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Silvr, looks like the info regarding Pfizer was a standard template used in coding their webpage. It shows up being blurred for other pharma companies as well.
Fun while it lasted.
Very interesting Silvr. I agree that there appears to be so many twist and turns that, it would make a great book.
Thanks Silvr, I figured he would have a good cause for selling, especially going into the results coming out for Libigel.
Acasti is an interesting company. I got a kick out of one of their directors Dr. Kottayil. According to his bio on the site:
Silvr, according to ANIP filings SS Pharma LLC supplies Tafamidis:
Silvr, according to Pfizer's Q2 presentation The Vyndaquel family of products accounted for 6.1% of their revenue and grew revenue by 43% over the previous year.
The LOE for the US is 2024, but they have a Patent Term Extension pending which should take it to 2028. Whereas the EU LOE expires in 2026.
A generic is already approved for FoldRX Pharms. So I imagine they will want to get it approved in the EU in 2025, which gives them time to switch existing patients to the new version.
Q2 Presentation
Silvr, I would not be surprised if ANIP/Novitium got the rights to Nuray Chemicals IP related to Tafamidis, and have entered into a collaborative agreement with Pfizer to develop a replacement for a new and improved version of their Vyndamax® (Tafamidis), and Vyndaqel® (tafamidis meglumine) which starts to lose some patents and exclusivity December 2023 through 2024. This will allow Pfizer to switch their patients to the new drug which patent coverage extends to 2041.
Nuray Patent
Samy is the lead inventor for the patent.
Vyndaquel IP expiration
Vyndamax IP expration
FYI, Vyndaquel and Vyndamax accounted for $782 million in revenue for Pfizer in Q2.
JMHO
I wish I could read that fast. I caught a glimpse of something when blurred out it looked like Pfizer Inc. as a sponsor. So I thought I would clear my history and cache and tried it again, but this time I took a video as I was opening the page. It worked.
Silvr, I was a looking up Clinical for both Ani and Novitium and found the Global Data sight shows 3 of 30+ trials. The first one I saw very briefly before it blurred out so you can't read it. It definitely shows a collaboration with Pfizer as a sponsor with a trial status as planned. No details about the phase, the indication or the drug.
Trials
FYI, Pfizer is a Testosterone API supplier that is listed under the USDFM and CEP/COS for Europe.
Correction: According to the Clinical Trials site, assuming the results are submitted by October 27th, it looks like the results are suppose to posted by November 27th , though I see that they don't always meet their deadline.
Thanks Silvr.
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.