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Company News: Curetis Enters into Distribution Agreement to Expand Commercial Activities into Greater China
– Exclusive Unyvero distribution agreement with Beijing Clear Biotech Co., Ltd. for Mainland China, Hong Kong and Taiwan
– Clinical trials for CFDA regulatory approval in preparation
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that it has signed an exclusive distribution agreement (the “Agreement”) for China, Hong Kong and Taiwan (collectively “Greater China”) with Beijing Clear Biotech Co. Ltd. The Agreement, effective from September 25, 2015, comprises the Unyvero Systems and P55 and i60 ITI Application Cartridges. Based in Beijing and founded in 2001, Beijing Clear Biotech is an experienced and prominent distributor of prime medical technology brands throughout Greater China. In the in vitro diagnostics market, Beijing Clear Biotech focuses on the distribution of point-of-care diagnostics, in particular European products and PCR devices.
Under the terms of the Agreement, Beijing Clear Biotech will conduct and fully fund all prospective multi-center clinical trials required for approval of the Unyvero System and its P55 and i60 ITI Application Cartridges by the China Food and Drug Administration (“CFDA”), including funding the systems and application cartridges required for the trials. Beijing Clear Biotech’s responsibilities also include leading the registration and approval process, inclusive of paying all fees, on behalf of Curetis. The anticipated CFDA license will be owned by Curetis. Curetis will pay Beijing Clear Biotech certain milestone payments upon clinical trial initiation and CFDA approval, respectively, and grant a commercial exclusivity for distribution in China, Hong Kong and Taiwan. Under the terms of the Agreement, Beijing Clear Biotech has agreed to certain minimum purchase numbers of Unyvero Systems as well as P55 and i60 ITI Application Cartridges per year.
Upon CFDA approval, Curetis will support commercialization through Chinese-language marketing materials and regular product training for the distributor’s sales force. Beijing Clear Biotech will be responsible for managing all local marketing and sales activities as well as handling storage and logistics support. Marketing in Taiwan will start earlier than in China and Hong Kong, as specific trials are not required for product registration there.
For the commercialization of the Unyvero i60 implant and tissue infection (“ITI”) Application Cartridge, Beijing Clear Biotech will partner with LandMover Medical Technologies Co. Ltd. (Beijing, China), the exclusive Chinese distributor of Heraeus Medical, one of the leading companies in the field of bone cement and biomaterials for elective orthopedic and trauma surgery. The i60 ITI Application Cartridge was co-developed by Curetis with Heraeus Medical to improve the management of patients with implant and tissue infections, including prosthetic joint and other orthopedic infections, to support an early and informed decision on the choice of antibiotic-supplemented bone cement in revision surgery.
Company News: EMC to assume costs of tumor analysis for employees and relatives with cancer
– The “Corporate Oncology Program for Employees” with Molecular Health –
As of September 1, 2015, EMC in Germany will be joining forces with Molecular Health to launch a Corporate Oncology Program for Employees (COPE). If an EMC employee or the spouse, partner, or child of an EMC employee are diagnosed with cancer, the program will fund an analysis of the patient’s tumor genome so that the most promising treatment options can be identified.
“Every day we spend many intense hours working together. No one is left unmoved when they hear that cancer has touched the life of a colleague or a colleague’s family member,” says Sabine Bendiek, managing director of EMC Germany, about the new program. Gabriele Schickel, the director of human resources at EMC, adds, “We asked ourselves what we as an employer could do in situations like these. We offer a great deal to healthy employees. But how can we support colleagues who get sick?” The answer for EMC Germany employees and their families is COPE. EMC, an IT compan with headquarters near Boston, Massachusetts (USA), employs some 70,000 people around the world; its main German office is located in Schwalbach am Taunus.
EMC is Molecular Health’s second COPE customer. “There’s been a lot of interest in COPE over the past few months. Typically it is forward-thinking companies like EMC that make special efforts to look after their employees,” said Lutz Voelker, CEO of Molecular Health.
Part of the COPE program involves Molecular Health’s TreatmentMAP™: the tool analyzes and interprets the tumor genome and the ways in which it differs from healthy tissue in a clinical context. TreatmentMAP compares patient-specific genetic information with the latest international biomedical knowledge. This allows treating physicians to manage the incredibly complex masses of data so they can match the tumor profile to a suitable treatment. As a result, they can identify the therapeutic option with the highest potential benefit while also avoiding side effects as much as possible. Confidentiality is a natural component of our process. The patient remains anonymous. All patient-relevant data remains confidential and is never given to third parties or the employer.
Company News: Aleva Neurotherapeutics Awarded Grant from The Michael J. Fox Foundation
– Funds will be used to prepare clinical study of Aleva’s directSTIM™ novel directional deep brain stimulation system in patients with Parkinson’s disease –
Aleva Neurotherapeutics, a leading company developing next-generation implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson´s disease, today announced that it has been awarded a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF).
The grant of up to $180,000 is dedicated to development of Aleva’s directSTIM™ device, a complete directional DBS system for sustained therapy in Parkinson’s disease and essential tremor. The funds will go toward the preparation of a clinical study assessing the long-term clinical performance of directSTIM™ in a prospective, single-arm, open trial in people with Parkinson’s disease.
“We are delighted to receive a grant from The Michael J. Fox Foundation for our directional deep brain stimulation system,” said André Mercanzini, CTO and Founder of Aleva Neurotherapeutics. “The grant will provide pivotal support for the validation of our cutting-edge directional stimulation system and for obtaining market clearance for directSTIM™ in Europe.”
Currently available DBS systems continuously radiate stimulation, leading to side effects such as nausea and numbness. The Aleva system controls the direction of the electrical current in the brain, aiming for fewer side effects and less post-operative maintenance.
“A primary goal of our Foundation is improved treatments for the millions of people living with Parkinson’s disease,” said Adria Martig, PhD, Associate Director of Research Programs at MJFF. “We are enthusiastic about the Aleva deep brain stimulation system as it may provide an optimized therapeutic option for treating the debilitating motor symptoms of the disease.”
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Company News: Molecular Health Licenses SafetyMAP™ to the U.S. Food and Drug Administration (FDA)
Molecular Health has entered into a commercial license to provide the FDA with use of its SafetyMAPTM software – formerly known as Molecular Analysis of Side Effect information (MASETM), to provide a comprehensive and dynamic analytical solution for the detection and molecular analysis of drug-induced adverse events for all marketed drugs and for predicting safety issues of new drug candidates. The license supplies the FDA with access to SafetyMAP for 10 concurrent users for a period of one year and can be extended for two additional years at the discretion of the FDA.
Lutz Voelker, CEO of Molecular Health said, “This FDA User License validates the importance of having the robust drug safety analytics that Molecular Health’s SafetyMAP uniquely provides.”
Following the acceptance of a proposal submitted in response to the FDA’s Request for Quotation, RFQ-1146774, “Molecular Health User Licenses for MASE (or Equal)”, Molecular Health and the FDA entered into a commercial license agreement. Prior to issuing the RFQ, the FDA had been evaluating this technology under the terms of a five-year research collaboration agreement with Molecular Health that began in 2012.
The FDA described in its RFQ the important capability that Molecular Health’s technology provides:
Drug safety prediction and the evaluation of post-marketing signals depend on the ability to find scientific data that can confirm relationships among drugs, drug targets, toxicity mechanism, patient susceptibility and clinical response. This requires the ability to interrogate a wide variety of data sources, including the FAERS database, MEDLINE, gene and protein databases, FDA drug product labels, patents and other document repositories to uncover hidden relationships between scientific findings and adverse events. The creation of molecular target adverse event profiles is advancing safety science. This capability is mission critical for assessing the importance of possible safety issues pre- and post-approval and for supporting our regulatory science mission at FDA. Over the past three years we have been using the MASE platform to achieve the goals outlined above. A large number of FDA safety issues have been evaluated and labeled using MASE data mining capabilities. This software has provided valuable, accurate and reliable information [emphasis added].
Leveraging Molecular Health’s platform technology of biomedical and molecular databases, analytical methods and visualization tools, SafetyMAP was developed by integrating clinical information from five million adverse event reports (FAERS), with molecular information about targets and drug mode action at the level of target pathways. This drug-centric data integration process enables the molecular transformation of clinical information, such that human clinical information can now be analyzed from the perspective of molecular parameters (e.g., targets or pathways).
Molecular Health is also marketing SafetyMAP to the pharmaceutical industry and to pharmacy benefit managers.