Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.
What did Boehringer-Ingelheim know, and when did it know it
News about the lethal cancer drug olmutinib continues to bubble out of South Korea. Members of the country’s opposition parties have used the controversy to float new reports of patient deaths as well as a document from Boehringer-Ingelheim dated August 23rd outlining serious safety issues with this drug that forced the end of clinical studies. It wasn’t until a month later, though, that Boehringer-Ingelheim washed its hands of the deal without initially even mentioning the problems publicly. The timing also triggered charges of insider trading in South Korea. At this stage, neither company is answering queries about the timing of their decision. A lack of transparency here will come back to haunt both companies, but Boehringer-Ingelheim — a well established private player — has the most to lose. Companies frequently like to stay mum about bad news, but this case involves patients who are still being given olmutinib in South Korea. They also have a debt to the patients they recruited for clinical studies to fully explain what’s going on. It’s time to come clean on what they knew and when they knew it.
Let’s refocus the debate around eteplirsen to regulating compassion
Yesterday we learned that BioMarin has begun to rethink its decision to jettison the FDA- and EMA-rejected drisapersen in the wake of the controversial FDA approval for Sarepta’s eteplirsen. It’s not hard to see why. If Sarepta can engineer an approval based on what it used for data, it stands to reason that developers are going to wonder what’s to be learned and whether there’s a way to benefit. Whatever happens at BioMarin, we’re now headed into uncharted territory. By dropping its standards on eteplirsen in the face of heated internal debate, the FDA has set in motion a new set of forces that will seek approvals at previously unheard of stages of development. The heat of public and private lobbying will start to play a bigger role. And, as Art Caplan put it to us earlier in the week, we need to seriously consider how we regulate compassion. That means some serious discussions outlining the kind of early-stage data needed to make a sensible decision, for starters. And how do you balance the need for clinical data with early access to compassionate use programs. This can be a positive process. Right now, it’s a shambles.
Biotech gets an F for how it handles compassionate use policies
Speaking of compassionate use. Despite seeing companies like Chimerix subjected to a blast furnace of viral hatred over the way it handled a compassionate use request, the industry clearly has a poor grasp of how it should handle the basics on this. That became more than clear in a recent survey from Avalere Health that highlighted how rare it is for small to medium-sized biotechs to post their policy on compassionate use online. That doesn’t mean inviting requests, which frankly few small companies want to deal with. But providing a contact and a clear outline of your policy is the kind of simple step that shows you’ve thought this one through — even if the answer is no. It might help avoid your own encounter with a viral lynch mob. And besides, it’s just the right thing to do. There’s no reason to wait and see if the 21st Century Cures Act mandates this change. Do it now.
Another huge week for immuno-oncology news keeps the field percolating
You would have thought that the Merck/Bristol-Myers story about lung cancer and checkpoint inhibitors would have been old news before ESMO rolled around last weekend. And you would have been wrong (as I was.) Bristol-Myers still managed to astound just about everyone with the complete story of the awful data it gathered trying to go broad, while Merck still managed to come out shining like a star. Cue big changes in share prices. Now well into the marketing game, it’s fascinating to watch how this big market continues to get redivided among the clinical victors. The Russian winter that Bristol-Myers now finds itself in is a sign that immuno-oncology still has a long way to go before we find out who will dominate this vital field. And that will help drive more investments into one of the most vital fields in R&D. That’s a solid plus for biotech, no matter which side you may have bet on in the Merck/BMS showdown.
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John Carroll, Editor and Co-Founder
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