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http://www.intellipharmaceutics.com/technology_portfolio.cfm
We are so wrapped up in Rexista... and rightly so... that we forget about the plethora of other drug delivery platforms IPCI has.
We need to get a healthy partner for Rexista and Regabatin... decent up front money so we're cash rich and can start hiring some product developers... dreamers that can think up of what products on the market today can be enhanced by which of IPCI's extended release platforms... and some scientists that can see it to fruition... under the Odidi's tutelage.
IPCI can become HUGE
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http://www.intellipharmaceutics.com/hypermatrix.cfm
Hypermatrix™ is a novel concept based on hyper-dimensionality in which a drug matrix assembly is defined as five dimensional in nature: length, height, width, space, and time. The understanding and controlling of properties associated with these dimensions facilitates time-release delivery of a wide range of pharmaceuticals.
Our Hypermatrix™ technology works within the human body, responding to the multivariate external environment of the Gastro-Intestinal Tract (GIT), releasing active drug at the desired time and according to the desired profile. This is achieved with:
Spatial Recognition and Control of the optimum GIT site for drug release
Defensive Control over adverse factors such as food effects or excess acidity
Temporal Control over the time when drug release commences or ends
Structural Control over the physical characteristics of the solid dosage form from ingestion to full release
Rate Control over the entire release profile to deliver true intelligent extended-release
I think the rate control is what is going to make this a "best in class" drug... besides the fed/fasting advantage.
I still believe the FDA is very interested in seeing if Rexista, once it gets the initial pop of drug and then turns into a steady state release... if that steady state is maintained for a full 12 hours
If so... Goodby Oxycontin.
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Whoever it is... I hope they are negotiating with at least 2 potential partners... that would pretty much guarantee that they are getting appropriate value.
Their cash reserve, or lack of, does not put them at a strong negotiating position... but the fear that the "other guy" might get it, is a an extremely strong motivator.
Ever been to an auction where 2 people want the same "used" product and the winner winds up paying more than what it would have cost him to buy it new LOL.
I think a healthy partnership will really put this small biotech on the map.
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Negotiating Partnerships on a product is rather common and basically follow well established practices.
First an assessment is made on... what the market potential is... what are the likelyhood of that product achieving that potential... when might that potential be achieved, and how much will it cost in $ to assure it achieves that potential.
One of the factors in a partnership is the royalty percentage - I once gave what expectations are on those, based on how far along the product is towards commercialization. At the stage Rexista is at... NDA submitted FDA approval not yet received... I would say the royalty % will be 20%-25% for up to $1 billion aggregate sales 25%-30% northwards of $1 billion aggregate sale if/when that figure is achieved.
If Partnership is AFTER FDA approval I would bump those % figures up by 5%
There will be milestone payments along the way - my guess is $40 to $50 million up front, plus an additional $50 million on FDA approval, + $100 million on achieving $1 billion aggregate sales and perhaps an extra $25 million if those sales goals are achieved before a certain date. I would guess another $100 million on achieving $3 billion aggregate sales.
As you see such a contract protects the sales partner if Rexista proves to be a dud, but also rewards IPCI if Rexista achieves great success... and of course there will be minimal sales clause or loss of contract with a return of sales rights along with a severance payment of say perhaps $50 million to IPCI.
So all of the above is standard practice and common occurrance... BUT... we do have a problem which will, or has, murkied up the waters, and I have no idea as to how it's going to be handled.
Supposing everything goes according to plan and 3 years down the road Rexista PODDS has sold over a billion $ worth, and is selling $750 million a year and well on it's way to that $3 billion aggregate sales milestone... another word, a great success... BUT... over the hill comes Rexista PODDS + PODRAS... WHAT THE HELL HAPPENS THEN!!!
I have no idea how they would handle that - of course you can build into the contract that the current partner gets "rights of first refusal" but who decides what that new partnership is worth - supposing a new entity makes a "wild bid" for Rexista PODDS + PODRAS, what happens then???
These things will all have to be ironed out BEFORE Rexista PODDS is partnered and you can't pull out template A and just change the #s a bit... although I imagine similar circumstances have been resolved before, so that there is some precedence.
Mostly what I'm saying is that IPCI's Rexista PODDS partnership is not such a cookie cutter format... and can become, or is, quite complex.
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“Some men see things as they are and say, why; I dream things that never were and say, why not.”
20K shares today makes you a millionaire in 3 to 5 years!
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I'm not sure I've said this... but if I did I'll say it again.
I think there will be days of $1.00+ rises as institutional accumulation takes place.
My gut... and years and years of investing in emerging biotechs, tell me IPCI should be valued at least as much as Egalet - $180 Million market cap - which would price it at about $6.50 a share... and that's not even pricing in Regabatin or their pipeline of ER generics.
p.s. Egalet has 67% institutional ownership - when IPCI has 67% my guess on pps will be between $12 and $20
This is what you said he said
Published On: Tue, Jul 26th, 2016
Oh yea... I forgot!
20K shares today... makes you a millionaire in 3 to 5 years!!!
Jeeezzzz
Looks like I own... by far... more than any other institution out there... and I'm not an institution!!!
How does it go... as Angelo goes... so goes IPCI ???... is that how it goes... LOL
I'm either brilliant or an idiot... what say you Doog???
http://www.latimes.com/projects/oxycontin-part1/
Numbers...
I'm interested in getting your "feelings" as to what you think IPCI's market cap / share price should be right now and what you see for IPCI going forward and possibly a progression timeline.
Rexista could possibly strike a death blow to Oxycontin
I wanted to write this post for several days now, but did not want to write it without the link to a very important article I had read, which is the basis of the following assumptions.
Well, I have just re-found the article and I think it's well worth reading.
http://www.latimes.com/projects/oxycontin-part1/
I'm not saying these are facts, nor probabilities... but I do think they are very high possibilities, and they make some pieces of the puzzle fit and make the picture make sense.
The condensed version of the article is basically that Oxycontin sells itself as a 2x day drug and gets premium coverage for being an extended release drug... however for many people it does not offer 12 hours of relief BUT if doctors prescribed oxycontin as 3 or 4 x a day... it would lose insurance coverage as a premium drug, so doctors are instead told to offer stronger dosages rather than more frequent doses... and there in lies the overdose issue.
In case anyone else is not clear on the Rexista Fast Track designation, here is an exchange between myself and Della Penna.
Hello Doog,
Was just thinking exactly the same thing... I presented here a factual case where a product inferior to and at an earlier stage than Rexista was valued at $430 million with 20% royalties and all you get here is nickle and dimers.
You're probably aware that as soon as this hits $3.00 to $6.00 most of these "investors" will be out the door... so we may be the only ones meeting in Vegas.
The hardest part I see going forward is to resist temptation to sell at every little pop.
Back in mid 2011 I bought ANIK for around $5.00. It was one of my 10 bagger picks... 1/2 a year later... due to margin calls, I had to sell it at $10.00 - fast forward 2 years later it hit $50.00
I could tell you a few more stories like that... but I'm just tired of trying to make the blind see.
Generic Drug Approvals Hit New Record in 2015
Here's a bit of good news... They expect/hope to be all caught up by end of 2017 so we should be expecting 6 ANDA approvals within the next year-and-half.
WHOOOOAAAHH - I FOUND IT!!!
http://www.in-pharmatechnologist.com/Ingredients/Pain-Therapeutics-and-King-Pharma-enter-opioid-alliance
A MUST READ FOR EVERYONE TO REALIZE IPCI's POTENTIAL.
My memory served me pretty well - BUT... it's even better than I remembered.
I thought that Pfizer/King paid Pain 20% from which Pain would kick back 9.1% to Durect, but that's not the case - King/Pfizer pays Pain 20% (after $1 billion Sales) PLUS... it pays the Durect 9.1% royalty - that's a total of 30% royalty for a drug that needed 100's millions $ more spent on it, and years of time - Rexista is "ready to go", so what is Rexista worth???
$150 million up front payment
$150 million regulatory development milestones
$ 15 million acceptance of filing
$ 15 million FDA approval
$100 million in research to be spent to develop it
$430 MILLION TOTAL - IN CASH - PLUS 15% royalties on SALES for first $ billion and 20% thereafter.
Based on the reality of the #s in that CONSUMMATED deal, my numbers are FAR from pie in the sky, but very close to the reality of what should happen.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123776072
http://finance.yahoo.com/news/pfizer-walks-remoxy-end-ulterior-170000862.html
re: Remoxy - As of their last update earlier in 2014, Pfizer was still guiding to re-file the NDA around the middle of 2015. Today's news is a big disappointment. We had previously stated that REMOXY had potential peak sales in the $1.5 billion range. Durect's tiered royalty – roughly 9.1% at $1.5 billion in sales – would have provided significant cash flow to the company.
I'm going by memory so I may be off in my figures... but it's to give a better understanding of what exactly IPCI's potential is.
Note that royalty payments to Durect is almost 10% of SALES or an estimated $150 Million a year in PURE PROFIT.
Also note that Durect's deal is not with Pfizer but with Pain Therapeutics - who bought the rights to Remoxy from Durect for around $20 million??? + 9.1% which a few years later,.. after bringing it along a little further, Pain Therap. sold it to King pharma for I believe $400 million, + I think 20% royalty... and Pfizer bought out King primarily to get Remoxy... and then spent hundreds of millions more to bring it along, and eventually dropped it.
You all need to open your eyes wide and realize what exactly IPCI is about - sure it's a buck and a half NOW, but that doesn't mean that's what it's worth, and good investing is finding a bargain and going all in before everyone else discovers it.
For the umpteenth time - 20K shares today makes you a millionaire in 3 to 5 years.
WAKE THE HELL UP!!!!!!!!!!
http://www.investopedia.com/articles/stocks/06/biotechvaluation.asp?ad=dirN&qo=investopediaSiteSearch&qsrc=0&o=40186
The above link is full of info if you're not familiar with how the pie is split between partners.
If IPCI chooses to manufacture, which I'm sure it will, it will do so on a cost + basis... not at all uncommon in these type of partnerships.
You get estimates on what Rexista will cost to produce when scaled up, and add 20% to that - because everyone is allowed to make a profit - so if cost is $1.00 a pill, then IPCI sells it to it's partner for $1.20.
Doog... where are you... have you seen this... a major piece of news to share with your "friend"
http://finance.yahoo.com/news/fda-issues-complete-response-letter-210707350.html
NORTHVALE, N.J., July 15, 2016 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the “Company") (ELTP) today announced that the U.S. Food and Drug Administration (the “FDA”) has issued a Complete Response Letter (the “CRL”) regarding the New Drug Application (the “NDA”) for SequestOx™
This is the reason I would like IPCI to partner BEFORE the application even if the deal means a lesser up front payment.
Would feel more confortable if I knew a major pharma was holding IPCI's hand and seeing that all the i's are dotted and the t's are crossed.
Although I think that any major pharma ready to sign on the dotted line would want an involvement in the filing... just to make sure.
http://www.investopedia.com/terms/n/new-drug-application-nda.asp?ad=dirN&qo=investopediaSiteSearch&qsrc=0&o=40186
Once a company reaches the NDA stage, the probability of the drug receiving FDA approval and being marketed in the U.S. exceeds 80%. Filing of an NDA typically does not result in a substantial increase in the share price of the sponsor company, as most of the stock appreciation is likely to have occurred as the investigational drug progressed through successive phases of earlier clinical trials.
Say what???
We haven't yet received our pie "with ice cream on top"... but I expect that to change soon - and expect several days of $1.00 plus pps increases as this needle in the haystack is found - every mutual fund that comes in looking to pick up a million shares will drive the price up $1.00 - 10 funds = $10 Plus.
It's really very dependent on who the partner will be - and what the deal will be... If there are more than one suitor... we will get fair value... which I expect to be considerable.
I'm hoping it will be Pfizer and see it as a first step of a takeover to protect their Lyrica franchise... a wild but not unreasonable guess... takeover at $3 to $4 billion in end of 2018.
http://www.investopedia.com/terms/n/new-drug-application-nda.asp?ad=dirN&qo=investopediaSiteSearch&qsrc=0&o=40186
DEFINITION of 'New Drug Application (NDA)'
The final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S. An NDA is a comprehensive document with 15 sections that includes data and analyses on animal and human studies, the drug’s pharmacology, toxicology and dosage, and the process to manufacture it. When an NDA is submitted, the FDA has 60 days to decide whether to file it for review, or reject it because some required information is missing. The goal of the FDA’s Center for Drug Evaluation and Research (CDER) is to review and act on at least 90% of NDAs for standard drugs within 10 months after the applications are received, and six months for priority drugs.
PDUFA date is set at 6 months from the date RECEIVED, not accepted - so if filed by mid August then PDUFA date by mid February... I'm fairly certain it was also granted priority review... as PODRAS was.
It would appear from the statement below, that along with Focalin, 5 other drugs are also partnered with PAR already.
re: the very strong commercial relationship between Par and IPCI I believe has since become an open marriage where Par can manufacture on it's own the drugs partnered with IPCI, likewise IPCI can partner those same drugs with other concerns... including Focalin... although it seems neither has strayed from the relationship re: focalin.
There was a RUMOR a couple years back that Par had offered ~ $8.00 per share, which the Odidi's turned down - RUMOR, not necessarily fact... but that might have soured the relationship some.
http://www.intellipharmaceutics.com/releases.cfm?Year=&ReleasesType=&PageNum=7
August 1, 2007
IntelliPharmaCeutics Announces Equity Investment by Par Pharmaceutical In Separate Agreement, IntelliPharmaCeutics to Collaborate with Par in the Development and Marketing of Controlled Release Generic Drug Products
TORONTO, Aug. 1 /CNW/ - IntelliPharmaCeutics Ltd. today announced that Par Pharmaceutical (NYSE: PRX) has made a significant equity investment in the Company. IntelliPharmaCeutics Ltd., through its operating company, IntelliPharmaCeutics Corp., develops, licenses and markets both new and generic controlled-release pharmaceutical products. Par Pharmaceutical is a major developer and distributor of generic and branded drugs in the U.S. market.
Under the terms of the investment, Par Pharmaceutical will acquire a 4.2% equity interest in IntelliPharmaCeutics, on terms typical for an investment of this sort and magnitude. The funds will be used by IntelliPharmaCeutics Corp. for general corporate and working capital purposes.
IntelliPharmaCeutics Corp. today also announced that it has signed a drug development collaboration with Par Pharmaceutical. Under the arrangement, IntelliPharmaCeutics will apply its proprietary technology to the formulation and development of four generic drug products (ANDA's) which are bioequivalent to significant branded drugs with substantial commercial sales in the United States. The terms of the deal provide that Par will be responsible for certain costs of development, and that IntelliPharmaCeutics will receive substantial milestone, incentive and success-based payments, together with a share of the profits of commercialization. Par will be responsible for the distribution of the drugs in the United States. These four new collaborations bring the total of drugs under development with Par to six, and represent the continuation and solidification of a very strong commercial relationship between the companies.
Dr. Isa Odidi, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics, expressed his deep satisfaction with the expanding relationship: "We are very pleased that Par believes enough in the present value and future prospects of the Company that they are prepared to make an equity investment of this magnitude and we are proud to have such a significant drug developer and distributor as Par as a collaboration partner. We view the completion of these new deals as a strong endorsement of our proprietary technologies, of our ability to apply them to a range of small drug molecules and of our willingness to engage in dynamic, cooperative and productive relationships with our development partners. We are confident that we will be able to leverage these investment proceeds to substantially advance our exciting internal pipeline products. These new products, and the next-level technologies they will utilize, could provide the impetus to propel the Company to the next level."
I posted the following on June 10th and hold to these numbers.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=123230322
I think what is far more important than the filing is the FDA acceptance of the NDA which is usually within 30 days after filing, and issuance at that time the PDUFA date... which should be for 6 months from date of filing since they are fast-tracked.
Acceptance of the NDA pretty much cements that they do NOT indeed need to do a phase 3 - which saves about 20 million $, and even more importantly around 2 years of time,
I think once that is known for sure... we'll see a partnership announced that takes all that into consideration.
I believe it will in fact be accepted and I am then expecting a $400 million total package -
$40 million up front + 20% royalty payments ON SALES OR REVENUE
$60 million on FDA approval
$100 million on $1 Billion aggregate sales milestone
$200 million on $3 billion aggregate sales milestone
or possibly 25% to 30% royalty payments on a $250 to $300 million total package. Also believe they will get a "rights of First Refusal" on Rexista w/ PODRAS
Royalty splits vary and depend mostly as to what stage of the approval process the drug is in - preclinical usually pays ~ 5% - if at successful phase 1, then usually ~ 10% - successful phase 2 can net you 12% to 15% - a successful phase 3 usually pays 20% - If FDA approved, easily 30% to 50% can be had - in Rexista's case if partnered before approval I would say 20% is conservative. Royalty payments are based on sales or revenues... not profits... so if IPCI negotiates 20% royalties it will be 20% of sales and the full payment is all profit to them... like the Focalin payments.
Rolling out a drug is very expensive and usually an agreed amount... say $30 million first year - 15 million 2nd year is set aside before royalties are paid... but long term profit margins on drugs - especially pills like Rexista are very high - my guess 65% to 80% profit margin - but, the royalty payments will be on sales or revenues, NOT profits.
Additionally... part of the approval process is that IPCI needs to have in place, proof that it can produce commercial quantities of Rexista utilizing current Good Manufacturing Process cGMP.
IPCI has always maintained that it intends to manufacture Rexista to assure trade secrets are not disclosed, so my guess is they will need around $20 million to set that up... I expect that will come from the partner as milestone payment once the deal is signed, I would also expect partner will want possibly 5 million shares at market cost... so any figures should reflect ~ 40 Million shares FULLY DILUTED.
Epizyme nabs combo trial deal with Genentech for NHL candidate
my understanding was that you were holding 46K shares.
Have you sold them and are you short now??
State your position... CLEARLY
Actually their fiscal year ends November 30... so even June would be considered 3rd quarter
Best forget which quarter and go by June/July timeframe.
I think what is far more important than the filing is the FDA acceptance of the NDA which is usually within 30 days after filing, and issuance at that time the PDUFA date... which should be for 6 months from date of filing since they are fast-tracked.
Acceptance of the NDA pretty much cements that they do NOT indeed need to do a phase 3 - which saves about 20 million $, and even more importantly around 2 years of time,
I think once that is known for sure... we'll see a partnership announced that takes all that into consideration.
I believe it will in fact be accepted and I am then expecting a $400 million total package -
$40 million up front + 20% royalty payments
$60 million on FDA approval
$100 million on $1 Billion aggregate sales milestone
$200 million on $3 billion aggregate sales milestone
or possibly 25% to 30% royalty payments on a $250 to $300 million total package.
Pfizer opioid given mixed report after posing a ‘quandary’ for FDA panel
http://www.fiercebiotech.com/biotech/pfizer-s-opioid-given-mixed-report-after-posing-a-quandary-for-fda-panel?mkt_tok=eyJpIjoiWVRnM1ltWmlOR1kyWVRBeSIsInQiOiJGYUdObGlBT0VMbk50RFpFQ2k4Ync0ckNxOFJWdzZVVWQrcFV4NjdLdlRpRnNtaGFXTkdOeHppUzBlYlRBM2dDTUZWYnNCcVd0WGhHSXpZNEJoN2hBUng4QzFYV29Ba0k2VDZlM2k1K0szZz0ifQ%3D%3D&mrkid=630788&utm_medium=nl&utm_source=internal
I'm on record for $50 a share - within 3 to 5 years - now within 3 years.
Again!!! 20,000 SHARES TODAY MAKES YOU A MILLIONAIRE IN 3 YEARS!!!
With me it was never about the generics - always been about Rexista and Regabatin... not that the generics are feeble in themselves, but they pale in comparison to the NDAs.
The IPCI platform is worth BILLIONS.
Do you hate lying FUDsters as much as I do???
here are facts: they raised $397,244 by selling 193,043 shares - they averaged $2.06 so I guess it was them with all that available stock on the ask - and they raised $122,092 by converting 58,139 warrants, so the warrants had an exercise cost of $2.10.
193,043 + 58,139 = 251,182 shares = 1% dilution. - very frugal as always.
All previous sales on the ATM have been at around $3.25 and IPCI has always been very stringent about diluting so why did they not sell ATM when it popped to over $3.00... why sell at an average of $2.06???
Here's my opinion: My guess is that they are working on a partnership that may pop it well above $3.00, and includes a sizeable up front payment, but it's not getting done in a timely manner, and therefore... the last minute sales at 2.06.