Amarin loses the patent fight of its life
Over the past two years, Amarin has overcome skepticism over whether its heart drug was effective, whether the FDA would agree, and whether doctors would actually prescribe it. Now, in the early days of reaping its rewards, the company has lost an all-important patent dispute.
As STAT’s Adam Feuerstein reports, a federal judge ruled that key patents covering Amarin’s drug, Vascepa, were invalid. The decision, which Amarin is likely to appeal, sent the company’s share price down about 60% last night, cutting what had been a surging stock down to single digits.
The decision came counter Wall Street consensus, as most analysts assumed Amarin would win the patent litigation.
Read more.
As STAT’s Adam Feuerstein reports, a federal judge ruled that key patents covering Amarin’s drug, Vascepa, were invalid. The decision, which Amarin is likely to appeal, sent the company’s share price down about 60% last night, cutting what had been a surging stock down to single digits.
The decision came counter Wall Street consensus, as most analysts assumed Amarin would win the patent litigation.
Read more.
How well does Axsome’s depression drug work?
Late last year, Axsome Therapeutics became a roughly $4 billion company on the somewhat surprising news that its drug significantly improved the symptoms of major depressive disorder in a pivotal study. But yesterday’s news that the same drug failed in treatment-resistant depression raises some questions about its future.
Axsome’s drug, AX-05, combines an ingredient found in cough suppressants with generic Wellbutrin. In last year’s successful trial, AX-05 was compared against placebo. In the latest, negative trial, Axsome tested it against Wellbutrin alone. That leaves open the possibility that Axsome’s combination therapy doesn’t offer much benefit beyond a cheap generic.
It’s entirely possible that the difference in patient populations explains the divergent results, and, as Axsome pointed out at length, AX-05 met its secondary goals in the treatment-resistant study. But the FDA, which is expected to consider Axsome’s drug in major depressive disorder some time in the next 18 months, might have some questions before considering approval.
Axsome’s drug, AX-05, combines an ingredient found in cough suppressants with generic Wellbutrin. In last year’s successful trial, AX-05 was compared against placebo. In the latest, negative trial, Axsome tested it against Wellbutrin alone. That leaves open the possibility that Axsome’s combination therapy doesn’t offer much benefit beyond a cheap generic.
It’s entirely possible that the difference in patient populations explains the divergent results, and, as Axsome pointed out at length, AX-05 met its secondary goals in the treatment-resistant study. But the FDA, which is expected to consider Axsome’s drug in major depressive disorder some time in the next 18 months, might have some questions before considering approval.
The VC whose panic proved prescient
The coronavirus pandemic has not exactly been a shining moment for venture capitalists on Twitter. But at least one VC, Arch Venture Partners’ Bob Nelsen, proved prescient after issuing some dire warnings about how the outbreak would affect the U.S.
As STAT’s Adam Feuerstein reports, if Nelsen sounded alarmist in January, he seems wise as March comes to a close. In the intervening months, authorities who downplayed the risk of the novel coronavirus have had to walk back their statements as case numbers quickly double and hospitals struggle to deal with the influx of infected patients.
“I would say that [there was] complete and utter failure of almost any of us to learn the lessons from what was happening, even from city to city,” Nelsen said. “It’s amazing, every city seems to repeat the errors of every other city, even in the U.S.”
Read more.
As STAT’s Adam Feuerstein reports, if Nelsen sounded alarmist in January, he seems wise as March comes to a close. In the intervening months, authorities who downplayed the risk of the novel coronavirus have had to walk back their statements as case numbers quickly double and hospitals struggle to deal with the influx of infected patients.
“I would say that [there was] complete and utter failure of almost any of us to learn the lessons from what was happening, even from city to city,” Nelsen said. “It’s amazing, every city seems to repeat the errors of every other city, even in the U.S.”
Read more.
How research funding trickles down to patient care
Each year, roughly the same amount of money goes into research for sickle cell disease as for cystic fibrosis, despite the fact that former disorder affects about three times as many Americans. And that, according to a new analysis, has had a marked effect on the quality of care patients receive.
As STAT’s Elizabeth Cooney reports, a team of researchers at Duke dug into the effects of that funding disparity by homing in on research productivity, measured by scientific papers and novel treatments in the pipeline. By that metric, cystic fibrosis, which predominantly affects people of European descent, ranked significantly higher than sickle cell disease, which is more common among those of African ancestry.
The effects of that disparity go beyond whether new drugs get developed, said John Strouse, the Duke hematologist who led the research. Scientific funding, whether from the government or private groups, is what advances academic careers, and the relative dearth of support for sickle cell research has the downstream effect of discouraging academics from committing to it.
Read more.
As STAT’s Elizabeth Cooney reports, a team of researchers at Duke dug into the effects of that funding disparity by homing in on research productivity, measured by scientific papers and novel treatments in the pipeline. By that metric, cystic fibrosis, which predominantly affects people of European descent, ranked significantly higher than sickle cell disease, which is more common among those of African ancestry.
The effects of that disparity go beyond whether new drugs get developed, said John Strouse, the Duke hematologist who led the research. Scientific funding, whether from the government or private groups, is what advances academic careers, and the relative dearth of support for sickle cell research has the downstream effect of discouraging academics from committing to it.
Read more.
The pandemic remains lucrative for microcap biotech
Just two weeks ago, Bellerophon Therapeutics was a roughly $15 million biotech company trying to advance its nitric oxide treatment for a handful of lung diseases. Then, on March 20, the FDA made the very commonplace decision to giving patients with Covid-19 emergency access that therapy under, and the company’s stock price quintupled. And yesterday, thanks to a timely offering, the company is in line to be about $15 million richer.
Bellerophon entered into an at-the-market agreement with some investors, flipping more than 1 million shares for $12 each, which is nearly four times the company’s pre-coronavirus value. An hour before announcing that offering, Bellerophone noted in a press release that a Covid-19 patient had received its nitric oxide therapy.
The company is hardly the first small-cap company to raise money on a potential coronavirus treatment that is quite a way from proving to be effective. But it appears to be the first to raise more cash than its entire previous market cap, which seems worth noting. It’s also perhaps worth noting that Bellerophon’s mythological namesake was punished by the gods for his hubris.
Bellerophon entered into an at-the-market agreement with some investors, flipping more than 1 million shares for $12 each, which is nearly four times the company’s pre-coronavirus value. An hour before announcing that offering, Bellerophone noted in a press release that a Covid-19 patient had received its nitric oxide therapy.
The company is hardly the first small-cap company to raise money on a potential coronavirus treatment that is quite a way from proving to be effective. But it appears to be the first to raise more cash than its entire previous market cap, which seems worth noting. It’s also perhaps worth noting that Bellerophon’s mythological namesake was punished by the gods for his hubris.
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