Marks Electrical Share Discussion Threads

[waldron] 03/3/2006 07:20

Actelion Shr Price Reaction Overdone -ZKB

Thursday, March 02, 2006 2:01:38 PM ET
Dow Jones Newswires



1749 GMT [Dow Jones]--Actelion's (ATLN.EB) share price reaction, closing -5.4% at CHF108.10, was overdone after US FDA asked for a labeling change of its flagship drug Tracleer to include info on possible liver damage, says Zuercher Kantonalbank analyst Hernani de Faria. Adds that from the beginning, it was known that the drug could raise liver enzyme levels, hurting the liver's functioning and thus, a monthly monitoring was already required. Keeps at market-overweight rating. (SWZ)

[waldron] 27/2/2006 12:07

Actelion "hold," target price reduced

Monday, February 27, 2006 2:04:20 AM ET
Canaccord Adams

LONDON, February 27 (newratings.com) - Analysts at Canaccord Adams maintain their "hold" rating on Actelion (ACT.ETR). The target price has been reduced from CHF128 to CHF126.

In a research note published on February 24, the analysts mention that the company has reported its FY05 results in-line with the estimates. Actelion's marketing/advertising costs rose 40% during the year and the company expects its cost base to expand further during 2006.

[waldron] 24/2/2006 10:42

Credit Suisse Cuts Actelion Target To CHF140

Friday, February 24, 2006 5:30:01 AM ET
Dow Jones Newswires



0908 GMT [Dow Jones] Credit Suisse cuts Actelion's (ATLN.EB) target price to CHF140 from CHF160, as higher-than-expected marketing and advertising costs are seen hitting net income going forward. Higher spending is a sign the company will further leverage its flagship drug Tracleer's considerable leading position, with the rival drug Thelin from Encysive (ENCY) expected US launch in April. Competitive newsflow, however, is likely "to cap the near-term performance of the stock." Keeps at outperform. Shares trade +0.4% at CHF117.70. (SWZ

[ariane] 18/2/2006 17:22

'Safer' sleep drug holds new hope of a good night's rest
LYNDSAY MOSS

A NEW type of sleeping pill that increases dreaming and boosts memory could soon be available, researchers said yesterday.

The new drug, being developed by biotech company Actelion, may also lack some of the more worrying side-effects of traditional sleeping tablets, such as addiction.


The developers believe the medicine could be on the market by 2012 if trials continue to show positive results. It is believed that only 10 per cent of an estimated 20-30 per cent of the population who suffer from insomnia use medication to try to tackle the problem.

In many cases this is because they worry about the side-effects, such as feeling tired during the day, as well as becoming addicted.

The new drug targets the hormone orexin, which is also linked with feeding and addiction. Experts believe a drug targeting this system could also be used in treatments for obesity and addiction, according to Chemistry and Industry magazine.

Orexin is also linked to narcolepsy - a sleeping disorder that causes people to fall asleep several times a day.

Initial tests in rats suggest the drug works differently to other sleeping aids.

Jean Paul Clozel, chief executive of Actelion, said: "The problem with most older medication is people often feel tired and unwell, and memory is affected."

But in the lab tests, rats given the drug slept soundly and performed better in maze tests the following day compared with rats given conventional sleeping drugs.

When the scientists measured muscle tone and brain activity, this also revealed that the "dream phase" of sleep, also known as REM, was increased.

This article:

Last updated: 06-Feb-06 10:23 GMT

[grupo guitarlumber] 13/12/2005 11:52

Vontobel Ups Actelion To Outperform

Tuesday, December 13, 2005 5:53:10 AM ET
Dow Jones Newswires



0933 GMT [Dow Jones]--Vontobel upgrades Actelion (ATLN.EB) to outperform, from sector perform, following Monday's strong price correction which leaves around 25% upside. Sees fair value at CHF132 from Tracleer in pulmonary artery hypertension stand-alone, which it had previously seen at CHF153. "We anticipate Actelion will publish strong FY '05 and 1Q '06 results," analyst says. Shares +0.8% at CHF106.50. (HJS)

[waldron] 29/11/2005 08:12

UBS Cuts Actelion Target After Negative Test

Tuesday, November 29, 2005 3:01:57 AM ET
Dow Jones Newswires



0654 GMT [Dow Jones] UBS cuts its target for Actelion (ATLN.EB) to CH150 from CHF170 after a test of Tracleer shows no statistically significant benefit in pulmonary fibrosis. Says there are some points of light; the non-statistically significant trend to mortality benefit could result in significant off-label use for idiopathic pulmonary fibrosis, UBS says. Keeps buy rating. Shares closed at CHF127.40. (HJS)

[Abuse team] 04/11/2005 03:29

Post removed by ADVFN

[hamsterape] 04/11/2005 02:17

What? No comment on yesterday's breakthrough news, or are you all still typing?

[waldron] 23/10/2005 09:51

In sickness and wealth: drugs firms on trial
Millions owe their lives to their products. So how did their reputation come to fall so low?
By Abigail Townsend
Published: 23 October 2005
There can be few industries that stir up as much emotion as the pharmaceutical sector. The UK is a leading player, with three FTSE 100 giants - GlaxoSmithKline, AstraZeneca (both of which have third-quarter results out this week) and Shire Pharmaceuticals - together worth £128bn. Every day, £9m is poured into research and development: thousands work in the industry, the Government loves it, shareholders have raked in returns and diseases have been treated.

And yet the industry's reputation is in tatters. In recent months rows have raged about controversial treatments, from breast cancer drugs to vaccines for bird flu, while the sector has for some time now been accused of sins ranging from skewing the results of clinical trials to putting drugs out of the reach of the poor.

So it is little wonder that many hate drug companies - though, as one analyst wryly notes, only until they get ill. Here The Independent on Sunday looks at both sides of the argument consuming one of the world's most talked-about industries.

Case for the defence

The biggest argument pharmaceutical companies have in their favour is that they make products that not only save lives but have changed the very way we live our lives.

And the industry believes that in this healthier day and age we have lost sight of this. "We have got to educate people as to how this all works," says an insider at GSK. "Not everything is certain and there's a lot of money spent on products that don't make it. But if you do get something on the market, it will be good and it will help millions."

The number of new breakthrough treatments may have slowed but they are by no means behind us. In the 1980s, HIV often led quickly to Aids as there was no way to delay the onset. Now, antiretroviral drugs mean that people with HIV live long, healthy lives. And only this month, Merck unveiled a vaccine for one of the most common forms of cervical cancer, a disease that kills thousands and can leave women unable to have children.

This sort of drug development does not come overnight, or cheap. According to the Association of the British Pharmaceutical Industry (ABPI), the average cost of developing a drug is £550m and it takes 10 to 12 years. Patents, ensuring that no one else can steal all that hard work and knock out cheap copies, last for 20 years - but minus the period spent in development. And if the drug is not a blockbuster, that is scant time in which to cover costs and turn in a profit for shareholders.

Prices for the finished product are also controlled in Western Europe. In the UK, the Pharmaceutical Price Regulation Scheme (PPRS) limits the amount of profit companies can make on sales to the National Health Service. "It's about trying to ensure that the NHS gets medicines at reasonable prices and that the industry gets a fair and reasonable return so it can continue its research into new medicines," explains an ABPI spokesman. "Over a period of time it has meant that the UK has retained a successful research industry while others have lost out. In detail it is arcane but in general it works."

And despite the high costs and risk, research and development is what the industry does best. In the UK, three-quarters of drugs R&D is done by the industry. The rest is carried out by academics, charities, the Medical Research Council (MRC) and the NHS. But a large proportion of that focuses on the actual illnesses rather than finding cures.

Industry is the only body willing to take on the risk, so it is little surprise it expects, at some stage, a healthy return for its pains. As the ABPI spokesman points out, Russia nationalised its R&D function under Communist rule with disastrous results. "In all that time, they came up with one major drug, and nobody can ever remember what it was."

Headlines are full of products that have been through R&D, including clinical trials, and were approved by regulators, only for subsequent side effects to cause the drug to be pulled. But clinical trials, as a matter of scientific course, focus on groups of between 4,000 and 6,000 people. So, for example, a side effect that occurs in one in 10,000 people is unlikely to be discovered.

The industry is not entirely impervious to its reputation, however, and efforts have been made to address it. The ABPI has reviewed the way companies promote and market their products, and has also compiled a global database of clinical trials. Other moves, claim industry experts, include the regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), accepting it needs to be seen to be free of industry influence, and pharmaceutical companies supplying drugs at a cost to poor nations.

Things are also improving on the stock market, and this week's third-quarter numbers from GSK and AstraZeneca are likely to show growth in both volumes and margins, as costs are cut. For all the hype, the drugs, it would seem, really can work.

The case against them

"We have unrealistic expectations of medicine. We're consumed about ideas of our own mortality. The motives, interests and modus operandi [of the pharmaceutical companies] encourage us to believe that drugs are in some sense a route to salvation. They have totally exaggerated the benefits of their products." So argues Charles Medawar, one of the staunchest critics of the industry. He is a director of Social Audit, a charity that is part of the Public Interest Research Centre and has carried out investigations into the growing use of antidepressants. He is not a lone voice. Many, from the man on the street to authorities such as Richard Horton, editor of The Lancet, are growing increasingly, and vocally, disenchanted with the pharmaceutical business.

It is accused of being too powerful, of not being properly controlled, of stifling independent debate and having little transparency. Clinical trials, opponents claim, are flawed but hard marketing ensures doubts are swept under the carpet.

Critics also claim that profits are put before everything, meaning that drugs are overpriced and HIV sufferers in Africa go without. The World Health Organisation wants three million people in developing countries to be on Aids drugs by the end of this year and, after growing public pressure, the companies now sell drugs to African countries at cost. But that is still expensive and they refuse to provide free drugs because they are worried they will be sold on. "They are trying to make themselves look like benefactors by selling at low prices," says Tony Harrison, a senior researcher at the King's Fund health think-tank. "But the companies have got to make money. They will never be free because of the risks of undercutting their own markets in other areas through exports."

The industry's involvement in Africa and the HIV/Aids crisis has been suspect from the start. The pharmaceutical companies caused outrage when they took the South African government to court to try to stop it importing cheaper, and desperately needed, generic copies of HIV and Aids drugs.

And only last week, as the world worried about a possible flu pandemic, Roche's shares soared as investors calculated how much money the company would make from its vaccine Tamiflu (although the company has now agreed to license the drug to generic rivals as demand soars).

Cancer patients, meanwhile, end up in court as they fight to receive the best - but expensive - treatments, as witnessed in the row over the breast cancer drug Herceptin.

The treatments themselves are often just as controversial. A US court recently found against Merck in a case arising from the death of a patient taking Vioxx, its blockbuster painkiller, which has been shown to increase the risk of heart attacks and strokes. During the case, which Merck plans to appeal, documents were produced that appeared to prove the company had deliberately hidden its own concerns about the treatment. The whole issue was brought to light only after a whistleblower at the US Food and Drug Administration went public last year and revealed his concerns.

"The industry has produced some great products, but in the past it has behaved atrociously," says Mr Harrison. "The trend now seems to be turning. There seems to be a general recognition that it has got away with too much. However, it's still not a fundamental change." He believes the Government should be more involved to ensure unprofitable areas of research are not neglected. "The public sector has got to play a bigger role, making sure the gaps the industry will never look at are filled. It must pay, or provide incentives."

Campaigners also want the industry - powerful yet, for many, unaccountable - to clean up its act. That includes publishing the data of ongoing clinical trials and putting less emphasis on profits. "The starting point has to be complete transparency," says Dr Medawar. "The industry is, frankly, running riot. It's like the 19th-century chemical industry in externalised costs: shove the pollution up the chimney and not give a damn about who lives downwind."

Nor is the situation good for investors. Robin Gilbert, an analyst at Numis Securities, says: "Drugs companies globally have been struggling and stock prices have not performed well. They are spending huge sums on research, but are not generating new products."

Generic companies, meanwhile, have gone from strength to strength as governments get tough on prices. Two of the UK's biggest pharmacies, Boots and Alliance UniChem, are set to merge and one of their strategies is to distribute generic drugs across Europe. And in the US the FDA is taking a tougher stance, and lawyers are scenting courtroom success.

Dr Medawar sums up the industry's predicament. "It is a victim of its own success. It has raised expectations extremely high, because in the past 50 years it has produced a few dozen really good drugs. But now [companies] are so big, so influential, so powerful, that they don't have qualitative and quantitative feedback that allows them to see where they are going wrong."

Investors can be won over by the hope of strong sales or a promising pipeline. Yet few others are so easily convinced - and the sector has a mountain to climb to achieve a reputation it can be proud of.

Big Pharma and its Blockbusters

The world's top 10 pharmaceutical companies, listed according to their market value

Pfizer, US, $161bn

Viagra (erectile dysfunction), Celebrex (painkiller), Lipitor (cholesterol lowering), Zoloft (antidepressant)

GlaxoSmithKline, UK, $147bn

Advair (asthma), Paxil CR (antidepressant), Combivir (HIV)

Novartis, Switzerland, $146bn

Diovan (hypertension), Gleevec (cancer)

Roche, Switzerland, $127bn

Tamiflu (influenza), Avastin (colon cancer), Mabthera (lymphoma), Heceptin (breast cancer)

Sanofi-Aventis, France, $114bn

Lovenox (deep vein thrombosis), Plavix (thrombosis), Avapro (hypertension), Ambien (insomnia)

AstraZeneca, UK, $74bn

Crestor (cholesterol lowering), Nexium (ulcers)

Wyeth, US, $62bn

Effexor (antidepressant), Prevnar (meningitis), Enbrel (arthritis)

Merck, US, $59bn

Gardasil (cervical cancer vaccine, to be launched), Zocor (cholesterol lowering), Vioxx (painkiller, withdrawn but FDA to review)

Eli Lilly, US, $58bn

Prozac (antidepressant), Zyprexa (schizophrenia), Gemzar (pancreatic cancer)

Schering-Plough, US, $31bn

Remicade (auto-immune conditions), Clarinex (allergies)

[grupo guitarlumber] 15/10/2005 07:29

October 15, 2005
Lipitor or Generic? Billion-Dollar Battle Looms
By ALEX BERENSON
The Lipitor war is about to begin.

Starting next June, insurers and government agencies will have the opportunity to save billions of dollars by moving patients from Lipitor, a cholesterol-lowering drug by Pfizer that is the world's top-selling medication, to an inexpensive generic version of Zocor, a similar but less potent drug now made by Merck.

Some insurers are already planning ways to move patients from Lipitor to generic cholesterol drugs after Zocor loses its patent protection. But Pfizer, which plans to use marketing muscle and clinical data to fight that migration, says that Lipitor has unique benefits and is worth a premium price, especially for patients at high risk of heart attacks.

Both medicines belong to a class of drugs known as statins, which are the nation's best-selling medications, with almost 150 million prescriptions expected to be filled this year at a cost of $16 billion. The insurers, and some cardiologists, say that switching patients from Lipitor to generic Zocor will be a safe way to cut costs in an era of skyrocketing pharmaceutical prices.

In many cases, they say, patients who now take the most commonly prescribed dosage of Lipitor - 10 milligrams daily - can reduce their cholesterol just as much with Zocor. Lipitor costs $2 or more a day, while generic Zocor will probably cost 35 cents or less.

"If I was taking a statin, I'd want to take the cheapest one, as long as I get to the goal that I wanted to get to," said Dr. Scott Grundy, a researcher who has consulted for both Merck and Pfizer. Dr. Grundy led a federal panel that in 2001 wrote guidelines for treating people with high cholesterol.

But other doctors and epidemiologists say that Lipitor may be the best drug for many patients. "It would not be good medicine to go to a cheaper medicine that has less efficacy in our high-risk patients," said Dr. Robert Vogel, a cardiologist at the University of Maryland, who has been paid by Pfizer to help conduct a clinical trial of Lipitor.

Pfizer says it will fiercely defend Lipitor. "By taking any dose of Lipitor, you will reduce the risk of a cardiovascular event faster and to a greater degree than you will with any other medicine," said J. Patrick Kelly, Pfizer's president of United States pharmaceuticals.

The fight over Lipitor involves a collision of fundamental forces in American health care. Spending on prescription drugs has jumped from $40 billion in 1990 to almost $250 billion this year, and continues to rise faster than overall inflation. But while many Americans say they believe that prescription drugs cost too much, they rarely want to accept generic medicines for themselves instead of more expensive drugs that may be only marginally better - especially since insurers or government agencies pay nearly 70 percent of all drug costs.

Dr. JoAnne Foody, a practicing cardiologist and a professor at Yale University School of Medicine, said she expected to continue prescribing Lipitor for her high-risk patients, who need the maximum possible reduction in cholesterol.

But she said she would be inclined to switch other patients off Lipitor onto generic Zocor, also called simvastatin, if the price difference was significant.

"There are a very large portion of patients where the data for simvastatin are equivalent and sometimes better than the data for Lipitor," Dr. Foody said.

But convincing American patients to give up a brand-name medicine and take a generic drug is not easy, said Albert Rauch, a drug industry analyst at A. G. Edwards, a regional brokerage firm based in St. Louis.

For example, even though the antacid Prilosec is available in an inexpensive over-the-counter form, people prefer three very similar but higher-priced prescription antacids - Prevacid, Nexium and Protonix. Those three will have $10 billion in United States sales this year.

"Therapeutic substitution - substituting one product for another in the same class - just hasn't happened yet," Mr. Rauch said.

And Lipitor has more than Pfizer's marketing dollars working for it. Last month, an analysis of 14 clinical trials by Oxford University and the University of Sydney in Australia found that the more potent the statin and the greater the cholesterol reduction, the lower the risk of heart disease.

Dr. Colin Baigent, who oversaw the analysis, did not directly endorse Lipitor but said he believed that statins were not interchangeable.

"The aim should be to get their LDL cholesterol as low as possible," Dr. Baigent said, referring to low-density lipoprotein, or LDL, cholesterol - commonly called bad cholesterol. "There is potential for many patients benefiting more."

Statins work by interfering with the liver's ability to synthesize LDL cholesterol. All statins are chemically similar, although Lipitor, whose active ingredient is called atorvastatin, is more potent than Zocor, or simvastatin.

The highest dosage of Lipitor (80 milligrams) can reduce cholesterol as much as 57 percent in an average patient, while the highest dosage of simvastatin lowers cholesterol 47 percent. But because most patients are not placed on the highest dosages, the two drugs can achieve comparable cholesterol-lowering results in many cases.

Several large clinical trials have shown that statins reduce the risk of heart attacks and strokes. And statins appear to be safe for most patients, although they can cause muscle weakness in some people and occasionally lead to severe muscle damage.

As a result, statins have become among the most commonly prescribed drugs. This year's forecast of 150 million statin prescriptions in this country is up from 82 million in 1999, according to IMS Health, a Pennsylvania company that compiles data about drug usage.

About half of those prescriptions will be for Lipitor, which is taken by 12 million Americans a year, at a cost of about $8 billion. Worldwide, Lipitor sales are forecast to top $12 billion this year, making the drug by far the best-selling prescription medicine.

Prescription drugs are protected by patents that give their inventors the exclusive right to sell them for up to 20 years, though they usually must spend part of that time gaining federal approval. The patent protection enables the drug maker that discovered the drug to earn back its development costs and make a profit. Otherwise, other companies could make and sell identical versions of the medicine, undercutting the company that invented it.

But when a patent expires, the legal protection disappears. At that point any company can make the drug, as long as it proves to the Food and Drug Administration that its version is identical to the original. The patent on Lipitor is to expire in 2011, but that patent has been challenged.

Zocor will lose its patent protection next June 23, and be opened to competition. Ivax, a generic drug company, has already said it will produce a generic version of the drug, and other companies plan to follow. As more generics enter the market, the price of generic simvastatin could fall to 35 cents a pill or less, compared with $3 or more now, according to Richard T. Evans, a drug industry analyst at Sanford C. Bernstein & Company.

Merck will lose billions of dollars in annual sales and profits when Zocor loses its patent protection. To recoup its profits, Merck has introduced another anticholesterol drug, Vytorin, which combines Zocor with Zetia, a medicine from Schering-Plough that is not a statin but also reduces cholesterol.

Vytorin is about as effective as Lipitor at lowering cholesterol, so both Merck and Pfizer have a stake in convincing doctors and insurers that they should pay extra for the increased potency their drugs offer over generic Zocor. But because Lipitor is so much more popular than Vytorin, Pfizer has more to lose than Merck and Schering-Plough if generic simvastatin becomes a standard treatment.

Last week, Express Scripts, a Missouri company that helps companies design drug benefit plans, said it would drop Lipitor from its list of preferred drugs. Instead, Express Scripts has devised a plan that will offer patients taking generic simvastatin a much lower co-payment on their prescriptions.

Steve Littlejohn, a spokesman for Express Scripts, said simvastatin was a viable alternative to Lipitor for most patients.

At its minimum 10-milligram dose, Lipitor reduces bad cholesterol an average of 39 percent. In contrast, a 40-milligram dose of simvastatin cuts cholesterol by as much as 41 percent. For patients who need a higher-potency statin, Vytorin will be available, Mr. Littlejohn said. "Consumers and physicians and employers have seen the steady, almost inexorable rise in pharmacy costs, and said nothing can be done," Mr. Littlejohn said. "We're saying something can be done."

Other insurers also say the Zocor patent expiration is an opportunity to reduce drug spending. Robert Seidman, the chief pharmacy officer for WellPoint, the nation's largest publicly traded health insurer, estimated that wide use of simvastatin could reduce the nation's drug costs by $2 billion or more a year. To encourage patients to switch from Lipitor, WellPoint plans to offer members four to six months of free simvastatin as soon as generic versions are available, he said.

But Pfizer is fighting back. To demonstrate Lipitor's benefits in different kinds of patients, Pfizer has conducted 400 clinical trials on Lipitor, covering 80,000 people. Lipitor's edge over other statins goes beyond its superior ability to lower cholesterol, said Mr. Kelly.

The data from those clinical trials has enabled Pfizer to repeatedly broaden Lipitor's label of approved uses, changes that must be approved by the F.D.A. Last month, the F.D.A. said Pfizer could begin to market Lipitor for the prevention of heart attacks and strokes in diabetics. To build brand loyalty, Pfizer also has thousands of sales representatives discussing Lipitor with doctors and spends at least $60 million annually to advertise Lipitor to consumers, according to Brandweek magazine. Pfizer declined to discuss how much it spends to market Lipitor.

Dr. David Hyman, professor of medicine at Baylor College of Medicine in Houston, said he did not expect many patients to be switched off Lipitor. He pointed to drugs that lower blood pressure, where expensive branded medicines dominate cheaper generics despite extensive research showing the generics work as well. "So much of the market is really not price-responsive."

But other experts on drug benefits said they believed that generic simvastatin might put a dent in Lipitor's sales, because companies, government agencies and patients had become so concerned about drug costs.

"It's very likely that a large portion of the market, especially those covered by managed care organizations, will switch to generic Zocor," said Albert Wertheimer, a professor of pharmacy at Temple University. "It seems like a reasonable thing to try."

[waldron] 09/9/2005 19:30

Actelion Drug Tracleer Has Competition

Friday, September 09, 2005 6:37:18 AM ET
Dow Jones Newswires



1023 GMT [Dow Jones] Current market expectations for sales potential of Actelion's (ATLN.EB) main drug Tracleer are too optimistic, says Helvea analyst Andrew Fellows. "The success of competing product sildenafil and its role in the treatment of pulmonary arterial hypertension are growing," he says. Rates shares reduce with CHF115 price target. Trades -1% at CHF145.50. (AAG)

[waldron] 09/9/2005 09:54

CSFB Keeps Actelion Outperform

Friday, September 09, 2005 2:01:46 AM ET
Dow Jones Newswires



0551 GMT [Dow Jones] CSFB "strongly reiterates" outperform rating for Actelion (ATLN.EB) after R&D day. Key message of "upbeat" meeting, says CSFB, is that Actelion has made considerable progress in extracting more value from flagship Tracleer treatment and in its overall pre-clinical and clinical pipeline. Major trigger for stock will be Tracleer's extension potential in two types of pulmonary fibrosis - SScPF and IPF - says CSFB, on which data are expected in 4Q. Target is CHF160. Shares closed at CHF144.10 Thursday. (KAB)

[maywillow] 06/9/2005 17:29

Actelion downgraded to "sell"

Tuesday, September 06, 2005 10:58:16 AM ET
Merrill Lynch

LONDON, September 6 (newratings.com) - Analysts at Merrill Lynch downgrade Actelion (ACT.ETR) from "neutral" to "sell," while reducing their estimates for the company. The fair value is set to CHF136.

In a research note published this morning, the analysts mention that market is over-optimistic about the prospects of the company's pulmonary hypertension drug, Tracleer. The analysts believe that sales of Actelion's Tracleer drug would decline in 2010 on account of increasing competitive pressure and the expected slowdown in the PAH market. The EPS estimates for 2006 and 2007 have been reduced from CHF6.18 to CHF5.67 and from CHF7.07 to CHF6.79, respectively.

[maywillow] 06/9/2005 15:53

Merrill Cuts Actelion To Sell From Neutral

Tuesday, September 06, 2005 10:11:55 AM ET
Dow Jones Newswires



1349 GMT [Dow Jones]--Merrill Lynch downgrades Actelion (ATLN.EB) to sell from neutral, saying market is overly optimistic about prospects for PAH drug Tracleer. Tracleer is going to stay number-one, says Merrill, but with increasing competition, sales will peak in '08. Were Tracleer to work in pulmonary fibrosis, shares could have considerable upside. But Merrill says Tracleer is unlikely to show clinical benefit in this indication, with next clinical data expected in December. Sees fair value at CHF136. Actelion trades -3% at CHF143.60. (KAB)

[maywillow] 05/9/2005 12:14

Actelion Drug News Should Support Share

Monday, September 05, 2005 6:21:55 AM ET
Dow Jones Newswires



1015 GMT [Dow Jones]--Actelion (ATLN.EB) positive study on long-term safety of flagship drug Tracleer is good news, Bryan Garnier says. "We do not expect a significant raise in the share price, but this news should continue to support the strong momentum of the shares," brokerage says. Confirms buy rating and a CHF150 price target. Trades -0.1% at CHF147.90. (MGE)

[maywillow] 04/9/2005 17:11

New blood pressure drugs plus statins can halve heart attack risk - study

LONDON (AFX) - An Anglo-Swedish study has found the risk of stroke and heart
attacks in people with high blood pressure can be halved by combining new blood
pressure lowering drugs with cholesterol lowering statins.
The final results of the trial, which was conducted in the UK, Ireland and
Scandinavia, showed that by taking a combination of two new hypertension drugs
the risk of stroke was reduced by about 25 pct, coronaries by 15 pct,
cardiovascular deaths by 25 pct and new cases of diabetes by 30 pct, compared
with the standard treatment.
The new drugs used in the study were amlodipine made by Pfizer Inc and
perindopril made by France's privately held Servier. They were compared with the
traditional treatment of a beta-blocker and a diuretic, which are off patent and
made generically.
The addition of a statin -- the study used Pfizor's Lipitor -- found that
risk was further reduced, irrespective of the patient's original cholesterol
level.
The study could give a boost to the reputation of statins, made by companies
including AstraZeneca PLC and Merck Inc, damaged in the last year by links with
increased risks of muscle toxicity and kidney failure.
The investigators believe that international recommendations for managing
high blood pressure may need to be reviewed and suggest that most patients with
hypertension should also be considered for a cholesterol lowering drug.
Britain's advisory body the National Institute of Clinical Excellence
announced it has decided to review its hypertension guidelines in light of the
results.
The Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) is the largest study
of high blood pressure treatment ever conducted in Europe, and included more
than 19,000 men and women with high blood pressure who were at a moderate risk
of strokes and heart attacks.
"Compared with patients receiving standard blood pressure lowering
therapy... the combination of the contemporary blood pressure lowering drugs,
amlodipine and perindopril, plus effective lowering of cholesterol abolished
about half the risk of strokes and heart attacks - the most important causes of
death in millions of men and women with high blood pressure," co-chairman of the
ASCOT Steering Committee, Professor Peter Sever of Imperial College, London,
said in a statement.
[e-mail]
ab/cml

[ariane] 31/8/2005 17:24

FDA CoTherix Move Good For Actelion - WestLB

Wednesday, August 31, 2005 7:23:31 AM ET
Dow Jones Newswires



1112 GMT [Dow Jones]--FDA grants CoTherix (CTRX) expanded label use in Ventavis with Actelion's (ATLN.EB) Tracleer for PAH. Move underlines view that Tracleer is and will be standard drug for PAH, says WestLB. Sees Tracleer not only benefitting from market trends in combination drug use in PAH, but also see market entry hurdles rising for other treatments in development, Encysive's (ENCY) Thelin and Myogen's (MYOG) Ambrisentan. WestLB rates Actelion at outperform, target is CHF155. Shares +1% at CHF143.20. (KAB)

[ariane] 28/8/2005 11:32

Merck needs radical surgery

The maker of the controversial drug Vioxx has plenty of other headaches, writes Heather Connon

Sunday August 28, 2005
The Observer


Can Merck survive the Vioxx disaster? On the face of it, the claims sound big enough to send even the most robust of companies into bankruptcy. Some analysts estimate that they could add up to at least $50 billion (£27.7bn), 200 times the $253.4 million the Texas courts awarded to a widow whose husband died after taking its painkiller.
Add in the legal bills - and, with Merck appealing the Texas decision and apparently determined to battle it out against the queue of cases following it, these could quickly run into tens of billions - and you quickly use up the $9bn or so of cash it generated last year.

But the tobacco industry, which has been fighting far more claims for two decades longer than Merck, has demonstrated that legal action, no matter how expensive, is rarely fatal.

That does not mean Merck will escape the litigation unscathed however: the Vioxx affair could prove the catalyst for significant changes both at the company and in the industry as a whole.

The case may have thrust Merck into the headlines, but it is simply the most potent symbol of the troubles which have afflicted the New Jersey-based company. While the Texas judgment may have knocked 8 per cent off its share price, the real damage was done at the start of the decade: between 2001 and 2003, the company lost a third of its market value and its price now is less than a third of the 2001 peak.

Last year, its net income fell 15 per cent to $5.8bn, below the level achieved in 1999. While that was partly due to the cost of withdrawing Vioxx last September, and setting up a $604m fund for fighting legal action over the drug, its income fell in 2002 and 2003 as well - both years in which the painkiller and osteoarthritis treatment was more than fulfilling its blockbuster potential.

Blockbuster drugs are becoming harder to find now that most of the major therapeutic areas are covered, and the regulatory and other costs of getting them to market have soared - but Merck has suffered more than most.

For much of the Eighties and Nineties, it was the most admired drug company. For seven years running, it held the crown as the world's most admired company. While others merged and demerged, switched management teams and went on drug-buying sprees, Merck preferred to rely on its own formidable research and managerial talent.

It was a successful strategy: Merck held on to its position as the biggest drugs company despite mergers such as Glaxo's with Wellcome and then Smith Klein Beecham; in five glorious years during the Nineties, it launched no fewer than 15 blockbuster drugs to treat everything from hypertension to Aids.

More recently, however, the pipeline has been much thinner. Even before the abrupt withdrawal of Vioxx - which had grown to be a $2.5bn-a-year drug during five years on the market - it was anticipating next year's loss of patent protection on Zocor, its cholesterol-lowering drug, which accounts for $5bn of sales.

Like many of its rivals, it spent too long in blind alleys, excited by the potential for innovation following the mapping of the human genome, the potential of which is still years, if not decades, from being realised.

While its rivals have been refilling their pipelines through deals with biotech companies and licensing agreements - such as Roche's Avastin and Tarceva targeted cancer products - Merck, says Mike Ward, an analyst at healthcare specialist Core Securities, still pursued a strategy of 'If it is not grown at Merck, it is not in the policy'.

That has been changing, albeit slowly. Ward points out that, over the past year, it has licensed 40 new products and the signs are that Richard Clark, promoted from within to be its new chief executive just after the Vioxx disaster last year, is willing to be more innovative.

In an interview not long after his appointment, he said: 'We have sound financial footing. So if we need to do mergers and acquisitions, we have the ability to do that. I don't want to give anyone the impression we're not open to good ideas.'

Even without the Vioxx disaster it would have been an uphill battle. Merck has already slipped into third place in the league and rivals such as Pfizer are openly searching for biotech and other acquisitions and slashing their costs.

And drug companies are much more prominent in the US than here, actively promoting their wares directly to the public. They may take some time to get over the shock that Merck was not only promoting a painkiller which caused heart attacks but, according to some critics, failed to act quickly enough when the first evidence of that emerged.

It is also likely to have an impact on the regulatory process. Vioxx was not the first drug to be pulled - around a dozen others have suffered the same fate in the last 10 years or so - but it was the most established. Usually, withdrawals occur shortly after new drugs are first prescribed, as unexpected side effects and other glitches appear. Vioxx had been on the market for five years and many users - Merck estimates there were 20 million in the US alone - were extremely happy with its efficacy.

The Texas court case has shone a brighter spotlight on the processes of the Food and Drug Administration (FDA), the US regulator responsible for approving all new drugs. There are certainly signs that it was more lenient with Merck than with others: Merrill Lynch has calculated that the company gained $3.3bn between 1995 and 2001 alone because of its faster track through the regulatory hurdles than its rivals.

The FDA has been under considerable political pressure since the Vioxx withdrawal, with one of its former executives, David Graham, leading the charge. It is now taking more time to consider new drug applications, particularly for innovative products or those in new therapeutic areas.

'There is a concern that the FDA will become increasingly safety conscious, making it even more difficult to get drugs to market,' said Ward.

With drugs taking between 10 and 12 years, and $800m, from discovery to prescribing, any increase would be most unwelcome.

[grupo guitarlumber] 22/8/2005 22:00

Kill or cure for the drug business?

Aug 22nd 2005
From The Economist Global Agenda


An American jury has awarded huge damages against Merck for a death associated with Vioxx, an anti-inflammatory drug that the firm withdrew last year. Further hefty awards against Merck and other big drug firms could cause great pain but might help to change the way they do business to the benefit of consumers










THE public's attitude to the world's leading drug companies has always been somewhat ambivalent. On the one hand they expect "Big Pharma" to deliver ever more effective cures for the ills that beset them; on the other they decry the vast profits that the industry makes as in some way exploitative. On Friday August 19th a handful of Texans did what they could to tip the balance back towards the consumer.

By a majority of ten to two, a jury in Angleton, a small town near Houston, decided that Merck, one of America's largest drug companies, was liable for the death of Robert Ernst. Mr Ernst died in May 2001 of a heart condition that the jury concluded had been brought on by Vioxx, an anti-inflammatory drug manufactured by Merck. Vioxx was withdrawn in September 2004 after a study showed that the product raised the risk of heart attacks in some patients. The jury awarded Mr Ernst's widow $253m, mainly comprising punitive damages, having decided that Merck was well aware of the potential risks associated with the drug. One document suggested that the firm was alerted to the troubling side-effects of Vioxx as long ago as 1997, two years before it came to market.

The decision could have unpleasant consequences for Merck. If its liability is upheld on appeal, Texan law will automatically restrict damages to around a tenth of the jury's award. But this will come as little comfort for Merck as more than 4,000 other suits have already been filed in America, and hundreds of others are expected from overseas. In total, some 20m patients have been prescribed Vioxx around the world.

Merck has promised to fight every one of these lawsuits, but if several more cases go against it the firm might conclude that it is easier and cheaper to make settlements. Estimates of the total payout Merck faces go as high as $20 billion. That would be a terrible blow, even for a company with profits of $6 billion last year. Merck's market capitalisation has fallen by about $38 billion since Vioxx was withdrawn.



Headaches all round
The scale of Merck's problems will spread alarm through an industry that has seen both its reputation and money-making potential take several heavy hits of late. Many of the ailments that afflict the big drug firms are a result of changes in the industry that began in the early 1990s. Most importantly, the advent of the blockbuster drugs on which Big Pharma relies also ushered in an era in which the focus shifted to profit-maximisation through heavy marketing, sometimes at the expense of scientific inquiry.

By some measures, this shift has done wonders for the big drugmakers-worldwide sales have nearly doubled since 1997 to around $500 billion. But in recent years sales growth has declined compared with the boom years of the 1990s. The "pipeline" of potential blockbusters has started to dry up, while competition from the generic drug firms that produce copycat versions of patented medicines has intensified.

At the same time, a slew of safety fears, including those over Vioxx, has further sullied the industry's reputation. Pfizer faces lawsuits over Bextra, a drug whose active ingredient, like Vioxx's, is COX-2 inhibitors. Novartis and GlaxoSmithKline (GSK) will have to decide the future of the COX-2 drugs in their pipelines. Eli Lilly recently reached a $690m settlement with thousands of users of Zyprexa, its schizophrenia drug. GSK could also face legal challenges over Seroxat: on August 22nd, new findings suggested previous warnings that the anti-depressant increased the risk of suicide among teenagers should be extended to adults.

The trial in Texas highlighted the efforts drug companies will go to in order to boost their profits and grab market share. America, which accounts for some 40% of global drug sales, introduced legislation in 1997 that allowed direct-to-consumer advertising of pharmaceuticals. Since then, the sums spent there on promotional advertising have more than trebled to around $19 billion a year, while research-and-development (R&D) budgets generally lag some way behind. Drug firms now use an array of promotional techniques to encourage doctors to prescribe their products. The jury in Texas disagreed with Merck's assertion that it had marketed Vioxx responsibly. The jurors were convinced that the firm knew of the heart risks associated with Vioxx but was reluctant to admit to them for fear that sales would falter.

The accepted practice in the drugs industry of not publishing bad test results has faced challenges of late. Last year, GSK settled a lawsuit over Seroxat with Eliot Spitzer, New York's attorney-general. Mr Spitzer accused the firm of suppressing data showing a link between its product and teenage suicide. Since then, other drug firms have followed GSK's lead and begun to publish the results of clinical trails on the internet.

Increased openness by Big Pharma is a step in the right direction towards responsible marketing. If more juries follow up the decision in Texas with big awards, drug companies are likely to reassess the aggressive marketing of new drugs as soon as they come to market. They may also want to rethink their heavy reliance on a small, and perhaps dwindling, supply of blockbusters.

[grupo guitarlumber] 22/8/2005 21:31

Merck may face French class action over Vioxx - lawyer

PARIS (AFX) - Patients' associations will hold talks in September or October
on whether to attempt a class action in France against Merck and Co Inc over its
Vioxx drug, a specialist lawyer said.
Jean-Marc Goldnadel, who also runs a website explaining how to bring a class
action, told Agence France-Presse: "We are going to have another look at the
case."
A US judge awarded the widow of a Vioxx victim 253.4 mln usd Friday and
according to yesterday's UK press, relatives of as many as 2,000 British victims
could start a potential multi- billion-dollar suit.
Goldnadel said until now "we didn't see any possibility of starting a
successful action, but in the light of a legal ruling" talks with possible
plaintiffs will start.
He said he agreed a September or October starting date when he spoke two
months ago to Georges-Alexandre Imbert, chairman of the AAVAM association of
patients who have suffered through taking medicines.
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