CRVO), and other eye diseases and disorders.
In a separate news release today, Regeneron and Bayer HealthCare announced plans to initiate a Phase 3 program later this year of VEGF Trap-Eye in the treatment of CRVO. Dosing of the first patient in the Phase 3 program will entitle Regeneron to receive a $20.0 million milestone payment.
The Phase 3 program (consisting of the VIEW 1 and VIEW 2 studies) that is evaluating VEGF Trap-Eye in patients with wet AMD continued to enroll patients during the first quarter of 2009. The companies expect to complete enrollment in both trials in 2009 and report initial data in late 2010.
Results of the extension stage of the Phase 2 study in wet AMD (the CLEAR-IT 2 study) will be presented on May 4 at the 2009 Association for Research in Vision and Ophthalmology (ARVO) meeting in Fort Lauderdale, Florida. In late 2008, the companies reported CLEAR-IT 2 study results, which demonstrated that patients treated with VEGF Trap-Eye achieved durable improvements in visual acuity and retinal thickness for up to one year.
In the original Phase 2 study, 157 patients were initially treated for 3 months with VEGF Trap-Eye: two groups received monthly doses of 0.5 or 2.0 mg (at weeks 0, 4, 8, and 12) and three groups received quarterly doses of 0.5, 2.0, or 4.0 mg (at baseline and week 12). Following the initial 3-month fixed-dosing phase, patients continued to receive VEGF Trap-Eye at the same dose on a PRN dosing schedule through one year, based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria.
The data to be presented at ARVO will report on 117 patients who elected to enter the extension stage of the study after receiving VEGF Trap-Eye for one year. These patients were dosed on a 2.0 mg PRN basis. On a combined basis, for these 117 patients, the mean gain in visual acuity was 7.3 letters (p<0.0001 versus baseline) at the 3-month primary endpoint of the original Phase 2 study, 8.4 letters (p<0.0001 versus baseline) at one year, and 7.1 letters (p<0.0001 versus baseline) at month 6 of the extension stage. Thus, after 18 months of dosing with VEGF Trap-Eye in the Phase 2 study, patients continued to maintain a highly significant improvement in visual acuity versus baseline, while receiving, on average, only 3.5 injections over the 15-month PRN dosing phase that extended from month 3 to month 18. Patients continue to be dosed in the extension stage of the Phase 2 study.
Among all the patients in the Phase 2 wet AMD study, VEGF Trap-Eye was generally well tolerated and there were no drug-related serious adverse events. There was one reported case of culture-negative endophthalmitis/uveitis in the study eye and two arterial thrombotic events; these were deemed not to be drug-related. Three deaths were reported--one patient with pancreatic cancer, one patient with squamous cell carcinoma of the lung, and one patient with pulmonary hypertension (a pre-existing condition), The most common adverse events were those typically associated with intravitreal injections and included conjunctival hemorrhage at the injection site and transient increased intraocular pressure following an injection.
In the Phase 2 DME study, additional clinical sites were opened during the first quarter of 2009. The study (called DA VINCI) is evaluating four different VEGF Trap-Eye regimens versus laser treatment. The study began in December 2008 and is expected to complete enrollment of approximately 200 patients in the U.S., Canada, European Union, and Australia by the end of 2009.
Bayer HealthCare has rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
Monoclonal Antibodies
Phase 1 clinical studies have begun with the first three human monoclonal antibodies generated by Regeneron using its VelocImmune(R) technology. REGN88 is an antibody to the interleukin-6 receptor (IL-6R) that is being evaluated in rheumatoid arthritis. REGN475, an antibody to Nerve Growth Factor (NGF) that binds NGF selectively without cross-reacting with other members of the neurotrophin family, is being developed for the treatment of pain. In addition, a Phase 1 trial is in the process of being initiated to evaluate REGN421, an antibody to Delta-like ligand-4 (Dll4), in patients with advanced malignancies. These antibodies are being developed within the Company's human antibody collaboration with sanofi-aventis. Over the course of the next several years, the Company and sanofi-aventis plan to advance an average of two to three new fully human monoclonal antibodies into clinical development each year.
As part of its Academic VelocImmune Investigators' Program (Academic VIP), during the first quarter of 2009 Regeneron entered into an agreement with The University of Texas Southwestern Medical Center that will provide researchers at the Dallas-based medical center with access to Regeneron's VelocImmune technology to discover fully human monoclonal antibodies. Regeneron retains the right to develop and commercialize any antibodies discovered under the program.
Financial Results
Revenues
Total revenues increased to $75.0 million in the first quarter of 2009 from $56.4 million in the same period of 2008. The Company's revenue was comprised of contract research and development revenue, technology licensing revenue, and net product sales.
Contract Research and Development Revenue
Contract research and development revenue relates primarily to the Company's aflibercept and antibody collaborations with sanofi-aventis and the Company's VEGF Trap-Eye collaboration with Bayer HealthCare. Contract research and development revenue for the three months ended March 31, 2009 and 2008 consisted of the following:
Three months ended March 31, (In millions) 2009 2008 Contract research & development revenue Sanofi-aventis $ 49.6 $ 35.7 Bayer HealthCare 10.0 9.0 Other 1.5 1.7 Total contract research & development revenue $ 61.1 $ 46.4
For the three months ended March 31, 2009 and 2008, contract research and development revenue from sanofi-aventis consisted of the following:
Three months ended March 31, (In millions) 2009 2008 Aflibercept: Regeneron expense reimbursement $ 5.4 $ 11.7 Recognition of deferred revenue related to up-front payments 2.5 2.1 Total aflibercept 7.9 13.8 Antibody: Regeneron expense reimbursement 38.4 19.3 Recognition of deferred revenue related to up-front payment 2.6 2.6 Other 0.7 -- Total antibody 41.7 21.9 Total sanofi-aventis contract research & development revenue $ 49.6 $ 35.7
Sanofi-aventis' reimbursement of Regeneron's aflibercept expenses decreased in the first quarter of 2009, compared to the same period in 2008, primarily due to lower costs associated with manufacturing clinical drug supplies.
Sanofi-aventis' reimbursement of Regeneron's expenses under the antibody collaboration increased in the first quarter of 2009, compared to the same period in 2008, due to an increase in research activities conducted under the collaboration's discovery agreement and increases in development activities for REGN88, REGN421, and REGN475 under the collaboration's license agreement.
For the three months ended March 31, 2009 and 2008, contract research and development revenue from Bayer HealthCare consisted of the following:
Three months ended March 31, (In millions) 2009 2008 Cost-sharing of Regeneron VEGF Trap-Eye development expenses $ 7.5 $ 5.7 Recognition of deferred revenue related to up-front and milestone 2.5 3.3 payments Total Bayer HealthCare contract research & development revenue $ 10.0 $ 9.0
In periods when the Company recognizes VEGF Trap-Eye development expenses that the Company incurs under the collaboration with Bayer HealthCare, the Company also recognizes, as contract research and development revenue, the portion of those VEGF Trap-Eye development expenses that is reimbursable by Bayer HealthCare. The Company incurred higher VEGF Trap-Eye development expenses under the collaboration for the three months ended March 31, 2009, compared to the same period in 2008, primarily in connection with the collaboration's clinical development programs in wet AMD and DME.
Technology Licensing Revenue Regeneron has entered into non-exclusive license agreements with AstraZeneca and Astellas that allow those companies to utilize VelocImmune(R) technology in their internal research programs to discover human monoclonal antibodies. Each company is required to make six $20.0 million annual, non-refundable payments, subject to the ability to terminate their agreements after making a total of four such payments. To date, the Company has received $60.0 million in payments from AstraZeneca and $40.0 million in payments from Astellas under these agreements. Upon receipt, these payments are deferred and recognized as revenue ratably over the ensuing year of each agreement. Regeneron will also receive a mid-single-digit royalty on sales of any antibodies discovered utilizing VelocImmune.
Net Product Sales
Revenue and deferred revenue from product sales are recorded net of applicable provisions for prompt pay discounts, product returns, estimated rebates payable under governmental programs (including Medicaid), distributor fees, and other sales-related costs. For the three months ended March 31, 2009, the Company recognized as revenue $3.9 million of ARCALYST(R) (rilonacept) net product sales for which the right of return no longer exists and rebates can be reasonably estimated. At March 31, 2009 and 2008, deferred revenue related to ARCALYST net product sales totaled $4.2 million and $0.8 million, respectively.
Expenses
Total operating expenses for the first quarter of 2009 were $94.2 million, 30 percent higher than the same period in 2008. Average headcount increased to 938 for the first quarter of 2009 compared to 714 for the same period in 2008, due primarily to the Company's expanding research and development activities principally in connection with the sanofi-aventis antibody collaboration. Operating expenses included non-cash compensation expense related to employee stock option and restricted stock awards of $7.7 million and $8.3 million, in the first quarters of 2009 and 2008, respectively.
Research and development (R&D) expenses increased to $82.1 million in the first quarter of 2009 from $61.3 million in the comparable quarter of 2008. In the first quarter of 2009, the Company incurred higher R&D costs primarily related to additional R&D headcount, clinical development costs for ARCALYST, VEGF Trap-Eye, and REGN88, research and preclinical development costs associated with the antibody programs, and facility-related costs to support expanded R&D activities.
Selling, general, and administrative (SG&A) expenses increased to $11.7 million in the first quarter of 2009 from $11.0 million in the comparable quarter of 2008. In the first quarter of 2009, the Company incurred higher selling expenses related to ARCALYST(R) (rilonacept), higher compensation expense associated with expanding the Company's SG&A headcount, and higher SG&A facility-related costs.
Other Income and Expense
Investment income decreased to $1.8 million in the first quarter of 2009 from $7.3 million in the comparable quarter of 2008. The decrease in investment income was due to lower yields on, and lower balances of, cash and marketable securities in the first quarter of 2009 compared to the same quarter in 2008. Interest expense in the first quarter of 2008 was attributable to the Company's 5.5% Convertible Senior Subordinated Notes; no Notes were outstanding in 2009.
About Regeneron Pharmaceuticals
Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for the treatment of serious medical conditions. In addition to ARCALYST(R) (rilonacept) Injection for Subcutaneous Use, its first commercialized product, Regeneron has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, inflammatory diseases, and pain, and has preclinical programs in other diseases and disorders.
Apr 30, 2009 -- Skyworks Solutions, Inc. (NASDAQ: SWKS), an innovator of high reliability analog and mixed signal semiconductors enabling a broad range of end markets, today introduced a new suite of low noise amplifiers (LNAs) featuring pseudomorphic high electron mobility transistor (pHEMT) and silicon germanium (SiGe) technologies. The new high performing, low cost product family serves various industry applications including GPS; infrastructure such as GSM, WCDMA and LTE base station transceivers; ISM band and satellite radio; and WLAN markets. In addition, Skyworks is expanding into higher frequency, higher linearity, and even lower noise figures with the company's latest pHEMT7 technology and enhancement mode pHEMT devices.
"This is an exciting development for Skyworks, and opens up an entirely new product line and market," said David C. Stasey, Skyworks' vice president of analog components. "Skyworks has uniquely designed these discrete pHEMT devices to achieve ultra low noise that supports the high performance requirements for modern receiver designs. We are also utilizing SiGe technology to produce integrated LNA devices. These new devices address low cost and efficiency while providing the added functionality of silicon. With the addition of these new LNA devices, our GPS, infrastructure, ISM, satellite and WLAN customers are thrilled with our new offerings."
About the SKY65050-372LF Low Noise Transistor
The SKY65050-372LF low noise transistor, the first released product in this family, is a high performance, low noise, n-channel, depletion mode pHEMT, fabricated from Skyworks' advanced pHEMT process and packaged in a miniature 4-lead SC-70 package. The transistor's low noise figure, high gain, and excellent third order intercept (IP3) allows it to be used in various receiver and transmitter applications.
The transistor is lead (Pb)-free, restriction of hazardous substances (RoHS) compliant, conforms to the environmental impact assessment (EIA)/European information and communications technology industry association (EICTA)/Japan electronics and information technology industries association (JEITA) joint industry guide (JIG) Level A guidelines, and is free from antimony trioxide and brominated flame retardants.
This new product has been released with a full toolkit of application resources to assist in securing new sockets. In addition, the new device will allow for higher gain and linearity while still providing noise figure solutions below 0.7 decibels (dB).
Pricing and Availability
The SKY65050-372LF is available now and priced at 25 cents each in quantities of 10,000 devices.
About Skyworks
Skyworks Solutions, Inc. is an innovator of high reliability analog and mixed signal semiconductors. Leveraging core technologies, Skyworks offers diverse standard and custom linear products supporting automotive, broadband, cellular infrastructure, energy management, industrial, medical, military and mobile handset applications. The Company's portfolio includes amplifiers, attenuators, detectors, diodes, directional couplers, front-end modules, hybrids, infrastructure RF subsystems, mixers/demodulators, phase shifters, PLLs/synthesizers/VCOs, power dividers/combiners, receivers, switches and technical ceramics.
Headquartered in Woburn, Mass., Skyworks is worldwide with engineering, manufacturing, sales and service facilities throughout Asia, Europe and North America.
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