This week's sponsor is Medical Device Success. MDS has a weekly podcast whose focus is helping medical device companies succeed in our current, challenging environment. We believe it's the
only podcast with this focus. They go over effective strategies/tactics that can be implemented economically, while also doing interviews with executives. If you're interested in the device space, check it out:
Medical Device Success
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BioPharmGuy
Medical Device/Region Splits
We are coming up on 10,000 companies in our directory. Some pages/categories have become unwieldy, namely Medical Devices, All of Europe & All of Asia so we split them up. Medical devices is now seven subcategories:
(Diagnostics has always been its own category)
Our Europe & Asia pages have been converted to include only companies in Europe/Asia who do not appear on a country-specific page. So those Europe/Asia pages are now
Europe (Other)
&
Asia (Other)
.
Addition & Attrition
15 companies added and 12 removed this week. Summary available on our
downloads
page
'Shoulda used Google Translate' email pitch of the week
"Pls kindly note that our intention to start our negotiations with your esteemed company is very grand as well would like to point out our company not only have a great power at Turkish MOH but also has a high importance in the whole market with also doctors in our territory. We work very valuable companies worldwide and now on going negotiations also with a global Japan manufacturer."
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Moderna/Vaccines
The phase 1 results were
finally
published
. The 45-person trial showed patients producing neutralizing antibodies (antibodies that bind the virus of interest), but only after a second injection four weeks later. These neutralizing antibodies started to trail off a couple weeks after that.
Only 15 people in this trial received the 100 ug dosage Moderna has selected for their phase 3 trial. Most of those, if not all, showed mild to moderate side effects. If side effects remain moderate across the board in future trials, it's definitely a lesser of two evils situation. But expanding from 15 to 30,000 people will be virtually guaranteed to exhibit a lot more serious side effects in different patient types. Phase 1 trials are healthy volunteers and if you have eyes, you probably know most Americans are not healthy.
Not only that, these trial results are not at all an indication of whether this vaccine actually provides immunity. The road to vaccine approval is littered with failures that looked this good or better in phase 1. T
his is still a long shot to provide extended immunity. Most likely these mRNA drugs will only provide fleeting immunity, if any.
Never in the history of vaccine development has so much hype been foisted on phase 1 results. Ken Frazier, CEO of Merck addressed the over exuberance in an
interview this week. He's probably the most professional CEO in the pharma space and provides many thoughtful quotes in this interview:
"I think when we do tell people that a vaccine's coming right away, we allow politicians to actually tell the public not to do the things that the public needs to do like wear the damn masks."
Acme Bioscience
Yes there really is a company with this name and they were
acquired
by Frontage this week.
Tranquis Therapeutics
Tranquis recently '
debuted
' with a $30M funding round. They were founded in 2016 and we've listed them in our database since at least October 2019. Apparently a company doesn't exist until some venture capitalists say so with their wallets.
Gilead
A few weeks ago the Institute for Clinical & Economic Review (ICER) attributed a new ~$2700 fair price value to remdesivir. This was based on a mortality benefit being clinically confirmed. Without that mortality benefit, the drug merely reduces symptoms by four days, so ICER noted $310 would be a reasonable price in that scenario.
As of now, mortality benefit has not been clinically shown, yet Gilead went with the higher price anyways. So they are realllly scrambling to spin things. They've come out with
cherry-picked retrospective data
showing a
possible
mortality benefit which they noted requires confirmation. They could have just as easily said 'it didn't show mortality benefit but we are hoping it does next time'. Maybe stop ripping people off if you don't have the data?
CEND Therapeutics
CEND is working on proprietary tumor-penetrating peptide technology. This particular moniker is only a couple weeks old - they were previously known as
DrugCendR
. That kinda sounded like they were drug mules, whereas this new name sounds more like an online pharmacy. Suppose that's better.
FDA back in action, sort of
The FDA is planning to
resume
on-site company inspections later this month after a four-month hiatus. They will be pre-announced inspections for the time being.
We feel for our FDA brethren - no idea what they could possibly have been filling their time with for the past four months, and now no more surprise inspections? The best part of the job is seeing the scramble that takes place when the big, bad FDA arrives. It's hilarious. Take that away and what's left? Safeguarding our nation's drug supply?
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Indoor/Outdoor Theory Followup
A month ago we put forth a theory that case counts were skyrocketing in hot climates because people were retreating indoors and thus in closer proximity to other people (with far less air movement).
Here we follow up and again use
NPR data
on state case counts for last week & three weeks ago plus Wikipedia population numbers and Google's average highs for July in U.S. cities. We exclude states that had fewer than 20 cases last week or three weeks ago.
This first chart compares the average July high temp in various states vs. % increase in cases over the past several weeks and the second is our comparable chart from June.
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In June, 85 degrees correlated with a marked jump in % case increases. As temperature rose in July, case counts duly rose. However, they rose pretty much everywhere. For July we see that every state with an average temp of >85 saw a case increase, but the cooler states showed much the same.
Second thing we looked at was cases per million residents:
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Sad thing here is just how massively case counts have increased in the past month. The x-axis went from a max of 180 per million residents to 800. Thanks a lot, California! California is a weird data point, though. Most of the cases are in Southern CA where the temps are warmer (average high in San Francisco in July is only 67 degrees - just two degrees warmer than Anchorage) so that state should probably be split into a couple regions. However, laziness has gotten the best of us so forget it. We couldn't even be bothered to remove a dialog box from one of these charts. Too hard.
Anyways, all the states with the biggest case counts per million are still the warm states. Not surprising since they had the largest numbers a few weeks ago so that's where you would expect the pandemic to rage.
Overall this indoor/outdoor theory maybe is a small part of why the pandemic has broke the way it has, but probably not the dominant factor.
NHS COVID Mortality study
NHS England conducted a
massive analysis
of their patient records - 17 million in fact - to conclude what the risk factors are for COVID-related deaths. They pretty much hewed to what we have already seen: male, old & poor, diabetic, asthmatic, ethnic minority.
More Disease, Less Death
A State Senator from Alabama has stated he would like to see
more
COVID infections. Direct
quote
: "In fact, quite honestly, I want to see more people because we start reaching an immunity of the more people have it and get through it".
Not the most eloquent guy, but the point was he wants people to get sick so we can get community immunity (copyright BioPharmGuy) more quickly. He went on to say he wants old people or people with pre-existing conditions to be protected.
Uhhh, dude, you are an elected official in
Alabama
where 36% of people are obese, 12% diabetic, 17% live in poverty, 21% are senior citizens. This is not a place that can just let the low-risk folks achieve herd immunity - there aren't enough of them! (Plus last we checked there is no herd immunity to common colds so not really sure why this respiratory disease should be any different - yet another example of the media probably getting peoples' hopes up.)
Interesting re-election strategy there to say the least. For what it's worth, Alabama was reporting 88% capacity in ICUs, with 206 beds available statewide when this guy made his comment.
Dumpster Fire aka Florida
Just how horrific is the US response to this pandemic? Florida (pop. 21M) is reporting over 15,000 cases a day while South Korea (pop. 51M) hasn't even had 15,000 the
entire pandemic
. A BBC headline
asks
"How did Florida get so badly hit by Covid-19?". Well, the governor downplaying from the start didn't help, but maybe the BBC missed this nugget of spring breaker wisdom:
"If I get corona, I get corona. At the end of the day I'm not going to let it stop me from partying."
Kane unable (to support mask ordinance)
Knox County, TN mayor Glenn Jacobs, better known as mask-wearing professional wrestler Kane, was the
sole dissenting vote
against a mask ordinance for Knoxville. In the 2001 Royal Rumble, Kane wrestled for almost 54 minutes, eliminating 11 opponents, all while he wore a mask. Of all people, you'd think he would believe the Tennessee undergrads could handle wearing one for a Bio 101 lecture, considering the lack of choke slams and what have you.
Thankfully, Kane...err, Jacobs was the only dissenting vote and the ordinance passed.
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