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INSTITUTE OF DRUG TECHNOLOGY AUSTRALIA LIMITED (IDT)
NEWS RELEASE
26 July 2004
IDT Signs Major Contract
with US Specialty Pharmaceutical Company
Institute of Drug Technology Australia Ltd (IDT), has signed a
major contract with a US-based specialty pharmaceutical manufacturer
covering development and manufacture of a range of finished pharmaceutical
products.
IDT Chairman and Managing Director, Dr Graeme Blackman, said today
IDT won the contract because of its expertise in the containment
of high potency products and because of the company's high level
of compliance with standards set by the US Food & Drug Administration.
Under the agreement, IDT will undertake a multi-million dollar
fee-for-service project for the US group that will comprise the
following elements:
" tablet formulation development
" analytical method development
" batch manufacture
" human bioequivalence studies at IDT's Adelaide-based clinical
division, CMAX.
After regulatory approval, IDT will manufacture, on a commercial
basis, a range of finished pharmaceutical products. The product
range will be made exclusively for the customer and is destined
for sale in the US.
"This is a substantial contract for IDT which will have an
immediate and favourable impact on revenue and earnings," Dr
Blackman said.
"IDT has demonstrated that it can handle difficult chemistry
and we have earned a reputation for being a "can do" company,"
Dr Blackman said.
To accommodate the contract, IDT will build a new manufacturing
facility at its Boronia, Victoria complex. The facility will cost
approximately $3 million and will be funded from internal resources.
It is expected to be operational within the next 12 months.
Dr Blackman said the facility would be designed to include additional
capacity for future growth opportunities.
The latest contract follows IDT's announcement of a substantial
deal with Pfizer Inc., the world's largest pharmaceuticals manufacturer,
for development and manufacture of a new development drug candidate.
Dr Blackman said the two agreements represented a major advance
for IDT.
"These agreements confirm IDT's international reputation for
the manufacture of pharmaceutical products that require containment,"
he said.
"Although IDT has been manufacturing active pharmaceutical
ingredients for international customers for many years, the company
has now developed facilities and infrastructure that will enable
it to successfully manufacture finished pharmaceutical products
in Australia for world markets."
Company Background
Institute of Drug Technology Australia Limited (IDT) is a leading
developer and manufacturer of active pharmaceutical ingredients
for local and international markets. The company also provides a
comprehensive range of consultancy, research and development, and
analytical services to the pharmaceutical and biotechnology sectors.
Established in 1975, IDT is an Australian-owned public company,
listed on the Australian Stock Exchange and employing over 140 highly
qualified scientific and support staff. The company has extensive
modern manufacturing facilities and laboratories in Melbourne and
is licensed by the Australian Therapeutic Goods Administration (TGA)
and the United States Food and Drug Administration (FDA) for production
of active pharmaceutical ingredients. The company has become especially
well known internationally for its dedicated facilities for the
development and production of anticancer drugs. In addition, the
company offers early stage clinical trial services from its base
at the Royal Adelaide Hospital through its CMAX division.
For information contact:
Dr Robyn Elliott
General Manager
Institute of Drug Technology Australia Limited
45 Wadhurst Drive
Boronia Victoria 3155
Telephone: 61 3 9801 8888
Facsimile: 61 3 9801 8773
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