ferret's stock to watch: institute of drug technol

Ferret's Stock To Watch: INSTITUTE OF DRUG TECHNOLOGY
08:18, Thursday, 9 June 2005

LOCAL BIOTECH FIRM RECEIVES FDA APPROVAL FOR THALIDOMIDE DRUG

Sydney - Thursday - June 9: (RWE Aust Business News)
***************************************************

OVERVIEW
********

About 45 years ago the name thalidomide sent chills of fear
through every Australian parent.

It was the scourge of babies that left with them with deformities
for life.

Thalidomide, given to pregnant women, was withdrawn after an
Australian doctor discovered that the drug was responsible.

Today the drug has useful properties for the treatment of a
number of diseases and is perfectly safe.

The Institute of Drug Technology Australia Ltd (IDT) earlier this
week announced it had just been granted US Food and Drug Administration
(FDA) clearance to supply commercial quantities of thalidomide to its
client, Celgene Corporation, a US-based global biopharmaceutical company.

IDT specialises in the development, scale-up and production of
active pharmaceutical ingredients to international standards of Good
Manufacturing Practice.

The company has over 10 years experience in the handling of
Cytotoxic Active Pharmaceutical Ingredients (APIs); High Potency APIs and
Hormones and Toxic Reagents.

IDT currently manufacture APIs for world-wide clients in its
FDA-inspected containment facilities located in Melbourne.

In the December half year the company announced that it had
signed an important contract with US-based pharmaceutical company Pfizer
Inc.

Under this contract IDT is providing fee for service development
support for a new drug candidate for Pfizer.

The project has progressed well during the past six months and
expansion of the company's specialised plant and equipment to meet the
requirements of this project is continuing.

This expansion is being fully funded by Pfizer under the terms of
the contract.

Two other projects with US-based pharmaceutical companies are
also on track to deliver good returns to the company in the future.

The first project, announced in November 2003, has reached
completion of the manufacturing validation program and has just been
approved by the FDA to allow commercial production to begin.

The final major project announced during the past few months
involves development and supply of products to a US specialist drug
manufacturer.

Design and installation of a new specialised manufacturing
facility is well advanced and development of a product range for this
client is also underway.

The company's CMAX clinical trials business continues to grow
with over 70 per cent of the unit's business now coming from
international clients.

New premises in Adelaide have been leased to provide extra
facilities for the clinical trial work at CMAX.

SHARE PRICE MOVEMENTS
*********************

Shares of IDT yesterday eased 1c to $1.80. Rolling high for the
year has been $2.72 and low $1.76. Dividend is 7.5c a share to yield 4.17
per cent. Directors expect a strong profit result for the year.

Revenue for the half year ended December 31 was $12.3 million, a
reduction of 4 per cent from the previous corresponding period.

Profit before tax slipped 2 per cent from $2.82 million to $2.77
million.

Profit after tax was also down 2 per cent from $1.98 million to
$1.95 million.

The ratio of pre-tax profit to revenue increased from 22 per cent
to 22.5 per cent and EBIT margin increased from 21.9 per cent to 22.2 per
cent.

Strong growth in the company's fee for service activities,
especially its CMAX clinical trials group, has been offset by continuing
downwards pressure on sales and margins for generic active pharmaceutical
ingredients.

As occurred last year, growth is expected in the second half and
a strong result is expected for the year ended June 30.

Despite a steady profit result for the half, directors declared a
fully franked interim dividend of 3.5c per share.

This represented a 17 per cent increase over the previous
corresponding period.

BACKGROUND
**********

IDT provides clinical research services to multinational
organisations throughout the world.

The company prides itself on completing projects on time and on
budget, delivering products and services of a high standard.

IDT provides clients with a highly personalised service, building
relationships with the client and the investigator, in order to maximise
the value of the client's study.

All phases of clinical trials are conducted according to the ICH
code of GCP (cGCP) standards, and IDT has been successfully audited by
company and regulatory auditors.

IDT has experience in many therapeutic areas including oncology,
HIV/AIDS, cardiovascular, CNS, endocrinology, gastroenterology,
immunology, and anti-infectives. In addition, the company has established
enduring relationships with key opinion leaders in all of these areas.

It can provide the full complement of services, from identifying
sites and designing protocols and CRFs, to producing a final integrated
report.

This means that IDT can provide some or all of these services,
depending upon requirements.

IDT is also licensed to manufacture therapeutic goods for
clinical trials; for example, ointments, creams, capsules and tablets.

IDT is the only Australian CRO that can offer the full range of
support services, including Pharmacy Services (drug randomisation,
labelling and packaging, distribution, accountability); regulatory
affairs (preparation of documentation to the TGA and/or ethics committees
requesting approval to run clinical trials) and report writing.

IDT also specialises in the entire post-discovery pharmaceutical
life cycle.

The company's expertise in the development of new chemical
entities from laboratory-scale to full-scale production, combined with
its ability to conduct phase I-IV clinical trials, uniquely positions IDT
to assist companies at many stages from synthesis to market level
production.

ENDS

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I don't hold IDT