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 am here too - lots of good write ups - shares mag etc. Looking for 85p ( so am I!!)

Sharp sp drop "Why" any one?

Cant find anything - but nearly 14% drop means some are in the know - GSK may be behind it. I will buy again to-morrow - if the price is right !

GSK says FDA halts distribution of Paxil CR due to manufacturing issues- News just out.

From another site:

U.S. Marshals Seize Lots of GlaxoSmithKline's Paxil CR and Avandamet Tablets Because of Continuing Good Manufacturing Practice Violations
In a response to ongoing concerns about manufacturing quality, the Food and Drug Administration (FDA) and the Department of Justice today initiated seizures of Paxil CR and Avandamet tablets manufactured by GlaxoSmithKline, Inc. (GSK). Manufacturing practices for the two drugs, approved to treat depression and panic disorder (Paxil CR) and Type II Diabetes (Avandamet), failed to meet the standards laid out by FDA that ensure product safety, strength, quality and purity.

"FDA and the Department of Justice will not allow drug manufacturers to ignore our high public health standards for drug manufacturing," said John M. Taylor, FDA Associate Commissioner for Regulatory Affairs. "Once we discover a company is not following the standards, which were created to ensure safety and quality, we expect them to correct the deficiencies in an expedited manner. American consumers deserve the best health care products on the market today, and companies that are not adhering to these standards cannot assure FDA and American consumers of the quality of their products."

FDA is not aware of any harm to consumers by the products subject to this seizure and it does not believe that these products pose a significant health hazard to consumers. Consequently, FDA urges patients who use these two drugs to continue taking their tablets and to talk with their health care provider about possible alternative products for use until the manufacturing problems have been corrected. FDA has determined that neither product is medically necessary and that alternative products are available for consumer use.

The agency is concerned that GSK's violation of manufacturing standards may have resulted in the production of poor quality drug products that could potentially pose risks to consumers. Among the violations noted during FDA's latest inspection was the finding that the Paxil CR tablets could split apart and patients could receive a portion of the tablets that lacks any active ingredient, or alternatively a portion that contains active ingredient and does not have the intended controlled-release effect. Additionally, FDA found that some Avandamet tablets did not have an accurate dose of rosiglitazone, an active ingredient in this product.

The seizures follow warrants issued by the U.S. District Courts for the District of Puerto Rico and the Eastern District of Tennessee. The seizures were executed today by the U.S. Marshals Service at GSK's Cidra, Puerto Rico manufacturing facility, its Knoxville, Tennessee distribution facility, and a Puerto Rico distribution facility. GSK has voluntarily recalled some of the affected lots of Paxil CR and Avandamet; however, it has failed to recall all affected lots of these products. This failure on the part of GSK resulted in today's seizures by federal authorities.

I don't hold SKP

2Richard2
Thanks for that sounds like a lot of hot air to me GSK will properly end up suing the federal authorities looks like may be a buy for skp on Monday morning.

Skyepharma PLC
04 March 2005


For Immediate Release 4 March 2005


SkyePharma PLC

PAXIL CR CLARIFICATION

LONDON, UK, 4 March 2005 -- SkyePharma PLC (Nasdaq: SKYE; LSE: SKP) notes the
announcement today by GlaxoSmithKline ('GSK') concerning the halting of the US
distribution of Paxil CR, a treatment for depression and several anxiety
disorders. GSK stated that the halt in distribution results from manufacturing
issues which do not pose a health risk to patients. The FDA is advising that
patients taking Paxil CR should continue taking their tablets and talk with
their healthcare provider if they have questions. GSK is working with the FDA to
resolve these issues as quickly as possible.

SkyePharma provided the formulation of Paxil CR, but has no involvement in its
manufacturing.

About SkyePharma PLC

SkyePharma PLC develops pharmaceutical products benefiting from world-leading
drug delivery technologies that provide easier-to-use and more effective drug
formulations. There are now ten approved products incorporating SkyePharma's
technologies in the areas of oral, injectable, inhaled and topical delivery,
supported by advanced solubilisation capabilities. For more information, visit

www.skyepharma.com

Fundamentalist
Thanks for that, panic selling at the end of the day there was no need it went down 11% more than GSK .

Driver

ultimately, Paxil CR is a larger part of SKPs business than it is GSKs (
approx 40% of royalty revenue without checking) - however, the problem is clearly at GSKs end - i was lucky seeing the news early and nicked 20 points out of shorting GSK - then bought back into SKP at 52.5p. Have held shares in the ISA for approx 3 yrs i sold my trading batch a few weeks ago at mid 60s. Monday could be a rocky day - depends on how the weekend press report it, but ultimately think the price will bounce from here prior to results. Then its down to management to finally deliver on the pipeline products, predominantly the pulmonary products

currently trading at the equivalent of 54.25p in the US

Fundamentalist
I have held these for years, normally buying on the dips as low as 44p this is just another one of those many dips.

SkyePharma suffers a 50m hit

Neil Hume
Saturday March 5, 2005
The Guardian

Around 50m was wiped off the market value of drug delivery group SkyePharma yesterday afternoon after the US food and drug administration seized a batch of GlaxoSmithKline's Paxil CR drug because of concerns over manufacturing quality.
SkyePharma designed the technology behind Paxil CR, an extended release version of the antidepressant, which generated international sales of 196m for GSK during the first six months of 2004.

SkyePharma is thought to make a 3% royalty on every Paxil CR pill sold. While the company has yet to report 2004 figures, analysts expect royalty income from the drug to total around 12m.

All of which led them to believe that yesterday's fall has been an overreaction. They also noted that SkyePharma had nothing to do with the manufacturing of the drug - a point the company later confirmed in a statement to the stock exchange.

However, the City was in no mood to listen yesterday, and SkyePharma shares fell 8.25p to 52p - the biggest drop by some distance in the FTSE 250.

AND:

7619


http://money.cnn.com/2005/03/04/news/fortune500/fda_glaxo.reut/
A spokesman for Glaxo in London said it was too early to assess the financial impact of the seizures.

Glaxo (Research) shares edged lower in after-hours trading from their closing price at $48.91 on the New York Stock Exchange.

Shares of SkyePharma PLC, a drug delivery specialist that developed the controlled-release technology in Paxil CR, ended off 13.7 percent at 52 pence in London. SkyePharma receives a low single-digit percentage royalty on sales of Paxil CR.

Supply shortage foreseen
Glaxo said it was working to resolve manufacturing problems as quickly as possible but said both drugs would be in short supply in the United States in the short term.

The seizures were executed by the U.S. Marshals Service at GlaxoSmithKline's Cidra, Puerto Rico manufacturing facility, and a distribution facility in Knoxville, Tenn., the FDA said.

There have been FDA inspections for some time at the Cidra plant, as Glaxo highlighted when it announced full-year results last month. The factory is the only source of supply of both drugs for the U.S. market.

The facility also makes a number of other medicines, including heart failure treatment Coreg, but the spokesman said they were not affected by the move and the FDA was not investigating other product lines.

The European Medicines Agency said European officials would soon inspect Glaxo's Puerto Rico factory.

Mike Ward, an industry analyst with Code Securities in London, said investors were clearly jolted by the news but he took comfort from the fact that no harm appeared to have been done to consumers.

"Market-makers in the stock are obviously worried but, as far as we can tell, there is no problem with any patients having suffered," he said.

"there is no problem with any patients having suffered," he said".

No but they are going to suffer now with out there pills.

sunday press articles

International Markets:

Market over reacts to Paxil jitters

Shares in Skyepharma (LSE: SKP) plunged more than 13% Friday after GlaxoSmithkline (LSE: GSK) announced the FDA had seized batches of its Paxil CR drug manufactured at its facility in Puerto Rico. The issue appeared to arise from a small number of the controlled release formulation pills, reported to be as few as 8 per million pills manufactured, cracking such that the controlled release characteristics of the pills could not be guaranteed. The FDA and GSK had been aware of these issues for some months, yet GSK had failed to recall all the affected batches as had been requested by the FDA, and thus the FDA acted to seize batches to stop further distribution of the drug. GSK indicated that this could cause a shortage of the drug in the short term, although there were no safety issues with patients continuing to use supplies of the drug they already had. Analysts concluded that as no safety issues had been identified, the problem appearing to be a relatively easy to rectify manufacturing issue, that Paxil CR would be back on the market in the US soon. GSK and FDA confirmed they were working hard together to ensure that was the case. Even though the pharma industry is currently sensitive to perceived 'bad news' post Vioxx withdrawal and other recent issues, the reaction of Skyepharma's shareprice was seen as an over-reaction by analysts as the bulk of Skye's current value relates to higher value double digit royalty deals on drugs such as Depodur, a controlled release formulation of morphine, rather than the low single digit royalties it receives from GSK on sales of Paxil CR. It was also noted that Skye may be entitled to compensation from GSK for any loss of Paxil CR royalties it might otherwise receive.


from The Sunday Times

http://www.timesonline.co.uk/article/0,,2095-1512500,00.html


Puerto Rico plant causes Glaxo pain
A MANUFACTURING plant in Puerto Rico is the source of the problems that have given Glaxo Smith Kline a splitting headache, writes Paul Durman.
Shares in the drugs giant, which reached a 15-month high on Thursday, slid on Friday when the powerful US Food and Drugs Administration seized millions of tablets of Paxil CR, a top-selling anti-depressant, and Avandamet, a diabetes treatment.

The FDA is concerned that some Paxil tablets are splitting in half, with one part containing the active ingredient and the other the chemical that controls its release. It fears such poor-quality pills could pose risks to patients.

Glaxo said yesterday: We are pressing to see the FDA as quickly as possible. The company said only eight in 1m tablets were affected.

However, the FDA has had concerns about manufacturing at the plant for at least two years. It also produces the Avandia diabetes therapy and Coreg, a heart medicine for Glaxo. The firm said production of these was unaffected.

The seizure is also bad news for SkyePharma, which supplies the control-release technology used in Paxil CR.

At least some instituions are still buying:

Skyepharma PLC
08 March 2005


For Immediate Release 8 March 2005





SkyePharma PLC ('the Company')

Notification of Major Interest in Shares



In accordance with the Companies Act 1985 (as amended) the Company was informed
on 7th March 2005 that following a series of market making transactions on 4th
March 2005 by Dresdner Kleinwort Wasserstein Securities Limited ('DrKWSL'),
Allianz AG and its subsidiaries, which include DrKWSL, had increased their
notifiable interest to 40,577,590 Ordinary Shares, representing 6.5% of the
issued share capital of the Company. These Ordinary Shares are registered in the
name of DrKWS Nominees Limited.
.

WHy is this falling in the USA on daily basis?

Because they have promised and not delivered (also unfortunate FDA intervention in closing the GSK factory that manufactures Paxil, and the Astralis failure).

Thanks. They were supposed to be profitable by now. Are they?
Can it fall further?

They are certainly not profitable - the question is how much they have lost (apart from total loss of management credibility). Can they fall further? Name a price.