Anybody else out there interested in these?

2002 Results are due in April, and they are expected to show a maiden profit.
Last week I opened a small speculative long (spreadbet), but I am looking to add to this position a lot more if we get any sort of resolution over Iraq crisis before the results which should spark a broad market rally from which SKP could really benefit and have a strong run-up.

DYOR etc.


Here is a recent research note from Merrill Lynch (they estimate 0.25p EPS for 2002):


Merrill Lynch FlashNote

7 February 2003

SkyePharma

Newsflow Set To Continue BUY

Reason for Report: Company Update

EPS (Dec): 2001A -1.19p; 2002E 0.25p; 2003E 2.13p
P/E (Dec): 2001A NM; 2002E 180.0x; 2003E 21.1x

Michael Ashton, CEO SkyePharma, gave an upbeat and informative presentation today.

Depomorphine appears on track for US submission in June 03. The two pivotal trials (hip and lower abdominal surgery) have been concluded. To date, the results appear encouraging. Management believe that safety (eg respiratory depression and nausea) is not an issue for the drug.The company is also conducting an additional trial in C section patients which is completing enrollment and should be included in the European submission for Depomorphine later this year. We expect the pivotal trial data for Depomorphine to be presented at the American Society of Clinical Anaesthesiologists in October 2003.

Paxil CR continues to grow (accounting for c.26% of total Paxil scrips in the US). 50% of these Paxil CR scrips are repeat and Paxil CR accounts for c.7% of the total SSRI antidepressant market in the US. Paxil CR is already filed for pre-menstrual dysphoria disorder (PMDD). However, GSK also plans to submit the intermittent treatment of PMDD later this year.

SKP also confirmed that Quintiles plans to present new data for Solaraze at the American Society of Dermatology in March. SKP believes that Solaraze is making in-roads into the actinic keratosis market and appears to be taking market share from Ephedrex (5-FU). Clinical trials in Australia are on track, with SKP planning to submit Solaraze to the Australian regulatory authorities in 2004 (second largest market opportunity after the US).

Enzon has already started to market DepoCyt in the US and SKP expects to see wider usage of the drug by key oncologists in the next few months. Phase IV studies for the neoplastic meningitis indication are on track, with an FDA Advisory Committee meeting (ODAC) scheduled next month.

Overall, we expect the newsflow for SKP to continue and reiterate our BUY recommendation with a price objective of 80p (based on applying the speciality pharma multiple to our 06E EPS of 14p and discounting back agressively at 30% p.a.). Risks to the stock include the general risk of drug development delay and product approval failure.

I have been in and out twice and am back again at 69 looking to an upturn when Ashton goes.

I got in 2day at 67.5

Some big hefty buys going thru, Any one know whats going on?

Azhar,

hisorically the main big buyer of this stock is Fidelity - they have built up a stake of about 15% over the last six months - if it is them we will get an RNS. If not I would expect it is just private investors. This stock goes through large patches of heavy buying and selling, partly due to fidelity building a stake and partly due to an ex director who is still selling in large chunks.
Don't know if either explain today but worth bearing in mind with this stock.

If neither of these, we can dream and hope someone knows that the Depomorphine announcement is imminent and they are buying in advance of the official notification. More likely is people building up positions in advance of the annual results at end March.

Skyepharma PLC
25 February 2004


For Immediate Release 25 February 2004



SkyePharma PLC



PAXIL CR(TM) RECEIVES FDA APPROVAL

FOR ADDITIONAL INDICATION



LONDON, UK, 25 February 2004 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) welcomes
yesterday's announcement by its partner GlaxoSmithKline that the US Food & Drug
Administration ('FDA') has approved an additional therapeutic application for
Paxil CR(TM) (paroxetine hydrochloride Controlled Release) for the intermittent
treatment of premenstrual dysphoric disorder ('PMDD'). Paxil(R) is a leading
selective serotonin reuptake inhibitor ('SSRI') antidepressant and Paxil CR(TM)
is already on the market in the US for the treatment of depression, panic
disorder, social anxiety and for the continuous treatment of PMDD. SkyePharma
developed the controlled release formulation used in Paxil CR(TM) and receives a
royalty on GlaxoSmithKline's sales.



Michael Ashton, SkyePharma's chief executive officer, commented: 'Paxil CR(TM) is
currently our leading source of royalty income. According to IMS market data,
Paxil CR(TM) today accounts for about one in twelve new US prescriptions for SSRI
antidepressants. The intermittent PMDD indication for Paxil CR(TM) should expand
the market opportunity for the product since the original version of Paxil(R)
was never approved for the PMDD indication.''



PMDD is a condition that affects about 5% of menstruating women and is
characterised by severe and disabling mood swings and physical symptoms around
the end of the menstrual cycle. With the new intermittent dosing option, women
suffering from PMDD can take Paxil CR(TM) once a day during the two week period
prior to the onset of their menstrual cycle rather than throughout the month.



In Paxil CR(TM) GlaxoSmithKline's SSRI antidepressant Paxil(R) was reformulated
using SkyePharma's Geomatrix(TM) oral drug delivery technology in which a
multi-layered tablet controls the rate of dissolution and site of absorption of
the drug in the body. Clinical studies have demonstrated that Paxil CR(TM)
significantly reduces the incidence of nausea, a common and troublesome early
side-effect that results in poor compliance with many SSRI antidepressants. The
low drop-out rate for patients on Paxil CR(TM) may increase the likelihood that
patients will obtain the full therapeutic benefit. For example, a study
published in the February 2004 issue of the Journal of Clinical Psychiatry on
the use of Paxil CR(TM) in treating social anxiety disorder showed that about
three times as many patients taking Paxil CR(TM) achieved remission compared with
placebo. In addition, the drop-out rate due to adverse events such as sexual
dysfunction was low and comparable to the placebo level.



GlaxoSmithKline launched Paxil CR(TM) in the USA in April 2002. The FDA has
already approved Paxil CR(TM) for the treatment of major depressive disorder,
panic disorder and social anxiety and for the continuous treatment of PMDD.
Paxil CR(TM) offers flexible dosing and is available in three different dosing
strengths: 12.5 mg, 25 mg and 37.5 mg. In 2003, US sales of Paxil(R) and Paxil
CR(TM) were 1.2 billion (US$1.9 billion). SkyePharma receives ongoing royalty
payments on GlaxoSmithKline's net sales of Paxil CR(TM).

Skyepharma PLC
02 March 2004


For Immediate Release 2 March 2004

SkyePharma PLC

Sanofi-Synthelabo begins marketing Uroxatral(R)
to US primary care physicians



LONDON, UK, 2 March 2004 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) welcomes
yesterday's announcement by its partner Sanofi-Synthelabo that it is to begin
marketing Uroxatral(R) (alfuzosin hydrochloride extended-release tablets), a
treatment for benign prostatic hyperplasia ('BPH'), directly to primary care
physicians ('PCPs') in the United States.



The 10 mg once-daily extended-release formulation was developed for
Sanofi-Synthelabo by SkyePharma and involves SkyePharma's proprietary
GeoMatrixTM oral controlled-release delivery technology. SkyePharma receives a
royalty on Sanofi-Synthelabo's global sales of the once-daily formulation of
alfuzosin (known as Xatral(R) OD outside the USA). Uroxatral(R) was approved
by the US Food & Drug Administration ('FDA') in July 2003. Since its November
launch, Sanofi-Synthelabo has focused on specialist urologists. Marketing to
PCPs will involve a considerable expansion in Sanofi-Synthelabo's detail force
for the product.



Michael Ashton, SkyePharma's Chief Executive, said: 'The US launch of
Uroxatral(R) in November was an important milestone for our GeomatrixTM drug
delivery technology. Initial progress with specialist urologists has been
encouraging and we anticipate a substantial increase in sales now that the
product is to be marketed to the wider general practitioner market. The ageing
population is driving an increase in the incidence of BPH, already a common
condition. Alfuzosin is an effective treatment with a low incidence of
side-effects and the once-daily formulation we developed for Sanofi-Synthelabo
has enabled a significant increase in the market share of Xatral(R) outside the
US. Rising royalty income from Xatral(R) OD and Uroxatral(R) will be a key
part of moving SkyePharma closer to its goal of having the greater proportion of
our earnings derived from product-related revenues.'



BPH (also known as benign prostatic hypertrophy) is a common chronic condition
that typically first affects males in middle age. Thereafter the incidence rises
steeply with age. The urinary symptoms of BPH affect 22% of men aged 50-59 but
45% of men aged 70-80. Currently 8 million men in the USA are affected. Gradual
enlargement of the prostate gland causes progressive obstruction of the urethra.
Patients feel the need for frequent micturition but this results in incomplete
emptying of the bladder. Left untreated, the symptoms may progress, which can
lead to serious health problems including urinary tract infections, bladder and
kidney damage, bladder stones, incontinence and acute urinary retention.



Alfuzosin is not a primary treatment for enlarged prostate but addresses the
urinary symptoms by selectively blocking alpha-1 adrenergic receptors in smooth
muscle of the urinary tract, causing smooth muscle in the bladder neck and
prostate to relax and thereby improving urine flow. Extensive clinical studies
conducted by Sanofi-Synthelabo have demonstrated that alfuzosin has a high
degree of selectivity for urinary tract smooth muscle, resulting in a low
incidence of vasodilatory side-effects such as postural hypotension and syncope
(fainting) that can affect patients treated with competing alpha blockers that
are less selective. In addition alfuzosin has a low risk of sexual side-effects
whereas erectile dysfunction and ejaculatory disorders are well-recognized
side-effects of competing alpha-blockers (and also of alternative treatments for
BPH). Alfuzosin has recently been approved in Europe for a second related
indication, acute urinary retention, and is in late-stage clinical trials for a
US filing for this indication. Alfuzosin is the only alpha-1 blocker that has
been shown in clinical trials to result in a significant decrease in post-void
residual urine volume, a known risk factor for acute urinary retention.



IMS estimates that the US market for treatments for BPH is currently in excess
of US$1.0 billion, two-thirds of which comes from sales of alpha-blockers. The
increase in the average age of the population as the post-war 'Baby Boom'
reaches middle age is expected to drive a significant increase in both the
prevalence of the condition and the size of the market. A 2002 analysis by Theta
Reports estimated that by 2006 approximately 115 million men in the 50+ age
bracket worldwide will suffer from BPH and that even though BPH is not
life-threatening, the rising incidence will drive the value of the global market
to nearly $10 billion.



Sanofi-Synthelabo has marketed alfuzosin as Xatral(R) outside the USA since
1988. Xatral(R) was initially introduced as a three times a day formulation and
subsequently a twice-daily formulation was marketed. Xatral(R) OD, the once a
day formulation developed by SkyePharma for Sanofi-Synthelabo, was launched in
Europe in April 2000 and is now on the market throughout Europe and in certain
territories in Africa, the Middle East, Asia, Latin America and Canada. In 2003,
Sanofi-Synthelabo's global sales of Xatral(R) in all forms were 222 million
including US sales of Uroxatral(R) of 9 million (US$11 million). No version of
Xatral(R) had been marketed in the USA before the introduction of Uroxatral(R)
in November 2003.

Azhar,

These announcements worry me slightly - SKP promised three announcements at xmas time, and it appears we have now had them and they are relatively all very small deals compared to the one that was hoped for - the Depomorphine license. Hopefully they are saving that for the annual results which are due out in 3/4 weeks time but I am concerned that annual results day is going to be disappointment again. i am still holding for the long term because the announcement has got to come, this company will come good, but until we get a big announcement, the delay is weighing heavily on the share price and affecting peoples views of how the company is managed IMHO.

Any views?

I have been in for years Adding when low, I am beginning to think this stock is
(Pie In The Sky When You Die)

Driver

likewise - been in for years adding several times. the last announcement has bought them another month - the reults have to be released by 29th April (on the 120 day rule) and they desperately want to announce the 3 contracts at the same time. I am holding until further news but will sell on results if the contracts aren't forthcoming.

I wont be selling, they have got dozens of products in R&D surely some must come good, also a couple of brokers have a 3.50 target on this stock over the next two years or so.

Difficult to understand above consternation, I too have been in and out of skp for about 6 years now, buying at or about 56 to 62 and selling ca 72 - 85 isn't that what its all about?

Well we've now got the first deal of the three. SKP announced this morning the deal for Depomorphine in Europe with Medeus. On the surface looks like they've done well - 100m euros + in milestones (including an upfront payment) and then 35-50% of future sales. Lets hope the other two deals are as good as this one (and announced prior to 29th April)

Consternation, you must have looked that one up jainsworth
Your kangaroo trading is OK but one day you might go to jump back on board and find the train has long gone, or you might be on board and get of at the wrong stop. Consternation to think of how much commission you pay.
P.S SKP could have done better than the 5m upfront payment they got.

Some good news for a change
LONDON (AFX) - Skyepharma PLC and Endo Pharmaceuticals announced that the US
Food & Drug Administration (FDA) has approved SkyePharma''s new drug application
for DepoDur for the treatment of pain following major surgery.

Previously referred to as DepoMorphine, DepoDur is a novel single dose
sustained-release injectable formulation of morphine.

Driver

Cracking news and a good reaction from the market. Glad I topped up at 52p last week. If we could just get the pulmonary deal in the next few weeks this could really take off. We should now start to see some forecasts for this year as the picture becomes clearer.

any thoughts price wise on this skyepharma big jump yesterday,slight fall today as to a buying in point,,,0.60 seems good to me at to it falling back to this point,doubtful. any views on price 12/months from now,seems a lot hinges on this deal ,,people are talking about ,with the yanks.

This share as well as future deals is a take over target, any price below 65p is a good price to buy in.

DRIVER,AS WITH A LOT OF THESE TYPE,, ITS ALL IN THE FUTURE,LETS HOPE THIS HAS A BRIGHT ONE?

Dave

I have held SKP shares for nearly four years now. If buying in, be under no illusion that this has always been a jam tomorrow company and has a track record of disappointing the city. Subsequently it (and its management) now has a very poor reputation. Also, historically most of its revenue has come from milestone payments which has led to a very lumpy profit performance over the years making it very difficult to value the future prospects of the company.

The products/drug pipeline are very strong but over recent times the management has been struggling to deliver these products to the markets.

At the end of the financial year 2003, SKye made its maiden profit and promised profit going forward. Prior to this yr end, it announced that there were 3 large deals in the pipeline which would be signed by the year end. Early Jan, they announced they were still working on the deals but they would be announced within the results. In April they released the results, having only announced one of the three deals. Last week they announced the second deal and also the FDA approval of Depomorphine.

The share price had dropped back to 50p and surged to 70p yesterday before falling back to 62p.

In the background, Ian Gowrie Smith the chairman who created the company stood down at the annual results, but Chief Exec Michael Ashton has been viewed as on borrowed time for a long time (he was in shares mags 10 bosses we want fired). Also, Dr Gonella who holds a vast quantity of stock has been selling into the rises over the past 18 months or so. He still holds in the region of 40m shares at the last count.

The outstanding deal is for a package of pulmonary products and is believed to be the biggest of the three deals. They admitted to turning down a deal late last year which had $90m up front milestone plus royalty payments, because this deal seriously undervalued the product. They are currently in due diligence with a partner for this package.

they are also trying to renogiate the terms of the deal with Glaxo for Paxil CR, looking for an increased share of the revenues. they also have a very long product pipeline at various stages of development.

the likelihood of a takeover in my opinion is not as high as often muted. the main reason for me thinking this is that they have several deals with a variety of pharma partners and a fair deal of this would need to be unravelled if they were taken over.

the short term looks very positive. Personally I sold half my holding yesterday at 68.5p and am looking to buy back in, hopefully below 60p. The pulomanry deal will be very positive for the share price.

Once this deal is signed, it will then be clearer as to a profit forecast for this and next year - these do not currently exist as the company refused to issue guidelines until the deals had been signed (learning from previous failures of promising the earth).

In the long term this is a winner, but in the short term is very volatile and has been a short term traders stock for quite a while. the pipeline is strong, the deals are starting to come through. However, they still need to convince the city of their ability to run the company successfully and deliver repeatable profits before it will achieve the rating its pipeline will eventually merit.

Over 2/3 years it is possible to see these shares at 2 or even 3, though a lot of investors have been saying that for the last 5 years. IMHO it will come good, and it could currently be on the verge of a re-rating if they can win the city round, but it will continue to be volatile in the short term. If buying in DYOR!!!!! and be prepared to wait.

cheers fundy,,i`ll look in to it,,its not something that i would normally select,i didnt think it had been around that long. i no theres been a lot of intrest in this from brokers,in the last 12/18 months but there seems more to this than meets the eye. i`ve followed this share recently,,say about 12 months
it first caught my eye when there antidepressant PAXIL was first mooted, if i remember the price then is roughly the same as the price now.lots of up beat news,if the price falls to levels of about 0.60 i`ll buy and wait, regards dave , cheers for the info.. ps i`am off to hunt in the loft theres about 5 years shares mags ,,investors chronicle up there.......