IntelliPharmaCeutics – IPCI - - Hot Stock - - 2015 – 2016 (Seite 230)

[DWL33]

Antwort auf Beitrag Nr.: 53.315.178 von DWL33 am 20.09.16 22:57:28

Interessant finde ich hier insbesondere die Kommentare, eine spannende Diskussion über die Zulassungwahrscheinlichkeit.
Lt. älterer Quellen war der Abschluss der Rexista HAL Studien für Q2 geplant, ich konnte aber hier keine Studienergebnisse finden. Dies ist letztendlich aber entscheidend für die Zulassungswahrscheinlichkeit von Rexista. Kann hier jemand Quellen einstellen? Würde mich gerne tiefer in die Materie einarbeiten.

[DWL33]

http://seekingalpha.com/article/3999753-abuse-deterrent-drug…

[DWL33]

Moin @illmatix schön Dich hier zu sehen

Die nächsten Tage lohnt sich auch ein Blick auf PTIE und DRRX, am 25.09.2016 ist PDUFA für REMOXY, ein direktes Konkurrenzprodukt für Rexista. PTIE ist weiteres Beispiel für die krasse Unterbewertung von IPCI im direkten Vergleich.

[Niller84]

Antwort auf Beitrag Nr.: 53.309.325 von M@trix am 20.09.16 09:31:04

Danke für die Research!

Das wollte ich doch auch mal gesagt haben, vielen lieben Dank dafür M@trix
Und willkommen hier Illmatix, ich hoffe doch wirklich, dass dein Telesta Abenteuer noch einigermaßen glimpflich ausgegangen ist für dich und wir hier zusammen Freude haben werden mit Intelli, gerne auch mit einer Übernahme zu 9,50$

[illmatix]

Antwort auf Beitrag Nr.: 53.309.325 von M@trix am 20.09.16 09:31:04

du gibst ja vollgas hier

werde mir mal ein paar reinlegen ...

grüßle

[M@trix]

Intellipharmaceutics hat eine Marke angelegt wohl für Rexista mit PODRAS:



ODR = Overdose Resistant Tablets

https://trademarks.justia.com/863/94/oxtenda-86394998.html

Das macht insofern Sinn, da ja der NDA für Rexista mit PODDDS™gestellt wird und es schnell zu Verwechslungen kommen kann, wenn das nicht anders bezeichnet wird. Zudem ist es natürlich zentral für jedwede Partnerschaft. Rexista mit PODRAS wird also künftig wohl als "OXTENDA ODR" entwickelt werden.

Zur Frage, ob Rexista PODRAS bzw. OXTENDA sämtliche klinischen Prüfungen bzw. klinischen Studien (Phase I-III) durchlaufen muss, hat ein User bei investorshub.advfn.com gepostet, dass er dazu folgenden Input seitens der IR erhalten habe:

"Ok after a call to IR in regards to their Rexista PODRAS enhancement here's what we know...

1. IPCI can in fact file a supplemental NDA to Rexista version 1 if they so choose or...

2. IPCI can decide to file a separate NDA on Rexista version 2 with PODRAS.

At this point which exact route they plan on taking is contingent on several ongoing moving parts behind the scenes these days. Considerations such as overall commercialization strategy for PODRAS, lucrativeness of any potential partner suitors pertaining to Rexista versus Rexista with PODRAS etc etc etc

PODRAS will definitely require extensive proof of concept and Phase 1 studies...and any Phase III trial requirements will be completely contingent on the success/results of Phase 1.

Also, because the PODRAS tech can also be implemented into Tylenol, Acetaminophen and all other over the counter pain killers...there's obviously a ton of moving parts in play these days worthy of strong consideration behind the scenes as to exactly which direction they take PODRAS over the coming weeks/months...but suffice to say they're very pleased that their Rexista NDA submission and PODRAS patent approval continue to both be on the near term horizon which will put a lot of the recent speculation to rest.

So in summary the answer is "both" as to whether or not IPCI can simply file an NDA-S with the PODRAS enhancement or file a separate NDA on the PODRAS enhancement glta"

http://investorshub.advfn.com/boards/read_msg.aspx?message_i…

Ich bin hier sehr gespannt, wie IPCI vorgeht. Da sie den Zulassungsantrag für Rexista ohne PODRAS stellen und PODRAS perspektivisch erheblich mehr Potenzial hat als "nur" Rexista an sich, wird IPCI womöglich einen Partner für Rexista mit PODRAS ins Boot nehmen um schneller voranzukommen. Denn sobald Rexista mit PODRAS die Phasen erfolgreich durchlaufen hat, wird IPCI vollkommen anders bewertet werden müssen. Dann ist allein PODRAS schon ein "Company Maker".

Rexista mit PODDDS ist dennoch ein zentraler Schlüssel, denn ohne diese Zulassung wird IPCI ständig weiter Kapital aufnehmen müssen.

Ich wiederhole mich also:

DIE zentralen News der nächsten Wochen sind

1. Erhalt Patent für PODRAS
2. NDA für Rexista mit PODDDS

Und ich halte es für durchaus denkbar, dass mit News 1 und 2 unmittelbar ein Partner und eine Strategie für PODRAS kommuniziert werden wird.

M@trix

[M@trix]

Antwort auf Beitrag Nr.: 53.272.611 von M@trix am 14.09.16 09:53:39

Zitat von M@trix: Wir werden sehr bald News zum PODRAS-Patent erhalten, dann folgt der NDA für Rexista. Beide News erwarte ich binnen 8 Wochen.

Eine KE wird vermutlich nochmal im November kommen, diese muss aber den Kurs nicht mehr groß belasten, wenn zuvor die genannten News kommen - zumal wir dann deutlich höher notieren sollten als jetzt.

"Zugleich weiß jeder potentielle Partner für Rexista, dass IPCI Geldsorgen hat, daher kann der Preis gedrückt werden. Die Aktie ist jetzt ein wahrer Zock."

Entscheidend für eine Partnerschaft wird wohl weniger der Cash-Bestand des Unternehmens denn das Marktpotenzial von Rexista und die Zulassungswahrscheinlichkeit durch die FDA sein.

Biotech ist immer irgenwie ein "Zock". Wen das stört, der muss sich in anderen Sektoren umsehen.

Ich halte IPCI für eine der aussichtsreichsten Aktien in dem Sektor und denke, dass nun die Zeit der "Ernte" kommt. Eine der wesentlichen Lehren in meiner inzwischen über 20-jährigen Investment-Erfahrung ist, dass man idealerweise dann einsteigt, wenn ein Wert mit viel Fantasie aufgrund von Rückschlägen und Verschiebungen von Investoren kaum noch beachtet wird, die Bewertung daher niedrig ist und ein potenziell großes Geschäft keine 12 Monate mehr fern ist. Genau das haben wir bei IPCI.

M@trix

Weiterer Zukauf von 5.500 St. und damit nun ausreichend positioniert.

Interessant (wenngleich Gerüchte keine Basis für Handlungen sind):

Potential $9.50 Buyout Rumor for Intellipharmaceutics

BriefingWire.com, 9/18/2016 - The rumor mill of mergers and acquisitions that surrounds the pharmaceutical industry has thrown up the names of Teva Canada Ltd. and Intellipharmaceutics, with the former reportedly poised to launch a takeover bid of the biotechnology firm based in Toronto, Ontario, Canada. The latest rumor serves to inspire that Teva is prepared to pay $503 million in stock to acquire Intellipharmaceutics. Teva denied that the two companies are discussing a takeover, but also declined to say whether any talks have been held in the past says our source.

http://www.briefingwire.com/pr/potential-950-buyout-rumor-fo…

Interessant daran ist natürlich, dass der IPCI-CFO Domenic Della Penna von Teva kommt. Aber wie gesagt: nicht mehr als ein Gerücht.

M@trix

[ahasja]

Die Frage, ob für REXISTA mit PODRAS eine zusätzliche NDA folgen muss oder ein einfaches Supplement möglich ist (NDA-S) wird ja im englischen Forum heiß diskutiert - auch die Frage, ob PODRAS alle Testphasen durchlaufen muss, oder nur Phase 3 etc. Ich habe selbst keine Ahnung und habe diesbezüglich die IR angeschrieben. Wenn ich eine Antwort bekomme, werde ich sie hier wiedergeben.

Interessant ist folgender Beitrag von samsa:
In reply to Angelo. I can tell you why I fee he is wrong. I am not misleading anyone. the facts are all in front of you. I have said for some time that Rexista with PODRAS will require additional testing and yes is a few years away. but its still tied to the original filing. the exact tests that will be required will be determined when the company files the Supplemental. but I can guarantee you that is how this is going down. The company has not filed 2 IND's. one with and one without PODRAS. yet, the FDA has granted fast track designation for PODRAS. so your talking about two versions but one application with the FDA. If they were going to file a second application they would need two IND's. you do the math and still tell me the company will file an entirely new NDA down the road for PODRAS rather than just filing a supplemental? how can the FDA make a fast track status for an application or indication not before it? there is currently one application to be filed before FDA that they are intending to file and have had only one IND for it. yet PODRAS has received fast track status. clearly, the signs point to 1 application being filed and down the road a supplemental being applied for the include the additional indication for overdose prevention. therefore, the issue of PODRAS needs to ironed out now along with the potential partner. People are looking for some nefarious reason for the company not filing yet and it all makes perfect sense to me. (siehe http://investorshub.advfn.com/boards/read_msg.aspx?message_i…)

[spassmatron]

http://archive.fast-edgar.com//20160913/AC22722CZC2EN2Z2222P…

[spassmatron]

...der Link ist wahrscheinlich puttig, deshalb nachfolgend ein kleiner Ausschnitt...


The Biovail connection

Prof. Odidi’s global reputation as a maverick inventor began to fully manifest shortly after he joined Biovail Corporation, Canada, in July 1995. His mission was to help establish the first viable controlled release drug delivery company in Canada. Meanwhile Dr Amina had also decided to work exclusively for Biovail as a consultant.

At the time the couple started working for Biovail, the company was merely a start-up firm as far as research was concerned. It had no research facility or team. Yet, as the Odidis, with their Midas touch of excellence, got to work, the company’s status was transformed from a state of near bankruptcy to being a billion dollar pharmaceutical company through a series of inventions, manufacturing successes and exceptional management style. In fact, through the couple’s contributions, the company soon became the biggest controlled-release drug research outfit in North America.

In Prof. Odidi’s words: “Our work was ground-breaking in every respect; it impacted pharmaceutical research and development, manufacturing, quality control and testing, quality compliance and regulatory affairs. It helped to put Canada on the world map as one of the best country for controlled drug delivery technologies and impacted positively and significantly on the Canadian economy’’.

Having successfully established the company’s research and development laboratories and training a team of first-rate scientists around him, Prof. Odidi went on to develop several popular drugs, including supergenerics of the very difficult to duplicate Adalat CC (Bayer) and Procardia XL (Pfizer). Soon, he was appointed chief scientific officer of the company, in addition to being the vice president – which was unprecedented for a person of colour, much less a Nigerian immigrant to Canada.

This feat seemed to further rouse his inventive spirit, as he subsequently led his team to invent and develop many other acclaimed drugs such as Diltiazem HCl CD capsules a generic of Cardizem CD; Metformin HCl extended release tablet; Tramadol extended release capsule; Buspirone extended release tablets; Gabapentin extended release tablets; and Bupropion extended release tablets.

Intellipharmaceutics: the incubator for innovation

On leaving Biovail in 1999, Prof. Odidi joined his wife at Intellipharmaceutics to be fully engaged in the business of research and innovation. Since then, the duo have invented, developed and patented a plethora of disruptive multidimensional controlled release technology platforms that can be applied to the efficient development of a wide range of existing and new pharmaceuticals.

Based on these technology platforms, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products (which have received final FDA approval) and product candidates in various stages of development in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain.

Intellipharmaceutics is certainly a success story by all standards. Currently, the company’s development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs. The company has also increased its research and development emphasis towards new product development by advancing the product development programmes for drugs currently taken multiple times a day and inventing a once a day product e.g., Regabatin™ XR (pregabalin extended-release capsules). On the commercial side, the company now focuses on profit-splitting deals with many pharmaceutical giants, offering patented technologies and drug formulas on a royalty basis.

“When we were a smaller company,” Prof. Odidi says, “we used to sell our patents. But now we only license them to use our patents

Prof. Odidi certainly has every reason to describe Intellipharmaceutics as having become a mega company. Aside from its world class facilities and the transcending quality of its outputs, the company is publicly traded on two of the best international stock exchanges i.e., NASDAQ in the United States of America and TSX in Canada. In fact, history was made on 22 October 2010, when the couple were asked to ring the opening bell at the NASDAQ stock exchange in New York on the first anniversary of their company going public.

According to Prof. Odidi, “It was really the height of the whole struggle, the whole work, to be recognized at that level, where you have so many millions of people watching and people in industry watching. We’ve done what we’ve had to do. And we’ve gotten there and we’ve gotten recognized.”

The pharmacist as a patriot

One remarkable feature of the life of Prof. Odidi is that even though he is based in Canada, his heart continually yearns for the well-being of his native country, Nigeria. And thus, he has been actively involved in processes and campaigns that are aimed at ensuring good governance and promoting socio-economic growth of the nation.

He was appointed to serve as member of the National Political Reform Conference in 2005 as one of 200 eminent persons by Olusegun Obasanjo, then President of Nigeria, to help draft a new Nigerian constitution. In April 2007 he contested in the Nigerian presidential election under the New Democrats (ND) political party which he founded.

On 15 April, 2013, he was appointed coordinator of Diaspora Nigerians for Congress for Progressive Change (CPC). On 3 February, 2015, he was appointed to serve as a member of the Fundraising Directorate of the All Progressives Congress (APC) Presidential Campaign Council. He was one of those who worked relentlessly towards the election of Mohammadu Buhari as president of Nigeria.

When asked how he’s able to combine all he has to do as a scientist, entrepreneur and politician and still record outstanding success, his answer is unequivocal: “Heaven helps those who help themselves. It’s a lot of hard work, a lot of hard work. Prayer alone won’t do it — hard work as well, they go together.”