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[fickena] 31/1/2006 07:49

FDA Update

RNS Number:6612X
Ardana PLC
31 January 2006


ARDANA'S NOVEL TESTOSTERONE CREAM REMAINS ON TRACK FOR Q4 2007 LAUNCH FOLLOWING
PRE-IND MEETING WITH US FDA.

- - Company completes Phase II dose-finding study enrolment - -


Edinburgh, UK, 31 January 2006; Ardana plc (LSE:ARA) the emerging
pharmaceutical company focused on improving human reproductive health, today
reports on a pre-Investigational New Drug (IND) meeting with the US Food and
Drug Administration (FDA) to discuss the development of its novel cream for
testosterone replacement in male hypogonadism.

Agreement was reached on the next steps in development of the product, which
should allow Ardana to meet its registration timelines and previously announced
launch target of end of 2007. Ardana is planning to submit an IND to the FDA
within a few months and expects to commence a Phase III pivotal registration
trial in the US at the end of H1 2006.

Additionally, Ardana announces that enrolment to a Phase II dose finding study
in the target patient population has now been completed. A Phase II
dose-titration study in support of the registration of Ardana's testosterone
cream is also on track to commence in H1 2006.

Dr Maureen Lindsay, Ardana's CEO, said: "We are very encouraged by the feedback
from the FDA and by the progress of development of this novel testosterone
cream, which complements our current and planned portfolio. We believe that the
delivery technology has broad application and we are assessing additional
compounds which could be developed using this platform."

In 2004, the testosterone replacement market in Europe and in the US was
estimated to be worth approximately $600 million. The US market is by far the
most attractive with a growth rate of 40% by value and sales of $537 million
(IMS Health).

[csterling] 18/1/2006 11:06

looks like a great thread. on the basis of the erectile dysfunction, should the company be called hardener?

What was time scale on Pipers target? I am in for long haul but missed press coverage,

[n_w_b] 15/1/2006 02:35

I posted incomplete major shareholder/Director list the other week.

Here's the full one

MERLIN BIOSCIENCES LIMITED 7.86m 14.16%

UBS GLOBAL ASSET MANAGEMENT (UK) LTD. 5.56m 10.02%

TECHNO VENTURE MANAGEMENT (TVM) 5.48m 9.87%

3I GROUP PLC 3.89m 7.01%

DEUTSCHE VENTURE CAPITAL (DVC) 1.74m 3.14%

SCOTTISH WIDOWS INVESTMENT PARTNERSHIP LTD. 1.67m 3.02%

BEST (SIMON GEOFFREY) 1.13m 2.03%

KENT IAN 319,768 0.58%

LINDSAY (MAUREEN) 186,538 0.34%

LEE (GRAHAM S) 50,000 0.09%

FERGUSON CAROL CECILIA 12,000 0.02%

BROWN (JOHN) 10,000 0.02%

[adgd2] 13/1/2006 14:54

on Ardana website presentation regarding erectile dysfunction

"30% of men do not respond to oral therapy"

[n_w_b] 13/1/2006 12:06

Agree.
A long way to go here especially with Piper Jaffray's £2.75 price target!

[fickena] 13/1/2006 10:27

This was definitely the most overlooked biotech listed IMO, just look what a little press coverage can do. People are begining to see the huge potential markets this tiddler is entering.

[fickena] 12/1/2006 18:35

Thanks to Tony (aka Powerbooks) for this.

Buy

ARDANA (ARA)

Ardana's shares have hardly set the stock market alight since floating in March, continuing to trade below their flotation price. But this is due to investors' lack of appetite for biotechs. The reproduction health specialist has an interesting pipeline and good prospects, and is targeting markets worth up to $24bn a year.

The company already has Striant on the market for testosterone replacement therapy. And, although sales were modest during the half-year at £164,000 (£22,000 in 2004), two new marketing partners have been signed up in Germany and Scandinavia. Ardana also sells Striant through its own sales team.

But the jewel in the pipeline is Teverelix for benign prostate enlargement and prostate cancer - markets worth billions of dollars. And following recent discussions with US regulators, the product could launch two years early in 2010.

Broker Piper Jaffray expects a full-year pre-tax loss of £9.7m (loss of £8.4m in 2004-05), with a loss per share of 16.4p (loss of 14.3p).

The shares disappointed last year. But with the launch of erectile dysfunction product Invicorp in the second half of 2006, they remain attractive.

Buy.

[n_w_b] 12/1/2006 16:37

Thanks Adam.

[fickena] 12/1/2006 16:34

N_W_B,

I only subscribe to Shares but I will ask those on the AZM board as some of them do.

[n_w_b] 12/1/2006 16:31

Anyone out there a paid subscriber to "Investors Chronicle" online? Or an early hardcopy?

There's an article dated tomorrow(13th Jan) about Ardana. Do a "search articles" for Ardana on

[n_w_b] 06/1/2006 08:19

Seems the stock overhang since IPO has cleared. Can only buy 500 online and small trades have been moving it recently. Unlike last month when I bought 40,000 and it didn't do anything, although the trades went through Virt-x.

[hyper al] 06/1/2006 08:17

n_w_b

This is certainly on my watch list.

Great prospects and remember Edinburgh has lots of big funds who could support this one.

[fickena] 06/1/2006 07:48

Thanks NWB,

Definately one of mine for 2006. Have thought about VEC too, but am yet to take the plunge. They might not be about much longer as they are a prime takeover target.

[n_w_b] 06/1/2006 07:25

Holder Holding Change %age Disclosed Previous
--------------------------------------------------------------------------------
UBS GLOBAL ASSET MANAGEMENT (UK) LTD. 5.56m +3.22m 10.02 26/10/2005 21/09/2005

So there is someone else on here ;-)

Undiscovered gem!

[hyper al] 06/1/2006 00:09

Does anyone have a list of major share holders for this one?

The 400k cross trade has got me thinking

[hyper al] 05/1/2006 23:35

Came across this as it is an Edinburgh based company!

[n_w_b] 03/1/2006 07:59

Independent stocks for 2006

"We are betting that the biotechnology sector will come into fashion this year as mining did in 2005. So into the portfolio goes Ardana, a drug development company specialising in reproductive health, which already has a business-oriented management and product revenues."

[n_w_b] 20/12/2005 07:54

Market Report: Shot in the arm for drug stocks on Pfizer ruling
By Michael Jivkov
Published: 20 December 2005

Pharmaceutical stocks received a shot in the arm yesterday after the US giant Pfizer drove out a challenge to the core patent to its cholesterol treatment Lipitor, the world's best-selling medicine. The audacious challenge by a copycat maker, the Indian company Ranbaxy, was turned down by an American court late last week. Investors reacted with delight yesterday, driving GlaxoSmithKline 23p higher to 1,483p, AstraZeneca 83p better to 2,830p and Shire 7p stronger to 732.5p.

Had Pfizer lost the case, share prices across the industry would have taken a pasting as it would have prompted fears that key patents held by giants such as GSK and AstraZeneca might also have been at risk. Analysts argued that AstraZeneca's own cholesterol-lowering drug, Crestor, is better off competing against a branded Lipitor sold by Pfizer than a series of generic versions produced by copycat manufacturers such as Ranbaxy.

Credit Suisse First Boston suggested the court win could spark a strong rally by the pharmaceutical sector. The broker said: "With the judgment coming so close to the end of the year and the Medicare Drug Benefit programme about to start in the US in January, there may be an attempt to create a sector rally in Europe or in the US or both that could run for a quarter or so."

[n_w_b] 15/12/2005 11:19

Writeup in last weeks IC(9th Nov) as speculative buy
In brief says:

The downward trend since IPO looks like it's over for two reasons:
1) Venture capitalist's have only sold 300,000 shares since the lockup in September.

2) Positive comment from the FDA, re Teverelix.

Highlights 10m cash burn a year, but to be offset by sales caused by the current product rollouts in Europe.

Say's could get the interest of large pharmas.

[n_w_b] 14/12/2005 10:04

Had me tempted for a few yesterday (Trades went though ARA.VX - Virt-x). Someones got a few still up for sale(small amount), so should move after that's filled. I might be the person to fill that order ;-)


Anyway, here's some Brokers comments from yesterday:

0810 GMT [Dow Jones] Ardana's (ARA.L) 1H release is in line with expectations, says Nomura. Says the company is very much on track, with the key event now being the license of Teverelexto as a major partner, which could happen within the next six months. This would validate Ardana's development work and gain money and management time to further expand the rest of the business. Keeps buy recommendation. Shares +0.4% at 114p. (EXB)




0934 GMT [Dow Jones] PiperJaffray reiterates Ardana (ARA.L) at outperform with 275p price target, following better-than-expected 1H results. "We believe Ardana is likely to continue to deliver on its pipeline as it has done since its IPO in early 2005, and, given its strong newsflow potential in the next 6-12 months as well as its relatively low valuation, our outperform rating remains firmly in place." Trades +0.4% at 114p. (DWE)

[fickena] 14/12/2005 08:01

A set of excellent results yesterday and plenty of press covering it also:

See

This should help this one appear on people's radar and get some more interest in this share,