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[ariane] 09/10/2009 05:33

PRESS RELEASE: Dose-Finding Phase IIb Study Started In Patients With Multiple Sclerosis - Actelion/Roche S1P1 Alliance Achieves (Actelion Ltd)





Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
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ALLSCHWIL, SWITZERLAND - 09 October 2009 - Actelion Ltd (SIX: ATLN)
announced today that the selective S1P1 receptor agonist ACT-128800/
RG3477 has achieved an important clinical milestone. Actelion's
first-in-class selective S1P1 (Sphingosine-1-phosphate) receptor
agonist has entered into a Phase IIb dose-finding study in patients
suffering from multiple sclerosis. This triggers a milestone payment
by Roche to Actelion of USD 20 million.

Guy Braunstein, M.D., Ph.D. and Head of Clinical Development at
Actelion, commented: "Together with our partner Roche, we are
committed to the rapid development of our selective S1P1 receptor
agonist for patients suffering from autoimmune disorders. With the
start of this dose-finding study in patients with multiple sclerosis,
we have made an important step forward."

About the Actelion / Roche alliance
Actelion and Roche entered into an exclusive worldwide collaboration
in July 2006 to jointly develop and commercialize Actelion's
selective S1P1 receptor agonist, an immunomodulator with the
potential for once-a-day oral dosing. The two companies plan to
jointly develop and commercialize this novel compound for multiple
autoimmune disorders. For the current selective S1P1 receptor
agonist, Actelion will fully fund all development activities up to
the end of Phase II for the first two indications. All subsequent
development and commercialization costs will be shared equally
between Roche and Actelion. Both companies will co-promote any
product resulting from this collaboration and will equally share
profit.

This S1P1 collaboration covers both the current selective S1P1
receptor agonist in clinical development, as well as any other
selective S1P1 receptor agonists resulting from Actelion's research
efforts in the field. Actelion received an upfront payment of USD 75
million in July 2006. In the case of future development and approval
milestones being achieved, Actelion will be eligible to receive
further payments of up to USD 535 million for the first compound for
all targeted indications. Further development and approval milestone
payments are due for additional compounds. Roche will pay Actelion
undisclosed royalties on all product sales.

Selective S1P1 receptor agonists
Sphingosine-1-phosphate (S1P) is a phospholipid released by
platelets, mast cells and other cells. It is currently established
[1,2] that S1P stimulates at least five different G-protein coupled
receptors (GPCRs): S1P1,2,3,4, and 5. Activation of these GPCRs
mediates a complex variety of biological responses, such as
lymphocyte migration, endothelial cell proliferation, blood vessel
constriction and heart rate modulation.

Actelion's efforts in the field of selective S1P1 receptor agonists
started in 1999 by focusing on GPCRs found on the endothelium, the
inner lining of blood vessels. The result of these research efforts
is Actelion's orally active selective S1P1 receptor agonist.


###

Notes to the editor

About autoimmune disorders
Autoimmune disorders are diseases caused by the body producing an
immune response against its own tissues. The cause of autoimmune
disorders is unknown. Some of the most common types of autoimmune
disorders include psoriasis, rheumatoid arthritis, multiple
sclerosis, inflammatory bowel disease and rejection of transplanted
organs. These disorders affect millions of people worldwide.

About multiple sclerosis
Multiple sclerosis (MS) is an inflammatory autoimmune disorder of the
central nervous system (CNS) and is the most common cause of
progressive neurological disability in young adults [3,4]. This
chronic demyelinating disease is characterized by heterogeneous
clinical expression, an unpredictable course and a variable
prognosis. MS results from a cascade of events involving an
activation of the immune system, acute focal inflammatory
demyelination, and axonal loss with limited remyelination,
culminating in chronic multifocal sclerotic plaques in brain and
spinal cord. The large variety of symptoms and signs of MS result
from axonal demyelination which leads to the slowing or blockade of
axonal conduction at diverse affected sites of the brain and spinal
cord. Repeated episodes of disease activity may lead to progressive
loss of neurological function.

The incidence of MS is about 7 cases per 100,000 persons per year and
although the etiology of MS is still unknown, the prevalence rate
varies between races and geographical latitudes, ranging from 50-120
per 100,000 [3]. It is widely accepted that it is an immune-mediated,
demyelinating disease precipitated by unknown environmental factors
in genetically susceptible people.

References
1. Huwiler A, Pfeilschifter J. Biochem Pharmacol. 2008 May
15;75(10):1893-900. Review.
2. Rivera J, Proia RL, Olivera A.Nat Rev Immunol. 2008
Oct;8(10):753-63. Review.
3. Compston A, Coles A. Multiple sclerosis. Lancet
2002;359:1221-31.
4. Compston A, Coles A. Multiple sclerosis. Lancet
2008;372:1502-18.

Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer®, an orally available dual endothelin receptor antagonist,
has been approved as a therapy for pulmonary arterial hypertension.
Actelion markets Tracleer® through its own subsidiaries in key
markets worldwide, including the United States (based in South San
Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in
innovative science related to the endothelium - the single layer of
cells separating every blood vessel from the blood stream. Actelion's
over 2000 employees focus on the discovery, development and marketing
of innovative drugs for significant unmet medical needs. Actelion
shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN).


For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
[phone]
[phone]




=-- End of Message ---

Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil
Switzerland

WKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP,
SMIM, SPI, SPIEX;
Listed: Main Market in SIX Swiss Exchange;



Copyright © Hugin AS 2009. All rights reserved

[waldron] 28/9/2009 13:09

Merck To Sell CSL's Flu Vaccine In US Starting Next Year





DOW JONES NEWSWIRES

Merck & Co. (MRK) has agreed to sell CSL Ltd.'s (CSL.AU) seasonal flu vaccine in the U.S. for a six-year period starting next fall, getting the drug giant into that sector.

Terms weren't disclosed for the deal between the companies, who have been vaccine-development partners since 1980.

Afluria was approved by the U.S. Food and Drug Administration two years ago. Merck said with selling the Australian company's vaccine, it will give Merck eight of the 10 vaccines on the recommended list for U.S. adults.

Vaccines have long been one of Merck's primary businesses, which showed strong growth in 2006 and 2007 but has had problems of late amid supply constraints and seen weakened demand. The unit's head will be leaving Nov. 1 ahead of the company's acquisition of Schering-Plough Corp. (SGP).

-By Kevin Kingsbury, Dow Jones Newswires; 212-416-2354; [e-mail]

[waldron] 18/9/2009 06:50

Sanofi-Aventis Completes Acquisition Of Merck Stake In Merial





PARIS -(Dow Jones)- French drug company Sanofi-Aventis SA (SNY) said Friday that it has completed the acquisition of Merck & Co Inc's (MRK) 50% interest in Merial Limited.

MAIN FACTS:

-Sanofi-Aventis acquired Merck's interest in Merial for a cash consideration of $4 billion.

-Formed in 1997, Merial is a leading animal health company that was a 50/50 joint venture between Merck and Sanofi-Aventis and is now a wholly-owned subsidiary of Sanofi-Aventis.

-The acquisition of Merial is expected to be accretive to Sanofi-Aventis' adjusted net income from the first year.

-As per the terms of the agreement signed on July 29, Sanofi-Aventis also has an option, following the closing of the Merck/Schering-Plough merger, to combine the Intervet/Schering-Plough Animal Health business with Merial to form an animal health joint venture that would be equally owned by the new Merck and Sanofi-Aventis. If the option is exercised by Sanofi-Aventis, the formation of the new animal health joint venture would be subject to approval by the relevant competition authorities.

Company Web site: www.sanofi-aventis.com

-By Paris Bureau, Dow Jones Newswires; [phone]; [e-mail]

[waldron] 16/9/2009 10:12

EU Clears Sanofi-Aventis To Buy Merck's Stake In Merial JV





BRUSSELS -(Dow Jones)- The European Commission Wednesday approved French pharmaceuticals firm Sanofi-Aventis SA (SNY) to buy the remaining 50% of its animal health joint venture Merial.

Merial was formed as a 50-50 joint venture with U.S. peer Merck & Co. Inc. (MRK).

-By Carolyn Henson, Dow Jones Newswires; [phone]; [e-mail]

[grupo guitarlumber] 24/7/2009 18:28

UPDATE: Argentina, Brazil Question Swine Flu Vaccine Patents (Merck)





(Updates to include comments and background on Brazil.)

BUENOS AIRES -(Dow Jones)- The presidents of Argentina and Brazil Friday suggested that developing countries be allowed to lift patent rights so they can produce more vaccines to battle the A/H1N1 swine flu epidemic.

In a speech at a regional Mercosur leaders summit in Paraguay, Argentine Cristina Fernandez said changing the status quo "does not mean disavowing the patents law," according to a report by the state news agency Telam.

Brazilian President Luiz Inacio Lula da Silva proposed that leaders discuss breaking the patents law to help contain the epidemic, according to a report by Brazil's state news agency Agencia Brasil.

The news agency also said Brazilian Health Minister Jose Gomes Temporao is negotiating with all vaccine producers to boost the vaccine's availability.

"Brazil is willing to defend the health security of its population," the minister was quoted as saying.

Brazil has been adept in recent years at getting pharmaceutical companies to offer discounts on HIV medication. In 2007 the government issued a compulsory license to break the patent on an anti-retroviral AIDS drug made by U.S. pharmaceutical giant Merck & Co. (MRK).

Argentina's Fernandez, meanwhile, said leaders to work "to lift patent rights and that way allow a vaccine to offer solutions for millions of people."

Fernandez said Argentina and Brazil both have highly developed pharmaceutical industries and should be able to produce vaccine "that wouldn't be free."

"But," Fernandez added, "it's beyond question that we're confronting a situation in which the needs of millions of people cannot be subordinated to economic interests."

Mercosur is a regional customs union founded by Argentina, Brazil, Paraguay and Uruguay.

- By Taos Turner, Dow Jones Newswires; 5411-4103-6728; [e-mail]

[grupo guitarlumber] 23/7/2009 07:17

Merck KGaA Files For Europe Approval For Cladribine





FRANKFURT -(Dow Jones)- Merck KGaA said Thursday it has submitted a marketing authorization application to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck's proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS).

MAIN FACTS:

-Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS.

-Merck will submit new drug applications for Cladribine tablets in several other countries, including the U.S. in the second quarter.


-Frankfurt Bureau, Dow Jones Newswires; 49-69-29725-500

[waldron] 21/4/2009 14:40

Actelion CFO: May End Up At High End Of 2009 Guidance (Actelion Ltd)





ZURICH -(Dow Jones)- Swiss biotech company Actelion Ltd. (ATLN.VX) may reach the high end of its 2009 earnings guidance range, Chief Financial Officer Andrew Oakley said Tuesday.

"We'll give an update of the guidance in July," Oakley said on a conference call detailing the company's stronger-than-expected first-quarter figures. Actelion reports half-year results July 21.

For 2009, Actelion expects 2009 sales to grow between 12% and 15% and cash earnings before interest and taxes to rise between 10% and 12%, both in local currencies.

Company Web site: www.actelion.com

-By Julia Mengewein, Dow Jones Newswires; [phone], [e-mail]

[waldron] 21/4/2009 07:01

Actelion Ends Phase I Blood Pressure Drug Development





ZURICH -(Dow Jones)- Swiss biotech company Actelion Ltd. (ATLN.VX) said Tuesday it has ended its early stage development of a renin inhibitor, which it develops with U.S.-based parter Merck & Co. Inc. (MRK).

"Based on the results of several clinical studies," the companies have decided to discontinue the clinical development of the renin inhibitor currently in phase one clinical trials.

The companies will continue to assess other renin inhibitors, which are used to treat hypertension, currently in the drug discovery phase, Actelion said.

Analysts view this step as minor, as early-stage programs are usually not incorporated into their estimates.

Company Web Site: www.actelion.com

www.merck.com

-By Julia Mengewein, Dow Jones Newswires; [phone]; [e-mail]

[waldron] 23/2/2009 18:26

Merck Tells Of 'Tortured Path' Toward Making Asthma Drug





By Peter Loftus and Thomas Gryta
Of DOW JONES NEWSWIRES

TRENTON, N.J. -(Dow Jones)- Merck & Co. (MRK) took a "tortured path" in developing its blockbuster asthma and allergy drug Singulair, a lawyer for the company told a judge Monday in an effort to ward off early generic competition.

In opening statements of a federal trial, Merck's outside attorney, Matthew Powers, said the U.S. patent for Singulair was valid and enforceable, and that Teva Pharmaceutical Industries Ltd.'s (TEVA) attempt to sell a generic version of the drug before the patent's 2012 expiration should be blocked. Teva argues the patent is invalid and unenforceable.

"Singulair was a revolutionary advance in the treatment of asthma," Powers told U.S. Judge Garrett Brown. "It should be respected. It should not be copied."

Singulair, which was introduced in 1998, generated $4.3 billion in worldwide sales last year, or 18% of total Merck sales. Merck, Whitehouse Station, N.J., is counting on preserving its monopoly on Singulair until the patent expires in 2012, particularly as the company deals with various other problems.

Israel-based Teva has applied for U.S. Food and Drug Administration approval of a generic version of Singulair, and Merck filed suit in 2007 to block such a launch. Both companies are hoping for a ruling by late summer, when a mandatory stay on Teva's generic Singulair launch is due to expire.

Powers said the validity of Merck's patent for Singulair was bolstered by the fact that its competitors tried and failed to find a drug similar to Singulair that would treat asthma, including Eli Lilly & Co. (LLY) and Wyeth (WYE). He noted Merck itself tested several hundred compounds against asthma before arriving at Singulair.

Also, Singulair's mechanism - blocking substances in the lungs known as leukotrienes - represented a new line of attack on asthma versus older treatments such as inhaled medications. Powers also pointed to Singulair's commercial success as evidence of its novelty.

A former Merck chemist, Robert Young, took the witness stand to begin detailing the long path of Singulair's development after he joined Merck in the 1970s and began working on asthma research. He cited several examples of Merck experimental compounds that held early promise but which failed in animal or human studies due to problems with safety or effectiveness, setbacks he called "very disappointing." Young left Merck in 2006 after a nearly 30-year career there.

Teva's lawyer, Ralph Gabric, told a different story about Singulair in his opening statement. He said Monday the success of the heavily advertised Singulair has more to do with Merck's marketing muscle and less to do with the innovation behind the drug.

"Singulair sells like a blockbuster drug, but performs like a middle-of-the-road drug" in real-world use, Gabric said in his opening statement.

Gabric argued the Singulair patent is invalid because prior research - including a paper published by Merck's Young in 1989 - would have taught anyone skilled in the art of drug development how to invent Singulair. The paper contained a model of a so-called leukotriene receptor. Under patent law, a patent can be declared invalid if so-called "prior art" rendered the claimed invention obvious.

Merck attorney Powers disputed Teva's claim in his opening statement, saying much more work than Young's paper was required to arrive at Singulair, and it wasn't obvious.

Also, Gabric said the Singulair patent shouldn't be enforced because Merck obtained it "under false pretenses." He said that when Merck applied for the patent in the 1990s, the company didn't submit Young's 1989 paper to the patent-office reviewer. Powers said the paper wasn't material to the application, and that Merck wasn't trying to deceive the patent office by not submitting it.

The trial is expected to last about a week and will include testimony from both Merck and Teva employees, and outside experts.

- Peter Loftus; Dow Jones Newswires; 215-656-8289; [e-mail]

[grupo guitarlumber] 13/2/2009 07:10

MS Drug Prize of $1.3 Billion Spurs Merck KGaA, Novartis Race
Email | Print | A A A

By Naomi Kresge

Feb. 13 (Bloomberg) -- Merck KGaA and Novartis AG are racing to market the first multiple sclerosis pill, a prize that may generate $1.3 billion a year in sales as patients switch from injectable drugs.

Merck and Novartis plan to ask regulators this year to approve tablets to fight the incurable illness. Initial test data showed that patients who took the drugs had fewer disease flare- ups than those who received placebo or existing treatments.

A pill may mean an end to painful injections or infusions that can cost $28,000 a year to control multiple sclerosis, which can rob people of their mobility and leave them with chronic aches and depression. Merck, of Darmstadt, Germany, and Novartis, of Basel, Switzerland, are running ahead of Teva Pharmaceutical Industries Ltd., Biogen Idec Inc. and Sanofi-Aventis SA in the chase for an oral treatment. The results may shake up the $6 billion multiple sclerosis market.

"It's going to be a neck-and-neck race between Merck and Novartis," said Markus Mayer, a Munich-based analyst for UniCredit SpA, after Merck released initial data last month.

The Teva, Biogen and Sanofi pills may not reach patients before 2012, according to Jack Scannell, an analyst for Sanford C. Bernstein Ltd. in London. Frost & Sullivan, a research company based in New York, predicts the market for drugs to treat early stages of multiple sclerosis may double by 2013.

Merck fell 73 cents, or 1.1 percent, to 67.37 euros in Frankfurt trading, while Novartis shares climbed 42 centimes, or 1 percent, to 42.51 francs in Zurich.

Cancer Cases

Merck said in January that four patients were diagnosed with cancer during the late-stage trial of its medicine, known as cladribine. An independent monitoring board didn't consider the cases a safety concern because there were too few to show a statistical significance, said Phyllis Carter, a Merck spokeswoman.

Conceived as both a leukemia and multiple sclerosis drug, cladribine was approved to treat the blood cancer more than 10 years ago and has been used by doctors in injected form to treat multiple sclerosis in so-called off-label use.

Novartis has also reported two fatal infections and seven successfully treated cases of skin cancer in patients who took its candidate, FTY720. Final test results later in the year will demonstrate how safe each of the medicines is.

If the tablets aren't linked to such side effects, either could "revolutionize treatment," Citigroup analyst Mark Dainty wrote in a note to clients in January. The products may generate a total $2.6 billion in revenue in four years' time, according to the analyst.

Vulnerable

Merck's existing drug Rebif, which is injected by the patient three times a week, had revenue of 1.22 billion euros ($1.57 billion) in 2007. Rebif loses patent protection in 2012, leaving the German drugmaker vulnerable to generic competition. Merck reports fourth-quarter results on Feb. 18.

Rebif vies with two other so-called beta interferons, Betaseron by Bayer AG and Biogen's Avonex, and with a fourth injected therapy, Copaxone from Sanofi and Teva. Interferons generally cut patients' rate of flare-ups by about 25 to 30 percent, Scannell of Bernstein said.

To take over the market, the oral medicines first need to overcome safety concerns.

"Concerns over cancer and opportunistic infection are the real barriers to what could be substantial first-line use in a multiple sclerosis market worth around $10 billion a year," Scannell said in a note to clients this week.

Infection Risk

Unlike interferons -- genetically produced versions of natural proteins that suppress the entire immune system -- cladribine and FTY720 affect only certain types of cells, said Doug Brown, research manager for the Multiple Sclerosis Society in London who doesn't have financial ties to either Merck or Novartis.

The pills work by lowering the amount of immune cells in the body, leaving patients susceptible to infections, Brown said. Long-term side effects from cladribine are unproven because leukemia patients took the drug on a shorter-term basis than multiple sclerosis sufferers would do, he said.

"We don't see anything in the study that could prevent the drug from being given to patients," said Bruno Musch, head of global clinical development unit for neurodegenerative diseases for Merck, in an interview before the preliminary results were released last month.

Emma Delahay, 30, a multiple sclerosis patient from Canterbury, England, who started taking injected Rebif about two and a half years ago and has since switched to Copaxone, said she suffered side effects, including skin rashes, while she was adjusting to the shots.

Disruptive

A pill would end the disruptive after-dinner routine of organizing syringes, preparing her shots and choosing a new place to inject herself every day, she said.

"Even though I can inject as part of my daily routine now, it's still having to prepare myself," she said. "With taking an oral therapy, it would be a second. With my injection, even though it's not that long, it's five or 10 minutes. It's the preparation time, making sure my injections get stored properly."

Merck's study results suggest cladribine and FTY720 could be as effective as Tysabri, the newest injected multiple sclerosis drug from Irish drugmaker Elan Corp. and Cambridge, Massachusetts-based Biogen Idec Inc., according to Scannell.

Tysabri has been plagued by safety concerns, with Biogen and Elan pulling the drug temporarily from the market in February 2005 after two patients died of a rare brain infection, progressive multifocal leukoencephalopathy. Five patients taking Tysabri have been diagnosed with the infection since it was reintroduced to the U.S. in 2006. One patient died.

Risk-Benefit

For patients, "it will be a case of weighing up the risk- benefit," said Brown of the U.K. multiple sclerosis group. "Doctors and neurologists will be weighing it up as well."

In tests, cladribine reduced the relapse rate for the disease by more than half compared with patients given a dummy pill in a two-year study, Merck said last month.

The pills, like the injected therapies, work against so- called relapsing-remitting multiple sclerosis, the most common form among the estimated 2.5 million people with the disease, according to the U.S. National Multiple Sclerosis Society. Symptoms such as loss of vision and numbness flare up and then subside, and the likelihood of full recovery can sink with each attack. There is no treatment for rarer forms of the disease in which patients experience a steady decline.

$1 Billion a Year

Merck, which isn't affiliated with U.S. drugmaker Merck & Co., said last fall cladribine could be its next $1 billion-a- year seller.

In December, Novartis said patients who took its candidate, known generically as fingolimod, had 38 to 52 percent fewer attacks than those on Biogen's Avonex.

The Novartis pill may surpass $1 billion in annual sales, Chief Executive Officer Daniel Vasella said on a conference call with analysts on Jan. 28.

The Swiss company made its first foray into the multiple- sclerosis market this year with Extavia, an injectable interferon identical to Bayer's Betaseron. Extavia was introduced last month in Germany and Denmark. Extavia will be important for Novartis to gain a foothold in the multiple sclerosis market before it begins selling FTY720, Vasella said.

To contact the reporter on this story: Naomi Kresge in Zurich at [e-mail]

Last Updated: February 12, 2009 18:00 EST

[grupo] 23/11/2008 21:41

Merck, Glaxo Vaccines May Be Recommended by WHO for Global Use

By Jason Gale

Nov. 22 (Bloomberg) -- Vaccines against rotavirus, the main cause of severe diarrhea in preschoolers, may win recommendation for global use by the World Health Organization, potentially boosting sales for producers Merck & Co. and GlaxoSmithKline Plc.

Rotavirus infection caused 40 percent of hospitalizations for diarrheal illness in children younger than 5, Geneva-based WHO reported yesterday in the online Weekly Epidemiological Record. The result from a study in 35 countries compares with two earlier reviews showing the infection in fewer than 29 percent of infants hospitalized for diarrhea.

Rotateq, produced by Whitehouse Station, New Jersey-based Merck and Rotarix, sold by London-based Glaxo, had combined sales of $707 million last year. Results of trials gauging the efficacy of the vaccines in developing countries may be completed as early as next year, WHO said.

"If they demonstrate that the vaccine is efficacious, rotavirus vaccines might soon be recommended for global use by WHO," the United Nations agency said. "The large health burden of rotavirus infection underscores the need for targeted interventions, such as vaccines, to control this disease as part of a comprehensive approach to the prevention and control of diarrhea."

Projectile Vomiting

The virus spreads rapidly, most likely through person-to- person contact, airborne droplets or possibly contact with contaminated toys, according to WHO. Symptoms usually appear two to three days after infection, and include projectile vomiting and very watery diarrhea, often with fever and abdominal pain.

There is no specific drug treatment for rotavirus infection. Immunity after infection is incomplete, though repeat infections tend to be less severe than the original bout.

About 527,000 young children die from rotavirus-induced diarrhea annually, 85 percent of them in lower-income countries of Africa and Asia, WHO says. Fourteen of those nations are eligible for funding to buy vaccines through the GAVI Alliance, a group supporting childhood immunization in poor countries.

"If ongoing trials in Africa and Asia show good efficacy, it is anticipated that this support will be extended to the remaining 58 countries eligible for support," the WHO report said. "The availability and use of rotavirus vaccines globally should have a substantial impact on the hospitalizations and mortality associated with rotavirus diarrhea."

Higher detection rates of rotavirus reflected in worldwide, hospital-based surveillance may reflect changing disease patterns during the past three decades, the report said.

Surveillance data collected at a hospital in Dhaka, Bangladesh's capital, found the proportion of hospitalizations for childhood diarrhea caused by rotavirus infection increased to 42 percent in 2002-2004 from 22 percent in 1993-1995.

Rotateq, given in a three-shot series, was approved in the U.S. in 2006. Glaxo gained approval for its two-shot Rotarix vaccine earlier this year.

To contact the reporter on this story: Jason Gale in Singapore at [e-mail].

Last Updated: November 22, 2008 00:44 EST

[grupo guitarlumber] 31/3/2008 13:53

Merck says Phase III study shows taranabant led to 'significant' weight loss




BOSTON (Thomson Financial) - Merck & Co. Inc. Monday said a two-year Phase
III study of taranabant, an investigational cannabinoid-1 receptor blocker used
to treat obesity, showed patients experienced "statistically significant" weight
loss when taking the drug in combination with diet and exercise.
In the study, patients taking taranabant 2 mg experienced more than double
the amount of weight loss at 52 weeks compared to patients treated with placebo,
the Whitehouse Station, N.J.-based company said.
The company's shares were down $5.01, or 11.2%, at $39.50 in premarket
trading.

Casey Logan
cl/vj

[grupo guitarlumber] 03/3/2008 14:19

Merck: 44,000 of eligible 47,000 people have enrolled to resolve Vioxx suits




NEW YORK (Thomson Financial) - Merck & Co. Monday said more than 44,000 of
the 47,000 people who registered eligible injuries have submitted some or all of
the material for enrollment that could qualify them for an interim payment in
the program to resolve legal claims filed against the company related to the
now-defunct pain killer Vioxx.
The program, which was announced in November 2007, is meant to resolve the
majority of myocardial infarction and ischemic stroke claims filed against the
company. Claimants need to fulfill several requirements before they're
considered eligible, and 85% of the claimants need to enroll in the program
before it can take effect.
Any claimant who enrolls automatically give up their right to sue Merck.
The number of people currently enrolled represent more than 93% of
claimants, meeting the 85% threshold, and obligating the company to start
payment of the $4.85 billion it has agreed to pay into a fund to settle the
claims.
Merck shares closed at $44.30 Friday.
Christie Rizk
cr/vj

[waldron] 23/2/2008 08:20

Actelion "sell," target price raised
9:09a.m. - Canaccord Adams
NEW YORK, February 22 (newratings.com) - Analysts at Canaccord Adams maintain their "sell" rating on Actelion N (ATLN). The target price has been raised from CHF40.9 to CHF46.7.

In a research note published this morning, the analysts mention that the company has reported its FY07 results in-line with expectations. Going forward, Actelion's performance will be driven by the company's capability to secure a deal on almorexant, a sleep drug, the analysts say. The company's Tracleer drug is likely to face intensifying competition in 2008, Canaccord Adams adds.

[waldron] 19/1/2008 10:09

Actelion upgraded to "outperform"

Friday, January 18, 2008 12:11:40 PM ET
Credit Suisse

LONDON, January 18 (newratings.com) - Analysts at Credit Suisse upgrade Actelion Ltd (ACT.ETR) from "neutral" to "outperform." The target price has been raised from CHF60 to CHF63.

In a research note published this morning, the analysts mention that despite competition from Letairis, the company's Tracleer drug is likely to post double-digit growth in the forthcoming two-to-three years. Actelion is expected to be able to achieve the top-line growth expectations for FY08, the analysts say. Actelion's FY07 results, scheduled to release on February 21, are likely to act as a catalyst for the company's share price, Credit Suisse adds.

[waldron] 19/1/2008 10:02

Merck & CO FDA weighs over-counter cholesterol drug




WASHINGTON (AP) - The government is questioning if too many of the wrong
people will take cholesterol-lowering Mevacor if it's sold without a
prescription, days before Merck & Co. makes its third try to move the drug over
the counter.
Merck says selling a low dose of this long-used medication on drugstore
shelves, next to the aspirin, could get millions of people at moderate risk of
heart disease important treatment that they otherwise may miss.
A preliminary Food and Drug Administration review released Tuesday agreed
that nonprescription Mevacor would be "a reasonably safe and effective" option
-- if consumers used it as directed.
But when Merck tested if consumers could judge who was a proper Mevacor
candidate, only 20 percent answered all the questions completely correctly -- 50
percent if researchers counted people who said they'd check some things with
their doctor before purchasing, concluded FDA's lead medical reviewer.
Moreover, about 30 percent of people who already were diagnosed with heart
disease, diabetes or had had a stroke wanted to purchase over-the-counter
Mevacor, people who need a doctor's care, the FDA documents say.
The studies "have not convinced this reviewer that there is adequate
consumer comprehension of the proposed product label to ensure safe and
effective use of this product," the preliminary assessment concluded.
Merck argues that most people made the right decision on whether they should
buy OTC Mevacor even if they missed some answers.
On Thursday, Merck will present its case to the FDA's independent scientific
advisers, hoping they will recommend that Mevacor become the first in the family
of cholesterol-lowering "statin" drugs to be sold in this country without a
prescription. Twice before, FDA has said no.

[waldron] 24/11/2007 14:26

From The TimesNovember 24, 2007

Pharmaceuticals soon fit to become part of the cureNick Hasell: Tempus
If there is one thought that might comfort a despondent holder of banking stocks, it is this. It could have been worse – you might have invested in healthcare.

Hard as it may be to credit, it is not lenders and deposit-takers whose shares have done the most to dent stock market returns over the past two years, but drug makers.

Research by Citigroup finds that healthcare is the only European sector to have delivered negative absolute total returns – share price appreciation plus dividend income - since the end of 2005. On that measure, banks have actually risen by 3 per cent, whereas healthcare has fallen 8 per cent. Neither is that underperformance readily explained by the stock market's preference for growth stocks over their defensive peers.

Healthcare has suffered not only against the wider market but also against those safe-but-dull sectors whose fortunes it traditionally tracks. For the first time, drug makers now trade at a forward earnings discount to food and drink producers, makers of personal and household goods, and utilities.

In share-price performance terms, the past two years have been as bad for drugs stocks as the sell-off that accompanied the dot-com boom, when all but technology, media and telecom stocks were out of favour, and worse than the dip triggered by Hillary Clinton's proposed reforms of the US Medicare system in the 1990s.

So why has "big pharma" been so comprehensively shunned? The biggest factor remains the toxic combination of declining research and development productivity, near-term patent expiries on blockbuster drugs and competition from generic drug makers. It is that threat that has sent the sector's heavyweights on sustained merger and acquisition sprees, buying in portfolios of promising experimental medicines in the hope that some will turn out to be bestsellers. In this way, AstraZeneca (AZ), some of whose biggest hopes, such as Exanta, a blood thinner, have failed in late-stage trials, has spent the past few years mopping up smaller rivals, from Cambridge Antibody Technology to MedImmune, of America.

Then there is the risk that, even once on pharmacy shelves, well-established medicines can face withdrawal or declining sales in the face of regulatory intervention or adverse scientific findings. Merck, whose Vioxx painkiller was pulled from sale in 2003, has been the most conspicuous casualty, but GlaxoSmithKline (GSK) has also suffered. Sales of Avandia, its second-biggest drug, tumbled after a study in the New England Journal of Medicine claimed that the diabetes treatment increased the risk of heart disease.

Aside from such operational difficulties, healthcare stocks have been hampered by three traits that have reduced their appeal to institutional investors: a high proportion of sales in US dollars, a lack of exposure to fast-growing emerging markets, such as India and China, and large market capitalisations, which has made them less susceptible to both takeover and activist investors pressing for change.

But has the relentless derating of drugs stocks now run its course? Citigroup thinks so and this week took the sector off its least-favoured list for the first time in four years. The investment bank believes that the traditional defensive characteristics of healthcare stocks should steadily return to the fore as the market continues to price in an American economic slowdown.

The nondiscretionary nature of spending on pharmaceuticals means that forecasts of annual revenue growth of between 4 and 5 per cent over the next three to four years are likely to remain steady. Similarly, while patent expiries and new drug failures remain a concern, the sector's rate of earnings growth should become more attractive as industries exposed to weaker consumer spending and reduced access to capital find it harder to increase profitability.

Nor should their dividends be overlooked. Yields on drug stocks are 20 per cent higher than the rest of the stock market, their best level since the early 1990s. The sector's average dividend cover, of twice earnings, is strong, as are its constituent's balance sheets, meaning that drug makers are far less likely to cut their payouts than other income plays, such as banks. The recent widening of the gap between healthcare dividend yields and US bond yields – now less than 4 per cent – enhances that allure.

Finally, there is the prospect that the pressures faced by the sector could trigger a further wave of large-cap consolidation driven by cost savings. Either that, or recent boardroom changes, may presage shake-ups from within. All of which suggests that drug stocks may start to aid stock markets in 2008 rather than being part of their ills.

[waldron] 13/11/2007 08:57

Acambis agrees 80 mln usd vaccine collaboration with Sanofi Pasteur UPDATE




(adds context, analyst comment)
LONDON (Thomson Financial) - Acambis PLC, the specialist vaccines
manufacturer, has agreed a collaboration deal worth up to 80 mln usd with Sanofi
Pasteur to jointly develop Acambis's ChimeriVax West Nile virus vaccine.
Acambis will receive an upfront payment of 10 mln usd this year and
milestone payments linked to product approval and US sales will be worth up to
70 mln.
The ChimeriVax vaccine is currently in Phase II trials. Sanofi Pasteur is
the vaccines joint venture between Sanofi-Aventis and Merck & Co.
Acambis CEO Ian Garland said: "This contract is an important step in
executing on our financing strategy for the company".
So far this year, 3,265 US patients have been diagnosed with West Nile
virus, Acambis said.
Ibraheem Mahmood at Investec said that the deal was important but that it
looked relatively small.
There seemed to be small numbers of West Nile virus patients in the US, he
said, although there may be scope for a price premium.

[e-mail]
jh1/ejp/jh1/ejb

[waldron] 12/11/2007 06:42

Actelion to launch phase III study on vasospasm treatment Pivlaz




ZURICH (Thomson Financial) - Actelion said it will launch a phase III
program for the endothelin receptor antagonist Pivlaz also known as Clazosentan.
The study is designed to evaluate the safety and efficacy of Pivlaz in
reducing vasospasm-related morbidity and all-cause mortality following
aneurysmal subarachnoid hemorrhage, the Swiss pharma group said.
In earlier studies, the use of Pivlaz was associated with up to 65 pct
reduction in vasospasm, a contraction of blood vessels in the brain.
The commencement of the phase III development of Pivlaz in this indication
triggers a milestone payment of 15 mln sfr to former Axovan shareholders, after
Actelion acquired Axovan in 2003.
Accordingly, the milestone payment to be payable in the fourth quarter of
this year and is booked through the balance sheet as goodwill.
[e-mail]
jmt/lam

[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.

[e-mail]
jlw/jlw