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Intellipharmaceutics Augments Its Rexista(TM) Oxycodone Development Program With Novel Overdose Deterrence Technology
TORONTO, Aug. 28, 2014 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced an enhancement of its Rexistaâ„¢ abuse-deterrence technologies with a significant improvement designed to prevent overdose when more pills than prescribed are swallowed intact. Intellipharmaceutics' new platform technology is branded PODRASâ„¢ (Paradoxical OverDose Resistance Activating System).
The PODRASâ„¢ platform technology is covered by patents pending with the U.S. Patent and Trademark office.
"We believe this significant advance in our abuse deterrence technology has the potential to positively differentiate Rexistaâ„¢ from other abuse-deterrent technologies of which we are aware, and represents an important step toward helping patients manage their pain safely," said Dr. Isa Odidi, Chief Executive Officer of Intellipharmaceutics. "In addition to its use with oxycodone, the new technology is potentially applicable to a wide range of drug products that are intentionally or inadvertently abused and cause harm by overdose to those who ingest them."
Intellipharmaceutics' most advanced application of the PODRASâ„¢ platform to date is to its Rexistaâ„¢ product candidate (oxycodone hydrochloride extended-release tablet), which is designed to deter abuse by both physical interference and overdose.
Preclinical studies of Rexistaâ„¢ suggest that, unlike other third-party abuse-deterrent oxycodone products, if more tablets than prescribed are deliberately or inadvertently swallowed, the amount of drug active released over 24 hours may be substantially less than expected, even possibly approaching zero. However, if the prescribed number of pills is swallowed, the drug release should be as expected.
In January 2013, the United States Food and Drug Administration ("FDA") published a paper titled, Guidance for Industry: Abuse-Deterrent Opioids — Evaluation and Labeling, which cited the need for more efficacious abuse deterrence-technology.
In this draft Guidance, the FDA stated, "Opioid analgesics are often manipulated for purposes of abuse. Most abuse-deterrent technologies developed to date are designed to make product manipulation more difficult or to make abuse of the manipulated product less attractive or rewarding. However, these technologies have not yet proven successful at deterring the most common form of abuse - swallowing a number of intact pills or tablets to achieve a feeling of euphoria."
Dr. Ed Sellers, an internationally recognized clinical pharmacologist and Professor Emeritus, University of Toronto, and President of DL Global Partners commented "The risk of overdose due to taking more opiate analgesic than prescribed is a real one. The lack of delivery technologies to reduce that risk is an unmet public health need. The announced technology is promising. Confirmation of its clinical importance in human clinical studies would be a significant contribution to deterring abuse."
Intellipharmaceutics currently expects to begin a series of clinical trials in Canada and the United States in the coming months to further evaluate Rexistaâ„¢ incorporating its PODRASâ„¢ platform.
There can be no assurance as to whether or when the FDA will approve any Intellipharmaceutics' Rexistaâ„¢ oxycodone application.
About Rexistaâ„¢ Oxycodone
Rexistaâ„¢ oxycodone is an investigational drug, with a unique long-acting oral formulation of oxycodone intended to treat moderate-to-severe pain when a continuous, around the clock opioid analgesic is needed for an extended period of time. Rexistaâ„¢ oxycodone is designed to discourage common methods of tampering associated with misuse and abuse of such prescription opioid analgesic.
About Intellipharmaceutics
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrixâ„¢ technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (our dexmethylphenidate hydrochloride extended-release capsules for the 15 and 30 mg strengths) and product candidates in various stages of development, including Abbreviated New Drug Applications ("ANDAs") filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.
Intellipharmaceutics also has New Drug Application 505(b)(2) product candidates in its development pipeline. These include Rexistaâ„¢ oxycodone, an abuse-deterrent oxycodone, based on its proprietary nPODDDSâ„¢ novel Point Of Divergence Drug Delivery System, and PODRASâ„¢ Paradoxical Overdose Resistance Activating System, and Regabatinâ„¢ XR pregabalin extended-release capsules.
Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as "may," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "potential," "continue," "intends," "could," or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, on capital availability, the potential dilutive effects of any future financing and the expected use of any proceeds from any offering of our securities, our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property for our drug delivery technologies, products and product candidates, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and collaborators with the ability to fund patent litigation and with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and collaborators, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, the difficulty of predicting the impact of competitive products and pricing and the timing and success of product launches, the timing and amount of insurance reimbursement for our products, changes in the laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third party sourced products and materials, difficulties or delays in manufacturing, the manufacturing capacity of third-party manufacturers that we may use for our products, and the successful compliance with FDA and other governmental regulations applicable to the Company and its third party manufacturers' facilities, products and/or businesses. Additional risks and uncertainties relating to the Company and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-3 (including any documents forming a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on www.sedar.com and www.sec.gov. The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document, and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Company Contact:
Intellipharmaceutics International Inc.
Shameze Rampertab
Vice President Finance & CFO
416-798-3001
investors@intellipharmaceutics.com
Investor Contact:
ProActive Capital
Kirin Smith
646-863-6519
ksmith@proactivecapital.com
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Is he implying that they have other drugs available now?? I think he's mixed up.
Just looking at recent approvals... Mylans looks like they filed their FROVATRIPTAN SUCCINATE on October 22 2010
http://www.drugpatentwatch.com/ultimate/preview/drug-master-files/frovatriptan+succinate/i
Just got approved in July
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/ucm409369.htm
and it was involved in a lawsuit.
so 44 months or so... This is annoying cause we should be right there.
I just hope we get a big run up like we did on the last approval. All the shorts get squeezed and send it to a nice spike before settling in a new range...
Hey Tony can you give me your email? I heard a few things I'd like to discuss with you.
Wish I knew his source. I live 20 min from Toronto. Could probably do it faster an easier....
No shares traded over last hour.... Everyone holding??
What's suspended mean? They aren't covering TEVA anymore? Kinda odd after they just said it was a better prospect and the technology was better....
The fact is both are protected by patents and secrecy applications that the only people who know what their product does are those working on it. Teva has np clue about ipci's and the have no clue about teva's. One thing for sure is that the analyst has no clue about either's technology.
Lol love that 70s charger comercial
Lol love that 70s charger comercial
I said I was going to do this. So heres my 71 Charger.
She's NOT as nice as she is in this photo. This was right after that paint job. I'm going to have to do a lot on this car as its been sitting for a while.
https://www.dropbox.com/s/kj4i3b8l7ogmazk/Charger.jpg
Hey muddy what did he tell you?
some positive news I posted a few days back may of got lost in the commotion. But teva is allocating doses of 5-10 mg so sales / production must of started if they are allocating already.
Everyone chill!
We're allowed to have different opinions here!
I do feel some sort of news would go along way here though. To just ignore joe retail investors is wrong. When you take a company public you owe it to all your investors not just the big ones.
Never mind government.. In my job I see it often people O/D or abusing prescription drugs.
Charities, NGO's, Doctors, Insurance companies, all are groups that would push for this stuff.
Doctors in the US are sued for this stuff.
http://www.amednews.com/article/20130304/profession/130309978/4/
I can see insurance companies wanting it in the drugs they will cover to reduce liability and payouts. Lots of ways to make money on this
Legislation?
The drug companies are being taken to task now for opioid abuse now forcing changes in drug delivery. Is it that much of a stretch to think that that a similar scenario in that respect?
Well in all fairness in the report they mention revenues will vary due to timing of par payments. Would e been nice if they said that was the issue though...
Found this though
http://www.ashp.org/menu/DrugShortages/CurrentShortages/bulletin.aspx?id=1079
Teva is allocating 5-10mg doses. That means its likely to ship soon and im assuming that means sales have started...
They need to launch 40 mg dose ASAP and provide some sort of positive news to stop the bleeding. A approval would go a long way right about now...
Unless teva is doing it on purpose so that we can't launch it...
SO are we thinking they're just being conservative here? I can't see them still needing to sell more shares / needing more funding if they get 1 or 2 more approvals. Especially since the other drugs are bigger markets than focXR. I guess ultimately it will come down to the agreement they work out and whatever future bonuses / payments are on their side.
So essentially we're stuck until the get their issues sorted out. Hopefully the 40mg dose can be a significant profit driver.
Quoting pg 8 on teva issue..
"Our 5,10,20 and 40mg strengths were also tentatively fda approved, subject to the right of another party or parties to 180 days of generic exclusivity from the date of first launch of such products by such parties."
They even go on to specifically mention that they haven't launched the 5,10,20.
They then say Par intends to launch these strengths immediately upon the expiry of those exclusivity periods.
So from the date of first launch would imply to me that it has to happen after they launch / produce which they haven't except for the nov 21 launch of the 40 mg dose.
So we can prob start the 40 mg dose which I'm not sure why we haven't yet. But the others I don't think we can start until Teva sorts their crap out and gets rolling.
So I read the whole report over last night and today and have a few questions and points from what I read...
On page 8. The final approval for the remaining doses of FocXR (5,10,20,40mg). It reads as if the doses cant launch until Teva has their exclusivity window. So are we essentially at their mercy while they try to launch their product? So basically if its 180 days from their launch and they never get around to launching it due to whatever issues they're having do we have to keep waiting? They launched their 40mg dose on November 21st... so its been over 220 days since that dose anyways. Should we not be launching a 40 mg dose by now?
On page 8. So nice news on rexista but what were really waiting for is further news. Most of us know this.
On page 9. Nice news on Regabatin.
They also mention that more money was put towards R&D due to being in a better financial position. My concern here is though that latter on they state the R&D includes stock options and performance bonuses. I'd like to know how much is options and bonuses vs how much went to actual R&D cost. Don't really see that in here. They touch a bit on this on page 15 but says the increase of $1,382,203 covers development cost (which I'm sure we're all ok with) and the payment of bonuses and salary increases.
On page 12. How do warrants change from a liability to equity? Could the earnings been even worse if they didn't?
On page 15. The SGA.. The increases again are to bonuses. Other expenses are down which is nice.
Page 22. They state they're not anticipating generating sufficient cash flow from operations. This concerns me a bit. I was hoping that with the near term possible approvals of the ANDA's that they could generate sufficient cash flow.
On page 23 there was a dilution of 1.85 million shares. Seems fairly Minimal. As of now I think we will continue to see minimal dilution probably from the exercising of warrants and what not. They seem pretty confident that there is enough cash to last till the end of this year.
The convertible debenture maturing on Jan 1st 2015. Any word when the Odi's plan to exercise it? Time is running out and its 500k shares..
Sorry if some of these are stupid questions. I'm Curious
He owns a yellow one... Saw it in person :/
The increase in cash looks like its from sale of common shares. Probably explains why the stock wasn't moving for so long.... Man we're really going to need some positive news since the earnings looks like its going to drag this down....
Lol are we all classic car fans? I got to get going on my 71 charger 440!
Is there any other kind? :P|
2014 eco diesel Laramie
Its about time.
I added last week a position I'm hoping to use to pay off my truck. If we get another 100-140% spike I'll be pretty much done :D
I've got a order in on the TMX @ $3.95 its only filled 100 shares. No one is selling :(
I've got a order in on the TMX @ $3.95 its only filled 100 shares. No one is selling :(
Warrants
At June 3, 2014, an aggregate of 2,418,575 common shares were issuable upon the exercise of outstanding common share purchase warrants, with a weighted average exercise price of $2.43 per common share.
(Does that mean 2,418,575 are issued as of yesterday?)
Options
At June 3, 2014, an aggregate of 4,708,039 common shares were issuable upon the exercise of outstanding options, with a weighted average exercise price of $3.99 per common share. Up to 387,212 additional common shares are reserved for issuance under our stock option plan.
(same as above)
Deferred Share Units
At June 3, 2014, there were 47,502 deferred share units issued to one non-management director.
(I think that's self explanatory)
So are we looking at 7,125,614 shares of dilution at a average price of $3.46?
OK! the issue with questrade has been sorted out. The money has been sent, waiting for it to arrive in the account and the I can buy some shares of the TSX shares of Intelli I.to
So consider the rocket ship fueling right now...
Its waiting for my wife's TFSA to get set up so I can pay off my truck... Stupid Questrade.
I think that will only happen if future approvals do t generate enough cash to fund future expansion. With 3 drugs due this year alone I don't know if they would need it...
The only thing that can bring this down imo is a negative rexista report.
Im debating opening a tfsa in my wife's name and maxing by line of credit on this :). Would almost be able to pay off my new truck if it spikes like it did last time...
So little volume that I thought it was halted =/
I wonder if it will keep spiking or pull back today.. I anticipate a pull back... Question how much....
yeah nice to see that from a company. Give a little back to its employees