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Alt 18-10-2004, 12:08   #31
Tester32
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Merck & Co. (nyse: MRK - news - people ) CEO Raymond Gilmartin has been in the hot seat since Vioxx was pulled from the market two weeks ago for causing heart attacks and strokes. He's due to retire in 2006, but those two years won't be easy, even if he sticks them out. There may be some bright spots on the horizon over the next few weeks, though. A decision from the U.S. Food and Drug Administration on Arcoxia, a successor to Vioxx, is due by the end of the month. Many analysts think it's a goner, but the FDA could still approve it with a serious warning label. Data on Merck's next big hope, a vaccine for the human papilloma virus, could be ready at the beginning of next month at a medical meeting. That could also give Gilmartin a boost. But the lawyers are swirling around the Vioxx recall, and Merck's prospects will be difficult to judge without a sense of the company's legal liability.
--Matt Herper
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Alt 18-10-2004, 20:51   #32
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Branchen-Analyse
Bei Pharmawerten ist kein Ende der Talfahrt in Sicht


http://www.faz.net/aktuell/finanzen/...t-1195653.html
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Alt 19-10-2004, 14:27   #33
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U.S. Merck CEO still opposed to big mergers-paper

Tue Oct 19, 2004 04:46 AM ET

FRANKFURT, Oct 19 (Reuters) - U.S. drugmaker Merck & Co (MRK.N: Quote, Profile, Research) still sees no value in large mergers but will continue its strategy of drug alliances, its chief executive was quoted as saying in a German paper on Tuesday.
"We have always said that large mergers do nothing in terms of broadening research," Raymond Gilmartin told Die Welt in an interview.

"They also do nothing for our long-term growth. That is incidentally the prevailing view in the pharmaceutical industry," he said.

The company's stock has lost about a third of its value since last month's surprise withdrawal of arthritis drug Vioxx from the market, and analysts have said pressure could build for it to do a deal.

Earlier this month the Wall Street Journal reported that Merck had begun vetting executive search firms to screen external candidates to succeed Gilmartin, a move analysts said may pave the way for a merger.

An external hunt could lead to the faster-than-expected replacement of Gilmartin, who is required to retire at age 65 in March 2006.

Gilmartin told the paper Merck would continue its strategy of working with other companies.

"We will stick with our strategy even after the Vioxx recall and continue to extend our partnerships," he said. He said the number of Merck's alliances had risen to 47 last year from 10 in 1999, and was at 41 this year so far.

He said the Vioxx recall was unlikely to change much in the way Merck developed its drugs as it had always been extremely cautious, and he did not expect regulators to tighten specifications for drug approvals.
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Alt 19-10-2004, 15:10   #34
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Merck evaluating why Vioxx raises risk to heart

Mon Oct 18, 2004 10:10 PM ET

LOS ANGELES, Oct 18 (Reuters) - Merck & Co Inc. (MRK.N: Quote, Profile, Research) is evaluating why its withdrawn painkiller Vioxx raises the chance of heart attack and stroke, but it has not found a mechanism of action, a company official said on Monday.
"There is no clear correlation between high blood pressure and those who had cardiovascular events," said Alise Reicin, vice president of clinical research at Merck Research Laboratories. "The mechanism of action is unknown.... We are continuing to look."

Merck recalled its $2.5-billion-a-year Vioxx last month after twice as many patients taking it for at least 18 months suffered heart attacks and strokes during a 2,600-patient trial of the drug's ability to curb colon polyps.

During the three-year study, 45 patients on Vioxx suffered cardiovascular events, compared with 25 on placebo, Reicin said at a meeting of the American College of Rheumatology in San Antonio.

She said 37 percent of patients going into the trial were at high risk of heart problems -- meaning they had a history of problems or at least two risk factors for heart disease.

Reicin said Merck is still collecting data on the impact of Vioxx on the formation of colon polyps and expects to have those results by early next year.

Two other cancer-related studies of the drug -- one in men at risk of prostate cancer and another related to preventing colon cancer -- have also been halted.

Reicin said Merck expects to have follow-up data more than a year from now on how patients in the original colon polyp trial have fared after being taken off Vioxx.

Vioxx is part of a class of drugs that work by blocking the COX-2 enzyme that causes inflammation.
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Alt 19-10-2004, 15:35   #35
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News zu Arcoxia

Press Release Source: Merck & Co., Inc.

New Study Showed Investigational Medicine ARCOXIA Had Improved Gastrointestinal Tolerability Compared with Diclofenac Sodium

Tuesday October 19, 9:01 am ET

ARCOXIA and Diclofenac Had Similar Rates of Cardiovascular Thrombotic Events in One-Year Study with 7,000 Patients with Osteoarthritis


WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Oct. 19, 2004-- In a new clinical study being presented today at the annual meeting of the American College of Rheumatology in San Antonio, ARCOXIA(TM) (etoricoxib) demonstrated significantly fewer discontinuations due to gastrointestinal (GI) side effects compared to diclofenac sodium, a commonly prescribed non-steroidal anti-inflammatory drug (NSAID). In this one-year study, known as the EDGE (Etoricoxib Diclofenac Gastrointestinal Evaluation) study, the rates of confirmed thrombotic cardiovascular events were similar for ARCOXIA and diclofenac sodium.

ARCOXIA is Merck & Co., Inc.'s investigational COX-2 specific inhibitor for arthritis and pain currently under review by the U.S. Food and Drug Administration. The goal Prescription Drug User Fee Act date for the New Drug Application for ARCOXIA is Oct. 30.

"The gastrointestinal and cardiovascular safety results from the EDGE study are consistent with data from the ongoing clinical development program for ARCOXIA, and add to the data already available on the safety profile of ARCOXIA," said Sean Curtis, M.D., senior director, clinical research, Merck & Co., Inc.

Design of EDGE study

The EDGE study was a randomized, double-blind, multi-center clinical trial that included osteoarthritis patients who were assigned to either ARCOXIA 90 mg once daily (n=3,593) - 1.5 times the maximum recommended dose for osteoarthritis - or diclofenac sodium 50 mg three times daily (n=3,518) for one year. Patients were treated for up to 16.5 months (mean duration of nine months), and were evaluated at screening, baseline, and months 1, 4, 8 and 12.

The study included patients 50 years or older (mean age 64) with a clinical diagnosis of osteoarthritis (knee, hip, hand or spine) requiring chronic treatment. Patients were allowed to take gastroprotective agents (GPAs) and low-dose aspirin, per current clinical guidelines.(1) In the study for both treatment groups, about four percent of patients had a history of an upper GI event, 37 percent were considered high-risk for cardiovascular disease, 45 percent were currently diagnosed with hypertension and 28 percent were taking low-dose aspirin at baseline.

The primary endpoint of the study was GI tolerability, defined as the cumulative incidence of patients who discontinued from the study due to either a clinical or laboratory GI adverse experience.

Pre-specified endpoints of interest in the study included: overall safety and tolerability; discontinuations due to edema-related adverse events, hypertension-related adverse events, hepatic adverse events, and renal dysfunction; incidence of hepatic adverse events and congestive heart failure; and efficacy as determined by patient global assessment of disease. Thrombotic cardiovascular safety, an additional prespecified endpoint, was assessed by comparing the two treatment groups for all investigator-reported thrombotic cardiovascular events that were confirmed by an independent cardiovascular adjudication panel. Gastrointestinal perforations, ulcers and bleeding (PUB) events were evaluated as an exploratory endpoint, although it was expected that these results would be confounded by GPA and low-dose aspirin use.

ARCOXIA reduced risk of discontinuations due to GI side effects by 50 percent

In the EDGE study, ARCOXIA significantly reduced the rate of discontinuations due to GI adverse events (clinical and laboratory) compared to diclofenac. There were 9.4 events per 100 patients per year for patients taking ARCOXIA versus 19.2 events for patients taking diclofenac sodium, for a risk reduction of 50 percent (p less than 0.001). Differences in GI discontinuation rates between the treatment groups remained significant when clinical and laboratory GI adverse events were evaluated separately, and the risk reduction favoring ARCOXIA was maintained in all subgroups evaluated, including the GPA and low-dose aspirin subgroups.

ARCOXIA and diclofenac had similar rates of serious cardiovascular thrombotic events

The EDGE study showed that there was no discernible difference in the number of confirmed thrombotic cardiovascular events between ARCOXIA and diclofenac. The relative risk of ARCOXIA compared to diclofenac was 1.07 (0.65, 1.74) for events that occurred within 14 days of discontinuing study treatment and 1.02 (0.64, 1.62) for events that occurred within 28 days of discontinuing study treatment. A relative risk of 1.00 means that the rate of events in patients in one treatment group is the same as the rate observed in the other treatment group.

This finding from the EDGE study is consistent with observations in the pooled analysis of controlled clinical studies for ARCOXIA that compared ARCOXIA (combined doses 60 mg, 90 mg or 120 mg) versus either placebo or the NSAIDs diclofenac 50 mg three times a day and ibuprofen 800 mg three times a day. The clinical studies in this pooled analysis, which included 6,700 patients, ranged up to 12 weeks for the placebo-controlled studies and up to 190 weeks for the NSAID-controlled studies. In the analysis, the relative risk for confirmed serious cardiovascular thrombotic events when ARCOXIA was compared to placebo was 1.11 (0.32, 3.81) and when ARCOXIA was compared to diclofenac and ibuprofen combined was 0.83 (0.26, 2.64). When ARCOXIA was compared to naproxen in the pooled analysis, the relative risk was 1.70 (0.91, 3.18) favoring naproxen.

In the EDGE study, each individual cardiovascular event type included in the prespecified composite cardiovascular endpoint was analyzed, and there was no significant difference in rates between ARCOXIA and diclofenac. The rates (per 100 patient years) of myocardial infarction occurring within 14 days after study therapy was discontinued were 0.68 for ARCOXIA and 0.42 for diclofenac. The rates (per 100 patient years) of stroke occurring within 14 days after study therapy was discontinued were 0.15 for ARCOXIA and 0.23 for diclofenac.

"The EDGE study showed there were similar rates of thrombotic cardiovascular events between ARCOXIA and diclofenac in a patient population that appropriately represents the actual clinical setting," said Dr. Curtis. "This observation was made in a broad group of patients who had a number of different medical conditions, including pre-existing cardiovascular disease."

ARCOXIA was generally well tolerated

In the EDGE study, fewer patients discontinued for any adverse event with ARCOXIA compared to diclofenac. Hepatic adverse events and discontinuations due to hepatic adverse events were more common with diclofenac than ARCOXIA.

Also in the study, significantly fewer patients taking diclofenac (0.7 percent) discontinued the study due to hypertension-related adverse events compared to patients taking ARCOXIA 90 mg (2.3 percent) (p less than 0.001). In looking at the clinical development program for ARCOXIA, the rate of discontinuations due to hypertension adverse events for ARCOXIA 90 mg - at a dose 1.5 times the proposed maximum recommended osteoarthritis dose - was generally similar to rates observed with comparator NSAIDs (naproxen 1,000 mg and ibuprofen 2,400 mg).

Efficacy data for ARCOXIA also presented

Data from efficacy studies evaluating ARCOXIA versus naproxen in the treatment of ankylosing spondylitis and ARCOXIA versus indomethacin in the treatment of acute gouty arthritis also are being presented at the annual meeting of the American College of Rheumatology.

About ARCOXIA and Merck

The Food and Drug Administration currently is reviewing Merck's New Drug Application for ARCOXIA, which seeks indications for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis. ARCOXIA has been launched in 48 countries worldwide in Europe, Latin America and the Asia-Pacific region.

Merck & Co., Inc. is a global research-driven pharmaceutical products company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2003, and in its periodic reports on Form 10-Q and Form 8-K (if any) which the company incorporates by reference.

(1) ACR Subcommittee on OA Guidelines. Recommendations for the medical
management of OA of the hip and knee: 2000 update. Arthritis Rheum
2000; 43: 1905-15.
American Heart Association (AHA). Aspirin in Heart Attack and Stroke
Prevention: AHA Recommendation.
http://www.americanheart.org/present...entifier=4456, Accessed
August 16, 2004.

ARCOXIA(TM) is a trademark of Merck & Co., Inc.



--------------------------------------------------------------------------------
Contact:
Media Contacts:
Anita Larsen, 917-833-7761
OR
Tracy Ogden, 484-686-4837
OR
Investor Contact:
Michael Rabinowitz, 908-423-5185



--------------------------------------------------------------------------------
Source: Merck & Co., Inc.


Kommentar: So wie es aussieht, wird Arcoxia von der FDA zugelassen. Bisher hat die FDA wohl auch keine Einwände gegen Vioxx erhoben, der Rückruf war von Merck freiwillig.
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Alt 19-10-2004, 20:30   #36
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Merck durch Vioxx-Rückname nicht gefährdet


https://www.boerse-go.de/nachricht/m...7,a114360.html
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Alt 20-10-2004, 16:05   #37
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Merck & Co., Inc. Earnings Conference Call (Q3 2004)

Scheduled to start Thu, Oct 21, 2004, 9:00 am Eastern
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Alt 21-10-2004, 14:27   #38
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Merck - Gewinn u. Erlös geht zurück


https://www.boerse-go.de/nachricht/m...7,a114376.html
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Alt 22-10-2004, 21:34   #39
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Merck hebt Margen-Prognose an


https://www.boerse-go.de/nachricht/m...7,a114393.html
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Alt 27-10-2004, 19:51   #40
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FDA To Hold COX-2 Advisory Committee In Early 2005, Woodcock Says

FDA will hold an advisory committee in early 2005 to discuss the cardiovascular safety profile of COX-2 inhibitors, Acting Deputy Commissioner of Operations Janet Woodcock, MD, said.

“We plan a public advisory committee to discuss how to evaluate the cardiovascular safety issue sometime early next year,” Woodcock said at an American College of Rheumatology meeting Oct. 18 in San Antonio, Texas.

“Part of it will be what type of evaluation should be done pre-market and potentially post-market for these products,” she added.

Woodcock noted that the cardiovascular events occur so infrequently that even large scale trials (containing many thousands of patients) are not adequately powered to detect a significant difference between the two arms.

“The FDA is going to have to look at the size and safety database and the kind of safety database in the future for these agents,” Woodcock said. “However, we have trade-offs between getting products on the market and determining their adverse event profile” she said.

Der gesamte Artikel bei FDA

Meine Meinung: Mir kommt diese Einstellung von Merck
Zitat:
Merck believes that such trials cannot be conducted due to ethical concerns of giving patients placebo for their pain over a long-term period.
plausibel vor. Hoffen wir, daß die FDA keine Verlängerung der üblichen Testzycklen verlangen wird, denn dieses würde finanziell alle forschenden Pharma-Firmen langfristig belasten.
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Alt 29-10-2004, 14:17   #41
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Merck Receives 'Approvable' Letter from FDA on New Drug Application for ARCOXIA (MRK) 31.22: The FDA has informed Merck in the letter that before approval of the NDA can be issued, additional safety and efficacy data for ARCOXIA are required. "We continue to believe that ARCOXIA has the potential to become a valuable treatment option for many Americans with arthritis and pain... We plan to work with the FDA to address what steps need to be taken before the application may be approved."


MRK 8:11AM ET 32.00 +0.43 (+1.36%)
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Alt 29-10-2004, 16:59   #42
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das Ganze auf Deutsch

FDA: Mercks Vioxx-Nachfolger hat Chancen


https://www.boerse-go.de/nachricht/f...7,a114442.html
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Alt 30-10-2004, 11:22   #43
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EURO am Sonntag: Merck & Co. Finger weg

18.10.2004

hier klicken zur Chartansicht Die Experten der "EURO am Sonntag" empfehlen, die Finger von der Merck & Co.-Aktie (ISIN US5893311077/ WKN 851719) zu lassen.

Der zukünftige Wegfall des Präparates "Vioxx" dürfte den amerikanischen Pharmakonzern langfristig belasten. Auch die weitere Produkt-Pipeline sehe nicht überzeugend aus. Die ABN Amro sei der Ansicht, dass mit dem Titel von Merck & Co. in den kommenden Jahren kein Geld zu verdienen sei.

Vor dem Hintergrund der schlechten Perspektiven raten die Experten der "EURO am Sonntag" zum Verkauf der Merck & Co.-Aktie.
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Alt 30-10-2004, 11:24   #44
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Der Aktionär: erck & Co. Finger weg

14.10.2004 12:53:34 (DER AKTIONÄR)

Die Experten des Anlegermagazins "Der Aktionär" empfehlen bei der Merck-Aktie (ISIN US5893311077/ WKN 851719) die Finger weg zu lassen. Nachdem bekannt geworden sei dass Merck sein Medikament Vioxx mit sofortiger Wirkung vom Markt nehme, habe der Titel heftige Kursverluste hinnehmen müssen. Bei Langzeitstudien über Vioxx habe sich heraus gestellt, dass das Arthritis-Präparat das Risiko von Schlaganfällen und Herzerkrankungen bei Patienten erhöhe. Die Experten von "Der Aktionär" raten bei der Merck-Aktie die Finger weg zu lassen.

Quelle: AKTIENCHECK.DE
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Alt 30-10-2004, 11:34   #45
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UPDATE 2-FDA holds off approval of new Merck arthritis drug

Reuters, Fri Oct 29, 2004 11:06 AM ET
(Updates with analyst comment, share price)

NEW YORK, Oct 29 (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) on Friday said U.S. regulators won't approve its experimental arthritis drug Arcoxia until the company provides more data showing it is safe and effective.

Arcoxia is a successor to Merck's arthritis drug Vioxx, which the company withdrew from the market after it was shown to double the risk of heart attack and stroke in patients who had been taking it for at least 18 months.

Investors had not expected the U.S. Food and Drug Administration to immediately approve Arcoxia, which, like Vioxx, is in a class of drugs known as COX-2 inhibitors. The withdrawal of Vioxx, which generated some $2.5 billion in annual sales, has cast a cloud over the entire class, including Celebrex and Bextra, made by Pfizer Inc.

"Arcoxia will not see the light of day until at least 2007, if it gets to market," said Barbara Ryan, an analyst at Deutsche Bank. "Even then, its future annual sales will probably not exceed $200 million because the drug has a lot of properties similar to Vioxx."

Merck did not say exactly what new data the FDA has requested, or whether the company needs to begin entirely new trials. Raymond Gilmartin, the company's chief executive officer, said the company plans to work with the agency to "address what steps need to be taken before the application may be approved."

Arcoxia has been launched in 48 countries around the world, including Europe, Latin America and Asia. Merck said it will continue to work with regulatory agencies in those countries to determine whether changes need to be made to the drug's prescribing label.

Before the recall of Vioxx, analysts had expected Arcoxia to generate annual sales of about $1 billion by 2008. Merck was counting on Arcoxia to help fill the financial void caused by the disappearance of Vioxx, which accounted for more than 10 percent of Merck's revenue in 2003.

Arcoxia could have a long road ahead of it. The only trial in which the drug has been tested against placebo lasted 12 weeks, though a one-year study of osteoarthritis patients taking the drug showed they had no greater incidence of heart attacks than patients taking diclofenac, a standard treatment.

Merck's shares rose 23 cents, less than 1 percent, to $31.81 on the New York Stock Exchange.
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