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If you are BP CEO and this news just came across the wire and you are sitting their with your legacy assets (drugs) that are not throwing off much growth or are facing patent expiration soon....what are you going to do?
Continue to sit on your hands or proceed to pick up the phone and call JT
We have a local partner on the ground in China, which is exactly what you want. This is how you do business there with a local. Our interests are aligned. They make money and we make money. Perfect setup with a high teen royalty.
The generics are having trouble getting supply for the USA....
Look at what Terrapharma said about Eddingpharm's reach in China
Bodes well for existing pathway that gets the REDUCE-IT population allowed in China w/o outcomes study. Eddingpharm has already completed the required ethnic studies.
— TerraPharma (@TerraPharma1) January 21, 2021
https://t.co/Gb5OKhJIN9 $AMRN #vascepa
China--See this from Terrapharma
Bodes well for existing pathway that gets the REDUCE-IT population allowed in China w/o outcomes study. Eddingpharm has already completed the required ethnic studies.
— TerraPharma (@TerraPharma1) January 21, 2021
https://t.co/Gb5OKhJIN9 $AMRN #vascepa
Will Big Pharma take notice of the inclusion of icosapent ethyl into the guidelines in China?
A Billion people live there......
Hmmmmmm
Do you think we are on the schedule next week for recommendation for approval?
Maybe someone should forward it to Amarin so they know about it.
Does anyone on Biden's coronavirus taskforce know about Vascepa?
anyone? anyone? Bueller?
This was interesting from the post earlier. I didn't realize vascepa was in the Guidelines in China.
"At present, Vascepa has obtained many atherosclerotic cardiovascular diseases ( ASCVD) treatment guidelines recommendations. Domestically, it has also been recommended in the "Guidelines for Primary Prevention of Cardiovascular Diseases in China" released on November 19, 2020."
It's good to hear our partner Edding is working fast over in China.
Can't wait to hear what else is in store in terms of full market approval.
"We commend our partner in the greater China region, Edding, for itsswift inclusion in this important program and look forward to continuing to support its efforts to obtain full market approval in Mainland Chinaand inHong Kong, Macau and Taiwan."
See this Barron's article today:
There’s No Quick Fix for the Vaccine Rollout. 5 Ideas From Experts.
By Josh Nathan-Kazis
Jan. 15, 2021 5:50 pm ET
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People stand in line to receive a dose of the Covid-19 vaccination at the Jacob Javits Convention Center in New York on Wednesday.
Jeenah Moon/Bloomberg
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It has been just over a month since the U.S. began the most sweeping mass vaccination campaign in its history, and progress is already lagging far behind what federal officials had projected.
That problem will soon fall to president-elect Biden, who said on Thursday that the vaccine rollout had so far been a “dismal failure.”
Amid delays, the Trump administration changed course this week, ordering states to vastly expand vaccine eligibility, at the same time saying they would release stockpiles from a reserve. But on Friday, it emerged that the reserve did not exist, meaning no major inoculation surge is coming.
There won’t be a quick fix. Vaccination is in the hands of dozens of state and local health departments, many of them crumbling after years of chronic underfunding and a long 2020.
“These state and local public health officials are exhausted,” says Dr. Howard Koh, a professor at the T.H. Chan School of Public Health at Harvard University who served as an assistant secretary at the U.S. Department of Health and Human Services. “We’re asking that completely overstretched group of professionals to now ramp up and make the most ambitious vaccination campaign in U.S. history a reality in record time.”
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On Friday, Biden announced proposals to marshal federal resources in support of a vaccination program. Those plans echoed suggestions that public health experts had made to Barron’s about what the incoming administration should do to get more shots in more arms. Here’s what they told us, and what Biden plans to do:
Simplify: “We can come up with the most elegant plan in the world, but our national ability to execute on these things is just not fantastic,” says Dr. Ashish Jha, dean of the School of Public Health at Brown University. “Simplicity, man. There’s nothing like simplicity.” The Centers for Disease Control and Prevention has set out a nuanced, multistep plan to prioritize vaccinations. But many states that stuck to those guidelines barely made a dent in their vaccine allocations. On Tuesday, federal health officials told states to begin allowing anyone older than 65 to get their first shot.
That new approach makes sense, says Dr. Cody Meissner, a professor of pediatrics at the Tufts University School of Medicine and a member of the Food and Drug Administration advisory panel that voted in favor of authorizing the Covid-19 vaccines. “What we should be doing is giving this vaccine to older people, and not trying to micromanage who is eligible to receive it,” he says. “The more restrictions you have on any vaccine, the less effective it’s going to be.”
Jha has argued for opening vaccinations to everyone over 55 in February, and then allocating doses to younger people through a lottery system. While the lottery may be a hard sell, the advice is clear: Getting shots in arms is the most important thing.
Target Hard to Reach Groups: That doesn’t mean that the government should give up on targeting people at greatest risk for serious illness. Covid-19 has killed Black and Hispanic Americans at far higher rates than whites, and health-care workers have died in large numbers. Jha has argued that simpler approaches, by their nature, will be harder for privileged groups to game, and as such be fairer.
But active outreach will also be necessary. “The more effort we put into speeding things up, the more risk we are at for widening disparities and blowing it on equity,” says Alison Buttenheim, a professor of nursing and health policy at the University of Pennsylvania School of Nursing. Even as states make vaccines available to wider populations, they need to continue to seek out high-risk categories. “A local health department ...has to be nimble enough to do both of those things,” she says.
Send Money: State and local health authorities need money to administer the vaccines, experts say. The relief bill signed by President Donald Trump in December allocated $8.8 billion to support the vaccine rollout. Those checks need to arrive soon. The Biden administration says it is planning to spend another $20 billion.
And Send Vaccinators: While chatting with a state health official the other day, Jha asked what the official would have the federal government do to help his state’s vaccine rollout, if he could ask for anything. “That is easy,” the official said. “I’d have them send 5,000 vaccinators.”
The money to hire those vaccinators was already on its way, the official told Jha. But the process of hiring those people could take a month or six weeks. A federal deployment of vaccinators would save valuable time.
Biden said Friday that he planned to pay for National Guard troops to support vaccine distribution, and to set up federally supported vaccination centers around the country. He also said the federal government would help train more vaccinators and create a public health jobs program.
Create Another Warp Speed:Operation Warp Speed deserves credit for the fast development of Covid-19 vaccines. But it hasn’t focused on how to get those vaccines into people’s arms. Indeed, its leaders waited months to approve a plan to distribute and administer vaccines, The Wall Street Journal reported. “Warp Speed seems not to have thought as much about the last-mile distribution,” says Julie Swann, a professor of industrial and systems engineering at North Carolina State University. “There is a lot that has to come after it leaves the distribution center.”
Buttenheim says that what’s needed is another Warp Speed: “The same kind of laser-sharp focus that was put into vaccine development absolutely needs to be put into vaccine rollout.”
That office could help with messaging, information sharing, and coordination among local and state health departments. On Friday, Biden did announce a federal public education campaign, among other coordinating efforts. The Warp Speed effort, Buttenheim says, was extraordinary. “Let’s be as extraordinary on the last mile,” she says. “Vaccines don’t save lives. Vaccinations save lives.”
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
If Vascepa works on COVID maybe the plan should be to get other countries to purchase it......
without a big pharma's help.....I am not sure the message of a covid-19 therapeutic is going to win out versus the vaccine push.
JMO
Let's say PREPARE-IT (covid) data is good. The problem we face is big pharma / media want the vaccines and that is what is being pushed to the public.
Even with good data, what makes you confident AMRN management can get the message out and it will be picked up on that Vascepa is a covid therapeutic?
We should know by now that great data does not carry the day.
Have to be effective at getting the message out and it has to be picked up.
Does Biden's coronavirus task force even know about Vascepa....
Do you think he knows the study will be successful?
Very positive. For sure she knows of Jon Singer. She worked at the same firm as him as a young associate.
But how much longer is this bull market going to continue? Hopefully JT and team act soon. This is starting to look more and more like the dot com era by the minute. We all know how that ended.
I know this time is different.
LOL
Great post!
Exactly. The issue has and still seems to be the messaging to the masses and to Wall Street.
Very few folks know about Vascepa.
Great post! Thanks for sharing.
That's not correct. JT said the branded maintained 60% of the market even when generics entered.
Somehow a zero is missing.
So does management need to test the generic product? It seems like we are ultimately going to need the FDA's help even if the generic product is inferior because the generics will just play dumb and insist they are not seeking the REDUCE-IT indication but just going after the MARINE indication.
Biden is growing frustrated with his COVID-19 response team. See story from Politico
President-elect Joe Biden has grown frustrated with the team in charge of plotting his coronavirus response, amid rising concerns that his administration will fall short of its promise of 100 million vaccinations in the first 100 days, according to people familiar with the conversations.
Biden has expressed criticism on multiple occasions to groups of transition officials — including one confrontation where Biden conveyed to Covid coordinator Jeff Zients and his deputy, Natalie Quillian, that their team was underperforming.
The tensions have surfaced as Biden's advisers plan a dramatic scale-up of vaccinations starting Jan. 20, when the incoming team inherits a troubled Trump administration vaccine rollout that has fallen well short of its initial targets.
In interviews, multiple senior transition officials defended Zients and stressed the enormity of the challenge, noting that the Trump administration has refused to share key information for weeks.
Still, the U.S. has conducted around 7 million vaccinations over its first three weeks, well below the million-a-day rate Biden will need to hit. While some Biden advisers insist it's possible to make good on the 100-million vow, others are privately worried that the federal response is already so chaotic that it will take a herculean effort to pull it off.
Transition officials described encountering a litany of challenges and a lack of long-term planning by the Trump administration, putting them in a hole so deep it could take weeks to get the vaccination campaign on track. They conceded that the team is still working to solve some of the most pressing issues.
"We’re uncovering new information each day, and we’re unearthing — of course — more work to be done," Vivek Murthy, Biden’s nominee for surgeon general, said in an interview. “We’re in an ongoing process of building the 100 million shots campaign, and we will make that goal work."
Biden's aggravation is rooted in the rush to build the foundation for an extended inoculation effort, a complex undertaking that includes untangling all manner of bureaucratic obstacles — from staffing issues to technology problems and insurance coverage dilemmas — that the transition had expected to already be well underway, 11 people close to the transition told POLITICO.
"They're inheriting a mess," said Andy Slavitt, a former Obama administration acting Medicare and Medicaid chief. "I think they're uncovering how bad it is."
In a statement, Biden transition spokesman T.J. Ducklo defended the team’s work, saying “Jeff Zients is the right person for the job and wakes up every day focused on how to vaccinate every single American as quickly as possible, and the President-elect has full confidence in the plan he and his team are putting forward to get that done."
From left, Bechara Choucair, Carole Johnson and Timothy Manning
Exclusive
Biden picks 3 coordinators for Covid-19 response
By DAN DIAMOND
The vaccination effort has been further hampered by divisions within Biden's own team, most recently over the decision to keep Gen. Gustave Perna in his role as chief operating officer of Operation Warp Speed, the government's vaccine accelerator.
Perna has faced sharp criticism over the turbulent first weeks of the vaccine rollout, which missed his initial prediction of 20 million shots by the end of December and instead vaccinated closer to 2.6 million Americans. Perna later shifted his projection, saying Warp Speed would deliver 20 million doses to states by the first week of January.
Biden allies now worry that retaining Perna will damage the new administration's effort to signal a fresh start and build public confidence in its own Covid-19 response.
“Everybody coming into this has an expectation that there’s a clean break,” a person who has been working with the transition said. “This last sordid episode is gone and we’re bringing new, fresh people in — certainly at the top. Of course you’re going to have holdovers — you have to for institutional memory — but as the face of the operation, it seems almost insane to have someone like Perna.”
Others have come to Perna's defense, arguing that he shouldn't be held responsible for the broad scope of the Trump administration's failures — and that his months of experience running Warp Speed will prove valuable within Biden's revamped response.
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Beyond Perna, though, there have been growing pains internally as Biden’s Covid team tries to get in sync to meet the lofty goal, according to people familiar with the effort.
Biden selected Zients to run the coronavirus response given his reputation as “Mr. Fix-it” in the Obama administration, where he served as director of the National Economic Council and led the effort to restore the Obamacare enrollment website HealthCare.gov after its botched rollout.
But Zients, a business executive, and Quillian, who was until recently a partner at Boston Consulting Group, do not have public health backgrounds, and there's been tension over their approach, which some people said was too broad-brush and not detailed enough for the complexity of the problem. Quillian had previously clashed with staffers on the campaign who felt the consultant-style mindset she tried to apply didn't fit with a campaign operation, according to multiple staffers.
Biden has emphasized the need for a dramatically different approach to the health crisis than Trump, and has pressed the team for more specifics on how they plan to execute on the vaccine distribution process. Biden is known to push his staff to brief him in layman's terms, urging advisers to avoid generalities and drill down on the particulars, the people said.
Biden on one occasion became exasperated with Zients and the team for not arming him with enough details on their planning ahead of a mid-December meeting between Biden and governors focused largely on the coronavirus response.
"They probably require some more practical doers with deep experience in navigating business and government," the person who has been working with the transition said. "People who have actually made a bill become law or pulled together industries and understand what businesses are capable of and what they're not."
Some Biden officials downplayed the incident as a sign of Biden's intense focus on the Covid-19 planning, and the high standards he's set for a team tackling the defining challenge of his first 100 days.
“He doesn’t want to just hear pipe dream ideas or just the headlines of the plan,” Murthy said. “He wants to know about the practical details. I think that’s a good thing because that makes sure the plans are grounded in reality, but I don’t take from those conversations that he doesn’t believe in his team.”
Sarah Bianchi, a longtime Biden aide who has worked on the transition, defended Zients' work, calling his role coordinating the various policy experts across government "the right model."
"Jeff Zients with the right policy team — there's no one better," she said.
Still, just 6.7 million Americans had received a coronavirus vaccine through Jan. 8, according to the Centers for Disease Control. Health officials across the country working to solve the slowdown are warning there is no easy fix, especially as they grapple with a brutal surge of Covid-19 deaths and hospitalizations.
And while the Trump administration insists that the vaccination rate will soon pick up, Democrats inside and outside the transition are increasingly questioning whether Biden's first big pandemic pledge placed too much confidence in an outgoing administration that has repeatedly overpromised and under-delivered.
Jeff Zients speaks at the White House on Feb. 9, 2016.
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"I'm very nervous about setting a target and not being able to meet it," Kavita Patel, a Brookings Institution fellow and former Obama administration official, said of the 100-million vaccinations vow. "I would feel much more comfortable if we could actually set something that we could succeed on early to give people faith."
A person familiar with the Biden transition’s work said the team also had to spend initial weeks negotiating with the Trump administration for access to information, including to Tiberius, the central government database used to monitor vaccine distributions. Biden’s Covid team continues to be denied access to certain standing meetings related to the government’s response across the health and defense departments, the person said.
In a statement, a spokesperson for the Department of Health and Human Services said the department is "committed to smooth, professional transition planning" and has held hundreds of briefings across the department with Biden's team during the transition, with plans to continue that work through Jan. 20.
Biden has criticized the Trump administration over its early vaccine push for “falling behind, far behind.” Yet he’s refused to back off his own goal, instead doubling down on the belief that his administration can get at least 100 million shots into arms by April 30.
“Will this be challenging? Absolutely,” Anthony Fauci, the country’s top infectious disease expert and Biden’s incoming chief medical adviser on coronavirus, told POLITICO. “This is an unprecedented effort to vaccinate the entire country over a period of time that’s fighting against people dying at record numbers. To say it’s not a challenge would be unrealistic. Do I think it can be done? Yes.”
The incoming Biden team is preparing a range of new initiatives aimed at speeding the distribution, including dispatching mobile vaccination units to rural areas and erecting new federal sites to administer the shots.
On Friday, the Biden transition said it plans to push out all available vaccine doses upon taking office — a break from the current approach of reserving half the nation's supply to ensure people who receive their initial shot can complete the two-dose sequence.
Biden officials are also focused on establishing clearer guidance for state health officials responsible for actually administering the shots, and laying the groundwork for staffing and funding reinforcements across the nation.
Inside the Biden camp, officials pinned the success of their plan — and the 100-million pledge — largely on the ability to persuade Congress to quickly pass another relief package that includes billions of dollars for state and local governments. Biden has acknowledged this limiting factor.
"I've laid out three challenges in our first 100 days. One of them is ensuring that 100 million shots have been administered by the end of the first 100 days," Biden said late last month. "If Congress provides the funding, we'd be able to meet this incredible goal."
Some transition advisers contended that even if Biden falls short of the 100-million mark, the pledge will have been critical to setting expectations across federal and state governments — and signaling those ambitions to the public. The administration is also planning to offer clear and regular updates on its progress, a practice absent throughout much of the Trump response and that officials believe will build goodwill.
Yet Biden allies have voiced skepticism in recent weeks, warning the transition about the overriding political consequences of breaking one of Biden's first major promises — a setback they worried would invite sharp criticism and only end up hurting his credibility.
"There is a palpable concern," said another person close to the transition. "The American people have some degree of patience, but things need to be dramatically improving in the first 100 days."
Capital gains taxes--I wonder to what extent any increase which now seems likely next year will motivate JT. He will be paying a lot more in taxes next year if the rate is hiked, which now seems likely unless he gets a deal done this year.
So if you are a BP, do you want / let Amrn negotiate reimbursement after approval or would you rather control that process. It seems approval is coming around March.
Mergers take months to close.
It’s gonna get interesting.
Agree. If we see the api / supply issues for Hikma....BP must surely see it too. JT alluded to this.
Great post. You think we hit $21 by end of year 21?
I was hoping we would not be around by end of 21. lol Meaning hopefully BP owns us by then. :)
Not to mention it's likely capital gains tax rates are going up next year so hopefully a deal gets done sooner than later. Don't most M&A deals take 4 to 6 months to close.
It will be interesting to see how fast the approval in China goes. He said application to be submitted late January or in February. I imagine China could respond at any point.
Also mentioned CV risk in China. Wonder if that is a clue that they are going for larger label in China.
We know JT is conservative by nature so have to read between the lines.
It's great we have a local on the ground partner in China who will be motivated to speed things up. They don't make money either until this is approved.
COVID-19 Task-force Leader Under Biden:
https://twitter.com/jeffzients?lang=en
Hopefully someone can let Jeffrey Zients know. He is heading up Biden's Covid-19 task force.
https://twitter.com/jeffzients?lang=en
Yep, I hope and pray that a BP (acquirer) will be handling the case tho. Let the BP take over the litigation and beat down Hikma in the court.
Put it this way...if this case survives the motion to dismiss ruling, it's headed to trial. It would be beyond reckless for Hikma's CEO to take this to trial given the possible treble damages. Judge Prost in her dissent said it would have been wiser for Teva to stay out the market than try to enter it given the damages.
This is a jury trial so we are not dealing with just one person (in terms of trying to dupe/influence a Judge).
The short answer: yes settlement post dismissal of motion to dismiss.
Correct. I think it will be difficult to dismiss Amarin's case as well especially given those screenshots Amarin grabbed of Hikma's actions and of course GSK v. Teva, which was a great surprise for Amarin.
The reality is Wall Street views the USA as lost for Amarin hence why we are a $5 stock right now. The consensus view says USA is dead for Amarin.The situation is very asymmetric meaning there's more upside for us with this suit than downside. The converse is true for Hikma.
Of course Hikma would file this motion to dismiss. Any lawyer worth his or her degree would do so. It's a standard move to try to get a case tossed. Hikma's downside is significant if this case goes to trial.
As far as en banc in the GSK v. Teva case. En bancs are hard to get and because they are so rarely granted it is a signal to the Supreme Court that this case is of importance so look at it. The great news here is that the Supreme Court likes Newman and the Supreme Court has a history of reversing the CAFC on patent cases.
In short, Wall Street already thinks the USA is lost so any positive developments are upside from here. The roles are reversed for Hikma versus the Nevada case. They now have everything to lose versus before they did not and we did. It's interesting how the tables have turned.
Moreover, we still have Europe, China, and perhaps a COVID therapeutic. Now if the consensus view is wrong about Amarin and the USA....look out above.
Is it FOMO.....going into JPM next week?
Great post.
Correct. Has management reached out to any state health official in Southern California to apprise them of Vascepa?
This won't be sold for $12 or $5bn. Not happening. JT & BOD won't even entertain that.
Of course BP could want it for $5bn, but the company won't be sold for that.
I think the "uncertainty" is a lot less now meaning likelihood of a deal is a lot greater....
JT's words at Jefferies interview with Michael Yee
Direct Quote below:
"So it probably didn't quite fit as a license opportunity. I -- are there other structures that, that might work? I think you at this conference last year asked me about M&A. I've been asked about M&A every -- throughout the 11 years that I've been here. I can't control that, but that probably would have been -- that would be a solution to this royalty approach. Right now, we're focusing on that, which we can control, which is the execution side of things, where we know that those companies are certainly aware of what we're doing. And we think with added clarity -- I mean, even the -- I think even the launch of the generic by Hikma ironically provide some substance, right? Okay, now we know, yes, it's sort of limited supply and it's not high price. The more we can answer and just nail down and take away the uncertainty, I think that helps with investors. I think that helps with strategic options as well."
If you're a BP, why would you want Amarin anywhere near handling the European rollout with strategy, hiring, negotiation of reimbursement, etc. You want control of that out the gate. Moreover, deals take time to close (4 to 6 months if not longer...) With EMA approval around the corner (Jan to March)....this could get interesting faster than we know it.
I'm sure BPs have had plenty of time to risk assess, do due diligence, etc. We are two years post REDUCE-IT readout....
Not to mention if USA can be salvaged you want control / ownership of that as well sooner not later.
JMO
Europe, China, Covid, some USA that remains.
Bristol Myers paid $13 bn for MyoKardia's heart drug, Mavacamten. That drug is expected to bring in $1.5 bn in sales by 2025. It is expected to get FDA approval next year.
But hey this is only my guess.