TORONTO, Aug. 8 IntelliPharmaC-Update
TORONTO, Aug. 8 /PRNewswire/ - IntelliPharmaCeutics is pleased to provide an update on our activities. References in this press release to the Company, include IntelliPharmaCeutics Ltd. and our operating affiliate IntelliPharmaCeutics Corp.
The Company has been very active with drug development work at our 25,000 square foot R&D and manufacturing facility in Toronto, Canada. We presently have 34 staff employed full-time including 21 scientists, 2 engineers and 4 R&D support staff.
Some information provided in this letter is consolidated from press releases previously issued by the Company and some is updated from the information included in the Company's filing with the U.S. Securities Exchange Commission ("SEC") last November.
We are actively working on developing 8 products for third-party pharmaceutical companies. In addition the Company is also actively pursuing development of 6 drug products for its sole benefit. These are comprised of 4 US abbreviated new drug applications ("ANDA's"), 1 US new drug application ("NDA") and 1 Canadian abbreviated new drug submission ("ANDS").
In March 2008, the Company issued a press release to confirm that it had completed a successful pilot clinical trial for its own new abuse-resistant, alcohol-resistant once-per-day oral oxycodone drug product which treats pain. We are currently pursuing the next stage of development for this product.
In May 2007, the Company filed an ANDA with the U.S. Food and Drug Administration ("FDA") for a drug developed in collaboration with a partner, Par Pharmaceutical ("Par") and intended for the US market. In August 2007, that application was accepted by the FDA as being complete and in condition for their further review. In October 2007, the owners of the branded version of this product commenced litigation relating to the generic version against our drug development partner Par and the Company. Our development partner Par has carriage of the defense. We consider such litigation to be in the ordinary course in relation to generic drug products and have been advised by Par that it will be defended vigorously. The Company previously issued a press release relating to both the FDA acceptance and the litigation and its defense.
We have also provided the table below to summarize the development status of the 14 drug products currently under development. This information has been updated since the information on 12 of the products was provided in our November 2007 filing with the SEC; and it now includes 2 additional drug products (Products XIII and XIV listed below).
As is customary in a competitive generic drug market where knowledge of development by a competitor can trigger or accelerate steps by other drug developers to complete their own development for that product and be "first to file" with various exclusivity and priority rights that can sterilize the value of a product under development, the drugs in the Company's current pipeline are indicated by a product number rather than by a name. The public disclosure of the name of a drug product under development would provide that information to competitors and would expose the Company's drug development of that product to exceptional and unusual competitive risks.
Summary of Status / Stage of IntelliPharmaCeutics Drugs Under Development
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Product (Country)Type Status
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Product I (USA) ANDA Scale-up to Manufacturing Scale
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Product II (USA) ANDA Scale-up to Manufacturing Scale
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Product III (USA)ANDA Pivotal Bioequivalence Studies
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Product IV (USA) ANDA Filed with FDA
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Product V (USA) ANDA Scale-up to Manufacturing Scale
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Product VI (Canada) ANDS Bioequivalence Studies
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Product VII (Canada) ANDS Production for Pilot Bioequivalence
Studies
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Product VIII (USA) NDA Pilot Bioavailability Studies
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Product IX (USA) ANDA Pivotal Studies
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Product X (USA) ANDA Pilot Equivalence Studies
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Product XI (USA) ANDA Formulation
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Product XII (USA)ANDA Pre-formulation
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Product XIII (USA) NDA Pilot Bioavailability Studies
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Product XIV (USA)ANDA Scale-up to Manufacturing Scale
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To provide additional context for the stages of development identified
above, we have also provided below a list of the major research and
development steps which the Company must execute or oversee for each ANDA or
NDA candidate prior to filing with a regulator such as the FDA:
1) Pre-Formulation
2) Formulation
3) Manufacture of Pilot Bio-batches
4) Conduct Pilot Bioequivalence Studies
5) Scale-up to Manufacturing Scale
6) Manufacture of Batches for Pivotal Bioequivalence Studies
7) Conduct Pivotal Bioequivalence Studies
8) Conduct Stability Studies
9) Prepare and File Dossier with the FDA
As noted above, we continue to advance development work on our partnered projects, while also working on the Company's own drug products.
SOURCE IntelliPharmaCeutics Corp.
