Apogenix GmbH (Heidelberg) has initiated a Phase II proof-of-concept study with its lead compound AGP101 + radiotherapy (vs radiotherapy alone) in 83 patients with Glioblastoma Multiforme (GBM). The clinical trial, which is...
Apogenix GmbH (Heidelberg) has initiated a Phase II proof-of-concept study with its lead compound AGP101 + radiotherapy (vs radiotherapy alone) in 83 patients with Glioblastoma Multiforme (GBM). The clinical trial, which is expected to run until 2011, is designed as an open-label, randomised, controlled study in patients with first or second relapse of glioblastoma. Primary endpoint of the study is the six-month rate of progression-free survival (PFS6). Secondary endpoints include overall survival, safety and tolerability of APG101, and parameters measuring the quality of life of the patients. PG101 is a human fusion protein combining the extracellular domain of the CD95-receptor and the Fc-portion of IgG1. APG101 is a fusion protein of the extracellular domain of the CD95-receptor and the Fc-portion of IgG1 that blocks CD95-mediated signaling pathways.
Funxional Therapeutics Ltd (Cambridge, UK) has completed the Phase I programme of its anti-inflammatory compound FX125L, which belongs to the therapeutic class of Broad-Spectrum Chemokine Inhibitors (BSCIs). In its second safety...
Funxional Therapeutics Ltd (Cambridge, UK) has completed the Phase I programme of its anti-inflammatory compound FX125L, which belongs to the therapeutic class of Broad-Spectrum Chemokine Inhibitors (BSCIs). In its second safety study, the selective chemokine migration inhibitor again provoked no severe adverse effects. The company announced it will go ahead with a Phase II trial in Q2/2010. FX125L is an orally available alpha-aminobicyclolactam derivative that is able to inhibit MCP-I induced leukocyte migration in vitro. The compound, which has a plasma half-life of 25h, is reported to have been taken up quickly. Funxional Therapeutics sees potential for the drug in the broad field of autoimmune diseases such as asthma, rheumatoid arthritis, multiple sclerosis, and disorders with an elevated TNF-alpha level.
The EMA has finished its review of the benefits and risks of taking Biogen Idec and Elan’s multiple sclerosis drug natalizumab (Tysabri) after 23 (14 EU, thereof 1 death) cases of potentially deadly brain infections with the JC...
The EMA has finished its review of the benefits and risks of taking Biogen Idec and Elan’s multiple sclerosis drug natalizumab (Tysabri) after 23 (14 EU, thereof 1 death) cases of potentially deadly brain infections with the JC virus occured following the reintroduction of the drug in 2006. In January, its Committee for Human Medicinal Products (CHMP) concluded that the benefits of the treatment outweigh the risk of contracting progressive multifocal leukoencephalopathy (PML) in patients with highly relapsing-remitting multiple sclerosis or in those who are non-responsive to beta-interferon treatment. CHMP said that the risk is around one case of PML for every 1,000 patients being treated for two years with the humanised monoclonal antibody drug that targets integrin alpha-4. The CHMP recommended stopping Tysabri treatment in patients suspected of having PML. The CHMP noted that this can put patients at risk of immune reconstitution inflammatory syndrome (IRIS), particularly if techniques to remove the medicine from the body quickly – such as plasma exchange or immunoadsorption – are used. IRIS is a condition where the recovering immune system can trigger the symptoms of infection. Furthermore, the prescribing information for Tysabri must be updated to reflect the fact that the risk of PML increases after two years of treatment. Patients should be fully informed about the risk of PML both by their doctor and in an updated ‘patient alert card’.
London – The European Medicines Agency (formerly EMEA, now EMA) reported in January that it is adapting its organisational structure to its increasing workload and interactions with patient and consumer organisations. Human pre-...
London – The European Medicines Agency (formerly EMEA, now EMA) reported in January that it is adapting its organisational structure to its increasing workload and interactions with patient and consumer organisations. Human pre- and post-authorisation activities have been unified into a single unit, a newly-created unit for patient health protection will be responsible for safety-monitoring of medicines, and a dedicated group for the management of product data and documentation will improve the Agency’s data-management processes. The organisational changes go hand-in-hand with the preparation of a new website to be launched by the end of Q2/2010, as well as a new logo. Additionally, the search is now formally open for the next head of the Agency, which employs more than 600 staff and has a 2010 budget of about EUR198m (2009: EUR194m). Current director Thomas Lönngren will step down at the end of this year. In January, the EMA Board proposed widening the scope of patient and consumer contributions to the Agency. One proposal was to define the conditions where it is meaningful to invite the representatives of various groups to participate in benefit-risk evaluations of medicines, or as observers in meetings of the Pharmacovigilance Working Party to help contribute to the Agency’s safety communications.
GM rice looks set to arrive on plates in China within the next few years following a decision by the Chinese Agriculture Ministry’s biosafety panel. Made up of 78 high-ranking experts, the panel has for the first time ever...
“If China is really serious about it and all the bureaucratic hurdles are overcome, then the cultivation of GM rice will have far-reaching positive implications for the spread of GMO technology,” Ingo Potrykus – the Swiss co-inventor of the vitamin-A-rich Golden Rice – told EuroBiotechNews. Xingwang Deng, a geneticist pursuing research at both University of Beijing and the elite US university of Yale, is convinced that “the world’s first genetically-modified rice will be a door-opener for other rice varieties grown in the area.” The GM crop, which Deng says “could be commercially planted in 2 or 3 years,” has been in development since 1998 at Huazhong Agricultural University in Wuhan. The team under Qifa Zhang has established a marker-free transformation protocol to transfer the Bt-toxin into the grain, which is a staple for half the world’s population. In productivity testing, which is carried out before GM rice receives the Chinese biosafety certificate for commercial acreage for initially 5 years, the Bt63 strain was re-crossed into the highly-profitable hybrid rice variety Huahui No. 1. According to Chinese officials, the insect-tolerant GM rice brings an 8% higher yield and an 80% reduction in pesticide use. According to a 2003 analysis from Jikun Huang, the director of the Centre for Chinese Agri-policy in Bejing, full adoption of GM rice in China would bring a net benefit of around EUR3bn per year to the country’s economy.
Decision with global repercussions
According to Deng, Bt63 is only the beginning. “China has invested more in rice improvement than any other country in Asia during the last 10 years, and there are a lot of GM varieties in the pipeline (see table, p. 10) just waiting for the green light from Beijing.” For political reasons, the Chinese government has held back on a decision to go ahead with GM rice since 2004, when Bt63 was first ready for commercialisation. Beginning in 2006, major trading partners have steadily complained as traces of the unapproved Bt63 rice turned up in imports in Germany, Britain, France, Switzerland, Japan, Thailand and New Zealand. The European Commission has ordered stricter testing for all products containing rice that are imported from China. The decision to commercialise GM rice had to come from the top levels of the Chinese government, according to Robert Zeigler from the International Rice Research Institute (IRRI) in the Phillipines. In summer 2008, Beijing sent out the first strong signal when Premier Wen Jiabao said “to solve the food problem, we have to rely on big science and technology measures – rely on biotechnology, rely on GM,” before rolling out a US$3.5bn R&D initiative on genetically modified plants to secure its food supply. Demand is growing. According to UN estimates, China’s population of 1.3 billion will need 30% more rice in 2020 than today. European experts see China’s decision as a signal with global consequences. Concrete estimates on the impact it might have on the rest of the world are expected in mid-February, when ISAAA chief Clive James is to present his annual report providing concrete figures on the global GM acreage pattern. “The question is – what percentage of the 650 million tonnes of rice produced annually will be GM?” says Marnix Peferoen, the head of rice research at BASF subsidiary CropDesign in Ghent (Belgium). Industry experts estimate that if adopted by farmers, GM rice could be planted on 15 million hectares in China alone. That translates into 96 million tonnes a year, or 75% of China’s annual rice consumption. GM rice could soon account for approximately one quarter of worldwide production.
Will the battle move to Europe?
When it comes to GMOs, the easy-to-reach fruit has already been harvested, says Jens Lerchl, managing director of SunGene, a BASF Plant Science company. Next up are crops like rice and wheat. The latter could have a major impact on Europe, as the EU is the largest wheat producer in the world. In 2004, GMO opponents in Europe prematurely began celebrating the demise of GM food when Monsanto officially terminated its programmes to develop GM wheat, giving as a reason rejection of the crop by export-orientated wheat farmers in the US concerned about resistance to GMOs in their markets in Europe and Japan. But last year, Monsanto restarted its GM wheat programmes, acquired Montana-based wheat specialist WestBred, and announced it will bring the first GM wheat varieties to the market by 2020. Around 75% of US farmers also revealed in a poll that they would be willing to cultivate GM wheat. The change of heart appears to be due to economic factors. Wheat production has been under pressure from competing biotech crops, which achieved higher productivity in 2008 – a year that saw a decline in wheat production. “If wheat continues on a non-biotech course, then farmers will continue to devote a greater share of their acreage to biotech crops, where profitability is relatively greater, resulting in lower world wheat production than would otherwise be the case,“ the wheat growers’ associations from the US, Canada, and Australia said in a joint statement in the spring of 2009. The change of course among the three largest wheat-exporting nations puts additional pressure on the EU. The organisations say that they “will work towards the goal of synchronised commercialisation of biotech traits in our wheat crops,” because they “believe it is in all of our best interests to introduce biotech wheat varieties in a coordinated fashion to minimise market disruptions.” The clear intention to develop wheat that is genetically engineered to resist drought, pests and pesticides is being picked up in the industry. According to Lerchl, most large agri-biotech companies have resumed GM wheat programmes. The conceivable large-scale cultivation of GM crops feeding over 70% of the world’s population poses a huge problem for the EU. It cannot act against the will of its citizens, but also cannot afford to ignore global market forces. A recent survey on attitudes towards GM foods could point the way to an eventual resolution. While a majority of Germans still say they wouldn’t buy GM foods, more than 55% of the younger generation (14 -19 year-olds) would now accept them provided it can be proven that they are not harmful to health. But will others in Europe agree?
Dr. Peter Heinrich has joined medical device company Magforce Nanotechnologies AG (Berlin) as Chief Executive Officer after former CEO Dr. Uwe Maschek chose to step down at the end of 2009. Heinrich co-founded MediGene AG, and...
Dr. Peter Heinrich has joined medical device company Magforce Nanotechnologies AG (Berlin) as Chief Executive Officer after former CEO Dr. Uwe Maschek chose to step down at the end of 2009. Heinrich co-founded MediGene AG, and served as its managing director and CEO from 1995 until the middle of 2009. Prior to MediGene, Heinrich worked at Wacker Chemie AG, where he held several positions in management, as well as in biotechnology research and development.
Optos plc (London) has announced two changes in its management team. Dr. Peter Fellner has taken the helm at the retinal imaging company after Dr. John Padfield retired from his position as Chairman of the Board at the end of...
Optos plc (London) has announced two changes in its management team. Dr. Peter Fellner has taken the helm at the retinal imaging company after Dr. John Padfield retired from his position as Chairman of the Board at the end of 2009. And after a three-month period as the company’s interim CFO, Christine Soden was confirmed in the position, and also became a member of Optos’ board. Fellner’s last stint was as Chairman of medical devices company Consort Medical plc, and he has played instrumental roles at biotech companies Vernalis plc and Astex Therapeutics Ltd. He is also the non-executive director of UCB S.A., Evotec AG, and Biotie Therapies Corp. Previously, Dr. Fellner was the CEO and then Chairman of Celltech Group plc. More recently he has served as Chairman of Acambis plc and Premier Research Group plc. Soden previously worked for BTG plc, where she became CFO in 2005. She was later appointed BTG’s Chief Operating Officer following the acquisition of Protherics plc in 2008.
Reykjavik – Icelandic gene-hunter deCode Genetics has emerged from bankruptcy and will continue its genetics research and gene-based diagnostics as a private company, but it will abandon its efforts to develop drugs from its...
Reykjavik – Icelandic gene-hunter deCode Genetics has emerged from bankruptcy and will continue its genetics research and gene-based diagnostics as a private company, but it will abandon its efforts to develop drugs from its discoveries. The Reykjavik-based firm became known for using its knowledge of the human genome to detect genes associated with the risk of common diseases such as schizophrenia, cancer and heart disease. But despite its scientific success, deCode Inc. was unable to translate its findings into marketable products, and ran out of money in November of last year. Now the company has begun a restructuring effort. It sold its Islenk Erfdagreining subsidiary, which is the custodian of deCode’s IP, to Saga Investments LLC. That alliance includes the two life science investment companies Polaris Ventures and ARCH Venture Partners. The step has faciliated the re-emergence of deCode as deCode genetics ehf. The bankrupt parent company will change its name to DGI Resolution Inc., and is expected to be liquidated. In its new form, the company will be run by a new chief executive, Earl Collier, and by deCode-founder Kari Stefansson. Collier is a lawyer, a previous vice president of Genzyme and a member of deCode’s board. He will now lead the commercial operation from Boston (US). Stefansson will give up his post as chief executive and become head of research and Executive Chairman. He said that the company’s genetic research in Iceland would carry on as before, and that deCode would “continue to outperform” its mostly university-based rivals in the US and the UK.
When the 2009 United Nations Climate Change Conference ended in December with the “Copenhagen Accord”, the final press release claims that the declaration “was supported by a majority of countries, including amongst them the...
To meet the goals that climate experts agree would limit “dangerous” global warming – the key 2°C threshold rise in temperature considered acceptable – industrialised countries would have to cut emissions by 25-40% within the next ten years and a whopping 80-95% by 2050. In concrete terms, that translates into a maximum of 750,000 megatonnes of carbon in total. Since the dawn of the Industrial Age, human beings have emitted some 500,000 megatonnes, leaving just 250,000 Mt to be divided if we are to avoid the worst of the danger. The real news that emerged from Copenhagen is that this pie is far too small. Even coming close to those goals is therefore looking increasingly unrealistic. But regardless of what future climate conferences might bring in terms of emissions agreements (and disagreements), one thing is becoming clearer by the day; along with clean-tech like wind and solar power, biotech is set to become a major factor in how we redefine energy consumption. Two fields in particular will play a key role in the process: industrial biotech and biofuel.
The future looks white
Even among groups that traditionally have adopted an anti-industry stance, white biotech is acquiring more and more adherents. For example, a WWF report from last September (see EuroBiotechNews 9-10/2009) backed the sector by saying enzymes have the potential to save between 1-2.5 billion tonnes of carbon dioxide annually by 2030 – around 5% of the total worldwide emissions of the gas in 2007. Overall, says the study, white biotech “could help create a true 21st century green economy.” The industry agrees, and white biotechnology is rapidly branching out into a wide spectrum of industrialised processes. The European Chemical Industry Council (CEFIC) estimates that by 2015, turnover will have grown to EUR305bn, a tenfold increase compared to 2005, and that around 20% of all chemical production will involve biotech processes. Novozymes CEO Steen Riisgaard thinks that ”we have only taken the very first steps in exploring how biotechnology can help us save energy and water,” but that products from his enzyme-manufacturing firm “reduced global CO2 emissions by about 20 million tons in 2007 alone.” The added bonus of being able to manufacture products with less energy is that it also reduces the pressure on land-use, ultimately leading to the dedication of more resources to the second great hope for emission reduction – biofuel. ”Bioenergy has established a firm position in the global strategies to combat climate change,” says Josef Spitzer, the Chairman of the upcoming 18th European Biomass Conference and Exhibition scheduled to take place this coming May in Lyon.
Away from petrochemicals
“This position is based on the relative advantages bioenergy has compared to other renewable sources of energy, which are determined by geographical, industrial and socio-economic criteria.” The field’s ability to gain a foothold in the world energy market, however, will continue to depend largely on how well it is able to cope with two important unresolved issues: its competitiveness with traditional energy sources, and its ability to skirt accusations that the industry is stealing food from the mouths of the world’s hungry. To turn a profit, biofuel producers all over the world continue to rely on government subsidies to make their product attractive. Consumption of biofuels nearly tripled in the EU between 2004-2007, and average subsidies kept pace. To become a viable and attractive means of reducing CO2 emissions, that will have to change. Even though supplies are limited, to compete with oil and other fossil fuels, biofuel must become cheaper. The furor over the ethical aspects of increased food prices for the world’s poor due to farmers planting seeds to fill fuel tanks instead of stomachs will only truly be solved by moving into second and third-generation biofuels that don’t use foodstuffs as a primary carbon source for the distillation of ethanol.
The UN Climate Conference ended on a sour note, because the “letter of intent” that is the Copenhagen Accord accomplished very little in terms of binding numbers or concrete steps to for preventing possible disastrous consequences from global warming. Even so, the current threat has been recognised, and trying to defuse it holds promise for certain industries. Markets for biofuels and enzymes will definitely boom. The question is how fast they will make a difference.
Frankfurt – Raupach & Wollert-Elmendorff is expanding into the life sciences sector. In January, the respected German advisors for business law announced they had hired Peter Homberg as an Equity Partner. Homberg is a renowned...
Frankfurt – Raupach & Wollert-Elmendorff is expanding into the life sciences sector. In January, the respected German advisors for business law announced they had hired Peter Homberg as an Equity Partner. Homberg is a renowned expert for life sciences and intellectual property (IP). The specialist for transactions will head up the firm’s office in Frankfurt, which will especially address the needs of companies from the life sciences sector. Homberg is arriving from Raupach’s competitor Jones Day, where he led the European Life Sciences team. He has a long track record in counseling companies from the pharma, biotech, diagnostics and medical devices branches. His colleague Andrea Veh has also moved to Raupach, and will work as an Associate in the new team.
“For our Frankfurt office, Peter Homberg gives an important growth impulse,” said Martin Imbeck, Managing Partner at Raupach. Homberg said he is looking forward to establishing a new life sciences practice at the top-50 German-based law firm. Up to now, Raupach has only provided counsel to firms in medical law. Homberg brings in additional expertise to accompany international financing rounds, M&As, licensing and patent deals – “From start-ups to large enterprises,” he says. Homberg told EuroBiotechNews that he expects to quickly expand the new Life Sciences team. One possibility would be to admit additional patent attorneys. Raupach ranks among the 50 largest German law firms, with more than 90 attorneys in seven offices throughout Germany, and an international network of partners. The company is a strategic partner of Deloitte, one of the leading international audit and consulting firms. Before taking over his function at Jones Day, Homberg was Deputy General Counsel at Roche Diagnostics (formerly Boehringer Mannheim). Previously, he worked as Head of Equity Projects at a Daimler subsidiary, and also headed the Singapore office of Thümmel, Schütze & Partners. In 2000, Homberg joined Jones Day’s Frankfurt office, and from 2003 on he established Jones Day’s life sciences and IP practice in Munich.
7th Berlin Conference on IP in Life Sciences: Big Data, Big Drugs
The health care industry faces significant transformation, driven by a boom in knowledge within biomedical sciences and breakthrough technologies such as gene sequencing. The management of "big data“ will change the understanding of diseases, development of drugs and treatment of patients. more