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NEWS ARCHIVE
IntelliPharmaCeutics
Ltd. Announces Health Canada Compliance for its Canadian Operating Affiliate
TORONTO, ONTARIO, CANADA – March 30, 2006 – IntelliPharmaCeutics
Ltd., a Delaware Corporation (the “Company”), today announced
that Health Canada has advised that IntelliPharmaCeutics Corp., the
Canadian operating affiliate of the Company, is to be approved for a
Compliance rating from Health Canada, following successful inspection
of its Toronto testing laboratory premises and procedures by the Health
Products and Food Branch Inspectorate.
This rating will permit IntelliPharmaCeutics Corp. to perform drug
testing and analysis services on the drug products of its own and of
third parties under certified GLP conditions. This represents another
major step in the full certification of the testing and manufacturing
premises of IntelliPharmaCeutics Corp. as both GLP and cGMP compliant.
When that process is complete, IntelliPharmaCeutics Corp. will have
total control of the entire drug development process in fully certified
facilities right through to the manufacture of clinical and commercial
batches of its drug products pipeline. The resultant streamlining of
these aspects of drug development will permit the fastest possible market
entry for IntelliPharmaCeutics’ pipeline and partnered products.
IntelliPharmaCeutics Announces Agreement
for the Development of a Second Controlled Release Product for Distribution
in Canada
TORONTO, CANADA, January 5, 2006 - IntelliPharmaCeutics
Corp. of Toronto, Ontario is pleased to announce that it has entered
into an agreement with ratiopharm inc. of Mississauga, Ontario, for
the development of a generic, controlled release drug product for the
Canadian market. IntelliPharmaCeutics Corp. is a Canadian specialty
drug development company, and operating affiliate of IntelliPharmaCeutics
Ltd., (Delaware). ratiopharm develops, manufactures, markets and distributes
generic pharmaceutical products in Canada.
The agreement follows an earlier agreement between the same companies,
announced December 18, 2005, for the development of another drug product
for the Canadian market.
Financial terms of the agreement were not disclosed.
Under the agreement, IntelliPharmaCeutics will develop the product using
its proprietary controlled release drug delivery technologies, and ratiopharm
will file the Abbreviated New Drug Submission (ANDS) with Health Canada,
and will manufacture and distribute the generic drug product for the
Canadian market.
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics,
stated, "We are very enthusiastic about this opportunity to develop
a second drug for ratiopharm using our proprietary drug delivery technologies.
We believe that our expertise in developing controlled release products
and ratiopharm’s considerable regulatory and marketing experience,
and promotional reach, will ensure its commercial success in Canada.”
IntelliPharmaCeutics Announces Agreement for the
Development of a Controlled Release Product for Distribution in Canada
Toronto, Canada, December 19, 2005 -- IntelliPharmaCeutics Corp. of
Toronto, Ontario is pleased to announce that it has entered into an
agreement with ratiopharm inc. of Mississauga, Ontario, for the development
of a generic, controlled release drug product for the Canadian market.
IntelliPharmaCeutics Corp. is a Canadian specialty drug development
company, and operating affiliate of IntelliPharmaCeutics Ltd., (Delaware).
ratiopharm develops, manufactures, markets and distributes generic pharmaceutical
products in Canada.
Financial terms of the agreement were not disclosed.
Under the agreement, IntelliPharmaCeutics will develop the product
using its proprietary controlled release drug delivery technologies,
and ratiopharm will file the Abbreviated New Drug Submission (ANDS)
with Health Canada, and will manufacture and distribute the generic
drug product for the Canadian market.
Under a previous agreement, IntelliPharmaCeutics will share certain
of the proceeds of commercialization with Elite Pharmaceuticals, Inc.
(Amex: ELI).
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics,
stated, "We are very pleased to be working with ratiopharm, a company
with international stature, on this significant product. We believe
that our expertise in developing controlled release products and ratiopharm's
regulatory and marketing experience, and promotional reach, will ensure
its commercial success in Canada."
IntelliPharmaCeutics and Par Pharmaceutical
Agree to Controlled Release Generic Drug Development
TORONTO, CANADA – Nov. 29, 2005 - IntelliPharmaCeutics Corp.,
a Canadian specialty pharmaceutical company, the operating affiliate
of IntelliPharmaCeutics Ltd., (Delaware), is pleased to announce that
it has entered into an agreement with Par Pharmaceutical Companies,
Inc. (NYSE: PRX) for the development of a generic, controlled release
drug product for the United States market.
Financial terms of the agreement were not disclosed.
Under the agreement, IntelliPharmaCeutics will develop the controlled
release product, and Par will submit the Abbreviated New Drug Application
(ANDA) to the U.S. Food and Drug Administration as the U.S. filing agent
on behalf of IntelliPharmaCeutics Corp., and will provide regulatory
and legal support for the applications.
IntelliPharmaCeutics will receive milestone payments during the development
of the product and filing incentives. The companies will share in the
net profits from sales of the resulting products, and Par will retain
all U.S. marketing rights.
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics,
stated, "We are very happy to be working with Par on this significant
product. We believe that our expertise in developing controlled release
products and Par’s support, marketing experience, and promotional
reach will ensure its commercial success.”
“IntelliPharmaCeutics’ innovative approach to drug delivery
technologies and their expertise in formulation make them an ideal partner
for Par,” said Michael Graves, President, Generic Products Division
of Par Pharmaceutical. “This agreement provides Par with another
controlled release product opportunity, and we look forward to a very
successful collaboration.”
Laboratory and Manufacturing Facility
Nears Completion
Toronto, Canada, October 19, 2005 –
The construction and build-out of our cGMP scale-up and manufacturing
plant is in the final stages. Manufacturing equipment has been installed
and is in the process of being commissioned. Our testing laboratories
and the manufacturing facility will shortly be inspected by the appropriate
regulatory agencies to confirm that they are in full cGLP/cGMP compliance.
The completion of this phase will represent a critical milestone in
our evolution.
The 25,000 sq. ft. facility will then include executive offices, full
cGLP analytical laboratories, and a state-of-the-art cGMP scale-up and
manufacturing plant. It will enable the Company to carry out the entire
drug development process at this single site, including all analytical
chemistry, formulation, pilot batch manufacture, industrial process
scale-up, production of batches for full-scale clinical trials, stability
testing, regulatory filing, and some commercial scale manufacturing,
labeling, packaging, warehousing and distribution. The facility will
be used for both pipeline and partnered drug development projects, as
well as for third party contract manufacturing when time permits.
IntelliPharmaCeutics and Elite Pharmaceuticals
Announce Agreement for the Development of a Generic Product
Toronto, Canada, June 22, 2005 -- IntelliPharmaCeutics
and Elite Pharmaceuticals, Inc. (Amex: ELI), announced today that they
have entered into an agreement for the development of a generic, controlled
release drug product with an addressable market in the U.S. of approximately
$4 billion in 2004. A pilot bioequivalence study has already been completed
and scale up will begin shortly. After scale up and completion of a
successful pivotal bioequivalence study for the product, an ANDA will
be filed with the FDA.
Dr. Isa Odidi, Chairman, CEO and Co-Chief Scientific Officer of IntelliPharmaCeutics
Corp., stated, “The fit between the two companies and the timing
provide excellent synergies. We have a significant product that is ready
to be scaled-up for a pivotal bioequivalence study. Elite has a fully
capable analytical laboratory and cGMP manufacturing facility, and our
combined capabilities put all the pieces in place for a smooth and timely
product development and commercialization.
Bernard Berk, Chairman and CEO of Elite, said, "We are pleased
to join forces with Dr. Isa Odidi and Dr. Amina Odidi, IntelliPharmaCeutic’s
President and Co-Chief Scientific Officer, recognized leaders in the
development of controlled release dosage forms. Elite will be combining
its capabilities with IntelliPharmaCeutics for the development of an
oral controlled release product with significant technological barriers,
which may be awarded a period of market exclusivity. This development
agreement supports Elite’s business strategy of expanding its
pipeline through in-licensing of controlled release products utilizing
proprietary drug delivery platforms. This is the second product agreement
completed this year.”
IntelliPharmaCeutics Again Doubles Size of its
Premises
Toronto, Canada, December 1, 2004 -- IntelliPharmaCeutics
has recently completed a planned move to new premises located only minutes
from Toronto International Airport. The new facilities are located in
a stand-alone 25,000 sq. ft. building. When fully built out, the premises
will house executive offices, full state-of-the-art GLP Research and
Development laboratories, and a GMP manufacturing facility suitable
for scale-up and commercial manufacturing.
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