Archive: Company News
Company News: Curetis Starts Final Validation Study for New Unyvero Blood Culture Application Cartridge
– Data and CE-IVD launch expected in Q2, 2016
– Company also prepares launch of 2nd generation ITI Application Cartridge and novel product for intra-abdominal infections
Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the start of a CE performance evaluation study for its third Unyvero Application Cartridge. The BCU Blood Culture Application Cartridge is designed to diagnose infections that are spreading through the bloodstream and is targeting clinically most relevant microorganisms and related antibiotic resistance markers. Curetis expects data from the study and the subsequent launch of the CE-IVD-marked BCU Application Cartridge in Q2, 2016.
The BCU Application Cartridge features a unique and differentiated test panel covering more than 100 diagnostic targets, including tests to identify Gram-positive and Gram-negative bacteria, fungi and mycobacteria, as well as tests for up to 16 antibiotic resistance markers. The Application Cartridge is using positively flagged blood culture samples from bottles inoculated with blood or punctate. Comprehensive results are delivered within 4 to 5 hours and require just a few minutes of hands-on time.
For the study, the BCU Application Cartridge is being validated in conjunction with the most common commercial blood culture systems, using about 250 blood culture samples. Previous studies testing around 200 BCU cartridges as part of the analytical and pre-clinical performance evaluation were already completed successfully. The data, which are to be published and presented at upcoming conferences, are expected to support the CE-IVD-marking of the BCU Application Cartridge. Three clinical sites in the DACH region already have agreed to further evaluate the Unyvero BCU Application Cartridge in routine clinical settings once it becomes available as a CE-IVD-marked product.
Curetis has also progressed with the development of a second-generation ITI Application Cartridge for implant and tissue infections and has started the development program towards a novel Application Cartridge targeting intra-abdominal infections.
Further pipeline updates and an outlook of additional future product opportunities will be provided in H2, 2016, including an update on the preparation of Curetis’ next US FDA trial for a second Unyvero Application Cartridge for the US market once the ongoing LRT55 FDA trial has been completed.
Company News: InDex Pharmaceuticals Receives Approval of the International Nonproprietary Name (INN) Cobitolimod for their Lead Drug Candidate Kappaproct®
InDex Pharmaceuticals AB today announced that the World Health Organization (WHO) has recommended cobitolimod as the International Nonproprietary Name (INN) for Index´s lead drug candidate Kappaproct®, which is a first-in-class Toll-like receptor (TLR) 9 agonist in late-stage clinical development for moderate to severe ulcerative colitis.
The aim of the INN system is to provide a unique and universally designated name for each pharmaceutical substance to facilitate the identification of active pharmaceutical ingredients. A nonproprietary name is also known as a generic name. The name cobitolimod has been selected and passed the review of the Expert Advisory Panel on the International Pharmacopoeia and Pharmaceutical Preparations. Following public consultation over four months, it has reached the status of recommended INN and will be included in the forthcoming list of recommended INN published by the WHO.
Kappaproct (cobitolimod) is InDex Pharmaceutical’s lead drug candidate in late-stage clinical development for moderate to severe ulcerative colitis, a debilitating, chronic inflammation of the large intestine. Kappaproct provides local anti-inflammatory effects, leading to healing of the colonic mucosa and improvement of clinical symptoms.
Kappaproct is a single-stranded, DNA-based synthetic oligonucleotide that functions as an immunomodulatory agent by targeting TLR9 and thereby mimics microbial DNA being the natural ligand of the receptor. Kappaproct has achieved clinical proof-of-concept in moderate to severe ulcerative colitis, with a very favorable safety profile. Data from four placebo controlled clinical trials show that Kappaproct has statistically significant effects on those endpoints that are most relevant both from a regulatory and clinical perspective, such as key clinical symptoms, i.e. blood in stool, number of stools, and mucosal healing.
Company News: Curetis Expands Commercial Team
– Company hires Willem Haagmans as Head of Sales EMEA –
Curetis N.V. (the “Company” and, together with Curetis AG, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced the expansion of its commercial and general administrative team.
As of February 1, 2016, Willem Haagmans has joined the company as Head of Sales for the EMEA region.
Willem Haagmans previously worked at Beckman Coulter as General Manager Benelux. He is a highly experienced commercial executive with a strong track record, including the successful commercialization of innovative products and solutions in the molecular diagnostics industry as well as the significant increase of top-line revenue growth. Among others, Willem Haagmans has held prior international molecular diagnostics sales management positions with Roche, Nimblegen, and Vela Diagnostics, bringing extensive leadership experience with both large and small-to-medium sized molecular diagnostics companies. He will be based in the Venlo area near the Dutch-German border, right at the heart of Curetis’ European direct sales territories, and will head all direct sales efforts in DACH, Benelux, France, UK and possibly Nordic countries.
Curetis´ recruiting activities for Key Account Managers, sales team members and Clinical Application Specialists is well under way in these Western European markets. Therefore, the company expects to hire additional key talents in the coming months to further grow its European commercial teams in sales, marketing and business development.
In addition, Curetis has made further key hires to augment its corporate and commercial functions:
Bernd Bleile joined on February 1, 2016 as in-house Legal Counsel to provide additional legal and corporate counsel support for the growing commercial operations of Curetis.
Dr. Jie Song, a Chinese native with 14 years of working experience in science and research in Germany and deep scientific and clinical expertise in microbiology, will join Curetis on March 1, 2016 as Application Specialist for China and Asia to support Curetis’ growing commercial activities in Asia. With new partnerships and the sale and delivery of 20 Unyvero Analyzers to its Chinese and ASEAN partners, Curetis in Q4 of 2015 has started to expanded its commercial reach into Asia. Preparations for a Chinese CFDA clinical trial are under way and expected to be kicked off in the first half of this year.
“The recent hires are the first steps to executing and delivering upon our expansion plans highlighted during our IPO in November 2015,” said Oliver Schacht, CEO of Curetis. “By growing our commercial team and strengthening our footprint in the EMEA region, we aim at significantly increasing the number of our direct sales accounts and to continuously grow the installed base of Unyvero Systems throughout 2016 and beyond.”
Company News: Aleva Neurotherapeutics and Greatbatch, Inc. Collaborate on Next-Generation Device for Deep Brain Stimulation (DBS)
– Agreement includes strategic investment in Aleva’s current Series C round by Greatbatch, Inc. –
Lausanne, Switzerland, February 01, 2016 – Aleva Neurotherapeutics, a leading company developing next-generation implants for deep brain stimulation (DBS) in major neurological indications such as Parkinson’s disease and essential tremor, today announced a strategic development, supply, and manufacturing relationship with Greatbatch, Inc. (NYSE:GB). In addition, Greatbatch will invest in Aleva Neurotherapeutics’ current Series C financing round.
Under terms of the development agreement, Greatbatch’s design and development team QiG Group, which is expected to be spun-off as Nuvectra Corporation, will provide Aleva with access to its unique implantable neurostimulation platform. Specifically, Aleva will receive a license to utilize Nuvectra’s platform in the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary microDBS™ technology platform, which includes cutting-edge directSTIM™ electrode technology for directional deep brain stimulation, into a complete system with Nuvectra’s proprietary 24-channel neurostimulator and paradigm-shifting programmers. The complete system is aimed to provide patients and doctors with an unparalleled, next-generation DBS solution resulting in increased efficacy and improved therapy control that may lead to improved outcomes for patients with Parkinson’s disease and essential tremor.
Nuvectra will also continue work with Aleva’s engineering team on the development of next-generation DBS technologies. In addition, Greatbatch will enter into an exclusive manufacturing and supply agreement for certain devices of the system.
“As a result of our partnership with Greatbatch and Nuvectra, we will significantly reduce our time-to-market and enhance our ability to deliver our novel Directional DBS therapy to patients in need,” said Andre Mercanzini, Chief Technology Officer and Founder of Aleva. “We are delighted to be working with some of the very best people in the neuromodulation business to commercialize our work.”
“We’re excited to be partnering with true pioneers in the field of DBS,” said Scott Drees, CEO of Nuvectra. “Aleva’s approach of building next-generation DBS therapies for this highly underserved market aligns perfectly with our plans to establish Nuvectra as an innovative player in the neuromodulation marketplace. We believe the Aleva partnership validates our strategy of developing platform technology that can be leveraged across multiple neurostimulation indications.”
Aleva is currently raising a Series C financing round, which will be led by Greatbatch. Existing investors BioMedPartners, BB Biotech Ventures, Banexi Ventures and Initiative Capital Romandie are also participating in the round. The proceeds will be dedicated to obtaining the CE mark for its proprietary directSTIM™ Directional Deep Brain Stimulation System and the completion of a chronic study in 60 Parkinson’s disease patients. The successful results of Aleva’s pilot study were published in BRAIN in 2014.
In October 2015, Greatbatch completed the acquisition of Lake Region Medical, with the combined company expected to be renamed Integer Holdings Corporation later this year (subject to shareholder approval).