Merck and three partners start ExploreBio, a € 20 million pre-seed investment initiative in Israel

03

Merck has announced ExploreBio, a pre-seed-investment vehicle by four investment funds targeted at early-stage companies in the biotechnology landscape in Israel. For this purpose the strategic corporate venture capital arm of Merck has partnered with Arkin Holdings, Pontifax and WuXi AppTec to create the € 20 million pre-seed investment vehicle.

“Israel’s start-up spirit is unique and so inspiring. We are proud to be an active part of this great success story. Now we are taking a next important investment step as we believe in the innovative potential of ExploreBio,” said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany.

ExploreBio is an initiative comprising pre-seed investments and management services for proof-of-concept-experiments in biotechnology. Additionally, companies benefiting from the ExploreBio initiative will be given the opportunity to work at the BioIncubator facilities of Merck KGaA, Darmstadt, Germany, in Yavne, Israel. Interested parties should submit their investment proposal here.

The commitment involves a total volume of € 20 million for five years. ExploreBio aims to invest € 1 million to € 1.5 million per company across up to four investments per year over a period of five years. The early-stage companies would benefit from quick access to funding and easy access to follow-up capital.

The four investors have worked together on investments in different companies in the past, such as Metabomed (targeted cancer therapy) and Artsavit (using apoptosis-induction to treat cancer).

With the new ExploreBio initiative, Merck and its three partners aim to engage with start-up companies in which it would otherwise be too early to invest. A second advantage for the four partners is being able to leverage the consortium’s resources and their strong relationships to work with the investments more closely and effectively.

ExploreBio complements the activities of Merck in helping early-stage companies in Israel to mature. The company set up PMatX last year and has been running its BioIncubator in Yavne since 2011.

PMatX addresses the topic of next-generation electronics and is a joint endeavor with Flex, San Jose, California, USA, and also backed by additional industry partners including HP, Palo Alto, California, USA, and the U.S.- based global investment firm Battery Ventures. PMAtX is supported by the Technology Innovation Lab program of the Israel Innovation Authority (IIA). The overall investment volume of the program involving all parties is around € 20 million and the initial commitment is for three years.

The site of Merck in Yavne houses the company’s Healthcare and Life Science incubator called BioIncubator. This successful undertaking was started in 2011 and has committed to invest up to € 10 million until 2018 in biomedically focused start-up companies in Israel.

Merck employs more than 300 people in Israel, mainly scientists, and has sites in Yavne, Herziliya, Rehovot, and Jerusalem. All three of itsbusiness sectors, Healthcare, Life Science and Performance Materials, have R&D sites in Israel.

The company also announces today that the Israel Patent Office as well as the Korean Intellectual Property Office have each issued notices granting patent applications of Merck KGaA, Darmstadt, Germany, for its CRISPR technology used in a genomic-integration method for eukaryotic cells. These decisions mark the fifth and sixth patent allowances for the unique CRISPR technology of Merck KGaA, Darmstadt, Germany, following Singapore, Australia, the European Union, and Canada. Merck KGaA, Darmstadt, Germany, also has patent filings for its insertion CRISPR method in the United States, Brazil, China, India, and Japan.

The future is now – Pharmapack Europe 2018 to showcase evolution and revolution in packaging and drug delivery

800-600_pharmapack

Pharmapack Europe 2018, Europe’s dedicated pharmaceutical packaging and drug delivery conference and exhibition, takes place on 7 & 8 February at Paris Expo Porte de Versailles, Paris. The packed event programme includes key note speeches from leading industry figures, a symposium, educational workshops, and a learning lab that will explore regulatory changes and impacts, challenges in packaging & devices development: biologics, materials, sustainability and quality consistency, and how new patient-centric innovations in drug delivery will revolutionise lives and improve treatment adherence. Furthermore, new for Pharmapack Europe 2018 is the Start-up Pitch, a unique opportunity for companies at an early stage or pre-commercialisation phase to present their idea in front of industry experts.

Pharmapack Europe is an essential event for industry insights and the latest industry innovations that are reimagining the capabilities of pharmaceutical packaging and drug delivery. One area that provides opportunities and challenges is biologics, a growth area for the pharmaceutical industry both now and in the future with biologics representing 70% of drugs currently in development. Pharmapack Europe 2018 will include keynote presentations on the key factors for successful collaboration on pharmaceutical packaging development for biologics, speeches on integrated approaches towards the design of drug delivery platforms for biologics, and case studies assessing delivery options for injectable biologics. In addition, patient-centric considerations provide new avenues of innovation in drug delivery solutions. Sessions will be dedicated to innovations in packaging that improve patients’ lives, identifying new areas of opportunity in designing the future of drug delivery packaging, and practical solutions to help stakeholders innovate in this area.

The 2018 Start-up Hub will showcase young companies as being amongst the most innovative in the industry. Companies in the Start-up Hub will benefit from increased access to potential customers, partners and investors at Pharmapack Europe 2018 from which to forge new and lasting relationships. New for 2018 is the Start-up Pitch, offering non-commercialised companies the opportunity to present in front of a start-up panel of experts and an audience of industry professionals. The Start-up Hub and Start-up Pitch are organised in collaboration with Early Metrics, the pan-European rating agency for start-ups and innovative SMEs, assessing the potential growth of early stage ventures by analysing a company’s non-financial metrics.

Register now for free! : https://registration.n200.com/survey/3l2lujn6zr6dx?actioncode=PAR1241

Sandoz announces exclusive global collaboration with Biocon on next-generation biosimilars

800-600_novartis_sandoz

Sandoz, a Novartis division has announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.

Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products, and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU, while Biocon will lead commercialization in Rest of the World.

“Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future,” said Richard Francis, CEO, Sandoz. “Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics.”

“Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization,” said Carol Lynch, Global Head, Biopharmaceuticals, Sandoz. “This collaboration further strengthens our ability to deliver next-generation biosimilar medicines to patients.”

Sandoz is committed to increasing patient access to high-quality biosimilars. We are the global leader in biosimilars, with five biosimilars currently marketed worldwide, as well as a leading global pipeline. Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.

As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from ‘lab to market’. The collaboration with Sandoz builds upon Biocon’s successful progress in its existing global biosimilars program. An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, trastuzumab and bevacizumab biosimilars in India and rh-insulin, insulin glargine and biosimilar trastuzumab in a few emerging markets; and it was the first Indian company to have a biosimilar approved by the US Food and Drug Administration.

Roche and GE enter partnership to develop integrated digital diagnostics platform to improve oncology and critical care treatment

800-600_roche

Roche has announced a strategic, long-term partnership with GE Healthcare in order to jointly develop and co-market digital clinical decision support solutions. The partnership will initially focus on products that accelerate and improve individualised treatment options for cancer and critical care patients.

The two companies aim to develop an industry-first digital platform, using advanced analytics to provide workflow solutions and apps that support clinical decisions. This will allow the seamless integration and analysis of in-vivo and in-vitro data, patient records, medical best practice, real time monitoring and the latest research outcomes. Clinicians will then have the comprehensive decision support for providing the right treatment and quality of care for their patients.

For example, oncology care teams with multiple specialists will have a comprehensive data dashboard to review, collaborate and align on treatment decisions for cancer patients at each stage of their disease. In the critical care setting, data from a patient’s hospital monitoring equipment will be integrated with their biomarker, genomic and sequencing data, helping physicians to identify, or even predict severe complications before they strike.

“This unique partnership will deliver innovative solutions and insights in clinical decision-making. Our goal is to support clinicians and other relevant stakeholders for the benefit of patients by providing the right decision support at the right time and through comprehensive digital offerings,” said Roland Diggelmann, CEO Roche Diagnostics.

Roche Diagnostics is the global leader in in-vitro diagnostics, and GE Healthcare is a worldwide leader in medical imaging equipment. “This is the first time that two major players in healthcare have combined digital, in-vivo and in-vitro diagnostics to this degree. We believe this alliance will help accelerate the delivery of data-driven precision health for customers, patients and the healthcare industry,” said Kieran Murphy, President & CEO of GE Healthcare.

Pre-diabetes discovery marks step towards precision medicine

actu-02

Researchers from the University of Sydney’s Charles Perkins Centre have identified three specific molecules that accurately indicate insulin resistance, or pre-diabetes – a major predictor of metabolic syndrome, the collection of medical conditions that include abdominal obesity, high blood pressure and high blood sugar levels.

The finding, from a study undertaken in mice, could make earlier detection of pre-diabetes in humans much easier for doctors and allow for more personalised and effective treatments for patients in the future.

Researchers combined the high-tech mathematical approach of machine learning with omics technology that examines the various types of molecules that make up the cells of an organism to successfully identify specific molecules in mice. That information was used to classify the mice according to what kind of food they eat, their genetic origin and their whole-body insulin sensitivity.

Published in the Journal of Biological Chemistry, the research was conducted with the Garvan Institute of Medical Research, Duke University (USA) and the University of Melbourne.

 

Technology key to uncovering factors that contribute to pre-diabetes

Co-lead author Dr Jacqueline Stöckli, a research fellow with the University’s Charles Perkins Centre and School of Life and Environmental Sciences, said the study suggested there are likely multiple factors that contribute to pre-diabetes and this is why more traditional approaches have failed to identify similar highly predictive signatures or indicators of disease.

“Our study identified a three molecule signature that was able to diagnose insulin resistance or pre-diabetes, a condition that is often associated with diabetes, obesity and high blood pressure,” she said.

“But we know the story is much more complicated; strikingly, each of the three molecules on their own was considerably less predictive of pre-diabetes than when combined.

“The next step is to further exploit these technologies to uncover the full suite of pathways and factors that contribute to pre-diabetes – which will include genetic, environmental and possibly epigenetic influences – at a population level.”

 

Customised treatments for pre-diabetes patients step closer

The study represented a segue into precision medicine for humans, said senior author Professor David James, Leonard P. Ullmann Chair of Metabolic Systems Biology at the Charles Perkins Centre.

Precision medicine classifies individuals according to their susceptibility or response to a particular disease, and tailors healthcare treatments and practices accordingly.

“Once we can identify the molecules and other factors that contribute to pre-diabetes, we can customise treatments to suit patients’ specific make up and needs,” Professor James said.

“This study demonstrates the power of combining technologies to solve some of the world’s biggest problems,” he added.

“The burden of the ‘lifestyle diseases’ the Charles Perkins Centre is dedicated to easing – which include obesity, diabetes and cardiovascular disease – stubbornly remain at high levels globally; we need to innovate in order to tackle these conditions effectively.”

Using Social Media Big Data to Combat Prescription Drug Crisis

actu-01

Researchers at Dartmouth, Stanford University, and IBM Research, conducted a critical review of existing literature to determine whether social media big data can be used to understand communication and behavioral patterns related to prescription drug abuse. Their study found that with proper research methods and attention to privacy and ethical issues, social media big data can reveal important information concerning drug abuse, such as user-reported side effects, drug cravings, emotional states, and risky behaviors.

Their work, “Scaling Up Prescription Drug Abuse and Addiction Research Through Social Media Big Data,” is reported in the Journal of Medical Internet Research.

Prescription drug addiction is a well-known nationwide problem. Many people who are unable to get help for their addiction seek out peer support groups on Facebook or other social media platforms to share stories about their experiences and also provide social peer-based support.

Lead author, Sunny Jung Kim, PhD, an e-health communication scholar in the departments of biomedical data science and psychiatry at Dartmouth’s Geisel School of Medicine, says that because we are prolific consumers of social media, which is not limited to geography—globally, people spend more than two hours every day on social media platforms generating vast amounts of big data about our personal communications and activities—we can use these platforms to enhance public health communication strategies to help people on a large scale.

“Harnessing social media platforms and data can provide insight into important novel discoveries of collective public health risk behavior, a better understanding of peoples’ struggles with addiction, and their process of recovery,” Kim says. “I started this project because there were few studies about why people use social networking sites to share unsolicited, highly personal information about their drug use, nor about the psychological effects or consequences of this type of user-generated communication.”

Co-author Jeffrey Hancock, PhD, a professor in the department of communication and the director of computational social science at Stanford University, says, “Given the importance of this problem for the U.S. population, it’s imperative that we understand how social media is playing a role and how it can be part of the solution.”

Based on their findings, the researchers designed an evidence-based, multi-level framework to inform future social media-based substance use prevention and recovery intervention programs.

“Our review and typology suggests that social media big data and platforms can be a tremendous resource for monitoring and intervening on behalf of people with drug addiction and abuse problems,” Kim says.

Russian biotechnology company BIOCAD prepares to enters the European market

biocard

The largest Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines. So far, there are seven molecules in the European portfolio of BIOCAD. This are innovative and biosimilar products, which could be used in treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.

“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time, “says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.

Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at CphI exhibition.

“As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs – docetaxel, paclitaxel, pemetrexed and irinotecan – will also enter the European countries.

BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

novartis

Novartis has announced, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® , a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT® and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

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

News 2

Merck 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 KGaA, Darmstadt, Germany’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 Belén Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. “Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany’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.

OncoQR ML’s Vaccine Platform closes the Final Gap in the Immunological Attack against Cancer

T-cells attacking cancer cell  illustration of  microscopic photos

OncoQR ML GmbH has announced that even a single therapeutic vaccine based on its proprietary S-TIR™ platform technology, is able to induce the killing of tumor target expressing cells by simultaneously activating all possible immunological pathways (humoral and cellular).

Scientific Breakthrough

By showing this, the Austrian Biotech is the first company* to succeed in controlling all the relevant immune checkpoints that prevent the immune system from attacking and defeating cancer.

Whereas current passive checkpoint specific immunotherapy lacks tumor cell specificity with the risk of massive autoimmune reactions, this new active therapy is totally tumor target specific.

Geert Mudde, PhD, inventor of the S-TIR™ technology and OncoQR’s Chief Scientific Officer, said, “We are proud and excited to have finally demonstrated the ability to activate and use the full potential of the patient’s own immune system to eradicate cancer. Previously, we had already shown all forms of antibody mediated tumor killing – now we have the definite proof that our S-TIR™ vaccines are able to simultaneously induce and activate tumor specific T Cell killing as well. With our approach, the tumor has no more chance to escape the immune system – it is attacked from all possible sides at the same time.”

Economical Aspects

Christof Langer, Chief Executive Officer of OncoQR ML, said: “These spectacular results confirm the viability and huge potential of our proprietary S-TIR™ platform. Besides constituting a significant milestone in the development of our immunotherapy platform technology, to our knowledge, no other anti-cancer drug has shown comparable results so far. The new data are not only spectacular from a scientific point of view: The S-TIR technology will also break the trend that new cancer therapies have to be unethically expensive. Our therapeutic vaccines are designed to have low cost of goods which is paired with a personalized low treatment frequency at low treatment dose. Drugs based on our technology can be used as monotherapy but can also be combined with existing therapies (like chemotherapy). Therefore, all in all, groundbreaking news for patients, and healthcare organizations, but of course also for us and our future partners.”