Spinifex Pharmaceuticals sold to Novartis

Australian biotech Spinifex Pharmaceuticals is to be acquired by Swiss-based big pharma Novartis for US$200 million (AU$264 million) with significant future milestone payments.

Spinifex was spun out of the University of Queensland (UQ) in 2005 with an investment round from UniSeed, UniQuest and GBS Venture Partners. Spinifex President and Chief Executive Officer Tom McCarthy and his team progressed the company over a number of years and it is now based in Stamford, Connecticut and Melbourne.

The company’s main focus has been based on a hypothesis developed by Professor Maree Smith in late 2003 and about a year later developed into early-stage technology with Dr Bruce Wyse for the potential treatment of neuropathic pain.

“I’m very excited to see Spinifex go forward,” said Professor Maree Smith, executive director of the Centre for Integrated Preclinical Drug Development based at UQ.

The drug candidate Spinifex has been developing, EMA401, shows potential as a first-in-class oral treatment for relief of neuropathic and chronic inflammatory pain.

EMA401 is an angiotensin II type 2 receptor antagonist. It inhibits neuropathic pain in preclinical animal models. Phase I trials in healthy human volunteers and phase II trials in patients with post-herpetic neuralgia show it is well tolerated and effective at reducing pain intensity compared with a placebo.

“Neuropathic pain is a significant unmet need and over the last two decades, EMA401 is the only orally active molecule that has shown efficacy in rodent models that has translated to analgesic efficacy in human patients suffering from this type of pain,” said Smith.

Neuropathic pain can be divided into more than one type, and the different types have heterogeneous pathobiologies triggered by various factors.

For example, the pain associated with post-herpetic neuralgia is chronic nerve pain that develops in some people after they have had the shingles. Shingles is caused by reactivation of the varicellar zoster virus, which can remain dormant in the sensory nerve cells of the dorsal root or spinal ganglia after a bout of chicken pox in childhood. The sensory nerve cells relay sensory information to the brain, including nociception and pain.

The pain associated with painful diabetic neuropathy develops as a long-term complication of diabetes thought to be as a result of biochemical changes involving small blood vessels that supply peripheral nerves, with the effects most prominent in the long nerves producing burning sensations and numbness in the feet.

Other types of peripheral neuropathic pain include pain that results from mechanical injury to one or more peripheral nerves, such as pinching of the sciatic nerve in sciatica or cancer chemotherapy-induced peripheral neuropathy.

Novartis will continue the development of Spinifex’s programs and plans to conduct phase IIb clinical trials on EMA401 in patients with post-herpetic neuralgia and painful diabetic neuropathy.

The intention is to progress the work by building on these two types of neuropathic pain and expand to a broader peripheral neuropathic pain treatment.

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