Marks Electrical Share Discussion Threads

[waldron] 09/11/2007 07:23

Merck to settle nearly all Vioxx suits for 4.85 bln usd




LONDON (Thomson Financial) - Merck & Co agreed to pay about 4.85 bln usd to
settle a large portion of the claims over injuries allegedly linked to its Vioxx
painkiller, after insisting for years that it would fight all 27,000 cases filed
rather than compromise, the Wall Street Journal reported.
The agreement is to be announced later this morning in New Orleans where a
federal judge is overseeing the litigation, the newspaper said.

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jlw/jlw

[waldron] 05/11/2007 07:04

Glaxosmithkline Sanofi-Aventis Gardasil study shows potential benefit for older women




LONDON (Thomson Financial) - A phase III trial conducted by Sanofi-Aventis
and Merck into its cervical cancer jab Gardasil, a vaccine against human
papilloma virus (HPV), has confirmed the product's efficacy for older women, a
development that could lead to a much larger marketing indication for the
vaccine.
Sanofi said that Gardasil prevented 92 pct of the diseases associated with
HPV for 24 to 45 year-olds.
The study's results will be presented at a HPV conference in Beijing. It is
the first time such a study has been conducted for an older age-group. The
vaccine is currently indicated for 9 to 26 year olds. Regulators would have to
define guidelines regarding the vaccination of older women, the company said.
GlaxoSmithKline's rival product Cervarix, which was later to market than
Gardasil, already has an indication for older women in Mexico and Australia and
the company is currently in discussions with EU regulators on extending the
vaccine's indication, GSK said.
GSK will also present Cervarix data at the HPV conference that will show the
effectiveness of Cervarix in older age groups.
Holger Rovini, lead vaccines analyst at Datamonitor, said that around half
the women in the 24 to 45-year-old age group could benefit from an HPV vaccine.
The downside is that women would have to be tested first for the virus
before a vaccine could be used because it has a preventative, rather than a
therapeutic effect, he said.
Vaccines are forecast to be a key growth driver for big pharma companies.
Datamonitor predicts that the global market for cervical cancer vaccines alone
will grow to 5 bln usd annually within a few years.
Global political conditions, such as the threat of bioterrorism, for
example, are fuelling the market for small-pox vaccines, to the benefit of
companies such as Acambis.





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jh1/jag

[grupo guitarlumber] 22/10/2007 11:54

Actelion "outperform"

Monday, October 22, 2007 6:58:21 AM ET
Credit Suisse

LONDON, October 22 (newratings.com) - In a research note published on October 19, analyst R Mehrotra of Credit Suisse maintains his "outperform" rating on Actelion (ACT.ETR). The target price is set to CHF80.

[waldron] 19/10/2007 06:20

Actelion's Zavesca receives negative opinion for new indication from EU's CHMP




ZURICH (Thomson Financial) - Actelion's Zavesca has received a negative
opinion for an additional indication from the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMEA).
Actelion had filed for additional Zavesca approval for the treatment of a
rare genetic disease called Niemann Pick-Disease Typ C.
The Swiss pharma group said it plans apply for a fresh review at the CHMP
with a new opinion unlikely to be issued before the first quarter of next year.
Zavesca is currently marketed for the treatment of type 1 Gauchers disease.
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jmt/hjp

[waldron] 18/10/2007 07:46

Actelion Ltd 9 months net down sharply as co takes charge from CoTherix buy




ZURICH (Thomson Financial) - Actelion Ltd said nine-months net profit
reached 36.1 mln sfr, sharply down from 171.8 mln sfr a year ago, as the company
took a charge in the first quarter related to the acquisition of US-based firm
CoTherix.
The pharmaceutical company however confirmed its guidance, saying that it
expects product revenues to reach between 1.275-1.315 bln sfr and a cash EBIT of
430-460 mln sfr for the year.
Net revenues for the nine months reached 946.4 mln sfr, up from 684.3 mln
year-on-year.
Meanwhile, for the third quarter alone, net revenues reached 320.1 mln sfr
while net profit was 89.1 mln sfr.
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hmn/lam

[ariane] 14/10/2007 05:38

Actelion to Discuss Financial 9 Month Results 2007



Invitation to Investor Conference Call / Webcast




Actelion senior management to host Q & A session

ALLSCHWIL, Switzerland, Oct. 12, 2007--Actelion Ltd will announce the financial 9 month results 2007 on Thursday, 18 October 2007, at 07.00 hrs Basel CEST / 06.00 hrs U.K. BST / 01.00 a.m. U.S. EDT. An investor conference call & webcast will be held at 15.30 hrs, Basel CEST to discuss the results.

To discuss the results, Actelion will host an Investor Conference Call / Webcast as follows: Date/Time: 18 October 2007 15.30 hrs - 16.15 hrs Basel (CEST) 14.30 hrs - 15.15 hrs U.K. (BST) 09.30 a.m. - 10.15 a.m. U.S. (EDT) Conference Call Connect #: Dial-in participants should start calling the number below 10-15 minutes before the Conference is due to start. Dial: Europe: [phone] U.K.: [phone] U.S.: [phone] Participant's mode: Listen-Only with possibility to open individual lines during Q&A session. Participants will be asked for their Name and Company. Webcast Access: Webcast participants should visit the Actelion website for further details 10-15 minutes before the conference is due to start. If you experience any access problems go directly to the URL: Participant's mode: Listen-Only with possibility to ask individual questions by clicking on the Q&A button. Participants will be asked to provide their Name and Company. Webcast Replay: The archived Investor Webcast will be available for replay through approximately 60 minutes after the call has ended.

Actelion Pharmaceuticals Ltd Gewerbestrasse 16 CH-4123 Allschwil Switzerland phone [phone] fax [phone] mobile [phone] [e-mail] www.actelion.com

[ariane] 13/10/2007 07:07

Merck & CO FDA approves Merck's new HIV drug




WHITEHOUSE STATION, N.J. (AP) - Merck & Co. said Friday the Food and Drug
Administration approved its Isentress twice-daily tablets as a treatment for
patients who have strains of the HIV virus resistant to multiple antiretroviral
drugs.
Isentress is the first of a new class of antiretroviral drugs called
integrase inhibitors, which work to prevent the virus from inserting its DNA
into human DNA, thereby stunting its ability to replicate and infect new cells.
Drugs currently on the market inhibit two other enzymes critical to the HIV
replication process -- protease and reverse transcriptase -- but Merck says
Isentress is the only approved treatment which inhibits the integrase enzyme.
The FDAs approval was based on a 24-week analysis of clinical trials in
which nearly 700 patients with HIV strains resistant to most medications
received Isentress in combination with other anti-virals. Those treated saw
significant reductions in HIV RNA viral load and increased CD4 cell counts.
Merck said it worked closely with the HIV community on pricing, and has
priced Isentress at $27 per day, or less than $10,000 a year.
In 2006, over one million Americans were living with HIV/AIDS and it is
estimated that approximately 40,000 new cases of HIV/AIDS are diagnosed each
year in the United States. Worldwide, an estimated 40 million people are
infected with HIV/AIDS, and more than four million new infections occurred last
year.
"As the AIDS crisis continues, new drugs like Isentress are needed, which
target the virus in unique ways," said Ben Cheng, deputy director, Forum for
Collaborative HIV Research. "The HIV advocacy community is really excited and
encouraged by this new treatment."

[ariane] 12/10/2007 09:06

Merck KGaA initiated with "buy"

Thursday, October 11, 2007 1:16:08 PM ET
ING Financial Markets

LONDON, October 11 (newratings.com) - Analysts at ING Financial Markets initiate coverage of Merck KGaA (MRK.ETR) with a "buy" rating. The target price is set to €110.

In a research note published this morning, the analysts mention that Merck has started facing earlier-than-anticipated competition in the liquid crystal market, due to which the company's share price has declined. The recent survey has indicated that the impact of the competition on Merck would be limited, the analysts say. Competitive NSCLC data, to be announced in 1H08, could be accretive to the company's peak sales estimates by €500 million, ING Financial Markets adds.

[ariane] 12/10/2007 08:59

Merck Kgaa Bayer, Genzyme to release new Phase II results on alemtuzumab in MS patients




CAMBRIDGE, MA (Thomson Financial) - Bayer AG and Genzyme Corp will publish
this weekend "important" new data on the use of leukemia drug alemtuzumab, which
they are jointly developing, in multiple sclerosis (MS) patients, according to
Genzyme.
The results of a concluded three-year phase II study involving 334
relapsing-remitting MS patients will be presented at the Congress of the
European Committee for Treatment and Research in Multiple Sclerosis in Prague on
Oct 14, the US biotech company said in a statement.
The companies in May said interim results based on the first two years of
the three-year phase II trial indicated that the drug led to fewer relapses and
was better at slowing the progression of disabilities than Merck KGaA's Rebif.
Bayer and Genzyme last month said they have already started testing the
compound on relapsing-remitting MS patients in the third and last phase of
clinical trials required for regulatory approval of the new use.
Alemtuzumab is also the active compound in Bayer's Campath leukemia drug.
The German drugmaker owns the exclusive rights to market and distribute the
ingredient.
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lb/mas/ak

[ariane] 10/10/2007 15:00

US pharma credit outlook cut to negative on nearing patent expirations - Moody's
Date : 10/10/2007 @ 15:50
Source : TFN


US pharma credit outlook cut to negative on nearing patent expirations - Moody's




MUMBAI (Thomson Financial) - Moody's Investors Service revised its outlook
on the US pharmaceutical industry to negative from stable mainly due to
approaching patent expirations, a tougher regulatory climate and a shift by US
pharma companies towards more aggressive financial policies.
In an industry update, Moody's, which rates 21 US pharma companies, said the
credit ratings for these companies have been essentially stable in 2007 but the
industry faces negative rating pressure over the next twelve months.
The ratings agency said cumulative patent expirations through 2012 affect
above 40 pct -- in some cases over 50 pct -- of current revenues for most of the
companies.
The recent pace of FDA approvals appears slower than prior years, Moody's
said.
It also said that larger number of pharma companies may consider aggressive
financial policies, like larger acquisitions and share repurchase strategies,
against the previously conservative ones which supported high credit ratings.
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aka/ran

[ariane] 04/10/2007 14:36

Merck "overweight," target price reduced

Thursday, October 04, 2007 8:23:17 AM ET
J.P. Morgan Securities

LONDON, October 4 (newratings.com) - Analysts at JP Morgan maintain their "overweight" rating on Merck KGaA (MRK.ETR), while reducing their estimates for the company. The 12-month target price has been reduced from €118 to €111.

In a research note published this morning, the analysts mention that the company's share price decline of €10 last week, on account of the concerns related to the liquid crystals business, was unwarranted. Although the underlying, preamortisation EPS growth rate expectation for 2007-2012 has been reduced from 14% to 11% per annum, it is still almost 100% more than the anticipated growth for the sector, the analysts say. The EPS estimates for 2007 and 2008 have been reduced from €6.51 to €5.56 and from €6.60 to €6.20, respectively.

[ariane] 29/9/2007 08:36

Merck "overweight"

Friday, September 28, 2007 11:25:04 AM ET
J.P. Morgan Securities

LONDON, September 28 (newratings.com) - Analysts at JP Morgan reiterate their "overweight" rating on Merck KGaA (MRK.ETR). The 12-month target price is set to €118.

In a research note published this morning, the analysts mention that the company's share price has been under pressure this week due to data indicating that Erbitux's benefits might be limited to only 60% of the colorectal cancer patients. Although KRAS selection would cut down the patient pool, given that the drug would be administered to patients who respond better, the average period of therapy per patient would rise from the baseline, the analysts say.

[ariane] 29/9/2007 05:05

Novartis says FDA influenced by politics
By Christopher Bowe in New York

Published: September 29 2007 00:15 | Last updated: September 29 2007 00:15

The Food and Drug Administration has become over-cautious in its assessment of new medicines following political pressure arising from safety controversies, Dan Vasella, chief executive of Novartis, said on Friday.

Mr Vasella, the only chief executive from one of the big pharmaceutical groups to attend the three-day Clinton Global Initiative in New York this week, said the medicine regulator had gone too far in seeking to evaluate drugs on criteria beyond their safety and efficacy.

"The FDA has become subject to politics," Mr Vasella said. "If they are assailed like they are now, the best thing to do is nothing."

Novartis has felt the sting of the FDA's increasing focus on safety that sprung partly from US drugmaker Merck's withdrawal of painkiller Vioxx owing to heart risks three years ago. Two drugs in Novartis's pipeline, Galvus for type II diabetes, and painkiller Prexige, have met significant regulatory delays with the FDA.

Both Prexige and Arcoxia, Merck's successor to Vioxx, have been denied approval by the FDA in spite of receiving approval around the world. The US safety issue has shaped their assessment to include a broader discussion of their place in the market and alternative treatments.

"The discussion on what this [drug] brings over and above what's on the market is a question that's being asked. The FDA doesn't seem to trust the physicians any more," Mr Vasella said.

On US healthcare reform, Mr Vasella said he was pleased the focus had shifted to getting all Americans healthcare insurance from the usual debate over rising costs, particularly of drugs.

But he expressed concern that US business could become less engaged in pushing for domestic healthcare reform as it increasingly passes more risk of the costs to individuals.

On his presence at the Clinton Global Initiative, Mr Vasella said drugmakers had been defensive in dealing with non-profits and developing world health problems, and he wanted to meet more of them to better understand their positions.

source:FT

[waldron] 06/9/2007 17:47

Merck & CO Supreme Court rejects Vioxx class action


TRENTON, N.J. (AP) - New Jersey's Supreme Court on Thursday rejected a
class-action lawsuit against Merck & Co. over its withdrawn painkiller Vioxx.
The ruling is a huge legal victory for the drugmaker, which faces nearly
27,000 individual lawsuits from people claiming Vioxx harmed them.
The state's highest court, reversing two lower-court decisions, ruled that a
nationwide class was not appropriate for the lawsuit. The suit had been brought
by a union health plan on behalf of all insurance plans that paid for Vioxx
prescriptions.
A lawyer for the New Jersey union had said the case could have cost Merck
$15 billion to $18 billion.
Had the class action been allowed to proceed, it also would have been a
major setback to the company's strategy of fighting the thousands of Vioxx
lawsuits one by one.
Merck shares rose $1, or 2 percent, to $50.40 in midday trading Thursday.
The Whitehouse Station, N.J.-based company said it was pleased with
Thursday's ruling.
Merck pulled Vioxx from the market three years ago after research showed it
doubled risk of heart attacks and strokes.
Chris Seeger, lead attorney for the West Caldwell, N.J.-based union that
sued, International Union of Operating Engineers Local 68, said that given the
ruling, he will now pursue separate claims on behalf of individual unions.
"Merck temporarily dodged a bullet. Merck didn't totally dodge the bullet,"
he said.
Seeger sued the drugmaker on behalf of the union in October 2003, arguing
that if Merck had disclosed those risks earlier, prescription plans would have
favored other painkillers.
A state judge and then an appeals court approved the class action, but Merck
appealed to the New Jersey Supreme Court.
The high court reversed the appellate court's decision on multiple grounds.
It wrote that it would be inappropriate to apply New Jersey's consumer fraud law
to claims by third-party payers around the country and that while Merck ran a
uniform marketing campaign for Vioxx, insurance plans made individual decisions
about covering the drug.
The judges also wrote that the engineers' union and the other third-party
payers "are well-organized institutional entities with considerable resources,"
and that it was unlikely their claims were too small to pursue individually.
Five judges heard oral arguments on a case in March, and all five sided with
Merck on the ruling.
"The Supreme Court recognized that a class action was improper because each
insurance company and HMO considered different types of information in deciding
whether to reimburse patients for Vioxx, and they all went through varied
processes with different experts in making those decisions," said Merck attorney
Ted Mayer.

[waldron] 06/9/2007 17:47

Actelion "overweight"

Thursday, September 06, 2007 11:09:48 AM ET
J.P. Morgan Securities

LONDON, September 6 (newratings.com) - Analyst Annie J Cheng of JP Morgan maintains her "overweight" rating on Actelion Ltd (ACT.ETR). The target price is set to CHF70.

In a research note published this morning, the analyst mentions that the company's almorexant product is still a viable insomnia drug candidate and further testing would show the drug's true profile. By yearend, Actelion is likely to provide updates on its Phase I products renin inhibitor and S1P1 agonist, which have excellent potential, the analyst says.

[waldron] 03/9/2007 07:12

Actelion's flagship drug Tracleer shows positive results in new study


ZURICH (Thomson Financial) - Actelion said data from a new phase IIIb1 study
has shown its best-selling drug
Tracleer can help to slow down the development of pulmonary arterial
hypertension in patients in the early stages of the disease.
Six months of treatment with Tracleer in patients with mildly symptomatic
pulmonary arterial hypertension significantly delayed the time to clinical
worsening, the Swiss pharma group said.
The study involved 185 patients and was the first controlled randomised
examination of Tracleer's efficiency in treating the milder form of the disease.
Tracleer, known generically as bosentan, is currently approved for treating
patients with the more severe and life-threatening form of hypertension only.
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jmt/ejb

[waldron] 02/9/2007 14:08

Actelion says insomnia drug study positive, plans phase III by yr-end


ZURICH (Thomson Financial) - Swiss pharmaceuticals group Actelion said new
study data showed its insomnia drug almorexant significantly improves sleep for
patients with primary insomnia.
Based on the initial positive results, Actelion said it plans to launch
phase III tests on the drug by the end of the year.
Actelion said that almorexant significantly improved the time patients with
primary insomnia spent sleeping in an eight-hour period at night. Primary
insomnia is when a person has trouble going to sleep, staying asleep or feels
unrested for at least one month.
The drug was tested on 147 patients in a proof-of-concept study, and was
shown to increase time spent in REM (Rapid Eye Movement) sleep as well as having
no negative side-effects the following day.
The study demonstrated almorexant's efficiency in 400 mg, 200 mg, and 100 mg
dosages, but Actelion noted that there was no noticeable difference in sleep
efficiency with the 50 mg dose.
Almorexant is the first-in-class orexin receptor antagonist line of drugs
for the treatment of insomnia.
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sf/ro

[waldron] 31/8/2007 15:08

Merck & CO FDA cites benefits of Merck HIV drug


WASHINGTON (AP) - A novel HIV-fighting drug from Merck & Co. appears
superior to options currently available for patients who have stopped responding
to established medicines, government health regulators said Friday.
The Food and Drug Administration said Merck's studies of Isentress
demonstrate it is safe and effective to treat HIV patients who have developed a
resistance to other medications.
If approved, Isentress would be the first in a new class of HIV treatments
called integrase inhibitors that block the virus from infecting cells and
reproducing.
The agency granted the drug priority review status earlier this year,
meaning staffers would review its application in six months, rather than the
standard 10. A decision is expected mid-October.
The agency posted its review of the drug to its Web site ahead of a
Wednesday meeting, when outside experts will vote on its safety and efficacy.
FDA is not required to follow the experts' recommendations, though it usually
does.
Shares of Merck & Co. Inc. rose 57 cents Friday to $50.24 in morning
trading.

[grupo guitarlumber] 24/8/2007 11:17

Actelion "overweight"

Thursday, August 23, 2007 8:00:41 AM ET
J.P. Morgan Securities

LONDON, August 23 (newratings.com) - Analyst Annie J Cheng of JP Morgan maintains her "overweight" rating on Actelion Ltd (ACT.ETR). The target price is set to CHF70.

In a research note published this morning, the analyst mentions that the company is expected to present positive Phase II data for its insomnia drug, ACT-078573, on September 5. If the data on ACT-078573 is positive, the drug is likely to be launched in 2012 and prove to be a blockbuster, the analyst says. Prescriptions for the company's Tracleer drug have so far been consistent, despite the launch of the competing Letairis drug in June, JP Morgan adds.

[waldron] 05/8/2007 21:08

Vaccines group defends hygiene
By Fiona Harvey in London

Published: August 5 2007 18:50 | Last updated: August 5 2007 18:50

Merial, the US-French company being investigated as a possible source of last week's foot-and-mouth outbreak, defended its hygiene practices on Sunday and said it was co-operating with government inspectors.

The company, jointly owned by Merck and Sanofi- Aventis, produced vaccines for foot-and-mouth disease at a site in Pirbright, south- west of London and a few miles from the farm where the outbreak occurred. Merial's vaccines included those made using the strain of the virus found on the affected farm. This strain is "very close" to that isolated from a 1967 outbreak, according to the Institute for Animal Health (IAH).

But the company said it had "no idea" how any foot-and-mouth virus could have spread from its facility and said it was too early in the investigation to say whether any had done so. Other transmission routes for the virus were also possible, the company said. It halted vaccine production at the plant on Friday.

Merial said: "Our centre operates to the very highest international standards and we insist on stringent adherence to processes and procedures for health, safety and environmental protection, quality control, quality assurance and regulatory compliance."

Bert Burns, a spokesman, said the company had never before experienced a virus outbreak arising from one of its facilities.

The IAH, which also has laboratories at the Pirbright site where suspected cases of foot-and-mouth disease are analysed, is also being investigated. The institute, a government-backed research laboratory, said: "IAH operates under strict biosecurity procedures. We have no evidence that these have been breached."

Martin Shirley, its director, rebutted the suggestion that the institute's facilities were in a poor state of repair, as suggested by a report in 2002.

Merial is one of the biggest companies involved in animal health, with a 14 per cent global market share. The company, which employs about 5,000 people worldwide, had a turnover last year of $2.2bn (€1.59bn, £1.07bn).

Sales of its foot-and-mouth vaccine made up 5 per cent of its global turnover, Merial said. The vaccine was made in the UK, though not sold there.

David Biland, Merial's UK managing director, arrived in Britain on Sunday after cutting short his holiday. He travelled to Pirbright to talk to investigators.

Britain's National Farmers' Union said that once the virus outbreak had been controlled, it would be looking for compensation for its members if the virus were found to have spread from a production facility.

[grupo guitarlumber] 14/7/2007 07:11

Merck & CO Merck seeks cut in $47.5M Vioxx award


TRENTON, N.J. (AP) - Merck & Co. on Friday urged a New Jersey judge to slash
a jury's $47.5 million award to an Idaho postal worker who successfully sued the
drugmaker over a heart attack he blamed on Merck's since-withdrawn Vioxx
painkiller.
Frederick "Mike" Humeston, 61, of Boise, won the award in March 2006 in his
second trial against Merck. He had lost the first trial, then was granted a new
one by Superior Court Judge Carol Higbee in light of new evidence.
The second jury awarded Humeston and his wife $20 million in compensatory
damages, plus $27.5 million in punitive damages, for the 2001 heart attack.
In Higbee's Atlantic City courtroom on Friday, Merck attorney Matt Shors
urged the judge to reduce both the punitive and compensatory damages.
He said afterward that the $20 million was more than 27 times the $730,000
limit on compensatory damages in Idaho. Shors also argued the punitive damages
were influenced by improper argument by Humeston's lawyers.
Higbee did not say when she would rule on the motions.
Humeston's lawyer, Chris Seeger, said "I'm optimistic there won't be any big
reduction."
Whitehouse Station, N.J.-based Merck also has requested a third trial in the
case; that request was not discussed Friday.
The $47.5 million total awarded to Humeston is the third-highest jury award
against Merck in the massive litigation over its former blockbuster arthritis
pill, which it withdrew from the market in September 2004 after research showed
Vioxx doubled the risk of heart attack and stroke. It is fighting more than
27,000 lawsuits one by one.
So far, Merck has won nine cases and lost five that have reached verdicts;
it is appealing all its losses and faces retrials involving three other
plaintiffs.