Tag Archives: PHA

Traditional Chinese Medicine Brand GuangYuYuan to make Global Debut at Paris Fashion Week

-China’s oldest TCM brand to sponsor rising fashion star in unprecedented collaboration with tech giant Tencent

— Oldest TCM brand in China, with a history of nearly 500 years

— Guo Jiaxue, Chairman of the Board of GuangYuYuan: “Very few companies in the world boast a heritage as long as ours. For GuangYuYuan, the preservation of traditional culture and encouraging innovation are two of the pillars our company is built on.”

BEIJING, Sept. 27, 2017 /PRNewswire/ — The oldest of the “Big 4” Traditional Chinese Medicine brands, GuangYuYuan, will be making its global debut at Paris Fashion Week on 1 October 2017.


Chinese designer Big-King sketches a GuangYuYuan inspired design for his Paris Fashion Week Debut

At an event organized by tech giant Tencent, during the finale of the biannual international “Big 4” fashion weeks, GuangYuYuan will sponsor an innovative runway show by up-and-coming Chinese designer Liu Qing, also known as Big-King, in what will be his first Paris runway show.

Guo Jiaxue, Chairman of the Board of GuangYuYuan Chinese Herbal Medicine Co., Ltd. explained the motivation behind this unique collaboration: “Very few companies in the world boast a heritage as long as ours. For GuangYuYuan, the preservation of traditional culture and encouraging innovation are two of the pillars our company is built on. We are excited to see how Big-King is able to incorporate distinctly Chinese elements into his designs, as well as some elements that reflect our own history of nearly 500 years.”  

The GuangYuYuan-sponsored show received special permission to be held in the magnificent Musee Jacquemart-Andre, the first runway Paris Fashion Week show ever held in the museum. GuangYuYuan will also have highlights from its brand culture and design aesthetics on display during its Paris debut.

About GuangYuYuan

GuangYuYuan was founded in 1541. In 2003 it was acquired by a leading Chinese pharmaceutical conglomerate, Xi’an Dongsheng Group, and is listed on the Shanghai Stock Exchange under the name GuangYuYuan Chinese Herbal Medicine Co. Ltd., stock number 600771. In 2006, GuangYuYuan was honored by the Chinese Ministry of Commerce, receiving its “Time-Honored Brand” appellation. Two of GuangYuYuan’s oldest products, GuilingJi and Dingkun Dan, have been declared to be part of China’s intangible cultural heritage and their formulas have been named national secrets.

Website: www.guangyuyuan.cn

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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.

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

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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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.

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.

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OpenEye Announces Pfizer To Adopt Orion Cloud Platform For Computational Chemistry

SANTA FE, New Mexico, Aug. 17, 2017 /PRNewswire/ — OpenEye Scientific Software, Inc., an innovative developer of molecular modeling and cheminformatics solutions, today announced that it has entered into an agreement with Pfizer Inc., to provide Orion, OpenEye’s new cloud platform, to the company’s Medicinal Sciences division.  Orion will equip chemists with all of OpenEye’s software, extensive tools for data visualization and communication, useful data sources and customizable, task-oriented workflows, all in a robust, scalable, cloud environment.

“We believe that Orion has the potential to revolutionize how computation is delivered to the pharmaceutical industry,” said Dr. Anthony Nicholls, CEO and founder of OpenEye Scientific Software, Inc. “Orion marries the immense resource of cloud computing services, with our insights, science and tools from two decades of helping customers. It continues and expands our tradition of computing at scale, reliable, predictive science and facilitating local innovation. As an open, collaborative platform for both industry and academia we think it can enhance the drug discovery process.”

“We look forward to implementing Orion’s workflow tools to help our efforts to deliver potential breakthrough therapies for patients,” said Enoch Huang, Executive Director of Computational Sciences at Pfizer.

About OpenEye

OpenEye has built a reputation as a scientific leader in the field of molecular design based on two decades of delivering useful applications and programming toolkits. Our scientific approach has focused on the power of molecular 3D structure to inform and guide, in particular via the concept of shape similarity. We have changed industry perception of what is possible with the speed, robustness and scalability of our tools and have recently built these into a ground-up, cloud-native platform, Orion. Combining unlimited computation and storage with powerful tools for data sharing, visualization and analysis in an open development platform, Orion offers unprecedented capabilities for drug discovery and optimization. OpenEye Scientific is a privately held company headquartered in Santa Fe, New Mexico, with offices in Boston, Massachusetts, Cologne, Germany, Strasbourg, France and Tokyo, Japan.  For further information on the company and its products, see www.eyesopen.com.

FOR ADDITIONAL INFORMATION

OPENEYE SCIENTIFIC SOFTWARE, INC.

Jeffrey Grandy, Vice President, Sales

+1 505-473-7385 x60

Email: sales@eyesopen.com

Decision Resources Group Acquires Context Matters to Expand Global Market Access Intelligence Offerings

BURLINGTON, Massachusetts, Aug. 16, 2017 /PRNewswire/ — Decision Resources Group (DRG), the life sciences industry’s most trusted provider of market intelligence and global data products and services, today announced that it has completed the acquisition of Context Matters, the innovative data technology start-up that developed a first-of-its-kind global market access integrated data platform. Previously the lead investor in a Series B funding round for the startup last fall, DRG’s full acquisition and planned integration of Context Matters cements its position as the partner of choice for global market access data products, analytics, and strategic guidance.

The acquisition of Context Matters reinforces DRG’s commitment to providing a deep understanding of global market access landscapes which life sciences organizations can leverage to drive profitable asset management from development through commercialization. It will fortify DRG’s global market access portfolio by combining the novel Context Matters data model, which links global regulatory and health technology assessment data to detailed clinical trial data, with DRG’s existing suite of products and services.  The addition of Context Matters will result in a full service global market access and drug value navigation partner to the life sciences industry, with the flexibility to deliver solutions scaled to client needs and timing—from tactical target points to end-to-end enterprise strategy.

“There is an ever-rising demand to optimize global access to treatments for patients in therapy areas that continue to have unmet need. In our increasingly complex and cost-benefit driven markets, it is imperative for healthcare companies to build robust, evidence-based approaches to plan and prepare their assets for successful global market access,” says Peter Hempshall, Senior Vice President of DRG. “With the acquisition of Context Matters, DRG is pleased to welcome an experienced team of pioneering global market access experts. They have been at the forefront of compiling and connecting disparate forms of data to provide life sciences companies with the depth of data and direction needed to plan and implement successful access, reimbursement and asset valuation strategies for varied global markets.”

“Context Matters was created from the idea that data from market access and reimbursement can be used to inform clinical trial design,” explained Yin Ho, M.D., M.B.A., the Founder and CEO of Context Matters. “It has been extremely gratifying to watch Context Matters become a force to change the thinking of the pharmaceutical industry around how to use data to position and honestly evaluate the value of customers’ assets in a global marketplace,” said Dr. Ho. “We have been leaders in the industry and our vision will continue to live on in our products, services, and customers as we move forward with DRG.”

About Context Matters, Inc.

Context Matters modernizes and improves the process of valuing drug therapies, empowering life sciences organizations to achieve optimal reimbursement for their innovation. The Context Matters Market Access Platform (MAP) defines a new product category for global drug valuation — a configurable technology platform linking drug development and market data through a sophisticated model making comparative analysis and contextual views possible to establish reimbursement and market access. The MAP is a disruptive innovation that provides pharmaceutical and biotechnology companies direct access to the insights they need to inform key product development decisions and gain optimal reimbursement value. Visit ContextMatters.com for more information.

About Decision Resources Group

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

For press inquiries, please contact Tori Gillern at tgillern@teamdrg.com.

Korea Institute of Science and Technology (KIST) Develops a New Drug for Alzheimer’s Disease

— Development of a new, innovative drug for Alzheimer’s disease overcoming the limits of existing medicines.

— Offering a new hope of developing a global cure for Alzheimer’s disease through technology transfer and clinical trial

SEOUL, South Korea, Aug. 9, 2017 /PRNewswire/ — As the world population is aging, the top priority of leading countries is to come up with solutions that can overcome dementia. Currently, a handful of anti-dementia drugs are used. But most of them just temporarily alleviate symptoms. Recently, there has been a series of failures of global candidate drugs that have been developed based on the conventional treatment mechanism. Due to the failures, now is a good time to develop a drug based on the root cause of dementia.

Through a fruitful collaboration, scientists at KIST, Ki-Duk Park, C. Justin Lee, and Ae-Nim Pae, developed a drug candidate for dementia with excellent drug-like properties and efficacy. The drug candidate (KDS2010) was based on the previous findings that reactive astrocytes, commonly found in the brain of Alzheimer’s patients, generate and secrete GABA, an inhibitory neurotransmitter, causing memory impairment and cognitive impairment (Nature Medicine, 2014).

This synthetic drug developed by the researchers is a substance that can reduce the amount of abnormally produced GABA. It is a drug candidate that can dramatically improve memory and cognitive impairment of Alzheimer’s disease patients.

* GABA: One of the transmitters of the central nervous system of mammals with strong inhibitory effect on neuronal excitability.

Researchers dissolved the drug in water and fed the mice that are genetically modified to mimic Alzheimer’s disease. They conducted Morris water maze and passive avoidance experiments to check the mice’s memory. They found that cognitive functions of the Alzheimer’s mice returned to the normal state. Furthermore, long-term administration of a low dose (1mg/kg) of the drug led to a long-lasting improvement in cognitive functions, even up to 4 weeks of treatment. This is in great contrast to the existing drugs, whose early efficacy is excellent but long-term administration has low efficacy. Furthermore, according to the results of verifying ADME/Tox, the drug candidate effectively transferred to the brain through oral intake and had drug-like properties without biotoxicity and any side effects on other nervous system.


The ability of candidate drug(KDS2010) to restore neuronal spike probabilities compared to pre-existing drug

This drug candidate provides a fundamental treatment option for cognitive function disorders through an entirely new treatment regime. So far it has been tested for long-term efficacy and toxicity. Currently, non-clinical trials are conducted at the GLP level. This could turn out to be a next-generation global drug for Alzheimer’s disease through immediate clinical trials.

On the 31st of May, Byeonggwon Lee, the president of KIST and Sangmin Park, CEO of MegaBioWood, an affiliate of KEMIMEDI(CEO, Geonseop Choi) had a signing ceremony for the technology transfer on “Drug Candidate for Alzheimer’s disease” at the KIST Seoul Campus. The total amount of the technology transfer contract was for 6 million US dollars, including $500,000 upfront payment and 5.5 million US dollars as a milestone technology payment. The running royalty was signed for 3% of net sales.

KIST (Korea Institute of Science and Technology)

Dr. C Justin Lee
Tel. +82-2-958-6940
e-mail. cjl@kist.re.kr

Dr. Ki-Duk Park
Tel. +82-2-958-5132
e-mail. kdpark@kist.re.kr

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Frost & Sullivan Lauds CytoSorbents for Leading the Critical Care Immunotherapy Segment with its Novel Blood Purification Solution, CytoSorb®

By controlling dangerous inflammation, CytoSorb® is enabling superior outcomes in critically-ill patients, with reduced overall costs of intensive care in its sights

LONDON, Aug. 2, 2017 /PRNewswire/ — Based on its recent analysis of the blood purification market, Frost & Sullivan recognizes CytoSorbents Corporation with the 2017 Global Frost & Sullivan Award for Product Leadership. CytoSorbents’ deceptively simple yet powerful blood purification therapy, CytoSorb®, helps critical care physicians and heart surgeons control deadly inflammation in their patients. CytoSorb® actively reduces circulating cytokines, toxins, and other substances in blood that feed and perpetuate uncontrolled inflammation in a diverse set of medical emergencies such as sepsis, infection, trauma, cardiac surgery, and liver failure. Its ultimate aim is to prevent a patient from being killed by his or her own out-of-control immune response.

“There were many factors that led to our selection of CytoSorb® for this year’s Global Product Leadership Award,” said Frost & Sullivan Research Analyst Aish Vivek. “Among the most important was the recognition that this innovative product is surprisingly well-positioned to help solve two long-standing, difficult, and tightly linked fundamental problems with hospital medicine today. These include the high rates of death from common critical illnesses such as sepsis that have no approved treatment, and the resulting staggering costs and losses in critical care that are financially crippling hospital networks and healthcare systems throughout the world.”

“Further strengthening CytoSorb’s position is the scarcity of viable competition in the lucrative and vast global critical care and cardiac surgery markets, the strong physician usage and revenue growth, and the external validation from well-respected industry partners, such as Fresenius Medical Care and Terumo Cardiovascular, and government funding agencies.  As a high margin, single-use product that works with existing blood pumps in hospitals, CytoSorb® also has an attractive business model that is expected to drive early and significant profitability of the company.”

“CytoSorb® has taken blood purification as a means to control inflammation to the next level, with its patented blood compatible, porous polymer bead technology,” concluded Aish Vivek. “This best-of-breed solution is approved in the European Union and has been used in more than 23,000 treatments to help save many lives across 44 countries.  As the clinical experience and scientific publications continue to grow, we predict that CytoSorbents, through CytoSorb®, will solidify its leadership in critical care and cardiac surgery, with expansion into other promising fields such as cancer immunotherapy, and treatment of chronic illness. We are also excited to follow along as CytoSorbents initiates a registration trial later this year that targets U.S. FDA approval.”

Overall, for positioning itself strongly with its CytoSorb® therapy and serving a wide array of applications, Frost & Sullivan is pleased to present CytoSorbents with the 2017 Global Frost & Sullivan Award for Product Leadership in the blood purification market.

Each year, Frost & Sullivan presents this award to the company that has developed a product with innovative features and functionality, gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables.

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 CytoSorbents Corporation

CytoSorbents Corporation (NASDAQ: CTSO) is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in 44 countries worldwide, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the “cytokine storm” or “cytokine release syndrome” that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, complications of surgery, cancer immunotherapy, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure. In 2017, the company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval.  CytoSorb® has been used safely in more than 23,000 human treatments to date.

CytoSorbents’ purification technologies are based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and surface adsorption. Its technologies have received non-dilutive grant, contract, and other funding in excess of $19 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (SOCOM) and others. The Company has numerous products under development based upon this unique blood purification technology, protected by 32 issued U.S. patents, multiple international patents, and many applications pending worldwide.  Products under development include CytoSorb-XL™, HemoDefend™, VetResQ™, ContrastSorb, DrugSorb, and others.  Visit www.cytosorbents.com and www.cytosorb.com

About Frost & Sullivan

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Contact:

Aish Vivekanandan
Phone: 210-477-8495
Email: aish.vivekanadan@frost.com