News
Food for Thought: Greek Ghosts Haunting Pharma
Up to the end of 2010, pharma companies were able to set the price for innovative new medicine at will upon introduction to the German market. Under the new AMNOG law, however, the price is dependent on the degree of innovation, as assessed by G-BA (Federal Joint Committee). G-BA requires pharma and biotech companies to provide information on medical benefits and advantages as compared to existing medicines across all indications the drug is approved for, and statistics on the (sub)sets of patients who will benefit from the drug. In addition, they have to provide spending figures of the statutory healthcare system and need to explain how quality can be assured during treatment.
G-BA can mandate the Institute for Quality and Efficiency in Healthcare (IQWiG) with the assessment (to make matters more complex, IQWiG can assess drugs and treatments also without assignment by G-BA) and once it has come to a conclusion, it needs to call for opinions of all parties (manufacturers, reviewers/experts, head organizations of patient/self-help groups and medical associations, etc.) – written statements as well as hearings.
If at the end of the process G-BA comes to the conclusion that the respective drug does not provide additional benefit, the medicine is subject to reimbursement under Germany’s fixed-price system and will be reimbursed in the price range of drugs already marketed in the same indication(s).
However, if the new medicine is ruled innovative, the bazaar is open: lobby groups of the pharmaceutical industry, including generics manufacturers, start debating with G-BA and representatives of the statutory healthcare system. The interesting part of this procedure is that pharma companies have to provide data on the selling price in “other European countries”.
But which are these “other” countries? With the European debt crisis, the debate has become heated: while manufacturers demand to select countries with similar economic power as comparators (such as France or UK), the statutory healthcare insurers are advocates of including Europe’s weakest economies: Greece, Portugal, The Czech Republic, Slovakia, etc. To resolve the problem, an arbitration board was founded.
Since last week, the jury is out, and it is not in favor of manufacturers. The arbitration board selected 15 European countries as reference countries for price fixing. The list comprises Austria, Belgium, the Czech Republic, Denmark, Finland, France, Greece, Ireland, Italy, The Netherlands, Portugal, Sweden, Slovakia, Spain, and the UK. At least five of them are economically weak countries with low drug prices.
The ruling will have consequences not only for Germany. If, as a result, prices for innovative medicines in Germany come down, prices elsewhere in Europe might follow as Germany is a reference country for pricing in many other European countries. To avoid a downward spiral, manufacturers may choose to introduce novel innovative drugs in Germany only with a considerable delay.
akampion Meets… Dr. Sanjay Mohan Shrivastava, General Manager of Venus Pharma GmbH
akampion: Can you tell us about the history of Venus Pharma?
SMS: Venus has its origin in the Indian generics industry and was founded in 1989 as Venus Remedies Ltd. However, the company meanwhile is very strong in innovative pharmaceutical products, in particular in fixed-dose combinations. Venus operates a large research center in India, which is accredited by the Indian government. Moreover, the company holds about 370 patents, has around 100 products and employs about 1,500 people in India alone. There are currently six offices worldwide – Venus Pharma GmbH was established in Germany in March 2006 and meanwhile has a staff of 15 full- and 30 part-time employees.
akampion: Why did the company decide to establish a German subsidiary?
SMS: We had innovative products and wanted a presence in the German market, as it is a very important market in itself and because it will help us to expand to other European countries. We acquired the Werne facility, which now serves as our EU-GMP facility for packaging of tablets and injectables, including quality control testing, batch release, packaging, warehouse and logistics etc. At present, we are the only Indian company that has accomplished this.
akampion: Which products are on the market in Europe right now?
SMS: We have CTD dossiers available for Meropenem, Gemcitabine, Irinotecan, Topotecan and Docetaxel, and we are searching for partners in various European countries. For Meropenem, Gemcitabine, Irinotecan and Docetaxel we have already been granted a Marketing Authorisation in some countries, and in addition we have ongoing registration procedures for these products as well as for Topotecan and Sulbactomax, a patent protected research product in Europe.
akampion: What are your plans for the future?
SMS: For the near future, we are planning to expand our product portfolio and to prepare CTD dossiers for anti-cancer drugs particularly Oxaliplatin and Cisplatin, and for the next years we have ambitious plans: within the next 2 to 3 years we aim to have a minimum of 15 products with European marketing authorization, including Sulbactomax, our proprietary novel antibiotic combination product, and a couple of other innovative medicines of cephalosporin and carbapenem group.
akampion: Can you detail the innovation of Sulbactomax?
SMS: Sulbactomax is patent-protected combination of Ceftriaxone, Sulbactam and VRP 1034. Ceftriaxone, a cephalosporin, breaks the bacterial cell wall, Sulbactam inhibits beta-lactamases, enzymes that are expressed by bacteria resistant to many antibiotics, and VRP 1034 is a potent chelating agent which competes with the microorganism for essential metal ions. As a result, it destabilizes the bacterial cell wall structure and enhances the susceptibility of bacteria to the antibiotics. This product provides excellent results against beta-lactam resistant E. coli and other bacteria.
akampion: Are you also interested in in-licensing of drugs or drug candidates?
SMS: No, not at present. On the contrary, we are seeking to out-license drugs. But we might be interested in in-licensing compounds to develop a new formulation. Already, we in-licensed a molecule suitable for cancer diagnostics for which we developed a new formulation.
akampion: How long have you been living in Germany now? We assume life here is pretty different compared to India?
SMS (laughs): I moved to Germany with my family two years ago. First of all, the weather is quite different. Of course, it is also another culture, but we have always been met with openness and friendliness here, even though sometimes people are a bit more reserved than in India. And certainly, rules and regulations are different. The move has probably been easier for me than for the rest of my family – I spend most of my time in the office, anyway.
akampion Meets…Dr. Roman Rittweger, Founder and CEO of Roman Rittweger Advisors in Healthcare and Organizer of the IIHC Conference
akampion: You are organizing a new conference called Innovations and Investments in Healthcare (IIHC). What is the idea behind this new event?
R.R.: I had been organizing an exclusive, invite-only German event for the past five years in Munich, but I felt it was time to open the format for new ideas and new people and also attract a broader, international audience. The past conferences have been very successful because we were not relying on the typical company presentations, but instead hosted interactive panels consisting of four experts and one senior partner of Roman Rittweger Advisors in Healthcare. No boring slides! The new event takes the concept even further and is, among others, inspired by the TED conferences.
akampion: So what exactly is the goal of the IIHC?
R.R.: Our goal is to present exciting international developments to healthcare players in Germany. We want to confront German opinion leaders with the latest business ideas from the US, Asia etc. As an example, take the mobile health businesses that arrived in the US and large parts of Asia already, but not here. We are also taking a look at how other countries organize and re-organize their healthcare systems, for example emerging countries. What is their cost-benefit assessment of proven and novel products?
akampion: Can you tell us more about the program?
R.R.: The program is a good mix of interactive panels, three-slide presentations in front of an expert jury, and so-called “speed-dating sessions”, which gives selected attendees the opportunity to tell others about his business. And the keynote is extremely important, too – this year, we got Brian David Johnson, Futurist and Director, Future Casting and Experience Research at Intel Labs, U.S. We even have panelists from Abu Dhabi and Kazakhstan, where the healthcare systems are currently being completely re-invented. Moreover, a trauma surgeon will introduce telemedicine approaches to improve the treatment of traffic accident victims, we will talk about the “quantified self”-movement and how health and gene data can help to improve quality of life and the healthcare system. We will also discuss what drives investments in healthcare, what regulators require these days from innovations and what pharma and medtech companies can learn from a venture capital fund.
akampion: Who is your target audience?
R.R.: We are primarily targeting German decision makers, but will increase the number of international attendees over time, e.g. from Scandinavia or Eastern Europe. It is important to us that we attract representatives from both start-ups and emerging markets, as well as established companies and countries. Regulators and payors are key target groups, too.
akampion: Sounds very exciting! Last but not least – why did you choose a venue in Berlin?
R.R.: We are fully aware that the informal part of a conference is extremely important, especially for networking and attracting a broader international crowd. Therefore, we have decided to host the conference in Berlin. We will also have evening receptions and offer our attendees the opportunity to explore Berlin´s fascinating nightlife.
More information about the IIHC can be found at www.iihc.eu
Company News: bubbles & beyond and Fraunhofer Center Nanoelectronic Technologies collaborate on the development of novel, eco-friendly cleaning solutions for microelectronics
bubbles & beyond, a technology company focusing on customized intelligent fluids®, and Fraunhofer Center Nanoelectronic Technologies (CNT), Dresden, today announced their collaboration to jointly develop novel cleaning solutions for the microelectronics industry.
During the two-year collaboration, bubbles & beyond and Fraunhofer Center Nanoelectronic Technologies will create novel decoating products for semiconductor applications with the goal to provide a more efficient, more cost-effective and eco-friendly alternative to currently available surface treatments, which are primarily composed of aggressive chemicals. The novel cleaning approach is based on bubbles & beyond’s proprietary phase fluid technology (intelligent fluids®), which is already used successfully for other microelectronic applications. Fraunhofer CNT brings the necessary semiconductor expertise, the respective research know-how and comprehensive, highly precise measurement analysis to the project.
The collaboration focuses on the assessment and optimization of the efficacy of customized cleaning solutions. Moreover, semiconductor-specific criteria will be analyzed, e.g. critical materials, process stability and contamination risks. Based on the findings, it will be examined if the new technology is suitable for the removal of lithographic laquers. Subsequently, the assessment will be expanded to other process steps.
