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Vir Biotechnology, Inc. (VIR)
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I think that VIR’s most profitable drug may be their small interfering RNA drug, VIR2218. It is a drug that has a synergistic effect with other drugs in eliminating chronic hepatitis B viral infections. Three different ongoing phase 2 clinical trials are pairing VIR2218 with other agents directed against HBV. Gilead’s TLR8 agonist, selgantolimod, plus the PD-1 inhibitor, Nivolumab, combined with VIR2218 is one trial. Another trial is combining Brii Bio’s BRII-179 with VIR2218 to combat chronic HBV infection. Finally VIR has started a phase 2 trial combining VIR2218 with VIR’s own HBV-neutralizing MCA, VIR3434.
The bottom line is that VIR’s small interfering RNA (siRNA) seems to have a synergistic action with multiple other anti-HBV meds. At this point it doesn’t seem clear which drug will best pair with VIR’s VIR2218. However, if a functional cure is achieved with any or all of these other anti-HBV agents, our drug VIR2218 will be the essential part of that cure.
Well it looks like GSK is chomping at the bit to throw more money at VIR. They just handed VIR $225 million cash & an additional $120 million in equity so that VIR could go full speed ahead with the development of their universal influenza neutralizing MCA.
By my account the new cash added to VIR’s already existing cash hoard gives VIR more than $1 billion in cash and, of course, no debt. But who’s counting? Oh yeah, can somebody explain to me again the concern about VIR’s current market cap?
how many drugs does this company have in its pipeline?
New order of 100,000 vials of sotrovimab coming (UK) which is good news. However, sales will be captured by GSK who have worldwide licensing for the product outside US. VIR will get royalty payment.
In the US, the FDA has reissued the sotrovimab Emergency Use Authorisation (EUA) letter specifically to insert a paragraph exactly the same as that in Regeneron’s REGEN-COV EUA. This has to do with the government controlling the distribution and use of the product. The move is to bring all neutralising monoclonal antibodies into government (Federal, state, local) control under the supervision of the Federal government, while under EUA. This issue has to do with logistics. Anticipated lesser supply than demand requiring judicious and timely distribution of product in the right quantities to where it is needed to achieve the EUA specified goals. Rather than sitting on shelves and warehouse where it is oversupplied and underutilised.
I think this is a development for the better because selling treatment vials and utilising them are 2 different things. There is tendency to hoard, restricting actual use by others which has long term determinant for the product. More so when the treatment is made into a political football. The products would be distributed to based on area/hospital infection testing counts, patient hospitalisation counts, past ordering amounts, actual utilisation etc in addition to ongoing side effects and patients’ characteristics reporting already mandated by the EUA.
The distributor, AmerisourceBergen, I expect would remain the same, but they cannot process orders initiated by sales reps or direct from purchasers/health providers. Orders/indenting will come through state and local government direction based on federal determined criteria.
I do not think there will be lesser sales. In fact, the condition is being set for better organisation, hence should see better real usage, hence growing adoption and in the months ahead, into flu season, more sales in the US. I read a few days ago sotrovimab ran out of stock in the US around the time a few state governors started speaking about mAbs and sotrovimab in particular as alternate to the REGEN-COV shortage their perceived.
The FDA had in September updated the EUA and Full Prescription Information to amongst others include the full results of phase 3 study COMET ICE as well as updated information on in vitro efficacy against new variants and amendments to make the insert easier to understand and the product easier to use.
Finally breaking nicely above $40… here we go
I must also say that GILEAD SCIENCES seems to have a good Pill coming along;
"Gilead Sciences is developing a pill version of remdesivir. And Denison suspects that if the antiviral were given to people as early as molnupiravir is — when symptoms have only just appeared and viral loads are high — it would be similarly effective. In a study presented at IDWeek, a virtual meeting of infectious-disease specialists and epidemiologists held earlier this month, researchers reported results of administering infusions of remdesivir to people in the early stages of COVID-19 every day for three days. The number of participants in the study was small, but remdesivir appeared to reduce hospitalizations by 87% in people at high risk of developing COVID-19.
Telegraph today.GSK/VIR SotrovimabToday 22:33
UK buys 100,000 doses of GSK's experimental Covid drug
The treatment has yet to be approved by UK regulators but has been given the green light in the US, the EU and Japan
9 October 2021 • 7:00pm
Order value is $2.1bn
Oct 8 (Reuters) - The U.S. Food and Drug Administration said on Friday distribution of GlaxoSmithKline GSK and Vir Biotechnology's VIR antibody treatment for COVID-19 would be controlled by the government.
The drug was authorized by the FDA in May but no supply deal was signed at the time with the U.S. government, which is already distributing rival treatments by Regeneron Pharmaceuticals Inc REGN and Eli Lilly LLY. nL3N2ND4CG
It was not clear whether a contract had been signed between the government and GSK/Vir. The U.S. Department of Health and Human Services did not immediately respond to Reuters' request for comment.
I am very surprised that no one, on here, has noticed the order for 42,110 doses. Anyone ?.
Both The UK & Israel publish precise, continually updated data about the percentages of hospitalizations & deaths from Covid19 in unvaccinated individuals, partially vaccinated individuals, & fully vaccinated individuals. The US doesn’t.
We continue to see anecdotal cases of individuals who were fully vaccinated and subsequently developed severe and even fatal COVID-19. Certainly Colin Paul is an example of this. Likewise Jesse Jackson, who was publicly vaccinated & a strong proponent of the C19 vaccine for the black community, was hospitalized for two months with complications of COVID-19.
The mainstream media downplayed vaccinated Jesse Jackson’s illness. It’s hard to downplay someone’s death!
I’m certainly no anti-VAXer. I’ve had both Moderna vaccines, & I’m considering getting the booster when it’s offered. Nevertheless, I know the limitations of the vaccines. They don’t guarantee neither contracting COVID-19 nor dying of it. The vaccines merely decrease the risk of the disease, very similar to the influenza vaccine.
Data shows that an unvaccinated 35-year-old has the same risk of dying from COVID-19 as a 50 year old vaccinated individual, assuming both individuals have no other risk factors for severe COVID-19.￼￼ Data also shows that natural immunity following COVID-19 infection is 13 to 27 times more effective at preventing COVID-19 then vaccination.
The USA government have just announced via Reuters that they are going to control the supply of Vir/GSK’s Sotrovimab, they have given any details of a supply contract yet, but they must have a contract otherwise they couldn’t control it.
Reuters are trying to ascertain further information.
Brilliant ‘potential’ news, watch this space.
GSK and Vir turn to US for distribution as Covid-19 mAb treatment nears blockbuster status. GSK said in an emailed statement to Endpoints News:-
"We can confirm that the U.S. government has agreed to purchase sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19. As part of the agreement, which is worth $279,862,800, GSK will supply sotrovimab to the U.S. government, enabling rapid access to sotrovimab at no cost to patients. As the pandemic continues, we recognize the continued urgency of patient need across the world and continue to engage with governments and procurement bodies to support the pandemic response."
Oh wow… some BIG news tomorrow
Does anyone know when our IM results will be released ?
Thanks to 'LostAllMyShirts' for highlighting 'order for 42,110 doses'. This is in US. Look for Health and Human Services website on 'State/Territory-Coordinated Distribution of COVID-19 Monoclonal Antibody Therapeutics' . For the period 11th - 17th October (todate) 42, 110 vials of sotrovimab has been distributed to various states and Indian nations and Veteran Adminstration. This process refers to the October 8th US FDA EUA amemdment bring sotrovimab under government supervision. So this is the 1st week. Click on the date to see the amount sent to each state.
My opinion is this is ongoing (new/current sales) from the distributor. I doubt if this is related to the US Army order (USD 270+million), though that could be to not ruffle Vir/GSK feathers. Look forward to a proper DOD-HHS/BARDA big order!! With this monitor we can see how sotrovimab is moving versus the 2 other competitors.
get ready for 62$
AstraZeneca’s TACKLE trial of AZD7442 combination LAAB (Long-Acting Antibody) in treatment of patients with mild to moderate Covid-19 and at least 1 high risk factor came out slightly short in efficacy for preventing progression to severe disease, compared to existing mAbs including sotrovimab. Probably why the share price today wasn’t impeded in coming back up, more so with news of future UK purchase.
VIR7832 (2nd gen sotrovimab) might have talking points to counter the LAAB long term benefit (next year onwards). Someone did a projection of 5 years sales for current approved (EUA) and filed Covid-19 treatment options including for sotrovimab. IF YOU LIKE, Google ‘evaluate’ ‘vantage’ ‘TACKLE’ and look at the pdf.
Even though I’ve invested in the stock market for more than 40 yrs, I just recently started reading & even posting on investment boards. Many of the posters have given me good knowledge & insight. However, I worry that the very nature of investment boards creates unrealistic expectations & dangerous impatience.
In the past month we’ve learned that VIR has sales orders of $1.4 billion. We’ve learned that VIR’s has zero debt. We’ve learned that VIR has $826 million in cash on hand. We’ve learned that a competitor pill that sells for $900 for a treatment course has less than half the efficacy of Sotrovimab. We also know that this competitor pill has definite mutagenicity (i.e. cancer & birth defect potential). Currently VIR has a market cap of $4 billion. ￼We also know that the results of our IM trial are imminent & likely will be a game changer.
Every investor has to determine what his comfort level is for any stock they own. The sad truth is, nothing is a sure thing. I’ve done my DD & have a medical background. I’ve bought a lot of VIR.
If you’re preoccupied with the price of a stock that you own, if you’re continually fretting when it goes up that you should have bought more, & when it goes down, you should have sold or not bought it at all, you really should sell a part or all of your stock. Like I said, every investor has to determine their own comfort level with any stock they own.
VIR currently is my largest holding. I’m very comfortable owning it even during down days, down weeks, & down months. I’m much better at knowing what is going to happen rather than when something is going to happen. In the short term I can guarantee one thing about the SP of VIR; it will fluctuate. Another thing I can guarantee is that VIR’s ER in a month will be shockingly good.
I can’t think of a worse medicine side effect than mutagenicity unless the medicine is only to be used in those with a life expectancy less than 5years.
An ethical trial of Molnupiravir would be to use it in patients incapable of reproduction with a limited life expectancy. If no excess cancers develop in these patients after at least 5 yrs follow up, the treated population could gradually be increased, continually monitoring all patients for an increased cancer incidence.
I don’t know how any medicine with legitimate mutagenicity concerns can meet the requirement of an EUA mandated by Congress, i.e. “SAFE and may be effective”
Molnupiravir supposedly lowers the risk of death 50% compared to what… substandard care?! The current standard of care would include Neutralizing MCA’s, not placebo. Compared to neutralizing MCA’s, Molnupiravir has excess mortality, not a reduction of 50%. Merck did the exact same thing that HGEN did. Merck constructed a trial comparing their drug to sub standard of care. HGEN excluded the use of tocilizumab & baricitinib in their standard of care placebo group of their trial of Lenzilumab. Unfortunately both of tocilizumab & baricitinib had become the standard of care. Rightfully the FDA refused granting an EUA to Lenzilumab.
The often quoted 85% figure underestimates the true benefits of Sotrovimab. The FDA considered all hospitalizations as failures in the treatment group but not in the placebo group. Some of these so-called treatment failures in the Sotrovimab group included hospitalizations for diabetic foot ulcers, small bowel obstructions from adhesions from surgery years earlier, heart attacks & strokes in these critically ill study patients. The trial design explicitly excluded obvious non-Covid related hospitalizations in the placebo group, but not in the treatment group.
Real world experience is substantially better than reported in our trial. From the results of a two-week study evaluation of 6,175 Covid-19 patients in Abu Dhabi receiving Sotrovimab treatment, the results showed 100% prevention of deaths, 99% prevention of admission to intensive care units, and 97% of patients making a full recovery within 14 days.
Do you honestly think that the UAE is going to buy any Molnupiravir if it gets an EUA?
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