News

Food for Thought: Trade Media Update

MedNous this week opens up with an article on FDA’s revoking the breast cancer indication for Avastin, saying that the decision did not come as a surprise after the FDA’s Oncologic Drugs Advisory Committee (ODAC) in June voted unanimously to have the indication removed. Avastin had been subject to FDA’s accelerated approval process in this indication.

In contrast, BioCentury Extra reports that FDA encouraged Genentech Inc to continue to study the drug in this indication to identify patients who may benefit and also details Genentech’s plans for Avastin in this indication. It also writes that in the previous months, the National Comprehensive Cancer Network (NCCN) continued to recommend Avastin as an option in breast cancer despite the negative ODAC vote.

The In Vivo Blog comments on the Avastin decision by saying that it introduced some predictability into the accelerated approval regulatory pathway. Companies should continue to use progression-free survival as a surrogate endpoint but not forget to that FDA has some expectations, e.g. for quality of life benefits, and that sponsors should design trials with supportive measures that can themselves turn into additional claims.

BioCentury this week in its cover story reports on the next-generation, interferon-free treatment regimes for HCV which have been in the focus of the recent Liver Meeting of the American Association for the Study of Liver Diseases (AASLD), stating that the new standard of care introduced only this year  following the approval of two HCV protease inhibitors, may be supplanted quickly by new regimes that are tailored to virus subtypes and patient populations.

SciBx is focusing on novel small molecule inhibitors of Monoacylglycerol lipase (MAGL), which regulates the levels of several compounds that signal through the endocannabinoid pathway. However, now that researchers have shown that it MAGL inhibitors reduce neuroinflammation, there is increased interest in the industry in these inhibitors. MAGL also is explored as a cancer target as reported by Derek Lowe in its “In the Pipeline” blog.

SCRIP this week deals with plans of the French health ministry to collect more than €290 million for the pharmaceutical industry in 2012 to reduce health care spending. In addition, it reports on plans to widening the tax on pharmaceutical industry promotion.In its editorial, SCRIP focuses on German media trying to scandalize the deaths attributed to Boehringer Ingelheim’s Pradaxa drug (see the akampioneer).

Food for Thought: Weekly Wrap-Up

Clemens Gleich in Die Welt reports on the development of super batteries able to power a smart phone or notebook for days without re-charging. While some researchers try to improve conventional lithium-ion batteries by modifying the carbon-based anode with silicon, others design lithium-oxygen or fluorine-oxygen batteries. Main challenges are safety, prevention of swelling and maintaining a high capacity.

Britta Verlinden in Die Zeit reports on the discovery that dimethyl fumarate, a standard drug used for the treatment of psoriasis since 1994, may also be used as a pill to treat multiple sclerosis. Preliminary results of a Phase III trial demonstrate its ability to significantly reduce the number of attacks. The drug candidate codenamed BG-12 is being developed by Biogen Idec. The paper raises the concern that BG-12 may be sold as MS medication at €15,000 a year – while based on the price of the same compound for psoriasis, costs would amount to €4,400 per year, which already “is clearly more costly than what might be expected based on the cheap basic material”.

The Economist this week features the discovery of Oxford University scientists that a small marine organism produces a water-resistant, flexible material which has the adhesive characteristics of barnacle glue and the structural properties of spider-silk fibres. Already, spider silk is being used for novel materials. A salt water tolerant silk might open up medical uses for silk where it would come in contact with salty body liquids. The paper also looks into the prospects of stem cell therapies. While Geron’s pulling out of the stem cell business is viewed as bad news for the field, the paper highlights good news coming from a Lancet paper describing how stem cells can be used to repair hearts. The injection of autologous heart stem cells into damaged heart muscles of patients which underwent coronary bypass surgery led to “remarkable” results, improving pumping volume and other parameters.

Linda Geddes in The New Scientist raises hopes that partial wave spectroscopic (PWS) microscopy some day may be used to screen the general population for diseases like cancer, Alzheimer’s Disease or autoimmune diseases. PWS microscopy can detect changes in the chromatin density of cells, and researchers already have shown that cancer patients even in apparently healthy cells have unusual chromatin densities not seen in cancer-free people.

Finally, Alex Knapp in Forbes proclaims the end is in sight: we may be approaching the day where coffee is both rare and expensive. For one, the demand is growing all over the world at an enormous rate, and second, at the same time yields are diminishing because of pests, climate changes and political instabilities. So enjoy your coffee while it lasts!

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 Venturewire, MedNous, 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.

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