Alchemia Granted Key US Patent

BRISBANE, AUSTRALIA--(Marketwire - Mar 6, 2013) - Brisbane based drug discovery and development company Alchemia Limited (ASX: ACL) has been granted a key US patent critical to its platform oncology technology.

The US patent, number 8,388,993, is regarded as a critical development milestone for the company and provides US protection for the use of the company's proprietary drug HA-Irinotecan in the treatment of metastatic colorectal cancer. This drug is currently being evaluated in more than 400 patients in a pivotal phase III clinical trial at 76 sites globally.

This important patent is titled Hyaluronan-Chemotherapeutic agent formulations for the treatment of colon cancer and also protects Alchemia's HyACT drug delivery platform as applied to a range of other anti-cancer drugs that can be used in the treatment of drug resistant colorectal cancer.

Alchemia's VP of Intellectual Property and Technology Transfer Dr Mike West said the patent demonstrated the broad clinical and commercial capability of the HyACT platform.

"This patent fits neatly in a suite of granted patents in other jurisdictions including Australia, Canada, China, Japan, Taiwan and Europe and will greatly enhance Alchemia's efforts in commercialising HA-Irinotecan," he said.

Further US patent applications of varying scope and specificity are currently pending. These applications are expected to further cement the company's monopoly rights over the entire platform technology.

The patent which has a term through to 13 July 2021 is presently awarded 846 days (approximately 2¹/₃ years) of patent term adjustment.

Dr West added: "This patent term adjustment may enable ACL to commandeer further potential revenues across 2.3 years resulting from the HA-Irinotecan asset. Taking into account the patent term adjustment, the patent may expire as late as November 6, 2023 subject to any further adjustments or restrictions by the US Patent & Trade Mark Office."

HyACT technology inventor and ACL Chief Scientific Officer Dr Tracey Brown said the patent claims substantiate HyACT's clinical novelty and provide protection for several HyACT targeted drugs in one of the world's largest oncology markets.

She added: "This patent substantially expands the commercial application of our proprietary HyACT technology, and provides Alchemia with the commercial rationale to continue to develop its extensive pipeline of oncology drugs."

About Alchemia Limited - www.alchemia.com.au

Alchemia is a drug development company with late stage oncology product pipeline (Phase II and III), and an FDA approved drug (Fondaparinux).

Fondaparinux (a generic version of GlaxoSmithKline's Arixtra®) is an injectable anticoagulant approved in the US for the prevention and treatment of deep vein thrombosis (DVT) after knee or hip surgery. The ANDA for generic fondaparinux was approved by the US FDA in July 2011 and launched in the US by marketing partner Dr Reddy's Laboratories. Alchemia received its first profits from sales of fondaparinux in August 2012.

Alchemia's pipeline of oncology products is built on the proprietary platform technology: HyACT® (targeted cancer delivery), which is used to selectively target cancer drugs to tumours. The primary objective of the HyACT® technology is to develop a new generation of anti-cancer drugs which demonstrate better efficacy. The Company has recently announced the final recruitment for its most advanced cancer drug -- HA-Irinotecan which is in Phase III for the treatment of metastatic colorectal cancer.

In addition, Alchemia has a platform technology, VAST®, drug discovery platform, which is based on Alchemia's chemistry expertise. VAST is run on a business model designed to limit use of cash expenditure through the use of partnerships and government grants. The company has projects running with academic institutions and evaluation underway with big pharma partners.