newsdigest
June
In this section, biotechnologie.de has summarised a number of recent and relevant biotech news from the past month:
Cabinet approves second round of pharmaceutical reforms +++ Hepatitis viruses can now infect mice +++ Federal Constitutional Court reviews Genetic Engineering Act +++ Morphosys complements pipeline with in-licensing +++ Egyptian Minapharm acquires Probiogen in Berlin +++ World premiere at the ILA: Flying with algaefuel
Cabinet approves second round of pharmaceutical reforms
In the future, manufacturers of new medicines will first have to prove the benefits of their products, and negotiate prices with health insurers. Health insurance companies will not be obliged to pay more for products that offer no additional benefits than existing drugs. This provisions can be found in the bill for the ‘reorganisation of the pharmaceutical market’, which the Federal Cabinet approved on 29 June. The draft on which the Bundestag will vote in the autumn also contains a clause stipulating that pharmaceutical companies must publish reports on all confirmatory results from clinical tests. Profit margins for wholesalers are limited to 60 cents per packet. The Bundestag already confirmed the statutory health insurance (SHI) amendments back in June within the first part of the austerity package from Health Minister Philipp Rösler (FDP).Thereby, the manufacturer rebate for patented drugs increased from 6% to 16%, although price increases are forbidden for the time being. In contrast to the second part of the austerity package, both measures are only valid up to 2013. Rösler expects short-term savings of around 1.5 billion euros in 2011, followed by around two billion a year. The Biotechnology Industry Association BIO Deutschland fears that the savings will hinder the development of novel drugs, especially for rare diseases. Innovation will be more difficult for smaller companies above all if opportunities to refinance development costs were held to ransom, said Bio Deutschland Chairman Peter Heinrich.
Hepatitis viruses can now infect mice
Researchers from Hannover and Brunswick have changed the human hepatitis viruses so that it can also infect the liver cells of mice. This is the first step towards a mouse hepatitis model, which is hoped to enable improved investigations of the dangerous liver disease. The researchers have reported on their results in the journal PLoS Pathogens (1 July 2010, Online). The hepatitis C virus (HCV), whose natural hosts are humans and chimpanzees, is highly specialised. Scientists around the world are working on vaccines and medicines to combat the virus. The problem is that while research using liver cell cultures is possible, any investigations of how the immune system controls an infection, or whether possible vaccines are indeed effective, have been extremely limited to date. Because humans or chimpanzees are not eligible for testing at such an early stage, researchers have been trying to develop a mouse model for the disease. The researchers at TWINCORE, a joint facility of the Helmholtz Centre for Infection Research in Braunschweig and the Medical University in Hanover, have converted the human-specialised virus in such a way that it is now able to dock to and infect mouse liver cells. Hepatitis C viruses have four key molecules on their surface that bind to the surface of our liver cells. These trigger a mechanism in the cells, allowing the virus to smuggle themselves inside. “In principle, mice also have these receptors on their liver cells,” says scientist Julia Bitzegeio, “but they don’t match those on the virus surface.” Particular difficulties are posed by are the molecules known as CD81 and occludin - these must be of human origin, or the virus will have no chance of infecting the cell. To make the hepatitis virus function in mice, the researchers removed the CD81 receptor in human liver cells, and replaced it with the mouse version. In an electric field, they then tore tiny openings in the cell membrane, and smuggled the HC viruses through these holes. Repeating this procedure over several generations, they managed to change the agents to such an extent that they continue to infect mouse cells, and without assistance from a surrounding electrical field. The mouse version of the virus is able to penetrate into the mouse cells, but the HC virus is so specialised for humans, that it is not able to multiply in the cells. “Successful penetration is the first step towards a new small animal model, which is so urgently required needed for immunological studies and vaccine development against the HCV,” said working group leader Thomas Pietschmann.
Federal Constitutional Court reviews Genetic Engineering Act
A hearing before the Federal Constitutional Court on the Genetic Engineering Act began on 23 June in Karlsruhe.The judges in Karlsruhe are debating a judicial review from the federal state government of Saxony-Anhalt, which regards as unconstitutional a number of the Act’s strict requirements on the use of genetic engineering in agriculture. The complainants are highlighting above all the requirement for farmers to be held liable if genetically modified (GM) maize is transferred to fields with traditionally bred crops. According to Marcel Kaufman, representative for Saxony-Anhalt, these regulations will strongly restrict the research, development and emergence of genetic engineering, and are therefore unconstitutional. He also said that the location register, which must list in detail every field containing genetically engineered crops, was a significant burden for landowners. On top of this, opponents of genetic engineering could easily use this freely available data to destroy fields. “This means that every field trial represents a significant financial risk,” said Kaufmann. The oft-amended Genetic Engineering Act has regulated the production, application and release of genetically modified organisms in Germany since 1990. The Red-Green government tightened the regulations for the coexistence of conventional crops and GM organisms, especially as regards liability and the public location register, in late 2004. Environmental groups have said that the action from the Saxony-Anhalt government is a frontal attack on GM-free farming and food, saying that if Saxony-Anhalt win their case, it will no longer be possible to distinguish between GM and GM-free foodstuffs. The judicial review decision from the Federal Constitutional Court is expected in the coming months.
Morphosys complements pipeline with in-licensing
For the first time, MorphoSys AG has purchased a drug candidate from another biotechnology company. As MorphoSys reported on 27 June, the Martinsried-based company has agreed an exclusive worldwide license for the cancer antibody XmAb5574 developed by US company Xencore for the treatment of B-cell tumours. The two companies will soon jointly conduct a Phase I clinical trial for use in lymphatic leukaemia, after which MorphoSys will be solely responsible for the product. Xencore will receive an upfront payment of approximately €10.5 million, and is in line to receive development- and marketing-related milestone payments, as well as tiered royalties on product sales. XmAb5574, renamed as MOR208 by MorphoSys, is a humanised monoclonal antibody that acts against the protein CD19 on the surface of specific immune cells (B cells). The molecule from Xencore has been designed to give an increased immune response for the treatment of malign B cell diseases. In B cell development, Cd19 is expressed earlier and more extensively than CD20, the target molecule of Roche’s cancer drug Rituxan, which is already on the market. Rituxan is also used to treat rheumatoid arthritis. MorphoSys is hoping for similarly broad application possibilities for their new substance. MorphoSys Chairman Simon Moroney sees the first in-licensing of a foreign molecule as an important step for the in-house pipeline, which to date has consisted exclusively of antibody candidates created using MorphoSys’ own HUCAL technology. “The stable cash flow from our business segment Partnered Discovery enables us to support an attractive private development program, in which MOR208 is an important addition,” said Moroney. MorphoSys ended the business year 2009 with a turnover of 81 million euros, and profits of around 9 million euros.
Egyptian Minapharm acquires Probiogen in Berlin
The pharmaceutical company Minapharm Pharmaceuticals in Cairo has acquired the Berlin-based cell lines specialist ProBiogen AG. Minapharm now owns 95 percent of ProBioGen shares. As ProBiogen reported in June, the total purchase price was 30.4 million euros. ProBioGen have stated that they plan to continue to work as an independent service provider for international clients in the biopharmaceutical industry, and to develop their own designer cell lines for vaccine and protein production. The new Chairman of the Board at ProBioGen will be Dr. Wieland Wolf. The biologist was previously an executive board member at the Swabian subcontractors Rentschler Biotechnologie GmbH, and is currently President of the European Association of Pharma Biotechnology. The new ProBioGen Board Chairman is Minapharm CEO, Dr. Wafik Bardissi. Hubertus Leonhardt, outgoing ProBioGen Board Chairman, was happy with the successful sale and the successful departure of existing investors: “ProBiogen could not have found a better partner. The combination of the two business models will benefit from a convincing strategic rationale, and a range of synergies.” Among the existing ProBiogen investors were venture capital fund SHS Gesellschaft für Beteiligungsmanagement, the CFH/LBBW Group, IBG, and tbg. Minapharm Pharmaceuticals, which is headquartered in Cairo and has production facilities in Ramadan City, counts among the leading pharmaceutical companies for prescription drugs in Egypt and the Middle East. The Minapharm Group has 700 employees. Since 2003, the biotechnology subsidiary Rhein Minapharm Biogenetics has focused on the production of biopharmaceuticals for liver diseases, thrombosis, and haemostasis. Minapharm has five therapeutic proteins on the market in this area. Probiogen has been cooperating with Minapharm since 2007.
World premiere at the ILA: Flying with algaefuel
At the International Aerospace Exhibition in Berlin, an aircraft powered only with algaefuel has taken to the skies for the first time. From 8-13 June, the European aerospace group EADS flew a DA42 New Generation from Diamond Aircraft equipped with two AE300 engines from Austro Engines over Berlin-Schönefeld airport. Because of the higher energy content of the algaefuel, the Diamond DA 42 New Generation consumes 1.5 litres per hour less compared to the conventional Jet-A1 fuel – with the same performance.Tests demonstrated that only relatively minor modifications and adjustments to the aircraft engines were required to be able to use the algae biofuel. “Our flight demonstration using pure biofuel from algae is a world first, and is an important milestone in our research,” said Jean Botti, Chief Technical Officer at EADS. “Third generation biofuels are more than just a replacement for conventional energy sources. They bring new possibilities for the motors of the future.” Emission measurements suggest that algae biofuel contains eight times less carbon than fossil fuel resources. Due to the very low nitrogen and sulphur content in biofuels in relation to fossil fuels, biofuels also emit up to 40 percent less nitrogen oxides, and very small quantities of sulphur oxides. The aviation industry has set a target of a 50 percent reduction in carbon dioxide emissions and 80 percent reduction in nitrogen oxide emissions by 2020. EADS is currently working with a number of partners in a pilot project to build industrial infrastructure that could produce the experimental fuel in larger quantities. Partnerships are in place with IGV GmbH Potsdam and the Austrian aircraft and engine manufacturer Diamond Aircraft. Oil extracted from algae supplied by the Argentine company Biocombustibles del Chubut and processed into biofuel by VTS Process in Schwedt was used for the flight-testing and demonstration flights. The production of algae oil is currently significantly more expensive than crude oil production.
