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I think I figured out ANIP's MO for Branded drug development. Novitium and Nuray Chemicals R&D work on finding way to improve existing drugs. Obtain generic approval and get patents for new discovery, Then they file sNDA for the improve vesrion of an existing Branded or Generic drug.
Novitium first got approval of a Generic Hydroxychloroquine Sulfate Drug, once approved, they were later able to get approval for Sovuna (Trademarked) by applying for sNDA and showing how it differentiates form the the original. I imagine it is supported by some form of patent protection somewhere,
Novitium has also obtained a patent for a new and improved carglumic acid for which they have patent. I imagine they have SNDA for this one also.
Novitium also has patents for:
- Oral Liquid Composition Of Terazosin
- hydrochlorothiazide
According to the www.pharmacompass.com, I have seen a pattern where SS Pharma owned and founded by Samy make the FDA GDUFA application with API supplied by Nuray Chemicals. Looking
US Manufacturing
Looking at the Patent Centre
Nuray Chemicals has received patents for the following:
- Levoketoconazole
- Tafamidis
They have applied for patents applications for
- Pitolisant Hydrochloride
When looking at at these three drugs SS Pharma has submitted GDUFA fees for these drugs. Hard to believe they don't make to ANIP' s Product portfolio. Where ANIP will then work toward a sNDA . All have competitive advantages making FDA approvals more likely.
Silvr, unless this was intentional, they need a better IR personnel working on messaging. They could of easily stated that we are raising guidance, based on our core business not, the short term bumps we get from filling voids such as short term shortages, as Q2 guidance was for an average of $105.5 million in Revenue per remaining quarter (mid-guidance) to $117.6 million for Q4. Though we are not ready to give guidance for 2024, we feel confident enough in our revenue growth to invest in an expansion the New Jersey plant coming on line in Q1 2024. I bet that would have garnered a much different market reaction.
May be just a coincidence, but according to Merck's website, dating back to 2015, they have never presented at this conference before.
Merck Presenting
I agree, Silvr, they were awkwardly answering questions. I mean when the Truist Analyst asked about the shelf-life, of Corti 1-ml they could of answered it. It is not a secret, it is in the prescription guidelines and the opthamology position is on their website. Not announcing Sovuna, even in light of the way it traded the day after approval. It certainly looks like they are restricted in what they can say. Makes me wonder if there is a global deal for Sovuna in place. Especially in dealing with malaria in children. Maybe that is what the Jefferies presentation in London is about. I see Merck is presenting on the 16th the day after ANIP.
Thanks for the testosterone link. Another future trial for an approved female T.
I agree Easka, and they have inputs that Lalawani would not commit to, but will likely materialize.
I find it interesting that they intentionally withhold Sovuna announcement. Avoid answering Les Sulewski's (Truist Securities) question about the shelf-life of Corti 1-ml vial (6 month vs 28 days) nothing about opthamology. Good for him at least trying. (Wish they had the nads to ask about testosterone.)
They guide towards lower Revenue and EPS lower than previously estimated.
Provide zero reason to counter EPS estimates for 2024 that estimate a reduction over 2023.
It looks they are intentionally trying to keep PPS low. Certainly something that could benefit a partner buying equity in ANIP.
No idea on earnings, as I not sure if they will some contingency payouts regarding Novitium. But my guess on revenue will be in between $125 to $130 million.
Thanks dasgrunt.
Jp2011, according to ANIP's last Corporate Presentation Acth category has grown 13 consecutive month. If this trend continues, it look like ANIP is capturing the majority of the growth. Obviously this is just a guess, but I believe we will see between $27 and $30 million in Corti sales. maybe more if the pulmonary sales started kicking it up a notch.
According to Mallinckrodt Earnings Release reported 2.9% drop in ACTHAR over last year. $122.1 million vs $125.7 million in Q3 2022.
Acthar® Gel (Repository Corticotropin Injection) Delivery Device Supplemental New Drug Application Accepted by U.S. Food and Drug Administration with a project launch in the second half of 2024.
One can hope. I would be interested in finding out more about them presenting in London.
GLTA
Novitium's Patent Application for Hydrochlorothiazide compositions was allowed today. Should be published once fee are paid.
Abstract
Disclosed herein is a powder for oral suspension and a reconstituted product thereof comprising highly pure hydrochlorothiazide, which is useful for treating hypertension and edema.
Plug in 18/053,197 in the Application box in the following link for more information. You can find more details under (Documents and Transactions)
Pantent Center
There was no information available under the patent term adjustment, yet. But it will expire on or after December 9, 2041 plus any patent term adjustment, if applicable.
Thank Silvr, I agree and see a boatload of clinical trials in the future, once approved.
Dasgrunt, it is interesting that ANIP topped the list. Don't know if they were the largest sponsor?
Not sure if it means anything either. But something to keep eye on.
Jp2011, analyst have raised the consensus earnings estimates over Q2's consensus estimates. This is line with ANIP raising guidance, they may however be using the low end in ANIP's guidance of $425 million. If so, then ANIP would only average $100.85 million over the next two quarters. Even using the top guidance of $445 million. ANIP would average $110.85 million for Q3 and Q4. Below the $116.5 million in revenue of Q2. They are also likely projecting Q3 will be lower than Q4, as consortiums will most likely make larger purchases in Q4 to take advantage of the lower price over 2024 prices.
I think it will be moot. As ANIP should easily beat estimates.
JMHO
Another potential future use for testosterone.
According to Correlation of serum circulating testosterone levels with stress urinary incontinence in postmenopausal women
Thanks Silvr.
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.