Erlangen/Stockholm - The German biotech company responsif GmbH and scientists from the prestigious Karolinska Institute in Stockholm, Sweden, have recently signed a cooperation agreement, which will bring a promising new treatment for cancer one step closer to clinical trials. The Swedish cancer researchers working in the Department of Oncology & Pathology in the Section for Experimental Oncology are now using an “anchoring” technique developed by responsif to pack tumour antigens into virus capsoids. The aim is to create an anti-tumour vaccine, which will mobilise the body's own immune defences against cancer cells. As part of the cooperation agreement, the Swedish scientists have obtained a license option for the specific use of the anchor technology. The agreement also gives them the option of acquiring industrial partners within the next two years to assist them in developing this technology up to market maturity. “Our consistent patent strategy has proved to be the right one”, commented Dr. Christian Reiser, Managing Director of responsif, recently at the BioTechnica in Hannover, Germany. “We are very pleased that these clinicians plan to deploy the anchor technology developed by responsif in the battle against cancer.” With the licensing agreement, the two partners have also entered into a scientific collaboration aimed at advancing the preclinical investigation of an anti-tumour vaccine based on the viral capsoid technology developed by the biotechnologists in Erlangen. The capsoid technology evolved from the idea of using Polyoma virus-like particles (VLPs) as delivery systems for tumour antigens. Since these particles do not contain any viral genetic information, moreover, they are not infectious. In addition to the anchor technology, responsif GmbH is working on another immunotherapeutic approach using autologous cancer cells from patients with advanced stage cancer. The company is a spin-off of the former Division of Molecular Therapy at november AG, a biotech company traded in the Prime Standard segment of the German Stock Exchange.
Jena – Almost 200 former Eastern German athletes who suffered devastating side effects after being given steroids as part of their training regime before 1989, have each received a9.250 in compensation from the German...
Jena – Almost 200 former Eastern German athletes who suffered devastating side effects after being given steroids as part of their training regime before 1989, have each received a9.250 in compensation from the German manufacturer Jenapharm AG. The company, today a subsidiary of Bayer AG, developed the synthetic male steroid hormone Turinabol in the 1960s. Together with a gain in muscle mass, the compound caused side effects such as uncontrollable weight gain, beard growth in women, infertility and unprovoked aggression. The victims will each receive a total of a30.000 with one third coming from the company and the rest from the local Olympic Association and insurance companies. The total cost to Jenapharm will be a1.7 million.
Berlin – After years of negotiations, the German governing coalition has agreed on principles for a new law on genetic engineering. Agriculture minister Horst Seehofer has evidently succeeded in resolving most of the key...
Berlin – After years of negotiations, the German governing coalition has agreed on principles for a new law on genetic engineering. Agriculture minister Horst Seehofer has evidently succeeded in resolving most of the key questions. However, clear definitions of the rules for good farming practice have yet to be defined. This is important as the liability for commercial losses by admixtures of GM crops in conventional products is important for farming and biotech associations. The planned law specifies that only GM presence over 0.9% requires compensation. Even for cases in which the farmer had violated the good farming conditions a voluntary self commitment – solely funded by the industry – shall compensate possible commercial losses. A key element of the good farming practice and the new law will be species-specific separation distances from fields containing GM crops and conventional fields. In the case of maize, the ministry proposes a 150 metres distance. Thereby, Germany’s rules would be in the European midfield. Whereas some GMO-sceptical countries propose distances of 400 metres (Hungary) or 800 metres (Luxembourg), the Czech Republic (70 metres) or The Netherlands (25 metres) have established more liberal rules. According to the proposal, personal arrangements between neighbouring farmers are possible. Changes to the site register, which was often used by environmentalists to identify GMO fields, are also planned.
Changes to field register
Under the current genetic engineering law, the publicly accessible section of a GMO registry contains the precise coordinates of all plots on which GM crops are grown. In future, this section will show only the district. However, farmers who grow GM plants must inform their neighbours of the fact. GM crops are unpopular among the majority of the German citizens. Thus, even in the governing parties, the principles were heavily debated.
Vienna/Berlin – Biotech and pharma organizations have criticized the new second-opinion system which the German government installed in the reform of the country’s healthcare system. With these measures, the government hopes to...
Vienna/Berlin – Biotech and pharma organizations have criticized the new second-opinion system which the German government installed in the reform of the country’s healthcare system. With these measures, the government hopes to cut healthcare costs by allowing expensive treatments – many of them biotech-derived – to be re-evaluated by a second physician. In Austria, one of the country’s largest trade unions AKNÖ (Arbeiterkammer Niederösterreich) has begun an advice service for workers who have received negative decisions under Austria’s second-opinion system for expensive medicines. The union installed a hotline which members can call to receive advice on how to overturn medical opinions issued by a specialist. It advises patients on the procedures for appeals and who to contact. The AKNÖ says that legal action should always be considered as a last resort, as the outcome is too unpredictable. The second-opinion system in Austria has come in for heavy criticism over an alleged lack of consistency in the decisions.
Heidelberg – Scientists at Heidelberg University have successfully completed Germany’s first HIV experiments on rats implanted with human genes. The tests may provide a viable animal model for antiretroviral drugs testing that...
Heidelberg – Scientists at Heidelberg University have successfully completed Germany’s first HIV experiments on rats implanted with human genes. The tests may provide a viable animal model for antiretroviral drugs testing that could give an accurate efficacy and safety portrait before the onset of human trials, says the University of Heidelberg. The research was conducted under the direction of Professor Oliver Keppler at the university’s virology department. His findings seemingly solve the problem of HIV’s infectiousness only in humans and certain other primates, which limits the ways that drugs can be tested. In certain rat cell lines, cellular entry constitutes the only absolute block to HIV-1 replication and this restriction can be overcome by coexpression of human CD4 and the human chemokine receptor CCR5, which comprises the cellular HIV receptor complex.
The almost complete sequencing of the genomes from numerous organisms paved the way for the development and application of new experimental and instrumental techniques which contribute to the understanding of complex biological...
A powerful tool for the investigation of biological systems is enzymology. Enzymology has made vital contributions to medicine and basic science long before the -omics-era. The past twenty years or so have shown rapid progress in structural and molecular biology including the study of enzyme structures, their interactions, their mutants and at least the study of activity and catalytic reaction rates. Thus, cell machinery is currently envisaged as a complex inter-relationship of enzymes, proteins and chemical compounds. However, both a large number of metabolic pathways and enzymes even in well-described pathways still remain unknown. It is therefore necessary to develop further experimental and mathematical methods to reconstruct unknown parts of the networks, to identify genes for missing enzymes and to characterize the kinetic behaviour of those enzymes that have been identified.
Quantitative compilation of data requires standardization
The enormous growth in the computation speed and data storage capability has fuelled new opportunities for both the accumulation of massive amounts of sequence, expression and functional data and the characterization, analysis and comparison of larger biological systems. Moreover, modern experimental techniques provide apparently endless opportunities to generate huge amounts of sequence, expression and structural data. The impact of these enormous data collections only becomes apparent after systematic compilation and organization of the results. This is obvious for sequence databases and protein structure databases. However, little effort has been invested in the systematic characterization of enzyme functions and therefore functional enzyme data have either limited accessibility or availability. Systems level investigation of genomic and proteomic scale information requires incomparably higher demands for data quality than in previous decades. Truly integrated databases that deal with heterogeneous data need to be developed to be able to retrieve properties of genes, for kinetics of enzymes, for behaviour of complex networks and for the analysis and modelling of complex biological processes.
Relevance of standardized
Despite fast paced global efforts in biological systems research, current analyses are limited by the lack of available systematic collections of comparable functional enzyme data. This may be because comprehensive analysis and compilation of enzyme data is less attractive for two possible reasons: deriving such data from experimental work is expensive and very time consuming, and it is inherently very difficult to collect, interpret and standardize published data since these are widely distributed among journals covering a number of fields, and the data itself is often dependent on the experimental conditions. On the one hand, strictly comparable and reliable experimental and computational data of high quality are required for the investigation of the catalytic mechanisms of enzymes and pathways, for the understanding of the contribution of complex pathways to human pathophysiology and disease, for biotechnological applications, for the representation of structure-function relationships, and for the generation of a enzyme compendium. On the other hand, reality sadly looks different. A brief examination of some enzymological and methodological data for the key enzymes involved in glycolysis found in the BRENDA database has shown that the functional enzyme data are fragmentary and that for some enzymes there is no functional information at all. This is clearly not the fault of the BRENDA database but arises from the inadequacy of the data in the literature. It is obvious that experimental data are highly dependent on the experimental conditions used but unfortunately the descriptions of experimental conditions in the materials and methods sections of many publications are often incomplete. Furthermore, the investigation of the material & methods sections of the appropriate publications revealed fundamental differences in the application of obviously commonly used methods. In conclusion, what we observed was both incomplete descriptions of material and methods in the papers and difficulties considering method-dependent results. These issues have been recognized most clearly in the measurement of enzymes in terms of the catalyzed rate of the reactions. In general, method dependency is the sum of a number of experimental variables: pH, the nature of buffers used, temperature, the presence of activators and inhibitors, as well as enzyme and substrate concentration. It is obvious that reliability and comparability of enzyme data are vital requirements for the analysis of biological systems. Researchers are often faced with the problem of the range of method-specific enzyme data ranges associated with individual methods found in databases or in the scientific literature. This indeed causes inconveniences when data move between researchers whose data are supplied by laboratories that employ different methods, and in the worst cases can lead to misinterpretations of laboratory findings. Thus, it is hard to imagine that metabolic simulation and modelling can be carried out with any degree of success on the basis of poor or incomplete data, fragmented descriptions of methods and broad differences in the application of commonly used methods.
It appears to be perfectly obvious that adopting a set of recommendations or standardizations could solve these problems. The term standardization may be used in several contexts: the putative easiest but self-evident way to reach comparability of enzyme data is Good Publication Practice. Here, materials, methods and results from functional enzyme experiments are published in a comprehensive way according to a guideline of recommendations as suggested by the STRENDA initiative, which was inaugurated under the auspices of the Beilstein-Institut in 2003 . The second goal of this initiative is the generation of a comprehensive data acquisition system, which allows authors to electronically submit their experimental data to a public database prior to publication . But there are at least two further meanings of standardization; to achieve a uniform standard of practice in terms of experimental conditions and methodology or to use enzyme reference material in methods which are themselves different. The reference material can have several applications such as for the development of reference methods, for the comparability of measurement results from specified methods and as calibrators. Calibrators can be standard enzymes whose properties are well known or defined against which experimentally generated enzyme data can be compared.
Clinical enzymologists have dealt with the problem of limited data comparability for about 30 years. The need for consistency of enzyme activity results from human samples was recognized at an early stage taking into consideration that these results should ideally be independent of reagent kits, instrumentation and the laboratories where tests were carried out. Consequently, the improvement of inter-method comparability of patient’s results was and still is the primary goal of clinicians. Thus, over the last 20 years the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has been concerned with the definition of guidelines on standard operation procedures for a number of certain enzymes. For instance, after about 80% of laboratories in the UK NEQAS (United Kingdom National External Quality Assessment Schemes) adopted the method for the measurement of creatine kinase activity as recommended by IFCC the inter-laboratory agreement was below 10% coefficient variation . However, despite the fact that the encouraged widespread use of these recommendations by the clinicians caused some success in increasing the quality and comparability of enzyme data, it seems to be a common agreement among clinicians that this approach has reached its limits of improvement. The difficulties of the establishment of standardized experimental conditions can be ascribed to the question whether the scientific community is ready to adopt a particular experimental specification while the consequent lack of a clear advantage of one method over another provides no incentive for users. The lack of this advantage can derive from the fact that analytical methods undergo constant development and improvement resulting in a slow response of method recommendations. Furthermore, these recommended methods could become corrupted, either inadvertently through misinterpretation, or deliberately to accommodate the limitations which are caused by automated instrumentation. And last but not least, after successful agreement on these methods it is necessary to convince researchers to avoid apparently popular methods and to adopt methods which show good inter-laboratory agreement to gain the full advantages of participation. Due to the shortcomings of the recommendation of a single and universally valid method, the requirement of additional components to the standardization of methods became simultaneously visible [6,7]. In particular the IFCC recommendations suffered from the fact that some characteristics proved to be impractical to be transferred to routine test practices such as temperature, the need for a sample blank, long reaction times and limited linearity . This drove the development of enzyme reference material as enzyme calibrators to be an additional component of standardized measurement procedures. The introduction of validated enzyme calibrators to determine enzyme activities replaced the use of theoretical and computational factors, which were usually dependent on the analytical system and allowed the transfer of specified methods. In 1998, guidelines for the validation of enzyme calibrators were published by the IFCC Working Group on Calibrators in Clinical Enzymology . Besides the specification, a series of advantages of the use of enzyme calibrators were described as the compensation of experimental variations since both enzyme calibrator and specimen are affected in the same manner, and the correction of undetected systematic errors by these calibrators. Also in 1998, at the IFCC General Conference in Seville, Spain, the project of a global reference system for the measurement of catalytic concentrations of enzymes was set up which included standardized measurement procedures, the creation of a network of reference laboratories at which those measurements would be carried out, and a certification system for enzyme calibrators . It is generally anticipated that the combined application of specified methods and enzyme calibrators would result in an improvement of inter-method agreement and in an increase of the reliability of routine enzyme test methods. However, the main disadvantages of this kind of standardization should not be concealed: There is only a relatively small number of standards of specific enzymes available and those which are available are very expensive, which means that – due to cost-reducing reasons – the introduction of a two-step quality system may be required consisting of master calibrators certified against certified reference material, and working calibrators certified by a reference method against the master calibrator.
The business of clinical enzymologists is to monitor the activities of known enzymes, which play specific roles in certain organ dysfunctions by using standard assays and reference materials. The result leads to valid diagnosis of the disease and to therapy. However, applied enzymology depends on standardized approaches and thus these standards are usually limited to routine test procedures in human healthcare. By contrast, for a high degree of comparability, enzymology in basic research relies, as a first step, on functional enzyme data, which includes minimum experimental information available from the literature along with their accepted enzyme names. The difficulty in basic research compared to clinical enzymology is that there are a variety of different organisms, e.g. plants, animals, fungi, and bacteria growing under a variety of different environmental conditions which themselves influence the presence and activity of the most current enzymes. Additionally, the location within organs, tissues and cells affect the behaviour of the enzymes. The physiological conditions are often unknown and therefore hardly to be mirrored in experiments. That is why, the STRENDA group set up a series of guidelines for enzyme data reporting to improve comparability, validity and reliability of these data . Since, as long as the data quality of the input and the resulting modelling data cannot be improved, the chances of this young discipline successfully escaping the verbally overused –omics-sciences are poor. One perspective of the output can be the investigation of cellular pathways involved in disease biology and targeted by newer molecular therapeutics. The understanding of these processes will assist the development of early diagnosis, prognosis and the prediction of
response to individual therapies. Due to this joint endeavour, it can be presumed that basic researchers could, at least partially, adopt the standardization methods of clinicians.D
References  www.strenda.de  Kettner, C. & Hicks, M.G. (2005) Current Enzyme Inhibition 1:171-181.  www.brenda.org  Apweiler, R., Cornish-Bowden, A., Hofmeyr, J.-H.S., Kettner, C., Leyh, T.S., Schomburg, D., Tipton, K. (2005). TIBS 30(1):11-12.  Moss, D.W. (1997). Ann. Clin. Biochem. 34:13-16.  Jansen, R.T.P. & Jansen, A.P. (1983). Ann. Clin. Biochem. 20:52-59.  Bowers, G.N., Jr. McComb, R.B. (1984). Clin. Chem. 30(7):1128-1136.  Panteghini, M., Ceriotti, F., Schumann, G., Siekmann, L. (2001). Clin. Chem. Lab. Med. 39(9):795-800.  Férrard, G., Edwards, J. Kanno, T., Lessinger, J.-M., Moss, D.W., Schiele, F., Tietz, N.W., Vassault, A. (1998).  Siekmann, L. (2001). eJIFCC, vol.13, no 3:www.ifcc.org/ejifcc/ejifcc/vol1no3/130301002n.htm  Robert Alberty, Rolf Apweiler, Kristian Axelsen, Athel Cornish-Bowden, Richard Cammack, Roland Eils, David Fell, Jan-Hendrik S. Hofmeyr, Hermann-Georg Holzhütter, Minoru Kanehisa, Carsten Kettner, Ursula Klingmueller, Nicolas LeNovere, Thomas S. Leyh, Friedrich Lottspeich, Dietmar Schomburg, Stefan Schuster, Mark Stitt, and Keith Tipton (2006). Nat. Biotech. submitted.
The Austrian vaccines developer Intercell AG has won this year’s European BioTechnica Award and will certainly be pleased to receive a cheque for the sum of a20.000. Europe’s most prestigious prize for a young biotechnology...
During the awards ceremony in Zürich – to which the three above mentioned finalists (Intercell, Genmab and Amaxa) were invited – Intercell scientific board member and founder, Alexander von Gabain thanked the jury and was presented with the prize by the German Federal Minister for Education and Research, Anette Schavan. The highly respected BioTechnica jury based their decision on Intercell’s impressive endeavours in research and development, which have already led them to enjoy brand name status in the market. Since their foundation in 1998, Intercell have become one of the most successful companies in the European biotechnology industry, a fact that is not least reflected in their stock market value.
With 140 employees in 16 countries Intercell will continue to be regarded as innovative, efficient and quality driven in the development of so-called “smart vaccines”. A number of joint ventures with other international pharmaceutical companies have provided Intercell with a yearly turnover of a8.5 million. In awarding the second prize the jury likewise recognised Genmab’s strong commitment to the development of therapeutic antibodies with which cancer, infectious diseases, as well as rheumatoid arthritis and other inflammatory diseases can be treated. Partnerships forged by Genmab with established pharmaceutical and biotech organisations such as Roche, Amgen und Serono helped Genmab achieve a turnover of a13.2 million last year and confirmed the jury’s opinion. The winner of the third prize, Amaxa GmbH of Cologne, have distinguished themselves with their system of non-viral transfection of primary cultures, as a real breakthrough in presenting drug development in research and industry. Amaxa’s turnover in 2005 amounted to a16.6 million. Karsten Henco, who as jury member deputized for the unwell chair Peter Stadler, praised, above all, the high quality of the entrants and the high level of internationalism in evidence: “All three of the placed companies are winners because they will all benefit from having participated at this year’s BioTechnica Award with their convincing concepts”.
Exchange of ideas
In her closing address, in the presence of around 200 invited guests, the German Federal Minister Anette Schavan emphasised that the competition leads to further European cooperation and the development of Europe into an attractive location: “The exchange of ideas and knowledge is gaining more and more importance. We all profit from the cross border transfer of knowledge. Holding the European BioTechnica Awards in Zürich is an important sign of borderless cooperation”.
Following the European Commission’s green light for the merger of the two US lab suppliers Thermo Electron and Fisher Scientific, the market is expected to see a further consolidation. Industry analysts have commented that the...
The EU commission has given clearance to the announced merger of Thermo Electron and Fisher Scientific. The combined company, Thermo Fisher Scientific, will have revenues of more than $9 billion and will employ more than 30,000 people worldwide. Earlier, the US antitrust regulators had given their ok for the deal. Like the EU authorities, the US officials demanded that Thermo Fisher divest their Genevac business. “This is not crucial at all for the merger. Fisher’s evaporator business only generated sales of $17 million last year. We put Genevac up for sale and will have completed the transaction within the next six months”, Thermo Fisher CEO Marijn Dekkers told EuroBiotechNews.
“Finely tuned instruments and chemicals”
The Dutch native Dekkers joined Thermo as Chief Executive in 2000 and led the company through a large number of acquisitions. “Through this enhanced merger we will be able to fine-tune the analytical instruments sold by Thermo with the consumables and reagents from Fisher. This gives us the opportunity to rationalize research processes in the labs of the pharmaceutical, chemical and biotech industry”, said Dekkers. Furthermore, the combined business cushions Thermos’ cyclical instrument business, which could suffer from slowed-down pharma growth. “You would only buy a new car in good times, but if you decide to continue driving your old one, you’ll still need gasoline”, explains Dekkers. Industry analysts have commented that the merger reflects broader changes in the industry, as customers seek to control costs by using suppliers which are able to provide their research scientists with a fully integrated range of lab services. Dekkers describes the merger as “industry transforming” because “what we will do is to create the world’s only provider of fully integrated, end-to-end solutions to the life sciences, laboratory and health sciences industry”.
Siemens, General Electric and Philips before entry?
Tech analyst Ross Muken of Deutsche Bank comments: “I think we will see a series of players coming together, and then we’ll see larger conglomerates like General Electric and Siemens becoming more aggressive”. Dekkers agrees: “I think we are now on the radar screens of the big companies.” Siemens has made two acquisitions this year and paid a5.7 billion for the US company Diagnostic Products Inc. and for Bayer’s diagnostics business. Although these transactions are more on the diagnostic side, experts say it could well be that a consolidated lab supply market could attract companies, which currently only manufacture and sell medical equipment. The new cash flow generation possibilities would also make it easy for Thermo Fisher to grow via acquisitions. But CEO Dekkers wants to dampen such speculation: “It could well be that we will attach smaller businesses to our company. But we are not eying companies of the size of Fisher”. Thus, companies that used to compete head-to-head with either Thermo or Fisher are now under pressure to grow. Kevin Hrusovsky, CEO of Caliper Life Sciences says this merger will provide “the assets to do something pretty formidable and which could could cause everyone in the industry to pause and try to figure out how to participate around Thermo Fisher, due to the strengths they may have in their sectors.” The chief executive adds: “Our strategy is to go after high-performing transformative technologies, develop relationships with customers where we can introduce those technologies, and show them how to use them. This allows us to grow those technologies organically”.
Geneva – In a surprising move, Serono’s majority owner and CEO Ernesto Bertarelli has found a buyer for his company Serono. German drug maker Merck KGaA is to buy the 64.5% stake owned by the Swiss Bertarelli family. The bid of...
Geneva – In a surprising move, Serono’s majority owner and CEO Ernesto Bertarelli has found a buyer for his company Serono. German drug maker Merck KGaA is to buy the 64.5% stake owned by the Swiss Bertarelli family. The bid of CHF 1,100 per share values Europe’s biggest biotech company at CHF16.6 billion (a10.6 billion) and includes a 20% premium on the final closing price before the offer. Combined, Merck and Serono would have pro-forma pharma sales of a3.6 billion, with biotech product revenues accounting for a1.6 million a year. This would place the new company, called Merck-Serono Biopharmaceuticals, at seventh place worldwide, well below major biotech players such as Amgen (a10.7 million) or pharma/biotech conglomerates such as Roche or Wyeth, which have a7.5 million and a5.4 million in biotech revenues respectively. Besides gaining a larger worldwide presence, including sales forces in the US and Japan, Merck CEO Michael Römer said that one of the main goals of the merger was to achieve a critical mass in research spending. Here, Merck-Serono ranks 16th with an annual budget of a1 billion. The combined pipeline of Merck and Serono includes 28 drug candidates, among them five in phase III. The headquarters of Merck-Serono bio-pharmaceuticals will be Geneva.
A newly identified receptor protein for the soluble vascular endothelial growth factor (VEGF) inhibits angiogenesis in the retina of patients with the aggressive wet form of age-related macula degeneration (AMD). With the help of...
The publication backs a new drug in Phase II development licensed-in by Bayer Schering Pharma AG from Regeneron Inc. (Tarrytown, US) in late October. The US-company has developed a VEGF trap, consisting of a fusion protein that binds VEGF-A and VEGF-B by its two Fab domains, which are fused to a human Fc part. In pre-clinical trials the antibody drug seemed to be superior to Genentech’s revolutionary AMD drug Lucentis, a VEGF-FabV2 fragment approved by the FDA in June, which will be marketed in the European Union by Novartis Ophtalmics by July 2007. Experts told EuroBiotechNews that it seems to be essential for drug efficacy which kind of VEGF is targeted. This might be a drawback for Pfizer‘s AMD drug Macugen, the very first VEGF inhibitor approved for AMD treatment. The aptamer drug binds specifically to VEGF-165 but was disappointing in clinical practice, according to ophtalmologists. “You can inject it for several times but the eye stays wet”, says Claudia Keilhauer from Würzburg Medical School. It’s the same with Novartis’ Visodyne, a systemically administered photo-reactive dye, designed to destroy the blood vessels in the macula after illumination, claims Keilhauer. “It can only halt but not reverse the progressive loss of vision.”
Off-label product challenges
drugs on market
The two already- approved drugs are under pressure by Genentech‘s VEGF inhibitor fragment Lucentis, which partly leads to remission of wet AMD. Analysts predict that the truncated form of Genentech’s colon cancer blockbuster Avastin will take 65% of the AMD market soon, according to Nature Biotechnology (24 (9), 1041-1042). But clinicans in the US as well as in Europe think differently, since the Miami-based ophtalmologist Philip Rosenfeld discovered in 2004 that even Avastin, the ‘big brother’ of Lucentis, works well in wet AMD. “The critical point is when it comes to costs”, according to the German AMD expert Bernhard Weber from Regensburg University. ”You can ask experts at all Medical Schools and Centers. They are all using the off-label product for treatment.“ “We have sensational results with Avastin, and no side-effects up to now”, confirms Keilhauer, “and it is significantly cheaper than Lucentis. Nobody really believed before that the full-length VEGF inhibitor would penetrate the retina, but obviously it does.” The finding is backed by clinical results. Doctors as well as clinical trials with up to 100 patients each tell of remissions after a few shots of Avastin. “Why should I use Lucentis, which costs a1,700 a shot or Macugen for a1,500 when I can have the same effect for a9, plus injection with Avastin?” asks Keilhauer. “Its so cheap because we need small quanitites per injection.” But whilst currently nine trials with Avastin in AMD treatment are underway, the doctors will have a problem, when drugs with the same efficacy enter the EU market. This might change if a head-to-head trial with 1,200 volunteers will start under coordination of the US National Eye Institute. It is to be the first large clinical trial which will compare safety and efficacy of Lucentis vs Avastin directly. Whilst Genetech said it would have no intention to support the trial, sponsorship of the trial is currently unclear. if Genetech would not support the trial, the Eye Institute woud have to buy the compounds on its own.
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