Eiffel opens Sydney drug facility

What is said to be Australia's first semi-commercial facility for producing 'sequel drugs' -- re-engineered versions of insulin, steroids, and asthma medications among others -- was opened today in Sydney by Prof Martin Silink, president-elect of the International Diabetes Federation.

The Eiffel Technologies (ASX:EIF) facility has taken 18 months to establish, and is housed at Sydney's Macquarie Park. Although it is not GMP certified, it allows the company to provide 'proof of concept' that it can scale up its production processes to manufacture up to 1 kilogram per day of re-engineered drug. Previously, the company was only able to turn out 5 to 10 grams of product at its university laboratories.

Eiffel CEO Christine Cussen explained that the new facility would enable the company to provide proof-of-manufacturing process to pharmaceutical companies interested in Eiffel's supercritical fluid re-engineering technology. The product could be used in pre-clinical and early clinical trials, but to provide product for late-stage clinical trials, Eiffel would need to team with a GMP-certified contract manufacturer.

Cussen said Eiffel was currently in discussions potential contract manufacturers, and expects to sign an agreement by mid-2005. She said the company was also scouting for work conducting feasibility studies using its technology, with an announcement in the asthma area expected "soon". Eiffel hopes to earn fees of between $200,0000 and $300,000 for this type of study.

The company sees its main revenues coming from the out-licensing the process IP for successful production of pharmaceuticals using its SCF technology.

Having established a Level 1 American Depository Receipt (ADR) program earlier this year, Cussen said the company plans to move towards Level 2 ADR -- effectively a listing on the Nasdaq small cap market -- within the next two years.

The supercritical fluid technology uses highly compressed gases to dissolve normally insoluble compounds. After the fluid is depressurised, the particles -- now smaller than 5 microns -- are precipitated out. The particles can be spherical or crystalline, and size is controlled within a narrow range, with particles as small as 200 nanometres possible.

Pharmaceutical particles smaller than 5 microns are inhalable, and Eiffel has already conducted pre-clinical studies with a 'nanomised' version of insulin for the treatment of type 1 diabetes.

Prof Silink said today the prospect of providing patients who must now inject themselves with insulin four times a day with inhalable insulin would provide extraordinary relief from the "discipline of diabetes" -- an unforgiving and unrelenting disease.