Aura Renewable Acquisiti... Share Discussion Threads

[n_w_b] 20/9/2006 08:14

Here's info on AIDS lipodystrophy:

People infected with HIV/AIDS are living longer and more productive lives. A large part of the reason is the introduction of medication combinations into standard HIV/AIDS care. But with the benefits of medications also comes some unforeseen problems. One such problem is fat redistribution syndrome or lipodystrophy. Lipodystrophy is characterized by sunken cheeks, thinning arms and legs, and fat accumulations in the abdomen, neck and the back of the neck.
Usually fat redistribution is not physically harmful to the person, although it can cause emotional consequences related to altered self image and appearance. Patients fear the physical manifestations of fat redistribution give them what is known as the "AIDS look". In some cases however, fat build-up in the neck and back of the head ("buffalo hump"), cause physical harm such as difficulty breathing, neck and back pain and headaches.

[n_w_b] 08/9/2006 04:13

Test results give Ardana a boost

SHARES in Ardana, the Edinburgh reproductive pharmaceutical company, rose 1.2 per cent to 125.5p last night after it received positive preliminary results from a phase-one study of the gonadotrophin releasing hormone antagonist, Teverelix LA, in healthy female subjects.

The company said additional data analysis is ongoing and a complete set of data is expected by the end of 2006. A phase-two study is planned to start also by the end of the year.

In a previous clinical study, Teverelix LA had been shown to reduce oestrogen levels rapidly.

This article:

[fickena] 07/9/2006 08:09

Research Update

RNS Number:6089I
Ardana PLC
07 September 2006

ARDANA ANNOUNCES PRELIMINARY POSITIVE PHASE I RESULTS OF TEVERELIX LA FOR THE
TREATMENT OF ENDOMETRIOSIS

Edinburgh, UK: 7 September 2006: Ardana plc (LSE:ARA), the pharmaceutical
company focused on improving human reproductive health, today announces
preliminary results of a Phase I study of the Gonadotrophin Releasing Hormone
(GnRH) Antagonist, Teverelix LA (Long Acting) in healthy female subjects.

Endometriosis arises in pre-menopausal woman when the lining of the womb
(endometrium) grows outside the uterus, often in the pelvic cavity. Symptoms
associated with endometriosis include cyclical or chronic pelvic pain, heavy
periods and infertility. It is well documented that endometriosis is a hormone
sensitive condition and a reduction in estrogen levels causes a shrinkage of the
endometriotic lesions and an improvement in symptoms. Current treatment options
include GnRH agonists. However this class of compounds is associated with side
effects, similar to menopausal symptoms, such as hot flushes, reduced libido and
loss of bone density, due to the reduction in estrogen to those levels seen in
post-menopausal women.

In a previous clinical study of two dose-regimens, different from those
investigated in this study; Teverelix LA has been shown to reduce estrogen
levels rapidly and in a dose-dependent manner.

Preliminary data from this Phase I, randomised, single-blind, placebo-controlled
study of a single subcutaneous injection of Teverelix LA, at one of two doses to
24 healthy female subjects, indicates that Teverelix LA can reduce estrogen
levels to a desired level at the lower end of the normal range which should help
to avoid menopausal symptoms. In this study estrogen levels were reduced to
average concentrations over a period of 8 weeks of 40.5 pg/ml and 49.0 pg/ml
respectively vs. 88.8 pg/ml for placebo.

The effect of Teverelix LA on certain bone absorption markers such as serum
telopeptides and urine deoxypyridinoline were also investigated in the study. On
the basis of the available data these markers appear unaffected by Teverelix
LA..

Additional data analysis is ongoing and a complete data set is expected by the
end of 2006.

This study provides data to support the further development of Teverelix LA in
endometriosis and a Phase II study is currently planned to start by the end of
2006.

Dr Maureen Lindsay, CEO of Ardana said "The results from this study confirm that
Teverelix LA is not only a potential treatment for male indications (prostate
cancer and benign prostate hyperplasia) for which we have previously reported
proof-of-concept Phase II results but is also a potential drug for female
indications that respond to oestrogen suppression, such as endometriosis and
eventually fibromyomas of the uterus, both conditions with an unmet medical
need."

It has been estimated that in 2005, there were approximately 17 million cases of
endometriosis in the seven major pharmaceutical markets (US, Japan, France,
Germany, Italy, Spain and the UK) of which approximately 3.9 million cases were
diagnosed.

For more information contact:

Ardana Financial Dynamics
Maureen Lindsay (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert
Tel: [phone]

[n_w_b] 01/9/2006 11:50

Ardana granted US patent for Teverelix
September 01 2006

MARK SMITH


Ardana Bioscience, a small-cap Scottish pharmaceutical firm focused on human reproductive health, yesterday said it had been granted a US patent covering the long-acting formulation of its drug Teverelix.
The drug is Ardana's lead development compound and is in phase II clinical trials for the treatment of both prostate cancer and benign prostatic hyperplasa, an enlarged prostate condition common in men aged 50 or more.
Prostate cancer is the most common type of cancer diagnosed in men in the US, after skin cancer.
It is also the fourth most-common cause of cancer-related deaths in men in northern Europe, and the market in treatment for prostate cancer is expected to be worth around $4bn (£2.1bn) by 2008.
The Edinburgh-based company said it was also conducting phase I studies for the Teverelix treatment of endometriosis, a painful female condition characterised by tissue that normally lines the uterus growing outside of it.
Research has suggested that some 10% of women suffer from endometriosis, and that 30% of these develop fertility problems.
Meanwhile, the company said the patent is subject to a US patent term adjustment, which means that it is not due to expire in the US until April 2023.
What makes Teverelix different is that it is able to raise or decrease testosterone levels through dosage, where as competitor drugs, claims Ardana, cut out testosterone production completely in the body, which often leads to further medical complications.
The drug is administered by injection into a muscle. Shares in Ardana, whose chairman Simon Best is head of UK industry body BIA, yesterday edged up 0.8%, or 1p, to close at 123.5p.
Ardana Bioscience, a small-cap Scottish pharmaceutical firm focused on human reproductive health, yesterday said it had been granted a US patent covering the long-acting formulation of its drug Teverelix.
The drug is Ardana's lead development compound and is in phase II clinical trials for the treatment of both prostate cancer and benign prostatic hyperplasa, an enlarged prostate condition common in men aged 50 or more.
Prostate cancer is the most common type of cancer diagnosed in men in the US, after skin cancer.
It is also the fourth most-common cause of cancer-related deaths in men in northern Europe, and the market in treatment for prostate cancer is expected to be worth around $4bn (£2.1bn) by 2008.
The Edinburgh-based company said it was also conducting phase I studies for the Teverelix treatment of endometriosis, a painful female condition characterised by tissue that normally lines the uterus growing outside of it.
Research has suggested that some 10% of women suffer from endometriosis, and that 30% of these develop fertility problems.
Meanwhile, the company said the patent is subject to a US patent term adjustment, which means that it is not due to expire in the US until April 2023.
What makes Teverelix different is that it is able to raise or decrease testosterone levels through dosage, where as competitor drugs, claims Ardana, cut out testosterone production completely in the body, which often leads to further medical complications.
The drug is administered by injection into a muscle. Shares in Ardana, whose chairman Simon Best is head of UK industry body BIA, yesterday edged up 0.8%, or 1p, to close at 123.5p.
Ardana Bioscience, a small-cap Scottish pharmaceutical firm focused on human reproductive health, yesterday said it had been granted a US patent covering the long-acting formulation of its drug Teverelix.
The drug is Ardana's lead development compound and is in phase II clinical trials for the treatment of both prostate cancer and benign prostatic hyperplasa, an enlarged prostate condition common in men aged 50 or more.
Prostate cancer is the most common type of cancer diagnosed in men in the US, after skin cancer.
It is also the fourth most-common cause of cancer-related deaths in men in northern Europe, and the market in treatment for prostate cancer is expected to be worth around $4bn (£2.1bn) by 2008.
The Edinburgh-based company said it was also conducting phase I studies for the Teverelix treatment of endometriosis, a painful female condition characterised by tissue that normally lines the uterus growing outside of it.
Research has suggested that some 10% of women suffer from endometriosis, and that 30% of these develop fertility problems.
Meanwhile, the company said the patent is subject to a US patent term adjustment, which means that it is not due to expire in the US until April 2023.
What makes Teverelix different is that it is able to raise or decrease testosterone levels through dosage, where as competitor drugs, claims Ardana, cut out testosterone production completely in the body, which often leads to further medical complications.
The drug is administered by injection into a muscle. Shares in Ardana, whose chairman Simon Best is head of UK industry body BIA, yesterday edged up 0.8%, or 1p, to close at 123.5

[n_w_b] 31/8/2006 13:23

Current Teverelix trials ongoing with results due this year.

• ARD-0301-003 and -008. These Phase II trials in prostate cancer patients are looking at two different dosing regimes of Teverelix.

• ARD-0301-007. This trial is a Phase I single dose PK/PD study in normal and obese male subjects with prostate cancer in the US.

• ARD-0301-001. This is a Phase II trial looking at two different single doses of Teverelix in BPH patients. The patients will be
followed for 3 months.

• ARD-0301-002. This is the follow-on part of the above trial, giving the patients the same dose they received in 001, after they have
become non-responders.

• ARD-0301-006. Phase I PK study of single-dose (2 different doses) of Teverelix or placebo in women with endometriosis.

Another tick in the box for the list of potential partenrs, some ready to deal now and some that are waiting for the above results to come out.

[wiganer] 31/8/2006 09:59

Yup, still have my small upbet in place.

[fickena] 31/8/2006 09:41

Excellent news continues to flow and trades to boot.

Anyone still here?

[n_w_b] 28/7/2006 08:59

A few bits from Piper Jaffray's research note on July 13th

Product pipeline shows significant progress. The progress in Ardana's product
pipeline has been significant during the past 12 months, with the most important
development being the Phase II data from Teverelix and regulatory clarity on the
next steps in prostate cancer and BPH - with the timelines on the potential launch
for the BPH indication brought forward by 2 years from 2012 to 2010.
Strong news flow expected. Ardana is moving into a period of very strong news
flow, with product launches, late stage clinical data and potential deals both on the
out-licensing and in-licensing front. We believe that the majority of this news will
be positive and should help close at least some of the chasm that exists between our
estimate of the company's worth (EV of £227.5m, $421m) and the value ascribed to
it by the market (EV of £50m, $89m).
Sufficient cash to H1-08, without any licensing deals. We have updated our
forecasts to take account of the full year results to 31 March 2006 and used this
opportunity to tweak our sales forecasts to reflect the slightly later impact of the
European launch of Striant. Ardana's cash of £19.1m at YE-06 (March) is sufficient
to take the company through to fiscal H1-08. It is important to note that our
forecasts do not include any upfront/milestone payments associated with licensing
deals.
Change in price target methodology. We have updated our discount rate
methodology to take account of the increased risk free rate and equity risk
premium. We are also using different betas depending on the stage of development
of the company. Our new price target methodology is described in full in this note.
Our new DCF-based 12 month price target is 298p.

New price target
We are expecting a lot of news from Ardana over the next 12 months. This includes the conclusion of the main Phase IIb programme
for Teverelix, allowing the product to move into Phase III in 2007, the start and completion of the Phase III trial for Testo-Cream, the
launch of Invicorp and the start of Phase II trials with EP1572. We believe the chances of failure on all these fronts is minimal.
Building these changes into our model lifts our NPV to £328.6m, i.e. 591.4p per share (Exhibit 7). This represents a 172p upside
potential on our current DCF calculation and, based on the VWAP15 of 125.9p, would suggest a price target of 297.9p. This still
leaves more upside from the potential impact of licensing news. However, as none of the original VC backers have yet reduced their
stakes in the company, we believe that significant share price appreciation is likely to be met with some selling pressure from VCs. To
arrive at an estimate of the price at which VCs may be happy to sell, we have looked at the recent example of Vectura. Vectura priced
its June 2004 IPO at 56p, giving it a valuation which, similar to Ardana (IPO price 128p), did not provide a significant uplift on the
last VC post-money valuation. The majority of the VC selling on Vectura came at around 85p and 125p, i.e. 52% and 100% above the
IPO price. Thus, we believe it is unlikely that VC selling pressure will materialise until Ardana's stock is well over 200p.

At the analyst presentation, Ardana also discussed a potential product in-licensing
opportunity with a global pharmaceutical company. Although not many details are available yet, the company did indicate that, should
the deal be completed, it will involve the UK rights to an approved product, which has excellent synergies with its current portfolio,
and could be launched by the end of the year. As the deal has not yet been completed, we have not factored in any revenues from this
product. Beyond the changes mentioned above, we have not changed our models.

Licensing discussions ongoing
Ardana has been looking at various partnering options for Teverlix over the past 9 months. We understand there are parties interested
in licensing the product prior to the release of any further data and there are those that would rather wait until after the ongoing Phase
IIs report, i.e. look to sign a deal in H1-07 rather than H2-06. Also, the company has announced that there have been two late entries
into the fray, both of which, Ardana believes, would be excellent partners. We continue to believe that Teverelix ticks all the necessary
boxes to make it a highly desirable product and think that the probability of licensing deal in 2006 is quite high:

EP 01572-Growth Hormone Secretagogue

We believe that EP 01572 has significant sales potential and could be the subject of a licensing deal sooner rather than later.


What about the US market?
We believe Ardana has a number of ways for building its US operations, given that it has two products in relatively late stage of
development (Testo Cream and Teverelix) which could be on the market in 2008 and 2009, respectively. These options are:
• Retain US co-marketing rights for some of the indications of Teverelix. Use the upfront payments and milestones to build a small
specialty sales force.
• Do a licensing deal where the partner would pay for a sales force which will co-market Teverelix, with a structure similar to the deal
between Endo and Vernalis. This sales force can then market Testo Cream.
• Partner/merge/acquire a small US company of similar size which has a complementary business model and a small niche sales force.
We believe that there are a number of such potential opportunities in the US. This sales force can then be leveraged in a
co-marketing deal for Teverelix.

[entj] 18/7/2006 14:21

n_w_b - good postings, thanks.
I have 1st Aug as an expected reporting date.
Do you think we will hear anything new by then?

[wiganer] 18/7/2006 12:10

and less healthy- at least it's not a boring flatline share

[n_w_b] 14/7/2006 08:05

Piper Jaffray's latest research note, following the results.

"We believe that the potential of Ardana's product pipeline is under-appreciated by the equity market: our current DCF valuation of the company (498p), is more than
300% above the current share price."

[wiganer] 11/7/2006 08:39

and healthy again....

[n_w_b] 06/7/2006 15:48

There's a piece in tomorrows IC

ARDANA (ARA)

Ardana may be small, but its products target the huge human reproductive health market, which is worth nearly $26bn in annual sales, and its now aiming to create value for shareholders by selling its products in the UK through its fledgling sales team. This is possible because its customers are a handful of specialist doctors. And, while the only product it currently has on sale is testosterone-replacement drug Striant, Ardana has the potential to launch a product every year for the next five years.

Erectile dysfunction drug Invicorp is expected to launch this year or early 2007, and chief executive Maureen Lindsay is already in discussions to buy in a new product to sell through the companies sales force. Ardana is also in licensing negotiations for prostate cancer drug Teverelix, which could be a blockbuster. Teverelix is being developed to treat benign prostatic hyperplasia and endometriosis too. Ms Lindsay is now considering possible acquisitions in the US, which could accelerate the companies expansion there.

IC View:
With the iminent launch of Invicorp and the possibility of a licensing deal for Teverelix soon, the shares remain a buy.

[n_w_b] 03/7/2006 16:44

Preliminary Results Presentation now available:


Anticipated Newsflow

Teverelix LA and other collaborations ongoing
Open IND Prostate Cancer/BPH H1 2006
Invicorp™ mutual recognition H1 2006
Results from PII trial of Terbutaline H2 2006
Further Testosterone Cream data H2 2006
Start PIII trial of Testosterone Cream H2 2006
Launch Invicorp™ H2 2006
Teverelix data – Endometriosis H2 2006
Teverelix data – BPH H2 2006
Teverelix data – Prostate Cancer H1 2007
PIII data and regulatory submission of Testosterone Cream H1 2007

Target Launch Dates

�� 2006/7
Striant
Invicorp
Additional marketed product ????

�� 2008 Testosterone Cream

�� 2009 Teverelix Prostate Cancer

�� 2010 Teverelix BPH

�� 2012 tbc
Teverelix Endometriosis
Oral GHS

Summary

�� Dynamic reproductive health company
�� Actively seeking to build critical mass
�� Strong clinical development pipeline
�� Potentially one product launch per year for next five years
�� At least one potential blockbuster
�� Significant deal flow expected
�� Extensive short-term newsflow

[n_w_b] 02/7/2006 19:31

With a number of "well known" pharmas looking at doing a deal, this will result in a higher deal or could end up with a pharma just making an offer for the group. I'd prefer to stay independent and reap the rewards in 3-5 yrs time, instead of a quick buck now.

[serdka] 01/7/2006 23:42

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[n_w_b] 01/7/2006 22:14

From Fridays FT

Ardana Sets sights on US M&A

Ardana, the maker of reproductive health products, has outlined plans for expansion into the US through acquisition.

Maureen Lindsay, chief executive, said "we expect to accelerate our growth through M&A. We would be looking at companies that are a similar size to us in the first instance."

Ardana also reported that a number of "well known" pharmaceutical groups had expressed interest in licensing Teverelix, its treatment for prostate cancer, which some analysts believe could be capable of delivering $1bn(£550m) of sales a year.

In the year to March 31, Ardana reported slightly higher pre-tax losses of £8.8m(£8.5m) as research and development costs increased from £3.98m to £6.4m. sales more than tripled to £490,000 (£135,000) due to revenue from the groups oral treatment for men with low testosterone levels. Losses per share were 14.7p (20.7p).

EDIT: In a seperate article from the analysts/press meeting, Ardana stated that they wanted a US acquisition of a company with an existing sales force, to sell Testo cream in the US instead of finder a partner in that teritory, therefore retaining more value. They expected to get a significant market share of the estimated $500m US annual sales. They did intend to go into the US market in the long term, but they wanted to bring it forward and "build critical mass" with the launch of Testo cream in early 2008.

This is very good news and could leap us up into the big league.

[n_w_b] 01/7/2006 22:00

From this weeks IC, Page 26.

Small but very profitable
Piper Terrett reports on the small pharmaceutical companies developing niche treatments for which they can charge a premium

Ardana
Scottish biotech Ardana was one of the few biotech companies to float on the main market in 2005. It focuses on developing drugs for human reproductive health. And as this is a huge and fast-growing market, worth $24bn (£12.8bn) in global sales each year, Ardana is initially targeting a handful of niche disease areas while it builds up its sales and marketing team. As with Vernalis's deal with Endo, the strategy is to seek co-marketing deals with partners, ensuring that it retails more value.

Striant, the company's testosterone replacement therapy, is already on the market, albeit with relatively modest sales. Ardana sells the product itself in the UK direct toa network of specialist doctors, and through distributors in Germany and Scandinavia. The company also has Invicorp, its injectable drug for erectile dysfunction, which is expected to reach the market later this year. Overall, the erectile dysfunction market is worth billions of dollars, but the drug will serve a niche market worth $83m in annual sales for patients unable to take Viagra due to heart problems.

In addition, Ardana's testosterone cream for male hypogonadism, targets a market worth $600m in annual sales, and should launch in late 2007. The biotech even has a potential blockbuster in its portfolio in the shape of Teverelix, a treatment for prostate enlargement, endometriosis and prostate cancer.

IC View: The sshares are down on our buy tip at 129p(19 May 2006). But with the possibility of a deal for Teverelix and plenty of news flow to come, they remain a buy.

[fickena] 30/6/2006 06:55

Ardana stands up to the challenge despite losses

MARK SMITH, Deputy Business Editor June 30 2006

Ardana Bioscience, a small-cap Scottish pharmaceutical firm focused on human reproductive health, yesterday reported slightly wider annual losses – but it said it was set to launch its treatment for erectile dysfunction during the second half of the year.

Pre-tax losses for the 12 months to end of March came in at £8.8m, compared with pre-losses of £8.5m in the same period last year.
Revenues climbed to £490,000 from £135,000, after the Edinburgh-based pharmaceutical developer introduced its first product, Striant, an oral treatment for hypogonadism.
However, costs climbed £1.4m to £10.5m – although it ended the 12-month period £19.1m in cash.

In its statement yesterday to the London Stock Exchange, the company said it was "very pleased with the progress across our product portfolio and are highly encouraged by the feedback we have received from the FDA" for Teverelix in the treatment of both prostate cancer and benign prostatic hyperplasa, an enlarged prostate condition common in men over the age of 50.
Ardana also said that Invicorp, its injectable treatment for erectile dysfunction, was "proceeding toward an anticipated launch in the second half of 2006".

The company also said it was pleased with feedback from US Food and Drug Administration for its Testosterone Cream, a gel treatment for hypogonadism, a condition in which men fail to produce sufficient levels of testosterone.
"The clinical development and launch of Teverelix for prostate cancer is on track according to our original schedule in this multi-billion dollar market, and the opportunity to bring forward the launch date for BPH is very exciting for ourselves and potential partners," Ardana added.
It also said there were a number of commercialisa-
tion options for Teverelix, which it wanted more time to consider. Agreements will be in place before Phase III trials commence, the group reiterated.
Shares in Ardana, which floated at 128p in March last year, yesterday closed down 1p at 121p, giving the group a market value of £70.2m.

[wiganer] 14/6/2006 12:01

Chart looking less healthy now....

[n_w_b] 06/6/2006 08:41

New company presentation posted on the Website today:

Newsflow expected:

Results from PII trial of Terbutaline - H1 2006
Teverelix LA and other collaborations - H1 2006
Open IND Prostate Cancer/BPH - H1 2006
InvicorpTM mutual recognition - H1 2006
Launch InvicorpTM - H2 2006
Teverelix data – BPH - H2 2006
Teverelix data – Prostate Cancer - H2 2006
PIII data and regulatory submission of Testo Cream - H2 2006
Start PIII trial of Testo Cream - H2 2006




3 weeks left until the end of the H1 and the full year results. Should be a lot of news flow as this is a recent presentation.

[n_w_b] 28/5/2006 09:42

Fri 26 May 2006
Safe ports can be found as market storm rages
DREW JOHNSTONE

"Another Scottish business winning City plaudits is Ardana, an early-stage drugs developer which some smart money believes has the potential to come up with a global blockbusting drug to fight prostate problems and other diseases some time in the future.

Losses are expected for the next few years but the upside has sparked the interest of some analysts who think the shares are well worth buying now.
"

[fickena] 26/5/2006 09:42

Interesting trading today, with a couple of large trades going through.