ANI Pharmaceuticals Inc (ANIP) Quote

Thanks Silvr

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.

The sponsor or the investigator has either requested or received a certification to delay submitting the study results.

Libigel Trial Results

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:
We recognized $359.4 million, $325.1 million, and $306.1 million in Orenitram net product sales, representing 15 percent, 17 percent, and 18 percent of our total revenues for the years ended December 31, 2023, 2022, and 2021, respectively,

However, the growth rate YOY for 2024 Q1 was over 20%, hopefully this a trend that keeps going creating a larger market by the time ANIP launches. So it looks like a good revenue generator for 2028 if not sooner.

They also have approval for a generic of AbbVie's Namzaric (21mg ) and tentative approval for the 28mg. Not sure when they can launch, as ANIP acquired it from Amerigen who was in patent infringement litigation with Forrest Labs ( AbbVie) but in the approval letter from the FDA it listed the following.

Agency’s publication titled Approved Drug Products with Therapeutic Equivalence
Evaluations (the “Orange Book”):
U.S. Patent Number Expiration Date
8,039,009 (the '009 patent) September 24, 2029*
8,058,291 (the '291 patent) December 5, 2029
8,168,209 (the '209 patent) May 22, 2026*
8,173,708 (the '708 patent) May 22, 2026*
8,283,379 (the '379 patent) May 22, 2026*
8,293,794 (the '794 patent) November 22, 2025
8,329,752 (the '752 patent) May 22, 2026*
8,338,485 (the '485 patent) November 22, 2025
8,338,486 (the '486 patent) November 22, 2025
8,362,085 (the '085 patent) May 22, 2026*
8,580,858 (the '858 patent) November 22, 2025
8,598,233 (the '233 patent) May 22, 2026*
*with pediatric exclusivity added .

The patent infringement case was dismissed. So it unknown if a settlement was reached and if a date ANIP could launch was part of a deal.

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

On April 1, 2021, United Therapeutics Corp. and Supernus Pharmaceuticals, Inc. (“UTC/Supernus”) filed a complaint in the United States District Court for the District of Delaware against ANI Pharmaceuticals, Inc., asserting that ANI’s proposed Treprostinil extended release drug product, which is subject to ANI’s Abbreviated New Drug Application No. 215667, infringes U.S. Patent Nos. 7,417,070, 7,544,713, 8,252,839, 8,349,892, 8,410,169, 8,747,897, 9,050,311, 9,278,901, 9,393,203, 9,422,223, 9,593,066 and 9,604,901 (“the Asserted Patents”). The complaint seeks injunctive relief, attorneys' fee and costs. ANI filed its answer and counterclaims on May 28, 2021, denying UTC/Supernus’ allegations and seeking declaratory judgment that ANI has not infringed any valid and enforceable claim of the Asserted Patents, that the Asserted Patents are invalid, and an award of attorneys’ fees and costs. On May 26, 2022, the parties’ respective claims and
counterclaims were dismissed pursuant to a confidential settlement agreement.

According to United Therapeutics 2024 Q1 filing.
In May 2022, we settled litigation with ANI Pharmaceuticals, Inc. (ANI) regarding its ANDA seeking FDA approval to market a generic version of Orenitram. Under the settlement agreement, ANI can market its generic version of Orenitram in the United States beginning in December 2027, although it may be permitted to enter the market earlier under certain circumstances. Competition from these generic companies could reduce our net product sales and profits.

In Q1 2024 United therapeutics reported $106.2 million in sales.

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

Thanks Silvr

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.

Researchers from the Baker Heart and Diabetes Institute and Monash University’s Women’s Health Research Program are leading a world first study to see if testosterone therapy can prevent the development of heart failure in postmenopausal women

Can testosterone therapy fight off heart disease in older women?

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.

Kissei paid to us a one-time upfront payment of $10.0 million and, in connection with the entry into the Kissei Agreement, purchased $30.0 million worth of shares of our Series D redeemable convertible preferred stock as part of our Series D financing. Kissei is obligated to make development, regulatory and commercial milestone payments of up to $100.0 million. We have also agreed to pay Kissei a royalty on net sales of Licensed Product outside the Kissei Territory and outside the Lepu Territory (as described below), including on any U.S. sales, in a low-single digit percentage, subject to certain reductions. We are entitled to receive a royalty on net sales of Licensed Product in the Kissei Territory in the mid-twenties percentage, subject to certain capped reductions. Also, Kissei has the right to offset the royalty payments due to us with respect to the cost for the supply of Licensed Product sold by us to Kissei, and to indefinitely carry forward credits for any excess supply amounts paid over royalty amounts owed in a given quarter. We are entitled to receive a specified minimum percentage of royalties on net sales of a given Licensed Product in a given country and a given quarter, unless, if for such Licensed Product in such country and such quarter, Kissei has taken the maximum allowable reductions and the ratio of the cost for the supply of Licensed Product to the sales price for Licensed Product exceeds a low-double digit percentage threshold, then we shall receive no royalties on the net sales of such Licensed Product in such country and such quarter. Kissei’s and our royalty obligations will expire on a Licensed Product-by-Licensed Product and country-by-country basis on the later of twelve years from the date of first commercial sale of such Licensed Product in such country or when there is no longer a valid patent claim covering such Licensed Product in such country.

CG Oncology filing

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

RESULTS:
We identified 33418 females diagnosed with HSDD at a mean age of 44.2±10.8 years. 850 females received TTh: 378 received 1 prescription, 195 received 2-3, 161 received 4-9, and 116 received more than 10. 461 females received prescriptions for injectable testosterone, 257 for topical, and 119 for pellets. 162 females were co-prescribed estrogen. A positive quadratic trend in prevalence of TTh for HSDD is observed across all age groups until September 1, 2015, after which there is an observable decrease in prevalence compared to the expected forecast (Figure 1). A positive linear trend in prevalence emerged from this point onwards. The slope of this linear trend is 0.0005 for the overall population (p

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

Method
A large electronic medical record and claims database, TriNetX Diamond Network, was queried to identify adult women with >3 testosterone prescriptions within a year for our study cohort. Our control cohort excluded women with testosterone prescriptions, polycystic ovary syndrome, or androgen excess. Both cohorts were propensity-matched and excluded women with prior heart failure, unstable angina, intersex surgery female to male, personal history of sex reassignment, or gender identity disorders. We assessed the association of TTh to MACE, upper or lower emboli or deep vein thrombosis (DVT), pulmonary embolism (PE), breast neoplasm, and hirsutism within three years of initiating TTh. Age-based sub-analysis (18-55-year-old and 56+ year-old) was also conducted.

The following table shows great promise especially when looking at Breast Cancer reduction.



Journal of Urology article

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.

From Pharmaceutical Technology ...

https://www.pharmaceutical-technology.com/data-insights/ani-pharmaceuticals-gets-grant-for-powder-for-oral-suspension-with-hydrochlorothiazide-for-hypertension-treatment/

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.

Mallinckrodt expects fiscal 2024 Acthar Gel net revenue to decline in the low single digits, compared with fiscal 2023. This represents significant progress toward net revenue stabilization for the brand. In addition, Mallinckrodt expects Acthar Gel net sales performance to improve over the course of fiscal 2024, as prescribing momentum within the category continues to grow.

Mallinckrodt plc Reports Fourth Quarter and Fiscal Year 2023 Financial Results

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.

Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA

Fast track.

I imagine they can file later this year and provide the final readout during the review period.

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.

1.57 “Royalty Term” shall mean, with respect to each GVAX Product, the period commencing on the Closing Date and continuing on a country-by-country, and product-by-product basis until the later of either (a) the expiration date of the last to expire of the Purchased Patent Rights covering the GVAX Product or any other applicable governmental or regulatory exclusivity period, including orphan drug exclusivity following approval (in either case, the “Regulatory End Date”), or (b) the seventh (7th) anniversary of the First Commercial Sale of such GVAX Product in that country; provided, however, that (i) if Net Sales in such country for any twelve-month period ending on the same month and day as the Regulatory End Date (a “Measurement Year”) but following the Regulatory End Date are less than 80% of the Net Sales in such country for the Measurement Year with the highest Net Sales during the Royalty Term, then the Royalty Term for such country shall expire as of the last day of the most recently completed Measurement Year; and (ii) if Net Sales in such country for any Measurement Year are less than 90% of the Net Sales in such country for the immediately preceding Measurement Year then the Royalty Term for such country shall expire as of the last day of the most recently completed Measurement Year.

4.1.4 GVAX-Other Product Royalty Payments. In further consideration of the Purchased Assets, and subject to the other terms of this Agreement (including the remainder of this Section 4), (a) commencing on the date of the First Commercial Sale of each GVAX-Other Product sold by Buyer and/or its Affiliates in each country in the Territory and continuing for the duration of the Royalty Term in such country, Buyer shall pay to Seller a royalty equal to [ * ] of Net Sales of any GVAX-Other Product sold by Buyer and/or its Affiliates in such country in the Territory; and (b) Buyer shall pay to Seller a one time milestone payment in the following amounts upon reaching the corresponding milestones for each GVAX-Other Product reaching such milestone, as follows:

(a) [ * ] upon [ * ];

(b) [ * ] upon [ * ];

(c) [ * ] upon [ * ]; and

(d) [ * ] upon [ * ].



Key definitions:
1.25 “GVAX-Other Field” shall mean any therapy relating to the treatment of cancer in humans, outside of the GVAX-Pancreas Field and the GVAX-Prostate Field, utilizing the Purchased Technology.

1.26 “GVAX-Other Product” shall mean (a) any product or service of Buyer or its Affiliates or Sublicensees, the manufacture, use, sale or performance of which infringes any Valid Claim included in the Purchased Patent Rights (excluding the GVAX-Pancreas Patent Rights and the GVAX-Prostate Patent Rights) in the GVAX-Other Field, (b) any product or service developed in whole or in part through the use of a process that is covered by a Valid Claim included in the Purchased Patent Rights (excluding the GVAX-Pancreas Patent Rights and the GVAX-Prostate Patent Rights) in the GVAX-Other Field, or (c) any product in the GVAX-Other Field not covered by (a) or (b) but that is developed and/or manufactured as a result of the use of the Purchased Technology.

Biosante Aduro Agreement

Thanks JTFM. What a payday that would be. We better get some questions on this at the next conference call.

Goldman Sachs estimates Cretostimogene's peak sales at $2.4 billion. If ANIP is successful, 5% would add $120 million in royalties per year.

Goldman Sachs starts CG Oncology stock with neutral rating, $42 price target