Marks Electrical Share Discussion Threads

[waldron] 24/4/2007 16:11

FDA expected to OK Pfizer HIV drug


WASHINGTON (AP) - Analysts expect Pfizer to win approval for a
first-of-a-kind drug to treat HIV despite safety concerns raised by government
regulators ahead of a Tuesday meeting.
A panel of experts meets in Rockville, Md., to advise the Food and Drug
Administration on whether to approve Pfizer's maraviroc to fight HIV. If
approved it would be the first in a new class of treatments that block HIV from
entering white blood cells through a pathway present in some patients that carry
the virus.
Although FDA reviewers noted a slight increase in liver problems among
patients taking the drug, analysts say the drug's effectiveness should outweigh
any safety concerns.
"While more controversial than we had originally expected, we believe the
favorable risk-benefit profile of maraviroc will lead to a panel recommendation
for approval," Piper Jaffray analyst Thomas Weil said in a research note. FDA is
not obligated to follow the recommendation of its panel, but it usually does.
The agency is scheduled to make its final decision on maraviroc in June.
Roughly 1 million people in the U.S. are HIV positive, but only a subset of
that group would be able to take Pfizer's pill, which will initially be labeled
for patients who have stopped responding to drugs already on the market.
"Out of the gate, I would expect maraviroc to be cubby-holed into the
salvage population of patients who have already failed a number of treatments
and have limited treatment options," said Dr. Jacob Lalezari, who was lead
investigator on Pfizer's study of the drug.
With its proposed labeling, maraviroc is expected to post sales of $25
million in 2007 and $375 million by 2010, according to Thomas Weisel Partners
analyst Peter Lawson. By comparison, Gilead Science's top-selling HIV drug,
Viread, posted $689 million in sales last year.
Maraviroc's indication could eventually be expanded to include patients with
early stage HIV, according to Lalezari, because the pathway the drug uses to
block HIV is more common in these patients. Only about half of late stage HIV
patients have the pathway.
By the time Pfizer is ready to market maraviroc as an initial treatment for
HIV, though, several competitors could have similar drugs on the market.
Pharmaceutical giant Schering Plough Corp. expects to begin final trials of
its own HIV-blocking drug before the end of the year. Also, Incyte Corp. is
working on a similar medicine in a once-a-day dosage, which could be a
competitive advantage over Pfizer's twice-a-day pill.
"We think our compound looks very good and having the potential to be the
best-in-class makes it worthwhile for us to take the time to focus on
development," said company spokeswoman Pamela Murphy. Wilmington, Del.-based
Incyte expects to enter late-stage trials in 2009.
Perhaps an even bigger potential competitor for maraviroc is an experimental
HIV drug which Merck & Co. Inc. is preparing to submit to FDA. Studies released
last month showed Merck's Isentress effectively controls HIV while causing
virtually no side effects. Because Merck's and Pfizer's drugs fight HIV in
different ways, AIDS researcher Dr. Albrecht Helmut said they could potentially
be used in combination.
"If they play well together they could be used together, but that remains to
be seen" said Helmut, who is a professor at the University of South Carolina.
"So there's a chance for collaboration here but also for competition as the two
companies try to be the first to get to these patients who have already failed
other treatments."
Shares of Pfizer Inc. rose 2 cents Tuesday to $26.37 in morning trading on
the New York Stock Exchange.

[ariane] 21/4/2007 06:46

Date : 21/04/2007 @ 00:15
Source : AFX


Merck & CO Ruling puts Texas Vioxx lawsuits on hold


HOUSTON (AP) - More than 1,000 personal injury lawsuits filed in Texas over
the once-popular pain medication Vioxx were put on hold Friday after a judge
ruled the drug's manufacturer had given adequate warnings about the drug.
State District Judge Randy Wilson, based in Harris County, granted a motion
by Merck & Co. Inc., the drug's manufacturer, to dismiss part of a lawsuit filed
by Ruby Ledbetter.
Merck's attorneys argued a 2003 Texas law prevents Ledbetter from claiming
she wasn't properly warned about Vioxx.
The law, passed as part of tort reform efforts, says a drug manufacturer is
not liable in allegations it failed to provide sufficient warnings about its
product if the drug in question came with warnings approved by the Food and Drug
Administration.
Friday's ruling put Ledbetter's case on hold. But Travis Sales, one of
Merck's attorneys, said Wilson had previously told lawyers in the case that such
a decision would put all Texas cases on hold until appeals courts rule on the
issue.
Wilson is presiding over all Vioxx lawsuits filed in Texas.
"The court got it right," Sales said. "It goes to the heart of what Merck
has always said. Merck gave proper information to the FDA and the FDA made
proper labeling information based on what was there at the time."
Tommy Fibich, one of Ledbetter's attorneys, did not immediately return a
telephone call seeking comment Friday.
Vioxx, an arthritis pain reliever, was pulled from the market in September
2004, when a study showed it could double the risk of heart attack or stroke if
taken more than 18 months.
Whitehouse Station, N.J.-based Merck said it now faces 27,250 personal
injury lawsuits over Vioxx, including 45,700 plaintiff groups.
The company is sticking by its plan of defending each of thousands of claims
over Vioxx rather than settling the suits.

[ariane] 17/4/2007 11:56

Actavis, Torrent seen as top contenders for Merck KGaA's generic ops - report


FRANKFURT (Thomson Financial) - Iceland's Actavis Group and India's Torrent
Pharmaceuticals Ltd could compete in a head-to-head race to win Merck KGaA's
generic operations, which according to financial circles could fetch more than 6
bln usd, reported the Times of India, citing sources.
Rival contender Teva Pharmaceuticals Industries Ltd could be put off by the
high price tag, as it already has a strong presence in markets where Merck
operates - including the US, Canada, Europe and Australia, added the report.

[e-mail]
kd/lam

[ariane] 13/4/2007 19:56

Sanofi-Aventis/Merck in 200 mln eur upgrade of French bird flu vaccine plant


EVREUX, France (Thomson Financial) - Sanofi-Aventis and Merck & Co Inc joint
venture Sanofi-Pasteur said it is to invest 200 mln eur in order to increase
production capacity at its Val-de-Reuil plant in Northern France, which produces
the group's bird flu vaccines.
The upgrade, which will raise output capacity of yellow fever and polio as
well as flu vaccines, is expected to be complete in 2009.
The factory produced 120 mln doses in 2006 and the new annual capacity will
be 210 mln, a spokesman told Agence France-Presse.
The Val-de-Reuil plant manufactured 1.4 mln doses of the H5N1 bird flu
vaccine in 2006 at the government's request and Sanofi-Pasteur has pledged it
can quickly supply 28 mln doses in the event of an outbreak.

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afp/mrg/amb

[ariane] 12/4/2007 17:34

Date : 12/04/2007 @ 17:29
Source : AFX


Merck & CO FDA scientist blasts proposed pain drug


WASHINGTON (AP) - A painkiller proposed as a successor to Vioxx may
substantially increase the risk of stroke and heart attack and is no more
effective for pain relief than other drugs of the same class, a federal drug
safety expert said Thursday.
Safety studies done on the proposed drug, Arcoxia, are neither adequate nor
reasonable to support its approval, Food and Drug Administration scientist Dr.
David Graham told a panel of agency advisers. Graham has been a leading critic
of Vioxx, also known as rofecoxib.
"What you're talking about is a potential public health disaster," Graham
said of Arcoxia. "We could have a replay of what we had with rofecoxib."
Merck & Co. Inc. seeks FDA approval to sell Arcoxia, also known as
etoricoxib, to treat the signs and symptoms of osteoarthritis. The Whitehouse
Station, N.J., company withdrew Vioxx in 2004, after it was linked to a higher
risk of stroke and heart attack when compared to dummy pills.
A Merck official said the company has "comprehensively characterized the
safety and efficacy profile" of Arcoxia. The prescription drug is the first of
its class to seek FDA approval since Merck withdrew Vioxx.
"We at Merck believe etoricoxib represents a valuable treatment option for
patients with osteoarthritis. We would like to emphasize there is more long-term
safety data ... for etoricoxib that any other NSAID," said Peter Kim, president
of Merck's research laboratories.
An estimated 21 million Americans suffer from osteoarthritis. NSAIDs, or
nonsteroidal anti-inflammatory drugs, are a common treatment. Arcoxia and Vioxx
are types of NSAIDs called Cox-2 inhibitors, developed to be gentler on the
stomach.
The FDA said this week that new NSAIDs that increase the risk of stroke and
heart attack shouldn't be approved if safer alternatives are available.
The FDA convened a panel of expert advisers to weigh whether to recommend
the agency approve Arcoxia. The FDA isn't required to follow the advice of its
advisory committees but usually does. Merck hopes FDA will make a final decision
by month's end.

[ariane] 10/4/2007 17:11

Merck & CO FDA may OK Arcoxia, a Vioxx follow-up


(AP) - Merck & Co. Inc. shares showed little reaction Tuesday to the release
of government documents reviewing the pain-relieving drug Arcoxia.
The Food and Drug Administration posted the Arcoxia review to its Web site
ahead of a Thursday meeting at which non-agency arthritis experts are expected
to vote on whether the drug should be approved. The agency is not required to
follow the panel's recommendation, though it often does.
Arcoxia would be the first in the same class of drugs as Vioxx and Bextra to
gain U.S. approval since those drugs were pulled from the market after showing
links to heart attack and stroke in 2004 and 2005.
The prospect of FDA approval of a drug similar to Vioxx, which attained
blockbuster status in its five years on the market, has attracted scrutiny from
patients and physicians. But Wall Street seems unconcerned with the drug's
potential on speculation that safety concerns would limit sales.
"Our position has been that it won't get approved, but even if it does, it
will hardly make an impact," said Kate Hohenberg, an analyst with pharmaceutical
research firm Decision Resources.
Arcoxia is part of a class of drugs called cox-2 inhibitors, thought to be
gentler on the stomach than over-the-counter medicines such as Tylenol and
Advil. Pfizer, which made Bextra, still sells Celebrex, another cox-2 drug.
In its summary, FDA staff note that while Arcoxia had blood-clotting risks
in line with another commonly prescribed pain reliever, it showed higher
incidence of hypertension-related heart problems when compared with the same
drug.
Hohenberg estimated Arcoxia sales could be limited by restrictive labeling
that Celebrex does not have. In Europe, for example, Arcoxia was approved with a
specific warning label indicating that it should not be used by patients with
hypertension.
"Merck has not revealed why anyone would be compelled to use its drug over
the one already available," said Hohenberg.
Whitehouse Station, N.J.-based Merck also could find Arcoxia competing
against cheaper generic versions of Celebrex after that drug loses patent
protection, which could happen as early as 2013.
And Merck's FDA application for Arcoxia seeks approval for use only in
patients with osteoarthritis. While the osteoarthritic population in the United
States is significant at 21 million, it is much smaller than the market had been
for Vioxx, which was approved for osteoarthritis, rheumatoid arthritis and a
variety of other chronic pain conditions.
Merck did not break out potential sales from Arcoxia in its 2007 guidance,
instead lumping the product in with other drugs that are not considered major
franchises. Together the group of more than a dozen products are expected to
bring in sales of $5.2 to $5.6 billion for the year. By comparison, Merck's
top-selling allergy medication Singulair is expected to generate revenues
between $3.7 and $4 billion next year.
Still, Dr. Patience White of the Arthritis Foundation says Arcoxia is likely
to find a niche among arthritis sufferers who do not respond to more traditional
pain relievers.
"There's a percentage of patients out there who recognize that they face a
greater risk from the disability associated with their pain than the reported
risk of the drug," said White, who is chief public health officer for the
not-for-profit group.
Shares of Merck & Co. rose 5 cents Tuesday to $45.70 in morning trading on
the New York Stock Exchange. Pfizer rose 3 cents to $26.02, also on the NYSE.

[waldron] 27/3/2007 17:19

Merck & CO Jurors side with Merck in Vioxx trial


EDWARDSVILLE, Ill. (AP) - Jurors in the Midwest's first trial over the
once-blockbuster painkiller Vioxx on Tuesday cleared the drug's maker in the
2003 deadly heart attack of a 52-year-old woman.
A Madison County court jury deliberated over two days before siding with
Merck & Co., which had argued that Patty Schwaller's weight and other health
issues might have posed risks that better explain her collapse and sudden death.
Schwaller had taken Vioxx for about 20 months. Her husband claimed that
Vioxx contributed to his wife's death and that Merck failed to sufficiently warn
consumers that the drug increased the risk of cardiovascular problems.
The victory was Merck's 10th in 15 cases that have been tried in the
mushrooming litigation over the drug Merck pulled off the market in 2004 after
its research showed it increased the risk of heart attacks and strokes.
During the monthlong trial in this St. Louis suburb, where large jury awards
favoring plaintiffs earned Madison County the label by some as a "judicial
hellhole," Merck lawyers insisted that Patty Schwaller had several risk factors
for heart disease, including obesity, diabetes, high blood pressure and a
sedentary lifestyle.
The 5-foot-2 woman's weight fluctuated between 250 and 300 pounds for
roughly two decades before her death, attorneys have acknowledged.
But attorneys for Schwaller's widower, Frank Schwaller, pressed that the
woman had no heart attacks, strokes or symptoms of congestive heart disease
before her fatal collapse, fueling their belief that Vioxx contributed to her
demise.
Mikal Watts, a Schwaller attorney told jurors Monday that Merck pushed
consumers like Patty Schwaller "over the cliff" by failing to adequately study
Vioxx's possible side-effects on people at risk of heart disease. Watts said
Merck publicly downplayed worries by outside researchers that Vioxx could put
users at greater risk of heart attacks or strokes.
Top Merck executives "kept cutting the data until it told them what they
wanted it to say," Watts insisted.
Watts argued that Merck put profits ahead of patient safety by allegedly
rushing Vioxx to market. The drug became the company's No. 2 drug, generating
more than $11 billion in sales from May 1999 through September 2004, according
to regulatory filings and other information from the company, based in
Whitehouse Station, N.J.
"I'm not against companies making money, but not at the expense of their
patients," Watts told jurors.
But Dan Ball, an attorney for Merck, accused the Schwaller family's attorney
of cherry-picking and misrepresenting Merck e-mails to "assault" the reputation
of a company he said was dedicated to making lives better.
Ball said Vioxx labels in 1999 and 2002 -- well before Patty Schwaller's
death -- urged caution among users with cardiovascular risks including
hypertension. He urged jurors to look to Schwaller's health troubles in deciding
what caused her death.
"A person with these kinds of issues sometimes can die early, tragically,
and medicine doesn't have a doggone thing to do with it," Ball told jurors.
"Let's try not to forget the undisputed fact that most people who took this
medicine had no issues at all."
The trial has been closely watched in Madison County, which has gained
national notoriety as a place where lawyers from across the country file cases
involving everything from asbestos exposure to medical malpractice, hoping for
big payouts.
Merck has been deluged with more than 27,000 personal injury lawsuits and
another 265 potential class-action lawsuits alleging harm from Vioxx. The
company has reserved $1.64 billion in its Vioxx legal defense fund, saying it
plans to fight each lawsuit.
On March 12, jurors in Atlantic City, N.J., found that Vioxx contributed to
an Idaho postal worker's 2001 heart attack, reversing the verdict in the man's
first trial and hitting Merck with a total of $47.5 million in damages.
If the verdict and damage amounts are upheld on appeal, it could be the
biggest hit to Merck so far.
In the only Vioxx case with a larger verdict -- $51 million awarded last
August to Gerald Barnett of Myrtle Beach, S.C. -- U.S. District Judge Eldon E.
Fallon in New Orleans ordered a new trial on damage award, calling the total
"grossly excessive."
A New Jersey Supreme Court panel also is considering whether to allow health
insurers and union health plans to sue Merck jointly to recover money they paid
for Vioxx prescriptions -- a lawsuit potentially worth more than $15 billion. A
New Jersey state judge granted that lawsuit class-action status in mid-2005, and
a state appellate court ruled last year that the nationwide suit could go
forward. Merck is appealing.

[waldron] 27/3/2007 05:52

Merck & CO Deliberations continue in Vioxx trial


EDWARDSVILLE, Ill. (AP) - Jurors at the first Vioxx trial in the Midwest
have begun weighing whether poor health or the once-blockbuster painkiller is to
blame for a 52-year-old woman's fatal 2003 heart attack.
Deliberations that lasted nearly 5 1/2 hours Monday night were to continue
Tuesday morning in Madison County.
Attorneys for Patty Schwaller's widower urged jurors during closing
arguments to sock Merck & Co. in the pocketbook, saying the company failed to
sufficiently warn consumers that the drug increased the risk of cardiovascular
problems.
Schwaller took Vioxx for about 20 months before suddenly collapsing in her
Granite City home near St. Louis in August 2003 and dying.
Merck pulled the drug off the market in 2004 after its research showed it
increased the risk of heart attacks and strokes.
Schwaller "shall not have died in vain," Mikal Watts, an attorney for the
family, told jurors.
Citing the company's own internal e-mails, Watts said Merck failed to
adequately study Vioxx's possible side-effects on people at risk of heart
disease and publicly downplayed worries by outside researchers that Vioxx could
put users at greater risk of heart attacks or strokes.
"I'm not against companies making money, but not at the expense of their
patients," Watts said. Top Merck executives "kept cutting the data until it told
them what they wanted it to say."
Vioxx, once Merck's No. 2 drug, generated sales exceeding $11 billion from
May 1999 through September 2004, according to regulatory filings and other
information from the company, based in Whitehouse Station, N.J.
Schwaller's family has claimed that the 5-foot-2 woman -- whose weight
fluctuated between 250 and 300 pounds for at least two decades -- had no heart
attacks, strokes or symptoms of congestive heart disease before her fatal
collapse.
Merck, Watts insisted, pushed consumers like Schwaller "over the cliff" by
putting profits over patient safety.
But Merck attorney Dan Ball accused the Schwaller family's attorney of
cherry-picking and misrepresenting Merck e-mails to "assault" the reputation of
a company he said was dedicated to making lives better.
Ball said Vioxx labels in 1999 and 2002 -- well before Patty Schwaller's
death -- urged caution among users with cardiovascular risks including
hypertension, but he suggested Schwaller's obesity, diabetes, high blood
pressure and sedentary lifestyle might have posed risks that better explain her
collapse and sudden death.
"A person with these kinds of issues sometimes can die early, tragically,
and medicine doesn't have a doggone thing to do with it," Ball said. "Let's try
not to forget the undisputed fact that most people who took this medicine had no
issues at all."
Still, he noted, "all medicines have risks, and sometimes bad things
happen."
The trial has been closely watched in Madison County, which has gained
national notoriety as a place where lawyers from across the country file cases
involving everything from asbestos exposure to medical malpractice, hoping for
big payouts.
Merck has been deluged with more than 27,000 personal injury lawsuits and
another 265 potential class-action lawsuits alleging harm from Vioxx. The
company has reserved $1.64 billion in its Vioxx legal defense fund, saying it
plans to fight each lawsuit.
On March 12, jurors in Atlantic City, N.J., found that Vioxx contributed to
an Idaho postal worker's 2001 heart attack, reversing the verdict in the man's
first trial and hitting Merck with a total of $47.5 million in damages.
If the verdict and damage amounts are upheld, it could be the biggest hit to
Merck so far.
In the only Vioxx case with a larger verdict -- $51 million awarded last
August to Gerald Barnett of Myrtle Beach, S.C. -- U.S. District Judge Eldon E.
Fallon in New Orleans ordered a new trial on damage award, calling the total
"grossly excessive."
A New Jersey Supreme Court panel also is considering whether to allow health
insurers and union health plans to sue Merck jointly to recover money they paid
for Vioxx prescriptions -- a lawsuit potentially worth more than $15 billion. A
New Jersey state judge granted that lawsuit class-action status in mid-2005, and
a state appellate court ruled last year that the nationwide suit could go
forward. Merck is appealing.

[waldron] 26/3/2007 17:23

Merck, Roche Cholesterol Drugs May Be Hurt by Pfizer's Failure

By Shannon Pettypiece

March 26 (Bloomberg) -- Merck & Co. and Roche Holding AG's efforts to develop the next generation of cholesterol drugs may be derailed by results showing Pfizer Inc.'s attempt proved both deadly and ineffective.

Pfizer's experimental drug torcetrapib, which cost about $1 billion to develop, doesn't reduce fatty plaque in arteries and raises blood pressure, according to two studies released today at the American College of Cardiology meeting in New Orleans. Earlier findings showed the drug increased death rates.

The results have set off a debate among doctors on whether torcetrapib's problems are unique to its chemical makeup, or if they'll carry over to similar pills in development. Torcetrapib was furthest along in a new class of drugs that analysts said may have annual sales of as much as $20 billion. The drugs block a protein that raises levels of HDL, or good cholesterol, which sweeps fatty plaque from arteries.

``What happened will be the source of an incredibly intense discussion,'' said Steven Nissen, the lead author of one of the studies and chairman of cardiology at the Cleveland Clinic. `` I don't want to kill a class that might work, but the bar is just a whole lot higher after seeing these data.''

The shares of Whitehouse Station, New Jersey-based Merck fell 5 cents to $44.40 at 9:57 a.m. in New York Stock Exchange trading. The shares of Roche, based in Basel, Switzerland, increased 60 centimes, or less than a percent, to 219.90 Swiss francs.

Testing Stages

Merck is entering the finals stages of testing on a drug similar to torcetrapib and Roche is in the second of three phases of testing for its drug. Pfizer also finished phase one testing last year on two other drugs that work like torcetrapib.

Merck and Roche said earlier this year they would be closely monitoring the data Pfizer released on its failed drug.

All three companies' drugs work by blocking the cholesterol ester transfer protein, or CETP, which converts good cholesterol into the bad form. Nissen said nearly every major drug company is studying the class of drugs, though only Pfizer, Merck and Roche have publicly acknowledged it.

Further research is needed before experts can determine whether the entire class of drugs is flawed, Nissen said. Those studies should be slower and more methodical than Pfizer's, meaning higher costs and a longer wait to market the drug.

``I don't think we can kill the class until we test a clean drug,'' Nissen said. ```I think someone will test the waters there and we'll help them do that, but I'm equally concerned about protecting our patients who enroll in clinical trials. This is a very, very challenging situation.''

Risk, Cost

The question for drugmakers is whether the risk and cost of pursuing this area of research is worth the reward considering Pfizer's failed attempt. In December, Pfizer halted development of torcetrapib combined with its cholesterol pill Lipitor after a study showed the drug increased death rates by 60 percent compared with Lipitor alone.

``If imaging results on torcetrapib are indeterminate, these companies will have to do some serious `soul searching' to determine whether they want to continue spending time and money developing their own respective CETP inhibitors,'' said Prudential Equity Group Inc. analyst Tim Anderson in a note to clients last week prior to the release of the torcetrapib data.

One thing that may distinguish the Merck and Roche drugs is that unlike torcetrapib neither has shown in early testing to increase blood pressure during short-term trials, the drugs' makers said.

Torcetrapib increased blood pressure an average of 4.6 millimeters, which is more than previously expected, according to one study presented today. Raising blood pressure may outweigh the benefits of increasing HDL or be a signal for the underlying problem causing the drug to not work, he said.

Months Vs. Weeks

The blood pressure effect didn't show up immediately and got worse over months. Merck has only studied its drug in patients for eight weeks at a time.

The studies' authors should have provided an analysis of whether they believe the blood pressure risk was linked to the drugs safety and ineffectiveness, said Jim Stein, head of preventative cardiology at the University of Wisconsin. He called that failure ``a real weakness.''

Pfizer said it hopes to determine by the end of the year whether the torcetrapib problems are unique to the drug or its mechanism of action, said Pfizer head of world wide drug development Michael Berelowitz in an interview.

-- Editor: Gale.

To contact the reporter on this story: Shannon Pettypiece in New York at [e-mail]

[waldron] 26/3/2007 14:21

Merck & CO Merck's Januvia diabetes drug wins European Union approval


LONDON (AFX) - Merck & Co., Inc said its once-a-day oral treatment for
patients with type 2 diabetes, Januvia, has been granted a license from the
European Commission.
The company said that Januvia is the first and only medication in a new
class of drugs known as dipeptidyl peptidase-4 inhibitors -- which enhance the
body's own ability to lower blood sugar when it is elevated -- to be adopted by
the European Commission.
The adoption applies to all of the 27 countries that are members of the EU,
including the United Kingdom, Germany, France, Italy and Spain, as well as
Norway and Iceland: Januvia will be launched shortly in the EU.
Merck said Januvia is now approved for use in 42 countries around the world
including Mexico, the United States, and the Philippines.
[e-mail]
rw

[waldron] 26/3/2007 14:21

Merck & CO Merck, Schering-Plough to develop new cholesterol-lowering medicine


LONDON (AFX) - Merck & Co Inc and joint-venture partner Schering-Plough Corp
have agreed to develop a new cholesterol-lowering medicine that will combine
their existing ezetimibe and atorvastatin products.
The combined medicine, to be produced by the two companies'
Merck/Schering-Plough Pharmaceuticals joint venture, could become available just
as patent exclusivity for atorvastatin expires both in the US and
internationally.


[e-mail]
ms1

[waldron] 22/3/2007 11:00

Merck Kgaa Aurobindo Pharma, CVC Capital jointly bid for Merck's generics ops - report


MUMBAI (AFX) - India's mid-sized drug maker Aurobindo Pharma Ltd, has tied
up with private equity fund CVC Capital Partners (Deutschland) GmbH to bid for
Merck KGaA's global generics business, reported the daily Mint, citing people
familiar with the bids.
CVC Capital Partners will extend manufacturing and management support in the
event that Aurobindo Pharma emerges the winner for the generics operations, the
article said.
Both Aurobindo and CVC Capital Partners declined to comment to the
newspaper.
Other Indian companies, Dr Reddys Laboratories and Ranbaxy Laboratories Ltd,
had pulled out of the bidding process over price issues, while Cipla Ltd, which
had tied up with a private equity consortium for the bid, is no longer a
contender, the report said.





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rba/ra/cmr

[grupo guitarlumber] 20/3/2007 18:27

Merck & CO Big business still opposes 51st state


WASHINGTON (AP) - The 108-year-old push to make Puerto Rico the 51st state
is thriving on the Caribbean island. But powerful U.S. business interests
continue to trump local politics, making it less likely than ever, experts say.
More than half of Fortune 100 companies operate there, with billions
invested in factories and trained workers. Eli-Lilly & Co., Abbott Laboratories
and others, including Microsoft Corp. and Coca-Cola Co., don't want to lose
Puerto Rico's tax-free commonwealth status, politicians and academics say.
At a congressional hearing set for Thursday, corporate lobbyists are
expected to remind statehood advocates that the lure of cheap labor and low
taxes available in Singapore, India and elsewhere would intensify if Puerto
Rico's status changed.
"The commonwealth (status) offers so much benefit to the major players
influencing the decision," says Edwin Melendez, a professor of urban policy and
management at the New School in New York who studies Puerto Rico's economy.
Like past hearings, this one is expected to be crowded and boisterous, with
interest groups debating competing proposals that would give the island's nearly
4 million residents another chance to vote on statehood. The desire for
statehood goes back to the U.S. seizure of Puerto Rico from Spain in 1898.
Residents on the island 1,000 miles off Florida's coast gained U.S. citizenship
in 1917, but they can't vote for president and have no voting representation in
Congress.
The island's tax-free status remains a key factor for big business. Congress
recently eliminated a credit allowing companies to avoid taxes on material
produced on the island. Concerns arose that Merck & Co. Inc. and Pfizer Inc.,
among others, might leave, and there was a "little pullback" after the credit
expired, Melendez said.
Puerto Rico Senate President Kenneth McClintock, a statehood advocate, says
the firms won't leave an educated, loyal and skilled work force.
Eduardo Bhatia, who runs the Washington office for Puerto Rico's governor
and whose $1 million annual lobbying budget is triple that of McClintock's,
disagrees. U.S. companies stay because they have reregistered as controlled
foreign corporations and still pay no federal taxes as long as the profits
remain offshore, he says. Numerous companies with Puerto Rican operations
declined comment on the subject or did not return calls.
Advocates argue statehood would increase investment and eliminate the stigma
that the island is a third-world entity.
"U.S. investors see it as something foreign, something Spanish, something
Caribbean," says McClintock.
Puerto Rico is "foreign" for tax purposes only, Bhatia counters. Statehood
is not needed to offer "psychological" reinforcement, he added.
The government's investment attraction team is in Washington this week to
tout the island as the "India for federal contractors," according to an e-mail
from a government-owned corporation that promotes investment in Puerto Rico.
Companies continue to expand there. Last year drug maker Amgen Inc. said it
planned to invest $1 billion over four years in new and existing plants. The
"global supply of our principal products is significantly dependent on the
uninterrupted and efficient operation of these Puerto Rico facilities," Amgen's
annual report said.
Amgen declined to detail Puerto Rican operation profits. Foreign profits
before income taxes in 2006 were about $2.33 billion, more than half the total
pretax profits.
Marjorie Powell, senior assistant general counsel at the Pharmaceutical
Research and Manufacturers of America, says drug companies migrated to Puerto
Rico because of tax incentives and remain because of a work force trained to
comply with complex regulatory standards.
Powell would not specifically address statehood, but said executives do not
decide to close or move plants "on a single factor. Companies don't move
production facilities very quickly or easily," she said.
The island's tax breaks aren't limited to profits. Horacio Aldrete, a
director at Standard & Poor's rating agency, said statehood could eliminate
Puerto Rico's rare "triple tax-exempt" status. Puerto Rican bond income is
exempt from federal, state and local taxes.
On the political front, Puerto Ricans have voted against statehood in three
nonbinding referendums over the past 40 years. In 1998, when the last vote was
held, more than 46 percent of voters favored statehood, while more than 50
percent opted for none of the choices, effectively maintaining the status quo.
On monthly trips to Washington, McClintock lobbies for legislatively
creating a two-step process toward statehood. Rep. Jose Serrano, D-N.Y., and
more than 90 co-sponsors including Democrat House Majority Leader Steny Hoyer of
Maryland and Republican Whip Roy Blunt of Missouri, endorse such a bill.
Residents would first choose between changing or remaining a commonwealth. If
change was approved, a separate vote would offer a choice between statehood and
independence.
"Lobbyists, financed by the (political) party in power, as well as
entrenched business interests that historically have tried to avoid the payment
of federal taxes, have always prevented the enactment of federal legislation to
authorize" that approach, McClintock wrote in a March 12 e-mail to the
Associated Press.
Gov. Anibal Acevedo Vila supports a different proposal asking Puerto Ricans
chosen for a constitutional convention to define the three options, present them
to Congress and then vote. That bill's sponsor, Rep. Nydia Velazquez, D-N.Y.,
earlier this month asked her colleagues to co-sponsor her bill and more than 20
agreed.
The White House says Puerto Ricans should decide, although statehood
advocates argue that if approval occurred before President Bush's second term
ends, it could add to his legacy.
At this week's hearing and a second one scheduled for April 25 by the House
Subcommittee on Insular Affairs, Melendez says new statehood proposals won't
affect corporate America's aim to keep things as they are.
"Financial incentives for the core investors, the people moving the economy,
it's not clear why they would want a move to the left or right," he says.

[ariane] 13/3/2007 10:27

Ranbaxy, Cipla bid 6 bln usd for Merck KGaA's generic ops, Dr Reddy's drops out


- Indian generic drug companies Ranbaxy Laboratories and Cipla said at a
press conference that they have presented their offer for Merck KGaA's generic
drug operations, and the offer is valued at 6 bln usd.
Competitor Dr Reddy's said it has withdrawn from the bidding process,
judging the price too high.
The announcement confirms reports by daily publication Mint and The Economic
Times, which reported the offer last night.

[e-mail]
afp/jfr/jsa

[ariane] 08/3/2007 07:20

Ranbaxy Laboratories Merck KGaA expects to see 5 bln eur gain from sale of its generics ops - report


FRANKFURT (AFX) - Merck KGaA chief financial officer Michael Becker expects
the sale of the company's generics operations to realise 5 bln eur, Financial
Times Deutschland reported citing a source.
Potential buyers are to submit non-binding offers to Merck by Monday, the
newspaper said citing other sources close to the transaction.
It added that Israel's Teva, US-based Mylan, Iceland's Actavis and India's
Ranbaxy are expected to bid.
Among financial investors Bain and Apax are seen making a joint offer as
well as KKR and Warburg Pincus, the report said.
Merck and all other parties concerned declined to comment, according to the
report.

[e-mail]
jcs/jfr

[waldron] 05/3/2007 07:31

Actelion Says Tracleer Drug Helps With Inoperable Lung Disease

By Joseph Heaven

March 5 (Bloomberg) -- Actelion Ltd.'s best-selling lung medicine Tracleer helps patients who suffer from an inoperable form of pulmonary arterial hypertension, the Swiss drugmaker said, citing a new study.

The patients studied were less breathless during exercise, the Allschwil, Switzerland-based company said in an e-mailed statement today. The study included 157 people in 13 countries.

Tracleer, which generates almost all of Actelion's revenue, is approved to treat a severe form of pulmonary arterial hypertension, a chronic disease in which the blood pressure is too high in the arteries between the heart and lungs. Actelion is seeking permission to sell it for other forms of the lung ailment to bolster revenue and fight competition.

The company last year agreed to buy U.S. rival CoTherix Inc. for $420 million to add a new lung medicine alongside Tracleer.

To contact the reporter on this story: Joseph Heaven in Zurich [e-mail]

Last Updated: March 5, 2007 01:29 EST