Marks Electrical Share Discussion Threads

[ariane] 10/10/2007 16:00

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 15:36

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 09:36

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 06:05

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 18:47

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 18:47

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 08:12

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 15:08

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 16:08

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 12:17

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 22:08

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 08:11

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.

[ariane] 31/5/2007 07:18

Actelion share split to take effect Wednesday


ZURICH (Thomson Financial) - Actelion said the previously announced
one-to-five split in shares of Actelion will take effect on Wednesday, 6 June
2007.
The group's shareholders approved this stock split at their Annual General
Meeting on, 4 May 2007.

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jmt/jfr

[waldron] 04/5/2007 17:58

Merck & CO Merck 'disappointed' at Brazilian decision to bypass HIV drug patent


LONDON (Thomson Financial) - Merck & Co said it was "profoundly
disappointed" by the decision of the Brazilian government to bypass the patent
protecting the company's HIV drug Efavirenz.
"Merck is profoundly disappointed by the decision of the Government of
Brazil (GOB) to issue a compulsory license for STOCRIN(TM) (Efavirenz), which
would break Merck & Co, Inc.'s patent and make it possible for Efavirenz to be
produced by a generic manufacturer," the company said in a statement.
Brazil and the Whitehouse Station, N.J.-based drug maker have been in
negotiations for a lower-priced version of the drug. The country asked Merck to
reduce the price of the drug from 1.57 usd a pill to 65 cents but Merck had
offered a 30 pct discount on Efavirenz at 1.10 usd.
Now, Brazil plans to issue a compulsory license under World Trade
Organization regulations to begin making or buying cheaper versions of the drug.
Merck said it had negotiated in "good faith" and was still "flexible and
committed" to reaching a mutually-acceptable agreement.
"This decision by the GOB will have a negative impact on Brazil's reputation
as an industrialized country seeking to attract inward investment, and thus its
ability to build world-class research and development," Merck warned.
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jlc

[waldron] 03/5/2007 14:39

Actavis bid for Merck KGaA generics ops less than asking price - source UPDATE


(Updating that Teva and joint private equity bid from Apax Partners and Bain
Capital still in running for Merck KGaA's generics ops)
FRANKFURT (Thomson Financial) - Generic drugs giant Actavis had offered
Merck KGaA a sum a few hundred mln eur lower than the sum being offered by rival
bidders for the company's generics operations, before last night being "advised"
by the pharmaceutical giant to pull out of the bidding process, a source close
to the situation told Thomson Financial News.
The source said that estimations that rival bidders were offering in the
region of between 4-5 bln eur were not incorrect.
"The gap between what Actavis was willing to pay and what Merck is expecting
was estimated to be too large, and would have meant stretching the company
significantly.
He added: "We are not talking about a billion or anything like that, we are
talking about a difference of a few hundred million euros.
"It seems that Merck is looking to create value rather than synergy
potentials."
Rumours began circulating in financial circles today that Actavis had been
"kicked out" of the bidding process, due to its inability to meet conditions set
by Merck.
"I do not know why these rumours were sparked, but they are completely
untrue.
"Actavis has the financial means to undertake this acquisition, but decided
simply that the expected price was too high," clarified the source.
Actavis is now planning to focus on smaller acquisitions in the region of up
to a few hundred mln eur, added the source.
In particular, it is hoping to expand in southern Europe, Latin America and
Asia.
Actavis said earlier today that it has the financial means for major
acquisition opportunities -- including that of Merck's generics operations --
and added that it will continue to evaluate other acquisition opportunities.
Sources today said that two further parties -- Israel's Teva Pharmaceuticals
and a joint private equity offer from Apax Partners and Bain Capital -- are now
battling it out in the war for Merck's generic operations.

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kd//cmr

[waldron] 01/5/2007 07:40

Merck Kgaa Bids for Merck generics arm rise above 4 bln eur - report


LONDON (Thomson Financial) - Aggressive competition for the generic drugs
arm of Merck KGaA of Germany pushed offers beyond 4 bln eur at the close of a
revised round of bids yesterday, the Financial Times reported, citing a source
familiar with the process.
Four rivals - Actavis of Iceland, Teva of Israel, Mylan of the US and a
joint private equity offer from Apax Partners and Bain Capital - all stayed in
the auction after completing due diligence in recent weeks, the FT said.
However, a definitive decision to proceed with the sale has yet to be made,
and one person with knowledge of the process said yesterday that the financial
information made available to the bidders remained limited and a further final
round could still be required in the weeks ahead.
Michael Roehmer, the outgoing chief executive of Merck, said at the
company's annual meeting last Friday that no decision had yet been made on
whether to proceed with the sale. He stressed that the disposal would be "the
right step for the future of the company", as Merck concentrated on its
remaining branded medicine, consumer healthcare and chemicals divisions.


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jlw

[waldron] 27/4/2007 16:40

Merck & CO FDA rejects Merck's Vioxx successor


TRENTON, N.J. (AP) - The Food and Drug Administration rejected Merck &
Co.'s request to market a successor to its withdrawn arthritis drug Vioxx in the
United States, the drugmaker said Friday.
The move was widely expected, after a panel of FDA advisers two weeks ago
voted 20-1 against approving the drug, Arcoxia.
Arcoxia is in the same class of drugs as Vioxx, which has become a poster
child for drug safety problems.
Merck pulled Vioxx from the market in September 2004 after research showed
it doubles risk of heart attacks and strokes. That triggered an avalanche of
lawsuits -- more than 27,000 so far -- and a nosedive for Merck's stock price,
which has since bounced back.
Despite the safety concerns in the United States, Arcoxia is on sale in 63
other countries, and Merck officials said as recently as Tuesday that they
intend to keep working to get it on the U.S. market.
Arcoxia had been poised for approval until Vioxx was pulled from the market.
Two months later, the FDA issued what's called an "approvable" letter, saying it
could approve Arcoxia, but only if Merck provided further safety and efficacy
information for the drug.
Merck has since produced results from further studies of Arcoxia, but
doctors questioned those results because Merck compared Arcoxia in its tests to
another painkiller that has elevated risk of heart attacks and strokes.
Peter S. Kim, president of Merck Research Laboratories, told company
shareholders at their annual meeting Tuesday that "there is more long-term
safety data on Arcoxia than" other drugs in the same class and traditional
anti-inflammatory medicines.
"We are committed to working with the FDA to determine the best approach" to
get it on the U.S. market, Kim said.
A Merck spokeswoman did not immediately return a call seeking comment Friday
morning.
Merck shares sank 55 cents, or 1 percent, to $51.88 in morning trading on
the New York Stock Exchange. They are still trading near their 52-week high of
$52.63. Their low over the past year was $32.75.