Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.
Ramaswamy strikes biotech gold, again, with trademark IPO stunt
Last year’s big IPO for Axovant $AXON from Vivek Ramaswamy never made any sense in my opinion. If you reach into the failure bucket and pluck out an asset for cheap, it didn’t make sense that investors would buy in and support it through a late-stage program. The risk/reward equation was out of whack, and the whole thing reeked of an end-of-days play for the biotech bubble. Ramaswamy, though, just pulled off another record IPO after whipping up a new company overnight, bringing in a couple of high-profile players to front the small team and touting a trendy focus on women’s health. The bubble, such as it was, is long popped. So I have to take my hat off to Ramaswamy. He may know little about actual drug development, but there’s no better financial engineer in biotech. Financial engineering, though, goes just so far in biotech. Inevitably, data will decide these companies’ fate. And I’ll be waiting for that.
Shame isn’t dilutive, when you’re Martin Shkreli
Despite the federal fraud charges, despite his exposure for financial ruin and charges of lying to everyone around him, despite his toxic and well-earned reputation as the most widely hated man on the planet, Martin Shkreli’s public persona remains unchanged. In his own mind, he’s still the smartest guy in the room, completely unrepentant. Or so he presents himself in the latest disastrous attempt to impress a journalist, this time David Crow with the Financial Times. That decision to go profiteering with an old drug? Simple business acumen, which he owed his investors. The criminal case coming up next summer? He’ll beat it, just like other high-profile defendants like OJ. “My whole life has been one theme of self-sacrifice for my investors,” he replies, without batting an eyelid. “I did it for my shareholders’ benefit because that’s my job. The political risk is being shamed — and shame isn’t dilutive to earnings per share.” And so it goes.
Why the Sarepta controversy won’t die
The Sarepta controversy just won’t go away. Nor should it. This week we saw two prominent Harvard policy experts weigh in with their own concerns about how the agency could have handled the Exondys 51 situation better. An approval for what is clearly still an experimental therapy raises all sorts of questions over who should pay $300,000-plus a year for an unproven drug desperately sought after by patients and their families.That part was underscored by Humana’s decision to reserve the drug for patients who could stay ambulatory. Wheelchair-bound patients will be denied this drug. The Harvard team suggested an alternative pathway that would make drugs available at cost, but the FDA’s Janet Woodcock had cited financial reasons for her unprecedented insistence on an OK. It will take some time to clean up this mess. And the FDA would be advised to do more than try to close the barn door after the wild horse has escaped.
AstraZeneca waited way too long to acknowledge that durvalumab setback
In pharmaland, big companies routinely prefer to keep bad news to a one-liner footnote in a lengthy quarterly report — or a painfully brief statement. AstraZeneca failed to meet even this low standard for transparency on durvalumab. The company knew more than a month ago that it had a serious safety issue to examine on its PD-L1 checkpoint program, which is essential to its future. But it chose to keep an FDA partial hold quiet until the safety issue slowly leaked out on Twitter. To its credit, the company did immediately explain what was happening rather than stonewall on a material event. But it was a day late and a dollar short on corporate responsibility, which played out with a painful drop in shares on Thursday. Novartis, Amgen, Boehringer Ingelheim and many other big players feel they have no debt to anyone to explain setbacks. But in fact they do owe the patients who volunteer for their clinical trials, the investment community, and the public as a whole much better than what they have received. There should be no whining from anyone in Big Pharma about their tattered public profile. These are all self-inflicted wounds.
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John Carroll, Editor and Co-Founder
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