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So in August it was "awaiting review".
When did review start? Has it? How would we know?
How long does the review process take typically?
Would love to see it happen believe me!
Ones in bold are ones I think we will see by 3/31/2012:
I'll take any and all of these though!
Here is a quick list, many I expect 1st quarter
Hydromorphone approval and Launch
Naltrexone approval and Launch
New un-named ANDA approval and Launch
Lodrane ANDA/NDA approved
Launch of 1st of 8 Epic Drugs
Isradipine Launch
Phendimetrazine Tartrate Manufacturing
HITK Intermediate for 100m market generic announced/Launch
Update on Patent for Eli 154
Update on Patent for Eli 216
Partner news for Either 154 or 216
Completion of second manufacturing facility for manufacturing
Yes. Are you familiar with their pipeline?
Latest FB posting.....
"The series "always" premiers on BIO first? Is that what happened last year?
Now they are saying "We're hoping CityTV will air Season 2"
===============================
Michael Tong Good episode last night
Sunday at 4:20pm · Like · 1
Mike Hangasluoma don't get either channel, why did citytv drop it?
Yesterday at 1:10am · Like
Dussault Inc. The series always premieres on Bio Canada first. We're hoping Citytv will air Season 2 as well, but no confirmation yet.
20 hours ago · Like · 2
Poorme:
The FDA only gave a 180 day notice on 3/2/2011 to discontinue the sale of Lodrane 24.
What the company is saying here is , despite the fact that they anticipated this happening back in 2010 the FDA did not give them enough time with the 180 day window to complete their submission.
Had the FDA either given them a "heads up" sooner (like in 2009) or given them more time to submit before having to pull it from the shelves (say a year+) they might have gotten it approved without it having been pulled off the market.
There is no other "segment". The FDA simply did not give them time to submit. No fault here at all on Hi-Techs/ECR's part. They are apologizing to the consumer for the inconvenience caused to them by the FDA.
So now it is off the shelves until they finish the approval process which they anticipate will be mid to late 2012.
I hope that clarifies it a bit.
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks_E/threadview?m=tm&bn=99215&tid=131077&mid=131077&tof=1&rt=2&frt=2&off=1
expexted mid to late 2012.
Regarding Lodrane 24 and Lodrane 24D availability: March 2, 2011 the FDA
published a notice that some 500 cough/cold/allergy products were to cease
manufacturer distribution on August 31, 2011. Our three Lodrane products
(Lodrane 24, Lodrane 24D, and Lodrane 12D) were included in this notice.
This notice was not a product recall and there were no safety issues with
our products. We now have an immediate-release, over-the-counter product
available, Lodrane D Capsules. I've attached product labeling for Lodrane D
Capsules. Lodrane D Capsules contain the same antihistamine
(brompheniramine) and the same decongestant (pseudoephedrine) that were in
Lodrane 12D and Lodrane 24D (Lodrane 24 did not contain a decongestant). The
FDA classifies Lodrane D Capsules as over-the-counter but many states and
pharmacy chains require a prescription because it contains pseudoephedrine.
More Background on Lodrane 12D, Lodrane 24, and Lodrane 24D: The FDA has
required additional work to fully approve these products as these Lodranes
were extended-release formulations and though these have been long marketed
(some similar products have been marketed for more than 30 years) a 1964
regulation classifies extended-release products as new products and hence
require a full NDA. We began the work in 2010 but the 180 day notice did not
allow the work to be completed by August 31. We continue to complete the
requirements and hope to be able to return these Lodrane products to the
market by mid-late 2012. We very much regret this occurrence and certainly
understand the negative effect this has. We also regret that no similar
product is currently available, a plea that we made to FDA. We wish we had
better news but the FDA action has resulted in a number of very beneficial
products being unavailable to physicians and their patients.
Thank you for your interest in ECR Pharmaceuticals,
Ginny Perrin
FB is all the DD I have it seems! But this seems to keep the possibility of cityTV alive:
Jason Dussault
The guitar the queen of metal signed for me in ep 2 of season 2 thanks @litaford http://t.co/9N8KJNxq
@jasondussault on Twitter · 11 hours ago via Twitter ·
4 people like this.
Geoff Wheeler who?
11 hours ago
Carlos Martinez Is there a website where i can watch season 2?
11 hours ago
Jason Dussault sorry no site play on BIO, have to wait for City TV
11 hours ago
Carlos Martinez When will it start on city tv?
11 hours ago
Jason Dussault Not sure
11 hours ago
Jason Dussault this is Lita
Well that would be about "now" then.
From the August CC:
Regarding the contract manufacturing, we expect, very soon, to begin contract manufacturing and packaging of the Pharma
Network's Methadone product. This is one of the short-term items that we can begin shortly in order to begin to reduce our
burn rate. Elite's also working on the transfer of 2 generic products for Mikah Pharma, products that would be distributed by
Activist.
The Isradipine will be sold through Actavis. Check the August CC.
So, yes it seems that we will compete internationally. Not sure how competitive we are cost wise vs Chinese and Indians but I guess we can compete elsewhere.
That being said, it's a $79,000,000 market worldwide.
I'd be happy with $2-3 million of that which might bring $1,000,000 a year to Elite.
How long does it take to transfer the ANDA?
Just to keep the home fires burning while we wait on the FDA "prior reviews"....
Let's talk about Isradipine today.
When will it launch? How much is it worth?
Some info to bring you up to speed:
http://www.drugs.com/mtm/isradipine.html
===========================
On June 6th:
http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=246966
Elite Pharmaceuticals, Inc. announced that it has entered into a commercial Manufacturing and Supply Agreement with Mikah Pharma, LLC (Mikah). Under the terms of the agreement, Elite will perform the laboratory stability studies, manufacturing and packaging for two generic products: Isradipine Capsules USP, 2.5 mg and 5 mg and Phendimetrazine Tartrate Tablets USP, 35 mg. Elite will be compensated at an agreed upon transfer price for the manufacturing and packaging of the products. For the Isradipine product, Elite will receive a 10% royalty on net profits of the finished products. Elite will also receive a onetime payment for each product for the work associated with the technology transfer.
===========
http://thepharmaceutical-news.com/elite-enters-manufacturing-supply-agreement-mikah-pharma
Isradipine capsules were originally marketed by SmithKline Beecham under the brand name Dynacirc; however, these have since been discontinued, although a 5 mg and 10 mg extended-release tablet version is marketed by GlaxoSmithKline under the brand name Dynacirc CR. Mikah’s generic 2.5 mg and 5 mg capsule version of isradipine was approved by the FDA in April 2006, and shares the market with Watson Laboratories, whose version was approved in January 2006.
+++++++++++
From Aug 2011 10Q
Contract Manufacturing of Isradipine and Phendimetrazine On June 1, 2011, Elite Pharmaceuticals Inc. ("Elite") executed a Manufacturing and Supply Agreement (the "Isradipine/ Phendimetrazine Agreement") with Mikah Pharma, LLC ("Mikah") to undertake and perform certain services relating to two generic products: Isradipine Capsules USP, 2.5 mg and 5 mg ("Isradipine") and Phendimetrazine Tartrate Tablets USP, 35 mg ("Phendimetrazine"), including (a) developing and preparing the documentation required for the transfer of the manufacturing process to Elite's facility and the appropriate regulatory filing for the ANDA, and (b) manufacturing finished dosage forms appropriate for commercial sale, marketing and distribution in the United States of America, its territories, possessions, and commonwealths in accordance with the requirements of the Isradipine/ Phendimetrazine Agreement; Elite shall perform, at its sole cost and expense, all Technology Transfer, validation and qualification services (including: equipment, methods and facility qualification), validation and stability services required by Applicable Laws to commence manufacturing Isradipine and Phendimetrazine for commercial sale by Mikah or its designees in accordance with the terms of the Isradipine/ Phendimetrazine Agreement. During the term of the Isradipine/ Phendimetrazine Agreement and subject to the provisions herein, Mikah shall purchase from Elite and Elite agrees to manufacture and supply solely and exclusively to Mikah, such Isradipine and Phendimetrazine as Mikah may order from time to time pursuant to the Isradipine/ Phendimetrazine Agreement. Mikah will compensate Elite at an agreed upon transfer price for the manufacturing and packaging of Isradipine and Phendimetrazine. For the Isradipine product, Elite will also receive a 10% royalty on net profits of the finished Product. The payment is to be calculated and paid quarterly. Elite will also receive a onetime milestone payment for each Product for the work associated with the Technology transfer. The milestone payment shall be made upon the successful manufacturing and testing of the exhibit batch. The Isradipine/ Phendimetrazine Agreement has a term of five (5) years and shall automatically renew for additional periods of one (1) year unless Mikah provides written notice of termination to Elite at least six (6) months prior to the expiration of the Term or any Renewal Term. Transfer of the manufacturing site to the Northvale Facility, a prerequisite of commercial launch of Isradipine and Phendimetrazine is currently in progress.
====================================
The worldwide market is said to be $79,000,000 (https://w.evaluatepharma.com/secure/Login.aspx?ReturnUrl=%2fUniversal%2fView.aspx%3ftype%3dEntity%26entityType%3dProduct%26id%3d4300%26lType%3dmodData%26componentID%3d1003%26tabId%3d&CanUseGuest=True&CookieTest=True)
, but the US generic market is said to be only $3,000,000. (http://www.ftc.gov/os/caselist/0710063/0710063analysis.pdf)
I am unsure as to number of manufacturers, but not many as Actavis almost had "monopoly" (see: http://www.ftc.gov/os/caselist/0710063/0710063analysis.pdf) on it.
There is one brand name, Dynacirc (Reliant Labs) and one generic made by Abrika.
There are two generics. Abrika was bought by Actavis in 2006. Abrika was required to divest themselves of the Isradpine and sell it to Cobalt Labs)
Brand names:
Clivoten (Italfarmaco (Italy))
DynaCirc (Novartis (Hong Kong, Malaysia, Mexico, New Zealand, South Africa, Singapore, Thailand, Turkey, United States))
Dynacirc CR (Reliant, GlaxoSmithKline)
DynaCire
DynaCire CR
Dynacrine
Esradin (Sigma-Tau (Italy))
Lomir (Novartis (Austria, Brazil, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Netherlands, Norway, Poland, Russia, Sweden), Sankyo (Belgium, Italy), Daiichi Sankyo (Portugal, Switzerland), Mizar (Spain))
Prescal (Novartis (United Kingdom))
Rebriden
=====================================
As Mikah "is" Actavis, basically Actavis is outsourcing the manufacture of Isradipine to Elite. Or Actavis sold Isradipine to Mikah and in turn Mikah is outsourcing production to Elite.
Final notes:
1) Isradipine may find new life as a treatment for Parkinsons:
http://parkinsonsfocustoday.blogspot.com/2009/02/future-of-isradipine-and-parkinsons.html
2) It appears that Actavis may be actively divesting itself of it's generics as it transforms itself....see:
http://health.yahoo.net/news/s/nm/actavis-prepares-for-end-of-generic-drugs-model
======================================
My guess is that, if the USA generics market = $3,000,000 and they share it with Cobalt we are talking maybe $1,500,000 in sales for Elite/Mikah. Elite gets 10% royalties + manufacturing, milestones etc. This mean that Isradipine might be worth perhaps $400,000/year in income to Elite. Now perhaps they think they will take market share from the branded product Dynacirc, or that the Parkinson's angle might provide growth or maybe they see a chance of exporting as the worldwide market is quite large. I don't think Isradipine will be real huge for Elite but they all add up.
Thoughts? Any thoughts on how long the ANDA transfer could take?
Well, maybe Jerry's FDA comments after Lodrane 24 getting pulled didn't help!
Either way, it's getting close.
Just some info you might find helpful in light of the CBE 30, now classified as "prior review" items.
See this link:
http://www.accessdata.fda.gov/FDATrack/track?program=cber&id=CBER-OCBQ-CBE-Supplements-reviewed-and-acted-upon-within-6-months
Essentially the FDA claims that 100% of all manufacturing supplements (CBE and CBE-30 day Supplements) were acted upon within 6 months of receipt.
Dictionary: Licensed manufacturers must submit a Changes Being Effected (CBE) or CBE-30 supplement to FDA for any change to a product that has a moderate potential to have an adverse effect on identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. Distribution of product made with the change may commence 30 days after FDA receipt of a CBE-30 supplement, or immediately upon FDA receipt of a CBE supplement. This measure will allow OCBQ to monitor its performance in issuing decisions for manufacturing supplements (CBE) within established timeframes.
Also, intersting PPT that gets into more detail.
https://docs.google.com/open?id=1R-ix9PwI3_NI1TxTWeKxpj5jENZ4NTwKIt70F42_5PnhaLVV5wlsADu7gtWk
Enjoy.
Just a refresher from the Q&A of last CC:
Tim Schwartz - - Private Investor
Hello, I'm rather new to Elite, so this question might not make much sense. But I was just looking at the 10-Q and it said the
interested party, with respect to the ELI-154 was identified that would - [on half ] the clinical trial, but that you are unable to find a way to find the remaining cost at this time. Does that mean that, that development is at an impasse now until, well I will just leave it at that. Is it at an impasse because you are unable to find the funding?
Chris Dick - Elite Pharmaceuticals, Inc. - President, COO
Yes, we're obviously pleased that they've done a bunch of due diligence, they believe in the opportunity, but their own model
doesn't allow them to fully fund it. So, yes, until we can identify a funding source or at some point come up with our own capital to fund it, we are stuck.We can't go forward until we deal with that piece of the funding of the development.
Jerry Treppel - Elite Pharmaceuticals, Inc. - Chairman of the Board, CEO
This is Jerry Treppel. It's a good news, bad news situation.The good news is that our partner did a lot of work in terms of market
research, in terms of what kind of clinical trials would be necessary to get an approval in Europe, which is information we really didn't have before, and there definitely is a market there, there's no question about that.
The question is, how do you get to the market.The way their business model works, they're require that the development costs
be shared.We obviously don't have the funds to do that. Either we come up with the funds to do that or we look for another
way to move forward.That's where it stands.
Tim Schwartz - - Private Investor
And, this is the company with which you - about of which you spoke of in the letter of intent, I believe, in the last conference
call?
Chris Dick - Elite Pharmaceuticals, Inc. - President, COO
(I don't know) that letter of intent. But, we certainly have been in discussions with them, as Jerry said, and they've done quite
a bit of due diligence work.
Got in a ways back in the 4's and 5's and out at 22.
Started buying again when it hit the 13's
Now holding @ .0922 average
This is my first penny stock and I'm learning a whole lot!
If we get the CBE 30's going and Lodrane 24 back we should hit .50 easy.
http://www.stockstobuy.org/forum/topics/elite-pharmaceuticals-eltp?commentId=3237573%3AComment%3A325607&xg_source=msg_com_forum
Elite Pharmaceuticals Inc. (ELTP) had a huge day today and closed above the 200 day moving average. ELTP will have resistance at $0.131 and $0.145 but then it could really move. I'd like to see a close above $0.125 tomorrow. The volume was really good today.
API = "Active Pharmaceutical Ingredient"
So there is a per bottle price for the manufacturing and packaging.
TPN provides the API (methadone) it seems here.
This is a small deal. Will pay some bills.
$44,000,000 market. About 6 competitors so $7,000,000 per competitor. If TPN does $4,000,000 in sales maybe 10-20% ($400,000 to $800,000) of that is probably packaging and manufacturing. Just my wild ass guess.
Here is what you need to look at:
http://www.faqs.org/sec-filings/110629/ELITE-PHARMACEUTICALS-INC-DE-_10-K/v227306_ex10-71.htm#b
EXHIBIT A
Product and Purchase Price and Minimum Annual Volume Requirements
Product
Mg
Bottle
Size
Cost Per Bottle
exclusive of API
FOB Elite
Minimum
Annual
Volume
Methadone
Hydrochloride 10 mg
Tablets, ANDA #090635
10mg
100's
Manufacturing
Cost ${***} (see
notes below)
{***}
Bottles
NOTE: The purchase price includes all costs except API cost which is the obligation of TPN.
ELITE shall produce Product in batch sizes between {***} bottles to {***} bottles per batch. Elite will begin with the smaller batch sizes and increase batch size as necessary. Orders shall be done based on a batch size of {***} bottles.
ELITE may also from time to time subcontract to Epic Pharma, LLC for bottling of batches.
{***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Read more: http://www.faqs.org/sec-filings/110629/ELITE-PHARMACEUTICALS-INC-DE-_10-K/v227306_ex10-71.htm#b#ixzz1jkrG3djU
Yahoo has it as 2/14
Slated:
to plan or designate (something) for a particular place and time; schedule: The premiere was slated for January.
Also, it's only $38,000 and it doesn't mature til April 2015.
Just to save time this is from last 10Q (7/31/11)
Note 6 - Notes Payable
On April 1, 2010 the Company issued a promissory note to Perati Finance Corporation for $38,000. The note matures in five years and accrues interest at 8%. The loan is convertible to common stock at a conversion price of 58% of the market price. The balance on this note as at July 31,2011 is $38,000 plus accrued interest which is reflected in accounts payable of $3,518.
Facebook Post:
Jody Quine I don't get the BIO channel... what are my options?
4 hours ago · Like
Dussault Inc. We are hoping that season 2 will air on Citytv at a later date, but we don't have confirmation yet. Unfortunately Bio doesn't have a video app, so your best bets are finding a friend with Bio or ordering the channel from your cable provider. Sorry that there isn't an easier solution!
ok
Here are some links that will help answer your question but there are comapny's making generics of Oxy in direct challenge of the patents enforceability
Court Says OxyContin Patent Is Invalid
http://www.nytimes.com/2005/06/08/business/08drug.html
http://www.bizjournals.com/sanfrancisco/news/2011/04/11/impax-oxycontin-purdue-pharma.html
Forum discussion:
http://www.pharmer.org/forum/new-medicines/new-generic-oxycontin-actavis-oxycodone-controlled-release-tablets
Patent lawsuit Actavis vs Purdue
http://news.priorsmart.com/purdue-pharma-v-actavis-elizabeth-l3Rz/
other good links...
http://nittanitcoa.ablog.ro/2012-01-04/oxycodone-30-actavis.html#axzz1jOdeRjSD
OxyContin Litigation Timeline
http://www.elsevierbi.com/~/media/Images/Publications/Archive/The%20Pink%20Sheet/70/010/00700100016/080310_oxycontin_timeline.pdf
I will say that my intent in posting that was not so much to demonstrate problems but that there is a clear connection with Nasrat-Actavis-Mikah-Elite ,,,,AND OXY.
I vaguely remember something on the Purdue/Actavis relationship....let me dig on that
I reached out to Nasrat on Linkedin....we'll see if he responds.
http://www.elsevierbi.com/publications/the-gold-sheet/43/005/actavis-resumes-manufacturing-of-oxycodone
Actavis resumes manufacturing of oxycodone
“The Gold Sheet” May 2009, Vol. 43, No. 005
Word Count: 135 / Article # 08430051009_b
Executive Summary
Actavis Totowa said FDA gave it approval to resume production of painkiller oxycodone 15 mg and 30 mg tablets at its Little Falls, N.J., facility following an agency inspection. The reopening will help ease a shortage of oxycodone that followed various FDA enforcement actions, including one that led Actavis last August to recall oxycodone and 65 other products made at its Little Falls plant, which shut down after FDA found numerous GMP violations. A Dec. 29 FDA consent decree set conditions for resuming production at Little Falls and two Totowa, N.J., facilities. "Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," said Nasrat Hakim, vice president of quality compliance and technical services for Actavis
Dumb question but I gotta ask!
Does this represent an increase or decrease in viewers vs. Season 1?
A little more light reading....
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3200070/
This article discusses several solutions in process, including Elite's.
http://www.medpagetoday.com/Psychiatry/Addictions/25888
did 1 earlier today but thanks for playing!
Don't mind me, I have to make 4 posts to do an experiment for LL8,
Don't mind me, I have to make 4 posts to do an experiment for LL8,
Don't mind me, I have to make 4 posts to do an experiment for LL8,
Nice place ya have here....oops was that off topic?
Not sure if I'm coming or going with the Dussault FB posts but this is the latest on season 2 I guess?
First the Season 1 finale at 7:30pm on Citytv: After Jason forgets her birthday, Mashiah heads to Sin City with Fiona Forbes. Jason schemes with Carrot Top to make it up to her with a Vegas wedding, unaware that marriage is the last thing on Mashiah's mind...
Find out what happens, and then immediately switch over to Bio for the Season 2 premiere at 8pm where Jason and Mashiah consider moving to the hills of Hollywood to try to hit the big time.
Regarding the NJEDA Bonds. From Q1 CC transcript:
David Altshuler - Meketa Investment Group - Analyst
David Altshuler, shareholder. I'm curious about something in terms of the default on the municipal bonds that are financing
the facility. Is this, in any way, an impediment to other people who are considering doing business with you, to see that you're
not up-to-date on this obligation? And, what is being done to remedy this?
Carter Ward - Elite Pharmaceuticals Inc - CFO
Well, with regards to an impediment of people doing business, no, we haven't experienced any problems related to the bonds.
What we are doing with this is, and this is in our reports, we have submitted a request, which we're allowed to do to defer the
principal payments. We're allowed to request up to a five year deferral of principal payments.
We have requested three years and we made the request through our trustee and we are awaiting for a response from the
bondholders. The bondholders have to approve that request, so that's where it stands right now. The three years requested
would be -- on the fourth year we would have to repay the entire three years principal payment plus the principal payment that
is due that year. So that's the proposal that's currently out there.
"Proceeds will be used for product development, including the scale-up of products using Elite's abuse deterrent technology, as well as other corporate purposes that management may deem necessary and appropriate."
http://app.quotemedia.com/quotetools/newsStoryPopup.go?storyId=47235988&topic=ELTP&symbology=null&cp=null&webmasterId=91011
Facebook:
Dussault Apparel how are you mitch, city archives a few eps here http://www.citytv.com/vancouver/show/micro/152770--dussault-inc
January 6 at 2:25am · Like
Rob Lehmann Will the show be on citytv for season 2?
January 6 at 11:38am · Like
Dussault Apparel havent received air date from City tv yet
Leads me to believe they fully expect it to happen.
Thanks Rizzo!