FDA approves Axiron topical solution CIII for testosterone replacement therapy in men

Nov 29 2010

Acrux (ASX: ACR), a drug delivery company that develops and commercializes patented pharmaceutical products for global markets, and Eli Lilly Company (NYSE: LLY) today announced that the United States Food and Drug Administration (FDA) has approved the Axiron® topical solution CIII for testosterone replacement therapy in men. Axiron is the first testosterone topical solution approved for application via an underarm applicator.

This announcement comes only eight months after Lilly acquired the global licensing rights to Axiron from Acrux for $335 million plus royalties. At the time of the deal, it was one of the largest ever Australian biotech licensing deals.

"The FDA approval is a major milestone for Axiron and for Acrux," said Dr. Richard Treagus, CEO of Acrux. "After years of research, we are excited to partner with Lilly to provide this novel application method for men with low testosterone."

This major milestone is just the latest testament to the strength of Victoria's biotech sector. The state has long been a hotbed for biotech innovation down under. Home to life sciences companies that have developed everything from the swine flu vaccine to the bionic ear, Victoria boasts more than 134 biotech companies and 13 major medical research institutes.

Biotech companies with operations in Victoria benefit from the state's cutting-edge infrastructure (including the Parkville Comprehensive Cancer Centre and the world's first life sciences supercomputer), financial stability (at the end of 2009, the market capitalization of Melbourne's listed life sciences companies stood at $23.2 billion USD) and a supportive government (the Victorian government has invested nearly $4 billion in science and innovation during the last 10 years) and more.

Because of these benefits, the state consistently attracts U.S. clinical trial programs and funding. Victoria was the only non-U.S. site chosen by U.S. company Plexxikon, Inc. for its Phase I trials of a new bio-marker-associated therapeutic treatment (PLX4032) for melanoma and colorectal cancer. In addition, the U.S. National Institutes of Health has awarded $50.4 million to a team jointly headed by a Monash University-based researcher for a large-scale trial (ASPREE) to assess low-dose aspirin for primary prevention in healthy elderly people.

"In what has been a challenging economic environment, Victoria's life sciences sector has demonstrated remarkable resilience," said Victor Perton, Commissioner to the Americas, State Government of Victoria, Australia. "This partnership between Acrux and Lilly is just the latest in a long history of international biotech partnerships formed between Victorian institutions and international biotech powerhouses – the Victoria-California Stem Cell Alliance and the Victoria-Israel Science and Technology R&D Fund are two additional prime examples."