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ACTIP
Bulletin 47 |
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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 Drug discovery and development Non-animal cell expression systems Science information and communication
Details about FP7Call for FP7 proposals open, to close on April 19The Seventh Framework Programme is now fully operational as of 1 January 2007 and will expire in 2013. The first call for proposals under FP7 has been launched. Deadline for submission of proposals is April 19, 2007. For ACTIP members, the most interesting are the 'Cooperation' programme, the 'People' programme (Marie Curie fellowships) and the 'Ideas' programme (the European Research Council). The Cooperation programme has been sub-divided into nine distinct themes (although the Council has identified separate budgets for the two elements of theme nine, security and space). Each theme will be operationally autonomous but will aim to maintain coherence within the Cooperation Programme and allowing for joint activities cutting across different themes, through, for example, joint calls. The themes identified for this programme are the following: Health, with emphasis placed on transferring basic research discoveries to clinical applications. Food, agriculture and biotechnology. Main objectives are new solutions to answer the demand for safer and healthier foods combined with sustainable agriculture and renewable bio-resources. Information and communication technologies. The ICT sub-programme aims to integrate technologies and result in new applications for industrial as well as domestic settings. Nanosciences, nanotechnologies, materials and new production technologies aims to generate new knowledge for breakthrough applications and thus transform European industry from resource-based to knowledge-based. Energy, with the focus placed on renewable energy sources and a significant lowering of CO2 emissions. Environment (including climate change) dealing with ways to predict climate change and the development of novel approaches towards earth observation. Transport (including aeronautics) developing environmentally-friendly and efficient pan-European transport systems. Socio-economic sciences and the humanities, an in-depth investigation of the complex social issues facing the EU, including employment, social cohesion, quality of life and growth and ways to affect policies through an improved knowledge base. Security and Space covering technologies developed to ensure citizen security with applications in the civil as well as the defence areas. According to the Council's agreement of July 2006 the area of 'security and space' would be split into two separate themes. All procedures will be simplified. Small and medium sized enterprises (SMEs) will be actively encouraged to get involved and the newly established European Research Council (ERC) will fund the best of European fundamental science. For the first call, Theme 1 (Health), we list some of the topics that are open for proposals: Health 2007 1.4-1: Development and production of new generation antibodies Health 2007 1.4-4 Development of emerging gene therapy tools and technologies for clinical application Health 2007 1.4-7 Development of stem cell culture conditions Health 2007 2.1.2-3 Fundamental approaches to stem cell differentiation In addition, there are many topics open fro proposals in the areas of brain research, immunology and vaccine development, novel therapoeutic approaches, HIV/AIDs malaria, neglected infections, cancer research, cardiovascular diseases, rare diseases, etc. For the full list, as well as the lkist for topics for the second call, please see the Workprogramme (downloadable from CORDIS). For more information, please visit: http://ec.europa.eu/research/fp7/home_en.html Source: CORDIS News, various dates
News from the CommissionScience chief recommends 'riskier research' in EuropePan-European research is limited by national thinking, too much fragmentation and putting research money into 'safe, non risk' projects. This is the message from Bertil Andersson, chief executive of the European Science Foundation. When discussing pan-European research, it is important to understand the difference between pan-European research versus national research for larger EU countries such as the UK, Germany, France or Italy (which have critical mass) versus national research for i.e. Norway, Iceland, Sweden or Poland. Pan-European research is really important only for the smaller countries. The main limitation for pan-European research is thinking on a national level, even in the small countries. Therefore, discussing building the European Research Area (ERA) is only a politically correct gesture. Only scientists think global. Their partners can be wherever in the world and they still conduct research. With respect to the added value of EU funded research and the EU's framework programmes, it is important to remember that the aim of EU research is to increase competitiveness and influence policies. The impact is limited, since the framework programmes (FPs) only represent some 5-10% of all European research money, and the remaining 90-95% is national. Despite the FPs being top down and bureaucratic, they have been instrumental in creating European thinking and common projects and they may also have been good in bridging private-public partnerships. Whether this has been cost-effective, is hard to tell. There is still too much fragmentation between different research programmes at European and national level - between Commission and ESF programmes and programmes where national organisations collaborate, such as private-research programmes. We can talk about 'multi-dimension-fragmentation'. One limitation with the EU's FPs is that they put money into too-safe projects. In general, we need to have more risk in research. We must be braver on the European scene, put money towards more risky research and take risks in research. Compared with European research, the American system is very good in putting money into new, risky projects, based perhaps only on a hypothetical idea. And still they do it, funded by the US National Science Foundation (NSF), private foundations or university endowments. It is easier for them to finance risky projects. In Europe, the funding systems do not promote risk. Promoting risk is about allowing a scientist to "fail". In the United States, they have greater flexibility on this. Source: EurActiv News, March 5, 2007
ERC launched, politics kept outAt the official launch (Feb 27-28) of the European Research Council (ERC) in Berlin, politicians have welcomed the announcement that EU-funded research will finally be based on excellence and independent decisions by scientists, without interference from politics. "The ERC's Scientific Council - not the European Commission, or anyone else - is responsible for scientific strategy and implementation. ERC operations will be autonomous, through an Executive Agency," explained Science and Research Commissioner Janez Potoãnik on the functioning of the European Research Council. Potoãnik hopes that the ERC will, in the long run, help determine research trends, industrial production and even Nobel Prizes. He hopes that the ERC will generate a snowball effect as "more competition will lead to better research. Better research will lead to more private investment in research. More investment will lead to better facilities and better facilities will attract and retain better researchers." In spite of the ERC being officially launched on 27-28 February 2007, the ERC's Scientific Council has met regularly since October 2005. Its first call for proposals was announced on 7 February 2007 and it is set to focus on funding, with some 300 million euros devoted to ERC Starting Independent Grant proposals , which support independent researchers who are at the stage of establishing their first research team or conducting independent research. Other news
Source: EurActiv News, February 27, 2007
European Institute of Technology - against all odds?By now it is well documented that various actors are not behind the idea of a European Institute of Technology (EIT). To succeed, it will need the full support and commitment of both business and academia as well as institutional backing from Parliament and the Council. But, at present, the only unconditional support comes from its initiator, the European Commission. The EIT is perceived as the European counterpart to the famous Massachusetts Institute of Technology (MIT) in the US. Originally proposed by Commission President José Manuel Barroso as part of the relaunched Lisbon Agenda, the aim of the EIT is to strengthen the European 'knowledge-triangle' of research, education and technology-transfer by providing a world-class model for teaching and research through partnerships between academia and business. The Commission adopted its official proposal for an EIT on 18 October 2006.Some 2.4 billion euros is scheduled to be spent between 2008 and 2013 for the establishment of six Knowledge and Innovation Communities (KICs). These are joint-ventures of partner organizations representing universities, research organizations and businesses which are intended to form an integrated partnership in response to calls for proposals from the EIT. The Commission proposes 310 million euros to be allocated directly from the EU budget, mainly for the initial start-up phase. The rest,2.1 billion euros, is expected to come from the private sector. The institute will also be eligible to apply for money from EU aid funds - the KICs can, for example, apply for project-funding under FP7, the EU's Seventh Framework Programme for Research (2007-2013). Education Commissioner Jan Figel has said that an "EIT foundation" could be established to gather the necessary funds. Since the idea was introduced in February 2005, there has been much criticism about the EIT: it was even rejected by the Commission's own research advisory boards (EURAB). In March 2006, the EIT suffered a second blow, when the European Council dismissed the possibility of establishing the EIT on a new or existing single campus. Instead, the heads of state and government supported its establishment in the form of a virtual network of existing institutions, which obliged the Commission to somewhat water-down its original proposal and propose the final regulation (October 2006) following the European Council's advice. The Commission's propsal is currently being discussed in two committees in the European Parliament (Industry and Research and Culture and Education) and in a special ad-hoc council working group organized and led by the German Presidency, which strongly opposes the whole project, and which is aiming for an agreement on only one "pet-KIC" to first test the concept before establishing a real EIT. In a recent panel discussion on 6 February 2007, involving all three institutions and business representatives, both the Council and European Parliament and business representatives said that the Commission proposal needed further clarification on:
These are crucial open questions and yet the German Presidency is determined to have Council's political orientations ready by July 2007 and the regulation adopted by end of the year 2007 for the decision on the first KIC to be taken by mid-2008 and the first KIC to be operational early 2009. Criticism from representatives were strong. Here some quotes:
Latest & next steps:
More reading:
Source: EurActiv News, March 7, 2007
EU funding made simpler for small businessA simplified template for consortium research agreements funded by the EU should aid small business participation. The new template aims to simplify the consortium agreements needed for participation in the seventh research framework programme (FP7) funding system. In the past, the complexity of different agreement models led to disagreements between project participants and was often seen as a stumbling block to the involvement of small business. The EU's FP7 was set up to fund and promote European research and technological development with a total budget of ¤50bn over seven years in order to gain leadership in key scientific and technology areas while stimulating and enhancing the creativity of European research and collaboration. The DESCA project (Development of a Simplified Consortium Agreement for FP7) to simplify the FP7 template agreements was initiated by a number of industry and research organisations. The new agreement "will be particularly beneficial to SMEs" as it "simplifies the administrative and management costs of project participation for SMEs" said a spokesperson from Eurochambres, one of the project initiators. The new model aims to avoid inconsistencies and make sure that consortium agreements take the interests of all participants, large firms, SME's, universities, public research institutes and other organisations, into account. Source: www.DrugResearcher.com, January 25, 2007
Commission allows more subsidies for SMEsThe Commission has adopted a Regulation doubling the level of government subsidies that small businesses may receive without breaking EU rules on state aid. According to current regulation on so-called de minimis state aid, financial support not exceeding ¤100,000 over a period of three years in favour of a given company is deemed to have "no substantial effect on competition and trade between member states", and therefore not to constitute state aid. The Regulation, adopted by the Commission on 12 December 2006, will raise this ceiling as of 1 January 2007, as part of a wider package of state-aid reforms, known as the State Aid Action Plan , launched in June 2005. The new Regulation will make a number of changes, aimed at facilitating the development of small and medium enterprises, which represent 99% of all European businesses and 70% of EU GDP.
Source: Euractiv News, December 13, 2006
Business acquisitions and alliances
Schering-Plough bids for OrganonOn
March 12, Schering-Plough bid ¤11bn for
Organon. This will double the number of new
molecular entities (NMEs) in its pipeline. Source: www.DrugResearcher.com, March 14, 2007
BioInvent and Genentech partner on cardiovascular diseaseBioInvent and Genentech will co-develop and commercialize BioInvent's antibody candidate, BI-204, for the potential treatment of multiple cardiovascular conditions. Genentech will make an upfront payment of $15 million. BioInvent could receive further milestone payments of up to $175 million as well as royalties on sales in North America. Under the terms of the agreement, Genentech and BioInvent will be jointly responsible for clinical development. Genentech will be responsible for and will solely control any commercialization of the drug in North America. BioInvent will be responsible for and will solely control commercialization in the rest of the world. Retaining the rights to the product outside of North America gives us an opportunity to increase our participation and involvement in the product's success," says BioInvent's CEO Svein Mathisen. Source: Genetic Engineering News January 12, 2007
Ablynx and Boehringer Ingelheim embark on Alzeimer's CollaborationBoehringer Ingelheim and Ablynx inked a deal worth almost $ 265 million to discover and develop new therapies for Alzheimer's disease. The worldwide collaboration and license agreement will use Ablynx' Nanobodies®, a novel class of therapeutic proteins. In addition Boehringer Ingelheim will commence a joint research program with Ablynx scientists. Boehringer Ingelheim will be solely responsible for the development, manufacture, and commercialization of any products resulting from the collaboration. The deal includes an upfront fee, development and commercial milestones, and sales-based royalties. Source: Genetic Engineering News, January 8, 2007
AstraZeneca taps Regeneron for antibody technologyAstraZeneca has continued to rapidly refocus and bolster its biologics pipeline through collaboration deals, this time with a deal for antibody producing technology. It will pay up to $120m (92m euro's) in a non-exclusive license deal to use Regeneron's VelocImmune technology to discover human monoclonal antibodies. The work will be conducted at UK-based Cambridge Antibody Technology (CAT), which was acquired by AstraZeneca last June. CAT will use its phage and ribosome display technologies to isolate specific antibodies from vast libraries of antibodies and their fragments. AstraZeneca anticipates that the combination of CAT's display technologies and the VelocImmune platform will provide enormous potential for creating antibody therapeutics. Furthermore, in early February, AstraZeneca acquired Arrow Therapeutics and signed two licensing deals. Arrow is a UK biotech which develops drug candidates for hepatitis C virus (HCV) and respiratory syncytial virus (RSV). The agreement with Palatin Technologies will focus on discovering obesity drugs that target melanocortin receptors and Argenta Discovery will collaborate with AstraZeneca to research improved bronchodilators to treat chronic obstructive pulmonary disease (COPD). All these activities are intended to strengthen the company's drug discovery pipeline. Source: www.DrugResearcher.com, February 7, 2007
Novo signs up for Crucell's STAR techDutch biotech Crucell last week announced it had signed a research licence agreement with Novo Nordisk for the company's STAR technology. Danish firm Novo will use the non-exclusive licence to evaluate the technology for the production of monoclonal antibodies (MAbs) using its proprietary mammalian Chinese hamster ovary (CHO) cell line. Novo's move to obtain the STAR research licence fits with the company's announcement earlier this month that it was cutting its small molecule development to concentrate on protein &endash;based therapies. The firm decided to refocus solely on large-molecule biopharmaceutical medicines, discontinuing small-molecule drug development projects such as oral diabetes treatments. Crucell's STAR technology is intended to increase production of recombinant antibodies and therapeutic proteins on mammalian cell lines. According to the company, the cell clones created by the STAR process produce five to 10 times more antibody or protein than clones produced by other processes. At present, CHO cell derivatives are used to produce over 90 per cent of all antibodies and therapeutic proteins. The STAR technology can be used with these cell lines (as well as others) to reduce the number of clones that need to be screened to generate a high producing cell line. Several biopharmaceutical companies have agreements and licences with Crucell for the STAR technology, including Genentech, Medarex and Genzyme. Novartis, UCB, Millenium Pharmaceuticals and Xoma all signed research licence agreements with Crucell for the technology during 2006. Source: www.DrugResearcher.com, January 22, 2007
Sartorius strengthens position in disposablesSartorius has merged its biotech unit with biopharmaceutical supplier Stedim Biosystems, forming a company anticipated to generate sales of ¤400-420m during 2007. The overall transaction is expected to be completed by summer 2007. This latest merger fits with Sartorius' expansion plans for its biotechnology business unit, with Stedim now contributing expertise in disposable bag systems for biopharmaceutical applications. In January Sartorius' also announced the acquisition of thermoplastics firm Toha Plast, further strengthening the company's position in biopharmaceutical disposables. The seven-member board of directors for the new company will be comprised of three Stedim representatives and four from Sartorius. While the new company will officially be headquartered in Stedim's main office in Aubagne, France, major global functions will be located at Sartorius' headquarters in Goettingen, Germany. Source: www.DrugResearcher.com. February 26, 2007
Alpha Biologics acquires CTM BiotechAlpha Biologics Sdn Bhd, the UK and Malaysian-based contract manufacturer of biologics drugs, has acquired CTM Biotech, a specialist process development company based in Cambridge. The cash deal was successfully concluded on 5th January 2007 As a result of the acquisition, Alpha Biologics European HQ will relocate immediately to CTM's present facility at the Babraham Research Campus near Cambridge in the UK. CTM founders Jon Mowles and Rod Smith have been appointed by Alpha Biologics as Commercial Director &endash; Europe, and Director of Process Development, respectively. Alpha Biologics area of specialisation is the production of mammalian cell secreted protein drugs for pre-clinical, phase 1 and phase 2 trials. It will provide all of the necessary services required to develop and produce drugs in full compliance with US and European cGMP guidelines. The acquisition of CTM Biologics is a key element of both Alpha Biologics' corporate growth and scientific development strategies. The company can now offer clients a European HQ and process development facility &endash; making it easier to participate in the process development stages of projects. The Babraham facility will also be used as a training base for scientists and technologists recruited locally in Malaysia. Source: Alpha Biologics Press Release, February 19, 2007
Genmab and GSK sign human antibody dealGlaxoSmithKline (GSK) and Genmab signed a worldwide agreement to co-develop and commercialize GenMab's HuMax-CD20™ (ofatumumab). HuMax-CD20 is a fully human Mab in late-stage development for CD20 positive B-cell chronic lymphocytic leukemia and follicular non-Hodgkin's lymphoma and in Phase II for rheumatoid arthritis. Genmab will be responsible for development costs until 2008, including costs of the two ongoing late-stage oncology studies. After this, development costs will be shared equally between GSK and Genmab. GSK will receive an exclusive worldwide license to HuMax-CD20 and will be solely responsible for the manufacturing and commercialization of HuMax-CD20. Genmab will be entitled to receive tiered double-digit royalties on global sales of HuMax-CD20. GSK will also receive exclusive worldwide licenses any other antibodies with affinity for the CD20 antigen that Genmab may develop. The company will also have an exclusive option to a CD20 UniBody™ to be developed in collaboration with Genmab. Source: Genetic Engineering News Dec 19, 2006
Bayer and Innogenetics launch HCV genotype assayBayer Diagnostics and Innogenetics have launched an assay that allows genotyping for the Hepatitis C Virus (HCV), permitting broader identification of HCV genotypes with improved accuracy, not possible by current HCV genotyping products. The assay aims to address an unmet need in HCV treatment management. Knowing which genotype and subtype a patient has is extremely important to physicians since each genotype responds differently to treatment. The launch of the Versant HCV Genotype 2.0 Assay (LiPA) provides identification of genotypes 6c-l (formerly known as genotypes 7, 8 and 9) and improves the identification of genotype 1a and 1b. To date hepatitis C infection remains an important challenge for the medical community. Approximately 200m people are infected worldwide, of whom more than 10m are located in the US and Europe. Once infected, 85 per cent of the individuals become chronic carriers, which ultimately results in liver failure. Bayer has the exclusive worldwide rights for the sales and marketing of Innogenetics' LiPA HCV products, while Innogenetics is responsible for the manufacturing of this product. Source: www.DrugResearcher.com, November 24, 2006
GSK invest in domain antibodiesGlaxoSmithKline are further investing in large molecule drug development with the acquisition of pioneering antibody technology. The company has agreed to acquire Domantis for £230m (¤340m). GSK will incorporate Domantis into their Biopharmaceuticals Centre of Excellence for Drug Discovery (CEDD), retaining all the UK staff. The UK based company have developed very small domain antibodies that can overcome the restrictions in therapeutic applications commonly seen with larger biomolecules. The domain fragments are up to 13 times smaller than normal antibodies (around 110 amino acids long). This leads to several advantages, including the ability to administer these domain antibodies (dAbs) orally, by inhalation or even through a cream. A further advantage of dAbs are that they are highly stable and remain active even under harsh conditions, such as free-drying. Some of them can even be boiled and then cooled with no loss of activity. This opens up an array of possibilities when considering manufacturing or storage. Often, more than one antibody is administered at once. Domantis also realised that they could stitch different domain antibodies together so one drug can selectively bind to two different targets. Each fragment behaves as an independent entity yet they are hard wired together." The fragments are relatively simple to engineer and so scientists can change how strongly they bind to each specific target thus controlling the drug's overall effect. They can also be produced using bacterial, yeast or mammalian cell systems enabling GSK to choose where to fit future products into their existing pipeline. Source: www.DrugResearcher.com, December 8, 2007
Invitrogen sells BioRelianceInvitrogen has decided to sell BioReliance. The contract service organisation, which provides biological safety testing, toxicology, viral manufacturing and laboratory animal diagnostic services, has been sold to Avista Capital Partners for approximately $210m (euro160m). This is despite only being bought at the start of 2004 for around $500m (including $ 70m debt). The decision to sell was announced along with the Invitrogen's financial results and is part of a refocus strategy designed to leave the company free to concentrate on its "platform of scientific technologies". BioReliance generated around a quarter of Invitrogen's Cell Culture Systems' revenues and about 9 per cent of Invitrogen's total revenues - about $110 million in annual revenue. Source: www.DrugResearcher.com, February 15, 2007
Business news
Industry revamps R&D for greater speed to marketRoche is the latest large pharma company to restructure its research and development into smaller disease-specific divisions to help get drugs on the market faster. The move is another example of a big pharmaceutical company restructuring its business as a result of challenges currently confronting the industry in terms of patent expirations leading to increased generic competition and declining research productivity. As research and development (R&D) costs soar and the process becomes increasingly complex, the restructure aims to simplify the drug discovery process. This can make it more efficient and allow new development projects to be integrated more quickly. Roche will create five Disease Biology Areas (DBAs) for oncology, virology, inflammation, metabolism and central nervous system, which will cover everything from drug discovery through to medical proof of concept, with oversight through to the market. Each DBA will have its own leadership team and be located at one of three Roche sites: Basel, Switzerland; Nutley, US; or Palo Alto, US. The Roche decision mirrors that of Pfizer, which last month announced its own R&D simplification. The difference is that Pfizer also announced job cuts (although mostly not from its R&D staff), up to five R&D site closures and an increasing reliance on outsourcing and in-licensing, whereas Roche says it expects to increase R&D staff numbers and budget - currently $ 4.8bn (euro 3.7bn) a year. AstraZeneca has also recently announced job cuts representing nearly 5 per cent of its workforce in the face of challenges posed by patent expirations and pricing pressures from government and private sector players.The cuts are part of a wider rationalisation plan that also includes streamlining its pipeline, focusing on fewer diseases and in-licensing more drug candidates. As far as GlaxoSmithKline is concerned, the idea of R&D divided into therapeutic ideas is not a new one, with the company having set up seven Centres of Excellence for Drug Discovery (CEDDs) years ago. Source: www.drugResearcher.com, February 7, 2007
Pharma companies to lose $ 100 bn to genericsA report published recently predicts that US and EU pharma companies will lose up to $100bn in revenues over the next five years as generic products take advantage of major branded products losing patent protection. 74 major drugs are due to come off patent in the period 2007-2011. The greatest impact will seen be between 2010 and 2012 as the patents covering Pfizer's blockbuster drug Lipitor (astorvastatin calcium) expire. The drug achieved worldwide sales of almost $13bn (euro 9.9bn) in 2006, representing the biggest opportunity ever for the generics industry. Patent expiration can cause revenues for the supplier to drop 10-fold over a period of just two years, said report author, Dr Peter Norman. Eli Lilly experienced this first hand on expiration of Prozac's (fluoxetine) patent, and Bristol-Myers Squibb saw revenues for Plavix (clopidogrel bisulfate) drop 90 per cent within a quarter as generic clopidogrel hit the market following the branded product's patent expiry. However, successful identification and exploitation of potential opportunities provided by patent expiration of branded products can offer a significant growth driver for pharmas who focus their business on generic therapeutics. The opportunities offered as major drugs such as Lipitor and Plavix come off patent will sustain the revenue growth for generics suppliers over the next five years, and will ensure that revenue growth of the generics sector will continue to outstrip that of innovative pharmaceutical companies, says the report. In 2005, generic drugs captured 15 per cent of the global healthcare market, with combined revenues of $65bn. According to the report, the five-year period 2007-2011 could see $20bn of additional revenues per year generated by generics companies such as Sandoz and Teva. Big pharmas likely to be hit hardest by the imminent generics flood include Bristol-Myers Squibb, Takeda, AstraZeneca and Eli Lilly, with over 40 per cent of their revenues under threat, while Merck and Pfizer risk losing 50 per cent of their 2005 revenues, says the report. On the other hand, neither Amgen, which currently markets only biological products, nor Merck KgaA, whose portfolio is primarily mature products, face any threat from generic competition, while Roche, Bayer-Schering, Abbott and Schering-Plough face limited threats to their revenues." The report, "Generic Competition 2007 to 2011 &endash; The impact of patent expiries on sales of major drugs", was published on February 26 and is produced by URCH Publishing. It provides overviews and detailed summaries of major generic and pharmaceutical companies, as well as the impact of patent expirations of over 50 major drugs. Source: www.DrugResearcher.com, February 22, 2007
Pfizer axes jobs and closes plantsPfizer has announced it will axe 10,000 jobs and close facilities in a further effort to save on costs; the move comes in the face of patent expiries for their biggest drugs and the failure of a late-stage pipeline project. The world's biggest drug maker announced that it would shut down two US manufacturing plants and try to sell a third in Germany. The closures will also affect research and development with three R&D sites in the US being deemed surplus to requirements and possibly two more, in France and Japan, under threat. By the end of next year, Pfizer plan to have cut its global workforce by 10 per cent, some 10,000 jobs. This includes the loss of 2,000 US sales jobs, announced last November and the newly-proposed plan to reduce its European sales team by 20 per cent. The reason for the change becomes abundantly clear in light of the impending loss of revenue with several of Pfizer's biggest selling drugs losing patent protection now or in the near future. Profits dropped 43 per cent in the fourth-quarter of 2006 as generic products began to make their presence felt. Zithromax (azithromycin) and Zoloft (sertraline) both came off patent in the last 14 months. Combined, this cost Pfizer over $2.5bn in sales last year compared with 2005. In September this year, Pfizer's $5bn blood pressure drug, Norvasc (amlodipine) &endash; the most prescribed brand name high blood pressure medicine worldwide &endash; will also come off patent. And it doesn't stop there: drugs representing 41 per cent of Pfizer's sales are coming off patent between 2010 and 2012. These are Aricept (donepezil), Lipitor (atorvastatin), Viagra (sildenafil citrate), Detrol (tolterodine) and Geodon (ziprasidone). The blow will be even more keenly felt after development of torcetrapib was halted amid safety concerns last December. The drug would have been prescribed as a combination treatment with Lipitor and had been pitched as a key foundation for Pfizer's cholesterol business, allowing it to defend its franchise once the Lipitor patent expired. The cost cutting programme aims to save the business up to $2bn annually and is part of a wider plan to "transform" the way Pfizer do business, according to Pfizer CEO Jeff Kindler, who was appointed last July. In addition, Pfizer hope to simplify the structure of its R&D teams with scientists focused on a given therapeutic area being moved to one of four major sites. The pharma giant will also stop drug discovery programmes in gastroenterology and dermatology. In a move that highlights there's no room for sentimentality in big business, one of the sites being closed is the Brooklyn, New York, address where the company was founded in 1849. It's not all bad news for Pfizer though. Sales of their new drug to combat nerve pain, Lyrica (pregabalin) exceeded expectations, with sales of $1.2bn. The drug is an improved version of off-patent gabapentin and works by binding to the A2D subunit of voltage-gated calcium channels. Pfizer is not the only pharma company that is being hit hard by patent expiries. The report from Prudential Equity Group shows that GlaxoSmithKline is set to lose 23 per cent of their total sales between 2010 and 2012. Source: www.DrugResearcher.com, January 23, 2007
AstraZeneca cuts could pave way for more outsourcingAstraZeneca's cost-cutting announcement this week could pave the way for the formation of future new outsourcing relationships. The UK-based firm's fourth quarter and year-end results publication detailed a series of "productivity enhancing" and "cost containment" measures, and the culling of 3000 jobs. The company also updated its externalisation strategy, stating that its "number one priority remains strengthening the pipeline by enhancing the productivity of its internal discovery and development and the continued pursuit of external opportunities.Outsourcing will be part of a mixture of steps taken, including acquisitions and research collaborations, in order to enhance productivity. The firm already outsources parts of some of its activities such as manufacturing and marketing and is also stepping up its involvement in emerging markets. Source: www.DrugResearcher.com, February 8, 2007
Drug discovery and development
Patients don't care about conflicts of interestMost cancer patients participating in clinical trials only care about their health, not whether researchers have financial interests in its outcome. According to a survey published in the New England Journal of Medicine (355:22, 2330-2337), more than 90% of 253 patients questioned said they had little or no worry about financial ties that researchers or medical centres might have with drug companies. Financial conflicts of interest could undermine the integrity of the science involved but, more importantly, could also impact on patient safety. The World Medical Association and others have called for such conflicts to be declared to patients. They claim this would help the patient judge whether or not to trust the trial and therefore participate. However, critics argue that asking patients to make this judgement is unfair and just moves responsibility to those who have the least power to do anything about it. Cancer patients were specifically chosen as earlier surveys had shown that patients would be less concerned with conflicts of interest if they suffered from life-threatening diseases. The survey revealed that most patients would still have enrolled in the trial if the researcher had been paid by the pharmaceutical company for speaking (82 per cent), consultancy fees (75 per cent), owned stock (76 per cent) or received royalty payments (70 per cent). Over three-quarters of the patients would also have participated if the cancer centre owned stock or received royalty payments from a drug company. The results were independant of age, gender, race, religion, income, type of cancer, cancer centre involved or phase of study. However, those with a higher level of education were significantly more likely to be concerned about financial conflicts of interest even though more highly educated people had not heard or read any more about the subject. The survey was conducted at five different US medical centres. Source: www.DrugResearcher.com, December 15, 2006
Proteotypic peptides: predicting proteomicsA new computer model could improve quantitative proteomics and speed up lead optimisation by predicting how a protein will break down during analysis. A new study published in January's edition of Nature Biotechnology from researchers at the Institute for Systems Biology, USA; the University of California, USA; and Cellzome, Germany, highlights the benefits of a new computational technique to predict which peptide fragments should be observed for a given protein during liquid chromatography (LC)/mass spectrography (MS). The study found that, on average, the identification of only three distinct peptides is needed to identify the majority (95 per cent) of proteins, and for over 25 per cent of proteins only one peptide is needed for identification. These identifying protein fragments have been dubbed proteotypic peptides. By defining approximately 500 physical and chemical properties of various peptides including charge, hydrophobicity and secondary structure, the researchers were able to find which properties best distinguished the proteotypic peptides from those peptides that are unobserved. Interestingly, the number of proteotypic peptides observed for a protein was not merely a function of the protein length, but factors such as amino acid composition and transmembrane domains also had a significant influence. The predictors showed good agreement between observed and predicted peptides, even for human gamma-secretase, a protein associated with the development of amyloid plaques in the brains of Alzheimer's patients that is notoriously difficult to analyse. Even with the current state of the art methods of protein identification, some parts of the proteome are not detected. The use of these predictors could allow the development of new experimental methodologies that ensure that important proteins are not missed. Source: www.DrugResearcher.com, January 12, 2007
Natural hormone inspires obesity drugScientists at Imperial College London's Hammersmith Hospital are developing a new obesity drug inspired by a natural hormone in the gut that tells our bodies when we are full: pancreatic peptide (PP) is secreted after every meal and signals to the brain to stop eating. Developing a treatment based on natural appetite suppression, mimicking our body's response to being full, has the potential to be safe and effective; other drugs target the brain and so are much less safe. Indeed, people with benign PP-secreting tumours have elevated levels of the hormone and although chronically thin, show no other side effects. In fact, the patients are not even aware they have a suppressed appetite: the tumour is always discovered by accident after the patient sees a doctor with a different complaint. When the tumours are removed, the patients gain weight. However, PP isn't the perfect solution yet. Its appetite suppression effects only last up to 24 hours so it currently needs to be administered daily. Further research will focus on human trials of PP and developing a longer-lasting form of the hormone. Initially, the group are aiming for an injectable form that can be administered weekly but haven't ruled out the possibility of utilising other delivery methods in the future. Eventually, the drug could be given through a nasal spray or even a weight-busting chewing gum. At the moment, the only drugs approved to treat obesity are: Sanofi Aventis' recently-introduced Acomplia (rimonabant), an oral appetite suppressant that is taken once a day and works by blocking cannabinoid binding to the CB-1 receptors found on the surface of cells; Abbott Laboratories' centrally-acting Reductil/Meridia (sibutramine) and Roche's Xenical (orlistat), a lipase inhibitor that prevents absorption of dietary fat in the gastrointestinal tract. Despite what are perceived as relatively modest effects on weight loss, Xenical and Meridia account for a market valued at a little over $1 billion, while Sanofi-Aventis has high hopes for Acomplia, which debuted last year, predicting that sales will be in the 'billions of dollars' range at peak. As pancreatic peptide is naturally occurring, a drug based on it could be used in people of all ages and also in cases of mild to moderate obesity. Source: www.DrugResearcher.com, January 15, 2007
GM bacteria eats cancerA genetically modified bacterium has been found to eat tumours and secrete a protein that opens up 'packaged' anti-cancer therapies. The genetically modified bacterium, Clostridium novyi-NT (C.novyi-NT) has been found to have a special taste for the oxygen-starved regions found at the centres of large cancerous growths by researchers at the John Hopkins Kimmel Cancer Centre. The bacterium also secretes a protein that opens up anti-cancer therapies encapsulated in liposomes, turning the normal slow-release mechanism into a targeted chemotherapy bomb. When the bacteria were administered to a sample of 100 mice alongside liposome 'packaged' chemotherapy drugs, such as doxorubicin or irinotecan, both large and small tumours were completely destroyed and more than two thirds of the mice were permanently cured. The synergistic mechanism of action arises because the bacteria secretes a protein, dubbed, by the lead author of the study Dr Ian Cheong, as liposomase, which disrupts the lipid packaging of the drug and delivers the payload. This liposomase also has the potential to work in a similar manner for other targeted treatments if the protein was attached to site-targeting antibodies or by attaching it to gene therapies. The genome for the bacteria was recently decoded by the Hopkins team was instrumental in identifying liposomase and will help improve bacterial based therapies. Source: www.DrugResearcher.com, December 8, 2006
Beta-peptides as potential cheaper drugYale University researchers have taken a step toward controlling the structure of beta-peptides. Eventually, these peptides could become the basis for drugs that are cheaper to manufacture than existing protein-based pharmaceuticals and last longer in the body. Most protein drugs in use and in development, such as antibodies that target cancer cells, are made from alpha-amino acids, which are the building blocks of naturally occurring proteins. But metabolic processes in the body's cells also produce strands of beta-amino acids, which differ from alphas in that they have one extra carbon atom. These beta-peptides are metabolized much more slowly than alpha-proteins. Before researchers can make beta-peptides into drugs, however, they must be able to control their three-dimensional structure. The Yale researchers are the first to have made a [beta-peptide] and shown it folds into a 3-D structure with a proteinlike interior. They made 'bundle' structures which are similar to the structure of proteins made by the body. Beta-peptides can probably do all the same things as the proteins the body normally makes, and in addition they are expected to offer a number of advantages: Strings of alpha-amino acids must be relatively long before they can fold into a three-dimensional structure, but strings of beta-amino acids are able to do so at shorter lengths. Thus, these peptides could be less expensive to manufacture; Another advantage stems from the slower breakdown of beta-peptides in the body. Protein drugs made of alpha-amino acids are easily recognized by the body and metabolized quickly--sometimes too quickly to perform their function. They also cannot be taken orally, because enzymes in the stomach would degrade them. Beta-peptides aren't readily recognized by the body's enzymes, so drugs based on them would last longer and could probably be taken orally. The next step for the Yale chemists is to make functional beta-peptides. Having shown that beta-peptides can form structures as complex as those formed by alpha-peptides, they must demonstrate that the novel peptides can perform the same complex activities. Source: www.technologyreview.com, Feb 23, 2007
Sanofi unveils new antidepressantSanofi-Aventis has announced promising clinical trial data for a new antidepressant drug that works in a different way to others currently available. Saredutant is designed to block the effects of a G protein coupled receptor (GPCR) called neurokinin 2 (NK2). The drug could prevent neurochemical changes induced by different stressful conditions in brain regions implicated in depression and anxiety disorders. Established antidepressant treatments work by causing serotonin levels to be increased. However, a report in the Journal of Clinical Psychology claimed that some mutations in the gene 5HT transporter gene could predispose patients to not respond well to these treatments. Therefore, there is a need for antidepressant s based on a different mechanism of action. Antidepressant drugs also fail because they are often associated with a variety of unpleasant side effects, such as decreased sex drive, gastrointestinal disorders and weight gain, which can lead to patients stopping taking their medication. Sanofi expects its once-a-day drug to have low incidence of these side effects. The company is conducting several Phase III trials looking at safety, efficacy (both short and long-term) and the effects of sudden withdrawal. Saredutant is in development to treat major depressive disorder and General Anxiety Disorder. Of four Phase III studies for depression, two showed statistically significant results and two studies were not statistically significant versus placebo. The results from four other Phase III studies are expected this year or in 2008. …..and dropped two experimental anti-cancer drugsSanofi also announced that it has dropped two experimental anticancer drugs from its pipeline. SR31747 was in Phase IIb trials for prostate cancer and tirapazamine was a Phase III drug candidate, designed to treat head and neck cancer. SR31747 binds to two proteins: sigma 1 receptor and emopamil-binding protein (EBP) and can inhibit tumour growth by preventing cell proliferation. Tirapazamine (SR 259075) is activated by hypoxia to make cancer cells more sensitive to chemotherapy. Source: www.DrugResearcher.com, February 14, 2007
1st computer model of human metabolism completedResearchers at the University of California, San Diego, have constructed the first complete computer model of human metabolism. Available free on the Web, the model is a major step forward in the fledging field of systems biology, and it will help researchers uncover new drug pathways and understand the molecular basis of cancer and other diseases. The computer model of metabolism, constructed by researchers in the lab of Bernhard Palsson, professor of bioengineering, connects all known metabolic chemical reactions in the body to every human gene. The new model includes every known gene and every metabolic reaction Palsson's group uncovered in an extensive search of the scientific literature. A given gene in the database is associated with its protein product, which might be associated with a number of metabolic reactions, which are associated with other reactions, which are associated with nutritional inputs like glucose and the output of energy or a product like melatonin. Palsson calls the model "a mathematical representation of all this data." The online database will be updated continuously. One of the model's most promising applications is as a "scaffold on which to project data" from gene-expression profiling studies. Using the model, researchers can input which genes are expressed in a diseased tissue and get as an output the metabolic pathways in which these genes are involved--as opposed to painstakingly searching the scientific literature for information one gene at a time. The model could help researchers better understand and optimize existing drugs. Because the metabolic network can identify multiple ways to generate the same outcome, it may help drug companies come up with compounds that have the same effects--alternatives to statin drugs like Lipitor, for example--without violating their competitors' patents. Source: MIT Technology Review, February 6, 2007
Bacteria resistant skin cells for better artificial skinA patient's skin cells, genetically modified and grown in a test tube, could provide the next generation of artificial skin. As a first step in creating such replacement skin, scientists in Cincinnati have engineered bacteria-resistant skin cells in the lab and are now testing them in animals. Ultimately, they hope to produce a type of artificial skin that can sweat, tan, and fight off infection. The researchers genetically modified skin cells to produce higher levels of an antibacterial protein. In a paper published in the current issue of the Journal of Burn Care and Research, they showed that these skin cells, when grown in a test tube, could kill more of a specific kind of bacteria than standard skin cells. However, the engineered cells are still a long way from clinical use. The true test of the bacteria-fighting properties will come in the complex environment of a real wound, which is littered with many different types of bacteria. The researchers are now planning experiments in animal models. Ideally, the researchers want to create even better cultured skin, with cells that can grow the molecular structures required to produce sweat, hair, and pigment. "If we can start with two cell types and add one or two genes at a time and get these structures to develop, that would be very exciting. Source: www.technologyreview.com, January 12, 2007
Stem cell news
Public consultation on UK chimeric stem cell researchThe UK's Human Fertilisation and Embryology Authority (HFEA) has called for a public consultation into the use of animal eggs to create cloned hybrid or chimeric human embryos for laboratory-based disease research. The HFEA has ruled that while it has the authority to license research into human-animal hybrid embryos and that while legislation doesn't prohibit it, it doesn't have enough evidence to grant licenses and so has called for a public consultation. The consultation will be completed by the autumn and forestalls the licensing decision about this controversial and potentially life-changing technology. Dr Stephen Minger, Kings College London and Lyle Armstrong, Newcastle University, have both applied to the HFEA for licenses to carry out research into human-animal hybrid embryos also known as chimeric embryos. The research would involve cloning human eggs inside the shell of rabbit or cow eggs from which the nucleus has been removed, a technique known as somatic cell nuclear transfer (SCNT). SCNT using human eggs is currently legal in the UK and the USA. The resulting clones, which would be 99.5 per cent human, could be used as a source of embryonic stem cells, as well as models on which to study new therapies for neurological disorders such as Alzheimer's and motor neuron disease. Source: www.DrugResearcher.com, January 12, 2007
Cellartis channels Scottish expertise in stem cellsCellartis has begun a new research programme in Scotland as part of a £9.5m (euro14.5m) programme by ITI Life Sciences to develop the world's first automated process to produce high-quality human stem cells. Cellartis are backed by a £1.2m government grant through Scottish Development International and the programme is expected to create an initial 75 new jobs. Stem cells are arguably best known as a possible source of regenerative cell therapies able to treat disease by themselves. However, they can also be used in drug discovery and preclinical research, a more realistic aim in the near term. For example, a drug designed to combat heart disease could have activity assessed on human heart cells or liver cells could be produced to test drug toxicity. The market for cell-based tools within the pharmaceutical industry was worth $1.4bn (euro1.1bn) in 2001 and has grown rapidly ever since, according to ITI Life Sciences. There are essentially two key technical hurdles to be overcome before stem cells can be used extensively for drug discovery and therapies: you need a robust process to produce large numbers of stable cells to work with and you need to control the way in which a stem cell changes into, say, a liver cell or a heart cell. Neither of these problems has been cracked yet, reason why the ITI programme is focusing on these problems. Cellartis is the world's largest source of human embryonic stem (hES) cells. These existing stem cells will be used in the research, meaning no new hES cells will need to be collected. Source: www.DrugResearcher.com, February 2, 2007
Research news
Watching the insides of a cellNew imaging tools provide nanoscale pictures of the happenings of individual living cells and neurons. Today's molecular imaging techniques come with a host of pros and cons. Among the most widely practiced techniques is electron microscopy, which creates highly magnified images of cells by using a beam of energized electrons. However, electron microscopes can't view the inner workings of living cells. In contrast, researchers at MIT's George R. Harrison Spectroscopy Lab have been able to image live, untreated cells by using an optical technique based on interferometry: a laser beam passed through a sample is compared with a reference beam of similar wavelength that is not passed through the cell. For example, it takes longer for light to travel through a cell than through, say, water. Researchers can measure that time delay, or phase shift, and then can map the cell and its motions on the scale of nanometers. It's a very sensitive technique but by now pretty much perfected. It is being applied to a number of different problems." Source: MIT Technology Review, November 21, 2006
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