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May 2007 |
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Next meeting ACTIP:The next plenary meeting of ACTIP will be held in Dublin, May 10-11, 2007 Information on the programme will be sent separately to ACTIP member companies through the ACTIP Secretariat
In this issue: Business acquisitions and alliances Production sites ups and downs
News from the CommissionWill European institute close technology gap?During a Friends of Europe debate, Commission President José Manuel Barroso expressed confidence that the European Institute for Technology will receive memberstate support and will succeed in connecting the three sides of the "education/research/innovation triangle". Commission President Barroso defended his innovation flagship during a Crossfire debate at Friends of Europe on 26 March. He underlined that the innovation gap with the US is closing, but also pointed to remaining weaknesses such as fragmentation of the EU's innovation potential, the lack of top-class excellence and low involvement of business in education and research. "For too long, the 'knowledge triangle' educationresearch- innovation has been disconnected," Barroso said The Commission president also pointed to the need for the private sector to support the EU's European Institute for Technology, citing good practices of the debate's sponsor Shell in the area of education and research (Jet-Net, hydrogen technology platform and Shell's Eco-Marathon). Barroso felt confident that he now has the full support of the German EU Presidency for the EIT and that adoption of the EIT regulation should be possible before the end of 2007. Source: EurActiv News, March 28, 2007 …………. however: EIT 'not feasible', UN experts warnThe decentralised European Institute of Technology (EIT) proposed by the Commission is "not feasible" and the proposed financial basis is considered as "not sustainable", argues an independent expert report published on 5 April 2007. The report, drafted by the United Nations University (UNU) at the request of the European Parliament, states that a decentralised institute would not significantly increase the research output, match Europe's top universities' training environment nor adequately organize technology transfer. In fact, the authors argue that not all EU countries, regions and institutions have problems with converting knowledge into commerce and critical mass, rewarding entrepreneurship and excellence in research and education. "Ignoring this fact might result in assuming too easily that a European level institutional solution is necessary in cases where national or regional approaches might be more appropriate," stress the authors. The report recommends an alternative model, a Cluster EIT, which would support existing local and regional strongholds in research, education and innovation. It would "see ambitious and successful regions and universities compete to create strong institutes at or linked to a strong university, and working closely with industry on problems that determine long-term industrial development". Up to 20 European Institutes of Technology could be created, each of which would have their own multidisciplinary theme, some 300 scientific and engineering staff in addition to PhDs and an annual budget of up to ¤70 million. With regard the financial basis for the Cluster EIT, the report proposes the establishment of a European Innovation Fund using part of the money that is yearly left over from the EU budget. A public hearing on the EIT will take place in the European Parliament on 8 May 2007.
Source: EurActiv News, April 10, 2007 Ministers approve 'slow motion' on technology instituteThe EU-27 ministers agreed, in the informal Competitiveness Council on 27-28 April, that the future European Institute of Technology (EIT) should be composed of networks of universities, research institutions and companies. These networks are, in the long run, expected to develop into partnerships. The ministers also supported a German Presidency initiative, which proposes establishing only two Knowledge and Innovation Communities (KIC) at first and others later once the projects have proven efficient. The Commission's proposal to make climate change and energy-efficiency research priorities of the first KICs was widely supported by the member states. Some ¤308 million of EU money is planned for the first phase of establishing the EIT. The private sector is expected to contribute around the same amount, bringing the current overall EIT budget plans to some ¤600 million. The Commission's initial plans, according to which some ¤2.4 billion were scheduled to be spent between 2008 and 2013 for the establishment of six KICs, have thus been seriously scaled down. Source: EurActivNews, April 30, 2007 Commission urges university-business knowledge transfer"Making better use of publicly funded R&D is an important problem," states a Commission policy document urging better exploitation of research results. The Communication, adopted on 4 April 2007, argues that an average university in Europe generates far fewer inventions and patents compared with North American counterparts. This is said to be largely due to "a less systematic and professional management of knowledge and intellectual property" in European universities. Other barriers include cultural differences between business and science communities, lack of incentives for them to work together as well as legal barriers hindering co-operation. The document highlights the need to improve knowledge transfer between research institutions and industry, in particular by creating the right conditions for successful knowledge transfer and by promoting an entrepreneurial mindset. It proposes, in its annex, voluntary guidelines to help universities, research and technology organisations and other publicly funded R&D bodies to do so. The guidelines highlight good practice regarding the management and transfer of knowledge and intellectual property and aim to help research institutions identify shared interests and mutually beneficial knowledge-transfer arrangements with industry. A group of high-level industry and academic actors will be launched in 2007 to further reflect and develop these guidelines and to provide advice on other possible actions to promote knowledge transfer in Europe. Source: EurActiv News, April 5, 2007 Europe's new strategy for life sciences and biotechThe Commission adopted, on 11 April 2007, a Communication on the mid term review of the strategy on life sciences and biotechnology 2002-2010. According to the Commission, the strategy has been successful, is still relevant and, therefore, its implementation will be continued. The main results of the implementation 2002-2006 are integration of regional clusters, inspiration of national action plans and adoption of a new legal framework on GMOs. Not much has changed with developing and facilitating innovation in the EU's biotech sector, which is dominated by SMEs. Small companies still have to cope with EU's fragmented patent systems, lack of risk capital to finance R&D and insufficient cooperation between science and business. The review proposes to refocus the EU's 30-point action plan on five interdependent priority actions:
The Communication is said to provide "an important step towards a competitive and sustainable Knowledge Based Bio-Economy (KBBE)". According to the Commission, bio-economy stands for sustainability and cleaner environment, improved population health, support for rural development, and increased industrial competitiveness through innovative eco-efficient bio-based products based on non-fossil fuels and materials. EuropaBio, the European Association for Bioindustries considers that the refocused actions proposed by the Commission are an important step towards building the bioeconomy. However, industry points to the lack of implementation of the EU biotech strategy by a number of member states. On the other hand, Friends of the Earth Europe warns that "the European Commission intends to promote genetically modified (GM) crops in Europe, even though it admits that that the European public does not want to eat GM foods" and argues that "environmentally-friendly farming will create more jobs and make the EU more competitive than if it grows GM crops." A recent Eurobarometer survey on biotechnology (2005) shows that there is widespread support for medical and industrial biotechnologies but a general opposition to agricultural biotechnologies in all but a few countries and that EU citizens see genetically modified (GM) food as "not being useful, as morally unacceptable and as a risk for society".
Source: EurActiv News, April 12, 2007 FP7 topics first and second call 2007
The deadline for the first call of proposals for FP7 was April 19, 2007. Varioustopics mentioned in the first call were of interest to ACTIP members. Here some of the topics: In area 1.4. Innovative therapeutic approaches and interventions: Immunotherapy- HEALTH-2007-1.4-1: Development and production of new generation antibodies. Projects should aim at developing new, efficient and safe preventive strategies and/or therapies by combining high specificity and effector function with stable production, preclinical studies, scale-up and GMP. Projects should combine academic, clinical and industrial expertise and implement a translational approach towards clinical trials. SME participation is strongly encouraged. Funding scheme: Collaborative projects (Small or medium-scale focused research projects with maximum EC contribution of ¤ 6,000,000/project). HEALTH-2007-1.4-2: Innovative approaches for the development of vaccines for young children. Projects should exploit new knowledge in vaccinology and innate immunity with the ultimate goal of developing vaccines for infants and toddlers (0-2 years) which meet the challenge of protective efficacy and provide strong and sustained immune response. Research should include screening, selection and validation of promising tools, such as novel delivery systems, immunomodulators, adjuvants, immunization schedules and/or prime-boost immunisation strategies, together with in vitro and in vivo proof-of principle, safety and scale-up studies. Projects should take a translational approach and aim towards clinical trials. Funding scheme: Collaborative projects (Small or medium-scalefocused research projects with maximum EC contribution of ¤ 6,000,000/project).
Second call: In addition, already topics for the second call, with a deadline of September 18, 2007, have been selected:Gene therapyHEALTH-2007-1.4-4: Development of emerging gene therapy tools and technologies for clinical application. HEALTH-2007-1.4-5: Gene therapy tools targeting the central nervous system.
Regenerative medicineHEALTH-2007-1.4-6: Stem cell lines for cell-based therapies. HEALTH-2007-1.4-7: Development of stem cell culture conditions. HEALTH-2007-1.4-8: Stem cells for kidney regeneration. HEALTH-2007-1.4-9: Adding value to EU stem cell therapy research: scientific communication and future perspectives.
Regulatory NewsEMEA adopts 'first-in-man' clinical trials guidelineThe EMEA's Committee for Medicinal Products for Human Use (CHMP) has released a list of requirements for a two-month public consultation period, after having extensively investigated the serious adverse reactions that occurred during the first-in-man trial of TGN1412 of TeGenero. The guideline, which has been prepared by experts in clinical trials, is one of the measures taken by the CHMP and EU national authorities to minimize the risk of such serious adverse reactions occurring in the future. It focuses on potential high-risk medicinal products - drugs where the mode of action, the nature of the target in the body or the limited relevance of animal models for the prediction of toxicological effects in humans raises concerns of serious adverse reactions during first-in-man clinical trials. In addition, the document gives guidance on handling the transition from non-clinical studies, such as animal or in vitro studies, to first tests in humans for this specific type of drugs. The committee's proposals also cover quality, non-clinical and clinical aspects, including the calculation for the first doses to be given to human subjects, the initial dose-escalation trials and the management of risk. Furthermore, one of the requirements relates to the immediate as well as long-term monitoring of adverse reactions. According to the proposals, a clinical trial should be designed with a specific plan for monitoring adverse events or adverse reactions, with clinical trial staff trained to identify those reactions and how to respond to such events. This draft guideline comes on the heels of a report published earlier this month which called for reforms in first-in-man clinical trials. Source: www.DrugReseracher.com, March 28, 2007 US: New biogenerics law will be no goldmine for CROsIf a new law is passed, the Food and Drug Administration (FDA) may soon have the authority to approve generic versions of biologic drugs in the US. As part of the proposed requirements, Congress heard proposals recently to make clinical trials mandatory as part of the approval process - which is not the case for traditional drugs. However, CROs who are licking their lips at the thought of the potential new business this could bring should not be so hasty. "The theory that this would benefit CROs since generics biotech companies usually don't have the resources necessary to conduct drug trials themselves and therefore would have to outsource to a CRO is correct. However, we are talking about a volume of clinical trials which is really small compared to the current market," Janice Reichert, senior research fellow at Tufts Center for the Study of Drug Development, told Outsourcing-Pharma.com. Reichert's argument is that first, if clinical trials are required to get a biogeneric approved, it will be a small clinical study, a Phase I conducted quickly as the biologic's properties are already known. So any potential benefits will be limited to those CROs with specialty Phase I units. Also, in the US, there are only a few protein-based therapeutics where the market is big enough to attract large competition, and not many generic companies would be brave enough to get into copying biologics that are not set to be blockbusters. The proposed Senate bill would grant the FDA powers to approve "follow-on" biologics (dubbed biosimilars by the European regulators) and would enable the agency to decide whether clinical trials and other data would be necessary to ensure the new biosimilars are safe and effective - a debate that has been going on for months. But in the past few weeks, the debate has shifted from whether the bill should pass to what level of testing it will require for the new drugs. According to Reichert, some biologics such as insulin and human growth hormones are relatively easy to reproduce, while others are complex and require additional testing. In addition, there are questions remaining regarding the actual savings that would potentially be made, should such biosimilars be introduced. Source: www.DrugResearcher.com, March 15, 2007
Business acquisitions and alliancesBioInvent and ThromboGenics to begin clinical trials for Anticoagulant TB-402BioInvent International AB
and ThromboGenics NV announced on February 12 last that they
have received approval from the Danish Medicines Agency to initiate
a Phase I clinical trial of the novel anticoagulant, TB-402.
TB-402 is a human antibody binding to Factor VIII. The study
is a randomised, placebo-controlled, dose escalation trial in
healthy volunteers, and the objective is to investigate safety,
tolerability and pharmacokinetic properties of the candidate
drug. It is expected that the first subjects will be recruited
in the study soon, and that the results will be presented in
late 2007. Given a positive outcome of the initial Phase I study,
the parties plan to follow up with a Phase IIa programme in patients
undergoing orthopaedic surgery who are at risk for thrombosis.
TB-402 is also expected to be developed as a potential treatment
to prevent blood clot formation in connection with certain types
of heart arrhythmia, such as atrial fibrillation. Source: Bioinvent Press Release, February 12 2007 Roche expands antibody presence with THP purchaseRoche has continued its spring
spending spree with the $56.5m (¤ 42.2m) purchase of antibody
research specialist Therapeutic Human Polyclonals (THP). The
move to acquire 100 per cent of THP comes just days after Roche's
Diagnostic division agreed to purchase the high-throughput DNA
sequencing technology innovator, 454 Life Sciences for $154.9m.
Roche plans to fully integrate the company into Roche's Pharma
Centre of Excellence for Protein Research in Penzberg, Germany,
which is less than two hours from THP's current headquarters
in Munich. This latest deal will grant Roche access to THP's
transgenic, rabbit-based mammalian platform for the creation
of both monoclonal and polyclonal human antibodies. Source: www.DrugResearcher.com, April 2, 2007 Bioton shells out $78M for biosimilar producer BiopartnersBiopartners Holdings has been purchased in a deal worth $78M by Bioton. The acquisition of Biopartners provides Bioton with access to innovative products and biosimilars in advanced stages of development, additional biotechnological know-how in product development and registration processing in the EMEA, and subsequent access to the highly profitable European and U.S. markets. Biopartners' main product is Valtropin, reportedly the second biogeneric to be approved in Europe. A biosimilar version of Eli Lilly's Humatrope, Valtropin is a recombinant human growth hormone (rhGH) for the treatment of growth hormone deficiency and Turner Syndrome. The company's interferon beta product candidate is a pH neutral formulation of interferon beta for the treatment of relapsing-remitting multiple sclerosis. It is currently in advanced Phase III trials and is expected to be submitted for market authorization in the first quarter of 2007. Additionally, a Phase I trial is planned for the second half of 2007 to evaluate a formulation of erythropoietin for the treatment of anemia due to renal failure and chemotherapy-induced anaemia. Also, Ravanex is a chemically delivered compound to be used solely in combination with interferon alpha for the treatment of chronic, active hepatitis C. "Bioton S.A. and Biopartners Holdings AG are complementary companies with excellent synergies in production and marketing, as well as sales and distribution," remarks Jean- Noël Treilles, CEO of Biopartners. "This acquisition will bring together each company's unique expertise, enabling expansion and acceleration of product development, reducing a product's time-to-market." Source: Genetic Engineering News, March 14, 2007 New deals for ProBioGen's cell engineering groupProBioGen has entered into two separate agreements to develop therapeutic proteins with Egyptian drug manufacturer Minapharm. In the first agreement, ProBioGen will develop a biopharmaceutical cell line for the production of a protein drug owned by Minapharm, which sells generic medicines and has latterly moved into the area of biosimilars via a joint venture with Rhein Biotech, a subsidiary of Dynavax Technologies. Minapharm will carry out the process research & development for making the protein, and have responsibility for manufacturing via its subsidiary, Rhein-Minapharm- Biogenetics, should it be approved for clinical trials and sale. In the second agreement, ProBioGen and Minapharm will co-develop a second generation biopharmaceutical product using either ProBioGen's pre-optimised CHO cell line or its proprietary human neuronal cell line, called AGE1.HN. In this case, Minapharm will exclusively market the product in Middle Eastern and African countries while ProBioGen will have promotional rights in elsewhere in the world. The firms will also share the revenue from the product. AGE1.HN has been adapted to growth in serum free media and has already attracted the attention of Serono (now part of Merck KGaA). Serono started a collaboration with ProBioGen a year ago to assess the potential of AGE1.HN in producing a range of recombinant proteins. Source: www.DrugResearcher.com, April 25, 2007 Protherics receives over $19M milestone from AstraZenecaProtherics reports that a £10-million milestone payment from AstraZeneca was triggered as a result of the successful scale-up of the CytoFab™ manufacturing process to a 600- L batch size. Upon receipt of this manufacturing-related milestone, Protherics will have received a total of over $50.7 million in milestone payments from AstraZeneca since the deal was signed in December 2005. Under the licensing agreement, Protherics may receive up to a further £161 million, or about $310 million, in milestone payments, in addition to a 20% royalty on global net product sales of CytoFab™. Source: Genetic Engineering news, March 12, 2007 Sanofi-Aventis well-placed in cancer vaccine raceAn exclusive license to a late stage product has enabled Sanofi-Aventis to up the stakes in a bid to be the first company to release a dedicated cancer vaccine. The French drug maker Sanofi-Aventis
has agreed to pay up to ¤ 518m for Oxford Biomedica's
lead cancer vaccine. Trovax is currently in Phase III trials
in renal cancer, although it could also be used to treat other
solid tumour types, according to both companies. Trovax targets
the 5T4 tumour antigen and consists of a poxvirus gene transfer
system, which delivers the gene for 5T4 and then stimulates the
patient's body to produce an anti-5T4 immune response. Sanofi, one of the major
players in the vaccine market, is already developing cancer vaccines
in a joint project between its pharma and vaccine business divisions.
The company identifies specific antigens carried by tumours in
order to then inject them and elicit an immune response that
can hinder the development of the primary tumour or metastases. The deal to develop Trovax is the first of two vaccine deals Sanofi announced this week. The second one relates to the company licensing reverse genetics technology from MedImmune, in order to develop and construct influenza vaccines. Vaccines developed using this technology would be made entirely from DNA. This means manufacturers would only have to work with segments of the virus's genome rather than potentially highly infectious pandemic strains, such as H5N1. Source: www.DrugResearcher.com, March 30, 2007 Production site ups and downs
Singapore growing biopharma strengthBiologics are forecast to be the fastest growing sector of the pharma industry, with big pharma estimated to be generating around 60 per cent of revenue through biologic products by 2010. With many companies looking to Asia for cheaper manufacturing options, Singapore is proving an increasingly popular choice and has been steadily adding to the list of firms who have established bases and manufacturing facilities in the country. Lonza: The facility that Lonza has recently started constructing is its second in the country, and will be a large-scale commercial mammalian cell culture manufacturing plant with up to four mammalian bioreactor trains each with flexible capacity of 1,000 to 20,000 litres. The facility is being built as part of a joint venture with Singaporean investment management company, Bio*One Capital. Following investment of up to $350m (¤262.6m), it should be fully operational by 2011. "This strategic partnership between Lonza and Bio*One has helped to build the biologics manufacturing capabilities and grow a critical mass of biologics activities in Singapore," said Singapore minister for trade and industry, Mr Lim Hng Kiang. Genentech: US-based biotech firm Genentech has also recently made moves in Singapore, lately having entered into a long-term land-lease agreement in the country for the construction and development of a manufacturing facility. The plant will be a 1,000 litre E.coli manufacturing facility for the worldwide production of the company's drug Lucentis (ranibizumab) for treatment of neovascular (wet) age-related macular degeneration (AMD). Construction is due to begin later this year with licensure expected by early 2010. In addition to this, Genentech also has an exclusive option to acquire an 80,000 litre mammalian biopharmaceutical production facility in Singapore from current owners Lonza any time between 2007 and 2012. The site is expected to be licensed by the US Food and Drug Administration in 2010, and will be available to Genentech for $ 290m plus $70m in milestone payments. GlaxoSmithKline: GSK has also boosted its investment in Singapore over the last year, in June 2006 having made its biggest investment in the area to date with a new primary vaccine manufacturing plant. The company is planning to spend over $ 300m over the next four years in the first phase of development of the plant, which will be for the primary production of paediatric vaccines. Eli Lilly: this is another major firm increasing its presence in Singapore, having just announced a $ 150m expansion of its drug discovery research activities in the country. In partnership with the Singapore Economic Development Board, the improved research facility will focus on epigenetic biology, adult stem cell biology, disease state modelling and computational sciences. Schering Plough: was one of the first pharmas to set up in Singapore back in 1997 with a $ 260m bulk pharmaceutical manufacturing plant, followed up by a $ 25m investment in facilities for its dry powder inhaler product, Asmanex (mometasone), in 1999. Since then the company has continued to invest in the country, and by the time construction is completed on the newest facilities will have half a dozen manufacturing plants in Singapore as well as an R&D site with investment in the area creeping toward $ 1bn. Source: www.DrugResearcher.com, April 2, 2007 More news from Asia: AstraZeneca's new PR&D centre in IndiaAstraZeneca is leveraging the process chemistry expertise accumulated in India's generics industry and universities by opening a $15m (¤11.3m) process research and development (PR&D) laboratory next to its existing research centre for tuberculosis in Bangalore. The newly inaugurated 8,000sq m facility on AstraZeneca's Hebbal campus can accommodate up to 75 process scientists as well as supporting office and engineering staff. The Bangalore laboratory will both consolidate the existing drug discovery programme for tuberculosis at the site and bolster the UK company's global PR&D network. This consists of one facility apiece in the UK and Sweden, plus a pending UK PR&D laboratory at AstraZeneca's Macclesfield site that is expected to start operating by mid-2009. The company, whose research pipeline has come under critical scrutiny following a succession of damp squibs in late-stage development, has been investing heavily of late in new R&D resources, partnerships and acquisitions. At the same time, it has been making deep cuts to boost productivity and cost efficiency in its supply chain. The recent announcement that 700 manufacturing and supply jobs would go at Macclesfield contrasted pointedly with the £63.5m (¤ 93.6 million) AstraZeneca is investing in its new PR&D laboratory at the same site. According to AstraZeneca, the co-location of Discovery and PR&D at Bangalore will help the company to "maximize scientific interactions and enable shared use of the PR&D infrastructure." All the same, the company says its current tuberculosis research programmes are still three to four years away from delivering a candidate drug for human trials. Source: www.foodnavigator.com, March 23, 2007 …and Indian Biocon to boost contract research bizIndian biotech firm Biocon is planning to boost its contract research business as global pharma companies are increasingly looking to outsource R&D to India, according to media reports. Last week, the Bangalore-based company said it will focus on increasing the share of its research services segment to a quarter of its total revenue in the next five years, Reuters reported. Currently, contract research services generate 15 per cent of the company's revenue, the firm said. Research to develop pharmaceuticals can be carried out in India at about one-fourth of the cost in the US mainly due to the availability of a large pool of cheaper talent, said Kiran Mazumdar-Shaw, Biocon's chairman and managing director. This latest move comes hot on the heels of an investment from giant drug maker Bristol-Myers Squibb (BMS), who inked two large R&D services contracts in India this month, including one with Biocon. As part of the first deal, Biocon, through its subsidiary Syngene International, is currently building a new R&D facility in Bangalore, which will house up to 400 Biocon scientists who will provide medicinal chemistry, biology, drug metabolism, and pharmaceutical development services on behalf of BMS. Source: www.foodnavigator.com, March 26, 2007
Puerto Rico, a 'Bio Island' on the goSingapore is not the only site attracting investors. A 'bio-island' in the making is Puerto Rico. US pharma Abbott: the company has announced the opening of its new state-of the-art biologics manufacturing plant in Puerto Rico. The 330,000 sq. ft plant boasts 12,000-litre bioreactor tanks and over 80 tanks and vessels for growing cells. The facility will now be the primary production site for Abbott's monoclonal antibody treatment, Humira (adalimumab), and large-scale manufacture of future products requiring advanced manufacturing technologies. The new facility, Abbott Biotechnology Limited (ABL), has significantly greater manufacturing capacity than the site previously used by the company for Humira production in Worcester, Massachusetts (USA). The plant represents Abbott's single largest capital investment to date coming in at $ 450m (¤ 336m). US Food and Drug Administration (FDA) approval to commercially produce Humira at the site for the US market was received in February this year, with the European Agency for the Evaluation of Medicinal Products (EMEA) currently reviewing the company's application. Abbott expects approval within the next few months. Abbott is by no means the only pharma company who has been lured to the Bio Island, which offers a variety of tax incentives that make it an attractive option for firms looking for a cost effective setting for their operations. Depending on the location on the island, for example, companies can benefit from income and property tax reductions for periods of 10 to 25 years, as well as a variety of other incentives that make the region an increasingly popular destination. Alongside Abbott sit other major firms such as Eli Lilly, Pfizer, Bristol-Myers Squibb, and US biotech firm Amgen, who last year announced a $1bn fund dedicated to the expansion of the company's manufacturing facilities in Puerto Rico, with the upgrades due to be complete by 2010. Source: www.DrugResearcher.com, April 11, 2007
Boehringer steps up contract manufacturing in MexicoBoehringer Ingelheim is stepping
up its commercial contract manufacturing operation in Mexico
to feed the ravenous North American market. This is not Boehringer's
first contract manufacturing enterprise in Mexico. The firm began
offering these services five years ago from the same plant but
stopped one year later due to a "change in strategy,"
after it no longer had any spare manufacturing capacity. Source: www.DrugResearcher.com, April 30, 2007 France: Sanofi Pasteur ups production capacity after vaccine go-aheadReports of a ¤ 200m expansion at Sanofi Pasteur's production plant in Rouen, France, have come hot on the heels of news that the US Food and Drug Administration (FDA) has approved the company's vaccine to protect humans against bird flu. The expansion could double the 120 million doses currently manufactured at the plant within five years. The added capacity at the plant in northern France will allow increased production of the firm's yellow fever and polio vaccines, as well upping manufacture of the vaccine to protect against the avian flu virus, H5N1. The investment in the Val de Reuil plant is the largest capital investment in France to date for the company, and will result in formulation, filling and packaging capacity facilities, which are intended to help significantly reduce time to market for the firm's vaccines. While the majority of the manufacture of the bird flu vaccine will take place at the firm's Swiftwater plant in Pennsylvania, the increased capacity at the European plants suggests that Sanofi holds out hope for further demands for its vaccine in Europe as well. The company has several agreements within Europe, including a contract with the French Ministry of Health to produce a 1.4 million dose stockpile of H5N1 vaccine with a clause to be called upon to provide enough vaccine to protect 28 million people in France should a pandemic strike. The firm also has an agreement with the Italian Ministry of Health. Sanofi Pasteur is the only vaccine manufacturer, indeed the only pharma firm, involved in the Flupan project funded by the European Commission. The project aims to improve pandemic preparedness in the EU by producing and testing experimental vaccines, compiling libraries of reagents and investigating new cell culture vaccine production techniques. Sanofi itself is responsible for producing a vaccine to combat another flu strain with pandemic potential, H7N1, that will be used in a Flupan clinical study. Source: www.DrugResearcher.com, April 18, 2007
Up's and down's in IrelandSanofi-Aventis: In the latest of a rash of pharmaceutical plant closures, Sanofi-Aventis has announced proposals to cease operations at its Waterford, Ireland site. The site, which manufactures mature and over-the-counter (OTC) products including Essentiale (polyene phosphatidylcholine) for liver protection and Flagyl (metronidazole) for microbial infections, is expected to close by the end of the year following discussions with authorities and working groups. Although the closure has not been formally stamped and the proposal must undergo a 30-day consultation, a spokesperson for the company said that there 'really seems no alternative" to the closure plans. Shutting down the plant will result in around 200 job losses. The decision to cease operations at the plant came following an evaluation of the company's plant network, which concluded that there was excess capacity and that other Sanofi sites would be able to absorb the Waterford product volume with little extra investment. The products manufactured at the site will be split between two sites in France and one in Germany, where the Essentiale is already manufactured. Pfizer: just last month Pfizer announced that its Irish plants were to be hit by restructuring plans, with the closure and sales of plants in Ringaskiddy, Little Island and Loughbeg. …but also new investments: However, despite the consolidation trend sweeping across pharmaceutical manufacturing in an attempt to tackle the challenges posed by generics, patent expiries and pricing pressures, the news isn't all bleak for the Irish manufacturing scene. For example, County Waterford itself, where the Sanofi site is due to close, was recently chosen by GlaxoSmithKline as the location for a ¤ 23m facility for the production of OTC medicines. Earlier this year, Eli Lilly, also announced its intentions to invest in its Irish facility to fulfil the company's biotech drug manufacturing plans. Last year, biotech firm Amgen also announced a $1bn (¤0.76bn) investment in new manufacturing facilities in Cork, due to become operational in 2009 and employ 1,100 people by 2010. Source: www.DrugResearcher.com, March 15, 2007
Business newsEuropean biotech sector recovered and in great shapeAfter years of downturn and
painful restructuring, the European biotech
industry is firmly back on the right path and is sustaining its
newfound progress and momentum, Ernst & Young said in their
new report 'Beyond Borders: global biotechnology report 2007'. Net losses of publicly traded companies fell by 37 per cent in the region creating momentum toward profitability. In addition, venture capital (VC) financings reached an all-time high of ¤1.5bn. Illustrating this good performance were several notable transactions including ThromboGenics, a Belgian company, which raised ¤ 39m on Euronext last July and increased its share price 168 per cent by year-end. The biggest IPO was completed by UK firm Renovo, which raised ¤84m on the London Stock Exchange and recorded a post-IPO gain of 101 per cent. An above-average IPO deal and good post-IPO performance were also reported by Irish firm AGI Therapeutics which raised ¤ 43m, and LifeCyclePharma from Denmark with a ¤ 75m IPO. Meanwhile, the pipelines of publicly traded companies grew 30 per cent, bringing the overall pipeline to almost 700 compounds, plus 27 in registration and awaiting regulatory approval, while Europe's privately-held biotechs have nearly 800 compounds in their pipelines, and 12 compounds in registration. The challenge in years ahead will be to translate two years of continuous growth into "an ongoing future of sustainable growth", the report concluded. Source: www.DrugResearcher.com, April 17, 2007 GSK meets no resistance for new antibacterialThe approval of GlaxoSmithKline's (GSK) Altabax by the US FDA gives clinicians the first new class of topical antibacterial treatments in nearly 20 years. Altabax (retapamulin ointment) is a first-in-class topical antibacterial for the treatment of impetigo - a superficial skin infection that most commonly affects young children with still-developing immune systems as well as people who play close contact sports such as rugby, football and wrestling. The drug has been cleared for twice daily use for up to five days in patients over nine months old and will make treating infants easier than with other topical antibacterials that may need to be used as often as three times a day for up to 12 days. In vitro, this new topical antibiotic has shown a low potential for the development of resistance, possibly because it works in a unique manner compared to other antibiotics. Altabax binds to the 50S sub-unit of the bacterial ribosome, inhibiting the bacteria's ability to synthesize proteins, effectively leading to the bacteria's death. Source: www.DrugResearcher.com, April 16, 2007 Covance establishes biomarker expert teamCovance is seeing the high potential of the booming market for biomarkers and has decided to devote an entire expert team to support clients with biomarker-related services. The contract research organisation (CRO) announced last week the launch of its biomarker expert team, which consists of a panel of scientists who provide technical and scientific expertise for customers in the selection, development, validation and testing of biomarker assays. The discovery and molecular identification of biomarkers assist biotech and pharma companies in compound selection, dose optimization, patient stratification, and efficacy and safety monitoring. "Effective use of biomarkers
leads to faster decisions to continue or suspend a drug's development,
saving pharmaceutical manufacturers money by reducing late stage
failures while improving predictability of success," said
Covance. As a result, drug makers are now using biomarkers for
nearly every new drug candidate, and it is predicted that within
the next ten years biomarkers will be a standard aspect of drug
development for any novel candidate, according to Covance. Covance provides a range of biomarker assay development and validation services as well as biomarker testing services (both large and small scale) from early proof of concept to commercial laboratory testing. In early drug development, biomarkers help identify viable drug targets by predicting early toxicological effects, while during late stage clinical trials, they help prove drug safety and effectiveness, guide trial design and support critical decision making. Source: www.DrugResearcher.com, April 2, 2007 Research NewsFragmenting bio-sugars yields sweet structural informationResearchers from the University of Michigan have shown that the application of electron capture dissociation (ECD) techniques to glycoconjugates can deliver more saccharidelinkage information than other techniques. The study was published in the latest issue of Analytical Chemistry and could help further our understanding of proteomics. Mass spectrometry (MS) has been shown to be an important tool for oligosaccharide characterisation, with tandem mass spectrometry (MS/MS) being used extensively for oligosaccharide structural analysis. During a MS experiment, oligosaccharides undergo two main types of fragmentation, either glycosidic cleavage, which breaks the bonds between the saccharide units and provides saccharide sequence and branching information; or cross-ring cleavages, which can provide important saccharide linkage information. ECD techniques introduce low energy electrons to trapped gas phase ions that cause more cross-ring cleavage than other techniques such as collision-induced dissociation (CID) and infrared multiphoton dissociation (IRMPD). While ECD produces significantly different types of fragment ions to other techniques, the technique can suffer from low fragmentation efficiency, especially with compounds without basic functionalities as they do not undergo multiple ionisations easily. The researchers managed to overcome this problem by utilising alkali earth and transition metals as charge carriers during the initial electrospray ionisation step to cause at least two charges to form on the oligosaccharides. The researchers showed that for certain metal-adducts of oligosaccharides, particularly maltoheptaose, cross-ring cleavage is the dominant fragmentation pathway in ECD. In contrast, IRMPD techniques yielded fragments that were dominated by glycosidic cleavages. While the researchers have managed to extend the utility of the ECD technique, their results "do not indicate that there is a clearly optimal metal which will maximise crossring fragmentation for both branched and linear oligosaccharides in ECD." Source: www.DrugResearcher.com , April 4, 2007
New therapy attacks multiple sclerosis on two frontsMultiple sclerosis (MS) is caused when the immune system destroys the myelin insulation around nerve fibres in the central nervous system (CNS). Now, scientists at the University of Bonn have genetically engineered bone marrow cells that can both treat MS by reducing inflammation and clearing tissue debris and could also be used to deliver drugs that promote nerve repair. Harald Neumann and his colleagues realised that bone marrow cells called myeloid precursor cells could be a potential therapy for MS because they naturally migrate into the CNS and can form microglia, which act as immune cells for the CNS and could clear the debris. Microglia also produce a protein called trigger receptor expressed on myeloid cells-2 (TREM2). The scientists collected myeloid precursor cells from mouse bone marrow and modified it to produce TREM2. These cells were then injected into mice with experimental autoimmune encephalomyelitis (EAE), which is used as an animal model for MS. Normal myeloid precursor cells were also injected as a control. In healthy mice or those only just beginning to show symptoms of EAE, neither cell type migrated to the spinal cord. However, when EAE symptoms were at their peak, both sets of myeloid precursor cells migrated into the mice' spinal cords where the TREM2-producing cells reduced nerve damage and halted myelin loss. The therapeutic cells also increased the amount of debris cleared, and an anti-inflammatory environment was created. Source: www.DrugResearcher.com, April 11, 2007
Alcohol and tobacco 'riskier' than some illegal drugsScientists call for a more rational debate about the relative risks posed by drugs as a study shows that alcohol and tobacco cause more physical and social harm than some illicit substances. The researchers have developed and tested a new framework to assess the actual risks posed to society by selected illegal drugs. Five legal drugs, including alcohol and tobacco, were also taken on board and classified for reference in the study, based on three parameters: physical harm, dependence and social harm. The research results, published on 24 March 2007 by The Lancet Magazine show that alcohol and tobacco, which together account for about 90% of all drug-related deaths in the UK, are among the top ten most dangerous substances. They rank higher (alcohol fifth, tobacco ninth) than some illegal substances such as cannabis (11th) or ecstasy (18th). Heroin and cocaine rank respectively first and the second. "Our results emphasise that the exclusion of alcohol and tobacco from the [UK] Misuse of Drugs Act is, from a scientific perspective, arbitrary. We saw no clear distinction between socially acceptable and illicit substances. This should be taken into account in public debate on illegal drug use," concludes the study.
Source: EuractivNews, March 26, 2007 Stem cell newsUnique: European stem-cell registry to boost new therapiesA European online registry for human embryonic stem-cell lines is expected to contribute to international standardisation and boost progress towards new medical therapies. The Commission decided on 29 March 2007 to fund the creation of a European registry for human embryonic stem-cell lines with some ¤1 million EU-funding from the Sixth Research Framework Programme (FP6). Keeping a register of all existing lines is expected to enhance the co-ordination, efficiency and rationalisation of human embryonic stem-cell research in Europe as it will provide a platform to allow the monitoring of existing research and ensure that the lines are better used by scientists. The initiative has no precedent in the world. Ten EU countries active in this research will be involved in the registry: Belgium, the Czech Republic, Denmark, Finland, France, Germany, Spain, Sweden, the Netherlands and the United Kingdom. A number of non-EU countries are also set to join the project - namely Australia, Israel, Switzerland, Turkey and the United States. The registry will be publicly accessible via the internet. The site will disseminate data about cell lines and inform interested parties concerning the latest developments on, for example, clinical trials. In addition, the registry will provide details on the provenance of the lines and contact information. To date, no approved medical treatments have been derived from embryonic stem- cell research and many countries have forbidden either embryonic stem-cell research or the production of new embryonic stem-cell lines. In the EU, Austria, Ireland, Lithuania, Poland and the Slovak Republic have prohibited the procurement of stem cells from embryos, whereas France, Germany and Italy allow the import of new stem-cell lines, but not their creation. The UK and Belgian policies are the most permissive on the issue as their respective laws allow the creation of human embryos for the procurement of embryonic stem cells.
Source: www.euractivNews, April 3, 2007
Stem cells could blow hole in insulin marketJulio Voltarelli from the University of Sao Paulo, Brazil, and Richard Burt from the Northwestern University Feinberg School of Medicine, Chicago, described results from their stem cell therapy as "very encouraging". After just one injection of stem cells, the vast majority of patients no longer needed insulin injections - with the effects lasting between one and 35 months. The scientists treated 15 newly diagnosed Type I diabetics with high-doses of drugs to suppress their immune system. They were then injected with stem cells originally collected from their own blood and measured the length of time the patients did not need supplementary insulin injections. "93 per cent of patients achieved different periods of insulin independence and treatment-related toxicity was low, with no mortality," the researchers said. However, how the stem cells exert their effect is not yet known.14 patients did not need insulin injections: one for 35 months; four for at least 21 months; seven for at least 6 months; and two with late response were insulin-free for one and five months respectively. One of the patients had to resume insulin replacement one year after the stem cell therapy. Stem cells are not the only option when it comes to treating diabetes without insulin replacement. Other possible cell-based treatments for diabetes include infusion of various immune system cells such as dendritic cells, T-regulatory lymphocytes, embryonic or adult stem cells, and allogenic bone marrow transplantation. Source: www.DrugResearcher.com, April 11, 2007 ReNeuron awarded EU stem cell patentsThe European Union Patent Office (EPO) has granted UK stem cell experts ReNeuron patent protection for three key human neural stem cell lines. The patents cover the composition, production and use of three neural stem cell lines, which could potentially treat stroke, Huntingtons disease, Alzheimers disease, traumatic brain injury and Creutzfeld-Jacob disease (CJD).The claims also cover the use of these cells in nontherapeutic applications such as cell-based screens for testing neurological drug candidates. The three lines covered by the patent are ReN001, ReN005 and an unnamed-as-yet back up cell line that is likely to end up in a therapy. The company has licensed cell lines to various organizations and made its ReNCell CX and ReNCell VM cell lines and cell media available to the stem cell research community for non-therapeutic applications via a licensing agreement with Millipore. Source: www.DrugResearcher.com, April 18, 2007 Stemagen acquires rights to uniparental embryonic stem cellStemagen acquired the exclusive rights to a patent for uniparental embryonic stem cells from the University of Pennsylvania. Because these stem cells are created without fertilization, they may represent an acceptable alternative for those who oppose the traditional method that requires the use of embryos that are potentially capable of reproduction, the company reports. "Because Stemagen has been successful in developing human uniparental embryonic stem cell lines, we believe we are uniquely positioned to capitalize on this patent," said Stemagen CEO Samuel H. Wood, M.D., Ph.D. Source: Genetic Engineering News, March 5, 2007
Healing bone with stem cellsImplantable materials that grab stem cells and spur their growth and survival could improve bone-healing surgeries. Linda Griffith and her colleagues at MIT have created a new tissue-engineering material that could help cells survive the harsh transplant environment--a key step in cell-transplant therapies. Scientists are now testing the material in animals to see how well it can help heal fractures. "Creating instructional biomaterials like this is an entirely new way of thinking about what could be put in the human body," says Richard Lee, a cardiologist and scientist at Harvard Medical School and Brigham and Women's Hospital, in Boston. "It could become an important component of regenerative medicine." Patients with severe fractures that can't heal on their own typically undergo a painful bone biopsy in which a bone fragment is removed from the hip and then transplanted onto the site of the wound. But improvements to an alternative procedure developed in the past few years could soon make this process obsolete. In the procedure, orthopedic surgeons withdraw bone marrow (which contains bone-forming stem cells) from the patient and then process and transplant those cells onto the fracture without the need for bone biopsy. Some 40,000 people have already undergone the procedure, but scientists say the technique could be improved by increasing the survival and proliferation of the transplanted cells. A new material that stops cell-death signals in their tracks could help. Over the past decade, materials called comb scaffolds have been developed that have been employed for a variety of tissue-engineering uses, such as growing new blood vessels. The comb consists of a Plexiglas backbone studded with molecular tethers that can hold different protein growth factors at their tips. In their latest round of experiments, the researchers modified the scaffold to hold epidermal growth factor (EGF) molecules, a protein that plays a role in growth and differentiation of many cells, including stem cells. According to research published earlier this year in the journal Stem Cells, adult stem cells grown on the EGF scaffolds were better able to survive. And preliminary evidence suggests that the scaffold also boosts cell proliferation, potentially increasing the number of cells available to make new bone after transplantation. Source: www.technologyreview.com, March 7, 2007 Agenda
Bio 2007
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13th European
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