– Series A financing round expanded to €34.1 million –
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the expansion of its Series A financing round by € 9.6 million. The additional funds increase the round to a total of € 34.1 million and the total capital raised to date to € 36.6 million. The financing was led by Forbion Capital Partners together with Roche Venture Fund. CD-Venture and Curetis ́ management also participated in the round. Holger Reithinger, Partner at Forbion Capital Partners, has joined Curetis’ Board of Directors. Roche will get an observer seat on the Board of Directors.
Since its inception in 2007, Curetis AG has developed the versatile Unyvero™ instrument platform which handles disease-specific disposable cartridges for the analysis of various marker panels, covering both pathogens and antibiotic resistance genes. The Unyvero™ platform combines a unique, fully automated sample preparation working with a comprehensive range of native clinical sample types, with isolation, amplification and highly multiplexed detection of DNA. The simplified, automated and uniform work flow enables testing at the point of need, eliminates operator-induced variations and ensures high-quality results in a short time frame. The first application, a solution for comprehensive pneumonia testing, has successfully completed extensive pre-clinical testing, is about to enter into pivotal clinical trials towards regulatory clearance and is scheduled to enter the European market as a CE-marked device in 2012.
The European Court of Justice today ruled that biological procedures cannot be patented if they are based on the prior destruction of human embryos, with “human embryo” defined in the broadest possible sense.
Background of the ruling is a patent filed by German stem cell researcher Oliver Bruestle in 1997. The patent covers isolated and purified neural precursor cells produced from human embryonic stem cells and used for the treatment of neurological diseases. The cells are already being used clinically for the treatment of patients suffering from Parkinson`s disease.
Greenpeace filed an opposition to the patent and after the Federal Patent Court, Germany, ruled that the patent was invalid in so far as it covers processes for obtaining precursor cells from human embryonic stem cells, Bruestle appealed to the Federal Court of Justice, Germany, which referred the case to the European Court of Justice, saying the concept of ‘human embryo’ was not defined in EU Directive 98/44/EC on the legal protection of biotechnological inventions. The question was whether the exclusion from patentability of the human embryo covers all stages of life from fertilization of the egg or whether other conditions must be met, for example that a certain stage of development is reached.
Today, the European Court of Justice stated that its decision was not about ethical or moral questions, but solely on the legal interpretation of the EU Directive, adding that the Directive defines “human embryo” in the widest possible sense, i.e. every human egg able to divide must be classified as a “human embryo”. This even comprises enucleated eggs, into which the cell nucleus of a human body cell has been transplanted, as well as non-fertilized human eggs, in which cell division and further development have been stimulated without fertilization, e.g. by parthenogenesis. Taking the definition even further, it adds that all inventions that are based on the prior destruction of human embryos or their prior use as base material are excluded from patentability.
Greenpeace hailed the decision as a “landmark case”, stating the ruling was protecting humans from being commercially exploited. The press release was illustrated by the picture of a baby carrying a “patent clip” in its earlobes.
Oliver Bruestle, who was placed under police protection together with his family when the campaign against his patent application was started, commented that fundamental research on human embryonic stem cells can still take place in Europe – however, it means that “others will pick the fruits in the U.S. and in Asia.”
The ruling is the result of the EU’s Directive, which was adopted in 1998 after a decade of debates and compromises between the EU member states, the EU parliament and the EU Commission.
Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the opening of its state-of-the-art production facility for disposable Unyvero™ cartridges in Bodelshausen (near Tuebingen, Germany).
The fully automated manufacturing line in a clean room environment is designed to be fully cGMP compliant and offers scalability and flexibility to meet the growing demands of clinical trials and commercialization with the scheduled 2012 EU launch of the Unyvero P50™ pneumonia cartridge.
Initial production capacity is 100,000 p.a. which may be easily expanded to an annual production capacity of 1 mio. cartridges. First product is the Unyvero™ P50 pneumonia cartridge for the identification of 17 pneumonia pathogens and 22 of their clinically most relevant antibiotic resistance markers.
Germany’s new Law on the Reorganization of the Pharmaceutical Market (AMNOG), which came into force January 1 this year, has substantially changed the rules for the introduction of new medicines on the German market. The akampioneer already has reported on the novel regulations and procedures – now it is time to look at the consequences AMNOG has had already.
Since the beginning of 2011, 18 dossiers for the required benefit assessment have been filed with the Federal Joint Committee G-BA, the highest decision-making body of the joint self-government of physicians, dentists, hospitals and health insurance funds in Germany. G-BA is then assessing the “additional patient-related benefit” of a novel drug, either itself or by assigning Germany’s Institute for Quality and Efficacy in Health Care (IQWiG). If G-BA identifies an additional benefit, the umbrella organization for the statutory health insurance funds and the pharmaceutical company negotiate the reimbursement price as a discount on the original selling price within six months. If negotiations fail to reach an agreement, an arbitration commission defines the reimbursement price using the European price level as a standard.
Most cases are still pending. In one of the 18 cases (the statin pitavastatin marketed by Merckle Recordati in Germany) , the manufacturer itself requested the drug to become reimbursed under the fixed price system. In two cases, marketing was halted in Germany by the manufacturer following a negative G-BA assessment: Boehringer Ingelheim and Eli Lilly decided not to market linagliptin, a DPP4 inhibitor for the treatment of type II diabetes; the companies think G-BA chose the wrong therapy for comparison and assessment of the additional benefit.
Novartis removed Rasilamlo from the market, effective September 1. The oral drug is a combination of aliskiren and amlodipine, which was approved in April this year for the treatment of high blood pressure patients not adequately controlled by either aliskiren or amlodipine alone. The company could not get to terms with G-BA on the data required for the assessment of the additional patient-related benefit.
The decision not to market a drug in Germany if the assessment is negative and the setting of a low price is imminent certainly reduces sales; on the other hand it prevents the setting of a lower price in other European countries that use Germany’s drug prices as reference.
The first completed assessment regards AstraZeneca’s platelet aggregation inhibitor ticagrelor, which was approved in December 2010 for the prevention of thrombotic events in patients with acute coronary syndrome or myocardial infarction with ST elevation, and is intended to be used in combination with acetyl salicylic acid (ASS). G-BA had assigned IQWiG with an assessment that deviated from the design of the studies used for approval and from the comparator therapy G-BA originally had agreed upon with the manufacturer. For approval, the drug had been compared to clopidogrel (plus ASS). IQWiG, however, defined subgroups and compared ticagrelor plus ASS with clopidogrel plus ASS in patients with unstable angina pectoris and myocardial infarction (with and without ST elevation) and prasugrel plus ASS as a comparator for patients with ST elevation, which had received a coronary bypass or a percutaneous coronary intervention (PCI) .
As a result, G-BA ruled that the drug has an additional benefit only in patients with myocardial infarction without ST elevation and in patients with unstable angina pectoris. In these cases, G-BA sees a moderate additional benefit. IQWiG had stated that the data provided by the manufacturer to support efficacy in patients with ST elevation did not sufficiently prove additional benefit in this subgroup.
While it certainly is a good idea to ask whether a novel drug not only meets regulatory requirements but also translates into patient benefit, the process of assessing this benefit and the degree of improvement as compared to existing therapies is a mess in Germany.
One important point is transparency. The crucial selection of the comparative therapy for the assessment takes place behind closed doors in G-BA’s pharmaceutical subcommittee. G-BA does not even disclose the subcommittee’s members – however, it is known that the members are picked from the National Association of Statutory Health Insurance Physicians and from the Statutory Healthcare System. The cheaper the comparative therapy chosen, the bigger is the hurdle to meet the cost/benefit ratio.
Second, as compared to the NICE procedure in the UK as an example, manufacturers are not involved in the process once it has started (except that they may be asked to submit more data), and if they are not happy with a decision the only possible procedural intervention is taking G-BA to court. Otherwise, they may wait for a year after which they can file an application for submitting novel data – which may be granted by G-BA or not.
Third, it is often very difficult to prove an additional benefit of an innovative medication immediately – except maybe for an antibiotic. Therapies for chronic diseases lead to measurable improvements often in the long or medium run only, and regulatory studies often are not large or long enough to meet the strict “evidence-based” criteria of IQWiG and G-BA. In addition, elderly patients often suffer from multiple diseases, making an assessment even more difficult.
Last not least, for the reference price system the devil is in the details. Will all European countries, including the poor economies of the former communist countries in Southeastern Europe, be included – or only the richer economies of the old European heartland?
All in all, the new regulations already have led to a slowing-down of novel drugs reaching the German market – a development that IQWiG’s new director Juergen Windeler in a recent interview declared as “expected”. He might as well have said “welcomed” as he added that of the about 60,000 drugs on the market in Germany, 95% were dispensable: “Experience shows that good medical care is possible with 2,000 to 3,000 drugs only.”
