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My probability estimate of no summary judgment for either party is 85%, FWIW. (I am not a lawyer.)
Thx Mouton
I guess there are 3 obvious outcomes here. PFE wins summary judgment and case is over, ENTA can win summary judgement, or the judge doesn't grant it to either party and it goes to trial. The second possibility, however small, would be hugely bullish, and the third option would as well bc once it goes to trial I would think PFE is more likely to settle
I guess a 4th option is the judge grants summary judgement in part narrowing the scope of what goes to trial?
always good to get a lawyer's opinion here thx - I have no idea how to handicap any of these possibilities frankly, but it seems at least so far today the remote possibility of a judgement in ENTA's favor in the next 2-3 months is dawning on some investors
I've read the Bloomberg article, and Dewophile, you are correct. The article just quotes a sentence from each of the summary judgement motions and then observes, as you do, that "the bulk of the arguments" of each side are under seal and that neither company responded to a request for comment.
I don't but pretty much everything is sealed so I am not sure how much info this article could possibly have:
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
ENTA did seem to score a small victory proving most (but not all) of certain documents that PFE was hoping to get unsealed are in fact privileged. This is from early May:
https://casetext.com/case/enanta-pharm-v-pfizer-inc-2
Anyone have access to this full article dated May 29, 2024?
Pfizer, Enanta Launch Dueling Bids to Gut Paxlovid Patent Case
https://news.bloomberglaw.com/health-law-and-business/pfizer-enanta-launch-dueling-bids-to-gut-paxlovid-patent-case
So far, all of the patent filings have benefitted the legal team that wrote and submitted them.
Do these patents really matter? (Contrary to my earlier post! )
Saturated spirocyclics as antiviral agents
Patent number: 11993600
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: December 6, 2022
Date of Patent: May 28, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Joseph D. Panarese, Samuel Bartlett, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
Enanta Pharmaceuticals to Participate at the Jefferies Global Healthcare Conference
May 29, 2024
WATERTOWN, Mass.--(BUSINESS WIRE)--May 29, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, and Tara L. Kieffer, Ph.D., Chief Product Strategy Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference on June 5, 2024 at 7:30 a.m. ET in New York, NY.
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-participate-jefferies-global-healthcare-0
FWIW - Good news for a potential buyer?
Enanta Pharmaceuticals sees highest patent filings and grants during February in Q1 2024
Excerpts:
Enanta Pharmaceuticals saw the highest growth of 199% in patent filings in February and 499% in grants in January in Q1 2024. Compared to Q4 2023, Q1 2024 saw an increase in patent filings by 24% and grants by 499%.
Patents related to rare diseases and Covid-19 lead Enanta Pharmaceuticals's portfolio
Enanta Pharmaceuticals has the highest number of patents in rare diseases followed by, Covid-19 and climate change. For rare diseases, nearly 50% of patents were filed and 38% of patents were granted in Q1 2024.
Respiratory syncytial virus (rsv) infections related patents lead Enanta Pharmaceuticals portfolio followed by cardiovascular disease, and fatty liver disease
Enanta Pharmaceuticals has highest number of patents in respiratory syncytial virus (rsv) infections followed by cardiovascular disease, fatty liver disease, non alcoholic fatty liver disease (nafld), and non-alcoholic steatohepatitis (nash).
Read more:
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-patent-activity/?cf-view
Thanks.
I just saw this amd thought there may be a counter suit.
Counter Claimant
Pfizer Inc.
Represented By
Thomas H.L. Selby
Williams & Connolly, LLP
contact info
Lee C. Bromberg
Mccarter & English, LLP
contact info
David I. Berl
Williams & Connolly, LLP
contact info
Wyley S. Proctor
Mccarter & English, LLP
contact info
Julie Tavares
Williams & Connolly LLP
contact info
Christopher Yeager
Williams & Connolly LLP
contact info
Erik Paul Belt
Mccarter & English, LLP
contact info
Counter Defendant
Enanta Pharmaceuticals, Inc.
Represented By
Donald R. Ware
Foley Hoag LLP
contact info
Barbara A. Fiacco
Foley Hoag LLP
contact info
Defendant
Pfizer Inc.
235 East 42nd Street
New York, NY 10017
Represented By
Thomas H.L. Selby
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
Clown finger is double clicking and iHub is taking it literally by posting my message twice.
I have not heard of any countersuit. It looks to me like the schedule of events I relayed on September 1, 2023 has been fulfilled:
Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024
Are there any clowns anywhere?
Yes I think we know if the suit has enough merit to go to trial before summers end
Re Lawsuit
Looks like there are several motions in connection with summary judgement in the PFE case. Luly said in the past a trial was expected by end of this year, but on the last earnings call said IF a trial happens will likely be later this year. Sounds to me a decent chance the suit gets thrown out (and there seems to be a countersuit against enta but i could be reading this wrong). However if the suit proceeds to trial then I would expect PFE to come to the negotiating table.
JMO
https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc
re RSV polymerase inhibitor (EDP-323)
ah got it - they only mentioned the 28M bc they had to record interest earned on that money for accounting purposes
32M is nothing to sneeze at for a company their size
There a $28M tax refund that ha been due for some time and a new $4M refund due.
The company mentions a 28M income tax refund on calls but in the filing it says 32M. It’s a small discrepancy but what am I missing?
ENTA’s fully-diluted share count @3/31/24=27.04M—essentially unchanged since 12/31/23.
The 27.1M figure above consists of: 21.18 basic shares on the 3/31/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024055581/enta-20240331.htm ); and 5.86M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, page 9).
ENTA’s pro forma net cash @3/31/24=$148.6M—treating ENTA’s deferred-royalty obligations as debt, as is done under GAAP [#msg-172603887]—but see note at bottom of this post. The $148.5M figure, which is down $27.7M relative to 12/31/23, consists of:
• $296.4M net current assets on the 3/31/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024055581/enta-20240331.htm );
• ($147.8M) deferred long-term liabilities on the 12/31/23 balance sheet relating to the OMERS royalty agreement. ($33.7M of liabilities relating to the OMERS agreement are booked as current liabilities and hence are included in the $296.4M figure in the first bulleted item.)
Note: Excluding the “debt” associated with the OMERS royalty agreement, ENTA’s pro forma net cash at 3/31/24 was $330.1M ($148.6M + $147.8M + $33.7M).
I think the panoramic trial is powered that they should be able to show efficacy on outcomes like hospitalization even with event rates much lower now in a more immune experienced population
If I were a pharma I would want to see the ensitrelvir data and then decide on 235 bc at this point you are talking only a few months (NIH is running the study so it’s not going to be suppressed long like epic-Sr
NIH of course could choose to fund 235 too if the data do suggest it might be better on efficacy than ensitrelvir
Hi Mouton - yes I was aware the EPIC-SR results were finally published (failure of the trial as you know was publicized nearly 2 years prior). I alluded to this in my post listing paxlovid as one of the drugs that failed to show a difference in sustained resolution of the 15 symptom endpoints. Japanese regulators allowed Shionogi to focus on fewer endpoints that were more common especially with current variants for approval.
As I said to Vin it could be when data from the SORPIO-HR trial (ensitrelvir) is made public (hopefully it won't be after a 2 year lag like the PFE trial) a cross trial comparison can be made to gauge EDP-235 relative to ensitrelvir on symptom endpoint.
Paxlovid - dewqophile and vinmantoo, I strongly suspect you both know this, but in the Paxlovid EPIC-SR trial reported in NEJM in April, Paxlovid flopped completely on syptom relief. https://www.nejm.org/doi/full/10.1056/NEJMoa2309003
Notwithstanding the "SR" or "standard risk" title, the trial did enroll a significant number of high risk patients if they had been vaccinated. And even in that subgroup, symptoms were not resolved materially sooner:
Sounds like a wonderful trip!
I think the endpoint is resolution of symptoms for one day, and we don't know the difference between placebo and treatment yet
Somewhat agree about virology - the differences could be due to pt populations (notably 30% were high risk vs essentially none in SPRINT), but we just don't know yet without the data. This is more supportive anyway - remdesivir for example was approved without showing any virology effects IIRC
Interestingly Shionogi DID see efficacy on the 14 symptom scale in Asia so they are different patient populations when it comes to immunity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858401/#note-ZOI231613-1-s
see table 2 14 symptom scale met stat sig
I don't know if the FDA will be more flexible in light of all these recent failures (add oral remdesivir to the list, paxlovid in standard risk, etc), but usign the 15 symmptom endpoint in a very immune population like we have now is a high bar and I don't know if someone really thinks 235 can clear it - they were 2 days on the 6 most common symptom scale but only a trend I think on the 14 but I don't really recall that data and it was from a smaller study
I think once the actual data are out from scorpio-HR you can try and make some cross trial comparisons
For sure at least some of the 2 billion would eat into Pfizer sales so 2025 paxlovid sales expectations should be revised up IMO
Ensitrelvir suffers from a lot of DDIs too so it wouldn’t have been such a big advance for high risk patients but it could have captured non high risk but now it probably is a stretch to thikk they make it to market at all although let’s see the 6 month long Covid data.
FDA is torpedoing next gen drugs with this strict 15 symptom primary. Japan approved using the most common handful of symptoms which I feel is a very reasonable endpoint (and more in line w flu which required 7 endpoints)
Perhaps the FDA will come around otherwise I’m not sure we are going to get anything other than paxlovid for Covid (and 235 IS an advance when it comes to DDIs but it doesn’t seem like anyone wants to touch it with the 15 symptom endpoint )
I still think this is bullish for enta by dint of a possible stake in paxlovid but the market doesn’t seem to agree
More on Shionogi’s COVID trial:
https://www.fiercepharma.com/pharma/shionogis-homegrown-antiviral-comes-short-global-covid-trial
Notably, the article cites Shionogi’s CEO saying that Xocova could generate $2B of annual sales if approved in the US. It’s unclear how much of this hypothetical sales figure comes from COVID patients who would otherwise have taken Paxlovid vs COVID patients who would otherwise have taken no drug.
Patent Assigned to Enanta Pharmaceuticals, Inc.
Spiropyrrolidine derived antiviral agents
Patent number: 11976084
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: November 22, 2021
Date of Patent: May 7, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Jun Ma, Yong He, Xuechao Xing, Hui Cao, Xuri Gao, Xiaowen Peng, Joseph D. Panarese, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
What are the benefits of pyrrolidine?
Pyrrolidines are very important nitrogen-containing heterocycles. It has glucosidase inhibitory activity, along with antiviral, antibacterial, antidiabetic, and anticancer activities.
Analyst Ed Arce of H.C. Wainwright maintained a Buy rating on Enanta Pharmaceuticals (ENTA – Research Report), reducing the price target to $27.00.
Ed Arce has given his Buy rating due to a combination of factors, including Enanta Pharmaceuticals’ promising developments in its RSV (respiratory syncytial virus) franchise. The anticipation of top-line data readouts from two key Phase 2 studies of their lead RSV program, zelicapavir, in the second half of 2024 is a significant driver. The enrollment progress in these studies, especially with one part fully enrolled and the other advancing, reflects positively on the company’s ability to execute its clinical trials. The high potential of zelicapavir in at-risk populations, including children and adults with RSV complications, underscores the market opportunity for Enanta’s product.
Additionally, the upcoming data from a Phase 2a challenge study of EDP-323, another oral RSV candidate with a different mechanism, enhances the company’s RSV pipeline strength. This candidate’s potential efficacy in combination with other RSV therapeutics offers a strategic advantage. Arce also considers the progress in Enanta’s immunology program, particularly the KIT inhibitor candidate for chronic spontaneous urticaria (CSU), which the company expects to select for clinical development by the fourth quarter of 2024. The innovative approach targeting the depletion of mast cells to treat CSU could address a significant unmet medical need, further justifying the positive outlook on Enanta’s stock.
In another report released today, JMP Securities also reiterated a Buy rating on the stock with a $22.00 price target.
https://www.tipranks.com/news/blurbs/buy-rating-affirmed-for-enanta-pharmaceuticals-amidst-promising-rsv-developments-and-clinical-trial-execution?utm_source=moomoo.com&utm_medium=referral&global_content={%22promote_id%22:13764,%22sub_promote_id%22:57}
Enanta Pharmaceuticals to Participate at the JMP Securities Life Sciences Conference
WATERTOWN, Mass.--(BUSINESS WIRE)--May 7, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, and Tara L. Kieffer, Ph.D., Chief Product Strategy Officer, will participate in a fireside chat at the JMP Securities Life Sciences Conference on May 14, 2024 at 10:00 a.m. ET in New York, NY.
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-participate-jmp-securities-life-sciences
ENTA updated corporate slides (5/6/24)
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The latest version of the slide set is almost identical to the previous version (from 3/13/24); the differences are:
• Slides 3 and 7 have updated financial info from FY2Q24 (ending 3/31/24).
• Slide 37, which shows 2024 news flow, has two small changes: 1) Data from the Zelicapavir (f/k/a EDP-938) RSVPEDs study is expected in 2H24 rather than 3Q24; and 2) Selection of a lead candidate in the CSU program is expected in 4Q24 rather than simply 2024. There is no specific guidance on the timing of topline data from the RSVHR study, which is recruiting patients in the Southern Hemisphere.
ENTA reports FY2Q24* results—raises FY2024 expense guidance:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-39
• 3/31/24 cash = $300.3M, a decrease of $37M relative to 12/31/23.
• FY2Q24 royalty revenue was $17.1M, -10% QoQ and -4% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $35.6M, consistent with ENTA’s updated fiscal-year guidance of $125-145M (raised from the $100-120M guidance given in Nov 2023).
• FY1Q24 SG&A expenses were $14.2M, consistent with ENTA’s updated guidance of $50-60M (raised from the $45-50M guidance given in Nov 2023). Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA says its cash and expected royalty revenue are sufficient to fund operations through the end of FY3Q27, which is one quarter earlier than the prior guidance of end of FY2027.
*ENTA’s fiscal year ends on September 30.
correct PFE completed their phase 2 months ago - it is still listed in their pipeline so it has not been formally killed, and data could just be under wraps for competitive reasons
Yeah for a study that most think will be positive I too am starting to think they may have a miss or at least some mixed data. We will probably know more in the coming days w their earnings
The long Covid endpoints are at 24 weeks in the trial listing but they said more than once they plan to unblind data at 12 weeks so??
I concur that Paxlovid 1Q24 sales and 2024 guidance are not surprising; however, I think some investors were confused by PFE's 4Q23 writeoff and didn't realize that the 2023 figure was an accounting artifact rather than a reflection of product demand.
Not sure but I wasn’t surprised by paxlovid sales and think they are lowballing guidance still. They are still the only game in town in western countries although most people think ensitrelvir will be on the market here by early 2025 (although the odds went down a bit IMO when they missed their own guidance for reporting top line data)
Is ENTA getting a delayed bounce from PFE’s $3B 2024 sales guidance for Paxlovid?
This is what Shionogi said on their call Jan 31:
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2023/3q/e20240202.pdf
“we have completed the enrollment of over 2,000 cases in December 2023. For the primary endpoint, the time to resolution of all COVID-19-related symptoms, all 15 symptoms, was determined after consultation with the FDA.
In addition, we have obtained data on the suppression of the incidence of Long COVID, so-called sequelae, at 12 weeks, and we are verifying this as well in SCORPIO-HR trial. We are keeping the data up to three months under blind, so we expect to be able to present our results to you in April on these results as a topline after a three-month follow-up starting in December.”
April came and went with no PR. You would think an outright hit or miss would be a straightforward readout so perhaps they are doing some post hoc data mining? Could also be they decided to keep the trial blinded out to 24 weeks who knows
Latest Patents Assigned to Enanta Pharmaceuticals, Inc.
Macrocyclic antiviral agents
Patent number: 11970502
Abstract: The present invention discloses macrocyclic compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: May 3, 2022
Date of Patent: April 30, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Jiajun Zhang, Xiaowen Peng, Yat Sun Or
Bile acid derivatives as FXR/TGR5 agonists and methods of use thereof
Patent number: 11958879
Abstract: The present invention provides compounds represented by Formula I, or pharmaceutically acceptable salts, stereoisomers, solvates, hydrates or combination thereof, The invention also provides pharmaceutical compositions comprising these compounds and methods of using this compounds for treating FXR-mediated or TGR5-mediated diseases or conditions.
Type: Grant
Filed: May 19, 2021
Date of Patent: April 16, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Yat Sun Or, Ruichao Shen, Xuechao Xing, Jiang Long, Peng Dai, Brett Granger, Jing He
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
Enanta Pharmaceuticals (from X)
Our team presented “Efficacy and Safety of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19: Results From the Phase 2 SPRINT Study” at
@ESCMID Global where it was named a “Top Rated Poster.” Congratulations to the team.
POSTER CONCLUSIONS
• EDP-235 treatment in standard-risk adults with mild or moderate COVID-19 yielded a favorable safety profile and improvements in clinical symptoms
• EDP-235 was generally well tolerated, as reflected by a low frequency of TEAEs that were mostly mild in severity, and there were no serious TEAEs or
TEAE-related discontinuations
• The 400 mg dose of EDP-235 achieved statistically significant improvement in TSS at multiple time points in the overall study population
– In participants enrolled within 3 days of symptom onset, along with significant TSS improvement at all time points, a median 2-day shorter
duration of 6 selected COVID-19 symptoms was observed
• The rapid decline of viral load across all study groups was consistent with an enrolled population that had prior immunity
• The results of the Phase 2 SPRINT study support further development of EDP-235 for the treatment of COVID-19
• As the therapeutic target is conserved across variants, EDP-235 may prove an effective tool to combat future variants of SAR-CoV-2 and potentially
other coronaviruses
Read more:
https://www.enanta.com/wp-content/uploads/2024/04/P0423_ECCMID_2024_SPRINT_Poster_FINAL.pdf
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