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LD, based on your assessment and info from MNK, I too am not expecting big numbers, but I do hope that they can at least give guidance that will considerably exceed their spend of $42-$46 million for the year. If analyst are estimating ANIP will hit the low end of their guidance for 2022 (ex-Corti), then they are estimating Corti sales of approx. $33 million for 2022.
As for Sammy and Chad, time will tell if we overpaid. Insider MVP had the largest dilutive impact from the acquisition and they okayed the deal. I am certain they know more than we do.
Hopefully they were able to forge some partnerships at the Rare Disease conferences they attended.
I guess we will find out on Tuesday.
Good luck with the races.
LD, I am not certain this is tied to Corti. Many generic companies are taking a hit today. There is no interest in ANIP, at the moment, less than 1% of outstanding shares traded have per day since March 31st. Good news generating sustained interest is what ANIP needs. Hopefully, it starts next week.
Biggest losers, so far, are insiders Sammy and MVP Capital partners. They can't be happy with current share price either.
Maybe just another coincidence, but on December 9, 2021 Wells Fargo initiates coverage of AbbVie with a price target of $165. On May 2, 2022, they increase their price target to $200. The highest of any analyst, even in light of concerns about Humira and Imbruvica sales eroding quicker than expected and some analyst starting to downgrade their price target.
It should be noted that MVP Capital Partners was a subsidiary of Wells Fargo when BPAX and ANIP merged in 2013, and later became an affiliate of the bank around 2016.
Possibly Jadite.
Jeff, the trademarks for Biosante (live) and Libigel (dead) were assigned from Citizens Bank to ANIP and then assigned to Truist Bank as part of deal for the $340 million financing they got. Citizen Bank also assigned every patent application related to the Libigel Clinical Trials back to ANIP. However, ANIP did not reassign the patent application over to Truist. If they were doing nothing with Libigel it all would be assigned to Truist.
I know that when the USPTO is looking at patent application the inventors must assign their claim on invention over to the applicant. I believe you will soon see a proper patent application exposing their partner including the missing breast cancer info. Additionally, the FDA would likely require that the clinical trial data be assigned to the applicant, in order to include the data in any filing and subsequent approval.
While their partner likely continued working on the trial, or at least monitoring the 3,656 participants for the full 5 years of the original study, if not longer, Citizens Capital and then Citizens Bank was assigned the Clinical trial related IP and Trademark IP starting in May 2016. Even as ANIP filled a the new patent but still held back the breast cancer information (filed October 21, 2016).
This combined with Clinical trial Certification/Extension to delay submitting results on October 27, 2021, leads me to believe a partnership will be announced in the not too distant future. How the deal is structure, I haven't got a clue, but given the litigation around Androgel and male testosterone, I would not be surprised if they form a Joint Venture LLC.
JMHO
Just found a March 2nd update from Cigna that Corti will not be covered under their Pharmacy Benefit.
I can see why Elliot Wilbur said the coverage all over the place at the last earning conference call.
The Cigna Corti info is buried in their resource library a copy and paste link to the page shows an error.
Google "Cigna Policy Updates February 2022" the first hit will take you to statistics.cigna.com. This page will show that Corti has new coverage. But more importantly select the link for Coverage Policies and select The Pharmacy (Drugs & Biologics) A-Z Index (view document). You will see that Purified Cortophin Gel is listed, but Acthar is not.
GLTA
The markets may be severely underestimating ANIP's ability to penetrate and grow the Corti market.
I can't remember if someone on this board mentioned that Cigna covers Corti (Supports medical precertification requirements) but does not appear to cover Acthar.
According to Cigna they have
- 22 million U.S. customers covered by Group Disability & Life
- Medicare Advantage plan in 16 states and Washington, D.C.
- Medicare prescription drug plans in all 50 states
Cigna
If I am reading this correctly, it looks like the NH Healthy Families Pharmacy & Therapeutics Committee requires that Corti be tried before authorizing Acthar.
NH Healthy Families
Though CVS Caremark only authorizes Acthar for Infantile Spasms, the following shows what Corti and Achtar are approved for. The indications in red are approved for Corti only.
According CVS Caremark, the use of Acthar and Purified Cortrophin Gel for the treatment of all other indications listed in the FDA product labeling has not been proven to be superior to conventional therapies (e.g., corticosteroids, immunosuppressive agents) and has a significantly higher cost than the standard of care agents. Use of Acthar and Purified Cortrophin Gel for these conditions is considered not medically necessary and is not a covered benefit:
Acthar Gel:
1. Multiple Sclerosis: treatment of acute exacerbations of multiple sclerosis in adults
2. Rheumatic Disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis; ankylosing spondylitis
3. Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis)
4. Dermatologic Diseases: severe erythema multiforme, Stevens-Johnson syndrome
5. Allergic States: serum sickness
6. Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
7. Respiratory Diseases: symptomatic sarcoidosis
8. Edematous State: to induce a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
Purified Cortrophin Gel:
1. Rheumatic Disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis; ankylosing spondylitis; acute gouty arthritis
2. Collagen Diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis)
3. Dermatologic Diseases: severe erythema multiforme (Stevens-Johnson syndrome), severe psoriasis
4. Allergic States: atopic dermatitis, serum sickness
5. Ophthalmic Diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior
uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
6. Respiratory Diseases: symptomatic sarcoidosis
7. Edematous States: to include a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
8. Nervous system: acute exacerbation of multiple sclerosis
CVS Caremark
Could be a fun ride starting May 10th.
GLTA
I didn't catch this before, but in the Schedule 14A filing I found it interesting that in justifying Mr. Lalwani's compensation, the BOD supported his three-year strategic plan to build a sustainable biopharmaceutical company. We are almost half through his plan. Looking forward what is yet to come in the second half of ANIP's transformation.
Catty, I believe we are good to June 18, 2023
Silvr, looks like AbbVie future growth took a little hit today. Humira and Imbruvica sales coming below analyst expectations. Share price dropped 10.5% before recovering to a 6 % drop. If female testosterone in in their cards , I don't think they can wait until next year, as you mentioned.
Catty, it all depends on how the deal is structured and what, if anything, ANIP invested in further development development.
Thanks LD, something to consider when they announce earnings.
I agree Silvr, getting approved and extend the life of the drug by adding indications would make sense.
Possibly, but I see that Thomson Siegel an Walmsley upped their stake in ANIP by 51.7 % adding 144,533 shares during Q1. It could also be more games by accumulating institutions.
Correction: the estimated completion date for a possible 10 year Libigel trial would have been August 2021 not June. Therefore the latest they can post results, with a granted extension, should be around August 2023.
Silvr, with respect to possibly sitting on 10 years of data. They would of had to submit results in June 2022, regardless of results being positive or negative. If it is an Extension request rather than a Certification request, they would now have until June 2023 to post results.
If AbbVie is behind it there has been shifting goal post. Initially They were concerned about facing Humira biosimilars in Europe in 2018 and in the US in 2019. They were able to secure deals, punting US Biosimilar competition to 2023. This gave them breathing room. Now they have no breathing room. By June 2023 they will face multiple biosimilar competitors for Humira. If an NDA has not been filed, yet, it will have to be filed in the near future. If additional trials were required they would have already been started in order to meet the June 2023 market imposed deadline. Though they face biosimilar competition in January 2023, the significant revenue hit will come when multiple players enter the market.
JMHO
Thanks Silver. With all the testosterone related data likely coming out this year, I believe the Global Position Statements will get updated in 2023 for both men and women.
I agree that share price has been disappointing.
Forgot to add: Why would Triust be assigned the Trademark for Biosante and Libigel (from Citizen Bank) as collateral for refinancing debt and facilitating merger, yet, the patent portfolio regarding Libigel was reassigned by Citizen to ANIP, rather than Triust?
Could it be, that if a new patent application is being sought the applicant will have to show proof of assignment in order to claim priority. (i.e, if AbbVie wishes to claim a priority date of December 19, 2015 for a claim that testosterone restoration reduces Breast Cancer), they will need to have ANIP assign them the related patent applications.
I don't know if it matters as much in a NDA application, unless the patent is granted.
Just something else to consider.
Silvr, Dr. Louis Sullivan was the most notable member of the BOD his specialties were internal medicine and hematology. Edward C. Rosenow III, M.D. was a Master Fellow of the American College of Physicians and the American College of Chest Physicians. I also found it interesting that Dr. John T. Potts, Jr., was an accomplished endocrinologist. Dr Snabes is also an endocrinologist.
Good point about the Biosante trademark being kept alive.
I remember reading a while back that analyst were discounting the lower CV events to the drugs participants were taking and not necessarily Libigel. They need the data readout to show how Libigel group differentiated from placebo to get the analyst behind it.
Hi Jeff, I am doing well and hope the same for you and your family. I agree the Libigel advancement is speculative. However, there are condition under which company can legally withhold material information.
The following is from the Principles for Ongoing Disclosure and Material Development Reporting by Listed Entities put out by the International Organization of Securities Commissions. available on SEC's website.
174ahc, if a deal wasn't in the works, what else would make ANIP:
1) Not disclose the Cardiovascular event reduction discovery?
2) Not disclose the Breast Cancer event reduction discovery?
3) Not disclose the information in their patent that proves or supports the claim that it reduces breast cancer events.
4) Abandon the patent application when asked to file an separate patent application for the breast cancer reduction discovery?
5) Submit on October 27, 2021, a Certification/Extension request to delay submitting trial results almost 9 years after the trial was allegedly completed. And, going into such detail as to change the location name of St. Louis to Saint Louis but not change the sponsor name from Biosante to Ani Pharmaceuticals? Especially when, if the true completion date was December 2012, there was no obligation to post results.
6) Hold a Stockholders meeting before first quarter results are released and identify the holder of record prior to the release of 2021 annual results (this is not the norm in pharma)
and
Finally, why would some employees for Abbott/Abbvie, including Dr. Snabes distort their Linkedin work history to hide a period of time where the employees worked simultaneously at Abbott/AbbVie and Biosante? One was when a key change was made to the the larger trial to seek women at greater risk of experiencing cardiovascular events in November 2009 the other following the completion of the pre-commercialization part of the study in December 2012.
Way too many oddities to strike it up to a bunch of coincidences.
JMHO
174ahc, if there is a deal in place, ANIP likely merged with Novitium to be able to enter in a co-development deal with AbbVie for future indications, in addition to a co-promotion deal for the US and a royalty deal ex-US. This potentially maximizes shareholder value for ANIP (with some added risk), in the long-run. Had ANIP secured the CV Patent, they likely would have bought out ANIP.
I guess we should soon find out.
Assuming ANIP and AbbVie are involved in some type of deal, if it were simply partnering on Libigel, they likely would of announced a deal long ago. There must be another piece to the puzzle, that justifies delaying any announcement.
Treating Heart Failure would be an interesting indication. If AbbVie has filed an NDA, they have amassed a significant amount of data to support their filing.
Thanks DewDilligence, you are most likely right about Androgel, but I found it odd that they had a 48 month estimated completion for their trial though having 60 month time frame. At the very least the estimated completion date should have been June 2023. Though the time to Major Adverse Cardiac Event is the primary outcome and they are looking a cardiovascular a nd prostate cancer safety. The trial is also looking at other indications including: sexual activity, depression, bone fractures and anemia diabetes.
As for Libigel, there appears to be more to the story. As you stated it did fail to show efficacy for HSDD due to a large placebo effect. But the larger safety trial was also measuring efficacy and had a surgically menopausal population similar in size to the total of the two pivotal efficacy trials. They efficacy her was being measured in similar method used in the Intrinsa trials. The results form this trial have yet to be released. Secondary outcomes for this trial were never disclosed, as well.
It is true that ABBT/ABBV have never publicly owned or expressed an interest in female testosterone. However, I and a few others can attest to the fact that Dr. Michael Snabes' Linkedin profile, at one time, stated that he worked for AbbVie as early as January 2013 while working for Biosante at the same time. His linked in work history now reads as if there was no overlap, with him starting at AbbVie in April 2013.
Additionally up until, ATRS was issued a patent for using Testosterone to treat HSDD, ABBT was seeking a similar patent.
Dr. Snabes discovered that Libigel reduced Cardiovascular events over placebo ( never publicly disclosed). It appears that Libigel safety/efficacy trial or at least the observation of the 3,656 participants went beyond the December 2012 completion date. This became evident on December 19, 2015, when during the patent prosecution for reducing cardiovascular events (Dr. Snabes as inventor) they added the claim that restoring testosterone also reduced breast cancer events. In September 2012, the reduction in breast cancer events by restoring testosterone was not present. Interestingly, the support for the claim that it reduced cardiovascular events is well documented in the specifications of their patent application, but there is no such support for the breast cancer reduction claim. If ANIP had continued the work to make such a claim they would likely provided the supportive information to their claim in the specifications document accessible through the Public Pair. It also would have shown up in their R&D expenses as ANIP is a smaller company and it would be hard to hide the expenses related the follow-up of the participants.
According to the American Heart Journal article titled "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder" which also credits Dr Snabes.
Looks like another testosterone trial for women should be completed this year. Starting a Testosterone and Exercise Program After Hip Injury (STEP-HI) has a Primary Completion Date of June 2022 and a Completion Date of December 2022
Interesting information Silvr. Looks like a concerted effort to truly understand who can benefits/risks from testosterone restoration and androgen depravation therapy. This is exactly what physicians want, a better understanding on when either should be prescribed.
Question for the board, is AbbVie interested in being the leader in male and female testosterone restoration and advancing the benefits beyond hypogonadism?
I see that AbbVie was the primary sponsor for the clinal trial titled A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE) which was estimated to have 6,000 participants and a study time frame to completion of approx. 60 months. However, when first posted they had an estimated completion of 48 month completion Start date May 2018 and completion June 2022. Additionally the stopped recruiting at with 5,246 participants.
It appears they were more concerned to meeting their original completion date of June 2022, than getting 6,000 participants.
Then I see that after 9 years of dormancy, the clinical trial titled Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM), involving 3,656 postmenopausal women at an elevated risk of cardiovascular events, was updated on October 27, 2021 by submitted a Certification/Extension request to delay submission of results. As it currently stands there us no obligation to submit results as the primary completion date was well before January 18, 2017 when the Final Rule for submitting results applied. It is more likely an NDA has been file or in the works, where a Certification request would be required. Arguably AbbVie would be best positioned to submit the NDA, as the Study Director, Dr Michael Snabes is now a Senior Medical Director , AbbVie Global Clinical Research and Development. In this trial he discover that restoring Testosterone reduced the risk of cardiovascular events by at least 70% over expected outcomes and by an undisclosed percentage over placebo. Additionally, by December 2015, it was discovered that it reduced breast cancer events over expected events and over placebo. None of this information has been made public other than in patent application and subsequent.
If AbbVie were intent on advancing the benefits of testosterone restoration, there is a 700,000 participant trial titled Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes due to be completed in November 2022, which could drive interest in the potential benefit of testosterone restoration.
Wondering if it is another tool in countering LOE for Humira.
Good luck to all.
Silvr, I believe the result of the 700,000 participant trial titled Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes will have great influence on how they tackle dementia. It is due to be completed in November 2022.
So you have the following potentially coming out this year :
-The AbbVie led 5,254 participant Men's testosterone trial (Completion June 2022)
-The Libigel 3,656 participant female testosterone trial potentially being released at some point this year, if approved for any indication.
-The results from the 700,000 participant dementia study. (Completion November 2022)
I too believe there are no coincidences. It looks more like a concerted effort by AbbVie to help combat revenue erosion from the LOE for Humira, starting in January 2023. Arguably a > $7 billion drop in revenue by 2024.
JMHO
Silvr, the announcement of Michael E Severino, AbbVie’s Vice Chairman and President, effective May 31, 2022, likely hit PPS as well. . He was responsible for research and development and the corporate strategy office. He previously served as Executive Vice President, Research & Development and Chief Scientific Officer of AbbVie. |If AbbVie is working on female testosterone, he would of had his hand on it.
Dementia is one of many future trials waiting for an approved product to help offset the cost.
AbbVie's Humira facing biosimilar competition in 2023 with an estimated 35% drop in revenue due to competition and AbbVie dropping Humira's price, and now J&J reported Imbruvica global sales shrunk by 3.9% losing sales to Astra Zeneca's Calquence which has proven to be safer. Imbruvica's is AbbVie second best selling drug.
Silvr, once proven safe, I envision a ramping up of clinical trials globally to see what conditions, including rare diseases, and therapies could benefit from the safe restoration of testosterone for both men and women. You can already see the difference in the number clinical trials involving male testosterone for conditions other than hypogonadism whereas most trials for women are still related to sexual dysfunction type conditions. This appears to be a potentially massive opportunity beyond the conditions listed in the Global Position Statement that needed further trials.
Silvr, I see that AbbVie's Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE) was more interested in completing on time June 2022, than enrolling the estimated 6,000 participants. The actual enrollment is 5,246. This becomes evident when you look at the outcomes. They a Time Frame: Up to study completion (approximately month 60). The start date was May 3, 2018 and an estimated completion date June 2022. A 60-month time frame would have had a completion date of June 2023.
Trial
If AbbVie is heading an NDA for Libigel. They will have be releasing a massive amount of data regarding testosterone use for both women and men this summer. It would have been a long orchestrated plan to counter the LOE for Humira.
Happy Easter Everyone.
Thanks Silvr, the delay in the results does seems odd, as well.
Upon taking a deeper dive into IP, I found it really odd or suspect that the Libigel and Biosante's Trademarks were reassigned to Triust from Citizens when ANIP refinanced its debt in November 2021. Whereas, all five Libigel related patent application were assigned back to ANIP from Citizens at the time of refinancing. ANIP kept the assignment, it did not go to Triust this time, as the Trademarks did, even if abandoned.
I believe these patents applications have been reassigned to AbbVie, and this is why Triust could not secure them as collateral.
JMHO
Silvr, as I understand it ATRs was suppose to maintain the IP (which they didn't, or so it seems) and ANIP was suppose to continue working towards commercialization. On the surface it looks like as of June 2022, ANIP has clear path to try tot market a female testosterone for at least 5 years (assuming approval), with no royalties or milestone payments to be paid to ATRS, as ATRS failed to maintain their obligation and the patents are currently unenforceable. However, this scenario seems highly unlikely, as that kills the the FDA 5-year patent restoration extension.
There has to be more at play. I guess we will soon find out.
Silvr, since analyst had a target price pf between $6 and $7, many investors are not happy with the deal at $5.60 PPS. I am not certain it will pass with their first offer.
TLANDO got full approval March 29th but came with a black box warning. Which I see as positive, because a large long term safety trial for the an oral method of delivery will likely be required by FDA to get it removed. The same would likely apply to a female equivalent.
According to the PR it looks like they want in on the Testosterone buisness
I see that Halozyme entered into an agreement to buy ATRS for $960 million. If Libigel were the subject of NDA , you would think ATRS would hold out before agreeing to a deal, unless their IP is no longer needed. The patent for the Libigel formulation expires in June 2022 and the method of use patents expire in May 2026 and December 2028 and they did not pay the maintenance fees for the method of use patents allowing the patents to expire.
ATRS buyout
On the other hand I can't help but think there is a connection to ANI Pharmaceuticals appointing Renee P. Tannenbaum, Pharm.D., MBA, to the Board of Directors last month. She was previously Vice President of Global Partnering at Halozyme, Inc. and Head of Global Customer Excellence at AbbVie, where she was responsible for building commercial capabilities for the organization.
I guess we should find out in the coming months.
I agree, hopefully the veil on Libigel will finally be lifted.
Good point on the accumulation.