News
Company News: Aleva Neurotherapeutics Expands Board of Directors
– Entrepreneur Martin Velasco and Industry Expert Scott R. Ward Appointed as Board Members –
Aleva Neurotherapeutics, a company developing next-generation implants for Deep Brain Stimulation (DBS) in major neurological indications such as Parkinson´s disease or depression, today announced the expansion of its Board of Directors. Martin Velasco, a seasoned entrepreneur and business angel, and Scott R. Ward, advisor and former Senior Vice President and President, CardioVascular at Medtronic, were appointed as members of the Board of Directors.
Martin Velasco is an entrepreneur and business angel with extensive experience in the IT, medical and biotech industries. He is the co-founder and former CEO of SpeedLingua, a company developing and marketing solutions for language learning. In addition, he has co-founded various technology companies and serves as a board member of several high-tech and healthcare firms including Anecova, Sumerian, AC-Immune, Cocomore, and Aridhia. Moreover, Martin Velasco is Vice President of the Board of the Foundation EPFL+ and Vice Chairman of the European Tech Tour Association. He has received numerous prestigious awards for his activities as a business angel.
Scott R. Ward is President of Raymond Holdings, LLC, a firm focused on the life sciences with activities in venture capital, corporate strategy, and transactional advisory services. From 1981 to 2010, he has held various senior management positions at Medtronic, Inc. with increasing responsibility, including Senior Vice President and President, Vascular and CardioVascular, Senior Vice President and President Neurological, Gastroenterology, Urology and Diabetes, and President Neurological Business. Mr. Ward is Chairman of the Board of MAP Pharmaceuticals, iScience Interventional and Gillette Children’s Specialty Healthcare. He also serves on the Board of Creganna-Tactx Medical, Respircardia Inc., and Surmodics, Inc.
André Mercanzini, co-founder and Chief Technology Officer of Aleva Neurotherapeutics, has stepped down as a board member of Aleva. The founders have elected Scott Ward as their representative. Markus Hosang of Biomedinvest AG and Juerg Eckhardt of Bellevue Asset Management AG continue to serve as members of the Board of Directors, which is chaired by Oern Stuge, MD. Mr. Stuge has a long-standing management track record with healthcare companies such as Medtronic Inc. and Abbott Laboratories Inc.
Company News: InDex Pharmaceuticals Develops Companion Diagnostic Test for New Ulcerative Colitis Therapy
– Personalized treatment option for patients with refractory ulcerative colitis –
InDex Pharmaceuticals today announced the development of a companion diagnostic test for Kappaproct®. Kappaproct, the lead product candidate of InDex, is currently in a phase III study as a treatment for chronic active, treatment refractory ulcerative colitis. In this study, the companion diagnostic test is being evaluated to demonstrate a correlation between test result and clinical response to Kappaproct.
In previous clinical trials, Kappaproct has shown positive effects for the treatment of steroid resistant ulcerative colitis patients. The companion diagnostic test aims to enable the pre-selection of steroid resistant patients that are most likely to benefit from Kappaproct. The proprietary in vitro test is based on a number of biomarkers and is performed on a blood sample prior to administration of Kappaproct.
A companion diagnostic is designed to assess whether a patient will respond favorably to a specific medical treatment or not. Companion diagnostics are a crucial element of personalized medicine, which is becoming increasingly important along with the demand for safer and more efficacious medicines. Companion diagnostics also reduce healthcare costs as the use of ineffective therapies can be avoided.
In 2009, InDex Pharmaceuticals launched the diagnostic test DiBiCol® in Sweden. DiBiCol differentiates between ulcerative colitis (UC) and Crohn’s disease (CD), the two major forms of inflammatory bowel disease (IBD).
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.