News

Food for Thought: Boehringer Ingelheim Puts Pradaxa Cards on the Table

When German pharma company Boehringer Ingelheim on November 12 said that 260 cases of fatal bleeding have been linked to its new stroke prevention pill Pradaxa, the figures were taken up by many media as evidence that Pradaxa dabigatran, which was launched in Europe in September this year, was a dangerous drug.

In a courageous move, Boehringer Ingelheim yesterday released detailed data from the drug safety database, data that are usually submitted to regulatory agencies only.

Now that the figures are out, several media have taken up the issue again to put it into perspective. Hartmut Wewetzer in Der Tagesspiegel writes that every drug inhibiting blood coagulation poses the risk of bleeding. Wewetzer cites Christoph Bode, a heart specialist from University Clinic Freiburg, as saying that Pradaxa is lowering the risk of fatal bleeding in the brain to 25%, which is a superior value compared to vitamin K antagonists such as Marcumar and Warfarin, the therapeutic standard of previous decades.

Wewetzer also features Boehringer’s calculation that – based on current data – Pradaxa each year can prevent 3,490 of 4,500 stroke cases among 100,000 patients with atrial fibrillation, but may cause 230 cases of fatal bleeding. In comparison, Warfarin is causing 330 deaths. Based on the sum total treatment duration of Pradaxa, which amounts to 410,000 patient years since market authorization, Pradaxa is causing 63 fatal cases among 100,000 patients and year, much less than the figures to be expected from the clinical study data.

Martina Lenzen-Schulte in Frankfurter Allgemeine Zeitung (FAZ) states that the figures reported do not constitute a scandal: “For one, it is in the nature of things that application of blood thinners can cause severe and sometimes fatal bleedings. And the bigger the number of patients treated, the more such complications are to be seen. … Second, it has to be asked whether the incidence of fatal bleedings following dabigatran administration is within the expected limits and – more importantly – whether conventional anticoagulants would have performed better.”

In her article “Deadly Speculations” Lenzen-Schulte also makes clear that competitors are often keen to scandalize side effects of novel drugs and mentions Bayer’s cholesterol-lowering drug cerivastatin as an example. Cerivastatin was withdrawn from the market by Bayer in 2001 following reports of fatal rhabdomyolysis. These cases mostly were due to combination with fibrate drugs – despite warnings on the label.

“It amounts to incapacitation, if one believes that patients always have to be dictated what it best for them”, she writes. “It would be better to put one’s cards on the table and let the patient decide what he wants and what not.”

Boehringer Ingelheim certainly has been quick to do just this, so that patients now can make an informed decision.

Company News: Keeping an Eye on Curetis

Curetis AG’s latest closing of its series A financing round, which now amounts to a total of €34.1 million, has garnered the attention of many media – in particular, as Roche Venture Funds and Forbion were attracted as new investors.

“With Roche Venture Funds now on board, Curetis may have a leg up in wooing parent company Roche as a commercial partner,” comments Ben Butkus in PCR Insider. Oliver Schacht, CEO of Curetis, is quoted as saying that Roche’s investment came with “no strings attached”, adding that “it is a great sign of validation that, after a lot of due diligence and looking at … our first product, that the PCR multiplexing capabilities that we bring to complex infectious diseases has convinced them, and they made the investment.” Butkus also goes into detail on the technology of Curetis AG’s Unyvero™ System and the roll-out plans for Europe and the US.

The news was also taken up by many other media, including articles in Bloomberg/Businessweek, Dowjones VenturewireMedNous, Genetic Engineering & Biotechnology News, Genome Web, Tornado Insider, IVDT Insight, and transkript – just to name a few.

Already in July, Susanne Kutter had featured Curetis in Europe’s biggest German-language business magazine Wirtschaftswoche in an article on hygiene deficits in German hospitals. In the article, Ingo Autenrieth, Medical Director of the University of Tuebingen’s Institute for Medical Microbiology and Hygiene, underlined that the very important advantage of the Unyvero System is its ability to quickly not only identify a disease-causing pathogen but also the antibiotic resistance genes it carries.

Food for Thought: Weekly Wrap-Up

Solar cells can become cheap bulk ware, even for developing countries, writes Manfred Lindinger in Frankfurter Allgemeine Zeitung (FAZ). He introduces a technology for printing a sheet of zinc oxide, a polymer containing fullerenes and an electrode made from polymers on paper. The technology developed at Technical University Chemnitz can use ordinary printing machines and paper, and the resulting solar paper can be bended and folded. However, the efficiency is still very poor (1.3% at 5 V compared to 10 or more with conventional ones). Life span will amount to a few months. For other approaches to make cheaper solar cells, see this post.

Martina Lenzen-Schulte, also in FAZ, explains how measle viruses leave cells to enter the airway. Today it is known that they do not proliferate in the outer epithelium cells but in lymph nodes. The way back is facilitated by the membrane protein nectin-4, which acts as a transporter carrying the virus through epithelial cells. Lenzen-Schulte also reports that the effect may explain why cancer cells, which often overexpress nectin-4, are vulnerable to measle and other viruses. This might pave a way to develop new oncolytic viruses.

Ernst-Ludwig Winnacker, the nestor of the German biotechnology industry, makes the case for green biotechnology in the weekly Die Zeit. Winnacker criticizes the concept of coexistence that tries to avoid a blending of genetically modified and conventionally bred plants by defining a minimum distance between cultivated areas. In Germany, a farmer cultivating GMOs is liable for every case of cross-breeding, a provision that effectively prohibits GMO cultivation as there is a zero threshold for “contamination”. Winnacker also criticizes the strategy of patenting genetically modified plants instead of protecting them with the traditional plant variety rights that allow for exemptions for the further use of GMOs by breeders and farmers. Green biotechnology, he writes, has – at least in Europe – become the scapegoat for everything that is wrong with modern agriculture, from monoculture to declining biodiversity to the death of bees, although Europe is almost free from GM plants. As 25 years of research into the risk of green biotechnology have not been able to reveal any real danger, Winnacker proposes to amend the German law on genetic engineering and to simply omit the measures restricting the cultivation of GMOs.

Diabetics may soon be able to measure blood sugar without pricking, reports Der Spiegel. A new technology developed by researchers of John’s Hopkins University enables measuring of blood sugar in tear fluid.

In Wirtschaftswoche, Matthias Hohensee introduces US-based 23andme company which offers genetic testing at a rate of $99 plus a flat fee of $9 per month for access to the data. The company, which was criticized for exaggerating the benefits of personal genetic testing, also changed its business model and is now offering its records comprising the data of 125,000 people for research purposes, e.g. to find out why certain hereditary diseases display incomplete penetrance in different carriers of the respective genes.

Theres Lüthi in Neue Zürcher Zeitung (NZZ) reports on clinical studies by Roche and Novartis in people suffering from Down’s or fragile X syndrome in an attempt to improve cognitive abilities.

Alyson Krueger in Forbes reports on a talk on synthetic biology given by Andrew Hessel of Singularity University during the Technonomy 2011 conference. Hessel describes synthetic biology as computer-assisted genetic design that goes from an idea to printing DNA to ultimately booting DNA and forecasts it will render the task of engineering life as straightforward as programming software, or creating a vaccine as simple as Tweeting.

Alex Knapp, also in Forbes, describes a “cyborg yeast” designed by researchers from the University of California at San Francisco and ETH Zurich, Switzerland. In the yeast, the expression of a certain gene can be switched on and off by different shades of red light. The technique may lead to advances in the production of proteins by yeast cultures.

The Economist reports on the first computational pathologist which can can distinguish between grades of breast-cancer cells to provide a more accurate prognosis than a human pathologist can manage.

And finally, scientists found a single gene which can make you appear kinder, reports Catherine de Lange in New Scientist. In experiments conducted at the University of Toronto, people with the so-called GG version of the oxytocin receptor gene were judged to be kinder than those with GA or AA versions. Those with GG variations used significantly more non-verbal empathetic gestures in their storytelling such as smiling and nodding which made them appear kinder.

 

Company News: Gallus Group chooses bubbles & beyond as preferred provider of printing roll cleansers

– Printing roll cleansing agent line enpurex® and surfiMAX cleaning sponges to be distributed with new printers by Gallus Group –

bubbles & beyond, a technology company focusing on customized intelligent fluids®, today announced that the company was chosen as the preferred provider for printing roll cleansing solutions by Gallus Group, St. Gallen, Switzerland. Gallus Group will recommend and distribute selected products of bubbles & beyond´s printing roll cleansing line. Samples of the enpurex® cleansers ONLINE and PRO as well as the surfiMAX cleaning sponges M-ON and M-OFF will be delivered with every printer sold by Gallus Group worldwide and are recommended as the cleansing products of choice.

enpurex® cleansers are designed to meet the criteria of sustainable green printing, while offering significant process cost savings, excellent compatibility of materials, optimum efficacy and operating safety. The cleansers are water-based, non-flammable, free from aggressive chemicals, biodegradable, and also superior to existing products in terms of efficacy. Based on bubbles & beyond´s novel, proprietary intelligent fluids® approach, the products remove all sorts of inks and lacquers used in the printing industry, including 2k lacquer, UV curing ink and calcium glazing, by a unique and fast easy-wipe effect. Thereby, down-time is reduced significantly and printing rolls can be used more versatile across different colors, reducing the need to stockpile print rolls. The enpurex® product line is completed by the surfiMAX cleaning sponges range, which are designed for use in combination with the cleansing agents to achieve optimum results.

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