HONG KONG, June 26, 2018 /PRNewswire/ — Ms. Kimberly Nearing, the Managing Director, Head of Life Sciences at Cedrus Investments (“Cedrus”), was invited to serve on a panel and as a judge at the Sino-American Pharmaceutical Professionals Association’s (SAPA) Pharma/Biotech Investment Summit and Roadshow held on June 16 at Columbia University in New York City.
The sold-out event featured plenary sessions about global life sciences investment environment in the morning and life science company roadshow in the afternoon. Keynote speeches were made by Aisling Capital, Lilly, BeyondSpring Pharmaceuticals, Inc., Asian Ventures, F-Prime Capital Partners, and the U.S. National Institutes of Health’s Office of Technology Transfer. A highlight of the event was a presentation delivered by Mr.Dennis Purcell, Founder and Senior Advisor at Aisling Capital and former Managing Director of the Life Sciences Investment Banking Group at Chase H&Q (formerly Hambrecht & Quist), who reflected on what has changed in the global biotech industry and the rise in China’s influence.
Ms. Nearing participated in the Business Development and Strategic Investments panel along with US Head of Global Business Development at Hengrui Medicine, Deputy General Manager, Strategic Development at Shanghai Fosun Pharmaceutical Development Co. Ltd., and Managing Director, Co-leader for China/US Cross-Border Deals at PwC. She also served as a judge on the Showcase and Roadshow session, along with the Director, Corporate Development at Merck, Senior Analyst at Citi’s Biotech Equity, and Senior Associate at OrbiMed Advisors.
Mr. Xiaodong Chen, Chair of China Affairs at SAPA said, “On behalf the SAPA Leadership, we’d like to thank Kim for her unique insights into cross-border partnering and investing in the healthcare industry between the U.S. and China in the fireside chat session and her wisdom as a roadshow advisor. Kim made a great contribution to another successful SAPA event.”
TAIPEI, Taiwan, June 26, 2018 /PRNewswire/ — Recently, BioGend Therapeutics, a leading regenerative medicine company that focuses on bone and cartilage repair and regeneration, announced that BioGend Therapeutics completes enrollment for the pivotal clinical trial of one-step autologous knee cartilage repair/regeneration.
The company is led by an experienced management team in business operation, orthobiologic R/D, and clinical and regulatory affairs. The Biphasic Cartilage Repair Implant (BiCRI) technology, one of BioGend’s two major orthobiologic platforms, is a one-step autologous cartilage repair treatment for knee chondral or osteochondral defects (see Figure 1). During the surgery, a small amount of healthy cartilage tissue is harvested from the non-weight bearing area and mechanically reduced to small fragments followed by a brief enzymatic treatment to improve chondrocytes bioactivity and mobility. The cartilage tissue fragments are delivered using a bioabsorbable porous cylindrical biphasic plug to the defect site. The entire operation can be done arthroscopically in less than one hour. The pivotal clinical trial just completed enrollment of all 92 patients required to demonstrate non-inferiority at one-year follow-up. BioGend expects to receive TFDA approval in late 2019. A small cohort of 10 patients treated with the BiCRI device in a pilot study continues to demonstrate sustained good clinical performance at 5 years follow-up. The company is in the process of discussing with potential global strategic partners to develop markets in China, EU and the US for its one-step simple and effective autologous BiCRI cartilage technology.
Osteoinductive Factor (OIF) technology, another BioGend’s orthobiologic platform, has more than 10 years preclinical data demonstrating the safety and efficacy of OIF as a bone graft substitute. OIF is produced from E. coli bacteria by a BioGend’s sister company to assure consistent high quality. A pilot clinical trial to investigate the safety of OIF/TCP for open fracture management is expected to start in the 2H2018. A multicenter multinational spinal fusion pilot study of OIF/TCP is planned to begin in the 1H2020.
BioGend is preparing to list in Taipei Exchange next year to raise the fund required for launching the BiCRI product in Taiwan in early 2020. The company is also planning to bring knee cartilage patients from China and Southeaster Asia to Taiwan for surgery. BioGend welcome to discuss with potential strategic partners for global business collaboration, including investment in BioGend company.
Intermittent Fasting, also known as IF, is a pattern of eating that is fast becoming popular. Instead of limiting what you eat, one simply has to change when you eat. There are many benefits of doing IF including gaining leaner muscles, losing weight effectively, and reducing inflammation, amongst others.
How you do IF is simple – you prolong the time you fast. The fasting time includes the times you do not eat such as when you sleep. There are many benefits of doing Intermittent Fasting, which includes weight loss.
There are many ways or methods of doing IF. Most of the time it is done on a daily basis so it becomes part of your routine. Some do a 24-hour fast within a week’s time frame. However, IF is effective only if you do it at around the same time every day.
Whether we are conscious about it or not, we are already eating around the same time every day so all that one needs to change when trying out Intermittent Fasting is to simply not eat after a certain amount of hours.
Here are some examples of Intermittent Fasting methods:
You have a window of 8 hours to eat in a day and the rest is slotted for fasting. You can “skip” breakfast or have it at noon and end your eating period at 8 pm. You can also choose to have your breakfast at your usual time and end your eating period 8 hours later. The timing is completely up to you.
The Warrior Method
A more extreme method of having only a 4-hour window to eat, some say that the Warrior Method has helped them gain a better relationship with food. However, it is not recommended that you start off your Intermittent Fasting journey with this method straight away.
The 24-Hour Fast
For this method, you only fast for effectively one day or continuously for 24-hours. For example, you have your last meal on at 8pm on Tuesday evening and don’t eat anything until 8 pm Wednesday evening. That is just an example and you can choose any day of the week to do this.
Spontaneous Method
This method is for those who are unable to follow any of the methods shown above. You are able to skip meals when you can or choose to fast for a whole day when you feel like it. Find the best timing to suit your needs and lifestyle.
There are many benefits of Intermittent Fasting but you will not be able to reap its benefits if you are not aware of what you’re eating and continue to consume junk food.
HONG KONG, June 25, 2018 /PRNewswire/ — On June 22nd in Hong Kong, Luye Pharma Group hosted a conference to unveil their Global Collaboration Strategy. Liu Dianbo, Chairman of Luye Pharma Group, said at the event, “Starting in 2019, Luye Pharma will gradually begin to enter into a period of harvest, with past work coming to fruition, the company plans to launch at least one new drug every year. At the same time, we are also making comprehensive plans for the company’s development over the next five to ten years. We will pursue global partnerships in three strategic areas – global R&D, global manufacturing and global marketing, to ensure the company’s goal of becoming one of the world’s top fifty pharmaceutical companies by 2025.”
The focus of the conference was on Luye Pharma’s “Whole Value Chain Global Collaboration” strategy, proposed by Liu Dianbo. This is the first time that Luye Pharma has released their official global collaboration strategy to the public:
From innovation, R&D and manufacturing to marketing and distribution, Luye Pharma is committed to close collaboration with global business partners to best leverage the resource advantage of every party in the entire industry value chain, to better serve patients worldwide.
Jiang Hua, Vice President, Strategy & Business Development at Luye Pharma Group, also discussed the strategic thinking behind the company’s recent acquisition of AstraZeneca’s Central Nervous System (CNS) products, Seroquel (quetiapine fumarate, immediate release, IR) and Seroquel XR (extended release formulation) in 51 countries and regions. Mr. Simon Mellon, Consul for Trade and Investment at the British Consulate General in Guangzhou and Assistant Director for Life Sciences, Health and Social Care for South China at the Department for International Trade, as well as Mr. Chen Bing, Vice President of Alliances & Business Development at AstraZeneca also attended the conference.
Global R&D: Strengthen the advantages of four innovative technology platforms and make comprehensive plans for development of new tech areas
Luye Pharma has always been focused on the development and manufacturing of innovative drugs, and has set up R&D centers in Europe, the United States and China. To integrate its global R&D resources, Luye Pharma follows a strategy of independent R&D augmented by external collaboration. The company to date has developed four innovative technology platforms; advanced drug delivery systems, new antibodies, structurally optimized small molecules, and cell & gene therapy, in addition to multiple existing collaborative agreements with leading biotechnology companies.
Luye Pharma’ s “advanced drug delivery systems” represent the company’s unique competitive advantage in the R&D field, an area Luye has been relentlessly pursuing for many years. The company’s microspheres, liposomes and transdermal drug delivery technologies are at an advanced international standard. Risperidone Extended Release Microspheres (LY03004), which was developed by Luye Pharma for the treatment of schizophrenia and bipolar disorder, has reached the NDA (new drug application) stage in the United States. Rotigotine Extended Release Microspheres (LY03003), indicated for Parkinson’s disease, have begun Phase III clinical trials. “These new drugs will go on the market one by one, starting from 2019, in countries and regions around the world, something of a harvest period for Luye” said Jiang Hua. “In addition to independent research and development, we will also seek external collaboration to strengthen the four major existing innovative technology platforms and to facilitate our forward-looking deployment for the next generation of innovative drugs.”
Since last year, Luye Pharma has been deploying its resources in multiple areas through a number of R&D collaboration projects, including novel target antibodies, protein drugs, immuno-oncology, cell therapy, and smart precision drug delivery systems. In August 2017, Luye Pharma acquired two monoclonal antibody drugs from Shandong Bo’an Biotechnology Co., Ltd. (LY01008 and LY06006), and obtained a “biological antibody technology” R&D platform. The two drugs have already started Phase III and Phase I clinical studies, respectively. At the end of 2017, Luye Pharma made an equity investment in Exicure Inc., a US-based biotechnology company. Exicure’s SNA technology will synergize with Luye Pharma’s established liposome and microsphere delivery technologies in discovering novel nucleic acid drugs for use in oncology and other areas of unmet needs. In the field of immuno-oncology, Luye Pharma has successively built strategic collaborations with three leading U.S. biotechnology companies – ABPRO, Excel Biopharm LLC and ELPIS BIOPHARM, to jointly develop novel bispecific antibodies, therapeutic antibodies for the next generation of immuno-oncology and CAR-T therapy, among others.
Global Market: To develop product pipelines with global competitiveness in core therapeutic areas
CNS, oncology, cardiovascular, and metabolism are Luye Pharma’s four core therapeutic areas of long-term focus, with Luye making a series of systematic and sustainable plans aimed at developing these areas. With the acquisition of Acino’s transdermal patch and implants business, as well as a number of new drugs independently developed by the company, Luye Pharma has been able to build a wealth of CNS product pipelines and therapeutic solutions. In addition to Risperidone Extended Release Microspheres (LY03004) and Rotigotine Extended Release Microspheres (LY03003), Ansofaxine Hydrochloride Extended Release Tablets (”LY03005”) for the treatment of depression have also entered into Phase III clinical trials. New drug development projects such as Rivastigmine Multi-day Transdermal Patch (30410) for the treatment of mild-to-moderate Alzheimer’s disease is also progressing smoothly. The recently acquired Seroquel and Seroquel XR from AstraZeneca is another blockbuster added to Luye Pharma’s CNS portfolio.
Seroquel and Seroquel XR are atypical anti-psychotic medicines with antidepressant properties. The main indications for Seroquel are the treatment of schizophrenia and bipolar disorder. Seroquel XR is also approved in some markets for major depressive disorder and generalized anxiety disorder. Because of their fast onset, good tolerability and high patient compliance, Seroquel series products are widely recognized by doctors and patients, and are currently marketed in more than 80 countries around the world, with the total number of prescriptions exceeding 10 million.
In accordance with the acquisition agreement, Luye Pharma will acquire the assets of Seroquel and Seroquel XR in 51 countries and regions including China, the United Kingdom, Brazil, Australia, Saudi Arabia, Mexico, Thailand, Argentina and Malaysia, as well as other countries and regions in Asia, Latin America, Africa, Oceania and Eastern Europe. The assets include marketing authorization, regulatory information, certain patents, relevant business materials and data, manufacturing know-how and sales networks, among others. In addition, AstraZeneca has agreed to grant exclusive, permanent, free and sub-licensable trademark licensing, along with other licensing rights, to Luye Pharma.
“In addition to our optimistic outlook about the business performance and growth potential of the Seroquel products, the deal was made to generate market synergy for Luye and to pave the way for the launch of other CNS products in global markets”, said Jiang Hua.
Seroquel and Seroquel XR can complement Risperidone Extended Release Microspheres (LY03004) and Ansofaxine Extended Release Tablets (LY03005) in both domestic and overseas markets, as they can serve the same patient population and there is no exclusive competition when these drugs share channels and promotional resources. Seroquel and Seroquel XR can also contribute, with their readily available domestic and international commercial resources, to the launch and accessibility of new CNS drugs, such as Risperidone Extended Release Microspheres (LY03004) and Rotigotine Extended Release Microspheres (LY03003), as well as comprehensively enhance the global competitiveness of Luye Pharma’s CNS portfolio.
“In the future, we hope to build and expand pipelines featuring global competitiveness in another three core therapeutic areas including oncology and cardiovascular, and we also look forward to continuing our comprehensive and in-depth strategic collaboration with our partners via out-licensing and in-licensing”, Jiang Hua added.
Global Supply Chain: Covering upstream raw material procurement right through to patient supply
Luye Pharma is combining its seven global sites into a global manufacturing platform to tap the overseas markets, and hopes to graft the relatively mature local industrial chains into the global advanced supply chain via means including raw materials procurement and CMO partnerships. The goal is to establish a global supply chain network covering everything, from raw materials procurement right through to patient supply.
It is worth mentioning that as a result of the acquisition of Seroquel products, production technology for the two drugs will be transferred to Luye Pharma upon completion of the initial payment to AstraZeneca. The Seroquel series products, especially Seroquel XR, has a very advanced production processes. Luye Pharma plans to introduce these technologies to China shortly after the acquisition, which will also be the first time that the production technology for Seroquel XR comes to China. Shandong Luye Pharmaceutical Co., Ltd. will be the future production base for the global supply of the Seroquel series, not only strengthening the production capacity of new formulations, but also allowing for further alignment with the global production quality system.
“On its path of global development, Luye Pharma has been actively seeking the best M&A opportunities with respect to the different components in the entire value chain, such as R&D, production, and distribution. We look forward to working with our global partners to complement each other and achieve win-win collaborations. We also hope to tap into new and more sustainable growth drivers for the company through a variety of extensive development models and further enhancements to the company’s core competitiveness in the global market,” Liu Dianbo concluded.
Inpeco’s deep understanding of automation processes, cost considerations, and customer expectations allows it to deliver industry-leading flexibility and ROI
SANTA CLARA, Calif., June 25, 2018 /PRNewswire/ — Based on its recent analysis of the global clinical laboratory automation market, Frost & Sullivan recognizes Inpeco with the 2018 Global Company of the Year Award for designing, implementing, and integrating world-class total laboratory automation (TLA) solutions. Rising labor costs and volumes of diagnostic testing have necessitated cost-effective and streamlined solutions, which Inpeco has efficiently delivered.
INPECO
“Inpeco’s comprehensive FlexLab™ solution for the TLA market combines unparalleled technological sophistication and scalability to address automation bottlenecks,” said Divyaa Ravishankar Industry Principal. “Unlike competing solutions, FlexLab enables a range of automation modules to perform all routine tasks before, during, and after the analytical phase. Coupled with the ability to work with over 50 different analyzers of all major specialties, FlexLab has unmatched integration capabilities, uniquely supports complex installations with high workloads (above 10,000 samples per hour), and can be fully customized.”
Additionally, Inpeco presents a portfolio of cutting-edge modules, along with extensive connectivity to vendors’ analyzers, thereby making laboratory processes extremely flexible. Inpeco’s solutions are used in more than 1,600 labs in 60 countries, and the leading in vitro diagnostics (IVD) clinical lab suppliers Abbott and Siemens Healthineers distribute Inpeco’s TLA systems.
Realizing the importance of automating and controlling the total testing process, Inpeco recently introduced ProTube™, a new device for extra lab phases. This solution facilitates an accurate and fully traceable phlebotomy process, wherein samples can be tracked from the collection phase to final processing. ProTube eliminates common errors, such as patient and tube misidentification and mislabeled samples. With these solutions, the company has set new standards in diagnostics services as they reduce the need for trained personnel, while enhancing test quality.
“Inpeco’s commitment to lean lab engineering practices optimizes workflows to generate a powerful return on investment (ROI),” noted Ravishankar. “The company is growing at a double-digit rate because of its ability to execute TLA solutions in underrepresented disciplines, such as microbiology. Currently, Inpeco is working toward automating evolving laboratory applications, such as anatomic pathology, thereby positioning itself for continued market leadership.”
Each year, Frost & Sullivan presents a Company of the Year Award to the organization that demonstrates excellence in terms of growth strategy and implementation in its field. The award recognizes a high degree of innovation with products and technologies and the resulting leadership in terms of customer value and market penetration.
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 Inpeco
Inpeco is the global leader in process automation for Clinical Laboratories; the company engineers, develops and provides integrated solutions for a better patient-centric healthcare.
The Inpeco Group is a multinational company operating for over 20 years in the design, development and production of automation systems for clinical laboratories, where it has created pioneering automation and traceability solutions for samples and data. The Group, headquartered in Switzerland, runs own branches in Italy, Belgium and the United States.
With a turnover of around 150 million euros and over 1,600 installations in laboratories all over the world, the Inpeco Group invests 12% of its resources in Research and Development. Inpeco solutions guarantee the operators’ safety by reducing any contact with biological samples and ensure the diagnostic process is free from errors – from blood drawing to result availability.
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.
Clinical One Randomization and Supplies Management Cloud ServiceEnables Unparalleled Transparency and Efficiency Throughout the Clinical Development Life Cycle
SANTA CLARA, California, June 21, 2018 /PRNewswire/ — Based on its recent analysis of the North American clinical trial IT solutions market, Frost & Sullivan recognizes Oracle Health Sciences with the 2018 North American Enabling Technology Leadership Award for its new eClinical platform, Clinical One™ and the first module released on the platform, Clinical One Randomization and Supplies Management Cloud Service.
Frost & Sullivan recognizes Oracle Health Sciences with the 2018 North American Enabling Technology Leadership Award for its new eClinical platform, Clinical One™.
“The Clinical One platform provides Oracle’s life sciences customers with a modern, collaborative cloud environment that eliminates massive redundancies, thus creating process efficiencies and seamless sharing of information across functions and all stages of drug development,” said Kamaljit Behera, industry analyst, Frost & Sullivan. “The platform empowers the clinical trial industry to reengineer its operations with a digital continuity theme, thereby driving unparalleled transparency and efficiency throughout the clinical development life cycle.”
Clinical One has been built from the ground up to support all functions in the clinical development life cycle, unlike other eClinical point solutions on the market today, which only support one function or process. The platform eliminates redundancies and creates process efficiencies by leveraging Oracle’s cloud services, such as platform as a service (PaaS) and infrastructure as a service (IaaS), and introduces foundational features and common functions that are shared across all modules, requiring data to be entered only once. The resulting cost and time savings help pharmaceutical companies, biotechs and CROs bring new therapies to market faster to patients waiting in need.
Oracle Health Sciences Clinical One was built with the latest microservice architecture that offers scalability for continuously developing and deploying large, complex applications. It also provides built-in interoperability for seamless integration with existing IT systems across client operations and incorporation of mid-study changes or amendments. Furthermore, it runs on the company’s RESTful Web services and allows users to modify or view resources on the server without performing any server-side operations. On the pricing front, the cloud-based, multi-tenant system and the scalable microservices architecture make it easy to provide the Clinical One platform at an extremely competitive SaaS-based flexible pricing model, especially when compared to traditional technology licensing models.
“We are honored to be recognized for reimagining the way technology supports clinical research with Clinical One,” said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. “We believe in universal access to clinical trial data that is entered once, secured in the cloud and shared across all study team members. This evolution in eClinical technology was long overdue, and we were in the best position to make it happen. Starting with the RTSM module now, and the other modules that will follow, our customers are excited about the cost and time savings Clinical One promises to deliver.”
In 2017, Oracle Health Sciences successfully launched the Randomization and Supplies Management Cloud Service as the first capability on Clinical One. The RTSM module has a built-in, self-guided workflow for study design and randomization to empower clinical teams to design, validate, and deploy a study in days instead of weeks or months. In addition to managing patient randomization and trial supplies, the RTSM module leverages Clinical One’s foundational capabilities to monitor recruitment with real-time status reports, manage emergency treatment code breaking, and perform calculations to ensure dosing accuracy.
Each year, Frost & Sullivan presents this award to a company that has developed a pioneering technology that not only enhances current systems or workflows, but also enables the development of new digital solutions and applications. The award recognizes the high market acceptance potential of the recipient’s technology.
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 Oracle Health Sciences Oracle Health Sciences breaks down barriers and opens new pathways to unify people and processes to bring new drugs to market faster. As the number one vendor in Life Sciences (IDC, 2017), the number one provider of eClinical solutions (Everest Group, 2017) and powered by the number one data management technology in the world (Gartner, 2018), Oracle Health Sciences technology is trusted by 29 of the top 30 pharma, 10 of the top 10 biotech and 10 of the top 10 CROs for clinical trial and safety management around the globe.
About Frost & Sullivan Frost & Sullivan, the Growth Partnership Company, works in collaboration 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, we have been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community. Contact us: Start the discussion.
TAIPEI, Taiwan, June 22, 2018 /PRNewswire/ — GNT Biotech & Medicals Co., Ltd. (GNTbm, TPEx Emerging: 7427) announced that it has awarded exclusive sales and marketing rights in Taiwan of anticancer drug Chidamide to pharmaceutical distribution company Taiwan Specialty Pharma Corp. (TSPC) for two indications; hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients; and peripheral T-cell lymphoma (PTCL). The licensing agreement includes upfront and milestone payments of up to NT$30 million (approx US$1mil), with royalties from sales to be awarded separately.
GNTbm also announced that it had already begun its Phase III clinical trial for Chidamide when administered together with exemestane (Aromasin®), an aromatase inhibitor, for the treatment of late stage breast cancer after receiving approval in 2017 for the trial by the Taiwan Food and Drug Administration (TFDA). The trial in six medical centers in Taiwan is being conducted in collaboration with Chipscreen Biosciences Ltd., of Shenzhen, China, using the same clinical trial protocol as its Phase III trial for the same drug combination in China.
Chidamide, a new generation of epigenetic regulator and subtype-selective HDAC inhibitor, was originally developed by Chipscreen Biosciences in 2003. HUYA Bioscience International, LLC, of San Diego, USA, received the exclusive license from Chipscreen Biosciences to develop and commercialize Chidamide outside Greater China in 2006, while GNTbm received the rights for the drug in Taiwan from Chipscreen Biosciences in 2013. Meanwhile, in 2016 HUYA granted Eisai Co., Ltd. of Tokyo, Japan, exclusive rights to develop and commercialize the drug for cancer indications in Japan, South Korea, Thailand, Malaysia, Indonesia, the Philippines, Vietnam and Singapore. Each licensee has Chipscreen Bioscience’s authority to initiate clinical trials for new indications in their respective territories.
The first approved indication of Chidamide was the rare disease refractory/recurrent peripheral T-cell lymphoma. Chipscreen Biosciences received China FDA (CFDA) approval for treatment of this condition in China in December 2014. A successful and popular drug, Chidamide was then included in China’s Category B medical insurance list in July 2017. To date, more than 4,000 patients with PTCL have been treated with Chidamide. GNTbm is expected to submit an NDA to the TFDA for PTCL in 2019, and hopes to receive market approval sometime in 2020. The second indication for Chidamide is in combination with Aromasin for the treatment of hormone receptor-positive, HER-2 negative late stage breast cancer in post-menopausal patients. With Chipscreen Biosciences announcing the preliminary results from its recent Phase III trial for the same indication in China, this has allowed GNTbm to move forward at full speed its own clinical trial for this indication in Taiwan.
Dr. Chia-Nan (Alex) Chen, Chairman of GNTbm, stated that GNTbm had in-licensed Chidamide with the intent to invest in the development of new indications through locally-conducted clinical trials, and also intend to produce the API for this drug locally. The company will invest large sums of money and manpower to do so, he said.
“We will partner with local drug companies Formosa Laboratories and Sinphar Pharmaceutical to manufacture the API and for formulation, respectively,” said Chen.
“We are very pleased to choose Taiwan Specialty Pharma Corp. (TSPC) as our sales partner in Taiwan. TSPC has many years of experience in pharmaceutical sales and marketing, especially in treatments for rare diseases, and in particular blood cancer. GNTbm and TSPC are very optimistic about the sale of Chidamide for peripheral T-cell lymphoma and advanced breast cancer patients in Taiwan,” added Chen.
Ming-Yi (Milton) Huang, chairman of TSPC, said “TSPC has long focused on hematology, oncology, and nephrology therapeutic areas, and also on medical nutrition. In 2002, it exclusively represented Baxter’s chemotherapy and radiotherapy nutrition product Sympt-X in Taiwan and purchased the global marketing right and trademark from Baxter in 2012. We have long admired GNTbm’s dedication to drug development and look forward to representing GNTbm’s anti-cancer drug Chidamide in Taiwan and to continue to improve patients’ quality of life.”
About GNT Biotech & Medicals Corp. (GNTbm)
Taipei, Taiwan-headquartered GNT Biotech & Medicals Co., Ltd. (GNTbm, TPEx Emerging: 7427) focuses on the development of new drugs and drug delivery systems. It uses nano-gold as the core technology of its drug delivery platform, Vaucarrin®, and in the development of drugs for the treatment of cancer and rheumatoid arthritis. Through cooperation with international pharmaceutical companies, the company aims to develop Chidamide, a new generation epigenetic regulator, for the treatment of peripheral T cell lymphoma, breast cancer, and other cancers. Targeting unmet clinical needs, GNTbm develops highly active and innovative formulations of nano-drugs to meet the urgent needs of patients.
Taipei, Taiwan-headquartered Taiwan Specialty Pharma Corp. (TSPC) is a pharmaceutical sales and marketing company, specializing in the fields of hematology, oncology, nephrology and medical nutrition. Its sales team manages sales channels through hospitals, GPs and drug stores. Chairman Ming-Yi Huang has extensive industry experience, having previously headed the local offices of some of the world’s largest pharmaceutical firms, including Pfizer, GSK and Novartis.
Shenzhen, China-headquartered Chipscreen Bioscience Ltd. was established as Sino-foreign joint venture in 2001 by several Chinese returnees from the United States with academic, scientific, and industrial experience, and is an integrated biotech company specialized in discovery and development of novel small molecule pharmaceuticals. Chidamide, a new generation of epigenetic regulator and subtype-selective HDAC inhibitor, was originally developed by Chipscreen Biosciences.
Medical technology company Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) has just signed license agreements for its world-leading PromarkerD predictive test for diabetic kidney disease with USA and Mexico partners.
NEW YORK, June 22, 2018 /PRNewswire/ — PromarkerD, a simple blood test kit that uses a unique protein ‘fingerprint’ to provide early detection of the onset of diabetic kidney disease, can offer accurate testing of the more than 43 million people with diabetes in USA and Mexico — and even people with pre-diabetes.
Proteomics International Managing Director Dr Richard Lipscombe
PromarkerD is the first test able to predict the onset of diabetic kidney disease, saving lives and billions in healthcare dollars by warning of a decline in kidney function up to four years in advance.
Proteomics International Managing Director Dr Richard Lipscombe is at the American Diabetes Association 78th Scientific Sessions (June 22-26, 2018, Orlando, Florida) to discuss PromarkerD license deals.
About the USA license agreement withPrismHealthDx, Inc. (PHDx)
USA PromarkerD launch targets the world’s biggest spending country on diabetes care
World–leading predictive test can save and extend lives by avoiding diabetic kidney disease
Test to be offered to patients through a partnership with precision medicine and diagnostic services laboratory PrismHealthDx, Inc. (PHDx)
PHDx will launch the PromarkerD test nationally
Potential to save US healthcare system billions of dollars in treatment and dialysis costs
About the Mexico license agreement with Patia Biopharma
Diabetes is responsible for one in seven deaths in Mexico, killing more people than cancer
Mexico has one of the highest rates of diabetes in the world, with 13 million adults suffering from the condition
Through Patia’s network the test will initially be introduced to private hospitals and private clinics, and then expanded into government hospitals and Carlos Slim Foundation programs.
Dialysis treatment alone costs US$72,000 per person per year, according to the US Renal Data System. Diabetes accounts for 44 percent of chronic kidney disease cases in USA.
Dr Lipscombe said PromarkerD was a major weapon in the battle against the diabetes epidemic. “Regular testing and early diagnosis of diabetic kidney disease with PromarkerD can help millions of people avoid costly and invasive dialysis treatment or a kidney transplant,” he said.
For every million people living with diabetes, 10 per cent — or 100,000 people — are expected to suffer a rapid decline in kidney function within the next four years.
The PromarkerD test is able to predict this decline in kidney function in 86 per cent of cases.
This means that, for example, if every one of the 30 million Americans with diabetes took the test it would potentially identify 2.6 million of the 3 million people on the path to kidney disease. Those identified would require systematic re-testing to verify effectiveness of treatments. Another 84 million American adults — more than 1 out of 3 — have prediabetes, a precursor to diabetes,may also benefit from taking the PromarkerD test.
Dr Lipscombe said the breakthrough deal for PromarkerD in the USA and Mexico is important because it paves the way for other licensing contracts. “It is great to see PromarkerD launching in the world’s largest healthcare market as we further negotiations to commercialise the test in other countries including Japan, Australia, China and Europe.”
BASEL, Switzerland and ORLANDO, Florida, June 22, 2018 /PRNewswire/ — Today, at the American Diabetes Association’s 78th Scientific Sessions in Orlando, Florida, Ascensia Diabetes Care has revealed that UK-based Whisk have been selected as the winner of the Ascensia Diabetes Challenge, a global innovation competition that set out to find digital solutions to support type 2 diabetes management.
Whisk’s winning innovation is a Culinary Coach that uses artificial intelligence (AI) to provide personalized food recommendations based on flavor preferences and food avoidance, that will be expanded to use blood glucose data for people with diabetes. Later today, Whisk will be presenting their winning solution to the diabetes community for the first time at the 2018 DiabetesMine D-Data Exchange Event in Orlando.
The Whisk platform is an AI-powered nutrition platform that currently enables users to browse recipes based on factors including their personal taste preferences, time constraints, budgets, weather and dietary restrictions or allergies. Once a user adds a recipe to their meal plan, it can be automatically added to an online shopping cart at some of the world’s leading grocery retailers, seamlessly allowing them to buy ingredients.
As winner of the challenge, Whisk plan to create a personalized food experience for people with type 2 diabetes that will learn from their blood glucose readings and make food recommendations that are more tailored to their own diabetes. Using readings from Ascensia’s blood glucose monitoring systems, the AI will learn how the user’s blood glucose readings react to specific foods and recipes, allowing them to build a tailored meal plan for their diabetes that can help to keep their blood glucose in range. The Culinary Coach for diabetes will start by providing personalized recipe recommendations, and will in the future develop to suggest convenience foods and restaurant options.
Michael Kloss, CEO and President of Ascensia Diabetes Care, said: “Nutrition and food selection is a huge component of type 2 diabetes management. The panel of judges and I were hugely impressed by Whisk’s current tool and how they plan to develop it for people with type 2 diabetes. By helping people with type 2 diabetes find personalized and tailored meal recommendations that are based on their own blood glucose data and food preferences, we have the potential to empower millions of people with type 2 diabetes to make healthier food choices that they will enjoy.”
Whisk’s solution was selected from 116 entries that were submitted to the challenge from 25 countries and they will receive a cash prize of euro100,000 to build and pilot this exciting new service for people with type 2 diabetes, working closely with Ascensia Diabetes Care to bring it to patients.
Whisk’s core technology uses extensive food ontology known as the Food Genome™, that incorporates and understands macro and micro-nutritional data, flavor compounds, store availability, price and promotions. Whisk is currently available in the US, UK and Australia, powering half a million shopping lists every month at grocery retailers including Walmart, Tesco and Amazon Fresh.
Nick Holzherr, Whisk Founder and CEO, said: “We are absolutely delighted to have been chosen as the winner of the Ascensia Diabetes Challenge. Type 2 diabetes has reached epidemic levels in recent years, and at Whisk we are excited to be building a solution that we feel can help support these patients to make lasting lifestyle changes. We hope that through our work with Ascensia Diabetes Care, we can help to change the way this condition is managed.”
The competition also awarded two runners-up prizes. US-based Qstream were awarded a runner-up prize for their mobile learning platform that combines a concept known as spaced education with engaging game mechanics. This platform is designed to encourage meaningful behavior change and has been proven in a recent randomized trial to generate sustained and meaningful reductions in HbA1c in people with diabetes.[1] xBird, a Germany-based medical artificial intelligence software company was also named as a runner-up. Their software analyzes micro-movements, collected by smartphones and wearables, and cross references them with historical blood glucose data, with the aim of being able to predict and detect potential hypo- and hyperglycemic events. Both runners-up will receive a cash prize of €30,000 to further develop their solutions.
Walk With Path were also recognized for their highly innovative active insole for people with peripheral neuropathy due to diabetes. Their insole provides vibrational feedback during walking that can be tracked via an app and is designed to help people achieve better balance, thereby reducing the risk of falls. Ascensia will support Walk with Path to conduct a proof of concept study in patients with diabetes.
Michael added, “We are very excited to partner with such high quality digital solutions that could help revolutionize type 2 diabetes management. These winning solutions highlight the exciting times we are now entering in the world of digital health and how technological advances and digital capabilities can play a massive part in meeting an urgent area of unmet need.”
TAIPEI, Taiwan, June 22, 2018 /PRNewswire/ — PharmaEngine Inc. (TWO: 4162) and its corporate partner, Nanobiotix S.A. (Euronext: NANO) announced today that PEP503 (NBTXR3) in combination with radiotherapy met the primary endpoint of pathological Complete Response Rate (pCRR) as compared to radiotherapy alone in a global pivotal phase II/III trial in patients with locally advanced soft tissue sarcoma (STS) of the extremity and trunk wall. The pCRR on the combination arm was 16.1% as compared to 7.9% for the control arm of radiotherapy alone (p = 0.0448). Also PEP503 activated by radiation demonstrated a significant increase of R0 resection rate as compared to radiation alone (p = 0.042). PEP503 demonstrated a good local tolerance among this patient population. The findings showed a very similar radiation-related safety profile in both arms.
This prospectively randomized, multi-national, open-label and active controlled two-arm (1:1 ratio) pivotal phase II/III trial, referred to as Study 301 (act.in.sarc study) has been conducted in partnership with Nanobiotix. PharmaEngine is the co-sponsor of this study in Asia-Pacific Region. The antitumor activity and safety of PEP503 combined with radiotherapy in Study 301 was compared with that of radiotherapy alone, as preoperative treatment. The primary objective of Study 301 is to enhance pCRR by dosing PEP503 through intra-tumor injection and then activated by standard dose (25 x 2 Gy) of external beam radiation therapy (EBRT). The secondary endpoints are the objective response rate (ORR) by imaging (MRI); the tumor volume changes; the resection margins (R0 rate) and the limb amputation rate, as well as the evaluation of the safety profile in term of clinical and laboratory adverse events. The detailed data analysis, with the exception of long-term follow up will be reported in an international medical conference in the next few months.
“We are very pleased to take part in the global study alongside with Nanobiotix, and are excited that PEP503 has achieved the primary and secondary endpoints of this pivotal study in STS patients,” said C. Grace Yeh, Ph.D., President and Chief Executive Officer of PharmaEngine. “The promising results from this study validated its fundamental mechanism of action as a radio-enhancer, which is expected to be generally applicable in other cancers treated with radiotherapy. In addition, previously reported preliminary data from a small set of tumor samples in this study demonstrated that PEP503 activated by radiotherapy induces a specific adaptive immune pattern as an immune-enhancer, while radiotherapy alone did not show any impact on triggering adaptive immune response.”
About Study 301 (act.in.sarc study)
The Study 301 recruited a total of 180 patients in Europe (36 sites in 10 countries) by Nanobiotix, and in Asia-Pacific region (7 sites in Australia, Hong Kong, and Philippines) by PharmaEngine. The Global Principal Investigator is Dr. Sylvie Bonvalot, MD, PhD (Head of Sarcoma and Complex Tumor Surgery Unit, Institut Curie, Paris, France). The primary endpoint of pCRR is defined as the rate of patients showing less than 5% of residual viable cancer cells in the tumor post treatment. A centralized evaluation of the pathological response was performed. For additional information, please visit www.clinicaltrials.gov. (Identifier: NCT02379845).
AboutPEP503(NBTXR3)
PEP503, the lead project of the NanoXray pipeline of Nanobiotix, is a nanoparticle formulation of hafnium oxide crystals. It is a first-in-class product designed to destroy, when activated by radiotherapy, tumors through physical cell death and metastasis via immunogenic cell death leading to specific activation of the immune system. In August 2012, PharmaEngine licensed the development and commercialization rights of NBTXR3 in the Asia-Pacific region from Nanobiotix. In addition to STS, Nanobiotix and PharmaEngine are performing clinical trials in head & neck cancers, liver cancers (liver metastasis and hepatocellular carcinoma), rectal cancer, prostate cancer, as well as in combination with anti-PD1 antibodies in head & neck cancers and non-small cell lung cancer. PEP503 has been classified as a class III medical device in many European and certain Asian countries.
About Soft Tissue Sarcoma (STS)
STS are rare malignant tumors that arise from extraskeletal connective tissues, accounting for 0.7% of all cancers. They can occur anywhere in the body, but most originate in an extremity and the trunk (78%). The conventional treatment for STS is wide margin surgery whenever possible with the addition of radiotherapy. In locally advanced STS, however, clear margins are not often achievable, which could lead to higher local failure rates, and negatively affect overall survival. Scientific reports have demonstrated how preoperative radiotherapy can offset the negative prognostic impact of marginal resection on local outcome and survival for patients with STS, extending the limit of limb and function preservation.
Although improvements in surgical techniques and preoperative radiotherapy have been made, local tumor recurrence and distant metastases have been frequently noted to develop. PEP503 (NBTXR3), a radio-enhancer designed to maximize x-ray absorption within the tumor, aims to improve the efficacy of radiotherapy and increase the feasibility of surgical tumor removal.
About PharmaEngine, Inc. (TWO: 4162)
PharmaEngine, Inc. is a commercial stage oncology company headquartered in Taipei, Taiwan with a wholly owned subsidiary, PharmaEngine Europe Sarl in Paris, France. PharmaEngine focuses on the development of new medications for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three ongoing projects: ONIVYDE® (Irinotecan Liposome Injection) has received marketing authorizations in Taiwan, US, Europe and other countries for the treatment of metastatic pancreatic cancer patients who progressed on gemcitabine; PEP503 (NBTXR3) in a global pivotal trial of soft tissue sarcoma and in other cancers; and PEP06 in preclinical development. For further information, please visit PharmaEngine’s website at http://www.pharmaengine.com.
