Neuren Pharmaceuticals IPO - Phase 3 time!

[Dazza]

if everything is so doom and gloom labslave

why has pfizer and the US army and also Auckland University not sold out yet?

and if it was all doom and gloom then why did it pass the Phase I trials?

yes i to do know that it takes awhile to get the drug on, but we are about to begin Phase II trials... thats pretty far down the track of the drug making process dun u tink?!?!?!

*im ill-informed only half way down the pharmacy degree*


and i take it that pfizer and the US army aswell as AU are not selling their share of the company?

they are only raising the money to fund the trials?

mark me if im wrong here though....

[Damo79]

quote:yes i to do know that it takes awhile to get the drug on, but we are about to begin Phase II trials... thats pretty far down the track of the drug making process dun u tink?!?!?!

Hi Dazza

Haven't checked out this company of the science behind it at all, although on the face of it Labslave sounded like he knew what he was talking about. The above comment just caught my attention since the following is good for a general rule (according to my 'Biotechnology Commercialization' lectures): About 1 in 10 drugs make it from pre-clinical testing to Phase 1 trials, 1 in 10 of those make it to Phase 2, 1 in 10 of those make it to phase 3, and 1 in 10 of them make it to market. That means that a drug beginning Phase 2 trials is really not very far down the track. Of course this is meant as a rule of thumb and it does sound pretty anecdotal.

On the other hand, the risks should be weighed against the positive of getting in before the strong 'value adding' stages of clinical trials. What I mean is, every single step of the way should increase confidence and value in the company, right up until the point when something goes wrong, and worse case scenario, drug candidate is dropped. See Bresagens E12R cancer drug as an example.

To summarize: investing in a biotech with a single main drug candidate should be considered as a bit of a gamble.

Cheers

Damo

[labslave]

Some of you guys really don’t seem to understand what’s going on here. You should read the Prospectus properly instead of relying on what’s reported in the media.

Dazza wonders why Pfizer, Auckland Uni and the US Army aren’t selling their shares. The answer to that’s simple. For a start, the US Army is not a shareholder and therefore has nothing to sell*.

As for Pfizer and Auckland Uni, can’t you see that getting rid of part of their shareholding is exactly what this IPO is all about? At the moment, according to the Prospectus (page13) Pfizer own 12.93% of Neuren and Auckland Uni, own 13.27% through Uniservices’ holding in Neuronz. After the float, Pfizer’s shareholding will be reduced to only 8.1% and Auckland Uni’s will be down to 8.26%. The same applies to all the other existing shareholders. In effect they are selling off about one-third of the company to the new investors, i.e. people like you, BubbleBoy. Once trading starts I doubt if it’ll be long before the likes of Pfizer, Auckland Uni, Tindall & Congreve sell off even more of their shares. I suspect the penny has finally dropped and they’ve realised they were sold a lemon when they bought into the company in the first place. Now they are trying to re-coup some of their losses by offloading shares onto anyone gullible enough to buy them.

Don’t forget that Pfizer, through their predecessor Pharmacia & Upjohn, originally owned 100% of the IP for glypromate. They couldn’t have thought it was worth much or they’d never have sold the original patent to Neuronz in the first place. Now, by chance (because of their shareholding in Endocrinz), Pfizer find themselves with a financial interest in the glypromate patents again, yet they are still aren’t interested. Instead of coughing up the A$7.3 million needed for the clinical trials (which would be peanuts to a company like Pfizer) they’re trying to reduce their shareholding in Neuren. That ought to tell you something about what Pfizer really think about glypromate.



* The Prospectus says the Walter Reed Army Institute of Research is a collaborator, not a shareholder. In fact, contractor would be a more accurate term than collaborator because Neuren has contracted them to test the glypromate analogue, NNZ-2566, in their animal models of traumatic brain injury. There’s nothing unusual about this – pharmaceutical companies contract out some of their drug testing all the time. If another lab has a relevant animal model up and running its often quicker and cheaper to pay that lab to test your drug than it is to set up the model yourself.

[Dazza]

thanks labslave for ur post

[mercury]

Have not been following this float. I would rather watch the chart.
But reading these above posts is most entertaining...and informative...and I say thank you for your insights Labslave.
Mercury

[labslave]

Neuren down more than 15% after barely an hour's trading. What does that say about what shareholders really think about Glypromate's chances?

[beautifulmind]

Neuren's focus turns to trials
Feb 04
AAP

Biotechnology firm Neuren Pharmaceuticals will aim to have both its lead compounds in clinical trials within a year, after the company made an inauspicious debut on the Australian Stock Exchange yesterday.

Neuren, which is developing compounds aimed at treating cell death associated with brain injury, opened at 40¢ - the same as its issue price - but slid back 3¢ by the close of trade. Almost 1.1 million shares were traded.

Neuren chief executive David Clarke said he was excited about the company's listing and now had to consider the long-term future.

"The first step now is to get our lead compound (glypromate) into phase II trials, which we're going to do in the middle of the year, and the second lead compound (2566) will be in phase I trials about six months after," he said.

Glypromate is a neuroprotective drug that has been validated in phase I clinical trials.

It aims to treat cell death associated with brain injury resulting from stroke or traumatic incidents, such as car accidents.

The second compound, 2566, is also aimed at rescuing brain cells but is longer-acting and more potent.

Mr Clarke said the US Army had shown interest in the pre-clinical work for 2566 and was looking at further development of the compound.

Neuren was also developing an oral version of 2566 for treatment of diseases associated with ageing, such as Alzheimer's.

Mr Clarke said Neuren had five product families in its portfolio, including a compound that could grow nerve cells across a gap.

"So, if you have a spinal injury, you crush your nerve cells, it'll grow fresh nerve cells across a gap - that is quite exciting," he said.

Mr Clarke said developing more partnerships would also be a key focus.

Neuren raised $15 million in an initial public offering, issuing 37.5 million shares at 40¢ a share. The company has 100 million shares on issue.

[labslave]

Clarke’s saying nothing new here. He’s spun the same old line about aiming to start clinical trials ever since he joined the company 3 years ago. This is just a selection of what he told the NZ Herald in 2002:

26/1/2002 – from the NZ Herald
“Neuronz is developing medicines that may stop those brain cells dying. It has hired a chief development officer from Pfizer in Britain, Elizabeth Hopkins, to manage clinical trials of medicines this year, and Clarke hopes to have the first ones on the market next year.”


24/5/2002 – NZ Herald
“At the same time, it is applying this month to the Ministry of Health's standing committee on therapeutic trials for approval to test GPE on human stroke patients through Auckland University's clinical trials unit from September.

Neuronz chief development officer Elizabeth Hopkins says the standard FDA process will be used: "First give it to three patients; if none have adverse effects, continue the dose; if still no adverse effects, give it to another three patients; and so on up to 15 to 30 patients.

"We will be able to test whether GPE crosses the blood/brain barrier in humans," Hopkins says.

If all goes well, Stage 2 will be a bigger trial, probably in Australia, this time using cardiac artery bypass patients who have surgery at planned times so their brain functions can be measured before and after. This could start next March [2003].”



17/12/2002 – NZ Herald
“ Neuronz operating expenses rose from $3.4 million in 2000 to $8.9 million last year.

With revenue of only $271,000, the net loss was $8.6 million.

Clarke said the decision to halve staff numbers had helped to halve the company's "burn rate" pending clinical trials of its first potential medical drug which are due to start in March [2003].”

It's just rhetoric and empty promises. Neuren seem to be no nearer to actually carrying out a Phase 2 trial than they were 3 years ago. They still haven’t answered 2 crucial questions:
1) Where are these Phase 2 trials going to take place?
2) Have they actually got scientific and ethical approval for a Phase 2 trial?

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[Dazza]

labslave, explain this eh

theyve skiped phase 2 trials granted by the FDA
u sure u aint a disgruntled ex-employee?

http://www.nzherald.co.nz/index.cfm?
c_id=3&ObjectID=10329379

Neuren’s shares surge on ASX


07.06.05


By Peter Nowak


Shares of Neuren Pharmaceuticals shot up 25 per cent on the Australian Stock Exchange on news that the Auckland-based company has permission to skip phase II testing of its brain drug glypromate.

Yesterday’s surge took the company’s market capitalisation to A$41.5 million ($44.9 million) - still a minnow, but a significantly larger one than it was just the day before.

The US Food and Drug Administration (FDA) ruling means that Neuren can proceed to phase III testing - the final stage before releasing the drug to the market - by 2006, or two years earlier than planned.

The company must still complete a phase IIa safety trial, but can skip the longer and expensive phase IIb.

Neuren says this will save the company A$6 million.

It expects to bring glypromate to market by 2009.

Glypromate helps stem the loss of brain function after coronary artery bypass grafting surgery.

Neuren says the FDA has acknowledged that there is currently no other treatment available, and the company is projecting a target global market of US$2 billion ($2.8 billion).

Neuren also says the drug can be used after strokes or other brain injuries - markets totalling a further US$4.5 billion.

"A 10 per cent share of those markets will do us quite nicely, thank you," said chief executive David Clarke.

"This a major business opportunity for Neuren on a number of levels.

"Our phase III trial programme is not only advanced to 2006, but the overall drug development programme should now cost many millions of dollars less because of this decision."

Clarke said the company’s potential to licence and generate nearer-term revenue had increased "substantially".

He said the FDA recognised no treatments existed to prevent the loss of brain function in the circumstances relevant to the use of glypromate "and we will be working with the FDA to refine the final design of the new study".

More than 400,000 patients have coronary artery bypass grafting surgery in the United States each year and some loss of brain function had been reported in up to 70 per cent of patients.

Sharemarket analysts were bullish about the news.

"I’m not aware of the FDA ever allowing a company to forego efficacy trials in phase II and move directly into phase III," said Thomas Duthy, biotech equities analyst with Taylor Collison in Sydney.

"I think that’s very unique and highlights the very elegant technological data that was supplied to the FDA by Neuren."

Duthy rated the stock a "strong buy," and said there would be a re-rating of the stock in the short term.

"It’s quite a big deal for Australian biotech as well," he said. "We’ve been lacking any sort of good news flow over the last six to 12 months, and this could actually be a shot in the arm for the whole sector."

Patrick Potts, senior analyst with Emerging Growth Capital in Sydney, said Neuren was "one of the region’s most promising biotechnology companies", and rated the stock a strong buy, with a valuation of 55Ac.

Neuren shares closed yesterday at 41.5Ac.

The company has operations in Auckland, where most of its 20 employees and consultants are based, and offices in Australia and the United States.

Who owns it

Auckland-based and Australian-listed Neuren is 50 per cent owned by New Zealanders.

Major shareholders include: University of Auckland (10 per cent), New Zealand Seed Fund (11.4 per cent) and Stephen Tindall’s K1W1 (6.3 per cent).

Foreign shareholders include: Pfizer (8.1 per cent) and Australia’s Macquarie Bank (9.6 per cent).


DISC: none

[marinesalvor]

yes funny how labslave disappeared - as did Donner's sycophancy