Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Yes, the timing can only help.
Looks like a good fit.
I thought the same about the London location. Libigel and Rare Disease focus would be excellent. It looks like they are only doing 1on 1 at the Truist event and will be presenting at Jeffries and offering one one ones.
It may be a very busy week for them.
Silver, this is Acthar's storage instructions.
Silvr, ANIP announced today they will be attending the Jeffries Healthcare Conference in London UK. On November 15, 2023. Two days after the American Heart Association - Scientific Sessions are completed.
They will also attending Triust Securities Biospharma Symposium where they will have one on ones, only on November 9, 2023.
PR release
From the most recent Corti label update posted on the FDA site shows the 1ml vial has a 6 month shelf life vs the 28 day shelf life once the vial is first used.
I have been checking trial results daily too.
Looks like AbbVie large testosterone study has shown Efficacy of Testosterone Replacement Therapy in Correcting Anemia in Men With Hypogonadism.
I figured some of the additional benefits would start surfacing.
Hopefully female testosterone will have a similar benefit.
JAMA Network Article
Silvr, it looks like Achtar is currently drawn from larger vials. There has to be some expensive waste in this process. 1ml vials should be appealing to prescribers. It might also be easier to get the cost covered by insurance plans.
ANIP is hiring a Area Business Director in Ophthalmology looking to increase Corti sales. I imagine approval for the 1 ml dose will help.
Job opportunity
I agree Silvr, Androfemme has limited safety data.
Silvr, UK Parliament debated Menopause today. And the topic of the lack of an approved female testosterone drug came up.
The following are interesting excerpts from the debate:
Silvr, another piece to the puzzle. The Journal of the Endocrine Society published The Impact of Testosterone Therapy on Cardiovascular Risk among Post-Menopausal Women today.
I agree BB, it should be interesting.
That is interesting, Silvr. Should help with sales.
I may be reading more into this, but Guggenhiem has issued four consecutive buy ratings when ANIP hits $57.44, regardless of their price target. It appears that is price where Institutions work to move PPS back up.
Vamil Divan's Stock Ratings
Last rating was issued October 19th.
The Waved put out a trading analysis tutorial on YourTube for ANIP through 2024. Saying it is in a positive trend and recommends a $118 exit. Interesting to see what the exit becomes when Testosterone is publicly in play.
Analysis
BB, I am still assessing the stock.
BB, their phase 3 trial was unsuccessful.
Acasti Pharma's CaPre flunks late-stage study, shares down 60%
Another piece that will help in launching a female testosterone drug. The American College of Obstetricians and Gynecologists came out with a Clinical Consensus against using compounded hormonal therapy, which is endorsed by the American Society for Reproductive Medicine. This replaces the Committee opinion from August 2012.
Clinical Consensus.
According to the article:
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.