NEWS


Cambridge Major expands US site API capacity Cambridge Major Laboratories


Janssen-Cilag International submits European MAA for tuberculosis treatment


Janssen-Cilag International NV has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval for the use of investigational drug bedaquiline (TMC207) as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults. If approved,


bedaquiline could be one of the first drugs with a new mechanism of action for tuberculosis in more than 40 years and one of the first ever to be specifically indicated for MDR-TB. Bedaquiline, an antibiotic, kills the bacterium that causes tuberculosis by targeting adenosine triphosphate (ATP) synthase, an enzyme that is essential for the generation of the bacterium’s energy.


The regulatory submission is supported by data from a Phase 2 clinical development programme that includes an open-label study and a controlled, randomised trial that evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR- TB in combination with a background regimen. In addition, Janssen submitted an NDA to the FDA for bedaquiline in June of this year under priority review status.


A Phase 3 trial comparing an intensive nine-month


background regimen containing TMC207 one containing placebo, is planned to start recruiting in Q4 2012. This study will evaluate seven drugs for a shorter treatment duration than the current 18 to 24 months WHO standard of care.


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(CML) has announced a significant expansion of its large- scale API manufacturing facility in Germantown, Wisconsin, USA. The company says this is in response to continued growth in demand for larger-scale API manufacturing services. The expansion comes only three years after the company commissioned the state-of-the-art


facility in line with its business model of focused investment in US-based assets.


The expansion will include additional reactor capacity as well as isolation equipment. CML has also made additional investments in engineering controls to ensure the sustainability of the business, including further investments in containment capabilities with engineering controls across


production trains. Additional containment capabilities will also be introduced into the


company’s European facility later this year.


Since 2009, when the large-scale API facility became operational, CML has invested in other supporting areas of the business, including solid-state services and an expanded analytical offering.


Symphogen in cancer therapeutics and biomarkers project


Symphoen A/S has joined the Immune Antibody Repertoires in Microdroplets project which is supported by the Danish National Advanced Technology Foundation. The project is using an interdisciplinary approach combining genomics,


bioinformatics, nanotechnology and drug development to provide improved therapeutic antibodies for the treatment of cancer and to


identify new prognostic biomarkers for allergy vaccines for cancer patients and chronically ill allergy patients. It aims to distribute cells of the immune system into microscopic droplets on a microchip which will enable mapping of the total immune response and


identification of those antibodies that may lead to an effective treatment.


Symphogen, ALK-Abello, the Department of Micro and Nanotechnology and the Center for Biological Sequence Analyses, Danish Technical University (DTU) are participating in the project. Its duration will be for four years with a total budget of $4.7 million, of which $2.5 million ha been invested by the Advanced Technology Foundation.


Biotage introduces new fully automated microwave peptide synthesizer


Biotage has introduced a new synthesis platform for peptide researchers, the Biotage® Initiator+ Alstra, a fully automated, single-channel, programmable microwave peptide synthesizer. The Initiator+ Alstra is designed for peptide chemists synthesizing peptides, peptoids, PNA and peptidomimetics, including extremely difficult modifications. The system’s flexibility for reagent set-up makes it suitable for both small- and large-scale synthesis from 5 ?mol to 2 mmol. With a working volume from as low as 0.6 ml, the Initiator+ Alstra


enables small-scale microwave peptide synthesis, especially when the use of expensive building blocks is required, for example PNA. The system’s robotic liquid handler and precise digital syringe pumps reduce reagent and solvent consumption, thus reducing cost and minimising waste. The Initiator+ Alstra is


programmable via a large 1touch screen with drag and drop functionality for optimising pre- installed or user-defined methods. A built-in wizard allows synthesis sequences to be programmed and a calculation table generated


characterisation in the pharmaceutical industry. In the collaboration, Cambridge Research Biochemicals will make key peptide substrates labelled with AssayMetrics’ Fluorescence Lifetime dyes. The peptides are used to screen novel drugs in equipment such as AssayMetrics’ Fluospec® FL reader and are


provides the quantities of reagents required, allowing the user to very quickly develop synthesis methods. For further information visit www.biotage.com


AssayMetrics and CRB collaborate on new assay technology UK discovery tools company AssayMetrics Ltd has formed a collaboration with peptide and antibody company Cambridge Research Biochemicals Ltd in the field of fluorescence lifetime technology, a new assay technology used in the biochemical screening of drugs and in compound


sp2 Inter-Active September/October 2012


employed in assays involving kinases, proteases,


protein:protein interactions and other target enzyme systems. The companies say the collaboration will enable them to offer solutions that will provide faster, more efficient and cheaper drug discovery and development, improving R&D effectiveness.


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