New Data Shows Abbott’s Bioabsorbable Drug Eluting Stent is Absorbed Within Two Years - Leaving Behind Functioning Blood Vessels
New Data Shows Abbott’s Bioabsorbable Drug Eluting Stent is Absorbed Within Two Years - Leaving Behind Functioning Blood Vessels
Data Indicate Bioabsorbable Stent Platform Has Potential to Become the Next Major Breakthrough in Interventional Treatment
WASHINGTON, October 13, 2008 /PRNewswire-FirstCall/ — Abbott today announced two-year data from 30 patients in its ABSORB clinical trial, demonstrating that its bioabsorbable drug eluting stent successfully treated coronary artery disease and was absorbed into the walls of treated arteries within two years, leaving behind blood vessels that appeared to move and function similar to unstented arteries. Patients who received Abbott’s bioabsorbable drug eluting coronary stent and were followed out to two years experienced no stent thrombosis out to two years and no new major adverse cardiac events (MACE) between six months and two years. These results confirmed earlier positive one-year clinical results with Abbott’s bioabsorbable drug eluting stent. The results were presented today at the Cardiovascular Research Foundation’s 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
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“Now you see it, now you don’t — for the first time, we have data in patients showing that Abbott’s bioabsorbable drug eluting stent does its job treating diseased coronary arteries and that it is absorbed by two years,” said John Ormiston, M.D., principal investigator in the ABSORB trial and medical director at Mercy Angiography in Auckland, New Zealand. “Clinical safety and effectiveness were sustained at two years, and the previously stented portion of arteries demonstrated the ability to expand and contract in a manner similar to a vessel that has never been stented. These are very exciting results that represent a potential major breakthrough in the future treatment of patients with coronary artery disease.”
Trends were observed in data from tests of artery movement and function, demonstrating a potential restoration of unstented artery movement to coronary blood vessels after the stent was absorbed — something that is not possible with permanent metal-based stent implants.
Abbott also will present groundbreaking intravascular ultrasound (IVUS) and optical computed tomography (OCT) imaging data on its bioabsorbable drug eluting coronary stent platform this week at TCT in the “Best of Coronary Interventions Abstracts” session at 9:20 a.m. Eastern time on Wednesday, Oct. 15, 2008. IVUS data will reveal a decrease in plaque area in treated arteries corresponding to a similar increase in blood flow area between six months and two years: 12.7 percent decrease in plaque area (p=<0.001, n=17); 10.8 percent increase in luminal area (p=0.03, n=17). OCT imaging data will show absorption of the stent into artery walls and that the blood vessel lining of arteries treated with Abbott’s bioabsorbable stent looks more uniform after two years than it did immediately post-treatment.
“The imaging technology data from the ABSORB trial indicate that Abbott’s bioabsorbable stent has the potential to restore vascular integrity and endothelial function to treated vessels after two years,” said Professor Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Hospital, Rotterdam, and co-principal investigator in the ABSORB trial. “With these ABSORB data, we have come full circle in interventional time, linking the past, when balloon angioplasty was used without stents, to the future, when disappearing stents may become the new standard of care for patients with coronary artery disease.”
Abbott is the only company with long-term clinical data evaluating the safety and performance of a fully bioabsorbable drug eluting coronary stent out to two years. Abbott’s bioabsorbable everolimus eluting coronary stent is made of polylactic acid, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. As with a metallic stent, Abbott’s bioabsorbable stent is designed to restore blood flow by propping a clogged vessel open, and to provide support until the blood vessel heals. Unlike a metallic stent, however, a bioabsorbable stent is designed to be slowly metabolized by the body and completely absorbed over time.
“The early success of our bioabsorbable stent marks the dawn of the beginning of a new era in the history of interventional medical device treatment,” said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. “Today’s data show that bioabsorbable stents have become more than just a wish for patients — they are now on their way to becoming a clinical reality.”
Abbott will begin enrolling the next cohort of 80 patients into its international ABSORB clinical trial in the first half of 2009.
ABSORB Clinical Trial Results
Two-year data from the first 30 patients enrolled in the ABSORB clinical trial demonstrated a low (3.6 percent, n=28) MACE rate, which was consistent with results at one year (3.4 percent, n=29) and before six-months (3.3 percent, n=30). One patient had a minor heart attack due to lack of blood supply at six-months, another was electively lost to follow up at one year, and one patient died from a non-cardiac cause at two years. A zero percent stent thrombosis rate persisted for all patients across all time points in the ABSORB trial. Potential restoration of unstented artery movement to coronary blood vessels after the bioabsorbable stent was absorbed was revealed at two years with the drugs acetylcholine and nitroglycerin used in nine patients, showing vasodilation in the previously stented area, and methergine used in seven patients, showing vasoconstriction in the previously stented area.
About the ABSORB Clinical Trial
The ABSORB trial is a prospective, non-randomized (open label) study designed to enroll up to 110 patients in Belgium, Denmark, France, New Zealand, Poland and the Netherlands. Key endpoints of the study include assessments of safety — MACE (defined as any event that resulted in re-treatment of the treated artery, heart attack or cardiac death) and stent thrombosis (blood clot formation) rates — at 30, 180 and 270 days, with additional annual follow-up for up to five years, as well as an assessment of the acute performance of the bioabsorbable drug eluting stent. Other key endpoints of the study include successful deployment of the bioabsorbable drug eluting stent, follow-up measurements assessed by angiography, intravascular ultrasound (IVUS), and state-of-the-art imaging modalities at 180 days and two years.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.
For images of Abbott’s bioabsorbable stent and other information, please visit the company’s online TCT newsroom at http://www.abbottvascular.com/presskit.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com.
CONTACT: Media, Jonathon Hamilton, +1-408-624-0314, or Karin Bauer,+1-650-868-2999, or Financial, John Thomas, +1-847-938-2655, or TinaVentura, +1-847-935-9390, all of Abbott
Web site: http://www.abbott.com/
Ticker Symbol: (NYSE:ABT)
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Kamada Reports Positive Phase II Data with Inhaled AAT in Cystic Fibrosis
Kamada Reports Positive Phase II Data with Inhaled AAT in Cystic Fibrosis
NESS ZIONA, Israel–(BUSINESS WIRE)–Oct. 12, 2008 - Kamada (TASE:KMDA), a biopharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced today positive data from its Phase II study evaluating inhaled Alpha-1 Antitrypsin (AAT) delivered via an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), in the treatment of cystic fibrosis. The results demonstrate the product has an excellent safety profile and shows promising signs of efficacy, as indicated by a reduction in lung inflammation.
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The Phase II trial was a double-blind, placebo controlled study, performed at the world renowned Cystic Fibrosis Center at the Hadassah University Hospital, Mount Scopus Jerusalem, Israel, led by Prof. Eitan Kerem, Head of the Department of Pediatrics and a world expert for Cystic Fibrosis. The trial was designed to evaluate safety of the inhaled product in cystic fibrosis patients and to assess its potential efficacy in decreasing lung inflammation. Study results revealed that daily inhalation of AAT for a period of 28 days reduced lung inflammation in comparison to placebo, as measured by neutrophil count and neutrophil elastase levels. There were no serious adverse events reported in either the active or the placebo group and no safety concerns were raised. This study was performed in accordance with clinical guidance received from the EMEA and under the ODD of the product.
Kamada plans to present the study data at an upcoming major medical meeting. In order to pursue clinical development of this product, Kamada will approach the regulatory authorities for guidance.
Kamada’s Chief Executive Officer David Tsur said: “This is a breakthrough for Kamada. This product is the next generation of AAT treatment that may be used, subject to success of clinical trials and regulatory approval, as an effective treatment for CF patients, to improve their quality of life. We believe that the inhaled product will offer significant advantages to cystic fibrosis patients and we are very optimistic about its further development in this and in other respiratory patient populations.”
Professor Eitan Kerem, the Principal Investigator in this study, said, “I would like to congratulate Kamada for successfully completing this trial. Kamada’s inhaled version of AAT is an innovative approach for the treatment of chronic inflammatory processes, including cystic fibrosis. Interventions that reduce these destructive processes could potentially prevent degeneration of lung function and could have a positive impact on patient lives. I look forward to monitoring the product’s progress in future clinical trials.”
About Inhaled AAT
Kamada’s Inhaled AAT, which utilizes an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), has been designated Orphan Drug, in both Europe and the U.S. for the treatment of cystic fibrosis and Alpha-1 Antitrypsin Deficiency as well as in the U.S. for the treatment of Bronchiectasis. This designation grants Kamada various benefits such as research fund support, tax incentives, reduced official fees and 7 to 12 years of exclusive distribution rights, if the company’s product is first on the market.
About PARI Pharma and the Investigational eFlow(R) Nebulizer System
Kamada’s Inhaled AAT is delivered by the Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH). The Investigational eFlow(R) Nebulizer System uses eFlow(R) Technology to enable extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane that includes thousands of small holes that produce the aerosol mist. Compared to other nebulization technologies, eFlow(R) Technology produces aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible period of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow(R) Technology reduces the burden of taking daily, inhaled treatments. The Investigational eFlow(R) Nebulizer System and eFlow(R) Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.
PARI Pharma focuses on the development of aerosol delivery devices and therapies. Based on PARI’s 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration optimized with advanced delivery technologies, such as eFlow(R) technology. Online at PariPharma.com.
About Kamada
Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals using its proprietary chromatographic purification technologies. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials.
For additional information, please visit www.kamada.com or contact Sivan Shatil, Marketing Communications Manager, at sivans@kamada.com, or - 972-52-666-5762
Contact
Kamada
Sivan Shatil, 972-52-666-5762
Marketing Communications Manager
sivans@kamada.com
Archimedes Pharma Announces First Positive Phase III Clinical Trial Results for NasalFent
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
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• 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.
Peregrine Pharmaceuticals’ anti-PS Technology Platform to Be Discussed at AIDS Vaccine 2008 Conference
Peregrine Pharmaceuticals’ anti-PS Technology Platform to Be Discussed at AIDS Vaccine 2008 Conference
CAPE TOWN, South Africa and TUSTIN, Calif., October 13, 2008 /PRNewswire-FirstCall/ — Peregrine Pharmaceuticals, Inc. a clinical stage biopharmaceutical company developing monoclonal antibodies for cancer and serious viral infections, today reported the company’s anti-phosphatidylserine (anti-PS) technology platform will be discussed in scientific sessions at the AIDS Vaccine 2008 conference in Cape Town, South Africa. Peregrine is developing a new class of anti-PS monoclonal antibody immunotherapeutics that stimulate the body’s immune system to respond to a viral attack by targeting and binding to cellular components that become exposed on the surface of enveloped viruses and on virally infected cells, but not on healthy cells.
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“Following on the heels of our recently awarded U.S. government contract to assess our anti-PS antibodies for the prevention and treatment of viral hemorrhagic fevers, we are pleased that our anti-PS approaches are being discussed at this leading scientific meeting of AIDS vaccine researchers,” said Steven W. King, CEO and president of Peregrine. “We and our collaborators have been preparing and submitting publications to key scientific journals highlighting the role of phosphatidylserine as a potential target for viral disease prophylaxis and therapy in general, as well as the potential of our anti-PS antibodies in specific virus infections. We look forward to reporting on the results of these studies in more detail as the research articles are published.”
Peregrine’s lead anti-PS antibody bavituximab has successfully completed two Phase I clinical trials as monotherapy in patients with chronic hepatitis C virus (HCV) infection and is currently being assessed in a trial for the treatment of HCV in patients co-infected with HIV. Bavituximab has also demonstrated encouraging activity in a model of viral hemorrhagic fever, and in July 2008, Peregrine was awarded a five-year contract worth up to $44.4 million from the Defense Threat Reduction Agency of the U.S. Department of Defense for the development of anti-PS antibodies as potential vaccines and therapies against viral hemorrhagic fevers.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing three separate clinical programs in cancer and HCV infection with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com.
Safe Harbor Statement: Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals’ intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that one or more of the anticipated research articles is not accepted for publication. It is important to note that the company’s actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the company’s SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2008 and the quarterly report on Form 10-Q for the quarter ended July 31, 2008. The company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts: GendeLLindheim BioCom Partners Investors Media info@peregrineinc.com Barbara Lindheim (800) 987-8256 (212) 918-4650
CONTACT: investors, 1-800-987-8256, , or media,Barbara Lindheim, +1-212-918-4650, both of GendeLLindheim BioCom Partners info@peregrineinc.com
Web site: http://www.peregrineinc.com/http://www.avidbio.com/
Ticker Symbol: (NASDAQ-NMS:PPHM)
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The Micell Rapid Absorption Polymer DES System to be Presented at TCT 2008
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.
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“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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Nymox NX-1207 Successful Clinical Trial Results Featured in Urology Times
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.
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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
Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of Taxus Coronary Stent Systems at TCT 2008
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.
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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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Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
Biogen Idec Announces Top-Line Results from Phase II Clinical Trial of Baminercept in Rheumatoid Arthritis
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.
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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
FDA Continues Review of Takeda’s New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
SYR-322
alogliptin
Treatment for Diabetes Mellitus Type II
FDA Continues Review of Alogliptin NDA
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.
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“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/
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
FDA Continues Review of Takeda’s New Drug Application for Alogliptin (SYR-322), a DPP-4 Agent for Type 2 Diabetes
SYR-322
alogliptin
Treatment for Diabetes Mellitus Type II
FDA Continues Review of Alogliptin NDA
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.
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“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/
Terms and conditions of use apply
Copyright © 2008 PR Newswire Association LLC. All rights reserved.
A United Business Media Company
