Archive for the ‘Healthcare’ Category
Virucidal Efficacy of BETADINE(R) Formulations Proven Against MERS[1]
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SINGAPORE /PRNewswire/ — Mundipharma today announced successful results from the testing of BETADINE® formulations against the MERS virus, which remains a serious health threat with a new outbreak in Saudi Arabia, the largest since the peak of the last MERS outbreak there in the summer of 20143. With more than two million pilgrims to the Muslim holy city of Mecca for the annual hajj pilgrimage expected in September4 and more than 5 million Saudi students starting classes this week, there is a significant risk of the virus spreading nationwide.
The South Korea outbreak which concluded in July 2015, where 185 people were infected, 36 killed and more than 16,000 quarantined, has demonstrated the need for effective preventative measures to reduce the spread of the virus5.
To date, there is no specific medication or vaccination available to effectively combat MERS or its spread, raising tremendous concern in today’s globally connected population. Hence, in an effort to contain the spread of infectious diseases, the World Health Organisation (WHO) has emphasised the importance of good hygiene and issued guidelines on maintaining good personal hygiene, highlighting regular hand washing with soap, as the first line of defence in disease prevention and infection control6.
A recent in-vitro research study, conducted at Marburg University, Germany, on BETADINE® range of products including 4% PVP-I (BETADINE® Skin Cleanser), 7.5% PVP-I (BETADINE® Surgical Scrub), 1% PVP-I (BETADINE® gargle and mouthwash) demonstrated scientifically proven virucidal in-vitro efficacy against the MERS virus and the modified vaccinia virus type Ankara, considered to be one of the toughest enveloped viruses (Ebola, influenza and coronaviruses are also enveloped viruses)7.
The study was conducted based on the latest EU test standard EN14476:2014 for antiviral enveloped virus testing (similar to that for Ebola). The three PVP-I products tested in this study demonstrated virucidal activity against MERS with a rapid kill rate of ≥99.99% within only 15 seconds of exposure, and reaffirms BETADINE®‘s broad virucidal efficacy against a wide range of viruses including MERs. Proper hand and respiratory hygiene coupled with PVPI antiviral efficacy will help in limiting the transmission of the virus and protect against the spread of infection among health healthcare workers and the public during future MERS outbreaks.
“This study not only highlights exciting new findings about the broad spectrum virucidal efficacy of PVPI against a wide range of viruses including MERs, it also reminds us that prevention through proper hygiene is still required to protect the health of both healthcare professionals and the public in the global fight against viral diseases,” said ProfMaren Eggers, Head of Experimental Virology and Department of Disinfectant Testing at the Laboratory Prof. G Enders, MVZ Stuttgart. “We must continue to be vigilant and employ all of the weapons including proven PVPI products in our arsenal to fight this unseen enemy.”
“To combat today’s health threats; we have turned to BETADINE®, which over the past 50 years, has repeatedly demonstrated proven effectiveness against a diverse range of pathogens including the MERS virus, and has kept generations of families protected from infections,” says Raman Singh, President, Mundipharma, Asia Pacific, Latin America, Middle East & North Africa. “By coupling our commitment to innovation and accessibility, we are delivering the right medicines to the populations that need it most, as part of Mundipharma’s model of patient-centred business growth.”
References:
- Eggers M et al. BETADINE® Solution, BETADINE® Skin Cleanser and BETADINE® Surgical Scrub demonstrated excellent virucidal in-vitro efficacy against Ebola virus Poster presented at Asia Pacific Society of Infection Control(APSIC), Taipei, 2015
- Eggers M et al. BETADINE® Solution, BETADINE® Skin Cleanser and BETADINE® Surgical Scrub demonstrated excellent virucidal in-vitro efficacy against Ebola virus Poster presented at Asia Pacific Society of Infection Control(APSIC), Taipei, 2015
- http://www.who.int/csr/don/21-august-2015-mers-saudi-arabia/en/
- http://phenomena.nationalgeographic.com/2015/08/22/mers-saudi-1/
- http://www.who.int/emergencies/mers-cov/en/
- http://www.who.int/gpsc/5may/tools/9789241597906/en/
- Eggers M et al. BETADINE® Solution, BETADINE® Skin Cleanser and BETADINE® Surgical Scrub demonstrated excellent virucidal in-vitro efficacy against Ebola virus Poster presented at Asia Pacific Society of Infection Control(APSIC), Taipei, 2015
For further information please contact:
Stephenie Vasko
Communications Director – Asia, Latin America & Middle East
PH +65-6303-9732
stephenie.vasko@mundipharma.com.sg
www.mundipharma.com.sg
About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis.
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Mundipharma Presents Research on Efficacy of BETADINE(R) Formulations Against MERS at Inaugural International Meeting on Respiratory Pathogens (IMRP)
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SINGAPORE /PRNewswire/ — The Middle East Respiratory Syndrome (MERS) is a viral respiratory disease caused by a novel coronavirus (MERSCoV) that was first identified in Saudi Arabia in 2012. MERS-CoV, like other coronaviruses, is thought to spread from an infected person’s respiratory secretions, such as through coughing. However, the precise ways the virus spreads are not currently well understood1. It has a high fatality rate of approximately 36%. Since September 2012, 1461 cases and at least 514 deaths in 25 countries2 have been confirmed, with a fresh outbreak appearing in Saudi Arabia on 18 August. More than two million pilgrims are projected to visit the Muslim holy city of Mecca in for the annual hajj pilgrimage in September and the Ministry of Health of Saudia Arabia has stepped up efforts to contain the current outbreak of the virus3.
BETADINE® (povidone iodine, PVP-I), has proven strong efficacy against a wide variety of clinically relevant viruses3A recent in-vitro research study4, conducted at Marburg University, Germany, on BETADINE® surgical scrub (7.5% PVP-I), skin cleanser (4% PVP-I), gargle and mouthwash (1% PVP-I) products demonstrated virucidal in-vitro efficacy against infectious pathogens such as MERs, SARs and Influenza that have reported to cause hospital acquired infections and serious consequences on public health.
The study was conducted based on the latest EU test standard EN14476:2014 for antiviral enveloped virus testing (similar to that for Ebola). The results of excellent virucidal activity of various BETADINE® products against Modified vaccinia virus Ankara (MVA) and Middle East Respiratory Syndrome coronavirus (MERS-CoV) were demonstrated with a rapid kill rate of ≥99.99% with 15 seconds.
To date, there is no specific medication or vaccination available to effectively combat MERS or its spread, highlighting the importance of good personal hygiene as the first line of defence in disease prevention and infection control5.
Multiple nonpharmaceutical interventions are required for successful infection control. During high risks of respiratory infections, healthcare workers are encouraged to use gloves and masks as physical barrier against infectious pathogens. Simple hygiene practices such as gargling and hand washing are among the principal means of the prevention of respiratory transmitted infections.
Current guidelines have also suggested healthcare workers to observe proper hand hygiene for decontamination against viruses before and after the change of gloves and masks. Aseptic hand washing with an antiseptic hand wash is deemed as a higher level of hand hygiene over social hand washing. Aseptic hand washing provides the removal and destruction of viruses via disruption of viral replication and metabolic processes6,7.
Encouragement of gargling is important for the control of opportunistic and community acquired infections inJapan8.The primary goal is to encourage everyone to take precautions not only to prevent infection to themselves but also prevent as much human exposure to the respiratory virus as possible.
The recently completed study indicates the potential role of PVPI in protecting against the spread of infection among healthcare workers and the public during infectious disease outbreaks. Adhering to WHO-issued guidelines on hand, respiratory and PPE (personal protective equipment), coupled with PVPI broad virucidal efficacy will help in disrupting the transmission of viruses and limiting the spread of infectious diseases.
“This study not only highlights exciting new findings about the broad spectrum virucidal efficacy of PVPI against a wide range of viruses including MERs, it also reminds us that prevention through proper hygiene is still required to protect the health of both healthcare professionals and the public in the global fight against viral diseases,” said ProfMaren Eggers, Head of Experimental Virology and Department of Disinfectant Testing at the Laboratory Prof. G Enders, MVZ Stuttgart. “We must continue to be vigilant and employ all of the weapons including proven PVPI products in our arsenal to fight this unseen enemy.”
“Healthcare professionals are the first and often, only line of defence against the phalanx of health threats including MERS facing the world today,” says Raman Singh, President, Mundipharma, Asia Pacific, Latin America, Middle East & North Africa. “Mundipharma will continue to work with healthcare professionals around the globe to ensure that they are fully equipped with protective measures including BETADINE® to enable them to continue the fight in this time pressing war against emerging and re-emerging infections.”
Mundipharma will be presenting the full research data BETADINE® antiviral efficacy results at the International Meeting on Respiratory Pathogens from 2 – 4 September 2015 in Singapore.
References:
- http://www.cdc.gov/coronavirus/mers/about/transmission.html
- http://www.who.int/csr/don/26-august-2015-mers-saudi-arabia/en/Kawana R et al, 1997,http://www.ncbi.nlm.nih.gov/pubmed/9403252
- http://phenomena.nationalgeographic.com/2015/08/22/mers-saudi-1/
- Eggers M et al. BETADINE® Solution, BETADINE® Skin Cleanser and BETADINE® Surgical Scrub demonstrated excellent virucidal in-vitro efficacy against Ebola virus Poster presented at Asia Pacific Society of Infection Control(APSIC), Taipei, 2015
- http://www.who.int/csr/disease/coronavirus_infections/risk-assessment-3june2015/en/http://www.who.int/emergencies/mers-cov/en/
- http://www.nhsprofessionals.nhs.uk/download/comms/CG1_NHSP_Standard_Infection_Control_Precautions_v3.pdf
- http://www.ipac-canada.org/pdf/2013_PHAC_Hand%20Hygiene-EN.pdf
- Keio University. 15th November 2013. Guidance for the Prevention of Influenza:http://www.hcc.keio.ac.jp/english/information/infection/influenza20131115.htm
Shiraishi T. Nakagawa Y. Evaluation of the bactericidal activity of povidoneiodine and commercially available gargle preparations. Dermatology, 2002;204 Suppl 1:3741
For further information please contact:
Stephenie Vasko
Communications Director – Asia, Latin America & Middle East
PH +65-6303-9732
stephenie.vasko@mundipharma.com.sg
www.mundipharma.com.sg
About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world’s pharmaceutical markets. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of oncology, pain, respiratory and rheumatoid arthritis.
Logo – http://photos.prnasia.com/prnh/20150302/8521501264LOGO
Elsevier Survey Reveals Challenges Doctors Face in Finding Trusted Clinical Content Online
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SINGAPORE /PRNewswire/ — Nine out of 10 physicians in Asia-Pacificuse some form of online search to aid clinical decision-making, with Google being the most popular and frequently used non-evidence based search engine. Yet searching for the “most trusted” and “most updated content” emerged as a priority for majority of those surveyed, highlighting a gap between what physicians are really looking for and the information sources they use to search, a survey amongst 210 Asia Pacific healthcare professionals reveals.
Click here to download infographic on findings.
The survey — Clinical Search – An understanding of healthcare professionals’ attitudes, needs and challenges —conducted by Global Growth Markets (GGM) and commissioned by Elsevier, a world-leading provider of scientific, technical and medical information products and solutions, underlines the integral role of the internet and online search to the way healthcare decisions are made today, while highlighting the challenges physicians face in their quest for clinical information.
Some of those surveyed (11 percent) also indicated that there is “too much published information available,” with 10 percent of the respondents saying they “need more training on how to search for clinically-relevant information.”
Findings from the survey were presented today, at the 14th Hospital Management Asia (HMA) conference in Yangon, Myanmar, which was attended by more than 800 hospital and healthcare leaders across the region.
A study conducted by Google found that doctors perform an average of six professional searches a day during their course of work.1 Furthermore, it was estimated that by 2020, it will only take 73 days for medical knowledge to double in volume; knowledge is expanding faster than people can assimilate or apply.2
“As physicians, we are increasingly aware that to consistently provide our patients with the best care, we must not only know where to look for the information we need to solve complex medical questions, but more importantly, we must find information sources that we can trust as evidence-based, current, and reliable,” said Dr. Peter Edelstein, M.D., FACS, FASCRS, Chief Medical Officer, Elsevier Clinical Solutions, who was also a plenary speaker at HMA. “Almost anyone can publish anything today on the internet. Thus we as doctors and healthcare professionals need to be careful and use only clinical search engines that quickly and easily deliver trusted and updated content to support our critical patient care-based clinical decisions.
The survey also found that 8 in 10 physicians indicated that having “instant access” to the latest reference content is “very” or “extremely important” in influencing their clinical decisions. However, the two most common challenges listed were limited subscriptions to clinical information services by hospitals or healthcare facilities and issues with Wi-Fi or network access.
Point of care where clinical information is used
The top reason cited for the search of clinical information was to “stay abreast of latest developments in their field,” followed by “reference during treatment and surgery.” Physicians also use online search to plan treatment therapy, diagnostic tests, ensure best care is delivered at the lowest cost, establish clinical standards of patient care, and to prepare for a patient interaction. The clinical specialties most reliant on search include cardiology, internal medicine, general surgery, neurology and oncology.
Survey results also showed that 58 percent of physicians prefer to access information from their computers while 14 percent still refer to printed sources of information. One in three physicians said they use a mobile device at the point of care, especially during patient consultation or treatment.
“Findings from this survey reveal that, regardless of which country and background doctors and healthcare professionals come from, their objectives and priorities with regards to clinical search is very much the same —trusted content and quick access to the most recent information,” said Pete Read, CEO, Global Growth Markets, who presented the survey findings at HMA together with Elsevier. “It would be valuable for healthcare providers to evaluate the effectiveness of their current clinical information services and tools, and see where they can direct their spending on information and technology to help fill the gap that doctors face when searching for clinical information.”
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1. |
Google, Manhattan Research, Screen to Script, The Doctor’s Digital Path to Treatment. June 2012. Accessed at:https://ssl.gstatic.com/think/docs/the-doctors-digital-path-to-treatment_research-studies.pdf |
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2. |
Densen P. Challenges and Opportunities Facing Medical Education. Transactions of the American Clinical and Climatological Association. 2011;122:48-58. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3116346/ |
About the survey
The Clinical Search – An understanding of healthcare professionals’ attitudes, needs and challenges survey was conducted with 210 doctors and healthcare professionals from seven countries in Asia-Pacific, including Japan,Taiwan, Indonesia, Philippines, China, India and Australia. The survey was prepared by Global Growth Markets, a global healthcare market information provider, and funded by Elsevier.
About ClinicalKey
ClinicalKey provides evidence-based clinical answers drawn from the single largest body of clinical content available, including 600+ journals, 1,100+ books, drug information, guidelines, patient education and Medline. The Smart Search enables ClinicalKey to understand clinical terms and thus discover the most relevant medical content and find related content often missed by other search engines. ClinicalKey is optimized for any mobile device, making it more convenient to search and validate on-the-go. www.clinicalkey.com
About Elsevier
Elsevier is a world-leading provider of information solutions that enhance the performance of science, health, and technology professionals, empowering them to make better decisions, deliver better care, and sometimes make groundbreaking discoveries that advance the boundaries of knowledge and human progress. Elsevier provides web-based, digital solutions — among them ScienceDirect, Scopus, Elsevier Research Intelligence and ClinicalKey —and publishes more than 2,500 journals, including The Lancet and Cell, and more than 33,000 book titles, including a number of iconic reference works. Elsevier is part of RELX Group plc, a world-leading provider of information solutions for professional customers across industries. www.elsevier.com
Media Contacts:
Jason Chan
Director, Corporate Relations, Asia Pacific
Global Communications
Elsevier
+65 6349 0240
j.chan@elsevier.com
Jasmine Chng
Director, Singapore Healthcare Lead
Waggener Edstrom Worldwide
+65-6303-8474
jchng@waggeneredstrom.com
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ResMed Provides Update on Phase III SERVE-HF Study of Adaptive Servo-Ventilation (ASV) Therapy In Central Sleep Apnea and Chronic Heart Failure
Study Did Not Meet Primary Endpoint
Safety Signal of Increased Cardiovascular Mortality Found For ASV Therapy In People With Predominant Central Sleep Apnea and Symptomatic Chronic Heart Failure
Results and Safety Signal Observed Only In This Specific Study Population
SAN DIEGO, May 13, 2015 /PRNewswire/ — ResMed (NYSE: RMD) today announced that SERVE-HF, a multinational, multicenter, randomized controlled Phase III trial did not meet its primary endpoint. SERVE-HF was designed to assess whether the treatment of moderate to severe predominant central sleep apnea with Adaptive Servo-Ventilation (ASV) therapy could reduce mortality and morbidity in patients with symptomatic chronic heart failure in addition to optimized medical care.
The study did not show a statistically significant difference between patients randomized to ASV therapy and those in the control group in the primary endpoint of time to all-cause mortality or unplanned hospitalization for worsening heart failure (based on a hazard ratio [HR] = 1.136, 95 percent confidence interval [95% CI] = (0.974, 1.325), p-value = 0.104). The results from SERVE-HF are preliminary and will be submitted for future publication after further analysis.
A preliminary analysis of the data identified a statistically significant 2.5 percent absolute increased risk of cardiovascular mortality for those patients in the trial who received ASV therapy per year compared to those in the control group. In the study, the cardiovascular mortality rate in the ASV group was 10 percent per year compared to 7.5 percent per year in the control group. There were no issues associated with the performance of the ASV therapy device in the trial.
“Patient safety is our first and foremost priority. We have alerted and are working with appropriate global regulatory authorities about the safety signal observed in this study,” said Glenn Richards, M.D., ResMed Chief Medical Officer. “The safety signal in SERVE-HF was observed only with the use of ASV therapy in people who have predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction. We are further analyzing the data to understand why this unexpected result was observed in this trial.”
ResMed is working with global regulatory authorities to proactively revise the labels and instructions for use for ResMed ASV devices to include a contraindication for people with symptomatic chronic heart failure (with left ventricular ejection fraction, LVEF, less than or equal to 45 percent). The company is also proactively informing healthcare providers, physicians, and patients of the cardiovascular safety signal observed in SERVE-HF.
The safety signal observed in SERVE-HF was observed only with ASV therapy in patients with moderate to severe predominant central sleep apnea and symptomatic chronic heart failure with reduced ejection fraction. The study did not include people with central sleep apnea in the absence of heart failure. It is also important to note that SERVE-HF did not include any patients with predominant obstructive sleep apnea, and did not include any other treatment modality such as continuous positive airway pressure (CPAP) or auto-adjusting positive airway pressure (APAP).
“SERVE-HF did not meet its primary endpoint, however this study provides valuable, practice-changing guidance on how to best care for people with chronic heart failure,” said Prof. Martin Cowie, M.D., the co-principal investigator of the study and Professor of Cardiology at Imperial College, London. “SERVE-HF was a well-designed and executed study and because of it we now know that ASV therapy should not be used to treat central sleep apnea in people with symptomatic chronic heart failure with reduced ejection fraction.”
Healthcare providers and patients who have questions or would like more information are encouraged to call 1-800-478-9010 and visit http://www.SERVE-HFFAQs.com
About Sleep-Disordered Breathing
Sleep-disordered breathing encompasses a spectrum of breathing problems during sleep. The two most common types of sleep apnea, a condition that results in repetitive pauses in breathing during sleep, are obstructive sleep apnea and central sleep apnea.
Obstructive sleep apnea (OSA) is a sleep disorder in which the throat muscles relax, block the airways and stop the flow of breath during sleep.
Central sleep apnea is a sleep disorder in which the brain does not transmit the “breathe” signal to the muscles that control breathing during sleep. In some cases, people with central sleep apnea also exhibit an abnormal breathing pattern known as Cheyne-Stokes respiration. With Cheyne-Stokes respiration, there is a period of shallow breathing followed by deep breathing, with intermittent central apnea, in which the breath is stopped for more than 10 seconds during each apnea.
In both obstructive and central sleep apnea, the lack of oxygen causes the person to wake up and start breathing again, interrupting continuous sleep. In central sleep apnea, this occurs more than five times per hour of sleep.
Sleep-disordered breathing is found more commonly in patients with heart failure than it is in the general population, and people with heart failure often report poor sleep as a symptom.
About SERVE-HF
SERVE-HF is a multinational, multicenter, randomized controlled Phase III study that was designed to assess whether treatment of moderate to severe predominant central sleep apnea with ASV therapy in addition to optimized medical care could reduce mortality and morbidity in patients with symptomatic chronic heart failure.
About ResMed
The global team at ResMed (NYSE: RMD) is united in their commitment to changing lives with every breath. With more than 4,000 employees and a presence in over 100 countries, the company has been pioneering new and innovative devices and treatments for sleep-disordered breathing, chronic obstructive pulmonary disease, and other key chronic diseases for more than 25 years. ResMed’s world-leading products and innovative solutions improve the quality of life for millions of patients worldwide, reduce the impact of chronic disease, and save healthcare costs. For more information about ResMed and its businesses, visit http://www.resmed.com or follow @resmed on Twitter.
Safe harbor statement
Statements contained in this release that are not historical facts are “forward-looking” statements as contemplated by the Private Securities Litigation Reform Act of 1995. These forward-looking statements — including statements regarding subsequent analyses of existing data and new data received from past, ongoing and future studies, the nature and scope of the impact that study results may have on the current or future markets for ResMed ASV devices, and the nature and timing of regulatory and other legal action — are subject to risks and uncertainties, which could cause actual results to materially differ from those projected or implied in the forward-looking statements. Additional risks and uncertainties are discussed in ResMed’s periodic reports on file with the U.S. Securities & Exchange Commission. ResMed does not undertake to update its forward-looking statements.
Contacts:
For News Media
For Investors
Alison Graves
Agnes Lee
Director, Corporate Communications
Senior Director, Investor Relations
O: 858-836-6789
O: 858-836-5971
news@resmed.com
investorrelations@resmed.com
SOURCE ResMed
Merck Receives FDA Fast Track Designation for Evofosfamide for Treatment of Patients Living With Advanced Pancreatic Cancer
DARMSTADT, Germany, May 12, 2015 /PRNewswire/ —
– NOT INTENDED FOR US AND UK BASED MEDIA –
Evofosfamide is an investigational compound currently in Phase III trials
Advanced pancreatic cancer is second indication to receive FDA fast track designation for evofosfamide
Merck, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. The compound, currently in Phase III trials, is being developed in collaboration with Threshold Pharmaceuticals, Inc.
Merck over the past years has bolstered its growth platforms in healthcare, life science and performance materials to provide solutions in areas with high demand for innovation. In its biopharmaceuticals business, the company has strengthened its research and development activities and is increasingly counting on partnerships to optimize relevance and efficiency.
“Merck is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat,” said Luciano Rossetti, Head of Global Research and Development of Merck’s biopharmaceutical business, Merck Serono. “Many patients with pancreatic cancer present with advanced, inoperable tumors, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer – the second indication for this compound to receive Fast Track designation from the FDA, following the granting of the designation in soft tissue sarcoma – will help to facilitate the timely development of this high-priority program for Merck Serono.”
Threshold received the first Fast Track designation for the development of evofosfamide in combination with doxorubicin for the treatment of advanced soft tissue sarcoma in November 2014.
“We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer,” said Barry Selick, Ph.D., Chief Executive Officer of Threshold Pharmaceuticals, Merck’s co-development partner. “Evofosfamide is currently being studied in patients with pancreatic cancer in the MAESTRO Phase III study, and based on current projections, we expect that the number of protocol-specified events for the trial may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter.”
The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.
Pancreatic cancer is a relatively uncommon, but lethal cancer.[1] Ranked as the 12th most common cancer worldwide, it is the 7th most common cause of cancer-related death, accounting for 4% of deaths.[1] With 93-95% of patients dying from their disease within 5 years, pancreatic cancer has a low survival rate.[2],[3] There has been little improvement seen in the survival of patients with this disease over the past 30 years[4] and there remain limited treatment options for pancreatic cancer.[5] Surgery remains the only curative approach for pancreatic cancer;[5] however, many patients (80-85%) present with advanced, inoperable disease.[6] For this large group of patients ineligible for surgery, the aim of treatment is prolongation of survival and palliation of symptoms.[7]
References
Ferlay J, et al. Int J Cancer 2015;136(5):E359-86.
National Cancer Institute. SEER Stat Fact Sheets: Pancreas. Available at: http://seer.cancer.gov/statfacts/html/pancreas.html Accessed: May 2015.
EUROCARE-4 database on cancer survival in Europe. Long-term survival expectations of cancer patients in Europe in 2000-2002. Available at: http://www.eurocare.it/Results/tabid/79/Default.aspx Accessed: May 2015.
Siegel R, et al. CA Cancer J Clin 2012;62(1):10-29.
Malik NK, et al. J Gastrointest Oncol 2012;3(4):326-34.
Loc WS, et al. World J Gastroenterol 2014;20(40):14717-25.
Seufferlein T, et al. Ann Oncol 2012;23(Suppl 7):vii33-40.
For more information on Merck Serono in oncology, please visit: http://www.globalcancernews.com.
About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug that is thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.
Evofosfamide is currently under evaluation in two Phase III trials: one in combination with doxorubicin versus doxorubicin alone in patients with locally advanced unresectable or metastatic soft tissue sarcoma (the TH-CR-406 trial), and the other in combination with gemcitabine versus gemcitabine and placebo in patients with locally advanced unresectable or metastatic pancreatic cancer (the MAESTRO trial). Both Phase III trials are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. The FDA and the European Commission have granted evofosfamide Orphan Drug designation for the treatment of STS and pancreatic cancer. The FDA has also granted Fast Track designation for evofosfamide for both STS and pancreatic cancer. Evofosfamide is also being investigated in a Phase II trial for the treatment of non-squamous non-small cell lung cancer, and in earlier-stage clinical trials of other solid tumors and hematological malignancies.
Merck signed a global license and co-development agreement for evofosfamide with Threshold Pharmaceuticals, Inc. in February 2012, with an option for Threshold to co-commercialize in the U.S.
Evofosfamide is currently under clinical investigation and has not been approved for use in the U.S., Europe, Canada, or elsewhere. Evofosfamide has not yet been proven to be either safe or effective and any claims of safety and effectiveness can be made only after regulatory review of the data and approval of the labeled claims.
All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.
Merck is a leading company for innovative, top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Merck Serono, Consumer Health, Allergopharma, Biosimilars, Merck Millipore and Performance Materials – and generated sales of around € 11.3 billion in 2014. Around 39,000 employees work for Merck in 66 countries to improve the quality of life for patients, to further the success of customers, and to help meet global challenges. Merck is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70% interest, the founding family remains the majority owner of the company to this day. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are Canada and the United States, where the company operates as EMD Serono, EMD Millipore and EMD Performance Materials.
Source: Merck KGaA
New Technology Allows Accuracy in the Treatment of Cancer Never Achieved Before
WIENER NEUSTADT, Austria, SALZBURG, Austria and REUTLINGEN, Germany, May 8, 2015 /PRNewswire/ —
An innovative system for accurate patient positioning already received attention at its market launch in 2014. Now the first of these systems has been commissioned at MedAustron, an Austrian Center for Ion Beam Therapy, and will there be used clinically for the first time. Cancer patients can be positioned better than ever before and will thus be able to receive pin-point accuracy radiation treatments.
To guarantee a successful Ion Beam treatment – a particularly accurate and effective form of radiation therapy – it is essential to position the patient accurately in relation to the radiation beam and to permanently observe and – if necessary – adapt the patient position during the whole treatment session.
MedAustron will be the first Ion Beam Therapy Center worldwide to use completely new medical systems for these tasks: the exacure system of BEC GmbH (Reutlingen, Germany) as well as the Imaging Ring of medPhoton (Salzburg, Austria). Both systems meet the special requirements for Ion Beam Therapy and ensure the highest degree of patient safety. Together they allow for highly accurate and efficient treatments.
A custom-modified industrial robot, designed and adapted for medical use, is the core of the exacure-system. Its most distinctive feature is the ceiling mount, which allows for movement in seven independent degrees of freedom. The robot can not only be positioned in all three dimensions and six degrees of freedom, but can also be moved along the ceiling towards and away from the beam nozzle in order to further improve flexibility of patient positioning. Another advantage of the ceiling-mounted system is the integrated optical tracking system: it monitors the treatment couch position 500 times per second and applies corrections in real time, if necessary, to ensure optimal treatment results.
The so-called Imaging Ring System (IRS) verifies the correct position of the patient prior to irradiation in order to treat the patient with highest possible accuracy. The IRS is integrated into the patient couch and allows very fast three-dimensional Cone Beam-CT imaging. The CT images are compared with the CT image set used for treatment planning. Any necessary corrections can be executed by the exacure robot immediately. This procedure guarantees that the tumour is irradiated exactly as planned by the physicians. The IRS – which has already received multiple technology awards – features a flat panel detector and an x-ray tube, assembled in such a way that they can be moved independently, thereby previously unreachable acquisition speed, field-of-view and image quality can be achieved and make the IRS the gold standard for image guided particle therapy.
“The unprecedented combination of these new systems at MedAustron provide unique accuracy, speed as well as image quality for radiation therapy, unparalleled in the areas of medical robotics and imaging. We are very proud to have engineered this highly innovative solution together with our partners BEC and medPhoton, establishing new standards in Ion Therapy,” commented Dr. Bernd Mößlacher, CEO of MedAustron, after the successful acceptance of the systems.
“Accurately irradiating a tumor while sparing the surrounding healthy tissue calls for the ultimate solution in patient positioning technology. Transferring technology from industrial applications to medical robotics was a key factor to successfully develop the exacure system. Our congratulations go to MedAustron for this unique and innovative treatment center,” said Matthias Buck, CEO of BEC GmbH.
“After years of pioneering work in the field of image guided radiation therapy, we are very pleased that patients in Ion Bean Therapy will also benefit from robot-controlled positioning combined with unique image guidance,” Heinz Deutschmann, CEO of medPhoton GmbH, added.
Dislaimer
The medPhoton Imaging Ring has not been cleared by the US Food and Drug Admininstration (FDA) for commercial distribution in the US and is not available for commercial distribution at this time.
Press Contact
Petra Wurzer
petra.wurzer@medaustron.at
+43-2622-26-100 – 111
Source: EBG MedAustron GmbH
Man’s Best Friend Helps Owners Build New Friendships
BRUSSELS, May 7, 2015 /PRNewswire/ —
People get to know each other more often through pets than through children’s schools according to a new study
While making friends is not always easy, new research shows that pet ownership can improve the likelihood of forming new relationships, especially in your neighbourhood. The international study, conducted by The University of Western Australia (Australia) in collaboration with the WALTHAM Centre for Pet Nutrition (UK) underscores the important role pets can play in helping humans build social relationships and support networks.
(Photo: http://photos.prnewswire.com/prnh/20150507/741550)
Overall, the study found that pet owners are significantly more likely to meet new people in their neighbourhoods than non-pet owners. Around a quarter of those who met people through their pet said that this resulted in at least one new friendship rather than a mere acquaintance. Dog owners fare even better as they are five times more likely to get to know people in their neighbourhoods compared with other pet owners, with dog walking being one of the top five ways for people to meet new people. The study surveyed residents in three US and one Australian city and found many similarities when it comes to pets. For instance, in all four cities people got to know others in their neighbourhoods through pets more often than through children’s schools or community events.
“We’re all guilty of being a little too fixated on our screen based devices these days, whether we’re walking and talking on the phone, texting or sending e-mails. Pets, and specifically dog walking, bring us out of the technology bubble and create opportunities for the kind of real interpersonal interactions that can lead to deep, human friendships,” said lead study author Associate Professor Lisa Wood from The University of Western Australia.
The study involved a telephone based survey of over 2500 randomly selected adults aged 18 and over +from four cities, including: Perth (Australia); San Diego, CA; Portland, OR; and, Nashville, TN (US).
The study was featured in the April 2015 edition of the peer-reviewed scientific publication, PLOS ONE http://www.plosone.org. The full article can be read here.
About the WALTHAM® Centre for Pet Nutrition:
Celebrating over 50 years of innovative science, the WALTHAM Centre for Pet Nutrition serves as a leading scientific authority in advancing the frontiers of research into the nutrition and health of companion animals. Located in Leicestershire, England, the renowned state-of-the-art science institute for Mars, Incorporated generates knowledge that enables the development of innovative products that meet pets’ needs in a practical way. Since the publication of its first original research in 1963, WALTHAM® has pioneered many important breakthroughs in the field of pet nutrition and human-animal interaction, resulting in more than 1,700 publications, including over 600 peer-review scientific papers. Today, WALTHAM® continues to collaborate with the world’s foremost scientific institutes, driving Mars’ Petcare vision to create a better world for pets and providing the science and expertise that underpins leading Mars brands such as WHISKAS®, PEDIGREE®, NUTRO®, IAMS®, EUKANUBA®, NATURA, TRILL®, CESAR®, SHEBA®, KITEKAT®, DREAMIES™, AQUARIAN®, WINERGY®, BANFIELD® Pet Hospital and ROYAL CANIN.
About Mars, Incorporated
In 1911, Frank C. Mars made the first Mars candies in his Tacoma, Washington kitchen and established Mars’first roots as a confectionery company. In the 1920s,Forrest E. Mars, Sr. joined his father in business and together they launched the MILKY WAY® bar. In 1932, Forrest, Sr. moved to the United Kingdom with a dream of building a business based on the objective of creating a “mutuality of benefits for all stakeholders” – this objective serves as the foundation of Mars, Incorporated today. Based in McLean, Virginia, Mars has net sales of more than $33 billion, six business segments including Petcare, Chocolate, Wrigley, Food, Drinks, Symbioscience, and more than 75,000 Associates worldwide that are putting its Principles into action to make a difference for people and the planet through its performance.
Mars brands include: Petcare – PEDIGREE®, ROYAL CANIN®, WHISKAS®, IAMS®, KITEKAT®, BANFIELD® Pet Hospital, NUTRO®, SHEBA®, DREAMIES®, CESAR®, EUKANUBA® and NATURA; Chocolate – M&M’S®, SNICKERS®, DOVE®, GALAXY®, MARS®, MILKY WAY® and TWIX®; Wrigley – DOUBLEMINT®, EXTRA®, ORBIT® and 5™ chewing gums, SKITTLES® and STARBURST® candies, and ALTOIDS® AND LIFESAVERS® mints. Food -UNCLE BEN’S®, DOLMIO®, EBLY®, MASTERFOODS®, SEEDS OF CHANGE® and ROYCO®; Drinks – ALTERRA ® Coffee Roasterscoffee, THE BRIGHT TEA CO.® tea,DOVE®/GALAXY® Hot Chocolate, and FLAVIA® brewer; Symbioscience – COCOAVIA®, WISDOM PANEL® and SERAMIS®.
For more information, please visit http://www.mars.com. Follow us: http://facebook.com/mars, http://twitter.com/marsglobal, http://youtube.com/mars.
Source: Mars Petcare
Sphenopalatine Ganglion Stimulation in the Pathway CH-1 Study Reduces Headache Burden Before and After Sustained Periods of Cluster Attack Remission
BUDAPEST, Hungary, April 8, 2015 /PRNewswire/ — During the world congress of controversies in Neurology, CONy, Autonomic Technologies[TM] presented long term data* (18 months results) on a segment of the CH-1 study patients experiencing Cluster Headache Remission periods. While Sphenopalatine Ganglion (SPG) stimulation with the Pulsante[TM] microstimulator has already shown safety and efficacy on chronic cluster headache, long-term benefits of SPG stimulation in cluster patients with remission suggest that the therapy is beneficial during the episodic phase of patients’ cluster bouts.
“This data strongly suggest that SPG stimulation could be beneficial also to episodic cluster patients”, commented Prof. Miguel Lainez, Head of Neurology Department at Catholic University of Valencia and Professor of Neurology in the Catholic University of Valencia who presented the data on March 28th.
Pulsante microstimulator is the first electroceutical device that has documented efficacy in a long term RCT for the treatment of cluster headache. The Pulsante microstimulator is MR Conditional since 2012. The device is inserted through the gum with a minimally invasive technique that leaves no visible scars.
Autonomic Technologies
Autonomic Technologies, Inc. (ATI[TM]) is a medical device company focused on the development and commercialization of innovative therapies for the treatment of severe headache. The company’s initial product, the Pulsante microstimulator, is CE marked in Europe for the treatment of cluster headache. The device is also under an IDE study in the US for the treatment of chronic cluster headache.
ATI is headquartered in the San Francisco Bay Area and is backed by blue chip investors: Kleiner Perkins Caufield and Byers, InterWest Partners, Versant Ventures, Novartis Ventures, Aberdare Ventures, and the Cleveland Clinic. http://www.pulsante.eu
Contact:
Eva Birle
+49(0)891395782711
birle@bskom.de
*Poster Presentation at 9th CONy Congress, Budapest, March 28th 2015
Source: Autonomic Technologies
Finesse Solutions Announces Cellworld 2015
SANTA CLARA, Calif., March 26, 2015 /PRNewswire/ — Finesse Solutions announced Cellworld 2015, a new event that is specifically designed for innovators, visionaries and senior executives in bio-processing.
The two day conference, by invitation only, will be held at the Hyatt Regency in Downtown San Francisco on September 21-22, 2015. It will be a forum for life science leaders to discuss the future of single-use biopharmaceutical manufacturing and to hear about both disruptive technologies and best practices from all facets of our industry.
The event sessions will cover both upstream and downstream single-use bio-processing with a focus on innovation through the use of novel measurement and automation systems. It will introduce new tools for managing process complexity and the resulting intelligent meta-data. Topics will range from new single-use sensors to implementing commercial-off-the-shelf, highly configurable manufacturing execution systems (MES) for single-use facilities.
“Our goal is to provide the senior leadership in bio-processing with a glimpse of the future in order to fully exploit single-use technologies and to remain globally competitive,” stated Barbara Paldus, CEO of Finesse Solutions. “We are very excited to create the first international forum to explore innovation and technology, so that as a community, we can accelerate the adoption of new bio-processing platforms and fully exploit highly intelligent tools that are rapidly becoming available through advances in electronics, software, and communications.”
About Finesse Solutions, Inc.
Finesse Solutions provides flexible hardware and software automation which allows for unmatched customizable bioprocessing. We are a research based, Silicon Valley company who believes in empowering our clients with innovative single-use sensors, bioreactors, controllers and software. Our SmartParts are the foundation of a Finesse solution using technologies from inside and outside of the biopharmaceutical industry. In addition to our own products, we are the only supplier with integration expertise offering clients the independence to select any preferred supplier of key unit operations from upstream to downstream. Whether it’s a stand-alone, single-use bioreactor for research and development or a fully integrated Smartfactory for cGMP-compliant manufacturing, we have a bioprocess solution for our customers.
For more information, please visit us at http://finesse.com/cellworld/
Source: Finesse Solutions, Inc.
Marken Wins As Best Life Science Logistics Service Provider Second Year In A Row
-Winner Announced at Annual BioPharma Asia Industry Event
RESEARCH TRIANGLE PARK, N.C., March 25, 2015 /PRNewswire/ — Marken announced today that they won the pharmaceutical clinical research industry award of Best Life Science Logistics Provider at the 5th Annual BioPharma Asia Industry Awards. The award was announced at a dinner and ceremony held in conjunction with the BioPharma Asia conference in Singapore, drawing an annual attendance of 1600.
The Annual BioPharma Asia Convention is the most prestigious regional gathering of executives, investors, and representatives from Pharma, Biotech, Contract Research, Contract Manufacturing Organizations, and Central Laboratories. The best organizations in the industry are recognized for their contributions to biopharmaceutical development in Asia. Marken competed against top global providers well-known in the industry and this win highlights the fact that Marken’s strategy to solely serve the Pharma and Clinical Research industry is appreciated and recognized by its clients.
Michael Culme-Seymour, Marken Vice President Asia Pacific Region, spoke about the back-to-back win for Marken. “It is truly an honor to be chosen by the industry to win this award again this year. Marken’s selection as the best service provider in this category speaks to the level of passion and expertise of our staff. Thank you to our Asia Pacific team members and to all of our Marken teams around the globe for their dedication and experience. Each and every day, these teams coordinate and ship sensitive and high value drugs as well as time and temperature sensitive biological samples around the world on time and within specification, across multiple time zones. We also humbly thank our clients for their vote and, more importantly, their continued partnership with Marken as the clinical logistics provider of choice. This win highlights our ongoing commitment to the bio pharma and life sciences industries. Having just opened a new office in Shanghai this week to join the existing network of facilities and depots, this has been an exciting week for us as we continue our partnership and expansion with clients in this part of the world.”
Celebrating 35 years, Marken is the world’s only Clinical Logistics Organization (CLO) solely focused on providing logistic services to the pharmaceutical, biotechnology, and medical device and life sciences industries. Marken has continued its expansive growth plan since winning last year and the organization now includes 580 full time employees. In addition to the recent opening of the Shanghai office, another new office will open in Philadelphia (US) in April.
About Marken
Marken is the leading global clinical supply chain solutions provider dedicated to the pharmaceutical and life sciences industries, supporting over 49,000 clinical investigators in more than 150 countries. Marken integrates depot and logistics into solutions that extend the reach of clinical trials to even the most remote treatment-naive geographies. Marken is 100% dedicated to the clinical research industry and a specialist in the transportation of investigational medical products and medical devices. In addition to services such as the storage and distribution of clinical trial materials and drug products to investigators or the patients directly, Marken maintains a leading position for the shipment of biological samples and offers additional services such as shipment lane qualifications as well as GDP, regulatory and compliance consultancy.
Source: Marken
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