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PRNews

Merck Expands Celonic’s Upstream Capabilities with Mobius® Single-use Bioreactors

DARMSTADT, Germany, Sept. 13, 2017 /PRNewswire/ —

  • Sizes range from 50-liter to 2,000-liter manufacturing scale
  • Industry-leading design offers flexibility, scalability and ease-of-use

Merck, a leading science and technology company, today announced that Celonic AG, a Swiss contract development and manufacturing organization (CDMO), is upgrading its manufacturing facility with five of Merck’s Mobius® single-use bioreactors.

Celonic, which produces biosimilars and also offers a cell line development platform, will add 50-, 200- and 2,000-liter bioreactors to its development and manufacturing facility in Basel, Switzerland. The upgrade will expand Celonic’s upstream capabilities, improving flexibility and scalability.

“Our extensive portfolio of single-use technologies allows us to support CDMO customers like Celonic as they adopt new technologies and expand their capabilities,” said Andrew Bulpin, Head of the Process Solutions business unit, Life Science at Merck. “Our new Mobius® single-use bioreactors will help Celonic streamline its processes and expand its capacity to better serve clients.”

“For our biotech customers, each step towards market authorization boosts the valuation of their assets, and that’s where Celonic’s breadth of services has been instrumental in creating tremendous value for our partners,” said Konstantin Matentzoglu, CEO, Celonic. “Merck’s Mobius® single-use bioreactors offer a flexible, scalable system that addresses our needs and those of our clients. With the addition of the 2,000-liter bioreactor, we are moving a step closer to our objective of serving customers with commercial manufacturing needs.”

Single-use, disposable equipment and systems have increased in popularity in the biopharmaceutical industry, as they offer many advantages over conventional stainless steel systems, such as improved batch success rates, less cross-contamination risk, decreased water and waste water requirements, shortened project duration and reduced project costs.

At the same time, biopharmaceutical manufacturers are moving toward end-to-end solutions — from process development and scale-up through to manufacturing for pre-clinical, clinical and commercial supply — as they seek to cut costs while increasing quality and efficiency.

Merck’s portfolio of 3- to 2,000-liter Mobius® single-use bioreactors delivers greater flexibility and continuity for scale-up, reducing the need for retraining operators. These are some of the multiple reasons that CDMOs such as Celonic have become early adopters of Merck’s technologies.

Merck is a premier supplier of process development and clinical-stage manufacturing solutions, materials and services needed for the production of biopharmaceutical drugs. The company is committed to delivering superior bioreactor technology to manufacturers, several of which are already collaborating with the company in that space in North America, Europe and Asia.

About Celonic
 Celonic AG is a privately owned CDMO based in Basel, Switzerland. Celonic offers include comprehensive GMP development and manufacturing services for New Biological Entities (NBEs) and Biosimilars worldwide. Applying empathy, efficiency and excellence, Celonic goes one step beyond expectations in all business aspects in order to help its clients attain their goals more efficiently and reliably. Celonic’s services include the development of cell lines, production processes, as well as the GMP and non-GMP manufacturing of biopharmaceutical drug substances. In addition, Celonic licenses its proprietary CHOvolution™ cell line technology to clients, drug developer and service provider. Visit www.celonic.com to learn more.

All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
 Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

PRNews

Fiasp(R) Significantly Improved Overall Blood Sugar Control in Type 1 Diabetes Long-term

LISBON, Portugal, Sept. 12, 2017 /PRNewswire/ — Fiasp® (fast-acting insulin aspart), the only approved, new-generation, ultra-fast acting[1]–[3] mealtime insulin, improved overall blood sugar (HbA1c) and post-meal sugar (postprandial glucose or PPG) control over 52 weeks, compared to conventional insulin aspart (NovoRapid®), in new study findings[4].

The findings were presented today at the 53rd European Association for the Study of Diabetes (EASD) Annual Meeting, and showed that Fiasp® maintained the significant improvement in overall blood sugar control that was seen in a shorter-term (26 weeks) study period[1]. The results also reconfirmed the safety profile of Fiasp®, showing comparable overall numbers of severe or blood-sugar confirmed hypoglycaemia (low blood sugar levels)[4].

“These results provide reassurance of the meaningful long-term benefits of Fiasp® versus conventional insulin aspart,” said Professor Chantal Mathieu, study investigator, chair of Endocrinology and professor of Medicine at Katholieke Universiteit Leuven, Belgium. “Accordingly, for people with diabetes who struggle to control their post-meal sugar levels, Fiasp® might offer a better option to meet their needs.”

After eating, blood sugar levels rise rapidly. In diabetes, the body either cannot bring these high sugar levels down, or struggles to do so. Sustained high post-meal sugar levels are associated with an increased risk of cardiovascular disease and other diabetes-related complications, including damage to eyes and kidneys and cancer[5],[6]. High post-meal sugar levels also contribute to inadequate overall blood sugar control[2],[5],[7].

While mealtime insulins aim to bring post-meal sugar levels down, conventional rapid-acting insulins are not as fast as the speed of the natural physiological insulin response. Due to this slower response, people with diabetes can remain in an elevated post-meal sugar state for an extended period[2].

“Compared to conventional insulin aspart, Fiasp® is a closer match to the natural physiological insulin response, leading to better long-term blood sugar control,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Fiasp® delivers benefits for people with diabetes, helping them to achieve better post-meal and overall blood sugar control.”

About the study 

The onset 1 trial (1,143 people randomised) was a phase 3a, partially double-blind, basal-bolus, treat-to-target trial, evaluating the efficacy and safety of Fiasp® compared with conventional insulin aspart in type 1 diabetes over 52 weeks, in two 26 week treatment periods. The findings from the 52 week study period were presented at the EASD Annual Meeting 2017.

In the 52 week study period, Fiasp® demonstrated a statistically significantly greater overall blood sugar reduction of -0.10% in adults with type 1 diabetes, in comparison to conventional insulin aspart. Fiasp® also showed a statistically significant reduction in 1-hour post-meal sugar increment of -0.91 mmol/L; no significant difference was seen in 2-hour post-meal sugar increment, compared with conventional insulin aspart. These results were achieved with a comparable overall rate of severe or blood-sugar confirmed hypoglycaemia between the two treatments[4].

About Fiasp® 

Fiasp® is the only approved, new-generation, ultra-fast acting[1]–[3] mealtime insulin. Fiasp® is insulin aspart in an innovative formulation, in which two excipients have been added: Vitamin B3 (niacinamide) to increase the speed of absorption and a naturally occurring amino acid (L-Arginine) for stability[8].

Fiasp® received marketing authorisation from the European Commission on 9 January, from Health Canada on 6 January, from Swissmedic on 7 June and from the Australian Government Department of Health on 28 June 2017. It is currently under regulatory review in over 10 countries.

After receiving a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) in October 2016, Novo Nordisk resubmitted the fast-acting insulin aspart new drug application (NDA) as a class II resubmission on 29 March 2017 and FDA approval is expected at the end of Q3 2017.

About Novo Nordisk 

Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,400 people in 77 countries and markets its products in more than 165 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube 

References 

  1. Russell-Jones D, et al. Fast-acting insulin aspart improves glycemic control in basal-bolus treatment for type 1 diabetes: results of a 26-week multicenter, active-controlled, treat-to-target, randomized, parallel-group trial (onset 1). Diabetes Care 2017; 40(7):943-50.
  2. Heinemann L and Muchmore DB. Ultrafast-acting insulins: state of the art. Journal of Diabetes Science and Technology 2012; 6(4):728-42.
  3. Cengiz E, et al. Moving toward the ideal insulin for insulin pumps. Expert Review of Medical Devices 2016; 13(1):57-69.
  4. Mathieu C, et al. Efficacy and safety of fast-acting insulin aspart are maintained over 52 weeks: comparison with insulin aspart in onset 1. Poster presentation at the 53rd EASD Annual Meeting. 11-15 September 2017; Lisbon, Portugal.
  5. Madsbad S. Impact of postprandial glucose control on diabetes-related complications: how is the evidence evolving? Journal of Diabetes and Its Complications 2016; 30(2):374-85.
  6. International Diabetes Federation (IDF). Guideline for management of postmeal glucose in diabetes. 2011.
  7. Monnier L, et al. Postprandial and basal glucose in type 2 diabetes: assessment and respective impacts. Diabetes Technology & Therapeutics 2011; 13(Suppl.1):25-32.
  8. Heise T, et al. A pooled analysis of clinical pharmacology trials investigating the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in adults with type 1 diabetes. Clinical Pharmacokinetics 2017; 56(5):551-9.

Further information
Media:        
Katrine Sperling
+45-3079-6718    
krsp@novonordisk.com

Åsa Josefsson
+45-3079-7708
aajf@novonordisk.com

Investors:        
Peter Hugreffe Ankersen  
+45-3075-9085
phak@novonordisk.com

Hanna Ögren
+45-3079-8519
haoe@novonordisk.com

Anders Mikkelsen
+45-3079-4461  
arm@novonordisk.com

Christina Jensen
+45-3079-3009  
cnje@novonordisk.com

Kasper Veje (US)
+1-609-235-8567  
kpvj@novonordisk.com 

ZINC#: HQMMA/FA/0717/0218

Date of preparation: August 2017

PRNews

Unleashing the Power of the Latest Pharmaceutical Research for Simplified Global Healthcare Solutions through Conference Series Pharma meetings

Conference Series has scheduled 300 more Pharma meetings for 2018 in 30+ countries

LONDON, and SINGAPORE, Sept. 12, 2017 /PRNewswire/ — Associated with over 1000 scientific societies and organizations, Conference Series is scheduled to organize pharmaceutical conferences in Europe, USA, and Asia Pacific with a view to unleash precious scientific findings for the benefit of humanity.

With the changing face of pharmaceutical markets around the world, the industry exhibits enormous potential exponential growth. In the US, healthcare spending is in the range of $3.12 trillion with pharmaceutical sales of around $333 billion. Of this, $244 billion comes from patented sales and $70 billion from generic sales. Considering this vast economy in the pharmaceutical field, we at Conference Series are organizing some of our best conferences in the USA, Europe and Asia-Pacific regions on the current topics, which are instrumental in the changing landscape of the pharmaceutical market.

Our pharmaceutical conferences scheduled during 2018 span all over the world and feature several pharmaceutical topics like drug delivery systems, drug discovery, drug designing, pharmacology, neuropharmacology, bioavailability bioequivalence studies, biopharmaceutical drug discovery, antibiotics, toxicology, clinical trials, best compliance methods, regulatory frameworks and other related topics. Conference Series Pharmaceutical meetings promote extended networking between experts and address all such challenges, which require early troubleshooting. Attendees of the conferences witness several hours of pharmaceutical knowledge exchange and sharing that would inevitably boost scientific research and developments in the pharmaceutical sciences.

ConferenceSeries and its partnered companies organise 3000+ conferences across the USA, Europe & Asia and publish 1000+ Peer Reviewed Journals, which attract over 50 million readers and feature over 50,000 eminent personalities and reputed scientists as editorial board members.

During these conferences we have also partnered with some of the best pharmaceutical and healthcare companies around the globe who are not only pioneers in drug discovery, but also the market leaders in terms of revenue, to unveil their latest discoveries. Reputed universities across the USA, UK, Europe and Asia grace these conferences with a view to promote industry-academia collaborations. These pharma conferences witness a web traffic total of one million visits, whereas the total page views are 4 million (analyzed twice a year).

For a glimpse of our conferences and testimonials visit our Conference Gallery & Meetings Experts Outlook

For assistances on registrations/exhibitions and other details Contact:

T: +1-650-889-4686
E: contact@conferenceseries.com

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PRNews

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Oncology Big Data Alliance

DARMSTADT, Germany, Sept. 11, 2017 /PRNewswire/ —

Not intended for U.K./U.S. based media 

  • Big data platform to help accelerate innovative discovery, development and delivery of new approaches in cancer care  
  • Enhanced analytical capabilities to better define personalized treatment options and help predict treatment outcomes 
  • Focused on areas of high unmet need to help enhance advancement in understanding, and empower and connect oncology community  

Merck, a leading science and technology company has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck’s Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belen Garijo, Member of the Executive Board of Merck and CEO Healthcare. “Merck is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck’s commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts. More information about the program can be found online at: http://www.grantforoncologyinnovation.org

About Project Data Sphere, LLC 

Project Data Sphere, LLC is an independent, not-for-profit initiative of the CEO Roundtable on Cancer Inc.’s Life Sciences Consortium. The CEO Roundtable on Cancer is a 501(c)(3) nonprofit corporation founded by President George H.W. Bush in 2001 to develop and implement initiatives that reduce the risk of cancer, enable early diagnosis, facilitate access to the best available treatments, and hasten the discovery of novel and more effective anti-cancer therapies.

For more information, visit http://www.ProjectDataSphere.org, or follow the Project Data Sphere initiative on Twitter at https://twitter.com/ProjDataSphere.

About the Global Oncology Big Data Alliance (GOBDA) 

The Global Oncology Big Data Alliance (GOBDA) will be a joint alliance, co-led by Merck and Project Data Sphere with the shared vision to connect and empower the oncology community with big data and advanced analytical capabilities. It is the goal of the initiative that by unleashing these data capabilities, this platform will help accelerate discovery, development and delivery of innovative treatment approaches for cancer patients, and address current significant unmet needs in this field.

A joint steering committee will monitor the initial progress of the collaboration including expansion of the PDS database with new data sets provided by the National Cancer Institute and other parties, designing the first FDA/Industry immuno-related adverse event Safety Meeting on December 15, 2017. The anticipated overall term of the GOBDA project and strategic collaboration shall be from 2018-2021.

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.

About Merck 

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Your Contact: Martina Brunner +49-6151-72-43959

PRNews

Galderma: Combined Use of Rosacea Therapies Ivermectin 1% Cream and Brimonidine 0.33% Gel Evaluated in MOSAIC Study

LAUSANNE, Switzerland, Sept. 11, 2017 /PRNewswire/ — Today, the results of a study evaluating the combined use of topical rosacea treatments ivermectin 1% cream and brimonidine 0.33% gel were published in the Journal of Drugs in Dermatology.

“This is the first study evaluating the benefit of using both ivermectin 1% and brimonidine 0.33% in combination to effectively target the multiple features of rosacea,“ commented study author Linda Stein Gold, Henry Ford Hospital, Detroit, MI. “This study develops a comprehensive and early treatment approach to this complex disease.“

“The visible signs of rosacea can significantly impact patients‘ quality of life,“ said Gregor Schaefer, Medical Lead at Galderma. “Galderma is committed to supporting patients through the development of practical treatment options.“

Reference:  

Stein Gold L, et al. J Drugs Dermatol. 2017;16(9):909-916.

About Rosacea 

Rosacea is a common inflammatory skin disease that presents variable clinical characteristics, of which the most common are flushing, permanent erythema, and inflammatory lesions. It mainly affects the central areas of the face, such as the cheeks and nose. The disease can affect both adult men and women, usually after the age of 30. Additionally, symptoms such as stinging, burning and increased sensitivity of the skin are common. The eyes are often affected, and might present as red, dry or itchy.

Although the cause of the disease is still under debate, various trigger factors are known, including spicy foods, alcohol, emotional stress, sun/UV-exposure, hot baths and beverages. Demodex, generally harmless mites, can also be found in the skin in an elevated quantity in people with rosacea.

Rosacea may worsen over time if left untreated. People that suspect they suffer from rosacea should visit their dermatologist or healthcare provider for diagnosis and discuss what treatment is right for them. Because rosacea is a highly visible disease, it is known to cause embarrassment and anxiety in some patients, which in turn may cause frustration and have a negative impact on their social life.

About Galderma 

Galderma, Nestle Skin Health’s medical solutions business, was created in 1981 and is now present in over 100 countries with an extensive product portfolio to treat a range of dermatological conditions. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically defined and medically proven solutions for the skin, hair and nails. For more information, please visit http://www.galderma.com

PRNews

Frost & Sullivan Applauds STANLEY Healthcare’s Design Innovation and Leadership in Addressing the Changing Needs of the Senior Living Industry

STANLEY Healthcare’s user-friendly, unobtrusive innovations address challenges in the market, making senior living communities tech savvy and future ready for implementing efficient senior care

SANTA CLARA, California, Sept. 7, 2017 /PRNewswire/ — Based on its recent analysis of the market for technology solutions for senior living communities, Frost & Sullivan recognizes STANLEY Healthcare with the 2017 Global Company of the Year Award. STANLEY Healthcare, a business unit of the Fortune 500 Company Stanley Black & Decker, is a leading solutions vendor for hospitals, health systems, and the senior living space. STANLEY Healthcare aims to expand its suite of solutions for the senior living market and deliver greater value to its clients in supporting their provision of senior care in an increasingly challenging environment.


STANLEY Healthcare receives the 2017 Global Senior Living Community Vendor Company of the Year Award

STANLEY Healthcare’s solutions serve several safety and security needs of senior living communities. These solutions include emergency call, wander management, staff security, facility security, and temperature monitoring. STANLEY Healthcare is the leader in fall management solutions, with over a million fall monitors installed over the past decade.

Going beyond its existing solutions and realizing the industry’s upcoming needs, STANLEY Healthcare is working to realize the ‘Smart Resident Room’. Integrating sensors in an Internet of Things fashion, the Smart Room concept will enable senior living communities to monitor residents unobtrusively while they carry on with their daily activities.

“Realizing the nature of technology and acknowledging the fast-changing pace of advancements, STANLEY Healthcare routinely partners with other technology companies whose solutions can integrate with its own to provide enhanced value for its customers,” said Industry Analyst Siddharth Shah at Frost & Sullivan. “It also partners with some of the WLAN and infrastructure providers to ensure its products and software work seamlessly with customers’ wireless infrastructure.”

An example of innovative technology founded on market needs is a wander management system using Bluetooth Low Energy (BLE) for wireless communication. “To lower the barriers to entry for wireless solutions, STANLEY Healthcare is moving towards using BLE solutions. Designing solutions that are appealing enough to attract residents is an approach that helps STANLEY Healthcare differentiate its solutions from others available in the senior living space,” said Shah.

Another key differentiator that distinguishes STANLEY Healthcare from the competition is its approach to customer care, including:

  • Product support services spanning the entire lifecycle of the solution.
  • The By Your Side™ customer support portal, which helps clients obtain answers to their queries, provides access to product documentation, and extends support for solving technical challenges.
  • 24/7 phone support, remote diagnostics, and on-site repair services.

Frost & Sullivan presents this award to the company that has leveraged competitive intelligence to execute successfully a competitive strategy that results in stronger market share, competitive brand positioning, and customer satisfaction.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About STANLEY Healthcare

STANLEY Healthcare provides over 5,000 acute care hospitals and 12,000 long-term care organizations with enterprise solutions that create a safe, secure and efficient healthcare experience across life’s stages. The STANLEY Healthcare solution set enables customers to achieve organizational excellence and superior care in critical areas: Patient/Resident Safety, Security & Protection, Environmental Monitoring, Clinical Operations & Workflow and Supply Chain & Asset Management. These solutions are complemented by STANLEY Healthcare’s By Your Side™ Lifetime Customer Care commitment to ensure that every customer achieves success and realizes the full value of their investment, through consulting, training, implementation and integration services. STANLEY Healthcare is proud to be part of Stanley Black & Decker, Inc. For more information, visit stanleyhealthcare.com. Follow STANLEY Healthcare on Facebook, Twitter, LinkedIn and YouTube.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, collaborates with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, Frost & Sullivan has been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community. Contact us: Start the discussion.

Contact:

Claudia Toscano
P: 210.477.8417
F: 210.348.1003
E: claudia.toscano@frost.com

PRNews

PQ Bypass Earns Frost & Sullivan’s European Technology Innovation Award for Its Proprietary DETOUR System for Percutaneous Bypass

Novel technology enables a new, minimally invasive treatment for patients suffering from extremely long peripheral artery blockages

LONDON, Aug. 31, 2017 /PRNewswire/ — Frost & Sullivan is pleased to recognize PQ Bypass with the 2017 European PAD Interventions Technology Innovation Award. PQ Bypass’ DETOUR System is a minimally invasive technology that enables physicians to re-direct, or detour, blood flow around extremely long blockages in the upper leg arteries to restore blood flow to the lower leg and foot.

“PAD is a potentially fatal condition that affects more than 200 million people worldwide—3 to 12% of the global population. PQ Bypass’ proprietary DETOUR System is a promising, innovative approach for patients with extremely long lesions whose current treatment options are not ideal,” said Frost & Sullivan Best Practices Analyst, Norma Vela. “We anticipate rapid, widespread technology adoption once the DETOUR System launches commercially. The global market potential for treating this type of advanced peripheral arterial disease is significant, and PQ Bypass has first-mover status in the space.”

Extremely long blockages in the leg arteries, especially those that are greater than 20 centimeters, are challenging to treat. Historically, physicians have treated these blockages with open bypass surgery (fem-pop bypass), which has the benefit of durability, however, it is associated with an increased risk of complications, longer hospital stays, and prolonged rehabilitation. More recently, minimally-invasive technologies have emerged that go through blockages. These technologies work very well on shorter blockages; however, they have not been as effective on these longer blockages as open surgery.

The DETOUR System is designed to deliver the durability advantages of open bypass surgery with a minimally-invasive approach. During a DETOUR procedure, a pathway is created by crossing from the SFA into the femoral vein and back into the artery that allows DETOUR stent grafts to be placed in a continuous line. The new path through the stent grafts re-directs oxygen-rich blood around the blockage and restores blood flow to the lower leg and foot of the patient.

“With an increased focus on value-based and patient-centered medicine, surgical advancements that minimize trauma to patients, reduce length of hospital stay and recovery times are critical global needs,” said Richard Ferrari, Chairman of the Board of PQ Bypass. “We designed the DETOUR System to be a transformative step forward in how physicians treat extremely long peripheral artery disease.”

In March 2017, PQ Bypass received CE Mark approval for the DETOUR System and is planning a pivotal investigational device exemption study to support premarket approval from the US Food and Drug Administration (FDA). The clinical results of the DETOUR I trial conducted in Europe were promising, demonstrating excellent safety and effectiveness with patency results of 84.7% at 6 months.

Each year, Frost & Sullivan presents this award to a company that has developed a pioneering technology that enhances current products and develops newer products and applications. The award recognizes the high market acceptance potential of the recipient’s technology.

Frost & Sullivan Best Practices Awards acknowledge companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.

About PQ Bypass

PQ Bypass, Inc. is a Silicon Valley-based medical device company working to transform the treatment of long-segment peripheral artery disease with minimally-invasive endovascular solutions.

PQ Bypass is operated by recognized leaders in the medical device industry. Our executive team members have held senior leadership positions at companies including Medtronic, Abbott, Johnson & Johnson, and Stryker and also have extensive experience developing medical devices for startups such as Evalve, Access Closure, Avinger, and DVI.

The underlying technology and technique used in the percutaneous PQ DETOUR procedure were co-developed by two world-renowned cardiologists and innovators, Dr. James Joye and Dr. Richard Heuser, who are recognized experts in PAD.

The PQ Bypass technology platform is not available for sale in the US. For more information, please visit www.pqbypass.com.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, collaborates with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants. For more than 50 years, Frost & Sullivan has been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community. Contact us: Start the discussion.

PRNews

Merck Collaborates with Angiex to Speed Clinical Readiness of New Cancer Therapy

– Project is first for Merck’s Massachusetts BioReliance® End-to-End Solutions center

– Collaboration gives Angiex access to Merck’s process development tools and technologies

DARMSTADT, Germany, Aug. 29, 2017 /PRNewswire/ — Merck, a leading science and technology company, today announced a new collaboration with Angiex, Inc., Cambridge, Massachusetts, USA to support the biotechnology start-up’s ability to speed its lead oncology antibody drug candidate to clinical use. Angiex is developing an antibody-drug conjugate (ADC) therapy for cancer against a vascular target, TM4SF1.

The collaboration with Angiex is the first project to be undertaken at Merck’s new biodevelopment center in Massachusetts, USA. Merck will give Angiex access to end-to-end process development tools, education programs and training to support its success.

“Companies benefit from our expertise and experience in developing GMP manufacturing processes for early clinical development programs,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “With an end-to-end approach, Merck can facilitate and accelerate scaling and technical transfer for companies like Angiex.”

Angiex CEO Dr. Paul Jaminet applauded Merck’s broad range of process development capabilities and services for customers at all stages of molecule development and commercialization. “Through this collaboration, Angiex hopes to accelerate our path to the clinic. We appreciate Merck’s expertise in bringing to cancer patients an innovative treatment capable of addressing the most dangerous solid tumors,” Jaminet said.

Merck’s BioReliance® End-to-End Solutions deliver products and services allowing biopharmaceutical companies to accelerate the progression of potential new therapies from the laboratory into clinical trial and on toward commercialization. The turnkey package includes process development, cGMP manufacturing, facility design, equipment for pilot-plant production, process and equipment training, technology transfer, equipment qualification and set-up for commercialization. To further support its global BioReliance® End-to-End Solutions, Merck will inaugurate its new biodevelopment center in Burlington, Massachusetts in October 2017.

Merck’s BioReliance® End-to-End Solutions is part of the Process Solutions business area within the Life Science business of Merck.

About Angiex
Angiex was founded by world-class scientists to develop vascular-targeted biotherapeutics. Angiex targets fundamental aspects of endothelial biology with a focus on angiogenesis. Angiex’s lead product is an antibody-drug conjugate therapy for cancer. Angiex is resident at LabCentral in Cambridge, Massachusetts.

All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

PRNews

Ganeden Brings Probiotic Exhibit and Expertise to Fi Asia

Global leader will discuss probiotic formulation trends, science updates and product launches

CLEVELAND, Aug. 29, 2017 /PRNewswire/ — As probiotic fortification continues to gain momentum around the world, probiotic leader Ganeden is expanding its presence at additional food and beverage events globally—including in Asia. This September, experts from the top probiotic ingredient supplier will be attending Food Ingredients Asia (Fi Asia) in Bangkok. Team members based locally and from the U.S. headquarters will be on site to discuss new probiotic research, offer insight into upcoming product launches and help manufacturers explore innovative probiotic formulations beyond traditional dairy applications.

Ganeden has become a driving force in the probiotic space internationally, helping hundreds of manufacturers use probiotic technology in their products in innovative ways—including many in Asia. As a global leader, the science-driven company is knowledgeable on probiotic trends around the world, including consumer demand, research advancements and innovative options for probiotic fortification beyond the dairy case. Experts can assist in probiotic ingredient selection, including providing details on strain specificity, study requirements and health benefits.

“There are tremendous growth opportunities for probiotic technologies in the Asian market, and Fi Asia gives us a chance to provide expertise on how health benefits can be added to products to drive consumer interest and purchases,” said Stephen Quinn, business and regulatory director for Asia at Ganeden. “We plan to meet with industry leaders and innovators to demonstrate how functional ingredients can benefit end-users and grow business. There is a strong tradition of probiotics in Asia, but nearly all of it is in the supplement and dairy categories, so having a chance to provide the same health benefits in other food and beverage applications is exciting for manufacturers and their customers.”

Ganeden is best known for GanedenBC30® (Bacillus coagulans GBI-30, 6086), its patented and shelf stable probiotic ingredient that remains viable through most manufacturing processes, shelf life and gastric transit—allowing it to be fortified into almost any food or beverage product. Years of ongoing studies confirm the strain’s safety, digestive and immune support, and protein utilization benefits. And because GanedenBC30 has been shown to survive 10X more effectively than yogurt cultures, it has become one of the top ingredient choices for probiotic benefits in both refrigerated and non-refrigerated products.

During the show, Ganeden will also introduce the newest addition to its ingredient portfolio—Staimune™. The new ingredient uses the inactivated cells of GanedenBC30, which have been shown to support immune health. Staimune’s ease of formulation opens up new opportunities in immune-focused, functional foods and beverages which involve processes too harsh for live probiotics.

To meet with probiotic experts at the Fi Asia show, contact Ganeden or visit booth #F34. For more information on the probiotic company, including its ingredient portfolio, research and international presence, visit GandedenProbiotics.com.

About Ganeden:

Ganeden® is at the forefront of probiotic research and product development with an extensive library of published studies and more than 135 patents for probiotic technologies in the supplement, food, beverage, animal health, sports nutrition and personal care ingredients markets. Ganeden is best known for GanedenBC30®, its patented, FDA GRAS, highly stable probiotic ingredient. Through the fermentation process of GanedenBC30, Ganeden developed Bonicel®, the first science-backed, probiotic-derived, personal care ingredient shown to dramatically reduce signs of aging. Ganeden’s newest ingredient, Staimune™ is a patented probiotic technology comprising of inactivated GanedenBC30 which has been shown to have immune benefits. For more information about Ganeden and licensing opportunities visit GanedenProbiotics.com. 

PRNews

Merck to Acquire Natrix Separations to Advance Next-Generation Processing Capabilities

— Boosts Merck’s single-use chromatography portfolio

— Accelerates Merck’s mAb and vaccine manufacturing offering

DARMSTADT, Germany, Aug. 28, 2017 /PRNewswire/ — Merck, a leading science and technology company, today announced that it has entered into an agreement to acquire Natrix Separations, an Ontario, Canada-based provider of hydrogel membrane products for single-use chromatography. The transaction is expected to close in Q3 of 2017. Financial details were not disclosed.


Merck signed an agreement to acquire Natrix Separations, a company known for its technology platform capable of delivering high productivity and impurity removal in a single-use format. This acquisition complements Merck’s efforts to drive next-generation bioprocessing, ultimately enabling faster, more efficient technology for customers. Pictured here is a magnified view of the Natrix HD Membrane pore structure, comprised of up to 95 percent functional monomer.

Natrix is known for its unique technology platform capable of delivering high productivity and impurity removal in a single-use format, an ideal fit with next-generation processing. This acquisition complements Merck’s efforts to drive next-generation bioprocessing, ultimately enabling faster, more efficient technology for its customers.

“The Natrix technology platform, and the development options and capabilities that this brings for single-use and rapid cycling chromatography, will allow us to accelerate our offering in mAb and vaccine manufacturing,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “This acquisition creates tremendous opportunity to drive growth and advancement in next-generation processing—an area of increasing importance to our customers.”

Next-generation processing is any technology, expendable or system that changes the existing monoclonal antibody manufacturing template through unit operation intensification, connection of unit operations, or fully continuous processing. Biomanufacturers are moving toward next-generation processing because of its many benefits, including increased plant productivity, facility flexibility, cost efficiencies and reduced risk. Next-generation processing is expected to triple in market size between 2020 and 2025.

Natrix markets both an anion exchange membrane and cation exchange membrane. Natrix is developing additional products to enable a fully single-use, full-scale biological purification process.

“Joining Merck gives us the opportunity to collaborate with some of the best minds in the industry, allowing us to further the great work done by our scientists,” says John Chickosky, CEO, Natrix Separations. “I am truly excited to become part of a larger effort and see the benefits of this combination in the advances we will make for our customers and the global scientific community.”

About Natrix Separations, Inc.
 Natrix Separations enables fast and flexible manufacturing of biopharmaceuticals through high-productivity disposable downstream processing products. The innovative Natrix HD Membranes overcome the limitations in efficiency, speed, and flexibility imposed by conventional capital-intensive approaches to chromatography. Natrix products feature well-established industry-standard chemistries, and are scalable from R&D to commercial manufacturing. Natrix is headquartered in Burlington, Ontario, Canada. For additional information, visit www.natrixseparations.com

All Merck news releases are distributed by email at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck
 Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of €15 billion in 66 countries.
Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the “Merck” name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Photo – https://mma.prnewswire.com/media/548923/Merck_Acquires_Natrix_Separations.jpg