Aura Renewable Acquisiti... Share Discussion Threads

[jonfa] 12/2/2007 18:27

I agree - bought in on friday. Looks to me like something is cooking!

[goodgrief] 12/2/2007 18:26

I rckon this has started to climb.

[qazwsx123] 07/2/2007 16:22

I rckon this has further to fall.

[n_w_b] 29/12/2006 09:25

The IC tip, posted last week, is in todays edition. There wasn't a printed edition last week.

[gnomet2] 24/12/2006 05:23

Thanks for your thoughts on that issue n_w_b. Have a good Xmas.

[n_w_b] 22/12/2006 21:35

Ok, I see what you mean now, no figures mentioned, but I and the press at the Analyst meeting take "The findings in this study confirm the effects of Teverelix LA on symptoms of BPH as previously reported." as what was reported before. Maybe was rushed out to statisfy investers, but they've been reported as a positive trial.

Trial ARD-0301-001 was to look at the safety and effects of two different single dosses of Teverelix in BPH patients for 3 months. There is a follow on trial ARD-0301-002, giving the patients the same dose they received in 001, after they have become non-responders.

Therefore it was a dose finding study which confirmed previous results "Teverelix LA, administered as a single subcutaneous injection, demonstrated symptomatic improvement from as early as week two and the duration of the effect appears to be in the order of 8 weeks based upon a preliminary analysis of the relevant clinical endpoint, the International Prostate Symptom Score (IPSS). "

Ok, they might not have had time to go through the data and report which dose was superior, but the effects were the same and this is what counts. Maybe once 002 is complete, they'll have a fuller picture.

Theres also another PII apoptosis study in the US in BPH patients. The aim of the study is to look at the effects of Teverelix on cell death in prostate biopsies from patients with BPH. This trial is mostly of acedemic value, however it opens the door into US clinics.

So these seperate PII trials are additional requirements the FDA requires and not "proof of concept" like the first PII trial.

[gnomet2] 22/12/2006 20:17

These the two trials for comparison btw

[gnomet2] 22/12/2006 20:10

Where did it say what? :) What I'm saying is what it didn't say, and couldn't say (at least at this point)- ie that these effects were of a degree that were statistically significant,which they were in the earlier trial.After all, that's what having placebo controls etc is all about - determining whether any positive effects could be down to chance.

This isn't a trivial issue because I think it's likely to influence the the size and cost of a phase 3 trial, the degree of effectiveness of the treatment(and hence its sales potential)and its perceived risk of failure at phase3 (very low,I think,but phase 3s typically require stats showing p = 0.01 or better, which was actually achieved in the earlier trial).

Maybe the data analysis takes a lot longer than I think, or they felt they had to rush out a preliminary statement with the results and the further analysis will be able to cite some good stats in line with those reported in the earlier trial.

[n_w_b] 22/12/2006 08:23

I'm lost, where did it say that?

This is what they said.

"The findings in this study confirm the effects of Teverelix LA on symptoms of BPH as previously reported. Further analysis of data is ongoing."

[gnomet2] 22/12/2006 07:41

No statistical significance figures cited this time - which were very strong
in the the first trial.Ok further analysis ongoing but I thought such figures very quickly established these days. I'd love to know whether this issue was queried in the analyst meeting. share price didn't fall on the day,though, so hopefully
my concerns are unjustified

[n_w_b] 21/12/2006 20:55

Why?,they were good with the same results as the previous trial.

"Teverelix LA, administered as a single subcutaneous injection, demonstrated symptomatic improvement from as early as week two and the duration of the effect appears to be in the order of 8 weeks based upon a preliminary analysis of the relevant clinical endpoint, the International Prostate Symptom Score (IPSS).

The study was a Phase II, randomised, double-blind, placebo-controlled study investigating the effects and safety of two different

[gnomet2] 21/12/2006 20:33

I'm actually a bit disappointed at the trial results- not as good as the previous ones and a fair old sample size for a phase2. Can anyone cheer me up on that front?

[n_w_b] 21/12/2006 19:23

Thanks, just us three here. :-(

[gnomet2] 21/12/2006 18:46

Thanks for that info both of you.

[fickena] 21/12/2006 18:21

Here you go:

22 December 2006
ARDANA (ARA)

BUY

Ardana is making decent progress towards becoming a speciality pharmaceutical company focused on reproductive
health. The Scottish company recently boosted its pipeline by in-licensing Emselex, a treatment for overactive
bladder, from Novartis. Management raised nearly £10m in October to fund its launch, as well as the development
oral growth hormone product Secretagogue. Emselex was launched in the UK in November and Invicorp,
injectable treatment for erectile dysfunction, is to launch in Denmark.
The human reproductive health market is worth an estimated $26bn in annual sales, and Ardana's growth-
product, along with prostate cancer and endometriosis treatment Teverelix, target markets worth a combined
in sales a year. Chief executive Maureen Lindsay says licensing discussions continue for Teverelix and that
hopes to sign a deal by the summer before the product enters phase III trials in 2007 for benign prostatic hyperplasia.
The company's testosterone cream is also entering phase III trials, with a launch planned for 2008. In the first
sales of testosterone-replacement drug Striant fell, but this was due to lumpy sales through partners.

[n_w_b] 21/12/2006 16:34

There's an article in tomorrows IC. Here's the heading,


ARDANA (ARA)

Ardana is making decent progress towards becoming a speciality pharmaceutical company focused on reproductive health. The Scottish...
22 December 2006 | 816 words | Investors Chronicle

[n_w_b] 20/12/2006 07:34

Ardana in 'advanced' talks on drug licence

HAMISH RUTHERFORD
([e-mail])
ARDANA, the Edinburgh-based specialist pharmaceutical, said it is in advanced talks for a licensing agreement for one of its key treatments.

Announcing interim results yesterday, the company said it was close to signing a deal with a partner to help pay for the remaining trials and commercialisation for Teverelix.

Chief executive Maureen Lindsay said the negotiations were at a sensitive stage, but the company was confident a deal could be completed before the phase-three trials for the drug are begun, currently expected for summer 2007.

Teverelix is an injection treatment for benign prostatic hyperplasia, an enlargement of the prostate gland, a common condition for males over the age of 50, causing urinary troubles. Ardana said phase-two trials showed the drug showed improvement in some patients after less than a fortnight, and lasted up to eight weeks.

Teverelix is expected to become a key drug for the company, with sales potentially running to hundreds of millions.

The company also announced its non-oral erectile dysfunction treatment, Invicorp, is now available for sale in Denmark.

In the six months to 30 September, it recorded a pre tax loss of £5.5million, compared with a loss of 3.6m in the same period last year. The widening losses came as research and development costs surged by more than 70 per cent.

The losses and the cash position of £13.7m were slightly better than forecast as the company made some overhead savings. Research and development costs are expected to almost double in the second half, to around £12m for the full year, with brokers forecasting a full-year loss of around £16m. The share price dropped 0.5p to 113.5p.

[n_w_b] 19/12/2006 18:20

Couple of bits from AFX news:

The Scotland-based company also announced today positive results from a
phase II study of its lead development compound Teverelix in benign prostatic
hyperplasia (BPH), enlargement of the prostate gland.
Chief executive Maureen Lindsay told AFX News that talks on an out-licensing
deal for the drug, to find a partner to help pay for the remaining trials and
commercialisation, are "very advanced."
"The talks are at a very delicate stage. We are very confident that the deal
will be done before we start final trials," next summer, she said in a telephone
interview.



While the company already has drugs on the market and a sales force in place
in Europe, Lindsay indicated that the company's US aspirations are also taking
shape.
Testosterone cream, treatment for male hypogonadism, or lack of
testosterone, will shortly enter phase III trials and is expected to reach the
market in the first half of 2008.
The US market for testosterone replacement therapies is by far the largest
in the world, worth 470 mln usd a year out of a global market totaling 530 mln
usd. Of that, gels account for 370 mln, and Ardana reckons its product could
take significant market share.
At the same time, its experimental GHS diagnostic test could be an advance
on current methods on the market, Lindsay said. It could also be ready for
launch by 2008, giving the Scotland-based company two marketable products.
"We're looking at options for the US, which includes potential acquisitions
of companies with established sales forces," the CEO said.
She said the company hopes to be able to report progress in the next 12
months.

[fickena] 19/12/2006 13:48

Fantastic article, many thanks.

Definitely the best undiscovered/ignored biotech imo.

[n_w_b] 19/12/2006 13:18

By Enda Curran

Of DOW JONES NEWSWIRES


LONDON (Dow Jones)--Ardana PLC (ARA.L), the specialist in reproductive health, Tuesday said its lead compound Teverlix LA should begin Phase III trials in summer 2007 and it expects to unveil a partnership deal for the drug with a leading pharmaceutical company early in 2007.

The Edinburgh-based group, which is listed on AIM, is developing potential blockbuster Teverelix to treat prostate cancer, prostrate enlargement and endometriosis, a condition linked to infertility in women. The company said in September it was in talks with potential partners with an eye to future commercialization of the treatment.

Phase III trials are designed to test the efficacy of a new drug and is one of the final stages of testing before a drug is ready to go to market.

Also Tuesday, the company reported a first-half pretax loss for the six months ended Sept. 30 of GBP5.6 million, compared with a loss of GBP3.3 million last year. It posted a loss per share of 9.3 pence, up from a loss of 5.9 pence per share the previous year. Revenues were GBP130,000, down from GBP270,000.

At 1150 GMT, shares in the company were trading up 0.5 pence, or 0.4%, at 113 pence.

In an interview with Dow Jones Newswires, Chief Executive Maureen Lindsay said talks with potential partners are at a "very sensitive" stage, but said the market should "watch this space."

Lindsay said an announcement is likely during the first half of next year.

"We're feeling very comfortable in getting that [the talks] completed, we certainly want to get it done [the announcement] before the Phase III trials," she said.

Lindsay said the potential partners are big names in the industry. "They're global names, household names and I think people would recognize them," she said, but declined to give further details.

Preliminary results from the Teverlix Phase II trials were positive.

The BPH pharmaceutical market is estimated to be worth $4.9 billion in 2005, the company said, citing Wood Mackenzie's Product View, April 2006.

Meanwhile, the company reiterated its plans to bring its other leading compound, Oral Growth Hormone Secetagogue, or GSH, to the U.S. market in 2008, subject to trial results and regulatory approval.

It has already had a positive Investigational New Drug, or IND, meeting with the U.S. Food and Drug Administration, and is about to submit the IND application to begin the required registration study.

"We're still on track for having that launched in the U.S. in 2008," Lindsay said.

The company also said it's Testosterone Cream is making progress, and expects a market launch in 2008. The cream treats patients who are unable to produce testosterone.

Ardana already has Striant, a testosterone replacement therapy, on the market. Separately, the group is launching Invicorp, an injectable treatment for erectile dysfunction, in Denmark. The product is already available under license in the U.K., and Ardana is to seek marketing approval from the European Mutual Recognition Procedure during the first half of 2007.

In September, the company announced a deal with Switzerland's Novartis (NOVN.VX) to market Emselex, a treatment for overactive bladder, in the U.K. Ardana was granted exclusive U.K. rights for Emselex for a period of ten years.

Ardana floated in March 2005 at 128 pence per share, and raised GBP9.9 million after expenses in September, of which GBP4.2 million went towards the launch of Emselex, which entered the market last month, and GBP5.7 million towards development of GHS.

The company said it has no immediate plans for any further fund raising.

Company Web site:

-By Enda Curran, Dow Jones Newswires; 44-20-7842-9275; [e-mail]


(END) Dow Jones Newswires

19-12-06 1201GMT

[february 30th] 17/12/2006 11:59

'...is expected to post another loss when it unveils its interim numbers on Tuesday.'

Who is expecting it to make anything else but all loss? Tomorrow is expected to be Monday.

[fickena] 17/12/2006 11:21

And finally, Ardana, the Edinburgh-based biotechnology company working on the development of a treatment for enlarged prostates, is expected to post another loss when it unveils its interim numbers on Tuesday. Like most biotechs, it has had a topsy-turvy year, and investors will be desperate for some promising news on its drug development programme.

[n_w_b] 17/12/2006 05:55

Scotland on Sunday
Sun 17 Dec 2006

Ardana to update investors


THE reproductive medicine developer Ardana will update investors on the progress of its prostate cancer treatment, Teverelix, on Tuesday when it releases its results for the six months to the end of September. Analysts believe Ardana is close to signing an industry partner for the drug, regarded as its most promising product.

[gnomet2] 14/12/2006 10:27

Results next tuesday, and maybe they're storing up some of that newsflow for then Hopefully there might be a nice little anticipatory price rise in the next day or two..