Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

FDA wants PFE to_test Paxlovid in_relapse_cases:

https://finance.yahoo.com/news/1-fda-asks-pfizer-test-201939904.html

The U.S. Food and Drug Administration (FDA) has ordered Pfizer Inc to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.

[vinmantoo]

Before moving to the financials, I want to address briefly our ongoing patent litigation in which we are seeking damages for Pfizer's infringement of our issued 953 patent in the manufacture, use and sale of its COVID-19 antiviral paxlobid.

We recognize the importance of paxlovid's availability for patients and we do not intend to seek an injunction or take other action in this litigation to impede the production, sale or distribution of paxlovid. And finally, in this lawsuit, we are taking steps to ensure that we will be fairly compensated for our intellectual property. Importantly, our 953 patent is completely separate from the patent estate covering our discovery of EDP-235 and our ongoing antiviral discovery work for coronaviruses. Indeed, we have a growing 3CL protease inhibitor patent estate, including several issued U.S. patents, one of which covers EDP-235. These patents describe compounds built on an independent and distinct chemical scaffold from the one described in the 953 patent and in Pfizer's patents for paxlovid.

Thanks Dew for the link. That sounds positive. The above is something else that I thought was interesting and quite positive. No matter how the lawsuit against PFE over Paxlovid goes, EDP-235 won't be affected.

All in all, I am feeling more confident than ever about ENTA as they seem to be firing on all cylinders, or damn close to it.

[DewDiligence]

Re: EDP-235 clinical-trial plans

On yesterday’s CC, Jay Luly may have slipped up by inadvertently revealing that ENTA is seeking to conduct a phase-2/3 trial for EDP-235 (rather than separate phase-2 and phase-3 trials). From the CC transcript:

https://www.fool.com/earnings/call-transcripts/2022/08/09/enanta-pharmaceuticals-enta-q3-2022-earnings-call/

“…generally speaking, the concept on the phase 2 piece would be fairly small and then we would head in to the larger [i.e. phase 3] portion, which would be registrational, obviously.”

I don’t think any of the analysts on the call caught this.

ENTA needs a buy-in from the FDA to run a phase-2/3 trial, of course.

Luly also said that the EUA regulatory pathway for EDP-235 is still open.

[vinmantoo]

ENTA might be able to commercialize without a partner in RSV, but I doubt they would attempt to do so in HBV, where a large proportion of the addressable market is ex-US.

That makes sense about HBV.

[DewDiligence]

ENTA's EV at the current share price ($71.27) is approximately $1.4B, based on the numbers in #msg-169621216 and #msg-169621212.

[DewDiligence]

ENTA’s fully-diluted share count @6/30/22=24.7M—unchanged since 3/31/22 (#msg-168831164).

The 24.7M figure above consists of: 20.7M basic shares on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022015515/enta-20220630.htm#consolidated_balance_sheets ); and 4.0M options outstanding at 6/30/22 (whether or not exercisable) (ibid, p.12).

[DewDiligence]

ENTA’s pro forma cash @6/30/22=$329.4M—a decrease of $23.9M since 3/31/22 (#msg-168831159).

The $329.4 figure above consists of: $290.0M of net current assets on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022015515/enta-20220630.htm#consolidated_balance_sheets ); and $39.4M of marketable securities on the 6/30/22 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).

Note: Net current assets on the 6/30/22 balance sheet include the $28.7M receivable from the IRS (#msg-169620450).

[DewDiligence]

Does this mean ENTA is thinking of going it alone down the line with perhaps with the RSV or HBV drugs?

ENTA might be able to commercialize without a partner in RSV, but I doubt they would attempt to do so in HBV, where a large proportion of the addressable market is ex-US.

[vinmantoo]

ENTA hires CMO with Big Pharma credentials:

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-appoints-scott-t-rottinghaus-md-senior

Thanks Dew! It sure looks like this guy has the goods to help ENTA move forward in dealings with the FDA. Does this mean ENTA is thinking of going it alone down the line with perhaps with the RSV or HBV drugs?

[DewDiligence]

ENTA is due a $28.7M tax refund from the IRS relating to NOL carrybacks allowed by the 2020 Cares Act.

[DewDiligence]

ENTA hires CMO with Big Pharma credentials:

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-appoints-scott-t-rottinghaus-md-senior

Dr. Rottinghaus brings over 20 years of clinical experience in drug development, with expertise in a variety of therapeutic areas including rare disease, hematology, nephrology, neurology, dermatology, rheumatology, and infectious diseases.

Prior to joining Enanta, Dr. Rottinghaus was Vice President and Head of Clinical Development for Hematology and Nephrology at Alexion, AstraZeneca Rare Disease, where he led clinical development for several assets, including ravulizumab, a humanized monoclonal antibody complement inhibitor medication designed for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome.

Before his time at Alexion, Dr. Rottinghaus was a senior director at Pfizer, driving the advancement of several drug programs such as tofacitinib in rheumatology and dermatology, as well as tigecycline, voriconazole, and anidulafungin in the infectious disease field. Earlier in his Pfizer career, he worked as a clinician on early stage clinical trials for influenza vaccine development. Dr. Rottinghaus’ experience includes multiple NDA and MAA submissions and FDA Advisory Committee participation.

During his industry career, Dr. Rottinghaus continued to practice as an attending physician and assistant clinical professor in infectious diseases at Yale School of Medicine. He has co-authored more than 30 scientific publications. Dr. Rottinghaus holds an M.D. from Mayo Medical School, an M.Sc. in Biology from the University of Cambridge where he studied as a Marshall Scholar, and a B.S. in Biology as well as a B.A. in Latin and Greek from Kansas State University.

ENTA’s previous CMO, Natalie Adda, retired in Feb 2022.

[DewDiligence]

ENTA FY3Q22* financials—royalty_revenue=$19.5M—6/30/22_cash=$292.7M (down from $322.5M at 3/31/22):

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-32

FY3Q22 R&D expenses were $39.1M, inline with prior guidance of $150-170M for FY2022; FY2Q22 SG&A expenses were $12.9M, higher than the annualized run rate of the prior guidance of $35-41M for FY2022 (#msg-166871344) due to an increase in headcount.

--
How ENTA’s Mavyret royalty is calculated

ENTA’s royalty rate on Mavyret sales from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret (a 2-drug combination). The royalty tiers reset at the start of each calendar year (like tax brackets), so ENTA’s royalty rate is highest in the fourth calendar quarter (ENTA’s fiscal* Q1) and is lowest during the first calendar quarter (ENTA’s fiscal* Q2).

*ENTA’s fiscal year ends on September 30.

[DewDiligence]

Elaborating on #msg-169566734, the MoA of EDP-235 could not be simpler: EDP-235 stops SARS-CoV-2 viral replication. If the next EDP-235 trial (either phase-2 or phase2/3—see #msg-169566784) has a well-chosen endpoint and an appropriate patient pool (e.g. rate of hospitalization, compared to placebo, in high-risk patients), EDP-235 is a big favorite to show meaningful efficacy. To put it another way, ENTA (and a potential partner) would have to screw up royally for EDP-235 to not be successful in the next trial.

p.s. The above may not be entirely clear to investors who are unfamiliar with clinical development of antiviral drugs. This is probably why ENTA’s recent 40% pop occurred over the course of a week rather than in a single day.

[vinmantoo]

So do we know for certain that the MOA of ENTAs drug identical?

ENTA's EDP-235 and PFE's Paxlovid both inhibit the Sars-Cov-2 3CL protease by interfering with the active site of that protease. ENTA is suing PFE for violation of their patent.

[randychub]

Thank you Vin and Willy. - this makes sense “the MOA of Covid protease inhibitors is well defined”

So do we know for certain that the MOA of ENTAs drug identical?

[vinmantoo]

Crazy good call.

Corporalagarn, well, if you make enough crazy calls sooner or later one will come true.

I actually bought a little more last Thursday at 48. Wish I bought more than I did.

Glad to see you got in before the EDP-235 phase I data came in. I always feel a bit like that when a stock jumps, that I wish I had bought more. I keep reminding myself that I could have bought less or none at all and that makes me feel better.

ENTA's earnings report comes out Monday after the market closes. If earnings miss, even by a little, I expect a drop of several dollars as people look for an excuse to sell after a big run up. Of course, if ENTA gives an update on their lawsuit against PFE for Paxlovid patent infringement then that could change, not that I expect it.

Have a good weekend!

[corporalagarn]

Crazy good call. I actually bought a little more last Thursday at 48. Wish I bought more than I did.

[vinmantoo]

ENTA is up over $3 today. I figured the rise over the release of the safety data on friday would continue this week. The questions remaining in my mind are how many days in a row will the stock price rise, and will it get to the mid $60s or, dare I say it, get back to $70 before the earnings report is released?

Wow, I can't believe this prediction might actually come true. Even a blind squirrel can find an acorn. I might have to start buying lottery tickets and betting on horse races. :)

[vinmantoo]

willyw, sorry I didn't see your response before I posted. Nice job.

[vinmantoo]

Was the risk any different for their RSV drug?

respiratory syncytial virus did not meet the primary endpoint in a Phase 2b clinical trial. The therapy did not reduce symptoms when compared to placebo;

Yes, the risk was very different as the ENTA drug EDP-938 has a novel MOA. In stark contrast, the MOA of Covid protease inhibitors is well defined and there is already a successful drug. By the way, ENTA is suing PFE for patent infringement over Paxlovid.

The recent EDP-938 failed trial was in otherwise healthy adults that had RSV. EDP-938 educed RVS levels but symptom relief was improved but didn't reach significance. The next trials are in very young people and in high risk patents. For Covid reference, Paxloivid's success has been in olde high risk patients, not as a prophylaxis.

[willyw]

From Enanta;
"Antiviral treatment for RSV, including EDP-938, has the greatest potential to show optimal efficacy in high-risk populations, as these patients have reduced RSV immunity which manifests in a longer duration of viral shedding and greater disease severity, allowing a bigger window to realize the full potential of EDP-938. Moving forward, our broad clinical development plan will focus on evaluating EDP-938’s potential in populations with the greatest unmet need, namely those who are at high-risk for severe disease, including pediatric patients, immune compromised, and a high-risk adult population."
---------------------------

Think of covid. Where is the business - what population group? The high risk.

Let me reframe "did not meet the primary endpoint in a Phase 2b clinical trial" as
failed to differentiate the treated group (those intentionally infected) to other healthy.

I think that it's because the normal healthy group recovered so quickly that there was little differentiation between the two groups.
The real question is whether the Enanta RSV drug (EDP-938) will create a differentiated response in the higher risk groups with weakened immune response and more attenuated recoveries.

Look at Paxlovid and covid.
What if you attempted to prove Paxlovid worked by comparing it to groups of covid infected "healthies" who were asympotmatic and who recovered quickly? You could easily conclude that Paxlovid didn't work due to the lack of differentiation.
Here is what the trial did show;
"Final data available from all high-risk patients enrolled in EPIC-HR study (n= 2,246) confirmed prior results of interim analysis showing PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19"

That's the way that I interpreted it.
Enanta took data where they could get it, but by no means was it going to be a trial that was going to be where the bulk of their business would be or on a group that would see the most benefit.

That's my quick take on it and there are many here far more sharp than I am.
I could be wrong. But I have to wonder if many on twitter who called the trial results a whiff or a failure are reading it right. Like you, I'm curious myself of other's interpretation of the results.

https://clinicaltrials.gov/ct2/show/NCT03691623?term=EDP-938&cond=RSV&draw=2&rank=2

[randychub]

Was the risk any different for their RSV drug?

respiratory syncytial virus did not meet the primary endpoint in a Phase 2b clinical trial. The therapy did not reduce symptoms when compared to placebo;

Appreciate the input??

[vinmantoo]

How many drugs get thru phase 1 with that type of data and never get approved or take a few years at minimum to get approved.

How long it take depends on the disease being treated. Cancer trials take many year or run. A drug to inhibit a rapidly dividing virus can take two weeks per patient. The EDP-235 trial will be 5-7 days of treatment. You give it 2-3 weeks more to assess the outcome for each patient. There are no sure things but I feel pretty good about the chances for EDP-235 success.

Pfizer's Paxlovid phase 2/3 trial for high risk patients started in July 2021. The interim analysis in November 2021 showed excellent efficacy so they stopped enrolling. The final data was ready on December 14 2021 and submitted.

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-additional-phase-23-study-results

The FDA approved Paxlovid on Dec 22, 2021.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

[randychub]

How many drugs get thru phase 1 with that type of data and never get approved or take a few years at minimum to get approved. There is still a fairly high degree of risk.

[DewDiligence]

If Luly can provide some color on what the approval process is it would be great.

The CC next week is too soon for Luly to provide any detail. ENTA needs to meet with the FDA to get a buy-in on the trial design and endpoints. I expect ENTA to seek a pivotal phase-2/3 design, but it’s unclear if the FDA will concur with such a plan.

[DewDiligence]

I will probably miss out on a lot of ENTA gains or maybe never have a chance to get in because I’m waiting for some patient results that show the drug works.

EDP-235’s MoA—inhibiting the viral protease and thereby blocking viral replication—is well understood. That makes it hard to see why EDP-235 would not have efficacy in COVID patients, now that we know it can safely be dosed at levels that provide excellent plasma coverage. This is why ENTA is foregoing the usual phase-1b trial and proceeding directly to phase-2—or even a pivotal phase-2/3, if the FDA allows.

[randychub]

Thanks dew. Seen that info on twitter and didn’t check into much because I’m in Belize diving.

Wishing ENTA well. I will probably miss out on a lot of ENTA gains or maybe never have a chance to get in because I’m waiting for some patient results that show the drug works.

It would be nice to see this drug work. While I’m here I found out my daughter who has trisomy 21, OCD and Autism got Covid. She has been vaccinated and boosted but she is also in the high risk group. Kept her away from Covid for 2 years literally the dayI leave she tested positive. Trying to get Pax for her.

R

[willyw]

I hope you are right. You sure nailed the other call; up $5.50 last Friday and up $4.50 today. 10 bucks in two days and 7 more days to go till earnings.

Biden is still positive for covid.
The rebound may be getting more attention than it would have a month or two earlier.
It may create a sense of urgency in tracking what the ideal dosing period is.
I hate to say.... or I have to say carefully---- It is good that they will have another decent or better antiviral to test against the Paxlovid benchmark. They are bound to learn a lot.

If Luly can provide some color on what the approval process is it would be great.
By no means do they seem to have this pandemic under control.

[vinmantoo]

ENTA is up over $3 today. I figured the rise over the release of the safety data on friday would continue this week. The questions remaining in my mind are how many days in a row will the stock price rise, and will it get to the mid $60s or, dare I say it, get back to $70 before the earnings report is released?

[DewDiligence]

Shionogi’s S-217622 has some issues:

#msg-168536263 teratogenicity
#msg-169462279 efficacy not proven

More info on S-217622 than you probably wanted to know:
https://www.biorxiv.org/content/10.1101/2022.01.26.477782v1.full

[randychub]

Conclusions
• Data presented in Ph1 first-in-human study indicate that S-217622 was well tolerated in healthy individuals, and the pharmacokinetics evaluations highlighted the potential for once-daily administration
• In Ph2a, treatment with 5-day oral administration of S-217622 demonstrated a rapid clearance of SARS-CoV-2 and was well tolerated in patients with mild-to- moderate or asymptomatic infection
• The results support further clinical development of S-217622 through large-scale clinical studies for the treatment of mild-to-moderate or asymptomatic SARS- CoV-2 infection

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/ECCMID%20Ph1_2a%20presentation%20final2.1.pdf

[vinmantoo]

What if Enanta did a 6 day versus 5 day (or 5 and 6 day cohorts) and there were no rebounds, even in a larger pool?

In the just completed EDP-235 trials, some of the dosing was for 7 days.

So both Fauci and now Biden have rebounded. I agree that it may not be a serious problem, but it may pose an opportunity.

Agreed.

Getting to your second point- an approved drug that doesn't use Ritonavir may be more likely to be approved immediately by a doctor or pharmacist- thereby treating more immediately, having lower viral loads, less secondary immune/inflammation reactions, a quicker and more complete recovery. That may be more true for the older or more immune compromised or those with other co-morbidities. That's where we are really seeing the serious health consequences.

In short- there looks like there is a lot of need and potential upside to EDP-235.

Agreed.

[willyw]

I don't think the viral rebound phenomenon is that common or too much of a problem. EDP-235 may have even less of a problem with rebound given its high potency and long half-life.
The biggest advantage for EDP-235 is indeed that it doesn't use ritonavir, and that advantage will be greatest in older patients since they are at higher risk for Covid and more likely to be taking other drugs.

https://www.aol.com/news/biden-tests-positive-covid-19-185019908-185837565.html

So both Fauci and now Biden have rebounded. I agree that it may not be a serious problem, but it may pose an opportunity. In the haste to get a drug approved Pfizer didn't try to evaluate a longer dosing period. What if Enanta did a 6 day versus 5 day (or 5 and 6 day cohorts) and there were no rebounds, even in a larger pool? It might help provide a quicker approval nod. Conversely, if Pfizer decided to test a longer duration, IF EUA is over would it be a much longer process? Either way- Enanta *may* have fewer rebounds. --Or perhaps it is merely a feature of covid and peoples immune system reactions.

IF in the process of testing on covid patients the drug was sufficiently differentiated from Paxlovid it really could encourage a more streamlined approval since the world needs it- not only the people, but economies.

Remember when Trump got infected and they pulled out all the stops to save him?

It may be very soon that the Enanta covid antiviral will be the first line of defense. If it is clearly superior I cannot imagine Paxlovid being used on future Fauci, Trump, or Biden like leaders.

As quickly as the virus has been mutating and continuing to pose a threat to people, economies, schools or supply lines it seems that vaccines alone will not provide a solution.

Unfortunately, as we are seeing that vaccines are providing less protection people are either waiting for the new improved versions- or worse yet they are rationalizing getting a booster isn't going to provide any benefit.

Getting to your second point- an approved drug that doesn't use Ritonavir may be more likely to be approved immediately by a doctor or pharmacist- thereby treating more immediately, having lower viral loads, less secondary immune/inflammation reactions, a quicker and more complete recovery. That may be more true for the older or more immune compromised or those with other co-morbidities. That's where we are really seeing the serious health consequences.

In short- there looks like there is a lot of need and potential upside to EDP-235.

[vinmantoo]

Covid isn't going anywhere.

Yes, the virus is a real bastard.

It also seems that problems with viral rebound are happening (Paxlovid -too weak or too short a duration??)
Recent virus strains are evading vaccines.
Many doctors are hesitating to prescribe due to the complicated nature of drug interactions w/ Ritonavir.

I don't think the viral rebound phenomenon is that common or too much of a problem. EDP-235 may have even less of a problem with rebound given its high potency and long half-life. The biggest advantage for EDP-235 is indeed that it doesn't use ritonavir, and that advantage will be greatest in older patients since they are at higher risk for Covid and more likely to be taking other drugs.

The last thing on the sheet I really liked?
"Select third mechanism for HBV combination regimen with EDP-514" (in 2022)

I believe that Enanta has reinforced confidence in their capabilities with antivirals.
If they can come up with a third compound for HBV......

I too have confidence but I sure wish that one or more third drugs will be coming. I know they said in the second half of 2022 but I hope it is sooner rather than later.

[DewDiligence]

[Slide #31]: "Select third mechanism for HBV combination regimen with EDP-514" (in 2022)…

Investors have implicitly written off the HBV program, so if ENTA comes through after all, it’s all upside.

[willyw]

Yesterday was a great day for Enanta.
I'm sure that the Earnings call will shed more light on the covid development plan.
Covid isn't going anywhere. Covid is evading vaccines, and other troubling issues like reinfection, long covid and additive damages from reinfections suggests we need a better antiviral.

It also seems that problems with viral rebound are happening (Paxlovid -too weak or too short a duration??)
Recent virus strains are evading vaccines.
Many doctors are hesitating to prescribe due to the complicated nature of drug interactions w/ Ritonavir.
So the emergency isn't really quite over- infections are once again rising.
There is a need for a faster pathway to approval for EDP- 235

The last thing on the sheet I really liked?
"Select third mechanism for HBV combination regimen with EDP-514" (in 2022)

I believe that Enanta has reinforced confidence in their capabilities with antivirals.
If they can come up with a third compound for HBV......

[DewDiligence]

ENTA’s updated corporate slide set—(including new EDP-235 info):

https://ir.enanta.com/static-files/fb5db89a-b15b-4820-9e77-b8c5b087f869

Slides 17-21 pertain to EDP-235. Slide 20 shows comparative potency vs other agents.

[DewDiligence]

Agreed. EDP-235 is plainly more potent than Paxlovid. And without the manifold drug-drug interactions consequent to ritonavir, EDP-235 should be considerably safer than Paxlovid too.

The clean safety profile of EDP-235 is the biggest news in today's dataset. That's because the MoA of EDP-235 is well understood, so efficacy at the doses selected for phase-2 is almost a fait accompli.

[vinmantoo]

ENTA’s PR on EDP-235 phase-1/1b data:

Thanks Dew. It looks good to me.

EDP-235 exposure increased approximately proportionally with increasing single and multiple doses, with a consistent half-life ranging from 13 to 22 hours, resulting in a PK profile suitable for once-daily dosing. Exposure was enhanced with food administration of a standard meal. EDP-235 once-daily taken with food, resulted in mean trough plasma levels at steady state that were higher than the plasma protein adjusted EC90 of EDP-235 in Vero cells as follows:

200mg: 3-fold for Alpha and 6-fold for Delta variant
400mg: 6-fold for Alpha and 12-fold for Delta variant
Considering a preclinical lung to plasma ratio of 4:1, lung levels are predicted to be as follows:

200mg: 12-fold for Alpha and 24-fold for Delta variant
400mg: 24-fold for Alpha and 48-fold for Delta variant

So if we take the mid-zone for half-life of 18 hours, let's look at 200mg and 400mg doses on delta in the lung.

Estimated Lung levels, fold higher than EC50 after last dose:
200mg: 6 fold at 18hrs, 3 fold high a 36hr and 1.5 times higher at 54 hrs.

400mg: 24 fold at 18hr, 12 fold at 36hr, 6 fold at 54hr, 3 fold at
72hr and 1.5 fold after 90hrs.

That means people might be less likely to suffer from rebound like sometimes seen with Paxlovid. I wouldn't be surprised if the 200mg dose is used and perhaps for 7 days rather than 5 days.

[DewDiligence]

ENTA’s PR on EDP-235 phase-1/1b data:

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-data-phase-1-clinical

Based on these positive safety and PK results, ENTA is advancing the 200mg qD and 400mg qD doses (without ritonavir boosting) to phase-2, which is expected to start in 4Q22.

[DewDiligence]

Yes, as far as I know.

[JK2016]

Are we due for a PR today or tomorrow on EDP235?

[DewDiligence]

All of those reasons plus the scary stuff people some people are writing about Omicron BA.5.

[vinmantoo]

ENTA broke $51 this morning. The stock price dropped to just under $39 in mid June. This rebound could be a delayed response to the the law suit for patent infringement against PFE, anticipation of the phase I safety data for their Covid-19 protease inhibitor EDP-235, a general rebound after a long decline or all three. We should soon know about the phase I data as ENTA is expected to release that data this month.

[vinmantoo]

The Canada approval is for the pediatric market (age 3-11).

Dew, yes I got that. I was wondering if Mavyret was approved for pediatric patients in the US or other countries. If not, this group could provide some additional new revenues, not blockbuster but still more revenues.

[DewDiligence]

The Canada approval is for the pediatric market (age 3-11). Mavyret was already approved in Canada for adults and adolescents.

[willyw]

It may be as simple as Enanta was the first to patent. The Pfizer PI entered trials spring of 2021.

https://www.marketwatch.com/story/a-small-biotech-says-pfizer-infringed-on-its-patent-with-paxlovid-11655915222?siteid=yhoof2
"The suit, which was filed Tuesday in U.S. District Court in Massachusetts, alleges that Enanta filed an application with the U.S. Patent and Trademark Office “describing coronavirus protease inhibitors invented by Enanta scientists” in July 2020. Pfizer’s patent for Paxlovid appears to have been filed three months later, and Enanta’s patent “does appear to cover the chemical space Paxlovid is in,” RBC Capital Markets analyst Brian Abrahams told investors this week."
------------
(my comment)
When Enanta comes out with the Phase 1 date for EDP-325 next month, it may appear that not only did Enanta discover and be granted a patent for a covid treatment, but they took a little longer to create a superior compound compared to many rushed covid compounds.

Much of the commentary on the case may be illustrated by the headline of this article. The uninformed may feel like a small biotech is trying to piggyback off of Pfizer's success. As time passes and data is released and comparisons made viewpoints *could* shift.

So Enanta's position in Covid may increasingly become stronger as time passes.
First to patent, more efficacious, fewer pills, no R- boosting, fewer drug interactions; "small biotech" or leader in anti-viral space?

[vinmantoo]

I just saw that Canada approved the use of Maviret and stated that ~250,000 patients are in this category. I wonder if Canada is just late to the party or whether they are early so a new substantial patient population may soon be realized in many countries.

https://finance.yahoo.com/news/maviret-glecaprevir-pibrentasvir-approved-health-120000965.html

[willyw]

Wow!
Thanks for providing the link as it gets into the specifics of the suit.
Even so it is difficult for me to clearly see what the courts will decide.
One must assume that Pfizer must have some sort of IP and response.

I am reminded of Gilead being sued for Sovaldi.

This is going to be a nail biter.
I hope that it has a Hollywood ending for Enanta investors.

It may be as simple as Enanta was the first to patent. The Pfizer PI entered trials spring of 2021.

[DewDiligence]

(ENTA)—PFE’s guidance for 2022 Paxlovid sales is $22B, of which a substantial portion is from the US market.

If ENTA’s patent suit resulted in even a low-single-digit royalty on US sales of Paxlovid, it would amount to a very sizable payday relative to ENTA’s existing enterprise value.