Archive: Company News
Company News: InDex Pharmaceuticals Appoints Stig Løkke Pedersen as Board Member
– Former Lundbeck Executive Brings Strong Commercial Experience and Extensive Pharmaceutical Industry Network –
InDex Pharmaceuticals today announced that Stig Løkke Pedersen has been appointed as a new member of the Board of Directors. Mr. Pedersen brings to InDex Pharmaceuticals over 25 years of longstanding life sciences industry experience in commercial operations and leadership.
Mr. Pedersen previously served as Executive Vice President of Commercial Operations at H. Lundbeck A/S. He joined Lundbeck in January 1992, being responsible for the company’s business development activities. Following a period as Managing Director of Lundbeck Netherlands, he became part of the corporate senior management in 1998. Mr. Pedersen was appointed Executive Vice President in April 2003 and held the position as EVP for Commercial Operations from 2007 until June 2011, when he resigned from his position at Lundbeck. Mr. Pedersen is a Partner at Executive Capital A/S and serves as the Chairman of the Board of Directors at Chemometec A/S and Nuevolution A/S. He is a member of the Board of Directors at MSI Methylation Sciences Inc. and a member of the Advisory Board of Atrium Partners A/S and JSB-Partners, as well as an advisor to the Lundbeck Foundation.
Company News: Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization
– Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.
The evaluation has demonstrated excellent performance characteristics of the Unyvero™ pneumonia application in terms of sensitivity and specificity. Overall sensitivity in 186 tested fresh and frozen clinical sputum, aspirate and lavage samples was above 75% sensitivity with a better than 95% specificity. The Unyvero™ P50 pneumonia application cartridge identified 74 additional pathogens missed by standard microbiology culture, which was used as gold-standard comparator in terms of performance. If confirmed with independent methods this might demonstrate that the Unyvero™ pneumonia test offers significant improvements in terms of sensitivity over current clinical standards. This analysis is ongoing.
Cartridge and instrument system have also passed other important criteria, such as repeatability, reproducibility, interference testing, and cross-reactivity. The complete performance evaluation study included 318 Unyvero™ P50 cartridge runs between January and April 2012.
Based on positive feedback from many potential distribution partners during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) earlier this year, Curetis has also begun establishing its international distributor network and expects to target an even broader international market than originally anticipated beginning in 2012/13 already.
Company News: Jean-Paul Prieels joins VAXIMM’s Board of Directors
VAXIMM AG, a Swiss-German biotech spin-off from Merck KGaA focusing on cancer vaccines, announced today the appointment of Jean-Paul Prieels as a new member of its Board of Directors.
Dr. Prieels is a renowned industry expert in the vaccine field. He held various executive positions at GlaxoSmithKline, where he headed the vaccine research and development in Rixensart, Belgium, among others. Dr. Prieels, who joined GlaxoSmithKline Biologicals (formerly SmithKline Beecham Biologicals) in 1987, has been instrumental in developing several marketed vaccines, including cervical cancer vaccine Cervarix™, Rotarix™ to protect from rotavirus infection, and Synflorix™ for the prevention of pneumococcal infections. He retired from GSK as Senior Vice President Research and Development in early 2011 and is currently a board member of several biotech companies in the vaccine field.
VAXIMM’s lead product candidate VXM01 is being evaluated in a placebo-controlled phase I dose escalation study enrolling up to 45 pancreatic cancer patients, with results expected in H1, 2013.
Company News: Nanobiotix and Thomas Jefferson University Start Research Collaboration
– Nanomedicine and Medical Education leaders are joining their forces in the United States to accelerate the development of NanoXray –
Nanobiotix, a company developing novel cancer nanotherapeutics and Thomas Jefferson University, one of Philadelphia’s premier medical and health sciences universities, today announced that they have entered into a research collaboration to accelerate the development of Nanobiotix’ lead compound NBTXR3 in the US.
Under the terms of the collaboration agreement, Nanobiotix will fund a 2-year preclinical research program, which will be directed by Bo Lu, MD, Professor in the Department of Radiation Oncology at Jefferson and Director of the department’s Division of Molecular Radiation Biology. The goal of the program is to study the therapeutic efficacy of NBTXR3, the lead product of Nanobiotix´ NanoXray pipeline.
NBTXR3, a nanoparticle consisting of hafnium oxide crystals, aims to enhance the local destruction of the tumor mass during radiotherapy. It accumulates in the cancer cells and, upon radiation, emits huge amounts of electrons leading to the formation of free radicals. These, in turn, damage the cancer cells and cause their targeted destruction. As a result, the destructive power of standard radiation therapy is locally and selectively enhanced within the tumor cells.
NBTXR3 has been classified in the EU as class III medical device and is currently being tested in a European Phase I trial to establish feasibility and safety of NBTXR3 in patients with soft tissue sarcoma. Preliminary data are expected by the end of 2012. Further clinical trials are in preparation in Europe and in the US, where NBTXR3 is classified as a drug.