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Silvr, Easka, you may already be ware of the process, but I noticed upon looking at various trial result submissions, it looks like when results are submitted, it won't show that the trial has been updated. However, when you look at the results tab, it will show Results Submitted on the tab. When you open the tab you will see the the 1st Cycle submission and will have to be regularly check it to see if it was sent back with comments from the QC review. This could take time, as there will be a lot of data to review. I figure one month may be longer. Then I have also seen delays in approximately a month before the results get posted, even after meeting QC guidelines on the first attempt. It could take over two months to see it posted, if everything is done right when first submitted.
I also learned that if they fail to submit by October 27, 2023, there is an enforcement process, with a letter being sent giving them 30 days to comply, followed up by a $10,000 per day fine while non-compliant. I figure this would only hinder their chance in any NDA filing. Some have submitted results after the two years without repercussions, but they had ongoing trials and were permitted to delay further to maintain the integrity of the ongoing blinded trials. That does not seem to apply for the Libigel safety/efficacy study.
I figure that if they don't make the splash in the lead up to American Heart Association Scientific Sessions running Nov. 11–13, 2023, they will likely make the splash in the New Year in the lead up to the The 42nd Annual Healthcare Conference will take place on January 8-11, 2024 in San Francisco, CA. Which they claim is the largest and most informative health care investment symposium in the industry which connects global industry leaders, emerging fast-growth companies, innovative technology creators and members of the investment community.
In the meantime, we will be keeping an eye on the trial results tab.
GLTA
Easka, Silvr, I was looking at the time between results being submitted and then posted for larger trials. We might be looking at over a month before they get posted on the Clinical Trial website. However, we might see on the website that the results have been submitted by the end of October.
Easka, I would be highly surprised if AbbVie is not involved in one way or another. We know that ANIP's R&D cost were too small to account for the follow-up with the 3,656 trial participants. AbbVie is the logical choice , especially with Snabes working simultaneously at AbbVie and Biosante in January 2013, later taking down his Linkedin page when this was discussed, and then activating his Linkedin page while editing it to make it look like he was let go by Biosante then got hired one month later by AbbVie. Additionally, in May or June, 2012, as Biosante is going through a reverse split to stay listed on NASDAQ, Biosante promotes Pat Fuller to VP of IT. She then goes on to contract work for AbbVie in 2013. I strongly believe it was her reward for ensuring a smooth transfer of all the Libigel trial data to AbbVie, so Dr. Snabes could continue following up with the patients. This is most likely how they made the breast cancer reduction discovery.
Though a partnership with Merck and Organon would be a very good alternative, with Organon focusing on HSDD and Merck focusing Cardiovascular and Breast cancer related indications.
I know Art had said they were exploring how to best use the safety data, it would be very interesting if ANIP was able to work out a deal bring all three companies to the table.
In any event the lid on this story should start lifting in the next two weeks. I don't know how long it will take to post the results, once submitted. If consistent with earlier findings, it will get lots of attention from investors and the medical science community.
GLTA
Possibly Silvr, If ANIP is going it alone in the US, Dr. Reddy seems like the logical choice. Yet, I also would not be surprised if they made a deal with Aspen as an API supplier. Aspen has USDMF and CEP/COS designation for Testosterone API, whereas Dr. Reddy only has the USDMF designation. If they have a partner such as AbbVie and/or Merck they will want be marketing in the Europe, especially the UK which has become more receptive to the need for am=n approved female testosterone drug.
I remember Art forging a partnership with Aspen during his tenure.
Testosterone suppliers
On a side note: I found this interesting Clinical Trials Results Information Submission: Good Cause Extension Request Process and Criteria
Thanks Silvr, interesting info.
Thanks Silver.
Thanks Silvr. We should see how ANIP will be able to monetize the trial data in approximately three weeks.
Maybe just a coincidence, but AbbVie's Q3 earnings release is scheduled for October 27, 2023. The last day ANIP has to submit results for the Libigel study.
AbbVie Earnings
Could be a very big day for both companies.
Typical market manipulation. ANIP announce the approval and launch of the only approved corti drug for acute gouty arthritis and PPS goes down.
Silvr, here is an interesting potential future use for testosterone.
Estrogen and Testosterone Supplementation Improves Tendon Healing and Functional Recovery After Rotator Cuff Repair.
Obviously it has only been proven in mice, but would be real interesting if it could be generally used to assist in healing tendons post surgery.
I agree Silvr, psilocybin has 4 phase three trials and 71 phase two trials, it will be interesting to see where efficacy will be proven.
Silvr, Vijayakumar Balasubramaniam is Head of HR for Novitium, Nuray Chemicals and Scitus in India. There seems to be a special interconnection between these companies. With Nuray Chemicals driving the IP. I expect ANIP to benefit from this partnership to help drive ANIP's long-term growth in relation their 505(2)(b) strategy.
Head of HR
JMHO
Silvr, they have 30 days after the Sovuna approval to submit any patents that apply. It will be interesting to see if they have any patents for it. It might give us a hint as to how scalable the technology is to other drugs.
Thanks Dasgrunt.
Nuray Chemichals picked up another patent. This one is for a process for preparing levoketoconazole.
Patent
It is anticipated to expire March 9, 2043.
I expect Novitium will seek approval for the drug. However, it won't likely be until after 2029 when the data exclusivity for Recorlev's data exclusivity expires.
Recorlev approval
Silvr, upon looking at all the approved version, it appear that only one other drug is authorized to be scored into two pieces, Accord Healthcare's 400 mg tablet.
Hydroxychloroquine Sulfate Drug Label Info for all that are approved
As I understand it, it looks like ANIP has the lock on pediatric patients between 23 kg and 31 kg. In addition to any prescribers wishing to titrate up or down the dosage by 50 mg vs 100 mg which is the only option currently available..
We should soon see if any patents protect the sNDA for Novitium's Hydroxychloroquine,
Silver, It looks Dr. Reddy's Laboratories distributes Appco's Hydroxychloroquine sulfate.
CPSIA Section 102 (a)(1) Certification
When you expand the Ingredients and Appearance of their Drug Label Information, it shows that it is not authorized to be scored.
Drug Label Information
ANIP 300 mg appears the only one authorized to be scored into 2 pieces.
Silvr, it looks like Appco Pharma LLC would be the only competitor with a US based manufacturing that offers a generic of 300 mg dosage. Though they only manufacture and develop generics.
Thanks Silvr, I agree and as more drugs, meeting these needs come out, their business strategy will gain credibility and attract more investors.
When comparing the Dosage and Administration with competitors I believe the sales team which is looking for Rheumatology experience, will launch targeting the following. Competitors do not appear to have the 300 mg option in their dosage guidance. They only offer 200 mg or 400 mg, ANIP will give prescribers more flexibility in titration of drugs upward or downward.
Rheumatoid Arthritis in Adults:
Initial dosage: 400 mg to 600 mg daily
Chronic dosage: 200 mg, 300 mg or 400 mg once daily (or in two divided doses)
Systemic Lupus Erythematosus in Adults which is looking for Rheumatoid
200 mg, 300 mg or 400 mg once daily (or in two divided doses)
The competitors are restricted to patients who are > 31 kg.
Silvr, my research indicates that Novitium found a way to score the 300 mg tablet and maintain the integrity of the tablet creating a 150 mg dosage. This allows them to prescribe to patients weighing 23kg or more whereas Concordia's Plaquenil and other ANDA's must leave the medication intact (no crushing or scoring).
Easka, I think they will have a lot of price moving catalyst coming out in the next quarter. Obviously institutions and possibly future partners are positioning themselves.
Silvr, the specialty pharmaceutical rep positions armed with Veeeva tools might be part of their strategy. Concordia is a Canadian company with parent Advanz Pharma headquartered in London. They likely will leverage their American manufacturing supply chain. Additionally, the only dosage form available is tablets. I wouldn't be surprised if they are working on an non-tablet form of the drug to meet the unmet need for those who have trouble swallowing tablets.
Massive at close and after hours. Bet it relates to Sovuna.
Makes sense.
Thanks Silvr. Yes having CDC backing will help.
The HC Wainwright presentation did not give any new info from the last. At least the questions were better. Asking for peak sales regarding Corti. All Lalwani would say is that he is not ready to give peak sales but that the volumes should at least match peak ACTHAR volume hinting at likely more. Stating that Corti is just starting their growth story.
They are still shopping for rare disease assets that tuck in nicely with their infrastructure.
Let's hope so.
Silvr, within six weeks we should find out. The Libigel results get posted on or before October 27th. I agree that there must be a good reason for the insider selling. After over 11 years, what is another two months to see this all play out.
Silvr, my take away is the following:
- Novitium likely gets first dibs on the 100+ drug submission Scitus roles out by the end of the year. It likely secures ANIP's long term growth of their generic pillar.
- Nuray Chemicals also has the patent for an improved Tafamidis. This will take some clinical trial work to get it approved once the Pfizer patent expires in 2026.
Given how expensive it has become to borrow, Samy may be using the proceeds from the shares he(or his companies) sold to fund their activities. If so, it is a win- win-win for him. It should grow the value of all three companies.
As for female testosterone, I would not be surprised to see a new private company formed with a partnership between ANIP, AbbVie and another big pharma (possibly Merck) built around female testosterone. I figure a multi company partnership is the reason it has not yet been announced. If only AbbVie were involved, I believe it would have already been announced by now.
JMHO.
Silvr, according to the Schedule 14A, it looks like Novitium was the largest customer for both Scitus and Nuray, both of which Samy owns a minority interest.
Silvr, it must be an unmet need, which is the companies focus.
I was thinking the same about Scitus. According to their linked page:
They actually have the following trial "To Evaluate the Safety and Efficacy of Ketoconazole Shampoo 2% for Topical Application of Novitium Pharma (a Subsidiary of Ani Pharmaceuticals Inc.) with Ketoconazole Shampoo 2% for Topical Application of Perrigo in Subjects with Tinea Versicolor" which they appear to be partnering with partnering with Scitus Pharma
Phase 3
Scitus partnership
Correction- This was Novum not Novitium.
Silvr, the Goods and service section on a number of trademark applications ANIP has submitted is as follows.
Silvr, that is awesome. Those taking the drug have already had a 64% increase in survival time over the average advanced breast cancer patient and the trail continues. These numbers will only get better over time.
Today was the second senior management team virtual presentation to investors as part of a non-deal roadshow in the last two weeks. Looks like management is now actively trying to attract investors.
Presentation
Someone more well versed in patent litigation may wish to jump in here. As I understand it, it looks like the Patent Examiner is ready to grant Novitium the patent for Hydrochlorothiazide Compositions, once they deal with the double patenting reasoning for the final rejection. According to the conclusion of the Final Rejection it looks like they need to reconcile their first patent application (parent) with this application to overcome the rejection. Simply filing a Terminal Disclaimer for the Parent patent application # 17/546,175 would render the rejection moot paving the way for their next submission to be approved.
The document can be accessed through the link below. Select Documents and Transactions, then go to the be conclusion of the Final Rejection.
Patent Application
Silvr, under Lalwani, ANIP has moved to an intelligence led approach which is best exemplified by their approach to Corti. I imagine they are well positioned and adaptable to the changes that are occurring.
JMHO