Alcohol Justice Reports: Alcohol industry misleading the public about alcohol-related cancer risk

Study identifies "denying, distortion and distraction" as main strategies

SAN FRANCISCO, Sept. 7, 2017 /PRNewswire-USNewswire/ -- Alcohol Justice is reporting the release of a new study in the UK showing that the alcohol industry (AI) is misrepresenting evidence about the alcohol-related risk of cancer with activities that have parallels with those of the tobacco industry. The new research is published in the journal Drug and Alcohol Review.

Led by the London School of Hygiene & Tropical Medicine with the Karolinska Institutet, Sweden, the team analysed the information relating to cancer which appears on the websites and documents of nearly 30 alcohol industry organisations around the world between September 2016 and December 2016. Most of the organisational websites (24/26) showed some sort of distortion or misrepresentation of the evidence about alcohol-related cancer risk, with breast and colorectal cancers being the most common focus of misrepresentation

The most common approach involves presenting the relationship between alcohol and cancer as highly complex, with the implication or statement that there is no evidence of a consistent or independent link. Others include denying that any relationship exists or claiming inaccurately that there is no risk for light or 'moderate' drinking, as well discussing a wide range of real and potential risk factors, thus presenting alcohol as just one risk among many.

"This study exposes Big Alcohol's standard operating procedure - deny, distract and distort evidence of alcohol as a dangerous disease-causing agent," stated Bruce Lee Livingston, Executive Director / CEO of U.S-based Alcohol Justice. "It is further evidence that any and all health claims made by the alcohol industry are nothing more than marketing rhetoric making it culpable for fueling over-consumption and massive related harm worldwide."

According to the study, the researchers say policymakers and public health bodies should reconsider their relationships to these alcohol industry bodies, as the industry is involved in developing alcohol policy in many countries, and disseminates health information to the public.

Alcohol consumption is a well-established risk factor for a range of cancers, including oral cavity, liver, breast and colorectal cancers, and accounts for about 4% of new cancer cases annually in the UK1. There is limited evidence that alcohol consumption protects against some cancers, such as renal and ovary cancers, but in 2016 the UK's Committee on Carcinogenicity concluded that the evidence is inconsistent, and the increased risk of other cancers as a result of drinking alcohol far outweighs any possible decreased risk².

This new study analysed the information which is disseminated by 27 AI-funded organisations, most commonly 'social aspects and public relations organisations' (SAPROs), and similar bodies. The researchers aimed to determine the extent to which the alcohol industry fully and accurately communicates the scientific evidence on alcohol and cancer to consumers.

They analysed information on cancer and alcohol consumption disseminated by alcohol industry bodies and related organisations from English speaking countries, or where the information was available in English.

Through qualitative analysis of this information they identified three main industry strategies. Denying, or disputing any link with cancer, or selective omission of the relationship, Distortion: mentioning some risk of cancer, but misrepresenting or obfuscating the nature or size of that risk and Distraction: focussing discussion away from the independent effects of alcohol on common cancers.

Mark Petticrew, Professor of Public Health at the London School of Hygiene & Tropical Medicine and lead author of the study, said: "The weight of scientific evidence is clear - drinking alcohol increases the risk of some of the most common forms of cancer, including several common cancers. Public awareness of this risk is low, and it has been argued that greater public awareness, particularly of the risk of breast cancer, poses a significant threat to the alcohol industry. Our analysis suggests that the major global alcohol producers may attempt to mitigate this by disseminating misleading information about cancer through their 'responsible drinking' bodies."

A common strategy was 'selective omission' - avoiding mention of cancer while discussing other health risks or appearing to selectively omit specific cancers. The researchers say that one of the most important findings is that AI materials appear to specifically omit or misrepresent the evidence on breast and colorectal cancer. One possible reason is that these are among the most common cancers, and therefore may be more well-known than oral and oesophageal cancers.

When breast cancer is mentioned the researchers found that 21 of the organisations present no, or misleading, information on breast cancer, such as presenting many alternative possible risk factors for breast cancer, without acknowledging the independent risk of alcohol consumption.

Professor Petticrew said: "Existing evidence of strategies employed by the alcohol industry suggests that this may not be a matter of simple error. This has obvious parallels with the global tobacco industry's decades-long campaign to mislead the public about the risk of cancer, which also used front organisations and corporate social activities."

The researchers say the results are important because the alcohol industry is involved in conveying health information to people around the world. The findings also suggest that major international alcohol companies may be misleading their shareholders about the risks of their products, potentially leaving the industry open to litigation in some countries.

Professor Petticrew said: "Some public health bodies liaise with the industry organisations that we analysed. Despite their undoubtedly good intentions, it is unethical for them to lend their expertise and legitimacy to industry campaigns which mislead the public about alcohol-related harms. Our findings are also a clear reminder of the risks of giving the AI the responsibility of informing the public about alcohol and health.

"It has often been assumed that, by and large, the AI, unlike the tobacco industry, has tended not to deny the harms of alcohol. However, through its provision of misleading information it can maintain what has been called 'the illusion of righteousness' in the eyes of policymakers, while negating any significant impact on alcohol consumption and profits.

"It's important to highlight that if people drink within the recommended guidelines they shouldn't be too concerned when it comes to cancer. For accurate and accessible information on the risks, the public can visit the NHS website."

The authors acknowledge limitations of their study including that there are many other mechanisms and organisations through which industry disseminates health-related information which they did not examine, although it is unlikely that the messages would be different.

The researchers also say there is an urgent need to examine other industry websites, documents, social media and other materials in order to assess the nature and extent of the distortion of evidence, and whether it extends to other health information, for example, in relation to cardiovascular disease.

For more information or to request interviews please contact the London School of Hygiene & Tropical Medicine press office on +44(0)20 7927 2802 or email press@lshtm.ac.uk.

A copy of the paper is available upon request.

Notes to Editors

Publication

Mark Petticrew, Nason Maani Hessari ,Cécile knai and Elisabete Weiderpass. How alcohol industry organisations mislead the public about alcohol and cancer. Drug and Alcohol Review. DOI: 10.1111/dar.12596

1Cancer Research UK: Statistics on preventable cancers.

2Committee on Carcinogenicity of chemicals in food, consumer products and the environment (COC). Statement 2015/S2.

About the London School of Hygiene & Tropical Medicine

The London School of Hygiene & Tropical Medicine is a world-leading centre for research and postgraduate education in public and global health, with more than 4,000 students and 1,000 staff working in over 100 countries. The School is one of the highest-rated research institutions in the UK, is among the world's leading schools in public and global health, and was named University of the Year in the Times Higher Education Awards 2016. Our mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice. http://www.lshtm.ac.uk

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SOURCE Alcohol Justice

New Data Demonstrate Aimovig(TM) (erenumab) Reduced Monthly Migraine Days In Patients Who Failed Previous Preventive Therapies

Aimovig Reduced Monthly Migraine Days for Patients With Chronic Migraine and Prior Treatment Failure, a Population With Significant Unmet NeedResults From New Dedicated Cardiovascular Study Support Overall Safety Profile Observed in Aimovig Clinical Study ProgramAimovig is the Only Investigational Biologic Product Specifically Designed to Prevent Migraine by Blocking the CGRP Receptor, Which is Associated With Migraine Activation

THOUSAND OAKS, Calif., Sept. 7, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced new data in patients with high unmet need, providing further evidence of the efficacy of Aimovig™* (erenumab) for migraine prevention. Aimovig is the first and only investigational biologic product specifically designed to prevent migraine by blocking the calcitonin gene-related peptide (CGRP) receptor, which is associated in migraine activation. The data include a pre-planned sub-analysis from the pivotal Phase 2 chronic migraine study, demonstrating that Aimovig reduced the number of monthly migraine days (MMDs) in patients who have failed previous preventive therapies. Additionally, results from a dedicated study in patients with stable angina adds further support to the safety profile of Aimovig. These results will be presented at the 18th Congress of the International Headache Society in Vancouver, Canada.

"Data from our robust clinical development program continue to show that Aimovig has demonstrated efficacy in a broad range of patients, including hard-to-treat chronic migraine sufferers who have previously tried and failed other preventive therapies," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Separately, new results from a treadmill safety study showed no adverse cardiovascular effect compared to placebo in patients with coronary artery disease and stable angina, which complements our extensive safety database and ongoing long-term extension studies of Aimovig for migraine prevention."

Studies have shown that up to 80 percent of people with migraine discontinue preventive treatment within one year. In a pre-specified sub-analysis from the Phase 2 study, Aimovig showed benefits for people with chronic migraine who have previously tried and failed preventive treatments. At the end of the 12-week study, patients who had failed two or more prior preventive treatments experienced a reduction of 7.0 days and 5.4 days in the Aimovig 140 mg and 70 mg, respectively, compared to placebo reduction of 2.7 days (p<0.001). Furthermore, in the Aimovig treated arms, the odds of cutting migraine days in at least half was three-to-four fold higher than in the placebo arm (140 mg: 41.3 percent, 70 mg: 35.6 percent, placebo: 14.2 percent (p<0.001 for both doses versus placebo). 

The safety profile of Aimovig was similar to placebo across both treatment arms in the Phase 2 study. No adverse event was reported in greater than five percent of patients treated with Aimovig; the most common adverse events were injection site pain, upper respiratory tract infection and nausea.

Aimovig was tested in a group of patients with stable angina due to coronary artery disease. A treadmill "stress test" is often used to gauge how well a patient's heart can handle exercise. The study met it primary endpoint of noninferiority, showing no difference in exercise time among participants receiving Aimovig or placebo. The treatment difference in mean change from baseline in exercise time was –11.0 seconds (90 percent confidence interval –44.9, 22.9). In addition, no significant differences were seen between the two groups in time to onset of angina or time to onset of electrocardiogram change consistent with onset of myocardial ischemia. Adverse events were reported in 27 percent of patients receiving Aimovig and in 32 percent of patients receiving placebo. The most frequent treatment-emergent adverse events (reported in >2 percent of patients) were headache (4.5 percent) and viral upper respiratory infection (4.5 percent) in the Aimovig group, and were hypotension (4.5 percent), influenza (4.5 percent) and viral infection (4.5 percent) in the placebo group.

"While the community has watched the next generation of migraine preventives with excitement, because CGRP has a vasodilatory effect, there have been questions about a potential impact on cardiovascular function especially in at-risk populations," said Amaal J. Starling, M.D., assistant professor of neurology at the Mayo Clinic in Scottsdale, Ariz., and a study co-author. "The results of this study provide some evidence that CGRP receptor inhibition did not aggravate myocardial ischemia in at-risk population of patients with stable angina compared to placebo and contribute to the growing body of evidence supporting the safety profile of Aimovig."

These results are consistent with the known safety profile of Aimovig, as seen across the broad clinical program involving more than 2,600 migraine patients.

Regulatory submissions for Aimovig have been filed in the United States (U.S.) and Europe. The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 17, 2018. If approved, Novartis and Amgen will co-commercialize Aimovig in the U.S. Amgen has exclusive commercialization rights to the drug in Japan and Novartis has exclusive rights to commercialize in rest of world.

About Aimovig™ (erenumab)

Aimovig is the only investigational biologic product specifically designed to prevent migraine by blocking the CGRP receptor, which is associated with migraine activation. Aimovig has been studied in several large global, randomized, double-blind, placebo-controlled studies to assess its safety and efficacy in migraine prevention. More than 2,600 patients have been exposed to Aimovig across the four placebo-controlled Phase 2 and Phase 3 clinical studies and their open-label extension.

About the Phase 2 Study

The 20120295 study is a global Phase 2, randomized, 12-week, double-blind, placebo-controlled study evaluating the safety and efficacy of Aimovig in chronic migraine prevention. In the study, 667 patients were randomized to receive once-monthly subcutaneous placebo or Aimovig (70 mg or 140 mg) in a 3:2:2 ratio, respectively. The primary endpoint was change in MMDs from baseline to the last four weeks of the 12-week treatment phase in patients with chronic migraine (the number of migraine days between weeks nine and 12). Secondary study endpoints included reduction of at least 50 percent from baseline in monthly migraine days, change from baseline in monthly acute migraine-specific medication days and change from baseline in cumulative monthly headache hours.

About the Treadmill Cardiovascular Safety Study

The 20140254 study is a double-blind, placebo-controlled cardiovascular safety study in patients with stable angina due to documented coronary artery disease. Patients were randomized 1:1 to a single intravenous infusion of Aimovig 140 mg or placebo stratified by baseline treadmill exercise test (TET) (<7 minutes or ≥7 minutes) defined as the average TET of two qualifying exercise tolerance tests (ETTs) performed during screening. Following study drug administration on Day 1, a post-administration ETT was conducted. The primary endpoint was the change from baseline in exercise duration as measured by TET with a non-inferiority margin of –90 seconds. Secondary efficacy endpoints included time to onset of ≥1 mm ST-segment depression and time to onset of exercise-induced angina during the ETT. Safety follow-up visits occurred every 2-4 weeks for 12 weeks. Adverse events were reported by 14 percent of Aimovig-treated patients and by 27 percent of placebo patients and were consistent with the known safety profile of erenumab.

About Migraine

People with frequent migraine may lose more than half their life to migraine days.1 Migraine robs individuals of time with their families, and impacts their daily activities at home and at work. Migraine patients endure debilitating pain, incapacitating physical impairment, and live in constant dread of the next attack – all of which is compounded by a widespread misperception of the disease.2 The World Health Organization ranks migraine as one of the most debilitating illnesses.2 For the approximately 10 million Americans whose migraine frequency or severity impacts daily activities, preventive medications may be an option.3 Approximately 3.5 million of these patients are currently on a preventive therapy, but up to 80 percent discontinue these within one year.3,4 Migraine is associated with personal and societal burdens of pain, disability, and financial cost, and it remains under-recognized and under-treated.

About Amgen and Novartis Neuroscience Collaboration

Since 2015, Amgen and Novartis have collaborated to jointly develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease (AD). This includes investigational Amgen drugs in the migraine field, including Aimovig (Biologics License Application accepted by the FDA in July 2017) and AMG 301 (currently in Phase 1 development). In April 2017, the collaboration was expanded to include co-commercialization of Aimovig in the U.S. For the migraine program, Amgen retains exclusive rights in Japan, and Novartis has exclusive rights in Europe, Canada and rest of world. The companies are also partnering in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD.

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Forward-Looking Statements

This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.

*The trade name Aimovig™ is provisionally approved for use by the U.S. FDA.

CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008 (media)
Kristen Neese, 805-313-8267 (media)
Arvind Sood, 805-447-1060 (investors)

References
1 Lipton RB, et al. Migraine prevalence, disease burden, and the need for preventative therapy. Neurology. 2007; 68(5):343-9.
2 Headache disorders - Fact sheets. World Health Organization. http://www.who.int/mediacentre/factsheets/fs277/en/. Accessed March 3, 2017.
3 Marketscan data on file. March 31, 2017. Ref Type: Data File
4 Hepp Z et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia. 2015; 35(6):478-88.

 

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SOURCE Amgen

The Launch of First-in-Class Biologic Therapies Will Drive Significant Growth Within the Osteoarthritic Pain Market Through 2026

BURLINGTON, Mass., Sept. 7. 2017 /PRNewswire/ -- Decision Resources Group finds that the launch of novel biologic therapies targeting nerve growth factor (NGF) will be the main driver of growth in the osteoarthritic pain market following these agents' launch, beginning in 2020, across the major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, Japan). Given the widely generic current market and the anticipated high price of these agents, their use will be reserved for later line in a small percentage of patients who are not surgical candidates or who prefer to delay surgery. Nevertheless, the sizeable osteoarthritic pain population and expected high prices of the anti-NGF therapies will drive overall major-market sales of nearly $23.5 billion in 2026.

For more information on purchasing this report, please visit our website:
http://bit.ly/2epFVRp

Other key findings from the Disease Landscape and Forecast report entitled Osteoarthritic Pain:

  • Anti-NGF therapies from Pfizer/Eli Lilly and Regeneron/Teva/Mitsubishi Tanabe Pharma will account for nearly three-quarters of major-market osteoarthritic pain sales in 2026. Current market-leading classes of opioid analgesics and NSAIDs will maintain the majority of patient share and consistent sales through 2026.
  • Sales within the opioid analgesics class continue to be driven by branded abuse-deterrent formulations (ADFs), reflecting efforts to curb prescription opioid abuse. However, the cost, perceived effectiveness, and continued risk of dependence with these agents limit future growth opportunities. Grϋnenthal/Depomed's cebranopadol, with its anticipated lower abuse risk, will propel sales of the class after its launch in 2022.
  • NSAIDs remain the most prescribed agents for osteoarthritic pain due to the variety and extensive generic availability in this class. Side effects associated with chronic use are a lingering concern for prescribers, and while nonoral formulations seek to resolve these concerns, development in this class has diminished from market saturation. Sales of the NSAIDs class will remain constant through 2022 before decreasing.
  • The prevalence of osteoarthritic pain will continue to increase through 2026 due to an aging population and rising obesity rates.

Comments from Decision Resources Group Analyst Joyce Spadafora, ALM:

  • "We expect the anti-NGF monoclonal antibodies will be the most commercially successful novel drug class for the treatment of osteoarthritic pain. While safety risks continue to shadow their perception among interviewed physicians, large ongoing Phase III safety trials may ameliorate lingering concerns. Their impressive efficacy demonstrated to date and anticipated premium pricing, together with the current absence of totally effective and safe analgesics and the large osteoarthritic pain patient population, will yield blockbuster major-market sales by 2026."
  • "Opioid analgesics will remain a key player in the treatment of osteoarthritic pain. Despite increasing safety and abuse concerns associated with this class, the presence of ADFs of long-acting opioid analgesics in the United States and the anticipated improved safety profile of cebranopadol will prevent erosion of class sales over the forecast period."

Additional Resources:

About Decision Resources Group
DRG, a subsidiary of Piramal Enterprises Ltd., is the premier source for global healthcare data and market intelligence. A trusted partner for over 20 years, DRG helps companies competing in the global healthcare industry make informed business decisions. Organizations committed to the developing and delivering life-changing therapies to patients rely on DRG's in-house team of expert healthcare analysts, data scientists, and consultants for critical guidance. DRG products and services, built on extensive data assets and delivered by experts, empower organizations to succeed in complex healthcare markets.

Media contact:

Decision Resources Group
Stephanie Cooper
scooper@teamdrg.com

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SOURCE Decision Resources Group

Micro Interventional Devices, Inc.(TM) Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA(TM) Technology

NEWTOWN, Pa., Sept. 7, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) has successfully completed the first in human tricuspid valve bicuspidization procedure utilizing its MIA (Minimally Invasive Annuloplasty) technology.  The successful bicuspidization resulted in a 34.5% reduction in valve area, reducing the patient's tricuspid regurgitation from severe/moderate to trace. The patient was the fourth to be enrolled in MID's STTAR Trial (Study of Transcatheter Tricuspid Annular Repair).  All four patients have been successfully treated with 100% procedural success and no adverse events reported.

"This patient represents an evolution in the clinical use of MIA.  This is the first time MIA was utilized to perform a bicuspidization of the patient's tricuspid valve," stated Michael Whitman, MID's President and CEO.  "The shift to a bicuspidization approach on our fourth patient provided a superior outcome and was easier to perform than our initial three patients.  This is not surprising as clinical experience is applied to greater procedural affect.  The acute results for this patient appear comparable to open bicuspidization procedures." 

The fourth patient enrolled in the STTAR study on Wednesday, August 23rd was treated with a second generation MIA implant that allows for greater annular reduction with fewer implants. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.  As with the other STTAR cases, there were no intraoperative complications or adverse events observed or reported. 

By using a bicuspidization approach with the second-generation technology, the annular reduction may prove to be easier, faster and more durable.  The tricuspid repair portion of the procedure was completed in 15 minutes.

"This fourth clinical case marks a significant milestone for the company as the MIA technology continues to prove effective in open surgery," stated Michael Whitman, President and CEO of MID.  "With the confirmation of the implant's effectiveness, our next step is to convert this technology to a 12F catheter-based delivery system which has been in development for some time.  We expect to perform the first percutaneous bicuspidization with MIA in Q4 of this year."

"The MIA deployment took approximately 15 minutes in open surgery.  Therefore, we expect the percutaneous deployments to take less than thirty minutes," stated Willard Hennemann, PhD, MID's Chief Science Officer.  "MIA percutaneous can be deployed from the atrium via transfemoral access, avoiding subvalvular structures, and improving the ease of use.  This may open the door for treatment of the approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation, as they are unable to tolerate open surgery.  This first in human result indicates that MIA will be a viable treatment for functional tricuspid disease."

MIA utilizes proprietary compliant PolyCorTM anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function.  The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.  

About Micro Interventional Devices, Inc. (MID):

MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.

Company Contact:
Micro Interventional Devices, Inc.
Katherine Whitman
Product Director
215 600 1270
info@microinterventional.com
www.microinterventional.com

 

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SOURCE Micro Interventional Devices, Inc.

Micro Interventional Devices, Inc.(TM) Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA(TM) Technology

NEWTOWN, Pa., Sept. 7, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) has successfully completed the first in human tricuspid valve bicuspidization procedure utilizing its MIA (Minimally Invasive Annuloplasty) technology.  The successful bicuspidization resulted in a 34.5% reduction in valve area, reducing the patient's tricuspid regurgitation from severe/moderate to trace. The patient was the fourth to be enrolled in MID's STTAR Trial (Study of Transcatheter Tricuspid Annular Repair).  All four patients have been successfully treated with 100% procedural success and no adverse events reported.

"This patient represents an evolution in the clinical use of MIA.  This is the first time MIA was utilized to perform a bicuspidization of the patient's tricuspid valve," stated Michael Whitman, MID's President and CEO.  "The shift to a bicuspidization approach on our fourth patient provided a superior outcome and was easier to perform than our initial three patients.  This is not surprising as clinical experience is applied to greater procedural affect.  The acute results for this patient appear comparable to open bicuspidization procedures." 

The fourth patient enrolled in the STTAR study on Wednesday, August 23rd was treated with a second generation MIA implant that allows for greater annular reduction with fewer implants. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.  As with the other STTAR cases, there were no intraoperative complications or adverse events observed or reported. 

By using a bicuspidization approach with the second-generation technology, the annular reduction may prove to be easier, faster and more durable.  The tricuspid repair portion of the procedure was completed in 15 minutes.

"This fourth clinical case marks a significant milestone for the company as the MIA technology continues to prove effective in open surgery," stated Michael Whitman, President and CEO of MID.  "With the confirmation of the implant's effectiveness, our next step is to convert this technology to a 12F catheter-based delivery system which has been in development for some time.  We expect to perform the first percutaneous bicuspidization with MIA in Q4 of this year."

"The MIA deployment took approximately 15 minutes in open surgery.  Therefore, we expect the percutaneous deployments to take less than thirty minutes," stated Willard Hennemann, PhD, MID's Chief Science Officer.  "MIA percutaneous can be deployed from the atrium via transfemoral access, avoiding subvalvular structures, and improving the ease of use.  This may open the door for treatment of the approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation, as they are unable to tolerate open surgery.  This first in human result indicates that MIA will be a viable treatment for functional tricuspid disease."

MIA utilizes proprietary compliant PolyCorTM anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function.  The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.  

About Micro Interventional Devices, Inc. (MID):

MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.

Company Contact:
Micro Interventional Devices, Inc.
Katherine Whitman
Product Director
215 600 1270
info@microinterventional.com
www.microinterventional.com

 

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SOURCE Micro Interventional Devices, Inc.

Micro Interventional Devices, Inc.(TM) Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA(TM) Technology

NEWTOWN, Pa., Sept. 7, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) has successfully completed the first in human tricuspid valve bicuspidization procedure utilizing its MIA (Minimally Invasive Annuloplasty) technology.  The successful bicuspidization resulted in a 34.5% reduction in valve area, reducing the patient's tricuspid regurgitation from severe/moderate to trace. The patient was the fourth to be enrolled in MID's STTAR Trial (Study of Transcatheter Tricuspid Annular Repair).  All four patients have been successfully treated with 100% procedural success and no adverse events reported.

"This patient represents an evolution in the clinical use of MIA.  This is the first time MIA was utilized to perform a bicuspidization of the patient's tricuspid valve," stated Michael Whitman, MID's President and CEO.  "The shift to a bicuspidization approach on our fourth patient provided a superior outcome and was easier to perform than our initial three patients.  This is not surprising as clinical experience is applied to greater procedural affect.  The acute results for this patient appear comparable to open bicuspidization procedures." 

The fourth patient enrolled in the STTAR study on Wednesday, August 23rd was treated with a second generation MIA implant that allows for greater annular reduction with fewer implants. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.  As with the other STTAR cases, there were no intraoperative complications or adverse events observed or reported. 

By using a bicuspidization approach with the second-generation technology, the annular reduction may prove to be easier, faster and more durable.  The tricuspid repair portion of the procedure was completed in 15 minutes.

"This fourth clinical case marks a significant milestone for the company as the MIA technology continues to prove effective in open surgery," stated Michael Whitman, President and CEO of MID.  "With the confirmation of the implant's effectiveness, our next step is to convert this technology to a 12F catheter-based delivery system which has been in development for some time.  We expect to perform the first percutaneous bicuspidization with MIA in Q4 of this year."

"The MIA deployment took approximately 15 minutes in open surgery.  Therefore, we expect the percutaneous deployments to take less than thirty minutes," stated Willard Hennemann, PhD, MID's Chief Science Officer.  "MIA percutaneous can be deployed from the atrium via transfemoral access, avoiding subvalvular structures, and improving the ease of use.  This may open the door for treatment of the approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation, as they are unable to tolerate open surgery.  This first in human result indicates that MIA will be a viable treatment for functional tricuspid disease."

MIA utilizes proprietary compliant PolyCorTM anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function.  The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.  

About Micro Interventional Devices, Inc. (MID):

MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.

Company Contact:
Micro Interventional Devices, Inc.
Katherine Whitman
Product Director
215 600 1270
info@microinterventional.com
www.microinterventional.com

 

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SOURCE Micro Interventional Devices, Inc.

Micro Interventional Devices, Inc.(TM) Completes First Clinical Tricuspid Bicuspidization Procedure Utilizing MIA(TM) Technology

NEWTOWN, Pa., Sept. 7, 2017 /PRNewswire/ -- Micro Interventional Devices, Inc.™ (MID) has successfully completed the first in human tricuspid valve bicuspidization procedure utilizing its MIA (Minimally Invasive Annuloplasty) technology.  The successful bicuspidization resulted in a 34.5% reduction in valve area, reducing the patient's tricuspid regurgitation from severe/moderate to trace. The patient was the fourth to be enrolled in MID's STTAR Trial (Study of Transcatheter Tricuspid Annular Repair).  All four patients have been successfully treated with 100% procedural success and no adverse events reported.

"This patient represents an evolution in the clinical use of MIA.  This is the first time MIA was utilized to perform a bicuspidization of the patient's tricuspid valve," stated Michael Whitman, MID's President and CEO.  "The shift to a bicuspidization approach on our fourth patient provided a superior outcome and was easier to perform than our initial three patients.  This is not surprising as clinical experience is applied to greater procedural affect.  The acute results for this patient appear comparable to open bicuspidization procedures." 

The fourth patient enrolled in the STTAR study on Wednesday, August 23rd was treated with a second generation MIA implant that allows for greater annular reduction with fewer implants. The procedure was performed by Professor Kestutis Rucinskas, MD, Chief of Cardiac Surgery, and Professor Audrius Aidietis, MD, Chief of Cardiology and Angiology, at the Vilnius University Hospital Santariskiu Clinic in Vilnius, Lithuania.  As with the other STTAR cases, there were no intraoperative complications or adverse events observed or reported. 

By using a bicuspidization approach with the second-generation technology, the annular reduction may prove to be easier, faster and more durable.  The tricuspid repair portion of the procedure was completed in 15 minutes.

"This fourth clinical case marks a significant milestone for the company as the MIA technology continues to prove effective in open surgery," stated Michael Whitman, President and CEO of MID.  "With the confirmation of the implant's effectiveness, our next step is to convert this technology to a 12F catheter-based delivery system which has been in development for some time.  We expect to perform the first percutaneous bicuspidization with MIA in Q4 of this year."

"The MIA deployment took approximately 15 minutes in open surgery.  Therefore, we expect the percutaneous deployments to take less than thirty minutes," stated Willard Hennemann, PhD, MID's Chief Science Officer.  "MIA percutaneous can be deployed from the atrium via transfemoral access, avoiding subvalvular structures, and improving the ease of use.  This may open the door for treatment of the approximately 2.3 million patients worldwide who are not currently being treated for mitral and tricuspid regurgitation, as they are unable to tolerate open surgery.  This first in human result indicates that MIA will be a viable treatment for functional tricuspid disease."

MIA utilizes proprietary compliant PolyCorTM anchors, the world's first low mass polymeric implant designed to comply with normal physiological valvular function.  The MIA implant is engineered to plicate and comply with cardiac tissue once deployed.  

About Micro Interventional Devices, Inc. (MID):

MID is the world leader in percutaneous transcatheter compliant fixation technology addressing unmet needs in structural heart disease.

Company Contact:
Micro Interventional Devices, Inc.
Katherine Whitman
Product Director
215 600 1270
info@microinterventional.com
www.microinterventional.com

 

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SOURCE Micro Interventional Devices, Inc.

Project ALS and Amylyx Enter Collaboration to Test AMX0035

Pre-clinical studies at Columbia University's Motor Neuron Center Complement Amylyx Phase 2 Clinical Studies of Lead Therapeutic Compound

NEW YORK and CAMBRIDGE, Mass., Sept. 7, 2017 /PRNewswire/ -- Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx's oral compound AMX0035 to advance the understanding of the compound's neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University's Motor Neuron Center will complement the company's recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS).  

The Project ALS Pre-Clinical Core at the Columbia University's Motor Neuron Center has established a unique integrated and standardized platform for the testing and validation of new therapeutic strategies in recognized experimental models of ALS and for biomarker discovery. The Core, developed in collaboration with Project ALS, will accelerate the translation of new promising therapies to patients by facilitating speedy testing of new therapeutic leads discovered by laboratories studying motor neuron biology, genetics and genomics.

"The collaboration will bring together a promising therapeutic candidate for a devastating disease with leading edge, fundamental neuroscientific research at Columbia," said Valerie Estess, director of research for Project ALS. "The studies in this collaboration will provide greater insight into the neurobiological effects of AMX0035, and hopefully optimize its beneficial effects."

The collaboration is an outgrowth of previous studies by The Project ALS Pre-Clinical Core at Columbia University of tauroursodeoxycholic acid (TUDCA), one of the components of AMX0035. "We look forward to evaluating AMX0035 in models of ALS. It is exciting that TUDCA has independently shown promise in both our labs and in studies conducted by the company," said Drs. Hynek Wichterle and Serge Przedborski, co-directors of The Project ALS Pre-Clinical Core and tenure faculty in the Departments of Pathology and Neurology at Columbia University.

AMX0035 is a combination of two drugs, sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA). Previous studies of PB and TUDCA as individual agents demonstrated efficacy in cellular and animal models of ALS.  AMX0035 has been shown to synergistically prevent nerve cell death and neurotoxic inflammation, hallmarks of ALS, in preclinical models. In addition, PB and TUDCA have been individually tested in ALS clinical trials and each demonstrated safety, tolerability, and preliminary signs of efficacy.  AMX0035 recently entered Phase 2 clinical development to evaluate its safety and efficacy in ALS. The trial, called CENTAUR, is a 24-week, randomized, double-blind, placebo-controlled study in 132 participants with ALS. More information on the CENTAUR trial can be found at www.clinicaltrials.gov, NCT03127514 and at www.Amylyx.com/Trials.

"Amylyx is very excited to partner with Project ALS and the researchers at Columbia's Motor Neuron Center to advance these experiments. We hope these studies will provide valuable insights into both AMX0035 and ALS biology that will ultimately improve the lives of patients with ALS," said Kent Leslie, Chief Scientific Officer of Amylyx.

About ALS

ALS is a brain disease that is closely related to Parkinson's, Alzheimer's, and Huntington's. Also known as Lou Gehrig's disease, ALS targets brain cells called motor neurons. Motor neurons send messages from the brain to muscles throughout the body. In ALS, as motor neurons weaken and die, a person progressively loses the ability to walk, speak, swallow, and breathe. ALS affects adults of all ages, from teens to seniors.

About Project ALS

Project ALS is a non-profit 501(c)3 that identifies and funds the most promising scientific research that will lead to the first effective treatments and a cure for ALS. The Project ALS Pre-Clinical Core at Columbia University is supported by generous donations from the Kleiner Family Research Initiative, Stu and Leslie Hendel, Team Chris Combs, and other donors.

About Motor Neuron Disease Center

The Center for Motor Neuron Biology and Disease at Columbia University, in short the Motor Neuron Center, offers an unparalleled pre-clinical academic initiative integrated with the ALS Clinic Center, the Columbia Precision Medicine Initiative, the Institute of Genomic Medicine, and the Zuckerman Mind, Brain, and Behavior Institute.

For the past decade, the Motor Neuron Center faculty members have utilized existing and novel models of ALS as well as patient derived iPS cell motor neurons to test a variety of therapeutic strategies ranging from pharmacological approaches, using small molecules, to gene therapies, using viral vectors or CRISPR based genome engineering. MNC scientists work with internationally renowned clinicians experienced in clinical studies including therapeutic trials for ALS and other paralytic disorders, eager to provide advice about the feasibility of therapeutic approaches and to test promising leads in clinical trials.

About Amylyx

Amylyx Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company currently developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS) and other neurodegenerative diseases. The company's therapeutic, AMX0035, targets the neuroinflammation and nerve cell death that characterize these diseases. AMX0035 is a proprietary combination of existing compounds that have worked synergistically to prevent cell death and neurotoxic inflammation in multiple preclinical models. AMX0035 entered a Phase 2 clinical trial (CENTAUR) in ALS patients in June 2017.

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SOURCE Project ALS

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Alnylam Pharmaceuticals, Inc. – ALNY

NEW YORK, Sept. 7, 2017 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Alnylam Pharmaceuticals, Inc. ("Alnylam" or the "Company") (NASDAQ:  ALNY). Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 9980.

The investigation concerns whether Alnylam and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here to join a class action]

On September 7, 2017, Alnylam advised investors that the Company had stop giving doses of fitusiran, Alnylam's experimental hemophilia treatment, to patients enrolled in the Company's clinical studies, following the death of a patient who developed a blood clot. 

On this news, Alnylam's share price has fallen as much as $12.37, or 14.38%, during intraday trading on September 7, 2017.

The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com

CONTACT:
Robert S. Willoughby
Pomerantz LLP
rswilloughby@pomlaw.com

 

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SOURCE Pomerantz LLP

Comprehensive Edaravone Clinical Program Data Published as Supplement to Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration Journal

JERSEY CITY, N.J., Sept. 7, 2017 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. today announced that the comprehensive clinical development program data for edaravone in the treatment of amyotrophic lateral sclerosis (ALS) have been published as a supplement to Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration (ALSFTD), a leading journal for ALS and FTD research.

The supplement, Edaravone in ALS, provides ALS specialists and researchers a full review of edaravone's 13-year clinical development program, offering a comprehensive overview of the rationale and progression by which researchers were able to demonstrate edaravone's clinical benefit. In a therapeutic arena as devastating and difficult as ALS, which has been challenged by negative trials for many therapeutic agents, key learnings from this development program may be applicable to other future ALS clinical research. 

Edaravone in ALS provides valuable insight into the process by which the sponsor conducted an extensive 13-year clinical development program leading to approval for patients in Japan and South Korea in 2015 – and the United States in 2017.

To view the supplement, please click here:
http://www.tandfonline.com/toc/iafd20/18/sup1?nav=tocList

About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's (MTPC) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. MTPA is dedicated to delivering innovative products that address the unmet medical needs of patients in the U.S. It was established by MTPC to commercialize approved pharmaceutical products in the U.S. with plans to expand its product line through collaborations with partners. For more information, please visit www.mt-pharma-america.com or follow us on Twitter at https://twitter.com/MTPharmaUS.

Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company and has the longest history of any listed company in Japan.1 In accordance with the corporate philosophy of "contributing to the healthier lives of people around the world through the creation of pharmaceuticals," the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 16-20. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — autoimmune diseases, diabetes and kidney diseases, central nervous system diseases, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA and the license holder of RADICAVA. For more information, go to http://www.mt-pharma.co.jp/.

Media inquiries:
Debbie Etchison
908-340-8578
Media_MTPA@mt-pharma-us.com

_______________
1 Research by TOKYO SHOKO RESEARCH, LTD.

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SOURCE Mitsubishi Tanabe Pharma America, Inc.