Glypromate Fails Phase 3

logo_neuren

Coming back from my summer holiday (all of one week) I discovered Neuren Pharmaceutical’s share price had plummeted from 5 to 1 cent. Why? Its lead drug candidate, Glypromate/ GPE recently had failed its Phase 3 trial. Not a great way to start the New Year. Neuren released the announcement on Christmas Eve – quite sneaky considering the majority of its shareholders were probably down on the Coromandel cut off from the internet. It stated that their pivotal Glypromate phase 3 trial for the treatment of cognitive impairment in patients undergoing cardiac surgery with bypass was unsuccessful, that is, GPE exhibited no significant difference between treated and untreated individuals. Strangely only 20% of the 325 patients exhibited cognitive decline after surgery (i.e. they were only testing 64 people total with placebo or drug). They mentioned this number (20%) was a much lower rate previously reported in the literature. A quick literature search only brings up a handful of papers relating to this cognitive decline, most of it coming within the last few years. The makes me wonder whether this was the best way to actually test the drug’s neuroprotective capability. Part of the pull of this condition was that there were no current treatments available enabling the fast track to Phase 3 and hence saving $$. However the trade off was that by bypassing Phase 2b this meant the drug’s efficacy in humans was still unknown for a condition that lacked a well established scientific history/background.

Neuren is or was seen as NZ’s leading biotech/pharma company since the downscale of Genesis R&D, and was hopefully going to be NZ’s first biotech success pioneering the way for other life science companies. Where does the pioneering burden lie now? LCT? CODA? PROACTA? Pathway Therapeutics? More so where to from here for Neuren? Unsurprisingly GPE’s development will be discontinued. However they do intend to develop the rest of Neuren’s pipeline. The underlying question now becomes – are they able to raise the funds to do so while carrying a dented reputation. This combined with the ‘crunch’ puts Neuren in a very difficult position, with investors possibly seeking less risk and organisations with a proven history. For all we know this positive stance is simply to convey a sense of confidence in their strong pipeline for the means of attracting a buyer. We have all heard about the potential shopping spree by big pharma under the current economic climate. And at one point NZ$1.3 million (now up to 2million) could buy you a NZ biotech company with 6 pipeline drugs.

The Pipeline

Motiva – acquired last year as part of the Hamilton Pharmaceuticals buy out. “A novel cyclic (GABA) derivative for neuropsychiatric and neurocognitive symptoms of stroke and other acute and chronic neurological disorders including Parkinson’s disease and Alzheimer’s disease.”- Ph2b

NNZ -2566 – neuroprotection – Ph2b

NNZ-2591 – learning and memory for dementia – Ph2

NNZ-4945 treats neuropathy – Preclinical (PC)

NNZ-3006 – Obesity PC

NNZ-8000- anti-TFF for cancer PC

The Share Price Fall – From 5 to 1 cent.

neu1

Related Links

The Neuren story http://www.sharechat.co.nz/features/unlimited/article.php/8e17929b

____________________________

Graeme

graemefielder.com –

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3 responses to “Glypromate Fails Phase 3

  1. Not a cynic- just realistic

    Seriously Graeme, couldn’t you see this coming years ago? Neuren is one of NZ’s leading Biotechs? I want you have been smoking, the demise of Genesis and anything remotely linked to any of it’s former employees is enough for any potential investers to run a mile let alone invest in ANY listed NZ biotech company albeit on the ASX or anywhere offshore.

    $1.3 mill for a biotech with a so-called pipeline of 6 molecules that someone else has already written off? Puh-lease, you have better chance of making money investing in a non-existant Lehman Brothers

  2. Thanks for your comments.

    I have had my concerns regarding the direction and operation of the company but I will keep those reservations to myself. Considering that $3 million in Aug 6th 2008 and another $2 million in Sept 30th 2008 was invested apparently shareholders didn’t see things coming either.

    Regarding Neuren as a leading NZ biotech– Let me reminder you that they were the only NZ biopharma with a drug candidate in Phase 3 trials, quite an achievement in itself. However there are also a series of other leading NZ biotechs/ biopharmas such as KODE Biotech, Aquaflow Corp, Lanzatech, Zygem, LCT and Proacta (most likely NZ’s next Phase 3 experience with PR-104) that deserve mention.

    The fall of Genesis has been…preventable? Probably? A complete failure? Definitely not. During a Chiasma event last year Jim Watson highlighted a very important point regarding measuring the success (or failure) of Genesis. He referred to the employees and students that have passed through Genesis as a vital contribution to NZ’s growing bioeconomy. These are likely to be a group of individuals hardened/experienced to the realities of corporate biotech (due to poor management? Possibly). I also believe you would be hard pressed to find any biotech in NZ that doesn’t have an ex-Genesis employee in it these days. In fact there are a few ex-Genesis employees who are now leading their own start ups which have recently attracted funding.

    Some of the ones I am familiar with include:

    Keith Hudson – ex Research Leader at Genesis and now founder and CSO of Androgenix who have raised $1-1.5million in Aug06 and >$2.5million in June 2008

    Sean Simpson – ex Senior Scientist at Genesis and now CSO and founder of Lanzatech which has attracted funding from Kholsa Ventures , Stephen Tindall, Cranleigh Merchant Bankers, VIF, Pacific Channel and FRST totalling >$15million

    Neil Domigan – ex Commercial Manager and Head of Business Analysis at Genesis and now CEO of Ingredient Solutions currently seeking an ambitious $27.5 million worth of investment. The latest update being that a North American investor has issued a statement of intent to purchase 40% of the shares. Neil is also Commercial Manager and a Director of EcoDiesel which has risen >$2.5million.

    Paul Tan ex Deputy Director and Head of Health Division at Genesis and now CEO of LCT which like Neuren raised money on the ASX ( AU$15 million)

    So in fact all hope is not lost. Investors are coughing up the dough for NZ Biotechs whether or not their management team has originated from NZ ‘failures’.

    Keep in mind Neuren recently purchased Hamilton Pharmaceuticals including their late Phase 2 drug candidate, Motiva. And with the amount of money being thrown around by big Pharma recently AU$1.3 (now 1.54) million for a pipeline with two Phase 2 candidates is a pretty good gamble.

    To sign off….Biotech is a tough game with dodgy politics and management, lemon drugs, stringent regulations, the constant need for money and a developmental route that can kill your product/lead dead at any stage. If you don’t like it, get out and play a different game.

    ____________________________

    Graeme @ graemefielder.com

  3. Pingback: Reply to:Glypromate Fails Phase 3 « graemefielder.com

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