News
Company News: Curetis Closes EUR 14.5 Million Extension of Series B Financing
– Curetis wins new investors QIAGEN and LSP-HEF, committing EUR 7 million
– Curetis well financed into 2017
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced it has closed a EUR 14.5 million extension of its Series B financing round, which was originally led by HBM Partners in April 2013. All existing investors – aeris Capital, BioMed Invest, CD Venture, Forbion Capital, HBM Partners, LSP – Life Sciences Partners, Roche Venture Fund, management, a trustee-pool of Curetis employees and private angel investors – participated in the extension financing, investing EUR 7.5 million on a pro rata basis. QIAGEN and LSP Health Economics Fund (LSP-HEF) are joining as new investors, committing a total of EUR 7 million. The financing brings the total amount of equity raised by Curetis AG to over EUR 63.5 million.
In addition, Rudy Dekeyser of LSP-HEF will join Curetis´ Supervisory Board, while Hans-Guenter Hohmann will step down after being a Board member for the past six years. Dr. Martin Potgeter, Vice President Business Development of QIAGEN, will take an observer seat on the board as second representative of a corporate investor alongside Simon Meier of Roche Venture Fund and Dr. Karsten Fischer of BioMed Invest.
The financing is supported by the achievement of key milestones, e.g. several CE/IVD-marked products, an ongoing FDA clearance trial and a growing commercial distribution network across Europe. The European market introduction of both the Unyvero P50 Pneumonia and i60 Implant and Tissue Infection applications, allowing a faster and better diagnosis of life-threatening infectious diseases, has shown increasing traction. In addition, the company is in talks with several parties on granting future U.S. commercialization rights and further expanding the commercialization into Asia and other global markets.
Company News: Curetis Joins European Prosthetic Joint Infection Cohort Study (EPJIC)
– Unyvero i60 ITI cartridges to be run on 500 prospectively collected patient samples from multi-center study across Europe
– All Unyvero testing to be conducted in central reference lab under the auspices of the PRO-IMPLANT Foundation and Prof. Andrej Trampuz
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced it has joined the European Prosthetic Joint Infection Cohort Study (EPJIC). EPJIC is an initiative of the PRO-IMPLANT Foundation to improve the management of Prosthetic Joint Infection (PJI) and to develop consensus guidelines across Europe. PJI is one of the leading causes of joint implant failure. Treatment often requires multiple surgical interventions and prolonged antibiotic therapy and is associated with a failure rate of 10 to 20 percent.
The investigator-initiated study has started in September 2014 and will enroll up to 5,000 PJI patients from up to 100 study centers across Europe. As part of the study, 500 patient samples will be measured by the Unyvero i60 ITI multiplex PCR cartridge system to identify pathogens involved in prosthetic joint infection, a key indication area of the Unyvero i60 ITI cartridge. The data will help build the body of evidence especially in PJI diagnosis using sonication fluid samples. As already demonstrated in the CE performance evaluation study of the i60 cartridge, the Unyvero system is able to detect pathogens frequently missed by microbiology culture. Also, Unyvero i60 results are available within about 5 hours compared to classical microbiological culture methods that can take up to 14 days with PJI samples.
The study’s Unyvero arm is expected to be completed by the end of 2015, with initial data anticipated in the first half of 2015. Data will be published at major conferences and in peer-reviewed scientific journals.
The Unyvero i60 cartridge, which is jointly marketed by Curetis and Heraeus Medical GmbH, covers a broad range of infections common after abdominal as well as bone and joint surgery, trauma (e.g. burns) or skin and soft tissue infections, including diabetic foot disease. Its multiplex panel covers a total of 114 targets – 91 pathogens (gram-negative & gram-positive bacteria and fungi) and 23 resistance markers – relevant for eight clinical indications.
In combination with the unique Unyvero L4 Lysator, it can process biofilm samples, an important prerequisite for the fast and reliable diagnosis of implant infections (catheters, joints etc.).
Company News: Curetis Presents New Unyvero Pneumonia Data at Major Clinical Microbiology Meetings
– Presentation of clinical data from a pneumonia study on multi-pathogen infections at ICAAC 2014 and DGHM 2014
– Rapid Multiplex PCR assays confirmed as valuable addition to conventional testing methods
Curetis AG, a developer of next-level molecular diagnostic solutions, today announced new data on the clinical performance of its Unyvero P50 pneumonia cartridge in multi-pathogen infections.
A study conducted by researchers from private laboratory medicine firm MVZ Dr. Eberhard & Partner (Dortmund, Germany) analyzed pneumonia patient samples with both Curetis’ Unyvero P50 pneumonia cartridge and with classical microbiology culture. The investigator-initiated study determined >80% sensitivity at >95% specificity for pathogen identification with Unyvero P50. Of note, 54% of all cases had polymicrobial infections, many of them involving between 3 and 6 different pathogens. In the trial, Unyvero P50 found additional polymicrobial infections and detected 17 pathogens, all of which were not identified by microbiology culture. In contrast, in 6 cases classical culture identified a total of 8 pathogens not detected by Unyvero P50.
The data have been presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington D.C. (U.S.) and will also be presented at the upcoming conference Microbiology and Infection 2014 in Dresden (Germany), a joint event of the Association for General and Applied Microbiology (VAAM) and the Society of Hygiene and Microbiology (DGHM).
During Microbiology and Infection 2014, Curetis will host a symposium on the “Clinical Relevance of Rapid Infectious Disease Diagnostics”. It will take place on Monday, October 6, from 12:15pm – 1:15 pm CET (Room: Konferenz 1 / International Congress Center Dresden). The symposium will be chaired by Prof. Dr. Helmut Fickenscher (Kiel University). Presentations will be held by Dr. Reno Frei (University of Basel) and Prof. Dr. Maria Déja (Charité – Universitaetsmedizin Berlin).
Company News: Patent Position of Merus’ MeMo® Mouse Strengthened by Ruling of European Patent Office
– Freedom to operate confirmed
– Successful opposition against Regeneron’s patent EP 1 360 287 B1 for transgenic mice producing therapeutic human antibodies
Merus B.V., a biopharmaceutical company focusing on innovative human antibody therapeutics, announced today that it has successfully retained full freedom to operate for its proprietary transgenic MeMo® mouse. In opposition proceedings at the European Patent Office, the opposition division ruled on September 17 that European patent EP 1 360 287 B1, owned by Regeneron Pharmaceuticals Inc., was revoked in its entirety.
In 2012, Regeneron was granted a European patent entitled “Methods of Modifying Eukaryotic Cells”. The patent is part of Regeneron’s IP portfolio around its VelocImmune® mouse for therapeutic human antibodies. Merus filed an opposition against this patent in June 2013, thereby requesting revocation of the patent.