News & Events

12 December 2013 Melbourne, Australia: Hatchtech today announced that it has received final written agreement from the FDA on the design of its Phase 3 clinical studies for DeOvo for the treatment of headlice under the FDA’s Special Protocol Assessment (SPA) scheme.

The SPA provides an agreement from the FDA that the Phase 3 clinical study design, endpoints, statistical analyses, and other aspects of the planned studies are acceptable to support efficacy claims and regulatory approval of the product. Hatchtech is in the final stages of preparing for the studies, which will commence dosing in February of 2014.

“Receiving this SPA agreement marks another important milestone which gives Hatchtech great confidence in moving forward with the final stages of developing DeOvo. We believe this phase 3 study design will allow us to thoroughly demonstrate the clinical benefits of DeOvo for treating head lice which is a common problem experienced by many children and adults alike,” said Hatchtech CEO, Hugh Alsop.

Hatchtech is also pleased to announce the further strengthening of its international intellectual property coverage in the form of two additional patents.

The European patent office has allowed the core Hatchtech patent, titled Methods and Compositions for Controlling Ectoparasites, patent number 12001094.7, which adds to the existing coverage of this patent in the US, Canada, China, South Africa, Australia, New Zealand, Japan and India, and importantly provides commercial protection for Hatchtech’s products in the important European market.

The second patent to grant was in Japan for patent number 5390503, titled Compositions and Methods for Controlling Infestations. This is the first granting in a major market for Hatchtech’s second patent family, which provides further protection for Hatchtech’s products that is effective against all stages of the lice life cycle.

“DeOvo is a class-leading head lice control agent and these latest patents add further strength to our intellectual property portfolio set for the treatment of head lice. This portfolio provides a strong basis with which to pursue commercial opportunities for DeOvo,” said Mr Alsop.

- ENDS -

For more information, please contact

Haley Price, Buchan Consulting, T: +61 3 9866 4722 / +61 (0) 423 139 163

Email [email protected]

Hugh Alsop, Hatchtech Pty Ltd, T: +61 (0) 439 080 353

Email: [email protected]

About Hatchtech

Hatchtech Pty Ltd is an Australian specialty pharmaceutical product company developing technology for the control of invertebrate pests. The Company’s lead product is DeOvo™, a class-leading head lice control agent that aims to overcome the frustrating, costly and inconvenient cycles of re-treatment experienced currently by children and their parents. The Company’s investors include, GBS Venture Partners, Queensland Biotechnology Fund, Uniseed, University of Melbourne Endowment Trust, Blue Sky Alternative Investments, Australian Super, and OneVentures Innovation Fund. The OneVentures Innovation Fund is supported by the Australian Government through the IIF program.

Hatchtech Pty Ltd

Suite 201, 697 Burke Rd,

Camberwell, Victoria, 3124,

Australia hatchtech.com.au