Aura Renewable Acquisiti... Share Discussion Threads

[n_w_b] 11/5/2006 07:44

Article in Shares Magazine


"Something in the Pipeline:

* Protherics - Skyepharma - Alizyme - Plethora Solutions - Ark Therapeutics - Phosphagenics - Ardana"

Fickena, can you post please.

[entj] 19/4/2006 09:04

This is a rare example of a small company which appears to be very professionally managed.
Even more rarely, they seem to have a good balance between the technology/science and the marketing/market understanding.
Good Scottish intelligence, I expect! (Sensibly balanced by an international outlook.)

I have now delved into most of their material and the various write-ups and feel very confident of the prospects and of the science.
It makes a pleasant change from overhyped BB favourites.

[n_w_b] 16/4/2006 13:24

The Sunday Times April 16, 2006


Scottish Business Digest
Scots firm takes hormone test to US


ARDANA BIOSCIENCE, one of Scotland's biopharmaceutical white hopes, will begin full-scale clinical trials of its testosterone gel in the US during the summer. The move comes after trials in Europe have proven to be highly effective in helping men with the hormone deficiency. The company now has US Food and Drug Administration approval. "We're very pleased with the way the data suggests that testosterone can be fully restored in hypogonadal men. The gel works well with our tablets, Straint, which are already on the market," said the chief executive, Maureen Lindsay.

Ardana has moved quickly from proof-of-concept phase II trials and now a phase III registration study, looking at full-scale commercial production, is expected to be completed by the end of the year. Shares rose on news of the trials, hitting 135.5p before the Easter break, and giving the company a market capital of £75m. Ardana, which was spun-out from the Medical Research Council's Human Reproductive Sciences unit at Edinburgh in 2000, has been listed on the London Stock Exchange since March 2005. Its opening price was 128p. "It's been a very hectic first year on the market. We're an ambitious business and we're determined to become a major Scottish biopharma success story. We are still well funded for the continuing work."

[n_w_b] 15/4/2006 07:56

The Week In Review: The cost of a healthy lifestyle
Edited by Michael Jivkov
Published: 15 April 2006

ARDANA

Ardana's announcement that its testosterone-replacement cream has passed an intermediate clinical trial was good news for many men, and the firm. It has a number of other drugs in the pipeline, the lead among them being Teverelix, a compound that has the potential to treat a range of conditions, including prostate cancer and endometriosis. Ardana is one of The Independent's stock tips of the year. Given the positive news, it remains very much a buy.

[n_w_b] 13/4/2006 18:05

Lots more news scheduled in the first half of 2006, according to company presentations.


- Results from additional PII trial of Teverelix LA for Prostate cancer

- Start of PII trial of Teverelix LA for the treatment of Endometriosis

- Start PIII and trial of Testo cream. Possible results from another PII, just started.

- Results from PII trial of Terbulatine

- Invicorp European Mutual recognition, with launch in H2.

- Results for the year ending 31st March 2006. Which should show a big leap in Invicorp sales, due to the German launch(Bigest market in Europe)

- And sometime this year a partner for Teverelix LA


As the CEO stated last month:

Lindsey said the coming year would be full of commercial opportunities.

"There are going to be significant milestones on all fronts, in clinical developments and product development and then another product launch at the end of the year as well as in-licensing opportunities throughout the year."


Won't be long before Piper Jaffray up their current £2.75 a share target!

[n_w_b] 13/4/2006 17:50

Techmark movers: Ardana still rising on results
Date: Thursday 13 Apr 2006

LONDON (ShareCast) - Ardana continued to make ground following yesterdays announcement of positive results from its testosterone cream in a Phase II study in hypogonadal men.

The group, focused on improving human reproductive health, said the Phase II dose-finding study provided "clear evidence" of the effectiveness of the bi-gel technology for the transdermal delivery of testosterone.

[entj] 13/4/2006 16:18

Agreed, Wiganer. I've been following ARA since IPO but only today feel there's enough data and shape for a chart prediction. My P&F chart looks good.

[wiganer] 13/4/2006 16:12

Chart looking beautiful now. Textbook cup/handle followed by breakout to new all-time high.

[wiganer] 13/4/2006 15:59

Chart looking beautiful now. Textbook cup/handle followed by breakout to new all-time high.

[goodgrief] 13/4/2006 10:57

Comment from the Scotsman:-

Breakthrough for Ardana's key testosterone product



A RACE to come up with a leading treatment for low levels of male testosterone, or hypogonadism, is hotting up after Ardana - the Edinburgh-based reproductive health specialist - announced positive results in the testing of its key product yesterday.

A phase II study provided strong evidence of the effectiveness of the company's cream technology for the delivery of testosterone through the skin, said Ardana, and its shares rose by almost 2 per cent to 130p.

The news came a day after Ardana's Galashiels-based rival ProStrakan was cleared to sell its key testosterone replacement gel across the EU.

A pivotal phase III registration study by Ardana is expected to be completed by the end of the year. Chief financial officer Graham Lee said the result confirmed progress on its product's development.

"We hope to get phase III finished by the end of this year. Then we are into registration and getting approvals in the United States and Europe."

The cream is seen as complementary to the company's Striant testosterone tablet already available for men with hypogonadism. While acknowledging ProStrakan was further ahead in the development, and other firms have already launched similar products, Lee said Ardana's cream has superior qualities.

"It uses a far smaller surface area - an arm's-worth rather than an arm and a torso," he explained. "There is virtually no alcohol, so there are no rashes if people have skin sensitivities, and it doesn't smell as much."

[n_w_b] 13/4/2006 07:17

Today Independent

Ardana

Our view: Buy

Share price: 130p (+2.5p)

Ardana's announcement yesterday that its testosterone replacement cream had passed an intermediate clinical trial was good news for many men and the company.

For Ardana its another step towards a launch of its cream in the United States next year and follows the positive discussions it had with the US Food and Drug Administration about the product in February.

For those men who do not produce enough testosterone it is also a breakthrough. Testosterone shortage is common in men, with about one in 200 suffering from it. The market for testosterone replacement is huge - worth about $473m (£270m) in the US alone. Ardana believes the cream has advantages over existing treatments such as injections, gels or tablets, as it can be applied over a smaller area than gels and contains less alcohol, which can trigger rashes in some people.

Ardana, headed by Maureen Lindsay, has been built around the discoveries of the Medical Research Council's human reproductive sciences unit in Edinburgh. It has a number of other drugs in its pipeline, the lead product among them being Teverelix - a compound drug with the potential to treat a range of conditions including prostate cancer and endometriosis, a condition of the uterus for which there is currently barely any treatment available.

Ardana is one of The Independent's stock tips of the year. Given yesterday's positive news it remains very much a buy.

[wiganer] 12/4/2006 07:52

Ardana PLC
12 April 2006


ARDANA ANNOUNCES POSITIVE PHASE II RESULTS FOR TESTOSTERONE CREAM

-- Company announces Phase II results--


Edinburgh, UK: 12 April 2006: Ardana plc (LSE:ARA) today announces positive
results of its testosterone cream in a Phase II study in Hypogonadal Men. This
Phase II dose-finding study provided clear evidence of the effectiveness of
Ardana's bi-gel technology for the transdermal delivery of testosterone.

The double-blind, randomised, placebo-controlled study involved 42 patients
diagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Three
groups, each of 14 patients, received in random order a single application of
the testosterone cream at a dose of 1.5g, 2.25g or 3.0g, or a placebo cream.
Both placebo and active cream were applied to one upper arm only.

The data show that maximal serum concentration was achieved between 10 and 12
hours after the application. For the three doses, 1.5, 2.25 and 3.0g, the
average concentrations of testosterone over 24 hours were 2.06, 2.13 and 2.63 ng
/ml and the maximal concentrations were 3.35, 3.53 and 5.66 ng/ml respectively.

This observed data is consistent with data reported previously. Pharmacokinetic
modelling of the data from this study predicts that testosterone can be fully
restored in hypogonadal men, to within normal range with one of the following
two doses; 1.5g or 2.25g, or combinations thereof; when administered on a daily
basis (i.e. at steady state).

Ardana has also initiated a further one month Phase II study in hypogonadal men.
In this study, steady state conditions of testosterone and longer-term
tolerability are being evaluated. A pivotal Phase III registration study is
expected to be completed by end 2006.

Ardana's testosterone cream, which is in Phase II of clinical development in
Europe, is a stable cream consisting of both an oil and water-based phase
together with the active ingredient, testosterone. Because of its reduced
surface area requirement, Ardana's testosterone cream appears to deliver
testosterone more efficiently than existing gel-based testosterone products and
also has a low alcohol content. Alternative therapies for male hypogonadism
include injectable formulations of testosterone, oral preparations, transdermal
patches, topical gels and subcutaneous implants.

Dr. Maureen Lindsay, Ardana's CEO, said 'We are very encouraged by the data and
development progress of this novel testosterone cream, which we see as
complementary to StriantTMSR, our buccal testosterone tablet already on the
market for men with hypogonadism.'

The male hypogonadism market has experienced rapid growth over the last five
years, driven by novel gel formulations which now make up 76% of the market by
value. The current US market size is estimated to be $473 million (IMS MAT Nov
05).

[wiganer] 12/4/2006 07:52

Ardana PLC
12 April 2006


ARDANA ANNOUNCES POSITIVE PHASE II RESULTS FOR TESTOSTERONE CREAM

-- Company announces Phase II results--


Edinburgh, UK: 12 April 2006: Ardana plc (LSE:ARA) today announces positive
results of its testosterone cream in a Phase II study in Hypogonadal Men. This
Phase II dose-finding study provided clear evidence of the effectiveness of
Ardana's bi-gel technology for the transdermal delivery of testosterone.

The double-blind, randomised, placebo-controlled study involved 42 patients
diagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Three
groups, each of 14 patients, received in random order a single application of
the testosterone cream at a dose of 1.5g, 2.25g or 3.0g, or a placebo cream.
Both placebo and active cream were applied to one upper arm only.

The data show that maximal serum concentration was achieved between 10 and 12
hours after the application. For the three doses, 1.5, 2.25 and 3.0g, the
average concentrations of testosterone over 24 hours were 2.06, 2.13 and 2.63 ng
/ml and the maximal concentrations were 3.35, 3.53 and 5.66 ng/ml respectively.

This observed data is consistent with data reported previously. Pharmacokinetic
modelling of the data from this study predicts that testosterone can be fully
restored in hypogonadal men, to within normal range with one of the following
two doses; 1.5g or 2.25g, or combinations thereof; when administered on a daily
basis (i.e. at steady state).

Ardana has also initiated a further one month Phase II study in hypogonadal men.
In this study, steady state conditions of testosterone and longer-term
tolerability are being evaluated. A pivotal Phase III registration study is
expected to be completed by end 2006.

Ardana's testosterone cream, which is in Phase II of clinical development in
Europe, is a stable cream consisting of both an oil and water-based phase
together with the active ingredient, testosterone. Because of its reduced
surface area requirement, Ardana's testosterone cream appears to deliver
testosterone more efficiently than existing gel-based testosterone products and
also has a low alcohol content. Alternative therapies for male hypogonadism
include injectable formulations of testosterone, oral preparations, transdermal
patches, topical gels and subcutaneous implants.

Dr. Maureen Lindsay, Ardana's CEO, said 'We are very encouraged by the data and
development progress of this novel testosterone cream, which we see as
complementary to StriantTMSR, our buccal testosterone tablet already on the
market for men with hypogonadism.'

The male hypogonadism market has experienced rapid growth over the last five
years, driven by novel gel formulations which now make up 76% of the market by
value. The current US market size is estimated to be $473 million (IMS MAT Nov
05).

[fickena] 12/4/2006 07:51

Research Update

RNS Number:4037B
Ardana PLC
12 April 2006


ARDANA ANNOUNCES POSITIVE PHASE II RESULTS FOR TESTOSTERONE CREAM

-- Company announces Phase II results--


Edinburgh, UK: 12 April 2006: Ardana plc (LSE:ARA) today announces positive
results of its testosterone cream in a Phase II study in Hypogonadal Men. This
Phase II dose-finding study provided clear evidence of the effectiveness of
Ardana's bi-gel technology for the transdermal delivery of testosterone.

The double-blind, randomised, placebo-controlled study involved 42 patients
diagnosed with confirmed male hypogonadism, i.e. testosterone deficiency. Three
groups, each of 14 patients, received in random order a single application of
the testosterone cream at a dose of 1.5g, 2.25g or 3.0g, or a placebo cream.
Both placebo and active cream were applied to one upper arm only.

The data show that maximal serum concentration was achieved between 10 and 12
hours after the application. For the three doses, 1.5, 2.25 and 3.0g, the
average concentrations of testosterone over 24 hours were 2.06, 2.13 and 2.63 ng
/ml and the maximal concentrations were 3.35, 3.53 and 5.66 ng/ml respectively.

This observed data is consistent with data reported previously. Pharmacokinetic
modelling of the data from this study predicts that testosterone can be fully
restored in hypogonadal men, to within normal range with one of the following
two doses; 1.5g or 2.25g, or combinations thereof; when administered on a daily
basis (i.e. at steady state).

Ardana has also initiated a further one month Phase II study in hypogonadal men.
In this study, steady state conditions of testosterone and longer-term
tolerability are being evaluated. A pivotal Phase III registration study is
expected to be completed by end 2006.

Ardana's testosterone cream, which is in Phase II of clinical development in
Europe, is a stable cream consisting of both an oil and water-based phase
together with the active ingredient, testosterone. Because of its reduced
surface area requirement, Ardana's testosterone cream appears to deliver
testosterone more efficiently than existing gel-based testosterone products and
also has a low alcohol content. Alternative therapies for male hypogonadism
include injectable formulations of testosterone, oral preparations, transdermal
patches, topical gels and subcutaneous implants.

Dr. Maureen Lindsay, Ardana's CEO, said "We are very encouraged by the data and
development progress of this novel testosterone cream, which we see as
complementary to StriantTMSR, our buccal testosterone tablet already on the
market for men with hypogonadism."

The male hypogonadism market has experienced rapid growth over the last five
years, driven by novel gel formulations which now make up 76% of the market by
value. The current US market size is estimated to be $473 million (IMS MAT Nov
05).



For more information contact:

Ardana plc Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 David Yates
Tel: [phone]




About Ardana

Ardana plc is a pharmaceutical company focused on the discovery, development and
marketing of innovative products to improve human reproductive health, a $23.8
billion market.

Since its foundation, Ardana has maintained a broad and balanced portfolio to
manage risk and actively pursues product and technology in-licensing and
out-licensing to maintain a robust pipeline.

Ardana's four lead products are summarised below:

* StriantTM SR, a testosterone replacement therapy for which Ardana has
marketing rights in Europe, has already been launched by Ardana through its
own sales force in the UK as a treatment for men with confirmed hypogonadism
* Teverelix LA, in development for three initial indications (prostate
cancer in Phase II, benign prostatic hyperplasia in Phase II and
endometriosis in Phase I)
* Testosterone Cream, a transdermal testosterone delivery system in Phase II
for the treatment of male hypogonadism
* Invicorp(R), an injectable combination drug treatment for erectile
dysfunction, already approved in Denmark and for which Ardana has marketing
and manufacturing rights in Europe. Launch is expected in H2 2006

In addition, Ardana has a strong portfolio of follow-on products in development.
Ardana has been listed on the main board of the London Stock Exchange

[fickena] 06/4/2006 18:25

Excellent!

Great find, I also hope it is one of the companies to most change the date of my retirement!

[goodgrief] 06/4/2006 17:26

Checking back through the thread, I don't think this was picked up. In June 2005 Ardana was selected by Harvard Business School as one of 25 companies 'most likely to change our world by 2010'. There is not even a reference to it on Ardana's website.



The 2010 Symposium: European Companies and Technologies That Will Change Our World

Please join us for the 21st June for a day focusing on the European companies and technologies that will transform our world in the next 5 years.

16.00-16.45 6-10 of ten Hot Companies
Moderator: Doug Richard (Chairman, Library House)
...
Dr. Maureen Lindsay (CEO, Ardana plc)
...

[n_w_b] 18/3/2006 12:08

Ardana brings in sales heavyweight with eye on second launch

Sat 18 Mar 2006

HAMISH RUTHERFORD

ARDANA, the Edinburgh-based reproductive specialists, has appointed an industry heavyweight to beef up its sales and marketing operation, in preparation of its second product launch later this year.

Yesterday, the company announced Klaus Falk had been appointed to the new position of vice-president of sales and marketing. The 46-year-old is a veteran of the pharmaceutical industry, with more than 20 years at German-based global giant Merck KGaA, including eight years as general manager in Central and South America.

Falk was also involved in the company's flotation in Germany in 1995. As European vice-president, he was responsible for sales and marketing and duties for the launch of the oncology franchise's first product, Erbitux, in 2003.

Ardana chief executive Maureen Lindsay said the company was gearing up a strong sales and marketing team as it prepared to expand its sales operations.

"Klaus's deep and broad experience over the last 20 years will bring significant benefits to Ardana as we build further on our sales and marketing capabilities in the UK and Europe." he said.

The company has already launched Striant, its testosterone replacement treatment for men with hypergonadism, and is planning to launch Invicorp, an injection to combat erectile dysfunction in the second half of this year.

Ardana has said the two products, and a testosterone replacement cream which is still under development, each have the potential to create sales of up to £15 million in Europe. Lindsey said the coming year would be full of commercial opportunities.

"There are going to be significant milestones on all fronts, in clinical developments and product development and then another product launch at the end of the year as well as in-licensing opportunities throughout the year."

Ardana's shares rose 1.5p to 129p.

[Abuse team] 11/3/2006 04:47

Post removed by ADVFN

[n_w_b] 11/3/2006 02:12

March 08, 2006 04:10 PM London Timezone

The Current Mature Market for Hormonal Contraceptives and Infertility Drugs is Estimated at US$7.1 Billion but is Forecast to Increase 40% to US$9.9 Billion by 2012

DUBLIN, Ireland--(BUSINESS WIRE)--March 8, 2006--Research and Markets ( has announced the addition of Spectra Intelligence Report "The Global Market for Hormonal Contraceptives and Infertility Drugs, 2005-2012" to their offering.


Drugs in reproductive medicine are evolving into highly sophisticated products with multifunctional pharmacological properties and clinical utilities. Novel contraceptive formulations with low side-effect profiles are providing women with flexible birthcontrol and menstrual management options whilst also offering secondary indications to treat coexisting endocrinological and gynaecological disorders. Furthermore, the increasing global prevalence of infertility is driving R&D to offer novel drug solutions to improve or restore male- and female-factor infertility, optimize fertilization and embryo implantation, and reduce miscarriage.

Recent advances in administering and formulating hormone-based drugs is enabling a revolution in contraception and infertility treatments. Over the next decade, the market for hormonal contraceptives and infertility drugs is predicted to expand considerably through innovation, new and expanding markets, and high value prospects that importantly offer novel solutions to unmet needs and demands of patients who wish to modulate or enhance fertility. The current mature market for hormonal contraceptives and infertility drugs is estimated at US$7.1 billion but is forecast to increase 40% to US$9.9 billion by 2012.

This report provides a detailed analysis of the global market for hormonal contraceptives and infertility drugs highlighting strategies for product extension and reformulation, sales forecasts to 2012 for leading products, and impact of late-stage pipeline drugs on the market. Therapy area forecasting and illustrative market data and analysis is also presented to offer insights into sector performance, which may enable the reader to make key assumptions about future markets and prospects.

Report Highlights and Key Findings

-- The current market for the hormonal contraceptives and infertility drugs is valued at US$7.1 billion, which is forecast to increase 40% to US$9.9 billion by 2012

-- Critical analysis of marketed hormonal contraceptives, reformulations, and infertility drugs

-- Analysis of over 10 key marketed products and inclusion of 38 R&D candidates identified in preclinical to clinical stages of development

-- Sales estimates (US$) to 2012 for leading products

-- Strategic insights for life-cycle optimization and product development

-- Commercial evaluation of leading reproductive health pharmacotherapies

-- Trend analysis of industry events and activities over past 2 years

-- Detailed R&D themes and clusters by therapy area

-- Data generation on sector and market values between 2004 and 2012 and therapy area forecasts by 2020 (US$)

-- High revenue-yielding prospects identified with projected sales estimations

-- R&D pipeline positioning for novel candidates

-- Market insights for product development and drug promotion

What Can I Learn From This Report?

-- Which contraceptives and infertility drugs are the current and potential future market leaders?

-- Insights into the extent of reformulations for hormonal contraceptive products

-- What impact new drug approvals will have on the reproductive medicine drug market?

-- Which premarket drugs are identified as high-value products?

-- Which companies are developing hormonal contraceptives and infertility drugs?

-- Sales predictions to 2012 for leading contraceptives and infertility drugs

-- How will newcomers affect the product positioning of market leaders

-- What are niche market opportunities in reproductive medicine?

-- What the future outlook holds for hormonal contraceptives and infertility pharmacotherapy?

-- How companies are expanding the global reproductive medicine market through sophisticated reformulations and secondary indications for endocrinological and gynaecological disorders

-- Which molecules and compounds are main R&D clusters in reproductive medicine?

-- Which of the pipeline candidates are identified as top prospects over the next decade and to 2020?

Plus Many Other Insights, Observations, Assumptions, and Predictions to be Garnered...

Companies Mentioned:

-- Acrux

-- Agile Therapeutics

-- Akzo Nobel

-- Antares Pharma

-- Ardana

-- Astrazeneca

-- Barr Laboratories

-- Berlex

-- Enhance Biotech

-- Ferring

-- Gropep

-- Johnson & Johnson

-- Laboratoire Theramex

-- Ligand

-- Organon

-- Ortho-Mcneil Pharmaceuticals

-- Pfizer

-- Polydex Pharma

-- Sanofi-Aventis

-- Schering Ag

-- Serono

-- Solvay

-- Vitro Diagnostics

-- Wyeth

[n_w_b] 10/3/2006 12:26

There's an updated company presentation now available on their Website. Was the Autumn one a couple of days ago.

[n_w_b] 06/3/2006 09:34

New Market Maker this morning, Evolution Securities, making five quoting prices for ARA.

We're getting there.

[drewz] 24/2/2006 05:16

From today's IC:

They quote Andy Smith, investment manager of the International Biotech Trust, as saying he believes some UK companies could see takeover interest, and he names Ardana as potentially being of interest to a major US company who may "swoop" on ARA to grab a European sales team.

IC reiterates that ARA is a 'BUY'.

Should add a bit of interest in the stock today.

[fickena] 23/2/2006 16:22

Biotechs mentioned all over recently.

Ardana, Alizyme and Protherics named as "One to Rocket" in Shares Mag this weeks, both make the top 10.

1. Strategic Thought Group
2. Autonomy
3. Pipehawk
4. Protherics
5. Accuma
6. Asos
7. Pipex
8. Hardide
9. Alizyme
10. Fenner


Other Bios Plethora (14), Anitsoma (48), Acvambis (43), Ardana (54), GW Pharma (63), Evolutec (74), Reneuron (96).

Ardana

Number 54

ARDANA (ARA)
Sector: Pharmaceuticals & Biotechnology
Price: 125p
Market cap: £70 million PE: n/a
1-mth rel. strength: 0.0%
6-mth rel. strength: 1.3%
2006 EPS growth: n/a
Has a promising pipeline of reproductive health
drugs. The most exciting of these is Teverelix,
which is in Phase II trials for prostate cancer and
Phase I trials for endometriosis and fibroids.

END

They have basically listed 100 of the most popular small cap shares and writen a little bit on each. With 100 they are bound to get a couple right!

[n_w_b] 23/2/2006 16:14

Ardana mentioned in tomorrow's IC:

Biotech consolidation likely

Pharmaceutical companies' dwindling development pipelines could drive corporate activity in the biotech sector, according to City...


Waiting for a kind person on another thread inorder to post full content.