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GLTA for tomorrow's earnings release. I never like Friday releases. They have two investor conferences later in the month so I would hope they have some positive news to share.
Thanks JTFM. I seem to recall a comment from Nikhil a couple of years ago about them working on a "resin" technology platform. It stuck with me and the active ingredient in this product is used as a cation-exchange resin. In this case, it replaces potassium with sodium. It looks like these resins are also used in controlled release for tablets so maybe that was the basis for the comment.
It does look like there are other medical applications for these resins. It reminds me of Cortrophin Gel where the drug was in use and the research done decades ago. Who knows, maybe we will see Kionex reborn for other indications as well.
Looks like ANIP is going to relaunch Kionex (Sodium Polystyrene Sulfonate) it is a drug obtained from Perrigo but had yet to bring it back to market. ANIP updated the trademark revived the trade mark for Kionex in March.
Drug Shortage
ANIP got approval for manufacturing on May 3rd.
Approval
Trademark
Easka, it appears that the FDA appear to give more time before issuing a pre-notice which informs the company that they have 30 days to submit result or risk facing fines for non- compliance. Companies usually post results shortly after receiving the pre-notice. Technically, the are at risk of facing fines now, but it is unlikely as long as they submit the results upon receiving the pre-notice, or sooner. The FDA shoots for posting pre-notices that were issued every quarter.
Interesting, I wonder if this would get them off the hook for the fines for delaying release of the results?
That's great news JT, thank you
ANIP now has some patent protection for Corti up to October 27, 2043.
Methods for Storing and Warming Purified Corticotropin Compositions
Now that the New Jersey plant expansion is completed, I believe these are the first jobs postings for a second shift at the New Jersey plant, that I have seen. They obviously are ramping up for more volume.
Careers
I generally look at the classic view as well. They are 18 month late for an extension, and no new trial was submitted which would have had to be registered and posted by October 27, 2022. Therefore, I don't believe a extension for good cause qualifies. Really looking like a certification request.
If AbbVie is involved, I believe they are waiting for July 1, 2023 when the Michael A. Roberts officially assumes the helm, as CEO. A good way to start under a new CEO.
Now, they don't have to worry about the Pre-notice for non compliance in submitting results coming out now until the first week of July.
JMHO
Hmm, I look at the classic version of the clinical trials page and it does not have this comment, so I cannot confirm that it is new. I looked at the rules again, and we can say for certainty that it is delayed for one of the below three reasons (perhaps the second reason does not even apply):
Certify Initial Approval: Trial studies an FDA-regulated drug product (including a biological product) or device product that was not approved, licensed or cleared by FDA for any use before the Primary Completion Date of the trial, and the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the drug product (including a biological product) or device product under study.
Certify New Use: Trial studies an FDA-regulated drug product (including a biological product) or device product that previously has been approved, licensed, or cleared, for which the manufacturer is the sponsor of the trial and for which an application or premarket notification seeking approval, licensure, or clearance of the use being studied (which is not included in the labeling of the approved, licensed, or cleared drug, product (including a biologic product) or device product) has been filed or will be filed within one year with FDA.
Extension: Request, for good cause, an extension of the deadline for submitting results information.
Could we FOIA this and find out what the delay reason was?
Silvr, regarding the Libigel trial results, the following may have been on their results page in the past, but I don't remember seeing it.
Good info, Silvr.
Thanks.
Good report out on CG0070 at today's AUA Annual Meeting.
May 3 Results
It also looks like one of the original Ceregene founders is still looking at using our AAV2 technology to treat Alzheimers, this time with a different payload. Here's the phase 1 clinical trial that is underway. Even if this works, by the time it completes its testing and regulatory approval, I can't imagine we would have any stake remaining.
AAV2-BDNF Clinical Trial
I agree that their limited disclosure is frustrating. For one reason or another, they are a public company, still operating as if it was still a private company. It would be a good fit within their current infrastructure.
According United Therapeutic's 10-k filing:
Excellent find JTFM. It amazes me how we have to find these things out ourselves and the management team is not sharing these wins and giving us a view of the pipeline. This looks like a large business, but there are multiple product forms.
Another way to look at this is that the treatment area (PAH) is a rare disease in pulmonology. Maybe this will be one of our first home grown rare disease products within the strategic treatment areas. It would be interesting to know it the strategy came first, or the opportunities drove the strategy to start up a pulmonology team. Regardless, it is excellent work.
According to the ANIP's 2022 Q2 filing
Excellent action JTFM. Power to the press!
Thanks Silvr, I like your favorite part. I wrote the author and provided info for a potential follow up article, including Clinical trial results and patent applications.
Here's a well-written article about testosterone for women. First time I have seen a reporter dig on this topic.
Can Testosterone Aid Women's Menopause
Here's my favorite part:
When asked to elaborate on why these two products were not approved, the FDA told MedPage Today in an email that the agency is generally unable to discuss existing or potential applications and that the data requested was confidential commercial information. Neither Procter & Gamble or BioSante Pharmaceuticals responded to a request for comment as of press time.
Thanks JTFM for an excellent summary of the bull case.
BB, I feel optimistic about ANIP continuing to beat estimates and raise guidance for the foreseeable future for the following reasons.
- Novitium should keep rolling out generic drugs to outpace erosion from competition.
- The market's under estimate Corti's peak sales
- Zero value has been given to female testosterone, with results pending.
- Zero value has been given ANIP's potential royalty and milestone payments for CG Oncology's Cretostimogene.
- Regarding Cretostimogene and female tetosterone, in 2023, 89% of NDA's were approved cancer. So for future filings.
- Though we don't know the details of the Cold Genesys Biosante deal, at the time Biosante was represented by Oppenheimer Wolff & Donnelly LLP the same law firm that hammered out the GVAX agreement with Aduro Biotech. So at a minimum, I expect a clause in the deal covering royalties during the FDA approval exclusivity period (even after patent expiration), just like they did in the GVAX deal. It the deal gave them 5% on Global sales.
- JP Morgan pegged peak sales at $2.3 billion.
- I read an article where effective cancer drugs reach peak sales within 5 years. Assuming it gets approved , JP Morgan is correct regarding peak sales and ANIP is successful in litigation ANIP could receive $530 million in royalties plus milestone payments between 2026 and 2032. This is most likely in addition to any royalties for other indications if approved.
Lots to be bullish about.
GLTA
[tag]https://www.statista.com/statistics/817552/key-measurements-of-us-cder-drug-approvals/[/url][tag]FDA Approval Rate[/tag]
I would like to thank you gentleman once again. With all the info you place here, makes a shareholder feel very optimistic for the future. 😃
Thanks Silvr, the FDA post the Pre-Notices for Potential Noncompliance in submitting trial results quarterly. ANIP was not in the last batch. I think it should not be much longer before it comes out.
Another ten-year study. Hopefully the Libigel study is next.
50% Reduction in Breast Cancer Incidence
We will get a read out on the CG0070 Phase 2 study with Keytruda at the early June ASCO meeting.
CG0070 ASCO Meeting
They probably already withheld a milestone payment, leading ANIP to request a declaratory judgement.
Silvr, if the CG Oncology agreement is similar the GVAX agreement. I find it hypocritical that CG Oncology is stating that they have no obligation to pay ANIP, especially when their agreement with Kissei Pharmaceuticals has a provision to make royalty payments on the first 12 years of commercialization or patent expiration, which ever is longest.
Silvr, that is a very interesting article. Hopefully peer review will support the assertions. If testosterone levels can help regulate your immune system, it has huge implications and yet another reason to get female product on the market.
Regarding monetizing Libigel, we should find out when the results are published. Though the way greedy pharma companies try to weasel out of their agreements does create a concern (e.g, Cabaret and CG Oncology).
That would be great and ahead of any final FDA approval. They probably owe us some milestone payments too.
Thank you JTFM. It would be great to see the Libigel study published. There is certainly a lot of activity in this space. I just hope some of it translates into money in our pocket.
Here's another article.
Long Covid
Here are a couple of parts I like:
The work has yet to undergo peer review, the typical process by which scientific studies are vetted, but I’m highlighting it now given the enormity of need in long COVID — recent data from the Centers for Disease Control and Prevention showed some 8.8 million people in the U.S. were living with the condition in 2022 — and this team’s track record in conducting high quality research.[/I]
]We can’t let the opportunity go to waste. For too long, sex hormone differences have been seen as an inconvenient liability in clinical trials rather than a variable worth considering. Until recently, many drugs were only studied in male mice (lest the results be muddied by fluctuating female hormones) and even human tests skewed toward men.
Meanwhile, chronic conditions like ME/CFS (commonly known as chronic fatigue syndrome), Lyme’s disease and now long COVID, tend to be more common or more severe in women. Time and again, those women’s symptoms are dismissed as psychological rather than physical.
This latest study illuminates our limited knowledge about the role of hormones in chronic disease and should be a clarion call for more work in long COVID and beyond. That can help "start to right the wrongs of this sort of sexism and ableism in women’s health,” says David Putrino, director of rehabilitation innovation for the Mount Sinai Health System, who helped lead the study
Silvr, ANIP commenced an action on June 10, 2019, seeking a declaratory judgment to determine the parties' rights and obligations under the Tripartite Agreement, Escrow Agreement and Assignment Agreement against Cabaret. The decision in ANIP's favor was rendered April 26, 2020. If the CG Oncology matter follows a similar timeline, we will hopefully get a decision in January 2025.
ANI Pharm., Inc. v. Cabaret Biotech Ltd.
A third Female TRT related article in the Journal of Urology May 1, 2024 edition.
MP47-19 EFFICACY AND SAFETY PROFILE OF TRANSDERMAL TESTOSTERONE FOR HYPOACTIVE SEXUAL DESIRE DISORDER: A SYSTEMATIC REVIEW AND META-ANALYSIS
Maybe next month addition of Journal or Urology publishes the Libigel trial study results.
Journal of Urology put out another article regarding TRT and HSDD titled MP47-04 EXAMINING THE TRENDS IN TESTOSTERONE THERAPY FOR WOMEN WITH HYPOACTIVE SEXUAL DESIRE DISORDER
Another study supporting TRT for women. According to PD52-06 TESTOSTERONE THERAPY IN WOMEN IS NOT ASSOCIATED WITH INCREASED CARDIOVASCULAR RISK—A US CLAIMS DATABASE ANALYSIS
Thanks auh2oman.
Thanks for the GVAX info Silvr, as demonstrated by their litigation against CG Oncology, at least they will defend their stake in IP, even if they won't articulate it openly.
I finished looking at the current status of Biosante GVAX patents. Healthtree is the sole assignee for two of them and shares assignment with Bristol Meyers for a third. Aduro (Chinook) is still listed for others and CG oncology for one as well.
This investment is always full of surprises which is why it has maintained my interest for so long. Here's the latest one. The GVAX trademark is now owned by "Healthtree Inc".
GVAX.com
I can't make heads or tails out of why this "foundation" would own this. However, when you look at the contact info you get directed here:
Meridian Therapeutics
Two of the principals of this company (Borrello and Noonan) are actually the researchers at Johns Hopkins investigating GVAX for multiple myeloma. It is the best testimony that they are now personally involved in its commercialization.
Maybe someday ANIP will get around and share our potential royalty pipeline.
Healhtree Inc is also listed as the assignee now for one of the Biosante patents (US7901902B2) for pancreatic cancer. Don't know the significance of this either.
Thank you JTFM. With the reported continued category expansion, this means that our product must be taking share from them and then capturing all of the category growth. Great news.
According to Mallinckrodt's 2023 Earnings Report, Acthar sales dropped from $140.9 million in Q4 2022 to $104.4 million in Q4 2023. Within two years ANIP has captured approx. 28.5% of the market, and is poised to keep growing market share.
Looks like Sovuna is starting to make the preferred tier of some formularies
Western Sky Community care Preferred Drug List
Silvr, according to the FDA Fast Track process they could have a rolling review.
Thanks again JTFM. Hopefully they did use the same royalty term definition in the CG0070 agreement. That "or" statement could end up having a lot of value. It is sad that we are paying a high royalty to Merck for a decades-old Cortrophin Gel, but CG Oncology is apparently unwilling to do the same.
There will be a 12-month readout on the pivotal phase 3 study coming up in May. I like the comment from their president that “we are excited to share encouraging 12-month Phase 3 monotherapy results from the BOND-003 study at AUA 2024". Any idea when they would begin the FDA approval process? Can they use the 12 month results or do they have to wait until the trial officially finishes next year?
Urology Conference
Silvr, ANIP will have to add it in their filing and I expect they will face question. Though they may be limited in what they will release regarding their legal strategy. It is hard to know what their potential argument might be without seeing the details of the agreement. As I understand it, the Supreme Court has ruled long ago on not being able to collect royalties when the patent expires in the US (1964 decision in Brulotte v. Thys Co.) and Kimble v. Marvel Entertainment, LLC . But neither speak to the lengthy process to commercialize drugs and the effect of conditions outside patent expiration, such as FDA's regulatory 7-year exclusivity period. Interestingly, should it ever stretch out this far, Justices Alito, Roberts and Thomas opinions lead me to believe that they would lean towards backing ANIP's position (assuming a similar agreement to GVAX).
I believe North is more versed in the nuances surrounding patents patents, and may be able to better inform us.
I imagine the terms for CG0070 would be similar to the agreement with Aduro for the GVAX portfolio. If so, it looks like ANIP might have a compelling argument, even if the patents have expired.
Thanks JTFM. What a payday that would be. We better get some questions on this at the next conference call.
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