News

Food for Thought: Germany’s Emerging Pirate Party Pillories the Life Sciences Industry

The recent election in Germany’s federal state of Berlin ended with a surprise: a previously almost unknown party, the Pirate Party (Piratenpartei) won 15 of the 152 state parliament seats; nearly every one in ten voters in Berlin casted his ballot for this group, which was founded in 2006 by mostly male young academics and internet-affiliate people.

The program of the party is not very detailed and focuses almost entirely on freedom of information, free access to the internet, free rides on public transport, legalization of drugs and a free basic income for everyone living permanently in Germany.

While the program does not say anything about economic policy (nor on defense or international policy), it includes several statements on the life sciences and pharma industry.

For one, the party opposes patents on genes and living beings (as it opposes software patents and patents on business ideas), and in the long run aims to abolish the entire patent system. The program also states that “patenting of findings from genetic research and biotechnology … poses a great danger to tomorrow’s society.” Such patents should be forbidden by law. Moreover, the program adds that patents on pharmaceuticals, too, should be abandoned as they have “ethically highly objectionable” consequences.

Second, the “Pirates” want to “reorganize” the pharmaceutical sector as it is “characterized by monopoly blocking innovation”. They criticize that the pharma industry is making profit from publicly funded basic research and that public institutions should conduct R&D of novel therapeutics. As a result, society would spend less money on buying drugs but more on developing better ones.

Certainly, it remains to be seen whether the party will have any political influence and whether the success will be sustainable. However, the fact that the few paragraphs on industry and economics in the program almost exclusively deal with the life sciences sector once again demonstrates that the pharma and biotech sector in Germany still has massive reputation problems: one of the most innovative industries is viewed as a stumbling block for a better life.

Company News: Probiodrug’s Hypothesis on Alzheimer’s Disease Onset Featured in German Radio

During the upcoming World Alzheimer Day, the German MDR radio will feature the efforts by German biotechnology company Probiodrug to develop novel strategies for the treatment of Alzheimer’s Disease (AD). MDR’s FIGARO am Vormittag morning magazine will introduce the company’s hypothesis on the onset of Alzheimer’s Disease (AD) and highlight the latest research results published by Probiodrug and co-workers from German and US research institutions in the recent  Journal of Neuroscience.

It is well known that the presence of so-called beta-amyloid (A beta) plaques in the brain is not necessarily correlated with the occurrence of AD. Probiodrug discovered that in AD patients, the core of the plaques is made form a certain variant of the A beta peptide which is more neurotoxic, less soluble and able to rapidly aggregate with modified and unmodified A beta. Further investigations revealed that this toxic variant is generated by an enzyme called QC (glutaminyl cyclase). QC is responsible for activating certain hormones and enzymes in the brain by modifying a certain chemical group in these molecules. If it starts acting on A beta, it produces the toxic variant. Probiodrug also has demonstrated in various experiments that it is possible to prevent the formation or spread of toxic A beta plaques by switching off the QC enzyme. The company therefore is developing drugs to inhibit the enzyme as a potential treatment strategy to either prevent the onset of AD or slow down the progression of the disease.

Food for Thought: IQWiG Says Benefit Of Ezetimibe Not Proven

Various studies have demonstrated that lowering cholesterol levels with statins is preventing heart attacks and other cardiovascular complications. However, some patients do not tolerate statins or do not achieve recommended cholesterol levels with statins alone. These patients often are prescribed ezetimibe (sold as Ezetrol by MSD Sharp & Dohme in Germany), an oral cholesterol-absorption inhibitor, either alone or in combination with statins. A fixed combination of ezetimibe with statin simvastatin is sold as Inegy.

Last year, Germany’s Federal Joint Committee (G-BA) which is deciding about drug reimbursements for the country’s statutory healthcare system, commissioned Germany’s cost-benefit watchdog IQWiG to assess the benefit of ezetimibe either alone or as combination therapy.

IQWiG published its report earlier this month. While it not disputes that ezetimibe is lowering cholesterol levels, the institute states in its report that it has been unable to identify any review or study demonstrating that the prescription of ezetimibe alone or in combination does provide patient-related benefits in terms of reducing “all-cause” or “vascular” mortality.

However, new data and findings supporting the benefit of ezetimibe will be available soon.  Pulse Magazine, a leading medical weekly in the UK, reported Sept. 2 that researchers looked into the effectiveness of ezetimibe in combination with statins on all-cause mortality over a period of 4.3 years. They concluded that the combination treatment – if used after a myocardial infarction – resulted in a 55% decrease in all-cause mortality compared to patients taking simvastatin alone. The trial was a retrospective study on a cohort of nearly 15,000 patients from the UK’s General Practice Research Database. The researchers already had announced a presentation of the results at the European Society of Cardiology Congress in Paris end of August, but cancelled the presentation to perform a more complex analysis of the data.

Company News: Nanobiotix Starts Clinical Trial with Lead Product NBTXR3

– A Completely New Cancer Treatment to Be Tested in Patients with Soft Tissue Sarcoma –

Nanobiotix, a company developing novel cancer nanotherapeutics, announced today that its lead compound NBTXR3 has received the formal authorization from the French Medicine Agency, AFSSAPS[1], to start the first clinical trial[2].

27 patients diagnosed with soft tissue sarcoma will be enrolled in the Phase I study and will receive NBTXR3 as an intra-tumoral injection with radiotherapy prior to surgery (first-line treatment) (www.clinicaltrial.gov). The primary endpoints of the clinical trial are the feasibility of NBTXR3 administration and safety. Preliminary data are expected by the end of 2012.

The trial is a prospective, open-label, dose-escalation, single arm, non-randomized trial. NBTXR3 will be administered to the patients prior to surgery by a single intra-tumoral injection followed by standard radiotherapy procedure. After completion of the regular treatment procedure, the patients will undergo surgery to resect the soft tissue sarcoma. Along with the safety and feasibility endpoints, the primary tumor tissue will then be available for the evaluation of the pathological response rate.

Further clinical trials are in preparation in Europe and in the US. NBTXR3 has been classified in the EU as class III medical device. In the US, it has been classified as a drug by the FDA.

NBTXR3, the most advanced compound of Nanobiotix´ NanoXray pipeline, is intended to enhance the local destruction of the tumor mass during radiotherapy. NBTXR3 is a nanoparticle consisting of hafnium oxide crystals. Once injected into the tumor, NBTXR3 accumulates in the cancer cells. Due to the physical properties of hafnium oxide, the particles emit huge amounts of electrons upon radiation. This leads to the formation of radicals within the tumor cell, which in turn damage the cancer cells and cause their targeted destruction. NBTXR3 particles are inert and emit electrons only during their exposure to radiotherapy. As a result, the destructive power of standard radiation therapy could be locally and selectively enhanced within the tumor cells.

Local treatment of malignant tumors is a cornerstone of cancer therapy. The standard treatments are surgery and radiotherapy, either as a stand-alone treatment or in combination. Radiotherapy has been widely used across most oncology indications for decades. About 50 to 60% of all cancer patients undergo radiotherapy treatment as part of existing treatment guidelines. All NanoXray products are compatible with these guidelines and do not require changes of surgery and radiotherapy procedures. Moreover, NanoXray products can be used with any existing standard radiation equipment available in almost every hospital world-wide.

[1] Agence Française de Sécurité Sanitaire des Produits de Santé

[2] Clinical trial, registration number RCB 2011-A00342-39

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