The French company Enterome Bioscience, established in 2012 and specialised in the development of drugs and diagnostics for personalized therapies in microbiome-related diseases such as Inflammatory Bowel Diseases (IBD), metabolic diseases, and related disorders, announced a new collaborative development agreement with AbbVie. Enterome’s proprietary metagenomic biomarker portfolio and other technologies will be used to develop non-invasive monitoring tools of the gut microbiome in Crohn’s disease.
Cristiana Bernini
A new clinical trial site in Germany
The new European Coordination Hub and Distribution Center of Parexel opened in Berlin-Schönefeld, Germany. The facility features more than 65,000 cubic meters of storage space and offers lab-kit assembly, storage and distribution of ancillary materials. The new opening expands Parexel’s capacity to provide comprehensive clinical trial supply and logistics services to support clients’ local, regional and global trial requirements, including synchronized coordination of clinical trial supplies, ancillary supplies and central laboratory services.
The new Hub will be licensed to store Investigational medicinal products (IMPs) and Non-investigational medicinal products (N-IMPs). It will also offer secondary packaging, re-labeling, and compliance with GDP of medical devices and ambient, refrigerated and frozen medicinal products, including controlled substances. All under the control of on-site Qualified Person (QP), Quality Control (QC) and production personnel.
Anti-viral deal
Johnson & Johnson will step deeper into the anti-viral market after the final acquisition agreement of Alios BioPharma, a privately held clinical stage biopharmaceutical company focused on developing therapies for viral diseases. The deal amounts to approx. $1.75 billions. Alios BioPharma’s portfolio includes compound AL-8176, an orally administered antiviral therapy currently in Phase 2 studies for the treatment of infants with respiratory syncytial virus (RSV).
A Challenge fund for bioelectronics
GSK announced a $5 million Innovation Challenge Fund (ICF) for the advancement of collaborative research as part of its effort to develop bioelectronic medicines. The fund will support academic groups and small companies who want to develop solutions for GSK’s Bioelectronics Innovation Challenge. The new funding programme adds to GSK’s prior commitment of a $1 million award, announced in December 2013, for the team that first solves the Challenge. Funding will be awarded in two phases to qualified teams, ultimately leading to the selection of up to three teams being awarded up to $1.2 million each by mid-2015.
Core therapeutic areas review
Teva has reviewed its core therapeutic areas towards long-term commitment to develop patient-centric solutions and significantly grow its specialty medicines business. The company will invest in Central Nervous System (including multiple sclerosis, neurodegenerative diseases and pain) and Respiratory (including asthma and chronic obstructive pulmonary disease). Teva has also identified 14 pipeline projects for discontinuation or divestment, for a total amount of more than $150 million in R&D costs in 2015 and in excess of $200 million for each of 2016 and 2017.
New production plant
Boehringer Ingelheim is planning to increase the production capacity for its Respimat® inhaler to 44 million units per year and will invest more than €100 million to enlarge its Dortmund site. Some 100 new jobs are expected to be created at the site. The Dortmund’s site was created in 2004 upon the acquisition of the microtechnology company STEAG microParts GmbH, which was integrated into the group. The device is then filled with the relevant active pharmaceutical ingredients at the company’s headquarters in Ingelheim to be distributed worldwide. Boehringer Ingelheim is also investing additional €72 million at the Ingelheim’s site for the expansion of the Respimat production.
Collaboration for lung cancer trial
Bristol-Myers Squibb and Novartis announced a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor nivolumab with three molecularly targeted oncology therapies from Novartis (ceritinib, INC280 and EGF816). Novartis will conduct two Phase 1/2 studies focused on non-small cell lung cancer (NSCLC). The studies will explore the potential of enhanced anti-tumor response using a combined immunotherapy and targeted molecular approach.
UK’s Prix Galien 2014
Novartis and Janssen won the 2014 UK’s Prix Galien awards. Novartis won the Innovative product award for their breakthrough meningitis b vaccine and Janssen won the Orphan drug award for their tuberculosis medicine bedaquiline, which is the first new treatment for this disease in four decades.
Bayer to focus on Life Sciences
The Germany based multinational company Bayer announced the intent to focus entirely on its Life Science businesses – HealthCare and CropScience. The MaterialScience division, specialised in the production of polymers, will give rise to a new company to be listed on the stock market within the next 12 to 18 months. Bayer had already acquired the OTC business of US’ Merck & Co. and launched several medicinal products in the areas of anticoagulant therapy, eye medicine, cancer, and pulmonary hypertension. Combined peak annual sales potential is expected to be at least EUR 7.5 billion. Employment levels are expected to remain stable over the next few years, both globally and in Germany.
Mega-merger for Life Sciences’ services
The Germany-based company Merck announced the acquisition of Sigma-Aldrich for approx € 13.1 billions. The deal will establish one of the leading players in the $130 billion global life science industry. The combined company will be able to serve life science customers around the world with a highly attractive set of established brands and an efficient supply chain that can support the delivery of more than 300,000 products.
“This transaction marks a milestone on our transformation journey aimed at turning our three businesses into sustainable growth platforms”, said Karl-Ludwig Kley, Chairman of Merck’s Executive Board”.
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