Archimedes Pharma Announces First Positive Phase III Clinical Trial Results for NasalFent
• Meets Primary Efficacy Endpoint
• Shows Significant Difference in Pain Within 5 Minutes of Dosing
• Improvements in Pain Maintained Throughout Pain Episode
READING, 9th October 2008 – Archimedes Pharma Limited, the UK based, pan-European specialty pharmaceutical company, today announces positive headline Phase III results for NasalFent®, the Company’s innovative fentanyl citrate nasal spray, developed to provide fast, effective and convenient treatment for breakthrough cancer pain.
Breakthrough cancer pain affects up to 95% of all cancer patients and is characterised by sudden, unpredictable episodes of intense pain that occur despite background pain medication. This pain is rapid in onset, often reaching maximum intensity in 5 minutes with duration of 30-60 minutes.
NasalFent met the primary efficacy endpoint in study 043, a pivotal Phase III clinical study for the product. Patients treated with NasalFent showed a highly statistically significant improvement in Summary of Pain Intensity Difference at 30 minutes (SPID30) compared to placebo (p < 0.001), meaning a greater reduction in pain.
Patients also reported statistically significant differences in pain scores with NasalFent compared to placebo within 5 minutes of dosing. NasalFent is the first product to have demonstrated, in a robust large scale Phase III programme, onset of pain relief as early as 5 minutes. The improvement in pain was maintained for 60 minutes after dosing with statistically significant results at all measured time points.
NasalFent showed both consistent effectiveness and high acceptability; 92% of patients completed the double-blind part of the study and 87% of patients elected to continue therapy with NasalFent in a long term Phase III safety study.
Russell K. Portenoy, MD, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center, New York and Principal Investigator for the NasalFent study programme, stated: “Breakthrough cancer pain is a significant clinical problem and there is a clear need for new analgesic formulations that are safe and effective, and provide pain relief in a time frame consistent with the rapid time course of most breakthrough pain episodes.”
Study 043 was conducted in the Americas, principally the USA, and involved 36 expert investigational sites. A total of 139 patients were screened and 114 (82%) entered the open dose titration phase. Eighty three (83) patients participated in the double-blind, placebo-controlled portion of the study. The protocol for study 043 was agreed with the FDA and is very close in design to studies for approved fentanyl-based products for breakthrough cancer pain.
Richard de Souza, CEO of Archimedes, commented, “We are pleased with the study results which position NasalFent, the first real intranasal form of fentanyl, as a product that redefines the standard of care for patients suffering with breakthrough cancer pain. This achievement validates our business model which is to build a fast growing commercial organisation capable of marketing the pipeline of products built around our proprietary nasal technology and developed by our in-house team.”
NasalFent consists of fentanyl in an aqueous solution delivered as a low volume nasal spray. The formulation incorporates PecSys™, Archimedes’ proprietary enabling drug delivery technology. NasalFent is designed to optimise the absorption of Fentanyl across the nasal mucosa, allowing rapid absorption for fast onset of pain relief but modulating the maximum amount of fentanyl absorbed in order to minimize side effects.
Donald R.Taylor, MD, Director of the Comprehensive Pain Care Centre, Marietta, Georgia added, “NasalFent, a new analgesic for breakthrough cancer pain, clearly provides more rapid pain relief than traditional breakthrough cancer pain medications and is well accepted by patients. It is also uniquely useful for patients with swallowing difficulties due to their cancer or its treatment.”
Archimedes intends to publish full results for 043, along with additional data on the pharmacokinetic and pharmacodynamic profile of NasalFent compared current therapies, at a series of scientific conferences in 2009.
- ENDS -.
Enquiries
Archimedes Pharma: Michael Clark, +44 118 931 5050
Citigate Dewe Rogerson: Chris Gardner/Heather Keohane, +44 207 638 9571
For more information on Archimedes, visit: www.archimedespharma.com
About Archimedes Pharma
Archimedes Pharma is a pharmaceutical company marketing an expanding portfolio of products to specialist prescribers in major European territories whilst building a platform for its future growth through the development of a high-value pipeline from its world-class drug delivery technologies.
Archimedes’ strategy is to expand its current European commercial presence through partnering and acquisition. It is also building a robust pipeline of in-house products in pain, Parkinson’s disease and critical care by applying its drug delivery technologies to proven molecules which have yet to achieve their market potential due to their current mode of delivery. This approach greatly reduces the development risk while promising significant clinical – and thus commercial – benefits. Archimedes’ lead product NasalFent®, intranasal fentanyl for rapid relief of breakthrough cancer pain, is based on Archimedes’ PecSys™ technology and is in Phase III clinical development. This product, which has blockbuster potential, is targeted for launch in 2010.
Archimedes technologies - ChiSys®, PecSys™ and TARGIT® - are also used in a number of partnered products in late-stage clinical development. Additionally, Archimedes’ innovative drug delivery technology has proven potential for vaccine delivery with pre-clinical and clinical studies of nasally administered vaccines demonstrating enhanced immune response.
Archimedes marketed products include Gliadel, a biodegradable wafer impregnated with an anti-cancer drug, carmustine, for high-grade glioma; Zomorph, an oral sustained release morphine product for pain; Nozinan, a neuroleptic used in psychiatry and as a supportive therapy for cancer patients; and Pabrinex, a high potency vitamin formulation used to treat the symptoms of malnutrition especially in patients with acute alcohol problems.
Archimedes Pharma is UK based, with offices in Reading and development facilities in Nottingham. Further European commercial operations are established in Ireland, France and Germany. The Company was founded in December 2004 and is backed by Warburg Pincus, a leading private equity investor with extensive experience in the healthcare sector. In 2007, Archimedes had sales of US$ 40million.
About NasalFent®
NasalFent is an innovative fentanyl citrate nasal spray aimed at providing a fast, effective and convenient treatment for breakthrough cancer pain – sudden, unpredictable episodes of intense pain that occur despite background pain medication and which can affect up to 95% of cancer patients with pain.
NasalFent uses Archimedes proprietary PecSys™ nasal drug delivery system to ensure rapid, but controlled, delivery of fentanyl to match the time-course of the typical breakthrough pain episode experienced by these patients. An international Phase III clinical development programme is approaching completion and the product is targeted for launch in 2010. First results from study 043 show that NasalFent achieved its primary efficacy objective of a significant improvement in pain versus placebo as assessed by SPID30. In addition NasalFent showed a significant difference in pain scores within 5 minutes of dosing, becoming the first product for this indication to show efficacy at this very early time point post-dosing in a large phase III study.
Fentanyl is a highly effective opiate analgesic and is seen as the drug of choice for breakthrough cancer pain. However, there remains a need for a presentation that provides fast and reliable onset of action coupled with ease of use and high patient acceptability. Archimedes believes NasalFent offers potential benefits over currently marketed oral and injectable presentations in these key parameters.
Archimedes will market NasalFent through its own commercial organisation in Western Europe and is seeking licensees for North America, Japan and other territories.
The Micell Rapid Absorption Polymer DES System to be Presented at TCT 2008
RALEIGH, N.C., October 10, 2008 /PRNewswire/ — Micell Technologies announced today that David E. Kandzari, MD, will present “The Micell Rapid Absorption Polymer DES System” during the Drug-Eluting Stent Summit at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC, on October 13, 2008. The MiStent(TM), a drug-eluting stent in pre-clinical studies, utilizes a bioresorbable polymer coating that delivers the potential therapeutic benefits of the drug during the healing process. The drug and polymer are both eliminated from the stent within 90 days.
“The Micell DES technology is exciting because it is the first of a new generation of stents being developed to precisely deliver a drug while safely eliminating the polymer faster than any other biodegradable coating that is commercially available,” said Kandzari. “The controlled drug release and kinetics enables a lower drug dose while using known and proven polymers and an approved anti-proliferative drug. Taken together, the Micell DES has the potential to offer the therapeutic benefit of a drug-eluting stent and the safety profile of a bare metal stent.”
Dr. Kandzari is the Director of Interventional Cardiology Research at the Scripps Clinic in La Jolla, CA.
About Micell Technologies
Micell Technologies is a privately-held, early-stage biomedical company dedicated to applying its unique surface and polymer modification technologies for improved patient benefits for medical device and drug delivery applications. Its first product, MiStent(TM), is a rapid absorbing coated drug-eluting stent (DES) with precise control of drug release and pharmacokinetics. To learn more, please visit our website at http://www.micell.com.
Contact: James McClain Ph.D., Chief Technology Officer
Micell Technologies: (919) 313-2111
CONTACT: James McClain Ph.D., Chief Technology Officer of MicellTechnologies, +1-919-313-2111
Web site: http://www.micell.com/
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FDA Approves Bayer HealthCare’s Kogenate FS Treatment for Routine Prophylaxis in Children with Hemophilia A
BERKELEY, Calif., October 10, 2008 /PRNewswire/ — Bayer HealthCare LLC announced today that the U.S. Food and Drug Administration (FDA) has approved routine prophylaxis with Kogenate FS Antihemophilic Factor (Recombinant) to reduce the frequency of bleeding episodes and the risk of joint damage in patients aged 0-16 years with severe hemophilia A with no pre-existing joint damage. This important approval provides these patients with the only factor VIII treatment that the FDA has determined safe and effective for routine prophylaxis — a treatment regimen recommended by the National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC).(1)
“The FDA approval of Kogenate FS as the first factor VIII treatment product in the U.S. to be used to replenish factor VIII levels in a prophylactic manner marks a significant milestone in the care of patients, especially young children, with hemophilia A,” said Craig Kessler, M.D., Hospital and Chair, MASAC. “The results from the pivotal clinical study confirmed that the administration of Kogenate FS to prevent bleeding into the joints was more beneficial to joint health and function than ‘on-demand’ treatment of acute episodes of joint bleeds.”
Dr. Kessler added, “The data justify the consideration of prophylaxis treatment for children with severe and moderate severity hemophilia A, uncomplicated by pre-existing joint damage, to be the medical standard of care. The FDA’s recognition that Kogenate FS is an effective prophylactic FVIII replacement product has ‘jump started’ the standard of hemophilia care in the United States so that it is now on par with other developed countries, especially those in Western and Northern Europe.”
The FDA approval of Kogenate FS for routine prophylaxis in children without pre-existing joint damage is based on the clinical data from a multicenter trial in the U.S. that included 65 boys with severe hemophilia A less than 30 months of age at study entry. Study participants were followed for up to 5.5 years. This Joint Outcomes Study (JOS), conducted over a 10-year period, was led by Marilyn J. Manco-Johnson, M.D., Professor of Pediatrics and Associate Professor of Pathology in the Department of Pediatrics, and Health Science Center, and Director of the Mountain States Regional Hemophilia & Thrombosis Center at the . Key findings from the JOS study, published in the August 9, 2007 issue of , include:
The study was designed with special emphasis on the “index joints,” including the elbow, knee and ankle joints, which are most prone to bleeding in severe hemophilia patients. Joint structural outcomes and functioning were measured at 6 years of age by radiography, magnetic resonance imaging (MRI) and physical exams.
“The value for prophylaxis for hemophilia A patients has been understood for many years, but until today we have not had the combination of clinical evidence, pharmaceutical indication and the alignment of healthcare professionals, patients and regulators needed to ensure this treatment option is available,” said Val Bias, CEO, National Hemophilia Foundation. “Bayer HealthCare’s pursuit of this approval shows leadership and commitment to providing the scientific evidence that proves the benefits of prophylactic use for joint health in pediatric hemophilia patients.”
This U.S. FDA approval may positively affect the prophylactic use of Kogenate FS in certain developing markets, including countries in Asia and South and Central America, where the product is approved based on the U.S. label.
“Today’s announcement is a milestone in Bayer HealthCare’s continuing commitment to advancing the science and treatment for the hemophilia community,” said Paul Bedard, Vice President, General Manager, Hematology Business Unit, Bayer HealthCare. “From the beginning, our goal in pursuing this indication was to provide treatment options that would reduce bleeding episodes and protect the joint health of children with hemophilia A, which are the everyday concerns of patients.”
Kogenate FS, Antihemophilic Factor (Recombinant), is a recombinant factor VIII treatment indicated for the control and prevention of bleeding episodes and peri-operative management in adults and children (0-16 years) with hemophilia A. Kogenate FS is also indicated for routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. The most serious adverse reactions are systemic hypersensitivity reactions including bronchospastic reactions and/or hypotension and anaphylaxis and the development of high-titer inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials (frequency greater than or equal to 4% of patients) were skin-associated hypersensitivity reactions (rash, pruritus, urticaria), inhibitor formation in previously untreated or minimally treated patients, infusion site reactions, and central venous access device (CVAD) line-associated infections.
Kogenate FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.
Please see the full prescribing information for important risk and use information at www.kogenatefs.com.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A, the most common type of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia.
Bayer HealthCare LLC is an affiliate of Bayer HealthCare AG, one of the world’s leading, innovative companies in the healthcare and medical products industry based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the United States, Bayer HealthCare Pharmaceuticals comprises the following business units: Women’s Healthcare, Diagnostic Imaging, General Medicine, which includes Cardiology and Primary Care and Specialty Medicine, which includes Hematology, Oncology and Multiple Sclerosis. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties, and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
BAYER, the Bayer Cross and Kogenate are registered trademarks of Bayer.
(C)Bayer HealthCare LLC
(1) MASAC Recommendation 179 Concerning Prophylaxis (Regular Administration of Clotting Factor Concentrate to Prevent Bleeding) “MASAC recommends that prophylaxis be considered optimal therapy for individuals with severe hemophilia A and B (factor VIII or Factor IX <1%)." Recommendation approved by MASAC on November 3, 2007, and adopted by the NHF Board of Directors on November 4, 2007.
(2) Manco-Johnson, Marilyn. “Prophylaxis versus Episodic Treatment to Prevent Joint Disease in Boys with Severe Hemophilia,” vol. 357:535-544, August 9, 2007.
CONTACT: Joanne Marlin of Bayer HealthCare, +1-973-305-5383, joanne.marlin@bayer.com
Web site: http://www.bayer.com/http://www.kogenatefs.com/http://www.pharma.bayer.com/
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Biogen Idec Announces Top-Line Results from Phase II Clinical Trial of Baminercept in Rheumatoid Arthritis
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Oct 9, 2008 - Biogen Idec (NASDAQ: BIIB) announced today that its Phase II trial of baminercept (BG9924, LT(beta)R-Ig) in rheumatoid arthritis (RA) patients who have had an inadequate response to conventional therapy with a disease-modifying antirheumatic drug (DMARD) did not meet its primary endpoint. The primary endpoint was defined as the proportion of baminercept-treated patients who achieved an ACR50 response, a standard measure of disease improvement in RA, compared to placebo at 14 weeks. The study also did not meet any of the pre-specified secondary endpoints. Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.
Based on these results as well as preliminary data from a Phase II trial of baminercept in RA patients who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, the company has decided to discontinue the development of the compound in RA.
About the 104RA202 Study
The 104RA202 study was a Phase II randomized, double-blind, placebo-controlled, multicenter, dose-finding trial involved 380 individuals with active RA who had an inadequate response to conventional DMARD therapy. The trial was designed to assess the efficacy of five different regimens of baminercept when administered over 12 weeks in combination with methotrexate within this patient population.
About the 104RA203 Study
The 104RA203 study was a Phase II randomized, double-blind, placebo-controlled, multicenter trial in patients with active RA who had an inadequate response to TNF inhibitors. About 120 patients were expected to be enrolled in the trial, which was designed to assess the efficacy of 200 mg dose of baminercept administered over 12 weeks in combination with methotrexate.
In both studies, the primary endpoint was the proportion of patients who achieved an ACR50 response, defined as a 50% improvement compared to baseline for swollen and tender joint counts and other clinical measures, at week 14. Secondary endpoints included the proportion of patients to achieve scores of ACR20 (a 20% improvement compared to baseline for swollen and tender joint counts and other clinical measures) and ACR70 (a 70% improvement compared to baseline for swollen and tender joint counts and other clinical measures), improvement in DAS scores, and accepted tools to evaluate improvements in Quality of Life.
The safety data to date, including incidence of overall adverse events, serious adverse events and infections, suggest that baminercept was well-tolerated.
About RA
RA is a debilitating autoimmune disease that affects an estimated 1.3 million Americans and hinders daily activities. The damage that occurs in RA is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability. Common RA symptoms include inflammation of the joints, swelling, fatigue, stiffness and pain. Additionally, since RA is a systemic disease, it can affect other tissues such as the lungs and eyes.
About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
Safe Harbor/Forward-Looking Statements
This press release contains “forward-looking statements” regarding Biogen Idec’s development of baminercept and therapies for autoimmune diseases that are based on current expectations and assumptions that are subject to risks and uncertainties. Only a small number of research and development programs result in commercialization of a product. In addition, the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve the therapies that we develop; and the company may encounter other unexpected hurdles. For further information regarding factors, risks and uncertainties relating to Biogen Idec’s drug research and development and other activities, please refer to the filings Biogen Idec has made with the Securities and Exchange Commission, including the “Risk Factors” section of Biogen Idec’s Quarterly and Annual Reports, copies of which may be obtained at www.biogenidec.com. Biogen Idec assumes no obligation to update and specifically disclaims any duty to update the information in this press release for any reason, except as required by law, even as new information becomes available or other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
Contact
Media Contact:
Biogen Idec
Naomi Aoki, 617-914-6524
or
Investor Contact:
Biogen Idec
Eric Hoffman, 617-679-2812
Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of Taxus Coronary Stent Systems at TCT 2008
NATICK, Mass., October 10, 2008 /PRNewswire-FirstCall/ — Boston Scientific Corporation today announced the schedule of the Company’s major events and press announcements at the Cardiovascular Research Foundation’s (CRF) twentieth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, which runs from October 12 to 17 in Washington, D.C.
Boston Scientific will be announcing a wide range of safety and efficacy data on its TAXUS(R) Express2(TM) and second-generation TAXUS(R) Liberte(R) Paclitaxel-Eluting Coronary Stent Systems, including 12-month subset data on patients with left main (LM) and three-vessel disease (3VD) from the SYNTAX trial, which compares percutaneous coronary intervention (PCI) using the TAXUS Express2 Stent System to coronary artery bypass graft (CABG) surgery in these most complex patient groups. In addition, the Company will present two-year results from the ARRIVE diabetic subset analysis (TAXUS Express Stent), three-year data from the ATLAS Workhorse and Direct Stenting trials and two-year ATLAS data on small vessels and long lesions (TAXUS Liberte Stent).
“We are pleased to be announcing new subset data on left main and three-vessel disease patients from the landmark SYNTAX study, the only randomized trial of its kind to provide physicians with critical data on the performance of drug-eluting stents (DES) in these very difficult patient populations,” said Keith D. Dawkins, M.D., Senior Vice President and Associate Chief Medical Officer at Boston Scientific. “We also plan to present additional detail on the SYNTAX Score — a new scientific measure for anatomical complexity designed to provide guidance to physicians is assessing treatment options for LM and 3VD patients.”
Schedule of Events Sunday, October 12 (all times are ET)
– TAXUS ATLAS Workhorse, Direct Stenting, Small Vessel and Long Lesion studies. Three-year data from the TAXUS ATLAS Workhorse study and two-year data from the TAXUS ATLAS Direct Stent study will be presented by the study’s co-principal investigator Mark A. Turco, M.D., in an e-poster session titled “TAXUS ATLAS and TAXUS ATLAS DIRECT STENT Trials: Durable Effectiveness of the TAXUS Liberte Stent and Long-Term Benefit of Direct Stenting”. In addition, two-year data from the TAXUS ATLAS Small Vessel and Long Lesion studies will be presented by John A. Ormiston, M.D., in an e-poster session titled “Durable Benefit of TAXUS Liberte vs. TAXUS Express in Small Vessels and Long Lesions in the TAXUS ATLAS SMALL VESSEL and TAXUS ATLAS LONG LESION Trials”. TAXUS ATLAS is a global, multi-center, single-arm study designed to demonstrate that the TAXUS Liberte Stent is non-inferior in safety and efficacy to the TAXUS Express Stent. The Company plans to issue a press release at this time.
– TAXUS ARRIVE diabetic data. A diabetic sub-group analysis from the TAXUS ARRIVE registry will be presented by John M. Lasala, M.D., PhD, in an e-poster session titled “TAXUS Mitigates the Effect of Diabetes on Restenosis Independent of Patient Risk Profile: Two-Year Results from the TAXUS ARRIVE Program”. The ARRIVE program is designed to collect and analyze “real-world” safety and clinical outcomes data from the TAXUS Express2 Paclitaxel-Eluting Coronary Stent System in the treatment of patients with coronary artery disease. The Company plans to issue a press release at this time.
Tuesday, October 14
– SYNTAX Study subset data. The latest 12-month outcomes subset data from the SYNTAX trial will be presented by Principal Investigators Patrick W. Serruys, M.D., Ph.D., and Friedrich W. Mohr, M.D., beginning at 11:10 a.m. in the Main Arena of the Washington Convention Center. Dr. Serruys will present a Featured Lecture on “Revascularization in Patients with Unprotected Left Main Coronary Artery Disease,” while Dr. Mohr will present on “Revascularization in Patients with Triple Vessel Coronary Artery Disease.” SYNTAX is the first randomized, controlled clinical trial comparing PCI using drug-eluting stents to CABG in patients with left main and/or three-vessel disease. The Company plans to issue a press release at this time. Dr. Serruys will present additional details on the SYNTAX Score during his Featured Lecture as well as during Tuesday’s Focus on SYNTAX Sessions in a presentation titled “SYNTAX Score: Methodology and Importance.”
– Focus on SYNTAX. From 2:00 — 6:00 p.m., a series of focus sessions titled “Revascularization for Left Main and Triple-Vessel Disease: Focus on SYNTAX” will take place in Room 147AB. Details on the topics and presenters can be found in the official TCT program.
– Symposium on SYNTAX Trial Data. From 8:00 — 10:00 p.m., the Company will sponsor a symposium entitled “The SYNTAX Trial: Understanding the Data in Complex Anatomies and Advanced Disease,” chaired by Dr. Serruys in the Grand Ballroom of the Renaissance Hotel. The symposium will offer an overview of the latest SYNTAX trial data and feature a panel discussion on subset case presentations for patients with multi-vessel disease and left main disease. The symposium will include panel members Ted E. Feldman, M.D., Michael J. Mack, M.D., Martin B. Leon, M.D., and Friedrich W. Mohr, M.D. A reception will be held prior to the symposium at 7:00 p.m.
Wednesday, October 15
– OLYMPIA High-Risk Subgroups. One-year results from Intercontinental and European Launch Phases of the global OLYMPIA registry will be presented in an oral abstract session by Waqar H. Ahmed, M.D., M.S., FACC, at 8:41 a.m., in Room 145AB. OLYMPIA is the world’s largest prospective, multi-center, multi-phased registry for a single drug-eluting stent. The registry is designed to analyze real-world clinical outcomes data for Boston Scientific’s second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System. Results from more than 22,000 patients will focus on safety and efficacy, and will highlight outcomes within high-risk lesion subgroups and patients with serious co-morbid conditions. The Company plans to issue a press release at this time.
– HORIZONS AMI data. At 11:00 a.m., Gregg W. Stone, M.D., will present data from the featured trial of the day “HORIZONS AMI: A Prospective Randomized Trial of Paclitaxel-Eluting Stents vs. Bare-Metal Stents in Patients with Acute ST-Segment Elevation Myocardial Infarction” in the Main Arena. The HORIZONS AMI trial is a randomized, controlled clinical trial designed to compare TAXUS stents to bare-metal stents in 3,400 AMI (acute myocardial infarction) patients. The Company plans to issue a press release at this time.
– SYNTAX Sessions. From 10:15 a.m. — 12:30 p.m., an additional series of sessions moderated by Dean J. Kereiakes, M.D., and Craig R. Smith, M.D., titled “Coronary Artery Disease I: Revascularization Controversies” will occur in Room 206. Details on the topics and presenters can be found in the official TCT program.
Boston Scientific will present its latest innovations at booth 814 on Level 2 of the Exhibition Hall, including the TAXUS(R) Express2(TM) Atom(TM) Paclitaxel-Eluting Coronary Stent System, which recently became the only DES approved by the FDA for use in vessels as small as 2.25 mm in diameter.
The safety and effectiveness of the TAXUS Express Stent has not been established in patients with left main, three vessel disease, or an acute MI. In the U.S., the TAXUS Liberte Stent is an investigational device and is not available for sale.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like “anticipate,” “expect,” “project,” “believe,” “plan,” “estimate,” “intend” and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, clinical trials, regulatory approvals, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item IA- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A — Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
CONTACT: Paul Donovan, Media Relations, +1-508-650-8541, mobile+1-508-667-5165, or Larry Neumann, Investor Relations, +1-508-650-8696,both of Boston Scientific Corporation
Web site: http://www.bostonscientific.com/
Ticker Symbol: (NYSE:BSX)
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Nymox NX-1207 Successful Clinical Trial Results Featured in Urology Times
HASBROUCK HEIGHTS, N.J.–(BUSINESS WIRE)–Oct 10, 2008 - Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is please to announce that the presentation of NX-1207 clinical study data at the AUA South Central Section annual meeting in Santa Ana Pueblo, NM was featured in the Urology Times, the widely distributed and most read publication of U.S. urologists. At the meeting, Raphael Wurzel, MD, reviewed clinical data from the most recent NX-1207 trial that showed that treatment with a single dose of NX-1207 significantly improved BPH symptom scores and significantly reduced prostate size after 90 days.
In addition, news of the NX-1207 clinical studies success has been shown on several U.S. television networks.
Dr. Wurzel’s presentation was one of series of recent presentations of NX-1207 clinical study data at annual regional meetings of urologists across the U.S. Further presentations are scheduled in the coming month. NX-1207 has entered its Phase 3 development program, the last stage before filing with the FDA for approval for commercial distribution and sale. The drug involves a new targeted approach to the treatment of BPH. NX-1207 is injected by a urologist in an office setting directly into the zone of the prostate where the enlargement occurs and the injection takes only a few minutes and involves little or no pain or discomfort. In multicenter U.S. clinical trials to date NX-1207 has been found to produce improvements in BPH symptom score that are approximately double that reported for currently approved BPH drugs without the side effects associated with those drugs, which can include sexual dysfunction, blood pressure changes and other adverse reactions.
Presentations of clinical study data at urology have been well-received and the Company has received a large number of communications from patients and doctors throughout the U.S. and internationally, interested in participating in clinical trials and wanting to learn more about the drug. Investigative site recruitment activities are proceeding well.
More information about Nymox is available at www.nymox.com, email: info@nymox.com, or 800-936-9669.
This press release contains certain “forward-looking statements” as defined in the United States Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. There can be no assurance that such statements will prove to be accurate and the actual results and future events could differ materially from management’s current expectations. The conduct of clinical trials and the development of drug products involve substantial risks and uncertainties and actual results may differ materially from expectations. Promising early results do not ensure that later stage or larger scale clinical trials will be successful or will proceed as expected. Such factors are detailed from time to time in Nymox’s filings with the United States Securities and Exchange Commission and other regulatory authorities.
Contact
Nymox Pharmaceutical Corporation
Roy Wolvin, 800-93NYMOX
www.nymox.com
FDA Approves New Injection Site for Risperdal Consta
FDA Approves New Injection Site for Risperdal Consta for Schizophrenia Treatment
TITUSVILLE, N.J., October 09, 2008 /PRNewswire-FirstCall/Patients with schizophrenia now have a new administration option for Risperdal Consta ([risperidone] Long-Acting Injection). The U.S. Food and Drug Administration (FDA) has approved a new injection site, the deltoid muscle in the arm, for Risperdal Consta for the treatment of patients with schizophrenia. Risperdal Consta was previously approved as a gluteal injection only.
“For many patients, this injection site may be a good option, as it will provide them with a choice of where to receive their long-acting therapy,” said Dr. Mohammed Bari, of Synergy Research Center in San Diego and one of the investigators in the trial.* “The fact that they will just have to roll up their sleeves and get the shot in their arm is going to be a big plus for many patients with schizophrenia.”
The application was based on a study showing that the deltoid and gluteal injections of Risperdal Consta were bioequivalent(a) routes of administration and thus interchangeable. An additional study was conducted that showed the safety and tolerability of Risperdal Consta injected into the deltoid muscle were similar to the gluteal injections. Both studies were presented earlier this year at the 161st Annual Meeting of the American Psychiatric Association (APA) in Washington, D.C., 2008.(1, 2)
The new Risperdal Consta dose packs will now include two separate (non-interchangeable) needles for injection and will be available to U.S. physicians by the end of 2008. The needle for deltoid injection is a smaller gauge and is shorter in length than the gluteal needle. Both are administered every two weeks. Not all patients will be appropriate for the deltoid injection site. As with all medications, it’s important that patients discuss their treatment options with their healthcare professional.
Risperdal Consta is marketed in the U.S. by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and manufactured by Alkermes, Inc. Risperdal Consta was initially approved for the treatment of schizophrenia in the U.S. in 2003 and is registered in more than 80 countries worldwide. Using Alkermes’ proprietary Medisorb drug-delivery technology, the Risperdal Consta formulation encapsulates risperidone in microspheres made of a biodegradable polymer, which are suspended in a water-based solution and injected into the muscle. Laboratory and clinical research has shown that the microspheres gradually degrade at a set rate to provide therapeutic blood levels of the drug in the bloodstream for an extended period. The polymer from which the microspheres are made breaks down into two naturally occurring compounds that are then eliminated by the body.
Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., based in Titusville, N.J., is the only pharmaceutical company in the U.S. dedicated solely to mental health. The company currently markets prescription medications for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. For more information about Janssen, visit http://www.janssen.com. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a member of the Johnson & Johnson family of companies.
Worldwide, it is estimated that one person in every 100 develops schizophrenia,(3) one of the most serious types of mental illness. An estimated 2.4 million Americans have schizophrenia, with men and women affected equally.(4) The disease is marked by positive symptoms (hallucinations and delusions) and negative symptoms (depression, blunted emotions and social withdrawal), as well by disorganized thinking, speech and behavior.
Risperdal Consta (risperidone) is used for the treatment of schizophrenia.
Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with Risperdal Consta and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with Risperdal Consta and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
High blood sugar and diabetes have been reported with Risperdal Consta and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with Risperdal Consta. Complications of diabetes can be serious and even life threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
Risperdal Consta and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. The connection between prolactin levels and side effects is unknown.
Some people taking Risperdal Consta may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.
Risperdal Consta may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.
Risperdal Consta should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with Risperdal Consta. Caution should be exercised when Risperdal Consta is administered to a nursing woman.
Risperdal Consta may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.
Some medications interact with Risperdal Consta. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while on Risperdal Consta.
In a study of people taking Risperdal Consta, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
If you have any questions about Risperdal Consta or your therapy, talk with your doctor.
* Mohammed Bari, M.D., is a consultant to Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
CONTACT: Media, Kara Russell, +1-609-730-3592, , orInvestors, Louise Mehrotra, +1-732-524-6491, Lesley Fishman,+1-732-524-3922, both of Johnson & Johnson krussel3@its.jnj.com
Web site: http://www.janssen.com/
Ticker Symbol: (:JNJ)
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Nation’s Teen Vaccination Coverage Increasing, But Below 2010 Goals
Survey provides first estimates for HPV vaccination
WASHINGTON, Oct. 9, 2008–The nation’s immunization coverage rates for preteens and teens are increasing for routinely recommended vaccines, but most still do not have all of the recommended immunizations, according to 2007 estimates released today by the Centers for Disease Control and Prevention (CDC).
“The overall trends are good news,” said Dr. Lance Rodewald, director of the Division of Immunization Services at the CDC′s National Center for Immunization and Respiratory Diseases. “We are seeing more preteens and teenagers being protected against serious, sometimes deadly diseases. But we remain short of our goals—for almost all of these vaccines we want at least 90 percent of adolescents to be fully immunized. As such, we have much work to do to get many more adolescents protected.”
The survey provides estimates for three vaccines recommended at 11 or 12 years of age: the tetanus-diphtheria-acellular pertussis (Tdap) vaccine, the meningococcal conjugate vaccine (MCV4), and the human papillomavirus (HPV4) vaccine for girls and young women. It also includes estimates of the percentage of 13- through 17-year-old teens who should have received the recommended immunizations for measles, mumps and rubella vaccine (MMR), hepatitis B (HepB) vaccine, and varicella vaccine (VAR) earlier in life.
According to Rodewald, the nation’s Healthy People 2010 goals for preteens and teens ages 13-15 years are not being met for any of the vaccines for which goals were set. The Healthy People 2010 goals are for 90 percent coverage for preteens and teens 13 to 15 years of age with three doses of hepatitis B vaccine, two doses of measles, mumps and rubella vaccine, one dose of either tetanus-diphtheria or tetanus, diphtheria and acellular pertussis vaccine, and one dose of varicella vaccine for those who have not previously had chickenpox. There is not a Healthy People 2010 goal for HPV vaccination, which was first licensed and recommended in 2006.
The survey found that, compared to 2006, there was a substantial increase in the percentage of preteens and teens who had received the recommended vaccinations. Specific findings included:
Vaccination coverage levels for three or more doses of hepatitis B (HepB) and two or more doses of measles, mumps and rubella vaccine (MMR) were over 80 percent;
Coverage with one dose of varicella vaccine (VAR) was high at 75.7 percent but coverage with two doses was low at 18.8 percent among preteens and teens without a previous history of disease;
32.4 percent of preteens and teens surveyed had received MCV4 vaccination, up from 11.7 percent in 2006 (a 20.7 percentage point increase);
30.4 percent had received Tdap vaccination, up from 10.8 percent in 2006 (a 19.6 percentage point increase);
25.1 percent of adolescent females had received at least one dose of HPV vaccine
Rodewald encourages parents to take their preteens and teenagers for routine medical checkups as a way to ensure they receive the recommended vaccinations.
Additional Background Information
The meningococcal conjugate vaccine (MCV4) vaccine protects against meningococcal meningitis, the tetanus-diphtheria-acellular pertussis (Tdap) vaccine protects against pertussis, also known as whooping cough, and the human papillomavirus (HPV) vaccine protects girls against cervical cancer. The recommended series consists of one dose of Tdap vaccine, one dose of the MCV4 vaccine, and three doses of the HPV4 vaccine.
CDC has conducted the National Immunization Survey for teens since 2006. It is similar to the standard NIS which began in 1994, that collects immunization information among children 19 through 35 months old. It is a random digit-dialed telephone survey.
For more information, visit http://www.cdc.gov/vaccines/default.htm.
####
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Contact: CDC Division of Media Relations, Phone: (404) 639-3286
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FDA Continues Review of Takeda’s New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
OSAKA, Japan, October 10, 2008 /PRNewswire/ — Takeda Pharmaceutical Company Limited (”Takeda”) today announced that Takeda Global Research and Development Center, Inc., a wholly owned United States (U.S.) subsidiary, received notification that the U.S. Food and Drug Administration (FDA) will not be able to complete its review of the alogliptin New Drug Application (NDA) by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.
“In our most recent discussion with the FDA, it indicated that due to internal resource constraints it will not be able to complete the alogliptin review by the PDUFA date,” said Dean Sundberg, senior vice president, regulatory affairs at Takeda Global Research and Development Center, Inc. “Additionally, the FDA did not provide Takeda with any guidance on when a review might be completed nor did it raise any issues with the data in the alogliptin NDA. Takeda remains confident in alogliptin’s potential as a new treatment option for people suffering from type 2 diabetes and we will work with the FDA as they continue this NDA review.”
Alogliptin is a dipeptidyl peptidase IV (DPP-4) inhibitor discovered by Takeda’s wholly owned U.S. subsidiary, Takeda San Diego, Inc. In December, 2007 Takeda submitted its NDA for alogliptin for the treatment of type 2 diabetes. This submission enhances Takeda’s position as a global leader in type 2 diabetes - one of Takeda’s core therapeutic areas.
The alogliptin NDA submission included six Phase 3 clinical trials involving more than 2,000 patients conducted in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other antidiabetic medications including sulfonylureas, metformin, thiazolidinediones (TZDs), and insulin. In the studies, alogliptin was associated with statistically significant reductions in hemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. Alogliptin was generally well-tolerated and weight neutral. There was no increase in hypoglycemia compared to placebo.
DPP-4 inhibitors inhibit the enzyme dipeptidyl peptidase-4 (DPP-4), which selectively metabolizes the insulin-increasing hormones glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). By maintaining the blood levels of GLP-1 and GIP, DPP-4 inhibitors are a new type of oral anti-diabetic with a novel mechanism of action for lowering blood sugar levels. GLP-1 and GIP are excreted in the digestive tract following food intake, and stimulate the beta-cells in the pancreas — thereby stimulating increased insulin secretion — and it has also been confirmed that they improve the functioning of the beta cells themselves. Furthermore it is known that because GLP-1 suppresses glucagon secretion from the pancreas, the production of sugar in liver cells is also suppressed and appetite is suppressed as well.
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, .
CONTACT: Matt Kuhn, +1-224-554-5609, or Seizo Masuda, +011-81-3-3278-2037,both of Takeda
Web site: http://www.takeda.com/
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AstraZeneca’s Purplepill.com Tops the List of Most Visited Pharmaceutical Brand Web Sites in Q2 2008
Ramped Up Marketing Efforts and FDA Activity Drive Growth at Top Brand.com Sites
RESTON, Va., October 09, 2008 /PRNewswire-FirstCall/ — comScore, Inc. , a leader in measuring the digital world, today released a study of the top pharmaceutical brand Web sites in Q2 2008. The study revealed that purplepill.com, AstraZeneca’s Web site for its heartburn treatment Nexium, generated the most site traffic in Q2 2008 with more than 1 million unique visitors, up 55 percent from year ago. Also showing substantial growth versus last year was diabetes drug Actos, ranking second with 855,000 unique visitors. Insomnia medication Ambien CR, ranked third with 756,000 unique visitors.
“AstraZeneca has aggressively marketed Nexium this year, running approximately twice as much online display advertising in Q2 as either of its major competitors, Prevacid and Aciphex,” said John Mangano, senior director, comScore Pharmaceutical Marketing Solutions. “This additional marketing muscle appears to have helped generate strong site visitation, a very important marketing step in the competitive pharmaceutical industry.”
Top 10 Pharmaceutical Brand Web Sites by Unique Visitors Q2 2008 vs. Q2 2007 Total U.S. -- Home/Work/University Locations Source: comScore, Inc. Unique Visitors (000) Web Site Q2 2007 Q2 2008 Percent Change Nexium (purplepill.com) 659 1,021 55 % Actos (actos.com) 34 855 2399 % Ambien CR (ambiencr.com) 1,949 756 -61 % Gardasil (gardasil.com) 912 722 -21 % Lexapro (lexapro.com) 530 549 3 % Veramyst (veramyst.com) N/A 538 N/A Januvia (januvia.com) 118 507 329 % Lyrica (lyrica.com) 368 501 36 % Topamax (topamax.com) 361 498 38 % Seroquel (seroquel.com) 359 447 24 %
Some highlights from the study include:
– Takeda Pharmaceuticals substantially increased marketing for the Actos brand beginning in the third quarter of 2007, helping build actos.com into the second most visited site in the category in Q2 2008 versus year ago.
– Merck’s diabetes treatment Januvia increased marketing activity beginning in the second half of last year, resulting in a nearly 330-percent increase in visitors to januvia.com.
– Pfizer has ramped up marketing and public relations efforts for Lyrica since the third quarter of 2007, when the product received FDA approval to be marketed for the treatment of fibromyalgia. The site, lyrica.com, has seen a 36-percent increase in unique visitors.
– With a number of migraine treatments nearing patent expirations, the makers of popular migraine treatment Topomax launched a heavy online display ad campaign to bolster awareness, resulting in a 38-percent increase in Q2 2008 versus year ago.
– Merck’s highly publicized HPV vaccine Gardasil was approved by the FDA in the second quarter of 2006. Although the number of site visitors has declined 21 percent during the past year since the company’s initial marketing and public relations push, the site still ranks among the top 5 most visited sites with 722,000 visitors.
These industry insights along with an analysis of other relevant online health trends will be presented during a complimentary webinar conducted by comScore and ePharma Summit entitled, Internet Trends and Usage in 2008 and Beyond, on Thursday, October 16 from 2 to 3 p.m. EDT.
To register for the webinar visit https://www1.gotomeeting.com/register/831770879 and mention priority code G1P1406W2COM.
For more information on comScore Pharmaceutical solutions, please visit: http://www.comscore.com/solutions/info_req.asp?industry=pharma.
About comScore
comScore, Inc. is a global leader in measuring the digital world and preferred source of digital marketing intelligence. For more information, please visit http://www.comscore.com/boilerplate.
CONTACT: Andrea Vollman of comScore, Inc., +1-312-775-6646, press@comscore.com
Web site: http://www.comscore.com/http://www.purplepill.com/
Ticker Symbol: (NASDAQ-NMS:SCOR)
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