Ballerup - Sophion recently introduced QPatchTM 16, a 16-channel automated patch clamp system. QPatch 16 has been designed to work with voltage-gated as well as ligand-gated ion channels. Anticipated screening capability of QPatch 16 is 250 to 1200 compounds per working day. There is a further scale-up of the technology in the pipeline for 2004, offering 96 parallel patch-clamp measurements and hence six times higher throughput compared with the QPatch 16.
Brussels/Frankfurt – Agrobiotech companies have warned against the implementation of national GMO bans on the basis of new guidelines that favour thresholds below the EU labelling threshold of 0.9% GMO admixtures. A position...
Brussels/Frankfurt – Agrobiotech companies have warned against the implementation of national GMO bans on the basis of new guidelines that favour thresholds below the EU labelling threshold of 0.9% GMO admixtures. A position paper sent to decision makers by the German biotech association DIB warns that any measure allowing EU member states or regions to establish thresholds for GMO admixtures below the official EU GMO labelling threshold of 0.9% will create a situation of permanent legal uncertainty for farmers wanting to cultivate biotech crops. On 13 July, the Commission is expected to replace the current coexistence guidelines (2003/556/EC) with legally non-binding recommendations that allow member states to prohibit cultivation by giving them the right to establish measures to achieve “the lowest possible presence of GMOs” in organic and other crops. Legal experts claim that this approach to coexistence may be “without legal basis” because EU law clearly states that products must only be labelled if above the 0.9% threshold. According to Ricardo Gent from the DIB, such rules would discriminate against farmers who want to plant GMOs. The Commission hopes to end the GMO deadlock with the new rules.
Tübingen – A single infusion with the immune modulator cyclophosphamide before vaccination with Immatics’ multi-peptide tumour vaccine IMA901 improves response rate in patients with advanced renal cell carcinoma. 83% of the...
Tübingen – A single infusion with the immune modulator cyclophosphamide before vaccination with Immatics’ multi-peptide tumour vaccine IMA901 improves response rate in patients with advanced renal cell carcinoma. 83% of the patients that received pre-treatment were alive after 18 months compared to 68% who received IMA901 alone, according to Phase II data. The effect is probably due to a lower level of regulatory T-lymphocytes that block the induction of a immune response by the multi-peptide vaccine.
London – It’s bad news for the European Medicines Agency. A new Eurobarometer poll (see page 10) shows that many European citizens don’t trust scientists whose work has been sponsored by industry – regardless of whether they did...
London – It’s bad news for the European Medicines Agency. A new Eurobarometer poll (see page 10) shows that many European citizens don’t trust scientists whose work has been sponsored by industry – regardless of whether they did a good job or not. But in fact, the EMA is also increasingly dependent on fees from its clients in the biotech and pharma industry. New data from last year clearly show that the agency’s share of EU funding shrank from 25% of the EMA budget five years ago to just 21% of the current a198.2m allocation. According to Scrip, the EU wants to cut its contribution even more. The final decision over the EUR219m budget proposed by the EMA will be taken in November. There isn’t a single regulatory authority in the world that is funded completely without user fee contributions. In Australia and the UK, the respective agencies are 100% funded by sponsors of clinical trials and other users. In the US, 50% of the budget is paid by users. However, in Europe the Commission’s minimum contribution is strictly controlled by what is known as “fee regulation”. The Commission will present a report on its implementation later this year, but it’s important for European industry-funding averse citizens to know that the level of fees is set by non-EMA bodies.These are also payable in advance, without any relation to the outcome of services offered by the agency. Additionally, the EMA has a peer review system for applications sent to the agency. Independence and transparency could soon become more important for the EMA, as pharma stakeholders are supporting initiatives to centralise evidence-based comparative efficacy assessment at the EMA instead of in the 27 national Health Technology Assessment (HTA) bodies throughout the bloc. Throughout Europe, it is still neither clear how the efficacy of new drugs should be assessed, nor which standard therapies should be used as comparisons. According to the EMA, centralisation of HTA is a political question, and must be cleared at the EU level.
Brussels – The European Commission has awarded EUR2.8m to a project intended to create ultra-sensitive chemical sensors and smarter, cheaper infrared (IR) photodetectors. IR-technology applications are currently expanding in...
Brussels – The European Commission has awarded EUR2.8m to a project intended to create ultra-sensitive chemical sensors and smarter, cheaper infrared (IR) photodetectors. IR-technology applications are currently expanding in metabolite and protein fingerprinting. The goal of the PLAISIR project is to improve spectroscopic chemical sensing (SCS) systems that are able to detect the climate gas CO2 as well as glucose, a key marker in Type II diabetes. The key to improving both mid-IR detectors and SCS is nanotechnology, which has the ability to confine and control light at both wavelength and sub-wavelength scales through a phenomenon known as plasmonics. The project, which includes the firms Xenics, Photon Design, Vigo System SA, Queen’s University Belfast, the University of Zaragoza and Dresden Technical University, is being led by the Swiss Centre for Electronics and Microtechnology.B
Brussels – The Innovative Medicines Initiative launched a EUR26m diabetes research project in mid-June. IMIDIA will focus on the factors that contribute to the functioning and survival of insulin-producing pancreatic islet cells....
Brussels – The Innovative Medicines Initiative launched a EUR26m diabetes research project in mid-June. IMIDIA will focus on the factors that contribute to the functioning and survival of insulin-producing pancreatic islet cells. The project, which is being coordinated by French Sanofi-Aventis, brings together eight pharma firms, the biotech Endocells SARL, and 12 academic groups to deliver in vivo beta cell imaging, diagnostic and prognostic biomarkers, as well as identification of disease-associated pathways. The researchers hope to establish predictive disease models. The EU Commission is contributing to the funding with EUR7m. The IMI is a joint initiative of the member firms of the European pharma association EFPIA and the European Commission.
Brussels/Geneva – Biofuel production from cheap resources such as wood waste, corn stover or grass could be the next huge market for biotech. According to estimates from the Geneva-based World Economic Forum, the market for...
Brussels/Geneva – Biofuel production from cheap resources such as wood waste, corn stover or grass could be the next huge market for biotech. According to estimates from the Geneva-based World Economic Forum, the market for biofuels alone is set to rocket to US$80bn within the next 20 years. “We are on the doorstep of a transition to a greener, more sustainable future,” said Feike Sijbesma, CEO of fermentation specialist Royal DSM N.V., which provided input for the market report “The Future of Industrial Biorefineries” together with the firms Novozymes (see. p. 19), DuPont and Braskem. However, the report also requested more political support for the establishment of a biobased economy.
Sustainability criteria for biofuels
As a first step, the European Commission in mid-June adopted criteria to establish a sustainable biofuel label. To be given the label, biofuels must lead to a minimum of 35% reduction in greenhouse gas emissions, and the raw materials used to make them may not be derived from natural forests, protected areas, wetlands, peatlands or areas with high biodiversity. The Commission hopes to implement the new criteria within the Renewables Directive by December. Biofuel producers such as Lars Hansen, European the President of Danish Novozymes A/S, said that the sustainability requirements are a welcome chance to kick-start the advanced biofuels industry. The Danish enzyme provider just signed deals to deliver enzyme cocktails for producing cellulosic bioethanol from wood or corn stover – the leaves and stalks of maize plants – to Canada’s Lignol Energy Corp. and Chinese fuel producer Sinopec. Hansen believes that cellulosic biofuels could produce 90% less CO2 emissions than fossil fuels. Other European companies such as Südchemie have also entered the promising lignocellulosic biofuel market. Sustainable biofuels could in principle significantly contribute to the EU‘s 20% renewable target.
Carbon tax on stand-by
Yet it remains unclear whether the 20% reduction target can be achieved by 2020, because member states are strongly resisting EU plans to implement a tax for CO2 contained in fuels. At the end of June, the EU Council did not adopt a proposal made by Taxation Commissioner Algirdas Semeta to establish a tax of a20/ton of CO2. Instead, the Commissioners response was ambivalent. They asked him to investigate the economic impact of such a tax.
New coexistence rules designed by the European Commission to give EU member states the right to ban acreage of genetically modified organisms (GMOs) from their territories will hamper cultivation of GMOs in Europe, say...
New coexistence rules designed by the European Commission to give EU member states the right to ban acreage of genetically modified organisms (GMOs) from their territories will hamper cultivation of GMOs in Europe, say agribiotech advocates. “The Commission proposals are aimed at establishing the opposite of coexistence,” complains a position paper issued by the German industry association DIB. Published in mid-July, the paper warns that any measure allowing EU member states or regions to establish thresholds for GMO admixture below the official EU GMO labeling threshold of 0.9% will create a situation of permanent legal uncertainty for farmers who want to cultivate biotech crops. Worked out before the Commission officially presented its proposals to change the current coexistence guidelines laid down in Recommendation 2003/556/EC, the DIB position paper warned against it. “This proposal discriminates against farmers who want to plant GMOs,” said Dr. Ricardo Gent, the association’s Managing Director.
With the new rules, Health Commissioner John Dalli is seeking to end the GMO deadlock in Europe. For years, member states have systematically blocked market approvals of GMOs that had been scientifically assessed as safe because they wanted to keep their territories GMO-free. Under existing laws, EU members had to have scientific reasons for their reluctance to plant GMOs that had been declared safe by food watchdog EFSA. The new rules would change this practice. The idea behind the Commission’s new “Recommendation on guidelines for the development of national coexistence measures to avoid the unintended presence of GMOs in conventional and organic crops” is to accelerate market approvals so GMO-friendly EU member states can move ahead with planting, while GMO-critical states or regions can continue to ban cultivation of genetically modified crops. “Member states will acquire the right to establish measures to achieve the lowest possible presence of GMOs in organic and other crops,” confirmed Dr. Michael Haas from the Austrian Health Ministry, a week before the Commission presented the new GMO rules. According to a legal analysis commissioned by the DIB, member states will be encouraged to adopt coexistence measures “which pursue a coexistence threshold below the legally mandated labelling threshold of 0.9%.” The experts claim that this approach to coexistence is “without legal basis” because EU law clearly states that products must only be labelled above the 0.9% threshold. For GMO advocates, the proposal appears to be linked too closely to the needs of the organic industry. They believe the new rules may act as a catalyst for litigation between biotech, conventional and organic farmers.
Diverse interests make odd allies
Criticism of the Commission’s plan has also come from both GMO proponents (Spain) and GMO sceptics (France and Poland). Both are opposed to applying the subsidiarity principle to GMO farming, saying it “could distort competition.” And Greenpeace officials claim that a trap lurks behind the new proposals’ seductive facade. “The wording makes no bones about it. The idea is to step up the pace of approvals,” said Arnaud Apoteker from Greenpeace France. “But the way GMO assessment is currently carried out is not satisfactory.” So the new rules intended to benefit both proponents and sceptics could actually end up leading to the next major GMO debate in Europe. Before the planned addition to Article 26 of the Directive 2001/18, both the European Parliament and the European member states have to adopt it.
Jessica Mann has been named Head of Translational Medicine at Swiss pharma giant Hoffmann-La Roche AG. Mann is leaving Swiss Evolva Holding SA, where she worked as CMO. Prior to that she was Medical Director and a board member at...
Jessica Mann has been named Head of Translational Medicine at Swiss pharma giant Hoffmann-La Roche AG. Mann is leaving Swiss Evolva Holding SA, where she worked as CMO. Prior to that she was Medical Director and a board member at Speedel AG, which was taken over by Novartis in 2008. Despite the move, Dr. Mann will continue to advise on Evolva’s clinical development. At Roche, she will lead the team in charge of early clinical development activities for Metabolic DTA.
As the present German Insolvency Act does not provide licensees with a satisfactory solution in cases of licensor insolvency, securing Intellectual Property rights by other means needs to be a major topic for negotiations between...
The present regulations in Germany’s Insolvency Act do not provide for any protection of licensees in case of insolvency of a licensor. A licensing agreement that has not been fulfilled by one or both contracting parties at the time of the opening of the insolvency proceedings creates an uncertain situation. In such cases, the insolvency administrator can decide whether the licensee has to fulfill the contract, and whether the license agreement should remain in full force and effect. But the insolvency administrator also has the choice to opt for non-fulfillment. In these cases, the license agreement is unenforceable for the time being. The German Insolvency Act only provides licensees with the
option to sue for damages, and those claims often end up worthless. The licensee is therefore dependent solely on the decision of the insolvency administrator, and has no influence on the effectiveness of the license per se.
What does that mean for the life sciences sector?
An analysis of a practical example clearly reveals the disadvantages of the present German Insolvency Act. For those active in the life sciences sector, Intellectual Property has essential value. Technological innovations, research and development and the resulting Intellectual Property rights are necessary in order to commercialise profitably products and meet the needs of consumers for innovative products. Many start-up companies are currently out-licensing rights to their Intellectual Property to generate additional revenues. And larger companies are at present willing to pay attractive royalties and/or milestone payments in order to in-license the results of early-stage innovations to fill their product pipeline. In cases where research and development activities are successful, new plants for the manufacture of a newly developed product have to be built, or existing plants may have to be altered to manufacture the new products. All told, the stronger partner – the licensee – generally invests significant amounts of money due to the development of in-licensed Intellectual Property and the commercialisation of a new product. In cases of insolvency of the start-up company,
the licensor, there is a great risk that the licensee will not be allowed to further use the existing license – in spite of all of the significant additional investment. In contractual negotiations with a start-up company, larger companies might therefore insist on certain “protection provisions” (e.g. a usufruct on the licensed Intellectual Property in case of the insolvency of the licensor). In negotiating a license agreement, the purchase of the respective Intellectual Property is at times also considered by the larger partner to overcome the “insolvency issue”. But very often, start-up companies aren’t interested in selling their patent or patent family, as due to such sale, an exit of the financing shareholders would become more difficult and later developments might to lead to significantly higher financial advantages (for example milestone or royalty payments – such advantages would be lost by a previous sale of the patent). It is therefore extremely important for all parties to solve this difficult problem under the existing legal regulations, and to unify interests by finding satisfying contractual solutions for everyone involved.
An unsolvable problem under existing German laws
Is has to be pointed out that all attempts to solve problems due to licensor insolvency by creating respective “contractual solutions” may not in the end be recognised by German courts, as case law in Germany for addressing these “creative” contractual solutions remains limited. In cross-border transactions, there are also problems when it comes to finding a common solution for all parties to the license agreement, as it is especially difficult to illustrate the German situation to lawyers from other countries transparently, and to explain the required contractual solutions that might help to avoid at least some of the pitfalls. Only a long-overdue change to the German Insolvency Act aimed at solving these problems might simplify negotiations between licensees and licensors in the future.
Advantageous regulations outside Germany
Rights to Intellectual Property such as copyrights, patents, and trademarks, are of enormous importance to companies – particularly those in the Life Sciences Sector. The right to use certain technologies often depends on license agreements. When a licensor becomes insolvent under German law, such licenses may be negatively affected. Due to its legislation, a major exporting nation such as Germany is therefore in a worse position than other countries like Japan or the United States, as the risk to the licensee in case of insolvency of the licensor is significant. Due to this lack of security measurements in a worst case scenario of licensor insolvency, many companies opt for an “escape” to countries where at least some legislation protection already exists. Other countries such as
Japan and the United States have accepted the necessity of adjustments to their legal regulations.
The future will show whether Germany’s
Federal Parliament will make all the necessary efforts to change the current pitfalls for license agreements in insolvency proceedings. But a more practical and more business-orientated solution should be taken into consideration, and will hopefully be passed during the current legislative period. This would strengthen Germany’s attractiveness as a prime location for research and development.D
Contact Peter Homberg Andrea Veh Raupach & Wollert-Elmendorff -
Rechtsanwaltsgesellschaft mbH Franklinstraße 48 60486 Frankfurt am Main, Germany Tel: +49-(0)69-7191884-0 Fax: +49-(0)69-7191884-4 email@example.com www.raupach.de
Basel – Roche AG has reported promising Phase III results with its anti-IL-6-antibody drug Roctrema (tocilizumab) in children with systemic juvenile idiopathic arthritis. Following 3 months’ treatment with the immunomodulator,...
Basel – Roche AG has reported promising Phase III results with its anti-IL-6-antibody drug Roctrema (tocilizumab) in children with systemic juvenile idiopathic arthritis. Following 3 months’ treatment with the immunomodulator, 85% of patients achieved 30% symptomatic improvement (ACR30) compared to 24% of patients receiving placebo. Further data showed 70% achieved ACR70 and 37% achieved ACR90. The adverse event profile was similar to adult RA studies, and as expected for this patient population.
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