Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

would anyone happen to know where I can go to find how many generics there are for each of our filed ANDA's.

Hey tedk10, great sticky post at the top, btw. You're looking for the fda orange book. It's got a new look and functionality recently, and I haven't explored much. This is where you can find all the NDAs and ANDAs for various drugs, including patent info, exclusivity, etc. As an example, let's look up my current favorite sleeper candidate for 2019 ELTP Drug of the Year. Go to the orange book and type 'isradipine', and this is what you see:


https://www.accessdata.fda.gov/scripts/cder/ob/









Very interesting. Glaxo is completely out, with both of the brand name products, DynaCirc and DynaCirc CR, marked as "Discontinued." Likewise, Mylan's generic is d/c'ed. That leaves Teva and Elite as the only two U.S. manufacturers. So, tedk10, you say- who cares? You say isradipine is the redheaded stepchild of the calcium channel blocker family- always living in the shadow of his more successful and handsomer older brother, Norvasc (amlodipine). Harsh, ted. Although it is true that total yearly sales of isradipine have been around $5 million for a long while, the situation may be changing soon. STEADY-PDIII is a very important Phase 3 study of isradipine in Parkinson's Disease, which afflicts more than a million Americans. The last patient will complete the 36 month observation period in November 2018, and final results are due in early 2019. There is great hope the results may prove at least a modest benefit of isradipine for slowing down progression of Parkinson's Disease, and some expect the results will show significant benefit.


A few important points. First, this is a specific effect of isradipine. Other CCB's do not seem to have a similar effect. It was first noticed that people who took isradipine for blood pressure were less likely to develop Parkinson's, and the effect was further substantiated with epidemiological and animal studies. There was a Phase 2 safety study that showed good tolerance of the middle dose: isradipine 5mg twice daily. Both the Phase 2 and Phase 3 studies were funded by the NIH, so it is kind of awesome that this old drug with only 2 competitors is being treated like a brand new novel drug. Elite stands to gain huge benefit if the results are good- without spending a penny. And the greatest part is that if the results are good, neurologists and PCP's will immediately start prescribing the drug, which is already approved and on the market. No waiting for the FDA on this one. If there is even a modest effect, we can expect 100's of thousands of new patients will be started on isradipine. If the effect is substantial, I would think we will see a majority of the million+ PD patients in the U.S. started on isradipine. And, it will happen basically overnight.


If isradipine becomes a major drug for Elite, it will be 100% thanks to Nasrat. First, it is a Mikah drug. But even beyond that, this drug has been Nasrat's baby. It was the only drug of the 12 that were contracted with Epic that he took back from them. He let 10 of the 12 sit on the shelf, but isradipine he took back. He brought Doug Plassche over in good part because Doug was familiar with isradipine manufacturing. Even then, it was quite an ordeal to get it out the door. Quite a lot of trouble for a $5 million dollar drug, so no doubt, Nasrat understood the significance of this one old drug, certainly above all the other Mikah drugs. He made sure this drug got on the shelf, and if STEADY-PDIII results are good, Elite will do very well. Nasrat will deserve all of the credit.



Nasrat Hakim 8/14/14:

The issues we encountered is the same issues that a lot public companies encounter. First, the API manufacturer was the only AP. We had single source API manufacturer in our application. So, in order for them to sell us product for us to go ahead and validate they requested first that we pay the PDUFA fee on their behalf. They were not using their DMF. So they wanted us to pay that. We paid it. It was like $36,000 or so.

Then they demanded that we buy all of the raw materials that go into making Isradipine. So we have to fork another check for $125,000 and then we had to buy the entire lot from them, which we did and the entire lot was API which is lot of API and a lot of negotiations took place between Doug Plassche and these people in order to finally to get us the API. Now that we have the API Doug needs a prioritize it and I anticipate that we will go ahead and finish that edition and launch in Q4 of this year.

There is a ton of work that’s been taking place, but it takes a while for us to be able to bring this all to conclusion and go ahead and validate and file the product or launch the product.

http://n.neurology.org/content/90/15_Supplement/P2.039

April 10, 2018; 90 (15 Supplement) APRIL 23, 2018

A Phase 3 study of Isradipine as a disease modifying agent in patients with early Parkinson’s disease (STEADY-PD III): Baseline characteristics and study update (P2.039)
Tanya Simuni, Robert Holloway, David Oakes, Kevin Biglan, Codrin Lungu


Abstract

Objective: To provide a study update in preparation for study close out and dissemination of results.

Background: The NINDS funded STEADY-PD III trial is a 36 month, Phase 3, parallel group, placebo-controlled study evaluating the efficacy of isradipine 10 mg daily as a disease-modifying agent in early PD. The study is being conducted at 54 Parkinson Study Group sites in US and Canada. Enrollment of 336 participants was 6-months ahead of schedule and participant retention has been excellent.

Design/Methods: The first study participant enrolled in November 2014 and the last participant is anticipated to complete the study in November 2018. The primary outcome is the change in the Unified Parkinson Disease Rating Scale (UPDRS) Part I-III score as measured in the ON state at month 36, in the active arm compared to placebo. Secondary outcome measures include: 1) Time to initiation and utilization of dopaminergic therapy; 2) Time to onset of motor complications; 3) Change in non-motor disability and a spectrum of other PD motor and non-motor outcome measures.

Results: As of October 13, 2017 of the 336 total participants enrolled, 327 are active in the study; (98% retention) and 315 are on study drug. There have been 9 premature withdrawals and 48 serious adverse events, 3 possibly related to study drug, 2 deaths ( unrelated). 278 (83%) participants started PD symptomatic therapy.

Conclusions: STEADY-PD III is fully enrolled and maintains high retention despite 3-year duration of intervention. Final study results are expected winter 2019. This study represents a unique opportunity to evaluate the potential impact of a novel therapy to slow progression of PD disability and provide clinically meaningful benefits.