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March 2005 |
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Next ACTIP meeting
The next ACTIP meeting will be held in Lund, Sweden
On June 16-17, 2005
The two central themes of the meeting will be 'Production technology' and 'Stem cell therapy'. Please contact the ACTIP Secretariat if you have suggestions for speakers (ACTIP Secretariat.)
Newly added to the secure page on the ACTIP website:An article and table with the results of the PhRMA survey 2004 on 324 biotechnology medicines in development. Includes information on development stage. Also on the secure page a fact sheet with key data on biologicals (including monoclonal antibodies) on the market and in development, published by EuropaBio.
In this issue:
Improved dissemination of clinical trials' results About biogenerics, patent expiry and evergreening Nanotechnology: issues for business
News from the Commission
Strong support for Commission's future R&D policy objectives
Analysis of the stakeholder consultation held last year June on Internet shows that Commission's plans for future science and research policy are on the right track. The consultation gathered reactions from over 1700 organisations and individuals. One third of the responses was received from individuals and one fourth from academic world. The objective of 'Making Europe more attractive to the best researchers' clearly ranks as the highest with nearly 100 per cent of stakeholders considering this priority very important. Each of the five other priorities set out in the June Communication received an equally strong, broad support. However, space and security related research, the two additional, specific priorities identified in the Commission's communication, received substantially lower support from the stakeholders, who stressed that such research "must strike the right balance with fundamental liberties, human rights and social values". Source: EurActiv News, December 22, 2004
Preparatory work underway for a European Research CouncilOn January 25, a first meeting took place of the Identification Committee convened by the European Commissioner for Science and Research, Janez Potoènik, to recommend the composition of the governing body of a future European Research Council. The Commissioner is keen to ensure that the European Research Council will remain scientifically independent, which is why he has asked Lord Patten to chair a group of experienced and respected scientists to identify possible members of the governing body. The members of the Identification Committee are:
The establishment of the European Research Council will be included in the proposal for a Seventh Framework Programme for Research and Development that the Commission will present in April 2005. A European Research Council will focus on basic investigator-driven research, in recognition of its importance for future innovation and economic growth. The Commission's intention with the creation of such a mechanism is to focus on scientific excellence, identified by fellow scientists, rather than the Commission. Source: Press Release European Commission, January 25, 2005 Slight increase in EU R & D investmentThe EU's goal under the Lisbon Agenda is to increase research and development (R&D) investment to at least 3 percent by 2010, with at least two thirds of the total expenditure coming from the private sector. The EU falls far short of reaching this objective. A Eurostat report on R&D expenditure in the EU, published on 24 February 2005, covers the developments in the EU-25 from 1998 to 2002/2003. R&D expenditure: The EU-25's R&D expenditure saw a total annual increase of 4 percent between 1999 and 2002 (only 2.7 per cent in the US, and 2.2 per cent in Japan). The fastest annual growth rates, more than 11 per cent, were registered by Estonia, Cyprus and Hungary. R&D intensity: EU R&D expenditure as a percentage of the GDP grew from 1.82 per cent in 1998 to 1.93 per cent in 2002. R&D expenditure in the US increased to 2.76 percent in 2003 and to 3.12 per cent in Japan in 2002. At this rate, the Barcelona objective of spending 3 per cent of the GDP on R&D will be achieved at 2045. Public and private sector funding: European business financed 55 per cent of the total R&D spending in the EU, whereas the shares of the private sector in the US and Japan were significantly higher - 67 percent and 74 percent respectively. However, in Sweden, Finland and Ireland more than two thirds of the expenditure was financed by the business sector. Source: CORDIS News, January 11, 2005
…. but serious decline in EU industrial R&D investmentThe first European industrial R&D investment scoreboard reveals that investment in R&D by the top 500 European companies between 2002 and 2003 fell by 2%, whereas for the non-EU 500 companies it grew by 3.9%. The scoreboard, which was produced as part of the European research investment action plan, makes it possible to compare research investment among EU companies and sectors, and with US and Japanese companies. Europe is seriously lagging behind in its objective of increasing investment in research to three per cent of GDP by the year 2010. The first industrial R&D investment scoreboard providing a full picture of the competitive situation of EU firms in the global R&D environment shows that European R&D investment is declining and highly concentrated along three dimensions:
To raise the number of European "industrial R&D champions we need to create an environment that supports such investment", said Janez Potoènik, the commissioner for science and research. However, "the commitment of the companies themselves is crucial". Source: EurActiv News, January 14, 2005
Fall in innovative productivity in pharmaceuticalsSince 1999, the number of applications for approvals on new drugs has fallen from 27 to 17, says a recent report commissioned by the European Commission. The report indicates that the decrease in innovation is due mainly to three type of factors: the increase in costs of developing new and innovative drugs, the expected low return from innovation and industry restructuring (mergers and acquisitions). To encourage innovation in the sector, the report recommends that the Commission, member states and industry co-operate closely on a number of issues. These include improving communication between regulatory authorities and industry during the key phases of product development, co-ordination of tax incentives for research and development and improving public-private co-operation in research. The upcoming Luxembourg and United Kingdom presidencies of the European Union have signaled in their common draft programme that "improving the state of the competitiveness of the pharmaceutical industry" is one of the priorities of the innovation and enterprise policy area. Source: EurActiv News, December 15, 2004
Pharma and biotech industry thriving in 'new' EUThe pharmaceutical and biotechnology industries in the 'new' EU countries are rapidly expanding, presenting considerable potential, although parallel imports remain a challenge. That is the verdict of a report from Frost & Sullivan, which has shown that while the old EU has been increasing at eight per cent annually, the new EU has grown at a rate of 16.5 per cent over the past five years. Globally, the EU healthcare industry is the second largest after North America. Estimated at nearly $7.0 billion (5.3 billion euro's), the pharmaceutical market in the 'new' EU countries', Cyprus, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Malta, Poland, Slovakia and Slovenia, represents about eight per cent of the EU 15 market. Both Poland and Hungary, which contribute 45 per cent and 23 per cent of the accession countries' total pharmaceutical market value respectively, have been growing by almost 20 per cent since 1998. Propelled by the advantages of low costs and easy patient recruitment, the 'new' EU offers tremendous scope for conducting clinical trials. Already, large multi-national pharmaceutical and biotechnology companies from Western Europe and from the United States are carrying out clinical trials on rare diseases and diseases relevant to large worldwide markets. With big pharma not dominating the 'new' EU market as it does the EU15 and the United States, the top position in four 'new' EU countries is still occupied by a local participant, acquiring a local company offers a means to gaining a foothold. Source: In-pharmatechnologist.com News, February 21, 2005 Recent EU projects
Blue biotechnology projects to exploit the seaThe European Commission has invested in a FP6 Network of Excellence called Blue Bio-net aimed at exploiting the sea for drug development. The project aims to network together researchers and companies. Institutes and companies interested in the effort are encouraged to contact the coordinator. For more information: schimmel@bis-bremerhaven.de Another recently started project funded with 10 million Euros is also a Network of Excellence: Marine Genomics, aiming to integrate approaches throughout Europe. One example will be the development of high-throughput gene sequencing techniques for the study of marine biology. Another aspect is offering partners access to technology platforms, for example experimental equipment and databases that integrate the produced data. The network brings together 44 institutes from 16 EU countries. Further on marine biotechnology: Spanish PharmaMar started in 2004 a Multicenter phase II trial of Aplidin, a novel marine anti-tumor agent derived from the marine tunicate Aplidium albicans, in small cell lung carcinoma. Source: EuroBiotechNews no 6, vol 3, 2004
10 million euro to biocrystallographyA 10 million euro grant from the EU will allow researchers throughout Europe to advance their research in the field of 'biological crystallography,' which aims to create precise, 3-D "architectural" models of biological molecules. The EU project BIOXHIT ((Biocrystallography on a Highly Integrated Technology Platform) plans to integrate and develop technologies at European centres for research in structural biology. One immediate effect of BIOXHIT will be a reduction in the time involved in obtaining each structure. The project specifically calls for improvements in the process by which samples are handled, the equipment needed to detect X-ray patterns, and the computers and software needed to model structures. One result of this might be to attract more researchers to work on protein structures. Source: CORDIS News, February 11, 2005
Cutting production costs of monoclonal antibodiesThe European Commission has launched an 11.4 million euro project to identify ways of improving the production of biologic drugs. The AIMs (Advanced Interactive Materials by design) initiative has brought together 24 partners from industry, academia and other organisations from 12 European countries and is supported by Sixth Framework Programme (FP6) funding. The four-year project, coordinated by Andrzey Gorak of the University of Dortmund in Germany, aims to find improved ways of making monoclonal antibodies (MAbs). The project will specifically aim at reducing costs in the downstream processing stage, which is estimated to make up 50 per cent of he total cost of goods for biological drugs. "The overall goals are to cut process development time by half and to reduce cost of goods by a factor of 10 to 100," according to Dr Gorak. The project will look at a range of purification technologies &endash; including membrane filtration, chromatography and ligand binding &endash; and try to develop ways of integrating them to speed up and increase the efficiency of the process. Industrial partners in the contract are German company Bayer and Dutch contract research organisation Syncom, which will be tasked with designing soluble supports for liquid/liquid extraction systems. Source: CORDIS News, November 25, 2004 Improved dissemination of clinical trials' results
The representative bodies of the innovative pharmaceutical industry at the European, US, Japanese and international levels have pledged to increase the transparency of the clinical trials sponsored by their corporate members. The voluntary commitment follows a series of withdrawals of a number of high-profile drugs which has cast doubt over the safety of drugs, especially in the US. The fast authorization system applied by the US's Food and Drug Administration was often cited as a good example for the EU when it comes to 'cutting red tape', notably in the review of the EU's pharmaceutical legislation which was completed last year. One of the issues which has come to the fore in the past few months is the pharma industry's lack of transparency concerning clinical data submitted with requests for authorisations. The industry has been accused of tending to publish positive results and hiding negative or inconclusive data. The pharma industry has thus committed to publishing the results of clinical trials for drugs which have been approved for marketing to a free, publicly accessible internet database regardless of the outcome and within one year from the first approval of the drug. In addition to completed trials, the pharma industry undertakes to publish basic information concerning ongoing clinical trials within 21 days of the initiation of patient enrollment and to do so in lay language. "By making public not just the results of trials that have taken place - whether positive or negative - but also information on those that are just starting, the industry has made a major step towards achieving greater transparency," said Brian Ager, the Director General of EFPIA, the representative body of the European innovative industry. Source: Euractiv News, January 6, 2005. For more reading, see also:
About biogenerics, patent expiry and evergreening
A recent report, published by Cutting Edge Information, estimates that biogenerics would command more than $12 billion (9.1 billion euro) of the drug market by 2010. By 2004, $13.5 billion in global sales worth of insulin, beta interferon and alpha interferon drugs will lose their patents. Front Line research estimates the size of the generic biologics market will reach $30 million worldwide in 2003 and nearly $12 billion in 2010. On average, branded drugs lose 15-30 per cent of their market share when a first generic version reaches the market. Sales erode as much as 75-90 per cent when subsequent generics launch. The first opportunity into generic biologics is likely to be open via insulin and human growth hormone. Unlike other biological products, these drugs receive FDA approval under the standard New Drug Application (NDA) process. The first generic forms of these drugs will expect to gain FDA approval within the next two to three years. Generics pioneers will be rewarded for entering this market &endash; recombinant human insulin and erythropoietin are projected to account for 27 per cent and 36 per cent of the biogenerics market, respectively, by 2010. The report also details companies' strategies and tactics for fending off generic competition and retaining market share. One such strategy that could help pharmaceutical brand teams block sales erosion is evergreening, the practice of producing improved versions of the branded drugs before their patents expire. An example of this is Amgen, which launched second-generation product Aranesp, an improved version of EPO, to render generic forms of the first-generation drug obsolete before they could even reach the market. Another example is AstraZeneca, which faced in 2001 patent expiration for one of the world's top selling drugs, Prilosec. The company set the bar for evergreening with the launch of Nexium, a second-generation drug to replace Prilosec. AstraZeneca actually grew its share of the gastrointestinal market after Prilosec's patent expired and generics and over-the-counter forms came to market. The pharmaceutical industry's biggest challenge is a regulatory one as there is no approval process for biologics not cleared for market under the USA NDA process. In addition it is not clear how much testing will be needed for drugs claiming to be comparable biologics. In contrast, the EU has become the first western market to formally clarify its approval process for biogenerics, passing legislation in June 2003 letting companies apply to sell generic versions of genetically-engineered drugs. As regulators seek to fine-tune the guidelines, biogenerics are likely to be evaluated individually. Also, new EU legislation due to take effect in 2005 should provide a boost to generics. With an ever-growing number of structural reforms in the pipeline, regulatory procedures will likely be streamlined to speed up the process of approving new generics. Source: In-pharmatechnologist.com News, January 6, 2005 Nanotechnology: Issues for Business
Many businesses have difficulty understanding the potential of nanotechnology and some are sceptical about its long-term potential. The term nanotechnology is a catch-all for any technology operating at 100 nanometres or less (a nanometre is 1 billionth of a meter). Although it is fairly advanced at the laboratory stage, it has proved more difficult to replicate on a commercial scale. Most of the current applications of materials nanotechnology are nano-particle based, and include sunscreens, cosmetics and thin film coatings for various objects. The use of nanotechnology is already delivering advanced products that could not be achieved using conventional technologies, however future applications of nanotechnology promise much more, with the potential for new and revolutionary applications across all sectors of business and industry. Here are some examples. Nanotechnology meets bioprocessingJapanese company GSI Creos has unveiled the first prototype of a new cell culture reactor that uses nanotechnology to support the growth of more cells than conventional reactors. The bioreactor could potentially boost the yield of biological drugs made in cells. GSI Creos exhibited its prototype at the Nano Tech 2005 exhibition, which opened at the Tokyo Big Sight exhibition on February 23. The system makes use of GSI Creos' proprietary Carbere carbon nanotube technology, used to form nanoscale cups that can be added to a bioreactor as a powder. Carbere has a unique herringbone structure of stacked bottomless cups, making them particularly suited for use as an additive with good dispersion properties. The result is a dramatic increase in the surface area for cell suspension. Initial experiments suggest that cells grow 30 per cent faster and lived 30 per cent longer than those grown in conventional reactors. The company is gearing up to provide Carbere prototype samples to laboratories in the pharmaceutical, medical and food sectors, so that specific applications of the technology can be explored. Source: In-Pharmatechnology.com News, February 24, 2005
Nanotech could be answer to gene therapy deliveryResearchers in the US (MIT and Lankenau) have shown that nanoparticles can be used to deliver genetic material into cells safely and effectively, potentially overcoming the primary obstacle to the development of gene therapy: the use of viral vector delivery systems (see the US death following gene therapy using an adenoviral vector and the French finding of a high number of leukemia cases following retroviral gene therapy in children with X-SCID). The nanotechnology-based approach used by the researchers has minimal toxic side effects to normal cells. The MIT group identified a polymer termed C32 capable of delivering genes to cancer cells more efficiently and with less toxicity than other polymers that have been tested in the field to date. C32 works by condensing the DNA in a gene and allowing the resulting nanoparticles that are formed to enter cells through a process called endocytosis. Therapeutic genes delivered to cells in this manner are able to drive cellular production of a gene-encoded protein through normal processes. The researchers used the polymer to deliver a genetically modified diphtheria toxin gene that would be produced only in prostate cells. When this was injected into the prostate tumours in animals, tumour growth was suppressed or reversed (in 40 per cent of cases), relative to untreated tumors. The results of the study were reported as a cover article in a recent issue of the Proceedings of the National Academy of Sciences. Source: In-pharmatechnologist.com News, January 25, 2005
Germany backs nanotech for medicineThe German government is the latest in Europe to start a programme to support companies and academics working in the emerging field of 'bionanotechnology'. Similar efforts to boost research in nanotechnology have already been unveiled in the UK and France. The Federal Ministry for Education and Research (BMBF) funded programme is aimed at supporting industry-led consortia that are working in the areas of pharmaceutics and medical technology. Key topics of interest include drug transport, nanoscale drug delivery systems, implantation and regenerative medicine, and in vivo diagnostic/molecular imaging. The Nanotechnology for Health and Society (NanoforLife) project is part of a wider set of government funding that has provided a fund of _50 million for bionanotechnology efforts between 2000 and 2006. The funding covers preclinical and Phase I clinical trials, and covers up to 50 per cent of costs for a company and up to 100 per cent of additional costs for research facilities. The submission deadline for NanoForLife is 15 April, 2005. Source: In-Pharmatechnologist.com News, February 14, 2005
Conference in BrusselsOn April 25-26, a conference will take place in Brussels devoted to issues for business in nanotechnology. This conference is applicable to all sectors of industry and all sizes of organization that have any involvement in manufacturing or producing goods. It is a critical event for those who want to understand the concepts behind nanotechnology, invest in the technology or incorporate it into their business strategy. The event will also be extremely useful for those currently involved in nanotechnology projects, especially those businesses needing to learn more about commercialisation and investing in the industry.
Nanotechnology: Issues for Business April 25-26, Brussels, Hotel President WTC Email: wtc.info@presidenthotels.be Website: http://www.presidenthotels.be/wtc/en/welcome.htm
Business News
Dutch scheme extends helping hand to biotech SMEs
The Netherlands has set up a programme to boost its biotechnology sector by helping small and medium-sized biopharma firms to develop and manufacture products. The scheme &endash; called BioConnection &endash; is a collaboration between the Dutch government, Akzo Nobel and the wider business industry, and is claimed to be the first 'one-stop-shop' in Europe to offer start-up biopharmaceutical companies the use of dedicated, centralised production facilities, as well as other activities such as formulation development. The aim is to provide a boost for the Dutch biotechnology sector, which ranks eighth in Europe with 138 companies at the end of 2003, employing 2,100 people and with an overall turnover of 170 million euro, out of a total European biotech sector turnover of 11.1 euro bn in the same year. Akzo Nobel's healthcare business Organon is at the heart of the project, and will house the BioConnection biotechnology centre at its Oss site in the Netherlands The Dutch government and Organon are putting _15m into the project, with the bulk of this money going towards the establishment of a lyophilisation (freeze-drying) unit at Oss. This is being built as part of Organon's previously disclosed plan to construct a new parenteral medicines production plant, due to come on-line in 2008. Similar schemes aimed at improving the access of small biotech players to development and production facilities have been set up in the UK and France, with the UK project leading the field at present with a dedicated facility &endash; the National Biomanufacturing Centre &endash; due to start operating in early 2006. Source: In-Pharmatechnologist.com, March 2, 2005
Acquisitions positions MorphoSys within top 5 antibody companies
On January 20, 2005, MorphoSys purchased 100 per cent ownership of Biogenesis Ltd and Biogenesis Inc, which will become wholly owned subsidiaries of MorphoSys. The acquisition of the Biogenesis group provides MorphoSys with an array of marketing options for the HuCAL antibody technology it has acquired in the deal. The antibody-generating HuCAL technology allows specific recombinant antibodies to be produced faster than existing animal based methods. The technology allows high-level expression of protein fragments for screening against the HuCAL Gold library using bioinformatic algorithms to select antigen sequences for expression and screening. The acquisition of Biogenesis is an important strategic step for Morphosys, in establishing its HuCAL technology in new antibody market segments. The latest acquisition follows the establishment of the Antibodies by Design unit in late 2003 to serve the research and diagnostics markets with custom monoclonal antibodies. While the therapeutic antibodies unit remains the key driver of the MorphoSys business, the expanded research antibodies unit becomes a more significant second pillar in the company's overall strategy. According to Datamonitor Healthcare the recombinant antibody market is a $32 billion industry with the prospect of future growth very significant. Figures from Frost and Sullivan place growth for the Monoclonal Antibody (mAb) therapeutics global market to increase to $16.7 billion in 2008. Although growth will rely on the rise of humanized and human antibodies, monoclonals, led by infliximab and rituximab (Rituxan; Genentech), will dominate with a 49 per cent market share in 2008. Humanised antibodies will follow, with sales forecast to reach $5.2 billion, or a 31 per cent market share by 2008. In addition, fully human antibodies with 2008 sales of $1.9 billion will capture 11 per cent of the market in 2008. Source: In-Pharmatechnologist.com, January 21, 2005
First licensee near for Crucell's STAR technology?Genentech is currently evaluating Dutch biotechnology company Crucell's STAR technology for the production of antibodies and other proteins, acquired by the latter firm when it bought ChromaGenics last March. In a joint evaluation programme that is funded by Genentech, the companies are investigating whether the technology can increase the production yields of Genentech's proprietary systems. The STAR technology is based on the concept of epigenetics - the study of cellular factors (usually DNA and protein factors) that are involved in the regulation of gene expression. In man, 80 to 90 per cent of genes are switched off, or silenced, because they code for proteins that are not essential for the functioning of cells. In fact, genes are silenced by default in cells, and those that need to remain active only do so because of the action of regulatory sequences. This means that when cells are transformed with the DNA sequence required to make a protein, "the chances that the gene is integrated into a silent part of the genome are large," says Prof Arie Otte, ChromaGenics founder. The solution is to use regulatory sequences &endash; known as STAR elements - on either side of the protein-coding sequence (transgene), to create a non-silent portion of the genome. The technology is thought to be particularly useful for the production of recombinant human antibodies and proteins. It has a potentially broad application and is effective for production of antibodies and proteins on mammalian cell lines such as Crucell's own PER.C6 cell line and the widely used Chinese hamster ovary (CHO) line. The first phase of Genentech's programme, now completed, evaluated production yields in screening assays. Based on these results, the biotechnology major has decided to enter into a second phase, in which it will test the effectiveness of STAR under scaled-down production conditions. If the final phase of the evaluation proves successful, Genentech has an option to sign a non-exclusive STAR license agreement, which will be the first license for the technology since the acquisition of ChromaGenics. Source: In-pharmatechnologist.com News, January 11, 2005
Safer cell culture supplement launchedRecently-formed cell culture specialist Celliance has introduced a new supplement (Hybri-CYTE) designed to boost the growth of cells used in research and bioprocessing, that does not contain fetal bovine serum. Hybri-CYTE &endash; the first of what will be a completely new range of serum free supplements - is designed for use in hybridoma cell culture and has been shown to work with mouse, rat and rabbit derived cell lines. It incorporates a number of Celliance's proprietary cell culture products, such as Celliance's flagship EX-CYTE growth enhancing media supplement, Probumin BSA and Incelligent Animal Free insulin. Celliance was formed last Autumn by Serologicals Corp of the US with the express aim of boosting the firm's presence in the serum-free supplement market. Source: In-pharmatechnologist.com News, February 16, 2005
Serologicals buys media firm to hike stem cell focusSerologicals has continued its acquisitive streak, buying the cell culture business Specialty Media from Sentigen Holding Corp. Specialty Media develops and supplies a variety of specialty stem cell culture media formulations and supplements, cells and research reagent tools to the life sciences industry. While in a fairly embryonic stage at present, the market for stem cell-based therapies and tissue engineering is tipped to grow to around $10bn in 2013, according to a recently published report from Visiongain. The cell culture market &endash; including media, sera and reagents used in R&D and production - is growing fast on the back of a rising focus on biological drug development by the drug industry. For example, the US market was valued at just over $900m in 2003, but looks set to swell to $1.7bn by 2008, according to data from BCC. Source: In-pharmatechnologist.com News, February 23, 2005
Proteomics market to reach $17.5 billion by 2009According to a recent report (Business Communications Company (BCC), projected sales for the worldwide DNA sequencing and proteomics markets are expected to rise at an average annual growth rate of 17.6 per cent from $7.8 billion (5.9 billion euro) in 2004 to $17.5 billion in 2009. Beyond 2009, growth is expected to continue as new applications are developed and global market penetration continues. Proteomics is a field that is younger than DNA sequencing and although applications are more limited, the impact of the technology could prove to be enormous. The industry is growing more by a diffusion process as the technology gradually replaces older laboratory methods. However, there are still problems to growth simply because the use of the technology changes so many existing processes that extensive retooling may be required, and researchers are cautious about quickly embracing such change. For example, the use of the latest DNA sequencing technologies may not be compatible with existing equipment and hence researchers may be reluctant to invest in new and complex diagnostic tools. Source:. www.bccresearch.com, February 23, 2005
Pharming buys out Australian transgenics companyPharming, a Dutch company specialising in the production of proteins from transgenic animals, plans to acquire ProBio International Holdings, a company in which it already holds a 45 per cent stake. Through the ProBio acquisition, Pharming will gain control of the Australian firm's intellectual property portfolio as well as rights to non-pharmaceutical applications of recombinant human lactoferrin. In addition, the company will benefit from the relationships of ProBio with pan-Asian entities, including the Singapore, Australia and New Zealand governments. Pharming has already demonstrated that recombinant human lactoferrin is safe, effective and comparable to the natural human lactoferrin. The company plans to file for Generally Regarded as Safe (GRAS) status for recombinant human lactoferrin and commercialise the product for nutritional applications. Source: In-pharmatechnologist.com News, January 3, 2005
New GMP plant in OuluA new GMP pilot plant has been inaugurated in Oulu, Finland, adjacent to the Medipolis Center, the Oulu University and the Kastelli Research Center. This Medipolis GMP plant, which was financed by the city, offers microbial (10 to 500 liters) and animal cell culture fermentor capacity (10 to 100 liters). It aims to be flexibly used by small companies or big pharma developing novel compounds. Source: EuroBiotech New no 6, vol 3, 2004 Research News
Feathery bioreactors: protein production in birdsA rooster has been genetically modified to make an antibody to treat skin cancer in its blood, the first stage in a project that aims to use birds as biological factories to make protein drugs. US company Viragen, which is developing the antibody in collaboration with the Roslin Institute in Scotland (best known for cloning Dolly the sheep) and UK firm Oxford BioMedica, said the achievement brought the use of chickens as bioreactors for protein production a step closer. The ultimate aim is to make the antibody in chicken eggs. The key objective now is to ensure that an intact, functional version of the antibody can handed down to subsequent generations of chickens that will form the production flock. Once running at scale, the companies believe that the eggs will form a reliable, efficient manufacturing vehicle for the antibody. According to the companies, eggs used as an alternative to standard biomanufacturing techniques such as mammalian cell culture would have advantages in ease of scale- up, lower costs of production and quality of the product produced. Source: In-pharmatechnologist.com News, February 23, 2005
Vaccines against heart diseaseA team from the Karolinska Institute in Sweden, headed by Goran Hansson, and a group headed by Jan Nilsson at Lund University, are trying to develop a vaccine that can prevent the formation of atherosclerotic plaques. Both teams are using fragments of the oxidised form of LDL to prime the immune system to attack plaques when they first begin to form. To test the idea, they have been injecting groups of mice with LDL fragments or a control. The mice given the LDL vaccination show as much as a 70 per cent reduction in the number of plaques, and existing plaques appeared to stop growing. There were no signs of any ill effects. Injecting antibodies to LDL fragments in mice shows that these antibodies are almost as effective in the short term as the vaccination. To develop the idea further, Nilsson has teamed up with Bioinvent. BioInvent believes that oxLDL is the key determinant of unstable plaques and aims to develop a treatment that specifically removes the oxLDL from circulation in serum. Nilsson and Hansson hope initial trials on human volunteers could begin within two years. But nobody yet understands the mechanisms involved, or if the approach will work in humans. Source: In-pharmatechnologist.com News, February 23, 2005
Affinium researches new class of antibioticsMethicillin-resistant Staphylococcus aureus (MRSA) is a hospital infection, which is now beginning to spread into the general community. The prevalence of nosocomial infections caused by MRSA has been increasing for several years in many countries around the world. The US Centres for Disease Control and Prevention estimates that between 60,000 and 80,000 Americans die each year from nosocomial infections and the cause in the majority of cases is S. aureus. Indeed, the annual cost for treating antibiotic resistant infections is approximately $30 billion (25.7 euro bn) in the USA alone. Affinium hope to develop a novel MRSA antibiotic to be used potentially as an IV and oral antibiotic for hospital and community settings. The candidate is one of multiple compounds from Affinium Galapagos program and operates via a novel mechanism of action with very novel chemistry, and distinct from any other antibiotic on the market." "Our drug candidates selectively inhibit a bacterial pathway to kill bacteria without any detectable side effects to the analogous human pathway. Because of their unique way of working, we believe resistance will be slow to develop," said Judd Berman, senior vice president of chemistry at Affinium. The recent advancements of this MRSA program represent an important milestone in the development of a new class of breakthrough antibiotics. The last time the industry targeted a new pathway with an antibiotic was the fluoroquinolone class in the 1960's. Fluoroquinolones now represent over $7 billion in world wide annual sales. Source: In-Pharmatechnologist.com, February 18, 2005
Low cost paclitaxel from yew needlesA new method to produce paclitaxel, the potent anti-tumour drug from yew needles has been discovered which provides a solution to the problem of finding a viable source of the raw material at a relatively low cost. Paclitaxel, marketed under the name of Taxol, is derived from the bark of mature Pacific yew trees. Oncologists use it to combat ovarian and breast cancer, and also to treat lung carcinomas. It gradually kills off cancerous cells by inhibiting cell division. The difficulty with Taxol is that the tree grows very slowly, that it produces minute quantities of paclitaxel only, that an effective drug can only be made from precursors derived from natural sources, and the chemical routes required to arrive at a final active pharmaceutical ingredient (API) tend to be complex and cumbersome. Researchers from the Institute for Bioprocessing and Analytical Measurement Techniques (IBA) in Italy found that the foliage of the cultivated European common yew offers a viable starting point. It produces the compound 10-deacetylbaccatin III (DAB), from which Taxol can be synthesized in a few steps. This involves using an an enzyme isolated from the yew-needle extract to process the DAB. This produces baccatin III, a precursor to paclitaxel, which pharmaceutical companies can then use to synthesize the final product. The production cost is five times lower than for processes that extract the product from natural sources. Source: In-pharmatechnologist.com News, January 6, 2005
Prions on the moveA recent article in Science warns that in mice suffering from chronic infections in kidneys, pancreas or liver, prions will start to accumulate in these organs. This effect is caused by socalled extranodal lymphe follicles, which appear with an infection and which contain follicular dendritic cells which carry prions. A similar phenomenon is known to exist in sheep infected with scrapie. It is uncertain whether such a phenomenon could also occur in BSE infected cattle.- Source: Science, January 20, 2005
Prions may enter the food chainFrench researchers found that the prion protein PrPSc accumulates in the muscle cells of experimentally and naturally infected sheep for several months before the clinical manifestation of disease. The infectivity in muscle is approximately 5,000 fold lower than in the brain. Earlier, it had been demonstrated that prion proteins may accumulate in the muscles of rodents and humans Source: EuroBiotechNews no 6, vol 3, 2004 On the web
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US FDA Medical Devices Regulations & Approval Process Training Seminar March 21-22, 2005, Paris France Information: www.usaspi.com
World Life Sciences Forum, BioVision April 11-15, 2005, Lyon, France Information: www.biovision.org
Molecular Medicine Tri-Conference April 19-22, San Francisco, USA Information: www.chi-MolecularMed.com
Nanotechnology: Issues for Business April 25-26, Brussels, Hotel President WTC Email: wtc.info@presidenthotels.be Website: http://www.presidenthotels.be/wtc/en/welcome.htm
Pathway Analysis for target and compound evaluation April 20-22, 2005, San Francisco, USA Information: www.chiMolecularMed
Stem cell strategies May 12-13, Anaheim, California USA Information: http://www.nsti.org/StemCellStrategies
ESACT 2005 5 - 8 June 2005 - Harrogate, North Yorkshire, UK Information: http://www.esact2005.org
2005 AAPS National Biotechnology Conference June 5-8, 2005, San Francisco, Ca, USA Information: www.aapspharmaceutica.com/nationalbiotech
ACTIP meeting June 16-17, 2005, Lund, Sweden Information: ACTIP@planet.nl
7th Conference Protein Expression in Animal Cell September 18 - 22, 2005 - Crete, Greece Information: HTTP://WWW.PEACE-CONFERENCE.ORG
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