ASX Release No. 576 19th September 2012 Page 1 of 2
ASX Release
EASTLAND’s ArTiMist™ MANUFACTURING UPDATE
Eastland’s Board is pleased to provide you with the following update on the manufacturing program for Eastland’s lead project ArTiMist™.
As announced earlier this year Eastland has signed a contract manufacturing agreement with Therapex, a division of E-Z-EM Canada Inc. which is a part of the BRACCO Group. Therapex is a contract manufacturing organisation that was founded in 1968 in Montreal, Canada. They specialise in the development and manufacturing of non-sterile semi-solids and liquids such as ArTiMist™. Therapex is acknowledged by the American FDA, Canadian HPFBI and the European EMEA regulatory agencies and has an outstanding quality and regulatory compliance history.
Therapex will manufacture the registration and validation batches and will be our primary contract manufacturer of ArTiMist™. The agreement is a fee for service agreement and is not a Manufacturing license or a joint venture agreement.
Therapex have progressed the manufacturing process substantially over the past 4 months and are on track to produce registration batches in December 2012. Scale up testing is now complete and the analytical and technical development programs are well advanced.
Therapex have begun the capital improvement programs on the ArTiMist™ filling equipment and filling room modifications are now underway to allow for the manufacture of ArTiMist™ at the Canadian factory.
We are looking forward to the equipment installation and qualification over the next 10-12 weeks and the filling of 20,000 units of ArTiMist™ in the first registration batches scheduled for December 2012.
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