Impact of antibiotic resistance is lower than expected
Bilthoven – The current impact of hospital acquired infections with multi-resistant bugs is lower than suggested by startling news articles. According to a study of Dutch researchers, bloodstream infections caused by multi-resistant S. aureus (MRSA) and third-generation cephalosporin-resistant E. coli contributed an excess of 255,683 and 120,065 extra bed-days respectively. This translated to an estimated extra cost of €62.0 million, according to BURDEN (Burden of resistance and disease in European nations), the first prospective clinical investigation into the societal burden of hospital acquired infections from 31 European countries. In PLoS Medicine (doi:10.1371/journal.pmed.1001104), Marlieke de Kraker, Peter Davey and Hajo Grundmann from the Dutch Centre for Infectious Disease Control report about excess mortality, excess hospital stay, and hospital expenditure calculated from data of the European Antibiotic Resistance Surveillance System (EARSS). Data from 1293 hospitals in 31 countries revealed that an estimated 5,503 excess deaths were associated with bloodstream infections caused by MRSA and 2,712 excess deaths from bloodstream infections caused by third-generation cephalosporin-resistant E. coli. By looking at trends in their analyses de Kraker et al. estimate that 97,000 resistant bloodstream infections and 17,000 associated deaths could occur in 2015, with associated increases in hospital stay and costs. They state that 'Forecasts about changes in the coming years are disturbing; despite anticipated gains in the control of MRSA, the persistently increasing number of infections caused by third-generation cephalosporin-resistant Gram-negative pathogens is likely to outweigh this achievement soon.
Brussels/Strasbourg – Health claims are set to be drastically limited in the EU. On Wednesday 21 March the Environment Committee of the European Parliament confirmed a proposal of the European Commission to prohibit 1,600 health...
Brussels/Strasbourg – Health claims are set to be drastically limited in the EU. On Wednesday 21 March the Environment Committee of the European Parliament confirmed a proposal of the European Commission to prohibit 1,600 health claims, most of them relating to probiotics. Only 222 of the claims got the green light by the EU food watchdog EFSA, which carried out a scientific assessment of about 44,000 applications that were grouped to more general claims. British MEP Chris Davis and Finnish MEP Sirpa Pietkäinen had called on to reject the Commission's list, because they believed the list was flawed due to rigid assessment methods of the EFSA. Especially, probiotics developers and nutrition experts had criticised the EFSA for taking a pharma-like approach to assess efficacy of functional food without accepting studies with people who had i.e. diarrhea. However the members of the Parliament's Committee rejected the objection of their two colleagues. Consumer organisations such as BEUC said the vote will stop consumers from being misled by unsubstantiated or untruthful claims about foods.
Parma/Stockholm – Foodborne bacteria such as Salmonella and Campylobacter are becoming more and more resistant to antimicrobial drugs, according to a joint report published by the European food watchdog EFSA and the European...
Parma/Stockholm – Foodborne bacteria such as Salmonella and Campylobacter are becoming more and more resistant to antimicrobial drugs, according to a joint report published by the European food watchdog EFSA and the European Centre for Disease Prevention and Control (ECDC). High resistance levels were recorded to ampicillin, tetracyclins and sulfonamides in Salmonella isolates from humans (13%-75%), whereas resistance to third-generation cephalosporins and fluoroquinolones remained low (0.2%-7%). In Campylobacter isolates from human cases, resistance to ampicillin, ciprofloxacin, nalidicic acid, and tetracyclins were high (21%-84%), while resistance to erythromycin was recorded at low to moderate levels (0.5%-25%). Most resistances are transmitted by meat consumption from animals that have become resistant to antibiotics, according to the „EU report on antimicrobial resistnce in zoonotic bacteria affecting humans, animals, and foods.“ The highest occurrence to ciproflaxin was noted in Salmonella from turkeys (28%) followed by fowl and broiler meat (24%). High resistance, ranging from 37% to 84% was also observed in Campylobacter isolates from fowl, pigs, and cattle. Methcillin-resistant Staphylococcus aureus (MRSA) in food and animals occurred at levels varying from 0% to 79%, and was most commonly found in turkeys. The surveillance data, which form the base of the report, were submitted in 2010 by 26 EU member states.
In mid-February, scientists and entrepreneurs from nine EU countries met at the Center for Genomic Regulation (CRG) in Barcelona to launch the 4DCellFate project. Positioned within the FP7 Programme, the consortium will receive...
In mid-February, scientists and entrepreneurs from nine EU countries met at the Center for Genomic Regulation (CRG) in Barcelona to launch the 4DCellFate project. Positioned within the FP7 Programme, the consortium will receive €12m from the European Commission over the next five years. The key question the project will be trying to solve is how stem-cell reprogramming and differentiation is regulated at the epigenetic level. In the spotlight are the polycomb repressive complex (PRC) and the nucleosome remodelling and histone deacetylase (NuRD) complexes, including the question of how they govern embryonic stem-cell differentiation in states of health and disease. The research is aimed at finding better ways of generating ethically unproblematic iPS cells, as well as opening up new pathways for directing the fate of stem cells into different specific tissue types. Headed by the CRG, the joint venture includes academic institutions from Great Britain, Denmark, the Netherlands, Belgium, Germany and Italy. Also on board are GlaxoSmithKline plc (UK) and three small biotechnology companies: Horizon Discovery Ltd. (UK), Cellartis AB (Sweden) and CLC bio (Denmark). Using its proprietary virally-mediated geneengineering technology, Horizon is in charge of generating cell lines with labelled versions of epigenetic target proteins. Cellartis will provide human embryonic stem cells (hESCs), and is also involved in large-scale proteomic analyses. CLC bio will build the bioinformatics framework, while pharma giant GSK will assess the potential of translating fundamental scientific findings into new drugs.
Brussels – The EU’s Innovative Medicines Initiative (IMI) will establish the European Lead Factory, an EU-wide public-private partnership aiming to facilitate drug discovery efforts. The Lead Factory will comprise a...
Brussels – The EU’s Innovative Medicines Initiative (IMI) will establish the European Lead Factory, an EU-wide public-private partnership aiming to facilitate drug discovery efforts. The Lead Factory will comprise a high-throughput screening centre and a substance library with approx 500,000 drug candidates. This will, according to IMI, create “an unprecedented effort to speed up the discovery of new medicines”. The implementation of the centre is the sole goal of the IMI’s 5th Call for Proposals 2012, which has just been announced by the public-private partnership. Participating pharmaceutical companies will provide 300,000 compounds and universities and small- and medium-sized enterprises are expected to contribute another 200,000 compounds. The project has a budget of €169m, with up to €80 million coming from the European Commission’s 7th Framework Programme for Research and the rest from in-kind contributions by member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA). Overall, the European Lead Factory will “provide to public partners an ‘industry-like’ discovery platform to translate cutting-edge academic research into high-quality candidate drug molecules on a scale and speed that was not possible previously”, IMI said.
T he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the...
T he societal and economic challenges facing Europe and the world are complex and interconnected. The Bioeconomy Strategy and Action Plan “Innovating for Sustainable Growth: a Bioeconomy for Europe”, which was adopted by the European Commission on 13 February 2012, offers a unique approach to addressing these challenges in a comprehensive way. In order to reduce heavy economic dependency on fossil resources and focus on mitigating climate change, Europe needs to move towards a post-petroleum society. The Bioeconomy Strategy will contribute to this transition by promoting research and innovation into sustainable production and exploitation of renewable raw materials, along with alternative energy and carbon sources. It will pave the way to a more innovative and low-carbon society that reconciles food security with the sustainable use of renewable biological resources for industrial purposes, while simultaneously creating new job opportunities. Biotechnology as an enabling technology will play a crucial role in enhancing sustainability and competitiveness in the EU’s primary production and processing industries. It will also significantly contribute to reducing EU industry dependence on fossil resources, and improve the resource efficiency of production processes through the use of renewable raw materials (including wastes) and more environmentally-friendly bio-based processes. The Bioeconomy Strategy is based on three complementary pillars. The first is aimed at increasing investment in research, innovation and skills. Under the European Framework “Horizon 2020” (2014-2020) Programme for Research and Innovation, €4.7bn of funding has been earmarked for bioeconomy research and innovation under the societal challenge “Food security, sustainable agriculture, marine and maritime research, and the bioeconomy” and for biotechnology as an enabling technology. It is estimated that this funding could generate about 130,000 new jobs and €45bn in value added in bioeconomy sectors by 2025, not taking into account other direct and indirect public and private investments into bioeconomy sectors. A Public Private Partnership for bio-based industries is under consideration. The second pillar aims to improve synergies and coherence between priorities of European research and innovation policy and other policies relevant to the bioeconomy. It will provide different platforms to enhance interactions between researchers, policymakers, industries and society, as well as supporting similar initiatives in the EU Member States and Regions. The Strategy will also further develop international cooperation in the area of the bioeconomy. In its third pillar, the Strategy provides support to new markets and the expansion of existing ones; for example, by promoting the development of standards, sustainability assessments and labels for bio-based products that will help facilitate their uptake in consumer markets and by green procurement. This promotes both the establishment of networks of integrated and diversified biorefineries, and demonstration and pilot plants across Europe. Finally, the Strategy promotes the development of science-based approaches that can better inform consumers about product properties (like environmental sustainability) and aid in the promotion of a healthy and sustainable lifestyle. Five Commissioners have demonstrated their strong commitment to the bioeconomy by co-signing the Bioeconomy Strategy. However, its success will very much depend on the commitment of member states, regions, stakeholders in the research and innovation community and citizens – like you.
Intellectual Property (IP) is without question one of the most vital aspects of any biotech venture, a key and undisputed factor for success. However, most biotech companies are still incapable of unlocking the value of their...
Intellectual Property (IP) is without question one of the most vital aspects of any biotech venture, a key and undisputed factor for success. However, most biotech companies are still incapable of unlocking the value of their intellectual property all on their own. They need another kind of IP – Intelligent Partnerships, especially in the expanding monoclonal antibodies market.
Since the beginning of the economic crisis, the biotechnology sector has had to endure a lot of negative news, even suggestions that the industry as a whole could collapse. Whilst overly exaggerated, the current viewpoint is certainly grave. But let’s look at the abbreviation of IP in another way: Intelligent Partnerships! Below are a couple of examples of this essential area that we consider important to the future of the biotech industry. IP between academia and industry is key to the sustainability of the sector. The raw material for new start-up ventures is mostly a transfer from universities into industries. Understanding how to manage the interactions between the public partner (which most universities are) and the private sector is an indispensable ability for future development of the company. Evaluating science amongst peers becomes more important as the industry grows more global. IP requires smart money! IP often requires good, experienced and well-connected investors. Only if smart money finds its way into the venture can you expect solid development of results and milestone achievements. The prudent investor base isn’t only involved in the Life Science and Biotechnology sectors. If investors see better (or safer) future exits for their money, they will turn away from our risky but highly-rewarding industry and invest in other areas. IP is also necessary with a view to fostering increased respect for the research community. Its members produce innovation, which leads to new products, new cures, new production methods, new companies and to more jobs. The service sector depends a lot on a pipeline of new ideas that can be turned into products with commercial value. In the past, society respected researchers and engineers much more than they do today. We should alter that current perception as quickly as possible and motivate young talents to look for professional success in science and engineering. IP works well in countries where major government and industry funding is available. These entities invest and manage start-up funds, and by doing so create a pipeline of new companies. Critics might say that too much state aid is not good for the sector, but managed well, rewards are higher than initial investments. After all, a larger and improved work force is the goal of any economy. IP needs cluster management Not many industries are better equipped to be grouped into clusters based on Porter’s theory of building competitive advantages. Hotbeds of biotech can be found in countries all over the world, and they compete with one another. If that competitive spirit leads to better science and economic output it’s all well and good, but if it becomes an obstacle for sustainable development then it’s better to change strategies. The size of a country also determines the number of clusters. Related to the IP of cluster management is the fact that transatlantic collaborations in the public sector need to be improved. For decades, academic institutions have worked with peers all over the world, but funding agencies still hold off on investments. The European Union’s FP-programmes are steps in the right direction, but the bureaucracy for each programme remains high. Partnering events like the BIO-Europe Spring are also good platforms for starting sustainable relationships.
Last but not least, IP in creating an improved and better image for biotechnology is a must. Biotech is a far-reaching instrument for providing good solutions to the world’s most pressing issues, but we all need to use its tools wisely and have patience. Intelligent Partnerships can only grow if we are all taking part.
Monoclonal antibodies have become a dominant class of therapeutic proteins. Several antibody therapeutics are sold and marketed worldwide, and many more are currently in various stages of clinical development. The discovery and development of these substances – particularly in oncology – is progressing at an ever-increasing pace, and, cancer continues to be by far the most common indication for therapeutic antibodies.
The therapeutic efficacy of an antibody is determined by its pharmacokinetic and pharmacodynamic properties – and N-linked glycosylation is by far the most deciding factor impacting on both[1-2]. For most oncology indications where a therapeutic antibody directly mediates the killing of tumour cells, the effector functions are of utmost importance for the antibody’s pharmacodynamic efficacy[3-6]. This is also true for another emerging class of therapeutic antibodies – those that are directed towards targets in infectious disease applications[7). The elimination of fucose from the N-linked sugar chains on an antibody has long been shown to dramatically enhance the antibody-dependent cellular cytotoxicity (ADCC), the most powerful anti-tumour activity mediated by antibodies[8). The ADCC-enhancing effect of missing core-fucose has recently been shown to be additive to the effect of antibodies that have been Fc-protein-engineered for enhanced ADCC[9). GlymaxX®-modified cells are shown to produce almost 100% fucose-free antibodies. Armed with a powerful ADCC-effector function for tumour annihilation, these fucose-depleted antibodies show an increased binding affinity to the Fc gamma receptor. The technology is based on the heterologous, cytosolic expression of RMD, an enzyme that redirects the de-novo fucose synthesis pathway towards a sugar-nucleotide that cannot be metabolised by eukaryotic cells. Thereby, the substrate for cellular fucosylation, activated GDP-L-fucose, is depleted and fucosylation is almost completely abolished(10). The activity of the RMD enzyme ensures fucose-depletion largely independent of RMD expression level. This independence directly contributes to a stable level of defucosylation over an extensive number of cumulative population doublings, and it also compensates efficiently for any possible scale-up related impact on the desired afucosylation level. In combination with state-of-the-art vector technology, the GlymaxX®-modified clones have shown stable transgene expression and function. The GlymaxX® technology is simple to apply and completely compatible with manufacturing processes in any eukaryotic host cell line, which means that it can be applied to already-existing producer cells regardless of species origin. GlymaxX® modified cells can be generated and reposited under GMP. Performance parameters of the host cell line – such as doubling time, growth rate, maximum viable cell density and achievable IVCD – remain unaffected by the GlymaxX®-modification, and thus remain identical to those of the parental producer clone. Taken together, GlymaxX® works seamlessly with the systems and processes our clients and partners already have in place.
References:  Goetze AM, et al. Glycobiology. 2011Jul;21(7):949-59  Shinkawa T et al., J Bio Chem, 278, 3466-73, 2003  Herbst R et al., J Pharmacol Exp Ther, 335, 213-22, 2010  Junttila TT et al., Cancer Res, 70, 4481-9, 2010  Busse WW et al., J Allergy Clin Immunol, 125, 1237-44, 2010  Kolbeck R et al., J Allergy Clin Immunol, 125, 1344-53, 2010  Zeitlin L et al. Proc Natl Acad Sci U S A. 2011 Dec 20;108(51):20690-4.  Ferrara et al., 2011 PNAS August 2, 2011 vol. 108 no. 31 12669-12674  Repp et al., 2011 J. IMMUNOL. MET. Vol. 373 ( 1-2 ), 67-78  von Horsten et. al., Glycobiology. 2010 Dec; 20 (12):1607-18
Contact Dr Gabriele Schneider VP Business Development ProBioGen AG Goethestr. 54 13086 Berlin, Germany Tel.: +49 30 924006-0 firstname.lastname@example.org www.probiogen.de
Schlieren – Swiss Cytos Biotechnology Ltd. has been authorised to restructure a convertible bond by Canton of Zurich authorities. The company does not have enough cash to pay it back. Negotiations with bond holders failed in a...
Schlieren – Swiss Cytos Biotechnology Ltd. has been authorised to restructure a convertible bond by Canton of Zurich authorities. The company does not have enough cash to pay it back. Negotiations with bond holders failed in a first attempt. However, in December, Cytos was able to collect enough votes for the restructuring. Listed on the Zurich stock exchange, Cytos is in urgent need of cash. In 2011, losses amounted to some CHF18m, leaving the company with only CHF29m in liquid reserves. After a number of drug development failures, the firm’s hopes now rest on CYT003-QbG10, a vaccine for treating hay fever. Cytos had already reduced its headcount from 80 staff to just 36. By May, another restrucuring will bring that number down to 10. In the search for cash to keep the company alive, Cytos’ management is now trying to convince a pharma partner to sign a licence agreement for CYT003-QbG10.
Munich – German 4SC AG jumped 39% to €2.05/share after oncology drug candidate resminostat met the primary endpoint of at least a 20% progression-free survival rate in a Phase II trial to treat patients with hepatocellular...
Munich – German 4SC AG jumped 39% to €2.05/share after oncology drug candidate resminostat met the primary endpoint of at least a 20% progression-free survival rate in a Phase II trial to treat patients with hepatocellular carcinoma (HCC) who had not responded to first-line treatment with kinase inhibitor Nexavar. In the study, resminostat was administered alone and in combination with Nexavar. In 24 evaluable patients, the treatments led to progression-free survival of 33.3% (resminostat alone) and 66.6% (combination therapy) after 12 weeks. Resminostat is an oral pan-histone deacetylase (HDAC) inhibitor. 4SC said it plans to consult regulatory authorities in the US and EU on advice for a pivotal trial with the substance. Last September, resminostat met the primary endpoint of overall response rate in a Phase II SAPHIRE trial to treat Hodgkin’s lymphoma. The drug was originally invented by German pharma Altana AG, which was acquired by Nycomed. 4SC used the windfall to buy assets left over following the restructuring of Altana’s former oncology portfolio.
The start of 2012 witnessed the tides turning in favour of small and mid-cap names in the European Life Sciences sector. Major global biotechnology indices like the NBI, BTK, and BIOTK are up over 15% year to date. The pace of...
The start of 2012 witnessed the tides turning in favour of small and mid-cap names in the European Life Sciences sector. Major global biotechnology indices like the NBI, BTK, and BIOTK are up over 15% year to date. The pace of the pick-up has been so rapid that those who were already positioned in small-cap names started thinking of taking profits, and those who had positioned themselves in big pharma to avoid anticipated market volatility were left second-guessing their defensive strategy. On the one hand, small-cap long-only funds are happy that their thesis seems to be working, and on the other hand long/short hedge funds see the opportunity to short the names which have rallied on newsflow that otherwise would not have impacted share prices. Now, the biggest lingering question is whether the party is over or if there is something left for latecomers. Despite the general market rally, at Kempen & Co we believe 2012 will be a year for stock picking when it comes to either beating the benchmark or generating an absolute performance in contrast to macro driven 2011 performance. The two major trends in 2012 that will benefit small- and mid-cap names in the Life Sciences sector will be partnering of clinical candidates and cost-cutting/outsourcing. The promise of products with external validation will drive valuations as long as the company has a cash runway of over 12 to 18 months. In partnering scenarios, there will be huge interest for potentially “best-in-class” and “first-in-class” candidates. To illustrate this point, Galapagos has seen its share price double in the last two months on the back of its potentially best-in-class JAK inhibitor. 4SC has seen a recovery in its share price after 2011’s vidofludimus disappointment in rheumatoid arthritis (RA) as its second drug resminostat reported data showing the potential to treat liver cancer where no other therapy seems to work. It is assumed that the market usually prices-in anticipated partnering deals into a share price after a key positive data point is achieved; however, at Kempen we believe that the companies with best-in-class or first-in-class drugs stand a fair chance of beating those expectations, leading to the share price jumps for which the biotechnology sector is known. Acquisitions have always taken centre stage in the Life Sciences sector, and we believe 2012 will see Big Pharma cherry-picking in small- and mid-cap space rather than mega-mergers. Antibodies will remain hot, as has already been seen with Amgen’s recent acquisition of Micromet. As far as earnings are concerned, FY11 performed well on a backdrop of positive macro developments, however Q1 guidance has not been as upbeat from corporates as one would expect. A cautious stance from corporates warns of volatility for the coming few months, but Big Pharma’s ever-growing hunger will pave the way for extraordinary returns for small and mid-cap Life Sciences firms.
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more