Marks Electrical Share Discussion Threads

[maywillow] 26/2/2005 09:24

The best medicine?

Feb 22nd 2005
From The Economist Global Agenda


Novartis has made two acquisitions that propel it to the top position among the world's generic drugmakers. Has the Swiss pharmaceutical giant found the best way to hedge against the problems that beset makers of branded drugs? Or should it stick to making patented blockbusters?

EPA






THE world's big pharmaceutical companies are not generally fans of generic drugmakers. These firms wait around for patents to expire on money-spinning blockbuster drugs and manufacture copies that sell at a fraction of the price of the originals, unburdened as they are with the huge costs of research and development (R&D) borne by the makers of branded drugs. Novartis, the world's sixth-largest drug company, is not so stand-offish. On Monday February 21st, the Swiss drug giant announced that it would pay $8.3 billion to acquire Germany's second-largest generic drug firm, Hexal, and a 67.7% stake in Eon Laboratories, an affiliate that is one of America's biggest generic suppliers. The deal moves Novartis above Teva Pharmaceutical Industries, an Israeli firm, to become the world's leading maker of generic drugs through its Sandoz division. Novartis hopes that its foray into generics will insulate it from the problems faced by the rest of the world's leading drug companies.

Recent results suggest that most big drug companies are in relatively good shape at the moment, though this disguises looming problems. Big Pharma relies on blockbuster drugs for its profits but the supply is dwindling. Drug pipelines everywhere are looking near-empty. In 2002, America's Food and Drug Administration approved just 18 new drugs, though in 2004 the number increased to 34. This compares with an average of 59 new drugs a year launched by big companies between 1998 and 2002. These firms spend up to 20% of their revenues on R&D but the time needed to develop drugs is getting longer-and 40% of products do not progress all the way through the development process. Moreover, less than a third of new drugs these days are first or second in their class and it is hard to charge blockbuster prices for the mediocre medications and line extensions that make up the rest of the new products.

Novartis announces its acquisition of Hexal and Eon Labs. The Food and Drug Administration and the European Generic Medicines Association offer information on generic medicines. Eliot Spitzer launches a lawsuit against GlaxoSmithKline.

Adding to the gloom is the risk that blockbuster drugs sometimes cause more harm than good to both patient and drug company. Merck, an American drug giant, suffered terribly after the withdrawal last September of Vioxx. It faces the prospect of billions of dollars of claims after studies concluded that taking the painkiller increased the risk of heart problems in some patients. In June, Eliot Spitzer, New York's business-bashing attorney-general, launched a lawsuit against GlaxoSmithKline (GSK) for allegedly suppressing data that linked one of its antidepressants to heightened suicide risks for children. Pfizer's Celebrex, which uses the same COX-2 inhibitors as Vioxx, was last week criticised by American regulators for increasing the risk of heart problems. But the drug will stay on the market as it was concluded that the product did more good than harm.

Since 1990, 14 drugs have been withdrawn from the American market, which accounts for 45% of the world's $378 billion retail drug sales per year, according to Public Citizen, a consumer group. Of those, only Lotronex, a treatment for irritable-bowel syndrome in women, has been re-introduced.

As patents expire, pharmaceutical giants can find themselves in a vulnerable position. In August 2000, a ruling cut three years off the patent for Prozac, Eli Lilly's hugely successful antidepressant, causing the company's shares to drop by 30% in one day. Another patent ruling on Zyprexa, the firm's current bestseller with sales of over $4 billion last year, is expected shortly. Some drug companies have struck back through the courts. In America, the lapsing of patents can be delayed automatically if drugmakers sue rival generic firms. Patent rules can be bent in a variety of ways to delay generic drugmakers from bringing previously patent-protected products to market. Some big drug firms are also suspected of colluding with generic rivals-ie, paying them-to delay bringing non-branded products to market. A Department of Justice investigation is currently under way.

Novartis is embracing a generic-drug market that has ballooned in the past few years as health-care providers have sought to put a brake on the ever-rising costs of treatment. The generic market will be worth some $100 billion a year by 2010, according to Daniel Vasella, Novartis's chief executive, and he has said that he wants a 10% slice. Mr Vasella claims that big buyers, such as Wal-Mart in America and health-care providers in emerging markets, want to be able to buy a full range of patented and generic products from one supplier.

Novartis is not the only big firm making moves into generic drugmaking. Last year, Pfizer launched a generic version of one of its epilepsy medicines to take some sales from non-branded competition. Sanofi-Aventis has said that it will move further into the generic business, and GSK has licensed some products with expiring patents to generic companies for a share of the profits. On the other hand, Roche, a Swiss rival to Novartis, has said that it sees no future in entering the generics market.

The business is certainly a tough one. If several firms choose to copy a drug, prices soon tumble. The best-placed firms are those with the lowest costs, and at present these are mainly in India. After this week's deal, some 15% of Novartis's revenues will come from generics but profits from that segment could be slender compared with those from blockbusters. Novartis may be wise to seek a measure of stability in an industry beset with ups and downs, but it could experience some unwelcome side-effects.

[brugha] 21/2/2005 20:17

Is pharma starting the long awaited and predicted come back?

25% anyone?

[waldron] 21/2/2005 09:08

LONDON (AFX) - The FTSE 100 opened with moderate gains, led higher by a
rally in pharma stocks following a favourable FDA decision on painkillers
produced by US giants Merck and Pfizer, dealers said.
At 8.04 am, the FTSE 100 was up 16.4 points at 5,073.6, while the broader
indices were also higher.
On Friday, the DJIA ended up 30.96 points at 10,785.22 as Pfizer and Merck
surged following a series of favourable regulatory decisions concerning a
controversial class of painkillers.
A Food and Drug Administration panel voted to allow Vioxx, Merck's pain
relief drug for arthritis, to return to the market. The same FDA panel voted to
continue to permit sales of Pfizer's Celebrex and Bextra, which also used in the
treatment of arthritis pain. The drugs came under scrutiny on concern their use
increased the risk of heart attacks and other cardiovascular incidents.
Meanwhile, the Nasdaq Composite slipped 2.72 points at 2,058.62
Over in Asia, the Nikkei 225 ended the day down 9.10 points at 11,651.02,
while at midday Hong Kong's Hang Seng index HANG was up 8.21 points at
14,096.08.
In London, drug stocks reacted positively to Merck and Pfizer's positive
news, sending GlaxoSmithKLine up 24 at 1,265, AstraZeneca up 40 at 2,115 and
Shire up 11 to 573.
Elsewhere in the sector, Novartis announced it has signed agreements to
acquire 100 pct of the privately-held number two German generic drugmaker Hexal
AG and 67.7 pct of US generics company Eon Labs Inc.
sm/tc

[alphorn] 20/2/2005 17:45

brugha - yes, I do understand the risk of bleeding from NSAIDs and the benefits of the class of Cox2 inhibitors. There is another element to take into consideration and that is pain.

[alphorn] 20/2/2005 12:05

..........in the meantime the lawyers will get richer :-)

[brugha] 20/2/2005 11:10

Continued FDA approval and a likely return to market for Vioxx will scupper the lawsuits

Get in quickly, it has a long way to go!

[ariane] 20/2/2005 11:01

LONDON (AFX) - More than 100 British patients who suffered heart attacks or
strokes while using the controversial painkiller Vioxx are pursuing its US
manufacturer Merck in what could become the biggest legal action against a drugs
company, The Business weekly reported, citing legal sources.
The alleged victims have joined forces with a US law firm preparing to sue
Merck in the US.
Locks Law Firm -- which already has 300 US patients bringing individual
actions in New Jersey, Merck's home state -- was still gathering evidence but
hoped to move towards the trial-setting stage in April, a partner at the comany,
Marc Weingarten, told the financial newspaper.
"The number of claims internationally will grow as more patients affected by
Vioxx come forward," it predicted.
Any relief from a decision on Friday by the US food and drugs watchdog to
allow Merck to return its drug to stores would likely be short-lived, The
Business said, warning that claims against the firm could total more than 18 bln
usd over the next decade.
Vioxx and other similar drugs widely prescribed for arthritis and severe
pain have all come under fire recently for being linked to a higher incidence of
cardiac problems in some patients.
A study last month revealed that Vioxx may have caused as many as 140,000
cases of serious coronary heart disease in the US before it was pulled from
shelves last September.
dmh/jmy/tr

[hell_fire_corruption] 15/12/2004 12:40

I'm interested in buying MERCk & Co, can somebody recommend an online broker. Thanks

[grupo guitarlumber] 09/11/2004 18:55

snow in the air on this side of the Lake

[alphorn] 08/11/2004 15:17

Biotech's very rarely come up with compounds to follow on from the initial ones on the company set up. Great day this side of the lake :-)

[waldron] 08/11/2004 07:16

Actelion Stops Study of Drug for Acute Heart Failure (Update2)
Nov. 7 (Bloomberg) -- Actelion Ltd., a Swiss biotechnology company, said it stopped a trial of its Veletri drug as a treatment for acute heart failure because the study was unlikely to show that the medicine was effective.

There were no safety issues, just ``too remote a chance for the efficacy endpoints to become statistically significant,'' the Allschwil, Switzerland-based company said in a statement sent by e- mail. It will hold a conference call for investors tomorrow.

Analysts estimated Veletri could have annual sales of between $400 million and $1 billion, even after the drug failed in 2001 in a phase III trial, the final stage of testing generally required before regulatory approval. The company said it won't be pursuing any other indications for the drug.

``This news will certainly have a negative impact because the next product in their pipeline is only in phase II,'' said Birgit Kulhoff, a pharmaceutical analyst at Bank Sal. Oppenheim in Zurich, in a telephone interview. Kulhoff, who has a ``buy'' rating on the stock, had expected the drug to make peak sales of 500 million Swiss francs ($425 million).

Actelion now expects ``considerably higher earnings in 2005 than in 2004 as pre-marketing and trial costs for Veletri won't occur,'' said the company's head of investor relations, Roland Haefeli, in a telephone interview.

Strategy

The decision to discontinue the current study, known as ``Veritas,'' was taken following the recommendation of the study's steering committee and the independent Data Safety Monitoring Board on Nov. 6, Actelion said.

About 1,300 patients were enrolled in the study, which was testing a lower dose than in the previous phase III trial.

Actelion said it will now concentrate on Tracleer, a treatment for potentially fatal lung disease that accounted for almost all of the company's 307.5 million Swiss francs ($257 million) in 2003 sales.

It will also focus on Zavesca, a medication licensed from UCB SA's Celltech unit for treating Gaucher disease, a genetic illness that affects about 100,000 people worldwide, causing liver and kidney enlargement, anemia, bone disease and pain.

The company, which was founded by a husband and wife team in 1997, said it will also reallocate resources to ``further accelerate development of its broad clinical and pre-clinical pipeline.''

The company's conference call for investors will be on Monday Nov. 8 at 8:00 a.m. Central European Time at [phone] for European listeners, [phone] for U.S. listeners and [phone] for U.K. listeners.

[grupo] 31/10/2004 16:13

ZURICH (AFX) - Novartis AG chief executive Daniel Vasella denied that the
COX-2 inhibitors class of painkillers is finished as a result of the withdrawal
of Merck & Co Inc's Vioxx earlier this year.
Speaking in an interview with NZZ am Sonntag, Vasella said: "As usual in
crisis situations, a lot of people go over the top."
Vioxx was a blockbuster drug marketed in more than 80 countries with sales
of 2.5 bln usd in 2003, but Merck withdrew it in September due to concerns about
cardiovascular side effects.
Vioxx belongs to a new generation of non-steroidal anti-inflammatory
painkillers (NSAIDS) known as COX-2 inhibitors, seen as safer than traditional
painkillers like aspirin that can cause stomach bleeding.
Novartis is also developing a COX-2 inhibitor known as Prexige, which it
aims to submit for US approval in 2007.
Vasella said that Prexige, which has been approved but not yet launched in
the UK, is the only drug is its class to have gone through a 12-month trial with
18,000 patients, including patients with cardiovascular problems.
"We saw no signs in that study that the drug increased risks for
cardiovascular patients," Vasella said, adding that most patients take these
drugs irregularly and for less than a year.
Vioxx was withdrawn after use of the drug for three years was linked to an
increased instance of heart attacks and strokes.
Vasella said he cannot rule out that patients who take Prexige for longer
than a year could develop side effects, but he stressed the benefits of the drug
in reducing stomach bleeding when compared to older drugs.
"Today a debate has broken out that talks about patients as though they only
consisted of a cardiovascular system. That's nonsense. You have to look at a
patient as a whole and decide which medication at the end of the day has the
greatest use," he said.
scs/jsa

[waldron] 27/10/2004 12:34

LONDON, October 27 (newratings.com) - Analysts at Morgan Stanley reiterate their "overweight" rating on Actelion (ACT.ETR), while raising their estimates for the company. The target price has been raised from Sfr144 to Sfr153.

In a research note published this morning, the analysts mention that the company has reported impressive third quarter results and raised its FY04 guidance. The company is well positioned to diversify its revenue base and deliver robust long-term earnings growth, the analysts say. The current valuation of Actelion's stock, however, does not reflect the company's growth prospects, Morgan Stanley believes. The EPS estimates for 2004 and 2005 have been raised from Sfr2.82 to Sfr3.50 and from Sfr4.28 to Sfr4.86, respectively.

[ariane] 26/10/2004 12:46

Source: Actelion Ltd

Actelion Announces 9-Month Results for 2004
ALLSCHWIL, Switzerland, Oct. 26, 2004 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN) today announced its financial result for the first nine months of 2004. With total net revenues for the first nine months of 2004 of CHF 341.5 million (9 m 2003: CHF 209.1 m) and operating expenses of CHF 277.6 million (9 m 2003: 181.1 m), the company reported an operating profit of CHF 63.9 million (9 m 2003: CHF 28.0 m). The net profit for the first nine months of 2004 was CHF 64.2 million (9 m 2003: CHF 23.1 m).


Total net revenues up 63% reaching CHF 341.5 million for the first
nine months of 2004
-- Strong organic Tracleer(r) growth in Pulmonary Arterial
Hypertension results in sales of CHF 325.4 m
-- Operating expenses of CHF 277.6 million reflecting continuous
business expansion
-- All clinical programs on or ahead of schedule
-- Operating profit of CHF 63.9 million
-- Upgraded guidance for Full Year 2004

Basic earnings per share (EPS) for the first nine months of 2004 improved to CHF 2.92, compared to CHF 1.07 in the first nine months of 2003. The gross cash position as of 30 September 2004 was CHF 273.7 million (30 June 2004: CHF 244.8 million).

Andrew J. Oakley, Chief Financial Officer commented: "I am very pleased with the financial result for the first nine months of 2004. Tracleer(r) sales growth has been higher than expected, most likely due to our ongoing educational activities. Our costs continued to increase in-line with both our expectations and the expansion of our business activities."

Andrew J. Oakley concluded: "Unforeseen events excluded, I now expect our total net revenues for 2004 to reach between CHF 455 to 470 million. Our overall cost structure should continue to develop in-line with our plans to further invest in both marketing and sales as well as research and development. Accordingly, I believe that Actelion should report a substantially higher than expected operating profit for the year."

Jean-Paul Clozel, MD and Chief Executive Officer, commented: "I am delighted with our overall performance for the first nine months of 2004. In addition to an outstanding financial result, our clinical programs have advanced further. Three clinical studies with Tracleer(r) -- in Digital Ulcerations and two forms of Pulmonary Fibrosis -- have achieved full enrollment. Also, the clinical study evaluating tezosentan in acute heart failure has now enrolled more than 75 percent of the foreseen 1'760 patients. This will allow the independent Drug Safety Monitoring Board to perform the second futility analysis sometime in early November."

Jean-Paul Clozel concluded: "With many advanced clinical trials reporting results in the next 15 months, a thriving early-stage clinical pipeline and a highly productive research effort, Actelion is well prepared for the future. For the months ahead, we are adding to the current sales momentum through the ongoing sales force optimization. Actelion is in the process of hiring around 50 territory managers in addition to the 150 already in the field. We believe this is the most efficient way to further capitalize on the strong trend of early diagnosis and treatment of PAH with Tracleer(r), a proven dual endothelin receptor antagonist directly addressing the endothelin dysfunction in this rapidly progressing disease."


Financial result overview -- Table 9 months 2004 vs. 9 months 2003

In CHF thousands Result 9 Result 9
months 2004 months 2003 Variance in %
Net Revenues 341'517 209'148 132'369 +63
Operating Expenses 277'628 181'122 96'506 +53
Operating Profit 63'889 28'026 35'863 +128
Net Profit 64'150 23'067 41'083 +178
Basic EPS in CHF 2.92 1.07 1.85 +173
Diluted EPS in CHF 2.78 1.03 1.75 +170
Cash & cash equivalents 273'727 136'639 137'088 +100

The full financial statements can be found on


For the three months period ended September 30, 2003, product sales equivalent to CHF 4.6 million (less respective cost of sales of CHF 0.463 million), have been reclassified to the three months period ended December 31, 2003 with no impact on full year 2003 product sales and cost of sales. The reason for the reclassification was the result of product dispatched before the end of September 2003, but was delayed en route and arrived only on the first day of October 2003 at the customer. The reclassification has had no impact on the audited 2003 full year financial statements.

Consistent quarter-on-quarter growth in Tracleer(r) sales

In the first nine months of 2004, Actelion had total net revenues of CHF 341.5 million (9 m 2003: CHF 209.1 m). On a quarter-to-quarter basis, net revenues increased by 11% percent to CHF 126.5 million (Q2 2004: 113.9 m).

Contract revenues for the first nine months of 2004 amounted to CHF 12.0 million (9 m 2003: 5.2 m). On a quarter-to-quarter basis, contract revenues were CHF 4.4 million (Q2 2004: 4.5 m).

Expanding market opportunities for Tracleer(r)

In the first nine months of 2004, Tracleer(r) sales were CHF 325.4 million (9 months 2003: CHF 203.7 m). On a quarter-to-quarter basis, Tracleer(r) revenues increased by 11 percent to CHF 120.4 million (Q2 2004: 108.0 m).

At the end of September 2004, Tracleer(r) was marketed in 18 countries worldwide, including almost all major pharmaceutical markets. In Japan, the Tracleer(r) registration dossier is still under review. The company expects the review process to conclude in 2004, with first revenues expected in 2005.

Actelion is also further pursuing market introduction of Tracleer(r) in the 10 new EU member states as well as in South-East Asia. In the period under review, Actelion has concluded for the latter a distribution agreement with PharmaLink, the marketing division of Zuellig Pharma Ltd.

Zavesca(r) sales continue momentum

Zavesca(r) sales in the approved indication type 1 Gaucher disease contributed in the first nine months of 2004 CHF 4.1 million to Actelion's revenue. (9 months 2003: CHF 0.3 m). On a quarter-to-quarter basis, Zavesca(r) revenues increased by 20 percent to CHF 1.8 million (Q2 2004: 1.5 m). Zavesca(r) is now available in 13 countries.

Additional clinical studies are under way to evaluate the potential use of Zavesca(r) in other lipid-storage diseases such as Late Onset Tay-Sachs disease, Type 3 Gaucher disease and Niemann-Pick Type C disease, for which currently no therapy exists.

Operating expenses reflect substantial efforts in both marketing and R&D

In the first nine months of 2004 operating expenses were CHF 277.6 million (9 m 2003: CHF 181.1 m). In Q3 2004, operating expenses were CHF 97.7 million (Q2 2004: CHF 98.6 m). This represents a slight decrease of 1% mainly due to seasonally reduced investment in marketing and advertising.

In the first nine months of 2004, marketing and advertising costs were CHF 69.9 million (9 m 2003: 57.1 m). In Q3 2004 marketing and advertising expenses were CHF 22.5 million. Compared to the previous quarter (Q2 2004: CHF 27.4 m), this represents a decrease of 18% due to the quiet congress season in the summer months.

In the first nine months of 2004 selling, general and administrative expenses amounted to CHF 70.1 million (9 m 2003: CHF 43.9 m). In Q3 2004 selling, general and administrative expenses were CHF 26.0 m, an increase of 17% compared to the previous quarter (Q2 2004: CHF 22.3 m) in line with the ongoing sales force optimization.

Research and Development cost increases reflect rapidly advancing pipeline

In the first nine months of 2004, research and development expenses were CHF 103.1 million (9 m 2003: CHF 56.9 m) including a CHF 5.0 million in-process R&D charge in Q2 2004.

In Q3 2004 research and development expenses were CHF 36.5 m, this represents an increase of 13% (Q2 2004: CHF 32.4 m) fully in line with our ongoing late stage clinical trial program.

In Q3 2004, Actelion achieved numerous clinical milestones, especially in relation to Tracleer(r) and tezosentan (Veletri(tm)).

In mid-September 2004, RAPIDS-2 (RAndomized, double-blind, Placebo-controlled, multi-center study to assess the effect of bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis) has been closed for enrollment. The study enrolled a total of 190 patients (enrollment target: 180 patients). These patients are now followed for up to 11 months, with final study results therefore expected in late 2005 or early 2006.

In late September 2004, the clinical program evaluating the safety and efficacy of bosentan (Tracleer(r)) in Idiopathic Pulmonary Fibrosis (BUILD-1: Bosentan Use in Interstitial Lung Disease) and the scleroderma-related form of Pulmonary Fibrosis (BUILD-2) have been closed for enrollment. BUILD-1 has enrolled 158 patients (enrollment target: 132) and BUILD-2 has enrolled 162 patients (enrollment target: 132). These patients are now followed for another 12 months, with final study results therefore expected in late 2005 or early 2006.

In early October 2004, Actelion also enrolled the first Class II PAH patient in the EARLY (Endothelin Antagonist tRial in miLdly sYmptomatic PAH patients) study. This clinical trial with Tracleer(r) is foreseen to recruit 170 patients. With patients being followed for at least six months, study results may become available in mid-2006. If successful, the data of this study would be submitted for regulatory review to potentially expand the existing labeling in the indication Pulmonary Arterial Hypertension.

In mid-October 2004, Actelion submitted raw data from more than 1'300 patients enrolled in the VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study) program to the independent Drug Safety Monitoring Board (DSMB). The second futility analysis is expected to take place in early November 2004.

Actelion also strengthened its early-stage clinical pipeline in the previous months. In early September, the company commenced a Phase I clinical program with a small molecule (labeled Actelion-1).

In mid-October 2004, Actelion concluded enrollment for its Phase IIa program with palosuran, an orally available urotensin-II receptor antagonist. Palosuran, a first-in-class agent, is evaluated as a potential treatment option for kidney failure associated with diabetes (diabetic nephropathy). First study results are expected in mid-2005.

In addition, further preparations were made to initiate towards year-end a Phase IIb/III program with clazosentan, an i.v. endothelin receptor antagonist to be evaluated in vasospasm prevention following subarachnoid hemorrhage. Actelion is still in discussion with regulatory authorities on this matter.

Strong operating profit as a result of strong top-line growth

In the first nine months of 2004, a strong increase in sales revenues resulted in an operating profit of CHF 63.9 million (9 m 2003: CHF 28.0 m). Despite pronounced increase in R&D spending, Q3 2004 operating profit of CHF 28.8 million was 88 percent higher than the previous quarter (Q2 2004: CHF 15.3 m).

Non-operating items and cash

In the first nine months of 2004, the net profit of CHF 64.2 million (9 m 2003: 23.1 m) includes interest income of CHF 0.5 million, interest expense of CHF 0.4 million, a non-cash charge on the Convertible Bond of CHF 5.5 m, foreign currency gains of CHF 0.8 m and an income tax expense of CHF 4.8 m.

In Q3 2004, the net profit was CHF 25.1 m compared to CHF 11.3 m in the previous quarter.

On 30 September 2004, the company held cash and cash equivalents of CHF 273.7 million (30 June 2004: CHF 244.8 million).


For documentation purposes -- table Q3 2004 vs. Q2 2004

In CHF thousands Results Q3 Results Q2
2004 2004 Variance in %
Net Revenues 126'527 113'937 12'590 +11
Operating Expenses 97'723 98'606 -883 -1
Operating Profit/Loss 28'804 15'331 13'473 +88
Net Profit/Loss 25'105 11'330 13'775 +122
Basic EPS in CHF 1.14 0.52 0.62 +119
Cash & cash equivalents 273'727 244'831 28'896 +12

Actelion Member of the Board announces retirement

Fred Meyer has informed the company that he plans to resign his board membership functions by year-end 2004 upon reaching age 74. Rob Cawthorn, Chairman of the Board of Actelion, commented: "On behalf of all Actelion shareholders and employees, we would like to thank Fred for his distinguished service. His wide strategic and financial background has helped tremendously to steer the company towards becoming one of the leading global biopharmaceutical companies in only seven years of operations.

Actelion Ltd

Actelion Ltd is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(r), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(r) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Australia, Canada and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).

For further information please contact: Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil


Investor Contact Roland Haefeli [phone]
[phone]

Media Contact Peter Engel [phone]
[phone]


Conference Call

Actelion will host an Investor Conference Call and discussion/Q&A on Tuesday, 26 October 2004, 16.15 CET / 10.15 a.m. EST / 15.15 GMT


Dial: [phone] (Europe)
[phone] (U.S.)
[phone] (U.K.)

Webcast -- Live and replay on demand

Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand. To access the webcast live, simply visit the link on our homepage 5-10 minutes before the conference is due to start.

Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay on our website "Investors/Past Events".

Note to the editor:

Please be advised that you are receiving all Actelion announcements and Media Releases in unformatted plain text only. This is intended to optimize delivery time and reduce transmission load.


Actelion's financial calendar 2005
Date: Event:
24 February 2005 Q4 and FY 2004 financial results
14 April 2005 Annual General Meeting
28 April 2005 Q1 2005 financial results
28 July 2005 H1 2005 financial results
27 October 2005 9-month 2005 financial results

CONTACT: Actelion Ltd.
Investor Contact
Roland Haefeli
[phone]
[phone]

Media Contact
Peter Engel
[phone]
[phone]

[alphorn] 25/10/2004 09:45

grupo - often visit Yvoire in the summer for lunch - great place. Boat out for the winter now :-(

[grupo] 25/10/2004 09:00

Source: Actelion Ltd

Actelion Ltd.: New scientific studies show higher than expected prevalence of Pulmonary Arterial Hypertension in patients with Connective Tissue Diseases (CTD)
ALLSCHWIL, Switzerland and SAN ANTONIO, Texas, Oct. 18, 2004 (PRIMEZONE) -- Actelion Ltd. (PinkSheets:ALIOF): Studies reported at the American College of Rheumatology (ACR) support early diagnostic intervention -- Echocardiography and confirmatory right heart catheterization as appropriate tools.

Two new scientific studies released today at the American College of Rheumatology (ACR) are reporting a high prevalence of both diagnosed and undiagnosed pulmonary arterial hypertension (PAH) in patients with scleroderma and mixed connective tissue disease (MCTD).

The two studies -- sponsored by Actelion Ltd. (SWX:ATLN) -- were carried out in the United States and Europe. They are presented at a joint scientific poster presentation on Tuesday. On Monday, the official media activities of the conference organizer will also focus on the important role of early detection and treatment of PAH especially in these patients at high risk for developing this rapidly progressing and ultimately fatal disease (see media advisory at the end of this release).

The UNCOVER study: PAH in community rheumatology centers UNCOVER, is a U.S.-based study conducted in 50 community rheumatology centers sought to determine the prevalence of diagnosed and undiagnosed PAH. Based on the prevalence of PAH and PAH symptoms in the patients surveyed, the data suggests Echocardiogram evaluation of CTD patients treated in community rheumatology practices is justified.

The study findings in detail are:



-- A significant number of patients (15%) in community
rheumatology offices have a current diagnosis of pulmonary
arterial hypertension.
-- A significant number of patients (13.3 percent) in community
rheumatology offices have estimated right ventricular systolic
pressure (ERVSP) greater than 40 mmHg on Doppler
echocardiogram, which is highly suggestive of PAH making the
total population with diagnosed or suspected PAH 28.3%.
-- A significant number of patients not diagnosed with PAH with
ERSVP greater than 40 mmHg have corresponding symptoms
suggesting more advanced disease.

Nine hundred and nine patients with scleroderma or MCTD across 50 community rheumatology practices in the U.S (46) and Canada (4) participated in the study. Patients were 18 years of age or older and were diagnosed with scleroderma meeting the American College of Rheumatology (ACR) classification criteria for systemic sclerosis or had three to five features of the CREST syndrome.

Patients were assigned one of two groups. Those with an existing diagnosis of PAH were assigned to the retrospective group, with further data collection obtained from patients' existing medical record. Patients that did not have an existing diagnosis of PAH were assigned to the prospective group and invited to join the study. These patients had a Doppler echocardiogram of the right and left chambers (unless previously done in the last six months), and completed a dyspnea questionnaire rating severity.

ItinerAIR study: A French prevalence study

Conducted in France, the objective of the ItinerAIR Scleroderma study was to evaluate the prevalence of PAH in a French population with systemic sclerosis (SSc). The diagnosis followed a step-by-step approach, based on symptoms (dyspnea) and a pre-defined algorithm on echocardiography and required right heart catheterization (RHC) for confirmation of PAH diagnosis.

Consistent with UNCOVER, this study confirms the high prevalence of PAH in scleroderma and the validity of echocardiography as a screening modality. Furthermore, it highlights the importance of RHC as a confirmatory tool for diagnosis of PAH.

The study findings in detail are:



-- The prevalence of PAH in this French SSc population is
approximately 10%.
-- Cardiac catheterization remains the reference method for
confirming the diagnosis of PAH (the main differential
diagnosis is left heart disease).
-- A step-by-step diagnostic approach, starting at identifying
symptoms, followed by echocardiography and right heart
catheterization is an applicable approach in pragmatic
situations.
-- Increased age at scleroderma onset is a risk factor for PAH.
-- Diffuse scleroderma is not less at risk than limited
scleroderma, reinforcing the need for screening all
scleroderma patients for PAH.
-- Systematic screening allows diagnosis of PAH at a less severe
time point of the evolution of the disease.

The study was conducted in France at 21 university hospitals experienced in scleroderma management, and included multidisciplinary teams -- internists, dermatologists, rheumatologists, echo cardiographers and PAH specialists -- involving 100 investigators. The trial enrolled a total of 617 patients, approximately 10% of the estimated SSc population in France.

All scleroderma patients at the participating centers, including patients with known RCH-diagnosed PAH, were invited to participate in the study as part of their regular care. Those excluded from the study were patients with known severe pulmonary function abnormalities (FVC and/or TLC or FEV 3 m/s or greater than 2.5 m/s in the presence of dyspnea not explained by another cause. The full echocardiography data will be presented as a poster at AHA.

Professor Eric Hachulla, M.D., Hopital Claude Huriez, Lille/France said: "This study also shows that a multidisciplinary approach and an active screening of scleroderma patients allows for detection of PAH at an earlier stage, which may lead to improved prognosis through early intervention."

About Scleroderma

In systemic sclerosis (scleroderma), an autoimmune rheumatic disease, there is increased accumulation of connective tissue in skin and internal organs as well as vascular injury and damage. Complications including pulmonary arterial hypertension (PAH) and digital ulcers are the result of vasculopathy (vascular dysfunction). Endothelin, a pathogenic mediator, is implicated in vascular damage. In addition to causing vasoconstriction, Endothelin also has direct deleterious effects, which cause fibrosis, vascular hypertrophy, and inflammation.

About Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.

About Tracleer(R) in Pulmonary Arterial Hypertension (PAH)

Tracleer(R), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Australia, Canada and Switzerland. In Japan, Tracleer(R) has been filed for marketing approval.

In clinical trials leading to the marketing approval of the drug, approximately 11 % of PAH patients receiving Tracleer(R) experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age who do not use a reliable method of contraception, must not take Tracleer(R).

Actelion Ltd.

Actelion Ltd. is a biopharmaceutical company with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(R) an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(R) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union as well as Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium -- the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).

Media Advisory:

Media invited to attend study preview at ACR/ARHP scientific meeting. The point prevalence of undiagnosed Pulmonary Hypertension (PAH) in patients with Connective Tissue Disease (CTD) attending community based Rheumatology clinics (Uncover study)

Media Session Scheduled for October 18; Poster Session To Follow on October 19



WHAT: Presentation for media at American College of
Rheumatology's annual conference (ACR/ARHP Scientific
Meeting) previewing Uncover Study results; poster session
to follow the next day.

Uncover Study -- The Point Prevalence of Undiagnosed Pulmonary Hypertension (PAH) in Patients with Connective Tissue Disease (CTD) Attending Community Based Rheumatology Clinics

PAH is a major cause of morbidity and mortality among patients with scleroderma (SSc) and mixed connective tissue disease (MCTD), yet physicians often do not detect its presence until the late stages of disease. Most prevalence data come from University or tertiary centers which are biased toward severe disease; therefore the true prevalence of PAH among patients with CTD is unknown. The study sought to determine the point prevalence of undiagnosed PAH in community-based rheumatology practices in the USA and Canada.



WHO:
Frederick M. Wigley, John Hopkins University

WHEN:
Media Presentation Poster Session
Monday, October 18 Tuesday, October 19
1:30 p.m. - 2:30 p.m. 12:15 p.m. - 2:00 p.m.

WHERE:
ACR/ARHP Annual Scientific Meeting
Henry B. Gonzales Convention Center, San Antonio, TX

CONTACT:
For further information please contact:
Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil

Investor Contact
Roland Haefeli
[phone]
[phone]

Media Contact
Peter Engel
[phone]
[phone]