Teva announced initial positive data in the trial of a drug for involuntary movements * Biondvax received approval for the continuation of the trial from the FDA * Redhill Biopharma reports success in the trial for the treatment of H. pylori infection * Diagnostir signed a cooperation agreement with the American Ora on a product for the diagnosis of dry eye syndrome
Pluristem won a grant of NIS 11 million from the chief scientist to continue developing its products
The Israeli biomedicine company Pluristem, which develops medical products based on stem cells extracted from the placenta, reported that it won a grant of 11.1 million shekels (about 2.9 million dollars) from the Chief Scientist at the Ministry of Economy in Israel. The grant is intended to support the company's research and development activities for 2015.
Zami Aberman, chairman and CEO of Pluristem, said upon receiving the grant: "We are very happy to have received the Chief Scientist's grant, which will support our innovative developments for the various uses of PLX cells and help finance the clinical trials in different geographic areas. This grant of the chief scientist is intended for the promotion of research and development in the fields of high-tech and biotech in Israel. Israel is emerging as a global center for the development of breakthrough technologies and the chief scientist's grant program is very important for supporting the industry. Pluristem is very proud to be among the leading Israeli companies in the field of life sciences."
According to the conditions of the chief scientist for receiving the grant, Pluristem is required to pay royalties at a rate of 3%-4% of sales of products and services that will be created as a result of technological development made with the help of the current grant and previous grants that the company received from the chief scientist, until 100% of the total money received in the grant is returned (plus the difference interest). In the event that there are no sales, there will be no demand to return the funds.
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The Israeli Batam won the first contract for a solution for dealing with biological waste
A first order was received, from one of the world's largest manufacturers of animal vaccines, in the amount of 320 thousand dollars, which is expected to increase to 1.2 million dollars
The Batam Group, a provider of real-time technologies, former telecom and medical equipment suppliers for laboratories and hospitals, announced that the medical waste sterilization unit from Batam's medical equipment division won its first significant contract, from one of the largest animal vaccine manufacturers in the world, for an advanced system it developed for waste treatment medical for the biopharma industry. The project is expected to have a total scope of about 1.2 million dollars, will be delivered during the years 2015 and 2016.
In the vaccine production process, all waste materials are required to be treated as contaminated medical waste due to the use of live viruses in the production process, as a result, a high volume of waste is generated compared to other industries. The company's management believes that this is the first time a solution has been developed that makes the process of disposing of polluting medical waste automatic and safe. Using the solutions available on the market, the polluting medical waste is handled manually at the production site, as well as during transport and then, again, at the landfill site. Batam's solution will allow the customer to treat waste on site, thereby reducing the risk of further contamination.
In the first phase, the company will receive $320 for installing the system at a production site in Europe this year. Batam anticipates that following the installation, additional orders will be received, in the amount of approximately 880 thousand dollars, for the installation of units at the customer's production sites in Europe and the USA during 2015 and 2016.
Dr. Zvi Marom, CEO of Batam: "We are very happy about winning the new contract, which is a significant first order for our new system for a solution in the treatment of medical waste in the biopharma industry. The new solution has the best cost-effectiveness and efficiency ratio for the treatment of contaminated medical waste today. In light of this, we anticipate increasing demand for the system, and continue to develop and provide the most advanced solutions for the treatment of medical waste in the bio-pharma and agriculture industries, to establish our position in the medical industry."
Teva announced preliminary positive data in a drug trial for involuntary movements
Teva Pharmaceutical Industries announced positive primary results in the main clinical study Aim to Reduce Movements in Tardive Dyskinesia - ARM-TD (treatment to reduce involuntary movement resulting from tardive dyskinesia) designed to evaluate the effectiveness of SD-809 (deutetrabenazine) for the treatment of moderate to severe tardive dyskinesia . The main data showed that the study achieved the main outcome objective and showed a positive trend in all secondary objectives. Importantly, the study also demonstrated a favorable safety and tolerability profile, including low rates of depression, somnolence, insomnia, and ectasia (physical restlessness).
Tardive dyskinesia, a disease for which there are no approved treatments in the US, is a hyperkinetic movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, center of the body and limbs. The disease, which often impairs function, affects approximately 500,000 people in the United States, and results from the use of common medications for the treatment of psychiatric problems such as schizophrenia and bipolar disorder, and certain medications used to treat various disorders of the digestive system.
"We are very pleased with the data received regarding SD-809 for the treatment of another condition where there are people with a great therapeutic need," said Dr. Pratik Shah, President and CEO of Auspex Pharmaceuticals. "We have great confidence in the potential of SD-809 to become the first therapeutic choice for tardive dyskinesia and other severe movement disorders that impair functional ability."
Biondvax received approval to continue the trial from the FDA
Biondvax Pharmaceuticals, which develops a universal flu vaccine, announced that it had received approval for the IND (Investigational New Drug Application) submitted to the US Food and Drug Administration, the FDA, and the company received 'approval to continue the trial' from its regulatory advisors. The receipt of the IND by the FDA constitutes approval for the distribution and provision of medical products in the US that have not yet been approved for commercial use, for the purpose of conducting clinical trials.
This IND is a continuation of the company's clinical program and will allow it to conduct a phase 2 trial with the M-001 product, under FDA control.
Dr. Ron Babkov, CEO of Biondvax: "The FDA's approval to start a clinical trial is a significant milestone for Biondvax as well as an important step in the progress of our development plan for the universal flu vaccine."
Dr. Tami Ben Yedidiya, Biondwax's chief scientist: "Influenza is a global problem - it spreads quickly and leads to severe morbidity, a disease that can directly or indirectly lead to death, especially among the elderly population. The vaccines given today are far from effective - they only protect against the strains represented in the vaccine, but a mismatch between these strains and the strains existing in the population leads to their low effectiveness. We believe that our solution, which is a single vaccine that protects against all types of influenza, will save the lives and ease the suffering of many millions of people around the world every year."
Redhill Biopharma reports success in the primary goal of the trial to treat H. pylori infection
The Israeli biopharmaceutical company Redhill Biopharma, which focuses on small molecule oral drugs, protected by patent, in advanced stages of clinical development, for the treatment of inflammatory diseases and diseases related to the digestive tract, including cancer of the digestive tract, today announced positive initial results in a phase III trial with RHB-105 For the treatment of H. pylori infection. The initial results from the experiment showed an efficiency of 89.4% in killing the H bacteria. pylori using RHB-105.
According to the company, the first phase III trial with RHB-105 successfully met its main goal - showing superior effectiveness in eradicating the H. pylori bacterium in treatment with RHB-105 over known historical effectiveness levels of approximately 70% in treatments currently accepted, and this with significance statistically high (p<0.001). No serious side effects or new or unexpected safety issues were noted during the trial.
Dr. Ira Kalfus, MD, Redhill's Chief Medical Officer, added: "Based on the clear success of the Phase III trial, and the accelerated development status granted to RHB-105, we look forward to meeting with
The FDA in order to discuss the clinical and regulatory pathway required to obtain approval to market the drug in the US. No new or unexpected safety issues were identified in the trial and the efficacy and safety data from the trial will be submitted for presentation at an upcoming medical conference."
Diagnostir from the Biolite Group signed a cooperation agreement with the American Ora to promote the development and commercialization of the product for the diagnosis of dry eye syndrome
The Biolight company, which invests in technologies in the field of life sciences, through the creation of clusters of companies around a defined medical condition, announced that its subsidiary Diagnostir has signed a cooperation agreement in the US to promote the development and commercialization of the company's product for diagnosing dry eye syndrome, which includes a license deal for exclusive use of the product in global clinical studies for a fee. Biolite and Diagnostir estimate that this collaboration will contribute significantly to the development of the product and the reduction of development costs, to obtaining regulatory approvals and to the creation of additional strategic collaborations in the future.
Diagnostir, which is engaged in the development of a product designed to perform a diagnosis, adjust treatment and monitor the treatment of dry eye syndrome by examining the composition of the tear fluid, entered into a cooperation agreement with the American company Ora, which is one of the world's leading companies in the field of clinical research management (CRO) and product development in the field of eyes .
As part of the agreement, Ora received a license from Diagnostir that grants it exclusivity to use Diagnostir's diagnostic product as part of services provided by Ora as a CRO to pharmaceutical companies around the world, which develop products in the field of treating eye diseases, in exchange for payment of about half of the consideration that Ora will receive for this service from those pharmaceutical companies. It was also determined that the Ora company will work to promote additional commercialization transactions for Diagnostir and will be entitled to the payment of single-digit royalties for transactions using the product.
In accordance with the provisions of the cooperation agreement, Ora undertook to participate in the financing of the clinical trials that Diagnostir will perform and in the financing of expenses related to obtaining regulatory approvals for the marketing of the product in the USA. Ora will even provide Diagnostir with clinical and regulatory consulting services by its people who are considered world experts in the field of eyes.
Susanna Nahum-Zilberberg, CEO of Biolite: "We are very proud and happy that Ora has chosen to team up with Diagnostir in a strategic collaboration. Ora, is a world leader in the field of eye research and as the one who conducted the first clinical trial for us, is intimately familiar with the trial findings and the business potential of the product."
