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No. ENTA's lawsuit against PFE concerns protease inhibitors for SARS-CoV-2; it has nothing to with RSV.
Might the following new patent be valid for inclusion in the PFIZER suit?
COMBINATIONS OF PHARMACEUTICAL AGENTS AS RSV INHIBITORS
File Date: .................... 2018-09-28.
Pub Date: .....................2024-03-20
Excerpts:
Background of the Invention:
RSV is the leading cause of acute lower respiratory tract infections (ALRI) and affects patients of all ages. The symptoms in adults are usually not severe and are typically analogous to a mild cold. However, in infants and toddlers the virus can cause lower respiratory tract infections including bronchiolitis or pneumonia with many of them requiring hospitalization. Nearly all children have been infected by age 3. There are known high-risk groups that infection with RSV is more likely to progress into the ALRI. Premature infants and/or infants suffering from lung or cardiac disease are at the highest risk to develop ALRI. Additional high-risk groups include the elderly, adults with chronic heart and/or lung disease, stem cell transplant patients and the immunosuppressed.
DETAILED DESCRIPTION OF THE INVENTION:
The compounds of the invention may be administered in a variety of dosage forms. Thus, they can be administered orally, for example as tablets, troches, lozenges, aqueous or oily suspensions, dispersible powders or granules. The compounds of the invention may also be administered parenterally, whether subcutaneously, intravenously, intramuscularly, intrasternally, transdermally or by infusion techniques. The compounds may also be administered as suppositories.
Read more:
https://www.patentguru.com/EP3687543B1
.
Enanta Pharmaceuticals files patent for 17ß-HSD13 inhibitors for treating metabolic disease - March 12
Enanta Pharmaceuticals. has filed a patent for compounds of Formula (I) as 17ß-HSD13 inhibitors for treating metabolic diseases** and liver conditions. The patent claim includes a compound represented by Formula I or its pharmaceutically acceptable salt or ester.
Furthermore, the patent application describes methods for preventing or treating 17ß-HSD13 mediated diseases or conditions in individuals by administering a therapeutically effective amount of the compound. The diseases or conditions targeted include nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), liver cirrhosis, liver fibrosis, and hepatocellular carcinoma (HCC). The use of the compound in the manufacture of medicaments for these specific diseases is also claimed, emphasizing the potential therapeutic applications of the disclosed compound.
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-files-patent-for-17-hsd13-inhibitors-for-treating-metabolic-disease/
**Metabolic disorders: Types, causes, and symptoms -
Examples of metabolic disorders include diabetes, Gaucher's disease, and hemochromatosis. Symptoms can include tiredness, weight loss or gain, and nausea and vomiting. Metabolism is a term that describes the biochemical processes that allow people to grow, reproduce, repair damage, and respond to their environment.
Is this how Amgen started out?
Everything you wanted to know about ENANTA's Patents -
Enanta Pharmaceuticals Patents – Key Insights and Stats
October 25, 2023
Enanta Pharmaceuticals has a total of 1607 patents globally, out of which 619 have been granted. Of these 1607 patents, more than 49% patents are active.
Read more:
https://insights.greyb.com/enanta-pharmaceuticals-patents/
Is this how Amgen started out? Was there a huge patent collection, but much difficulty in establishing collaborations and getting their products into the market? At nearly two decades Enanta must be getting close to their breakout, next Amgen.
I’m not saying that Hepludex infringes ENTA’s new HDV patent, but for the sake of discussion let’s assume that it does. Hepludex has had minimal sales to date (it’s not yet approved in the US), so almost all of the hypothetical upside from a patent lawsuit is still obtainable.
I'll have to echo that. The more I thought about that the more confused I got about it.
Surely the Gilead product has it's own patent/IP and I couldn't quite grasp how a new patent ....would *suplant* (in the sense of replace) be an appropriate word? Or would two patents in effect fighting it out to decide who gets the money mean a lawsuit?
Also, wouldn't having a product protected by an IP that made possible a HBV treatment (remains to be seen, of course) be a greater "win" as Enanta could conceivably become best in class, first highly effective to approval, with TWO patentable drugs owned by Enanta or coformulated so as to make it less possible for a competitor to use to test their in-the-works program? My simple take was the hope that the new compound/method would make that possible.
Perhaps I should have posted this in response to Dew's post instead of yours, but yours prompted me to also respond.
Ha! I was appreciative of Dew's post but was stopped while I pondered about how to reply. I hoped I'd be smarter the next day;
I'm not. : )
Is this too much? Am I getting carried away or what??
Last current one - for now
December 2023 -
Tetrazole containing apoptosis signal-regulating kinase 1 inhibitors and methods of use thereof
Patent number: 11834436
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts and esters thereof: which inhibit the Apoptosis signal-regulating kinase 1 (ASK-1), which is associated with autoimmune disorders, neurodegenerative disorders, inflammatory diseases, chronic kidney disease, cardiovascular disease. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from ASK-1 related disease. The invention also relates to methods of treating an ASK-1 related disease in a subject by administering a pharmaceutical composition comprising the compounds of the present invention. The present invention specifically relates to methods of treating ASK-1 associated with hepatic steatosis, including non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Type: Grant
Filed: April 13, 2021
Date of Patent: December 5, 2023
Assignee: Enanta Pharmaceuticals, Inc.
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
Inventors: Guoqiang Wang, Ruichao Shen, Brett Granger, Jing He, Xuechao Xing, Yong He, Jiang Long, Jun Ma, Bin Wang, Yat Sun Or
In addendum:
Patent Assigned to Enanta Pharmaceuticals, Inc.
Spiropyrrolidine derived antiviral agents
Patent number: 11919910
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 9, 2022
Date of Patent: March 5, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Xuechao Xing, Yong He, Matthew C. Rhodes, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
Read on -They're cornering the market!! Same page -
Spiropyrrolidine derived antiviral agents
Patent number: 11912714
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 9, 2022
Date of Patent: February 27, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Hui Cao, Wei Li, Xuri Gao, Jiajun Zhang, Xiaowen Peng, Jorden Kass, Ruichao Shen, Guoqiang Wang, Yat Sun Or
Benzodiazepine derivatives as RSV inhibitors
Patent number: 11912695
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, esters, or prodrugs thereof: which inhibit Respiratory Syncytial Virus (RSV). The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from RSV infection. The invention also relates to methods of treating an RSV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: January 13, 2022
Date of Patent: February 27, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Kaicheng Zhu, Kevin McGrath, Solymar Negretti-Emmanuelli, Adam Szymaniak, Jianming Yu, In Jong Kim, Yat Sun Or
Functionalized heterocycles as antiviral agents
Patent number: 11891393
Abstract: The present invention discloses compounds of Formula (I), or pharmaceutically acceptable salts, thereof: which inhibit the protein(s) encoded by hepatitis B virus (HBV) or interfere with the function of the HBV life cycle of the hepatitis B virus and are also useful as antiviral agents. The present invention further relates to pharmaceutical compositions comprising the aforementioned compounds for administration to a subject suffering from HBV infection. The invention also relates to methods of treating an HBV infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention.
Type: Grant
Filed: November 3, 2021
Date of Patent: February 6, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Joseph Panarese, Dexter Davis, Samuel Bartlett, Katherine Chong, Nathaniel Kenton, Yat Sun Or
Alkyne-containing antiviral agents
Patent number: 11858945
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 9, 2022
Date of Patent: January 2, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Joseph D. Panarese, Samuel Bartlett, Guoqiang Wang, Yat Sun Or
Background—HDV infection is essentially a subtype of HBV infection that comprises the most intractable cases. The most advanced programs for HDV are GILD’s Hepludex and VIR’s VIR-3434/VIR-2218 combination. Hepludex is approved in the EU but not in the US, where GILD received a CRL in 2022 (#msg-170307133); VIR’s combination is in phase-2.
The 3/6/24 Form-4 transactions were grants to the company's independent directors following the annual shareholders' meeting.
I was excited to see this too. To already own a good HBV asset is an advantage, but being able to select various in development compounds that might play well with that asset (EDP-514) and/or with a nuke, things could ramp up quickly. It brings to mind the Abbott/Abbvie collaboration where not once but twice the two companies were able to tailor complimentary compounds in the HCV space.
I'd venture that they already have a start or starts (various potential compounds) and hope we may soon get an update on when and whether to expect preclinical data or sense on how far away a trial could be.
I'll admit- I have almost stopped following the HBV space since the 514 asset seemed to have been shelved.
It also came to my mind that Jay Luly often refers to Enanta as a drug discovery company.
I'm wondering, if that were the case, (as it pertains to a certain PFE lawsuit) wouldn't it behoove you to have a solid branch of the company to protect those IP assets?
It would be windfall for investors if there was a settlement or win against Pfizer over Covid intellectual property this year.
Enanta Pharmaceuticals PATENTS new compounds for HBV and HDV - MARCH 9, 2024
Enanta Pharmaceuticals Inc. has disclosed new fused heterobicyclic derivatives reported to be useful for the treatment of hepatitis B virus (HBV) and hepatitis D virus (HDV) infections.
https://www.bioworld.com/topics/520-bioworld-science
The options in question did not expire until 2033, so this is a bullish signal. Thanks DEW.
Several insiders did the same on March 8, 2024. These options would have expired on March 6, 2034.
https://ir.enanta.com/static-files/e961f549-17bf-40f1-8310-7474cbd22802
My next post may be the BULLISH rationale.
THRD had a presentation yesterday by the way. They reiterated a few things that ENTA mentioned:
1. the biology is very much mast cell mediated, and kit inhibitors are really the master regulators of mast cells. So all the other mechanisms may hit upstream or downstream, but you simply don't get the immediate inactivation of resident mast cells (followed by decrease in mast cells) with other mechanisms, so this is likely why you see such high efficacy
2. ENTA had mentioned that you can use a biomarker (tryptase) in phase 1, but THRD emphasized this point. They said there is now enough efficacy data in the indication linked to tryptase that the efficacy curves and tryptase curves "sit on top of one another". So it is a VERY good biomarker of efficacy that you can employ in phase 1. And you can drive tryptase levels down to undetectable levels with Kit inhibition
3. As for safety it (and efficacy) following the CLDX gives good insight, and it seems the more data there is the more reassuring the safety profile (e.g. the neutropenia and other on target effects don't seem to be that significant at all).
4. reiterated ENTA's take to a tee - that if you can get efficacy even close to an antibody for KIT w an oral drug it is a clearly attractive profile (they used psoriasis as a model where oral drugs are given first line most often even when efficacy is even lower than parenteral drugs/biologics)
5. They had 2 cases of DILI (drug induced liver injury) in their first 3 patients! They think they have identified the metabolite causing this and are hopeful. In total 5 patients were enrolled but they never made it past the lowest dose and even at that lowest dose they found significant tryptase inhibition
6. They mentioned they are still doing preclinical work on follow on compounds in addition to this second generation compound that should enter the clinic mid year. This tells me even they think there is room for better potency, selectivity, or both. Hopefully ENTA can come up with a compound that can compete or exceed because they will be at least 6-12 months behind (THLD ended up with a nearly 2 year delay when their first gen compound ran into liver issues)
7. The second indication they will be looking at is asthma. Even though plenty of biologics from GSK, REGN, etc., no new oral drugs for 25 or so years here. I don't need to tell you that would be a massive opportunity, but first things first!
I'm getting more excited about this area for ENTA if they can get a good compound. Liver tox is tough to predict preclinically (THLD acknowledged this), so the phase 1 next year is going to be quite meaningful (especially with a good biomarker of activity to go along w safety)
There is probably room for both. Assuming safety equivalent milder cases go for an easier to take oral agent more severe an injection. The sweet spot is obviously a more efficacious oral drug which is the opportunity enanta sees. Safety will be paramount the first oral kit drug for CSU was pulled for liver tox. That’s why phase 1 is actually going to be an important inflection point for this drug (along w the fact you can check bio markers to confirm target engagement even in healthy volunteers )
Looks like c-KIT inhibitors are the way to go for CSU.
Report from Jefferies discusses CSU data from AAAAI24, $CLDX's cKIT looks superior to BTK inhibitors (but both classes look active). Will it be enough to justify monthly injections? I personally think it would. pic.twitter.com/RH48q3Nq4y
— Ohad Hammer (@ohadhammer) February 27, 2024
ENTA’s GC exercised and held $73K of stock:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324004659/xslF345X05/form4.xml
The options in question did not expire until 2033, so this is a bullish signal.
A unique organizational chart? The position search for "Head, Biometrics" includes the primary responsibility of, "Be responsible for final review and sign off with respect to all controlled documents."
I can understand having a biostatistician in the executive crowd, but I do not see marriage of the head of biostatistics and QA authority of all controlled documents being the same individual.
ENTA has_a_brand_new 5% shareholder—Krensavage Asset Management:
https://www.sec.gov/Archives/edgar/data/1177648/000160925124000004/xslSCHEDULE_13G_X01/primary_doc.xml
https://krensavage.com/
Note that this 13G filing is as of 2/22/24 (not 12/31/23).
Looks like Molnupiravir isn't such a good choice for treating Covid. Slow clearance and induction of mutations doesn't seem like something you would want in an anti-Covid drug. It sure seems to me that EDP-235 is a good option to treat Covid. Now if ENTA can just convince another company to think so and partner we will be in business.
ENTA’s pro forma net cash @12/31/23=$176.3M—treating ENTA’s deferred-royalty obligations as debt (as is done under GAAP [#msg-172603887]—but see note at bottom of this post). The $176.3M figure, which is down $24.3M relative to 9/30/23, consists of:
• $327.9M net current assets on the 12/31/22 balance sheet (https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001177648/000095017024012796/enta-20231231.htm#consolidated_balance_sheets );
• ($151.6M) deferred long-term liabilities on the 12/31/23 balance sheet relating to the OMERS royalty agreement. ($36.5M of liabilities relating to the OMERS agreement are booked as current liabilities and hence are included in the $327.9M figure in the first bulleted item.)
Note: Excluding the “debt” associated with the OMERS royalty agreement, ENTA’s pro forma net cash at 12/31/23 was $364.1M ($176.3M + $151.6M + $36.5M).
ENTA’s fully-diluted share count @12/31/23=27.1M—an increase of 1.1M since 9/30/23, due primarily to the issuance of new options following the end of the fiscal year on 9/30/23.
The 27.1M figure above consists of: 21.16 basic shares on the 12/31/23 balance sheet (https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001177648/000095017024012796/enta-20231231.htm#consolidated_balance_sheets ); and 5.93M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, page 9).
Shares, not persons. Thank you for the correction, but wouldn't it be great if 100,000 individual people suddenly took interest?
All 100,000 persons.
ENTA has now gone over $13/share today, a price it hasn't seen in 5 months. The push into immunology along with the statement that ENTA has enough cash to last through the end of 2027 must have made ENTA look like a better risk to people.
Oppenheimer Keeps Their Hold Rating on Enanta Pharmaceuticals (ENTA)
Feb. 9, 2024, 06:58 AM
Oppenheimer analyst Jay Olson maintained a Hold rating on Enanta Pharmaceuticals (ENTA – Research Report) today and set a price target of $17.00. The company’s shares closed yesterday at $12.36.
Olson covers the Healthcare sector, focusing on stocks such as Biogen, Neurocrine, and Viking Therapeutics. According to TipRanks, Olson has an average return of 13.1% and a 43.99% success rate on recommended stocks.
Currently, the analyst consensus on Enanta Pharmaceuticals is a Moderate Buy with an average price target of $19.67, which is a 59.14% upside from current levels. In a report released on February 7, Leerink Partners also maintained a Hold rating on the stock with a $13.00 price target.
https://markets.businessinsider.com/news/stocks/oppenheimer-keeps-their-hold-rating-on-enanta-pharmaceuticals-enta-1033051923
Baird lowered the firm’s price target on Enanta to $26 from $40 and keeps an Outperform rating on the shares. The firm said results largely met expectations, and we are encouraged that management continues to expect to readout data from the RSVPEDs study of zelicapavir in 3Q24, which Baird continues to view as a key catalyst with potential to drive upside potential on the stock.
https://www.tipranks.com/news/the-fly/enanta-price-target-lowered-to-26-from-40-at-baird?utm_source=markets.businessinsider.com&utm_medium=referral
Why in the world would you think a challenge study would merit breakthrough designation?
Too bad that the challenge study results did not yield and opportunity for breakthrough therapy designation. If so then the peds and HR studies could have been powered for approval.
ENTA updated corporate slides (2/7/24):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The only differences between the latest (2/7/24) slides and the previous version (1/8/24) are:
• Slide 7 includes FY1Q24 royalty revenue.
• Slides 24-26 (new) contain additional info about the CSU program.
People can read for themselves, I know, but as a matter of discussion topics between investors I would like to highlight the following from the QA:
While the peds RSV population may be considered more naive than the COVID phase 2 population it is striking that the answers from Enanta indicate that in the RSV peds study virology readouts are key vs symptoms. In the COVID phase 2 symptom measures were the big deal. I also recognize that perhaps scoring symptoms in a pediatric subject is more complex than in an adult subject, but still there was a reversal of logic.
With regard to communication and audience interpretation I felt that the answers provide more doubt that there will be an RSV phase III trial, the answers did not exude confidence although the introductory statements were quite powerful, but they were also powerful for NASH and COVID.
Still good?
Enanta Pharmaceuticals (ENTA) PT Lowered to $26 at Baird - Feb. 8, 2024
{Premium - no article}
https://www.streetinsider.com/Analyst+PT+Change/Enanta+Pharmaceuticals+%28ENTA%29+PT+Lowered+to+%2426+at+Baird/22738803.html
ENTA reports FY1Q24* results:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-38
• 12/31/23 cash = $337M, a decrease of $33M relative to 9/30/23..
• FY1Q24 royalty revenue was $18.0M, -5% QoQ and –20% 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).
• FY1Q24 R&D expenses were $36.4M, somewhat above the quarterly run rate of ENTA’s FY2024* guidance of $100-120M.
• FY1Q24 SG&A expenses were $16.5M, somewhat above the quarterly run rate of ENTA’s FY2024* guidance of $45-50M.
• Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA reiterated that its cash and expected royalty revenue are sufficient to fund operations through the end of FY2027.
*ENTA’s fiscal years end on September 30.
I am uncertain, but I think it relates to information that will be considered for the purpose of establishing a monetary value for damages. It does not mean that there will be an award and it does not indicate that the case is near decision, probably still far from a decision. A little more insight into this topic can be gleaned from the information at https://www.finnegan.com/en/insights/articles/d-mass-patent-litigation-update-july-2023.html
It is only a single page, but especially the paragraph which starts with, "Last, the court found..." gives a glimpse of the type of considerations.
I made my post in hopes that a more informed person would extend additional thoughts, or even provide a correction to my implied input.
Maybe you could explain what that is for those of us unfamiliar with legal jargon. Thanks.
The part where Pfizer is required to admit that they know how much food the cat has eaten without acknowledging that there is a cat in the bag, below information taken from (https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc)
Friday, February 02, 2024
163 motion Seal Fri 02/02 4:42 PM
MOTION to Seal Memorandum in Support of Motion to Compel Pfizer to Provide Damages-Related Discovery and Accompanying Exhibits (Unopposed) by Enanta Pharmaceuticals, Inc..(Fiacco, Barbara)
ENTA has had an EHS Manager for the last ten years. The existing manager is moving to a new industry hence the job posting. Part of the reason for the move is the lease expiring in a few years and the building is in “ band aid shape”. The new facility is very close by and new construction.
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