Biolite will work to implement level 1 ADR in the USA * Endymed Medical enters the domestic market in the USA * Advisory committee for Compugen * Israel-Germany joint biotechnology conference * The chief scientist extended the concessions for the Mesgav and Mufet technology incubators
Important news for bone marrow transplant recipients facing VOD: a life-saving treatment on its way to approval
The European Agency for the Evaluation of Medicines (CHAMP) recommended approving DEFIBROTIDE for the treatment of VOD (severe obstructive disease of the hepatic vein), which is a life-threatening complication after bone marrow transplantation
With approval, dafibrotide will become the first life-saving drug found for this rare and life-threatening disease
The European Agency for the Evaluation of Medicines (CHMP), gave a positive opinion, and recommended the approval of the treatment of Defibrotide, for severe obstructive disease of the hepatic vein (veno-occlusive disease - VOD), which is a complication with a mortality rate of up to 50% , among adults and children who underwent stem cell transplantation.
VOD is a life-threatening disease, which is a possible complication of bone marrow transplantation. Bone marrow transplantation is currently a common treatment for hematological malignancies and other diseases in both adults and children. In preparation for a bone marrow transplant, patients receive chemotherapy treatments in high doses. The chemotherapy treatment may cause blockage of small veins in the liver and consequently cause VOD, which may lead to liver failure and may end in failure of other organs such as the kidneys and lungs (severe VOD). The overall incidence of VOD cases among bone marrow transplant recipients is 9-14% and 11-20% among bone marrow transplant children, and as mentioned has a high mortality rate. Today there is no other approved treatment for the treatment and prevention of VOD.
In Israel, about 430 bone marrow transplants are performed each year among adults and about 120 bone marrow transplants among children. To date, there has been no solution for the prevention and treatment of severe VOD, apart from treatments that have not been developed and tested specifically for the disease, and accordingly their effectiveness is relatively low and they are mainly used to treat the symptoms of the disease.
The treatment with defibrotide is based on a mechanism that suppresses the activity of the coagulation system as well as the dissolution of the clots formed as a result of the intense chemotherapy damage to the endothelial cells in the sinuses and the small blood vessels in the liver. The treatment is suitable for adults, adolescents, children and toddlers and is given directly into a vein, every 6 hours.
Now that Dafibutide has received the positive recommendation of the European Agency for the Evaluation of Medicines, the actual marketing authorization has been transferred to the examination of the European Commission (EC). With the approval, defibrotide will become the first dedicated drug for the treatment of obstructive disease of the hepatic vein.
According to Dr. Paul Richardson, RJ Corman Professor of Medicine, Harvard Medical School, and Medical Director of the Jerome Lipper Center for the Treatment of Multiple Myeloma, a physician at the Dana Farber Cancer Institute in Boston, Massachusetts (USA) And the main researcher of defibrotide: "We believe that the treatment with defibrotide will be a very important treatment option for patients who have undergone hematopoietic stem cell transplantation surgery. The drug provides a potentially life-saving treatment for severe obstructive disease of the hepatic vein, a complication in which the mortality rate is very high and for which there are no other approved treatments."
The Chief Scientist extended the concessions for the Mesgav and Mofet technology incubators
Last week it was decided in the Office of the Chief Scientist at the Ministry of Economy to extend the concessions of the Mashgav Greenhouse and the Moft Greenhouse from the Trendlines Group, until the end of 2014. Steve Rhodes, Chairman of the Trendlines Group: "Recently, various news have been published regarding the non-renewal of the licenses for the Trendlines Group's greenhouses. Today we put an end to the rumor mill and are happy to announce that the concessions have been renewed by the Office of the Chief Scientist until the end of 2014. At the same time, Trendlines will participate in the future competitive process in order to ensure the renewal of the concession for another 8 years, for the two greenhouses it owns."
About the Trendlines Group: Through the two government-licensed technology incubators that it owns, the Trendlines Group nurtures businesses and companies that work to improve and promote the living conditions of the human race. As an investment fund based in Israel, Trendlines Group owns the Mashgav Technology Incubator, which focuses on companies in the field of medical devices, and the Moft Technology Incubator, which focuses on companies in the field of agriculture. The two incubators are a home for Israeli start-up companies at the beginning of their journey.
Biolite will work to implement level 1 ADR in the USA
Biolight Life Sciences Investments announced today that the company's board of directors has decided to implement level 1 ADRs (American Depository Receipts), which will be traded as part of over-the-counter trading in the USA, subject to the completion of the necessary procedures.
Biolite intends to take proactive actions to raise awareness of the company and its research, clinical and business activities in the American capital market. The company estimates that the implementation of ADR in the USA, along with the continued implementation of the work plan, will lead to an increase in the level of interest and awareness in the company and the technologies it is developing among strategic investors, specialized investment funds and the American capital market. Biolite clarifies that the application does not include raising capital in the initial phase and its main purpose is as stated above.
As the procedure progresses, the company will report on the structure of the ADR, the schedules and other details as required.
Susanna Nahum Zilberberg, CEO of Biolight: "We have decided to promote the implementation of ADR at the first level (level 1) in the USA, which will allow Biolight to reveal its unique management model and the leading technologies it is developing, to a wide spectrum of American and international investors.
Endymed Medical enters the US domestic market:
Endimed Medical received FDA approval for marketing the new home product for reducing wrinkles and firming the skin. The home product also recently received sales approval in Canada and Europe
The Newa product applies Endymed's unique technology, the 3DEEP, in a tiny device designed to reduce wrinkles and rejuvenate the facial skin
Uzi Blumenzon, CEO of Endymed Medical: "We are proud to be the first to win FDA approval for a device with RF technology for home treatment for the indications of reducing wrinkles and firming the skin. The approval is a competitive advantage for Endimed, and we will now work to exhaust the business potential inherent in it."
First US patent for Excelanase in the field of the liver: the patent protects a method for improving the accuracy of breath tests in the field of the liver
Excellanz received the approval of the US Patent and Trademark Office to register the first patent in the US in the field of liver. The obtained patent protects tests and materials for breathing tests and monitoring patients with acute and chronic liver diseases. The patent refers to the technology and algorithms developed by Ecclesense to improve the accuracy of tests of liver function and the assessment of portal venous pressure, both of which are the main uses in the field of liver tests to which the company addresses. Excellanz also reports that an application has been submitted for a continuation patent to expand the coverage in other aspects.
An extensive market survey carried out by Excelanz found that there is a clear need for a simple, fast and non-invasive test to measure the portal venous pressure, which is the source of the central blood supply to the liver. High portal blood pressure occurs in the advanced stage of chronic liver diseases. Quantitative measurement of the level of high venous blood pressure (HVPG) can be used as an effective tool in the management of chronic liver diseases.
Excellanz is in talks with the FDA to consider conducting experiments required for the approval of the HVPG test using the BreathID technology as a diagnostic and follow-up tool for liver cirrhosis patients.
The CEO of Excellanz Business Sciences, Lawrence (Larry) Cohen, said that "We are happy to register the first commercial patent in the USA for Excellanz in the liver field. This patent will support the further strengthening and expansion of our activity also in the field of the liver. In our estimation, and as already proven in several first clinical trials, the BreathID technology has important therapeutic potential in the field of liver diseases, and we are examining ways to implement the development plan and the business plan to leverage the advantages of the system we developed and its achievements also in the field of liver disease diagnosis and management. Receiving the patent in the USA in the field of the liver is further evidence of the technological innovation and the unique knowledge we have developed".
Excellanz announced about a month ago the commercial launch of the BreathID Hp system, which is the next generation of the company's Breath ID technology, the system recently received the approval of the American Food and Drug Administration FDA for its marketing in the USA for the field of diagnosing the presence of the bacteria H pylori. The new system allows non-invasive diagnosis and management of the H bacterium. pylori with the most advanced, accurate, specific and fastest technology. The system is sold in the USA by the new sales organization that the company recently established.
Compugen: Establishing a scientific advisory committee to guide the development of its drug pipeline
Compugen announced today the establishment of a Scientific Advisory Board (SAB) that will provide advice and guidance regarding the company's activities in the fields of immunology and oncology, including the pipeline of therapeutic proteins and antibodies that are in early stages of development. The members of the SAB are four well-known scientists and clinicians in the fields of oncology and immunology: Dr. Charles G. Drake, professor of oncology, immunology and urology at the Kimmel Cancer Center at Johns Hopkins; Prof. Ian B. McInnes Director of the Institute of Infectious Diseases, Immunization and Inflammation at the University of Glasgow; Dr. Howard R. Sol, Vice President and Chief Scientist of the Prostate Cancer Foundation; and Prof. Anthony Reeves, from the Department of Medicine, Hematology and Oncology at the University of California, Los Angeles.
Dr. Anat Cohen-Deig, President and CEO of Compugen, said, "We are extremely happy to welcome this prestigious group of scientists to our scientific advisory committee for oncology and immunology, two main focus areas of Compugen where there is a significant unmet medical need He still has an answer. We greatly appreciate the enthusiasm and willingness of the scientists to cooperate with us as SAB members, and see this as evidence of our growing presence in these important medical fields."
Dr. Cohen-Deig added, "We recently announced the signing of our first agreement for products identified as part of the company's drug discovery program, based on the company's unique computational discovery infrastructure. In this particular program, we focused on proteins that regulate the activity of the immune system (immune checkpoints), and the agreement signed with Bayer deals with the development and commercialization of antibodies that will be directed against two new oncological targets for immunotherapy in cancer."
Dr. Cohen-Deig concluded, "We are confident that the knowledge and experience of the company's new scientific advisory committee, which includes global experts in the field of proteins that regulate the immune system, are valuable assets and will greatly contribute to the continued development and commercialization of our potential drugs, to future discovery programs, and to improving Our computational infrastructures with the help of deeper insights into the science behind them."
Dr. Drake specializes in cancer immunotherapy, with a focus on proteins that regulate the immune system (immune checkpoints) and vaccines against cancer. Dr. Drake has extensive experience in conducting clinical studies testing these treatments. He is co-director of the Multidisciplinary Prostate Cancer Clinic at the Kimmel Cancer Center at Johns Hopkins, Baltimore, Maryland, and is an associate professor of oncology, immunology, and urology. Dr. Drake is also a member of the Prostate Cancer Foundation's Scientific Advisory Committee. Dr. Drake received his PhD in immunology from the National Jewish Center for Immunology, and his MD from the University of Colorado Health Sciences Center in Denver.
Prof. Ian B. McInnes deals with the biology of synovitis in rheumatoid arthritis, psoriatic arthritis, and infectious arthritis. He holds the Muirhead Chair of Medicine, and serves as the Director of the Institute of Infectious Diseases, Immunization and Inflammation at the University of Glasgow. He oversees an applied science program and is active in a clinical trials center testing new biologic drugs for arthritis. He served as the principal investigator of many clinical drug development trials. Prof. McInnes studied medicine at the University of Glasgow, and did his PhD and postdoctoral studies at the National Institutes of Health (NIH) in Bethesda, Maryland.
Prof. Antony Reeves holds positions in hematology/oncology and oncological surgery at the University of California, Los Angeles (UCLA). He conducts basic and clinical research on new strategies for cancer immunotherapy, and in particular for malignant melanoma. He served as the principal investigator of clinical studies for drug development. He is the Director of the Cancer Immunology Program at the Johnson Comprehensive Cancer Center (JCCC) and is the Chair of the Melanoma Committee at SWOG (Southwestern Oncology Group). Prof. Reeves is also a member of the committees of the National Cancer Institute (NCI) for examining proposals for research grants and a member of the American Society for Clinical Investigation (ASCI). Prof. Reeves studied medicine at the University of Barcelona, Spain, and did his postdoctoral fellowship at the Sidney Kimmel Cancer Center in San Diego and at UCLA.
Dr. Howard Saul is one of the leaders in the world in the discovery and development of new drugs for prostate cancer. Dr. Saul serves as the Vice President and Chief Scientist of the Prostate Cancer Foundation, and a Senior Fellow at the Milken Institute. He coordinates global research activities of the academic, governmental and biopharmaceutical sectors and is responsible for implementing the global research strategies of the Prostate Cancer Society. He received his PhD from Baylor College of Medicine in the field of virology and epidemiology, and he did his postdoctoral fellowship in immunology and vascular biology at the Scripps Research Institute. Dr. Saul has rich experience in research and development and business development in the biopharmaceutical and diagnostic industry.
Joint investments in Biomed Germany-Israel
For the first time, the governmental Ministry of Economy and Technology in Germany initiates the establishment of a body called Health - Made in Germany, which will be operated by the economic development agency in Germany, Germany Trade & Invest (GTAI), will promote collaborations and invest directly in the bio-medtech industry in Israel.
This initiative will be presented by Health made in Germany representatives at the Life Sciences Israel TM business development conference which will be held in Tel Aviv on October 16-17, 2013.
The conference initiated by Sigal Weisswasser, owner of TBN Group, which deals in international trade in life sciences, is based on one-on-one meetings of companies and investors from the field of pharma, biotechnology and medtech from Israel and the world, with strategic partners and leading decision makers in the field for the purpose of business development, Promoting collaborations and business opportunities.
The Health - Made in Germany program is headed by Dr. Mandri Tilo (Doctor of Law and expert in medical and pharmaceutical law and chairman of the German-Israeli Committee for Life Sciences), Dr. Tilo is the representative of the Government Ministry of Economics and Technology in Germany which, together with the Agency for Economic Development in Germany (GTAI), enjoy a close system of relationships with organizations that represent the health industry in over 50 countries in the world. The new body decided to promote and invest in Israeli companies from the field of life sciences, with the emphasis being placed on the field of biotech.
Israel, which is considered one of the leading countries in the world in the field of innovation, research and development in the biopharma and medtech industry, is an important strategic partner for Germany, which represents the largest market in Europe, and one of the strongest markets in the world in the field of life sciences and medicine.
In fact, Israel is the only country in the world with which Germany promotes a unique research and development project with start-ups, universities, incubators, hospitals and more.
The purpose of the establishment of Health - Made in Germany is the existence of various interfaces for cooperation which will allow practitioners in the fields of life sciences in both countries to find opportunities for the development of joint technological innovation and spending, business entrepreneurship, joint research, development and marketing, in the field of medtech but especially in the field of biopharma.
Among the companies participating in the conference from the field of medtech and biopharma: Medtronic Devices, Bayer Pharma EU, Hoffman - Roche Asia, Teva, BD USA, GCP China, Merck, Swiss Medtech, MLM Labs, Boehringer Ingelheim Pharma AG, Rambam Medical Center, Actellion, MSD Europe, Sanofi, ABF Pharmaceuticals, EuroMedChina, BioNegev, BiolineRX, Peakfactor, Petron Dental, Assign Group and more companies, organizations, incubators, TTo's (technology transfer offices)..
