SANOCHEMIA REMINYL ist zugelassen
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| Eröffnet am: | 01.03.01 02:33 | von: LiveInScience | Anzahl Beiträge: | 9 |
| Neuester Beitrag: | 01.03.01 13:53 | von: mischek@gm. | Leser gesamt: | 6.902 |
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New York (vwd) - Reminyl, ein Alzheimer-Medikament von Janssen Pharmaceutica Products, einer hunderprozentigen Tochter von Johnson & Johnson, New Brunswick, hat die Zulassung der US-amerikanischen Food and Drug Administration (FDA) erhalten. Dies teilte Janssen am Mittwoch mit. vwd/DJ/28.2.2001/mkr
J&J unit Janssen says Alzheimer's drug approved by FDA
WEDNESDAY, FEBRUARY 28, 2001 4:52 PM
- Reuters
NEW YORK, Feb 28 (Reuters) - A unit of diversified healthcare giant Jonhson & Johnson (NYSE:JNJ) said on Wednesday it has received U.S. regulatory approval for a new treatment for Alzheimer's disease called Reminyl.
Titusville, N.J.-based Janssen Pharmaceutical Products, a unit of J&J, said the U.S. Food and Drug Administration approved the drug based on data from tests of 2,650 patients. The drug was co-developed with Britain's Shire Pharmaceuticals Group Plc. (NYSE:SHP)
Janssen said about four million Americans have the disease, which causes loss of cognitive function, such as thinking, remembering and reasoning. The company said the new drug showed improved cognitive performance.
Side effects in clinical trials included nausea, vomiting, anorexia, diarrhea and weight loss. Janssen said the treatment is derived from the bulbs of daffodils.
Shares of J&J closed up $1.38 at $97.33 on Wednesday ahead of the news.
Rtr 16:52 02-28-01
STRONG BUY ist hier echt untertrieben!!!
entweder die sind alle besoffen oder die PR Madam bei Sanochemia (Hoch) ist abselut unfaehig.
Selbst J&J hat Reminyl Zulassung als Headline auf der HP!
WWW.JNJ.com
REMINYL®, New Treatment For Alzheimer’s Disease, Receives FDA Approval
REMINYL® Derived from the Daffodil
Titusville, NJ (February 28, 2001) -- REMINYL® (galantamine hydrobromide) -- a new treatment for mild to moderate Alzheimer’s disease derived from the bulbs of daffodils -- was approved today by the U.S. Food and Drug Administration (FDA).
Data from four placebo-controlled, double-blind clinical trials involving more than 2,650 patients show that REMINYL® can have a beneficial effect on patients’ daily function and ability to think. To be available by prescription in May, REMINYL® was developed by the Janssen Research Foundation under a co-development and licensing agreement with the UK-based Shire Pharmaceuticals Group plc.
An estimated four million Americans have Alzheimer’s disease -- a progressive loss of cognitive function (thinking, remembering and reasoning) so severe that it interferes with an individual’s ability to function. That number is expected to grow to 14 million by the middle of the next century. The disorder is the third-most-expensive illness in the United States, behind only heart disease and cancer.
“Alzheimer’s disease patients progressively deteriorate,” says Gary Small, MD, director of the Center on Aging and professor of psychiatry and biobehavioral sciences at the University of California in Los Angeles. “But the studies show that REMINYL® can benefit many individuals with the disease. In studies lasting up to six months, many patients’ symptoms initially improved or stabilized, and even when they begin to decline, they remained better than those who were treated with placebo.”
In studies ranging from 12 to 26 weeks, the effectiveness of REMINYL® was measured using two primary tools. Patients' abilities related to memory, orientation, reasoning and language were assessed using the cognitive portion of the Alzheimer’s Disease Assessment Scale (ADAS-cog). Across all studies, the results consistently demonstrated that more patients taking REMINYL® showed significant improvement in their cognitive performance than those receiving placebo (inactive medication).
The second primary measure of effectiveness was the Clinician’s Interview-Based Impression of Change plus Caregiver Information (CIBIC-plus), which provides an overall assessment of patient functioning -- including behavior, organized thinking and activities of daily living (such as dressing, eating and managing family finances). The CIBIC-plus results from all studies also showed that the overall scores for patients taking REMINYL® were statistically superior to placebo.
REMINYL® will be available in 4 mg, 8 mg or 12 mg tablets. It should be taken by patients twice a day, preferably with meals. The approved product labeling recommends that physicians start by prescribing 8 mg of REMINYL® per day (in two divided doses), then increase the dose to 16 mg after at least four weeks. Physicians have the flexibility to increase the daily dose to 24 mg after an additional four weeks.
With this recommended dosing regimen, the percentage of patients who dropped out of the clinical research due to side effects after taking REMINYL® (seven to 10 percent) was comparable to the discontinuation rate for individuals receiving placebo (seven percent). Overall, the most common side effects experienced by patients who followed the recommended schedule for REMINYL® were primarily gastrointestinal in nature. Side effects that occurred in five percent or greater of patients included nausea, vomiting, anorexia, diarrhea and weight loss.
“REMINYL® is a major addition to Janssen’s growing CNS (central nervous system) franchise. We are committed to improving the lives of both Alzheimer’s disease patients and their caregivers,” says Luc Truyen, MD, PhD, global medical leader for REMINYL® with the Janssen Research Foundation. “In fact, support for family caregivers will be an important element of the educational programs we will initiate in conjunction with the introduction of REMINYL®.”
REMINYL® also has been approved in 21 other countries to date, including most major European markets. REMINYL® will be marketed by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical in the United States, Janssen-Ortho in Canada (approval pending) and Janssen-Cilag elsewhere -- with the exception of the United Kingdom and Ireland, where it is registered and marketed by Shire under a co-promotion agreement with Janssen-Cilag.
Janssen Pharmaceutica Products, L.P., is a wholly owned subsidiary of Johnson & Johnson with a long track record in developing and marketing treatments for central nervous system disorders. Other specialty areas include pain management, treatment of fungal infections and therapy for gastrointestinal conditions. More information on the company can be found at www.us.janssen.com.
Shire Pharmaceuticals Group plc is an international specialty pharmaceutical company with a strategic focus on four therapeutic areas: central nervous system disorders, metabolic diseases, oncology and gastroenterology. The group has a sales-and- marketing infrastructure with a broad portfolio of products. On December 11, Shire entered into an agreement to merge with BioChem Pharma Inc. to form a leading global specialty pharmaceutical company. More information on the company can be found at www.shire.com.
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Meine Theorie: Sano-PR wartet auf ein NM-Reversal und sendet dann adhoc-Meldung um mit Schwung die 40€-Marke zu erobern...
wenn das so ist ist das Strafbar! Ich frag mal Anwaelte bei uns im Haus ob man dagegn klagen sollte! Nach boersengesetz dienen AdHocs nicht zur Kurspflege sondern zur Information von Kursrelevanten nachrichten. Und die Zulassung von Reminyl ist Kursrelevant!
Boersen Recht sollte auch bei Euch Oezis gelten!!!
Schau Dir lieber Deine super Ossi-Wessi-Firmen an, da hast du genug zu tun - ich sage nur: Metabox, LBC, Gigabell, EM-TV, Intershop usw...
Und noch was: Sanochemia wird schon ganz genau wissen, ob bzw. wann sie eine adhoc-Meldung schalten müssen, die werden nicht auf so einen Schlaumeier wie Dich warten...
Metabox, LBC, Gigabell, EM-TV, Intershop usw... diesen Dreck hab ich nie besessen!
Aber in Punkto Boersen-Erfahrung ist Sanochemia kein Top Unternehmen! Um die gesammte PR kuemmert sich lediglich eine Frau Hoch Und wenn Du mir mal ne private mail schickst zeig ich Dir mal meinen Schriftverkehr mit Frau Hoch (dann kriegste Angst und glaubst die braucht Reminyl)!
Ausserdem wollt ich Dich nicht persönlich beleidigen oder so! Es regt mich nut auf das wegen solcher langsamkeiten wahrscheinlich Ärger mit der Börsenaufsicht entsteht!
Ansonsten Denk ich Das wir im Sommer Kurse ueber 80 Euro sehn (schön wär es)!
Und dann haste Du auch wahrscheinlich soviel Kohle das Du mich besuchn und auf nen Veltliner oder sowas einladen kannst. Ich arbeite übrigens in Bosten
CU
Ich stelle mir die Frage, ob Sanochemia überhaupt verpflichtet ist in diesem Fall eine adhoc-Meldung zu schalten: was ist schon eine kursrelevante Nachricht? Das ist doch Definitionssache, kann auch für den Kurs relevant sein, wenn ich 5 Mitarbeiter entlasse, trotzdem wird keine Firma da eine adhoc-Meldung schalten...
Falls Sanochemia wirklich die 80€ sieht (werde auf jeden Fall keine Aktie unter 60€ herschenken), dann seh ich kein Problem mit dem Veltliner -> und ich nehme an, Du arbeitest in BOSTON (USA), oder?