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Company News: Anergis Closes CHF 18 Million Series A Financing Round to Develop its Innovative Allergy Vaccines and Expands its Board of Directors

Anergis SA announced today that it has closed a Series A financing round raising CHF 18 millions from European biotech funds and private local investors. Anergis SA is a clinical-stage biopharmaceutical company developing innovative immunotherapies against allergies. Its lead product, called “AllerT” and made of so-called Contiguous Overlapping Peptides (COPs), is designed to provide ultra-fast and safe desensitization to birch pollen allergy, a widely spread condition in developed countries.

The financing round was co-led by three major European funds with extensive biotech experience: Vinci Capital-Renaissance PME (Lausanne, Switzerland), BioMedInvest (managed by BioMedPartners AG, Basel, Switzerland) and Sunstone Capital (Copenhagen, Denmark). The syndicate was also joined by Esperante (Limhamn, Sweden), Initiative Capital Romandie (Lausanne, Switzerland) and by private investors. Up until now, Anergis has invested CHF 3 million in its innovative allergy vaccines. These funds were raised from private investors and from a grant by the Swiss Innovation Fund (CTI).

The newly joining investors also bring substantial pharmaceutical experience and know-how to Anergis: Patrick Scherrer (representing Vinci Capital-Renaissance PME), Markus Hosang (representing BioMedInvest) and Sten Verland (representing Sunstone Capital) have joined the Anergis Board of Directors. The Board will be chaired by André J. Mueller, a professional with unique executive and non-executive experience in biotech ventures, which he gained with Biogen and Actelion and as the Chairman of the Boards of Cerenis Therapeutics (Toulouse) and Addex Pharmaceuticals (Geneva).

Food for Thought: Weekly Wrap-Up

Sebastian Matthes, Thomas Kuhn, Dieter Duerand and Susanne Kutter this week in Wirtschaftswoche introduce the winners of Innovationspreis 2011 (innovation award 2011). In the “Startup” category, the winner is Human Machine Intelligence, a Heidelberg-based IT company that developed the “Lingua” software able to understand and answer complete spoken sentences. “Big corporation” category winner is machine building company Freudenberg for its development of production processes that save 85% steel and do not produce waste. In the “medium-sized business” category, the winner is med tech firm Carl Zeiss Meditec which developed Intrabeam, a new cancer radiation therapy device that saves breast cancer patients week-long radiation therapy cycles and improves quality of life.

Also in Wirtschaftswoche, Andreas Menn features innovative printing technologies based on conductive ink and provides glimpses into the future of organic electronics for everyday products: flexible and printed electronic displays for ads and packages, loudspeakers from plastic foil, broadcasting metro tickets and pill containers that inform a cell phone software once a patient has withdrawn a pill. Among others, the article introduces German startup Printechnologics, based in Chemnitz, whose Aircode Touch technology can mark any type of paper with an invisible code that can be recognized and processed by smartphone touchscreens so that it can direct users to websites and/or authenticity certificates. Another German startup, Heliatek in Dresden, is developing printed solar cells that are to be sold by the meter in building supply stores.

Steven Salzberg in Forbes this week features a vitriolic comment of the decision of respected BioMedCentral (BMC), owned by Springer Science publishing house, to add a journal devoted to “Traditional Chinese Medicine”, or TCM,  to its portfolio of respected, peer-reviewed scientific journals. He introduces a “laughably bad study” and states, readers should bring “a high tolerance for quackery”, concluding: “BMC should be embarrassed to be publishing journals that promote anti-scientific theories and otherwise muddy the literature. By supporting these journals, they undermine the credibility of many excellent BMC journals. They should cut these journals loose.”

The Economist this week writes about “a serious gap in biologists’ understanding of the diversity of life”, featuring metagenomics research results that points to the existence of a new domain of life in the oceans, adding to the already known domains of archaea, bacteria, and eukaryotes. Another feature deals with back-scattering interferometry (BSI) that can be applied to studying membrane proteins unmodified and in situ using a laser in a simple, low-cost way. The technology may be used to study the interference of membrane receptors with drug candidates and to understand side effects and differences in the response of patients to already marketed drugs. Already, the inventors founded a startup, Molecular Sensing, in San Francisco, Calif.

In New Scientist this week, Helen Thomson reports that a brain electronic implant in a paralyzed women successfully passed the 1,000-day milestone. Wendy Zukerman describes that a new, non-invasive test might soon be available to diagnose the nerve damage associated with diabetes to predict the amputation risk of diabetes patients, and Peter Aldhouse writes about his first encounter with robots at Complete Genomics, a California-based startup that offers large-scale, complete human genome sequencing services as an end-to-end outsourced service to companies and research institutions.

Food for Thought: In Search of Faster Cures

Last month, The Wharton School of the University of Pennsilvania dedicated a special edition of their prestigious Knowledge@Wharton newsletter to the biopharmaceutical industry. Most importantly, the authors dealt with the pressing question how the industry may continue to develop innovative drugs – and get them approved faster.

Summarizing the current challenges, the report states that “no one doubts that the drug industry’s traditional model for developing new cures is badly broken. Fewer exciting new medicines are reaching patients these days, even as spending on research and development has risen and blockbuster drugs that have long been the backbone of pharmaceutical profits have lost their patent protection. A widening gap divides the discovery of promising new laboratory compounds from the ability to turn them into innovative therapies. A similar gap separates recent scientific gains in understanding genes from the creation of new drugs that use this knowledge to fight disease.”

The report tackles key elements of the ongoing transformation of the biopharmaceutical industry, ranging from novel drug development approaches such as personalized medicine, open-source research, pricing policies, and the latest efforts at the U.S. Food and Drug Administration (FDA) to speed up regulatory processes. One of the most conclusive observations is that partnering and strategic alliances are becoming more important than ever to meet the requirements of the changing pharma industry. However, despite identifying the crucial pieces of the puzzle, it remains to be seen how both established and new biopharmaceutical companies can cope with the challenges of a transforming industry.

Food for Thought: Future Reimbursement of Novel Cancer Drugs in Germany

Germany’s new law regulating the reimbursement of drugs, the so-called Arzneimittelmarktneuordnungsgesetz – AMNOG, requires companies planning to introduce a novel drug to the German market to provide a value dossier, if they want reimbursement of the full price for the first year of marketing (See the akampioneer, “Germany’s New Reimbursement Law“). This value dossier not only needs to demonstrate efficacy and safety, but also has to provide evidence that the drug is more advantageous to existing treatments in terms of patient-relevant endpoints such as morbidity, mortality and quality of life.

This is difficult to prove as many novel cancer drugs are approved on the basis of surrogate endpoints such as slowing or stopping cancer growth (objective response rate ORR, time to tumor progression TTP, time to treatment failure TTF or progression-free survival PFS).

Late last month, Germany‘s Institute for Quality and Efficiency in Health Care (IQWiG) has published details on how it is going to evaluate the patient benefit in these cases. IQWiG usually is evaluating drugs on behalf of the so-called Gemeinsamer Bundesausschuss G-BA (Federal Committee), a decision body within Germany´s statutory healthcare system.

In cancer, IQWiG plans to primarily address „the question as to whether a therapy can prolong the life of affected patients. In addition, a new therapy should alleviate symptoms, prevent complications, and improve quality of life.“ If surrogate endpoints have been used for approval, IQWiG will only accept them as evidence for patient benefit, if the validity of these endpoints for demonstrating patient benefit can be proven by correlation-based approaches based on randomized controlled trials.

In a 160 page „rapid report“ (available in German only) IQWiG details its approach to search available literature for studies on the correlation between surrogate and patient-relevant endpoints. In addition, it describes how it is performing a meta-analysis of these studies for assessing the strength of the correlation (three levels) and the reliability of the validation studies (four levels) to reach an overall conclusion about the validity of the surrogate endpoint for a decision whether the new drug is providing patient benefit.

While the institute so far has only differentiated between „proof“ of surrogate endpoint validity and „indication“ of validity (meaning medium reliability), it proposes to introduce a third category called „hint“ for the fulfillment of certain minimal requirements for the available studies. This category will be applied in cases where the validity of a surrogate endpoint is unclear – a situation IQWiG expects to be quite common. In these cases, IQWiG states, „it can also be taken into account how strong the effect of a treatment turns out to be“. IQWiG would then seek to find a threshold value for the surrogate marker and evaluate whether the new treatment exceeds this value, e.g. whether it decelerates tumor growth for longer than a specified period of time.

Last not least, IQWiG appeals to drug makers and study groups to make accessible their analyses on the validity of surrogate endpoints and the specification of threshold values, e.g. in special registries.

A short English summary of IQWiG‘s basic assumptions on how to recognize at an early stage whether a new cancer therapy prolongs life can be found here. IQWiGs proposals for the early benefit assessment of cancer drugs can be read, also in English, here.

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