Archive: Food for Thought
This week, NYC-based Immune Response BioPharma, Inc. announced that the company has terminated partnering discussions on its multiple sclerosis vaccine NeuroVax with GlaxoSmithKline. The news per se may not trigger a lot of interest – but the company has managed to create a significant buzz around its announcement, with CEO David Buswell stating that (quote from corporate press release):
“GSK is a joke and seems very ignorant on how multiple sclerosis drugs work and how to develop one, we gave them a chance to develop NeuroVax but their management appears to be very poor. We have decided to terminate any collaboration or development with GSK. GSK is a loser in the MS market and will continue to be a loser.”
When we first saw this press release, we immediately did some research to verify if it was a joke or not. However, it was posted on the company’s website on May 24. While the CEO certainly has shut the door for any further discussions with GSK, the PR has generated a lot of attention in the industry and everyone will be out following the company and the further fate of its compound. Still, we believe that the impact on Immune Response BioPharma´s corporate reputation will not be as positive as the buzz suggests.
What was your first thought when you read this statement?
There has been a frenzy about new media and information sources, especially since the emergence of social media like Twitter. Keeping track of all the different media available today is very time-consuming.
Which media do you really use? Do you primarily rely on established trade and financial media? Or are you taking advantage of free online news sources? Do you use Twitter, Facebook, LinkedIn on a regular basis?
We are curious to hear your thoughts!
Crowd-funding is a widely discussed and disputed financing approach these days. It has proven to work in many industries, including the entertainment sector. But what implications will it have for the healthcare industry? Will it have any impact on healthcare at all?
So far, there are only few examples of crowd-funded healthcare ventures. One of them is the Rare Genomics Institute, a US-based non-profit organization dedicated to providing better and faster diagnostics and therapies for rare diseases. They decided for a personalized approach by putting up individual cases of rare disease sufferers on their website and organizing funding for the diagnosis and treatment of the affected patients. Thereby, Rare Genomics Institute provides treatment opportunities for patients who otherwise would not be able to pay their medical bills, as these kind of therapies (and diagnostics) are usually not funded by healthcare providers.
What seems to work as a fundraising approach for individual cases in the US still has to prove its viability in other regions of the world – and in a larger healthcare context. Could expensive drug development eventually be financed by crowd-funding? According to an article in Genetic Engineering News, there is currently not much evidence that biopharmaceutical companies could benefit from crowd-funding, as their financing requirements are significant and long-term oriented. In fact, there are only very few examples of biopharmaceutical companies which have managed to close a financing by crowd-funding, e.g. cancer immune therapy company Urodelia (France). However, the financing volume has not been disclosed. Others, like AMD Therapy (Germany), a fund dedicated to finance the development of novel therapeutics to combat age-related macular degeneration, or Selexel (France), which is developing cancer therapies based on RNA interference, are still raising funds. Interestingly, AMD Therapy aims to raise as much as EUR 60 million by crowd-funding – much more than other biopharma companies in Europe were able to raise by private equity financing during the past 12 months.
At the end of the day, many questions are still unanswered. Will private sponsors continue to be willing to pay a stranger´s medical bills in the long run? Will start-up healthcare companies financed by crowd-funding eventually have to fulfill strict reporting and transparency requirements?
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.