ELAN ---50%---Heute
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Schmerzmittel, welches keine Gewöhnungserscheinungen blicken lässt. Hierzu eine
älterer Nachricht:
Elan erhält FDA-Zulassung für Prialt
Die Elan Corp. (Nachrichten) der größte irische Pharmakonzern, erhielt von der U.S. Food and Drug Administration die Marktzulassung für ihr Schmerzmittel Prialt.
Dieses Produkt basiert auf dem Gift einer Meeresschnecke und dient zur Behandlung von Patienten, die unter starken chronischen Schmerzen leiden, aber die Morphine in klassischen Arzneimitteln nicht vertragen. Prialt wird voraussichtlich ab Januar erhältlich sein und könnte Analystenschätzungen zufolge jährliche Peak Sales von bis zu 250 Mio. Dollar generieren.
Für die EU erwartet Elan die Zulassung des Medikaments im ersten Quartal 2005. Im November hatte sich das European Committee for Medicinal Products for Human Use positiv zu Prialt geäußert. Gestern gingen die Aktien mit 18,83 Euro aus dem Handel.
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Das fand ich unter Quarks.de:
Erstes Schmerzmittel auf dem Markt
§
§
Der Mechanismus des Schneckengiftes ist besonders interessant für die Entwicklung von Schmerzmitteln. Zunächst untersuchten Forscher die wirksamen Substanzen genau und bauten sie künstlich nach, um die Schnecken nicht auszurotten. Dann testeten sie die Gifte an Zellen, und tatsächlich fanden sie dabei einige sehr viel versprechende Stoffe. Im Dezember 2004 wurde in den USA das erste Medikament zugelassen, das auf einem Gift der Kegelschnecke basiert. "Prialt" blockiert die Kalziumkanäle an den Nervenzellen, Schmerzsignale werden nicht weitergeleitet. Das Mittel ist tausendmal wirksamer als Morphium und macht nicht süchtig. Probleme gibt es noch bei der Verabreichung des Medikaments, denn die Substanz muss als Flüssigkeit direkt ins Rückenmark gelangen. Daher bleibt das Medikament vorerst extremen Schmerzpatienten vorbehalten. Bislang gibt es "Prialt" nur in den USA.
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und das fand ich in der Stuttgarter Zeitung:
Von der Kegelschnecke zum Schmerzmittel
Medikament aus einer neuen Wirkstoffgruppe stammt aus dem Meer - "Blaue Biotechnologie" gilt als viel versprechend
Meereslebewesen könnten noch Schätze für die Medizin bergen. So ist aus dem Gift der Kegelschnecke ein neues Schmerzmittel entwickelt worden. Unter dem Schlagwort "Blaue Biotechnologie" arbeiten Forscher an weiteren Projekten.
Von Monika Rößiger
Ein kleiner Meeresbewohner ist die große Hoffnung für Schmerzpatienten, bei denen Morphine in klassischen Arzneimitteln versagen oder nicht vertragen werden. Auf dem Gift der Kegelschnecke (Conus magus) basiert ein neues Medikament, das Ende Dezember in den USA zugelassen wurde und nun auch in der EU auf den Markt kommt. Die nur fünf bis sieben Zentimeter messende Kegelschnecke überwältigt Fische, die schneller und größer sind als sie selbst. Zwar sind Schnecken nicht gerade als Raubtiere berüchtigt, aber diese schafft es, ihre Beute mit Hilfe einer Giftharpune zu erlegen, die das Opfer auf der Stelle lähmt. Da das offensichtlich ohne Schmerzempfinden geschieht, vermuteten Wissenschaftler bereits in den siebziger Jahren, die Schnecke könnte im Besitz eines hochwirksamen Neurotoxins sein, das möglicherweise in der Medizin einsetzbar wäre.
Bis zum fertigen Medikament war viel Forschungsarbeit nötig; herausgekommen ist das erste Präparat in einer neuen Gruppe von Schmerzmitteln, die nicht auf Opiaten basieren. Der Wirkstoff, ein synthetischer Nachbau eines Eiweißmoleküls aus dem Schneckengift, muss direkt in die Rückenmarksflüssigkeit gespritzt werden. Er blockiert die Kalziumkanäle der Nervenzellen und verhindert so die Weiterleitung der Schmerzsignale ans Gehirn. Das Medikament ist für Patienten mit schweren Schmerzen gedacht, die länger als sechs Monate andauern und verschiedenste Ursachen haben können. Dazu zählen Unfälle und Krankheiten wie Krebs oder Aids.
Klinische Studien mit mehr als 1000 Patienten zeigten, dass weder ein Gewöhnungseffekt noch Abhängigkeit oder Sucht einsetzen. Frei von Nebenwirkungen ist das "Schneckenmittel" aber nicht, der Hersteller warnt vor Schwindel, Übelkeit und Verwirrung.
Die Kegelschnecke ist nur ein Beispiel dafür, wie sich das Meer für die Entwicklung von Medikamenten nutzen lässt. In diesem Forschungsbereich, auch "blaue Biotechnologie" genannt, gibt es für die Forscher noch viel zu tun. "Zurzeit sind etwa 12 000 marine Substanzen bekannt, doch nur wenige sind genau erforscht", sagt Uwe Waller von der Arbeitsgruppe Marikultur im Leibniz-Institut für Meereswissenschaften in Kiel. "Da ist weiterhin sehr viel Grundlagenforschung notwendig." Gemeinsam mit seiner Kollegin Nicole Kube hat er eine Studie zu den Perspektiven der "blauen Biotechnologie" erarbeitet.
Die größte Schwierigkeit liegt darin, ausreichende Mengen einer wirksamen Meeressubstanz zu produzieren, um mit den klinischen Tests beginnen zu können. "Um beispielsweise ein Gramm Wirkstoff von einer Schwammart zu testen", erläutert Nicole Kube, "müsste man rund 1000 Tonnen dieses Schwamms aus dem Meer holen." Das wäre nicht nur unrentabel, sondern auch ökologisch unverantwortlich. Als Alternative bleibt nur, die Organismen in Aquakulturen zu vermehren - was nicht immer möglich ist - oder den Wirkstoff im Labor herzustellen. Und selbst dann dauert es im medizinischen Bereich noch Jahre, bis ein Produkt reif für eine kommerzielle Anwendung ist.
Immerhin in der vorklinischen Phase befindet sich eine Substanz für ein selektives Medikament gegen Blutkrebs. Der Wirkstoff, Sorbicillacton genannt, stammt aus Pilzen, die in Meeresschwämmen leben. Im Tierversuch hat sich gezeigt, dass er Tumorzellen zum Absterben bringt, aber gesunde Zellen nicht attackiert. Projektkoordinator Werner Müller vom Kompetenzzentrum Biotecmarin in Mainz hofft, dass die Ethikkommission nächstes Jahr grünes Licht für Tests am Menschen gibt. An Biotecmarin sind auch Forscher der Universität Stuttgart beteiligt. Vor drei Jahren hatten sie bei ihren Untersuchungen per Zufall in der Stuttgarter Wilhelma eine neue Schwammart entdeckt. Sie erhielt den Namen Tethya wilhelma.
Aktualisiert: 05.04.2005, 06:15 Uhr
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näheres unter: http://www.3sat.de/3sat.php?http://www.3sat.de/hitec/magazin/74633/
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Wiederholung der Sendung von heute ist am Freitag um 15.30
lesen konnte, sind die Todesfälle in Zusammenhang mit klinischen Phase III-Versuchen
aufgetreten, also dürfte hier Klagemäßig nichts kommen ( Ich nehme mal an die
Firmen wissen sich diesbezüglich abzusichern), oder hat jemand andere Infos?.
P.S: Der Umsatzbeitrag von Tysabri betrug gerade mal 6%..., am 28. April kommen
die Zahlen zum 1. Quartal, dann wird man sehen wie sich Prialt entwickelt...
Optionen
| Boardmail an "Parocorp" |
Wertpapier: Elan Corp ADR |
Optionen
| Boardmail an "Parocorp" |
Wertpapier: Elan Corp ADR |
Grüße
-hippeland-
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Wertpapier: Elan Corp ADR |
Wäre ein Wahnsinn, wenn sie nicht versichert wären.
Insofern, die Frimen zwar verklagt werden, aber die Versicherung den Schaden vermutlich bezahlen. Insofern ich die Aufregung umd die Sorge um die Schadesnsersatzklagen nicht ganz nachvollziehen kann. Versicherungen zahlen nur dann, wenn fahrlässig gehandelt wurde, das kann man in diesen Fällen ausschließen.
gruß
geldschneider
interessieren wie Prialt am Markt ankommt. Hab versucht die ersten Umsatzbeiträge rauszufinden, aber den Quartalsbericht gibt es wohl noch nicht. Trotzdem, der Tipp
war echt gut und die Tiefstkurse im Feb sind Historie. Hätte ich meine Strategie
nicht umgekrempelt würde ich den Wert auf jeden Fall mit einem langen Zeithorizont
halten, ich bin absolut überzeugt. Weiterhin viel Erfolg den Investierten...
interessieren wie Prialt am Markt ankommt. Hab versucht die ersten Umsatzbeiträge rauszufinden, aber den Quartalsbericht gibt es wohl noch nicht. Trotzdem, der Tipp
war echt gut und die Tiefstkurse im Feb sind Historie. Hätte ich meine Strategie
nicht umgekrempelt würde ich den Wert auf jeden Fall mit einem langen Zeithorizont
halten, ich bin absolut überzeugt. Weiterhin viel Erfolg den Investierten...
Optionen
| Boardmail an "Parocorp" |
Wertpapier: Elan Corp ADR |
Doch nicht immer gehört den Mutigen die Welt.
Hätte auch anders ausgehen können!
Gratuoiere jedenfalls denen, die den Einstieg gemacht haben. mir fehlte das Kapital.
Da ich mit einer anderen Bio Aktie so viel verloren habe und noch auf die Erholung warten muß.
Prana.
Optionen
| Boardmail an "Parocorp" |
Wertpapier: Elan Corp ADR |
geh mal auf www.finanznachrichten.de und such mal nach elan. da stehts!!
Scheiße, bei 7 wollt ich raus aus dem Dreck!!
Elan Retires over $240 Million of 2008 Debt
Elan Corporation, plc today announced that it has retired $211.8 million of
its 2008 outstanding debt and has agreed to retire a further $31.0 million which
is expected to close within the next few days.
Shane Cooke, Elan's Chief Financial Officer, said, "We continue to actively
manage our capital structure and have availed ourselves of opportunities in the
capital markets to retire over $240 million of our 2008 debt with cash and
equity. Our cash balances at the end of March 2005 will be reduced by about $80
million but remain in excess of $1.3 billion. These transactions will result in
no additional dilution to our shareholders and will reduce our annual interest
cost by about $16 million."
6.5% Convertible Guaranteed Notes due 2008
Elan purchased $175.0 million, and agreed to purchase a further $31.0 million in
aggregate principal amount of 6.5% Convertible Guaranteed Notes due 2008 for
approximately $255.0 million at an average premium of approximately 4% to the
market price of the Convertible Notes at the date of purchase. The purchases,
which represent approximately 45% of the issue, were made through a number of
separate, privately negotiated transactions. The consideration was, or will be,
satisfied with the issuance of 27,762,801 American Depositary Shares at the debt
conversion price of $7.42, together with $49.1 million in cash and accrued
interest of $0.7 million. The number of shares issued represents the same number
of shares that were issuable upon conversion of the Convertible Notes, resulting
in no further dilution to our shareholders. After giving effect to the
repurchases, $254.0 million in aggregate principal amount of the Convertible
Notes will remain outstanding.
Athena Notes
Elan has also purchased $36.8 million in aggregate principal amount of the 7.25%
senior notes due 2008 (Athena Notes) for $33.3 million plus accrued interest of
$0.6 million. The purchases, which represent approximately 6% of the issue, were
made through a number of separate, privately negotiated transactions. After
giving effect to the repurchases, $613.2 million in aggregate principal amount
of the Athena Notes remain outstanding.
As a result of these transactions, Elan will record a net charge of
approximately $53 million in the second quarter of 2005, of which approximately
$48 million will be cash and approximately $5 million will be non-cash
unamortized financing costs. After deducting this charge and giving effect to
these repurchases, Shareholders' Equity at March 31, 2005 would have increased
by approximately $153 million, and Elan's annual interest charge will be reduced
by approximately $16 million.
About Elan
Elan Corporation (NYSE: ELN), plc is a neuroscience-based biotechnology company.
We are committed to making a difference in the lives of patients and their
families by dedicating ourselves to bringing innovations in science to fill
significant unmet medical needs that continue to exist around the world. Elan
shares trade on the New York, London and Dublin Stock Exchanges.
Forward-Looking Statements
This release contains forward-looking statements about Elan's financial
condition, results of operations and business prospects that involve substantial
risks and uncertainties. You can identify these statements by the fact that they
use words such as "anticipate", "estimate", "project", "intend", "plan",
"believe" and other words and terms of similar meaning in connection with any
discussion of future operating or financial performance or events. The factors
that could cause actual results to differ materially from those described or
projected herein include the risk that the additional purchase of $31 million in
aggregate principal amount of Convertible Notes will not occur when expected, or
at all. A further list and description of these risks, uncertainties and other
matters can be found in Elan's Annual Report on Form 20-F for the fiscal year
ended December 31, 2004, and in its Reports of Foreign Issuer on Form 6-K filed
with the Securities and Exchange Commission. Elan assumes no obligation to
update any forward-looking statements, whether as a result of new information,
future events or otherwise.
Elan continually evaluates its liquidity requirements, capital needs and
availability of resources in view of, among other things, alternative uses of
capital, debt service requirements, the cost of debt and equity capital and
estimated future operating cash flow. Elan may raise additional capital,
restructure or refinance outstanding debt, repurchase material amounts of
outstanding debt, consider the sale of products, interests in subsidiaries,
marketable investment securities or other assets, or take a combination of such
actions or other steps to increase or manage its liquidity and capital
resources. Any such actions or steps, including any sale of assets or repurchase
of outstanding debt, could be material. In the normal course of business, Elan
may investigate, evaluate, discuss and engage in future company or product
acquisitions, capital expenditures, investment and other business opportunities.
In the event of any future acquisitions, capital expenditures, investment or
other business opportunities, Elan may consider using available cash or raising
additional capital, including the issuance of additional debt.
SOURCE: Elan Corporation, plc
CONTACT: Elan Corporation, plc
Investors:
Emer Reynolds, 353-1-709-4000 or 800-252-3526
or
Media:
Elizabeth Headon, 353-1-498-0300
or
Brian McGlynn, 212-407-5740
Copyright Business Wire 2005
KEYWORD: Ireland
Europe
INDUSTRY KEYWORD: Health
Pharmaceutical
Professional Services
Finance
Boston, Jun 01, 2005 (MidnightTrader via COMTEX) -- The top 5 most activepre-market OTC stocks on Archipelago are: JDSU, GOOG, IIJI, LJPC and ISON.The top 5 listed issues on ARCA are: NOK, SAP, ELN, STM, CPN.GET MIDNIGHTTRADER IN REALTIME: This report is delayed. The full MidnightTraderextended-hours trading analysis and news service is available in real-timethrough COMTEX. For more information and to signup for a FREE TRIAL visithttp://www.MidnightTrader.com/free_trial.html ABOUT MIDNIGHTTRADER: MidnightTrader is the premier source of extended-hours USequity trading analysis, news and forecasting for the retail and institutionalinvestment community. MidnightTrader's extended-hours analytical trading serviceempowers both retail and institutional equity traders by providing theinformation necessary to make the most informed and opportunistic investmentdecisions.URL: http://www.midnighttrader.comCopyright (C) 2005 MidnightTrader.com. All rights reserved. Unauthorized reproduction is strictly prohibited.SUBJECT CODE: TCHAN-MN MKTUP.MN FREE.MN PMKT.MN
by: yedistock
Long-Term Sentiment: Strong Buy 06/02/05 09:12 am
Msg: 673412 of 673445
Read the Globe article. The death was in a Ty Avonex combo therapy case. We already know this! What an opportunity to buy. The ultimate shake out!!!! The day before BIIB meeting!! If BIIB follows this story with positive Ty news, this stock is going to suffer whiplash. What a ride!
hxxp://finance.messages.yahoo.com/bbs?.mm=FN&action=l&board=7076797&tid=eln&sid=7076797&mid=673320
The Trouble With Tysabri
Dr. Scott Gottlieb, Forbes/Gottlieb Biotech Investor, 06.03.05, 3:32 PM ET
TABLE-->NEW YORK - Reports yesterday that a fourth case of a rare, often fatal, brain disease might be linked to the now-withdrawn drug for multiple sclerosis, Tysabri (developed by Elan and Biogen Idec), has added a new and more difficult wrinkle to the saga of this drug.
Earlier this week, I reported on my weblog www.FDAInsider.com (which focuses on U.S. Food and Drug Administration policy issues that impact investors) that there were at least four principal questions that the FDA needed to answer before it would have enough comfort to allow this drug to be reintroduced. Those questions are listed at the end of this article. But the latest case of the brain disease in a patient using Tysabri probably puts the answers to these questions further out of reach.
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The patient who contracted the latest case of PML was apparently taking the drug in combination with another multiple sclerosis drug Avonex. There have been rumors that there was a fourth case of PML since the American Academy of Neurology meeting in April.The Boston Globe apparently got the latest report after filing a Freedom of Information Act request for adverse event reports related to Tysabri. This means the report is old and not part of the ongoing investigation that the companies and the FDA are making into the drug. So other cases could well emerge from that ongoing investigation.
Biogen Idec and Elan (nyse: ELN - news - people ) announced on Feb. 28 that they were suspending sales of Tysabri after two patients were found to have contracted the disease. A review of clinical trial records later identified a third patient. Two of the patients have since died.
Ever since they announced the drug's suspension, the companies have been examining patients' records for other instances of PML. Biogen has said that they will present their findings to the FDA by the end of the summer.
Each new case of PML reduces the chances for a quick return of Tysabri. Also complicating matters is that there is no discernable pattern to which Tysabri users are at highest risk of contracting PML.
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At first, it was thought that the risk was apparent only when Tysabri was used in combination with Avonex. Then a case of PML emerged in a Crohn's patient who was not on Avonex (although the patient was reported to be on other immunosuppressive drugs).Then it was believed that the risk of PML increased with long-term use of Tysabri. But the latest case of PML is rumored to have emerged in a patient who had received only three doses of the drug. That could mean the risk of PML is apparent even with short-term use of Tysabri.
In fact, Tysabri is beginning to fit the profile of the kind of medicine that gives the FDA the most discomfort: a drug for which the factors that increase a risk of suffering a certain side effect cannot be readily identified, and where the side effect is fatal and does not respond to withdrawal of the offending treatment.
Tysabri is a highly effective medicine with a unique mechanism of action. The road to bringing it back on the market, however, is unclear.
The drug is likely to play an important role in very sick MS patients who have not responded to existing therapy, and indeed, the benefits may well outweigh the risk in these patients. But FDA is likely to tread cautiously here: perhaps taking many months to convene expert committees on both the drug and on PML, to see which if any of the four questions I posed can be more readily addressed.
So history should be a guide here as to what the FDA is likely to do:
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If the FDA cannot identify reasonable criteria that would help guide doctors and patients as to who may be at risk for PML, and how that risk can be reduced, there is very little advice the agency can offer the drug's users, and very little chance that the agency will soon feel comfortable making the drug available again, except perhaps under the most limited circumstances.The Pfizer (nyse: PFE - news - people ) antibiotic Trovan and the Johnson & Johnson (nyse: JNJ - news - people ) gut drug Propulsid are perhaps a harbinger of what is next. Both of those drugs were withdrawn from the market for safety concerns, and then reintroduced in very limited circumstances, mostly for extraordinary uses that require those drugs' unique mechanisms. That's hardly the kind of market Elan and Biogen were angling for, but it may be what they and patients need to settle for, at least for the foreseeable future.
Questions the FDA needs to answer to reintroduce Tysabri:
- Can those at risk for PML be reliably identified through prospective testing?
- Can the FDA determine whether the risk of PML is the same if Tysabri is given alone, without co-administration of other immunosuppressive drugs?
- Can the FDA determine whether use of the drug in certain dosages or for certain lengths of time modulate the risk of PML?
- Can the FDA identify characteristics that would allow doctors to prospectively identify patients with rapidly progressive disease, unlikely to respond to other medicines, for which the risk of PML is outweighed by the benefits of Tysabri?
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| Das ist aber nicht die News, die den Kurs anhob, diese Nachricht ist versteckt und hängt glaube ich mit einem Aids Medikament zusammen. muß ich nochmal rausssuchen. Weil ich von Elan kaum was fand. | |||||||||||||||||||||||||
Pharmaceutical Announces FDA Approval of Megace(R) ES for Anorexia, Cachexia, or an Unexplained, Significant Weight Loss in Patients With a Diagnosis of AIDS
WOODCLIFF LAKE, N.J., July 6, 2005 /PRNewswire-FirstCall via COMTEX/ -- Par
Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that the U.S. Food and Drug Administration (FDA) has approved Megace(R) ES (megestrol cetate), a concentrated oral suspension for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). The approval of Megace ES represents the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. New Megace ES is an advanced formulation of megestrol acetate oral
suspension, the appetite stimulant most commonly prescribed by physicians.
Megace ES can be taken without regard to meals and is dosed at one-fourth the
volume of the original product.
"Unintended weight loss and cachexia, also known as wasting, have been shown to
be determining factors in progression of disease in AIDS patients," said Lynn
Kramer, MD, senior vice president, clinical development and medical affairs.
"For patients who have difficulty swallowing a large dose, or those with a lack
of appetite who cannot eat without the help of medication, the approval of
Megace ES is a crucial advance."
Megace ES utilizes Elan's NanoCrystal(R) Technology delivery system* to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension. Recent data have shown that the bioavailability of the original formulation is reduced substantially when taken on an empty stomach. With Megace ES, this reduction in bioavailability is minimized in the fasted state, resulting in improved bioavailability in patients who have not eaten. Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are bioequivalent in a fed state.
Patients taking Megace ES will be able to take a one-teaspoon (625 mg/5 mL)
daily dose, or one-fourth of the volume of the original product. Previously,patients had to drink one 20 mL cup (800 mg/20 mL) of megestrol acetate oral suspension daily to receive the drug's full benefit. Megace ES also is 16 times less viscous (10 cP versus 163 cP) than the original formulation.
"Par Pharmaceutical is committed to the science of improving treatment solutions for patients," said Scott Tarriff, president and chief executive officer. "It is gratifying to be able to offer patients this advanced product. Improved bioavailability and reduced volume per dose of Megace ES should allow patients to receive the complete benefit of the therapy."
Efficacy of Megace ES
The FDA approval of Megace ES was based on pharmacokinetic studies demonstrating
bioequivalence between 625 mg of Megace ES and 800 mg of megestrol acetate oral
suspension when dosed in a fed state. The clinical benefits of megestrol acetate
oral suspension in treating patients with anorexia, cachexia, or an unexplained, significant weight loss have been clearly demonstrated in patients with AIDS. In one of two placebo-controlled, randomized efficacy trials in patients with AIDS,
megestrol acetate oral suspension effectively stimulated appetite in nine out of 10 patients, increased mean caloric intake by 646 calories per day, and increased mean weight gain by 10.7 pounds versus placebo in 12 weeks. Patients also reported an improved sense of well being. In a second placebo-controlled study, seven out of 10 patients experienced improved appetite, mean caloric intake was increased by 464 calories a day, and mean weight increased by 13.3 pounds versus placebo.
Moreover, a bioavailability study directly comparing the rate and extent of
absorption of Megace ES and megestrol acetate oral suspension revealed that the
Cmax** level with the original formulation was 1,364 ng/mL in fed patients and
187 ng/mL in unfed patients. In contrast, the Cmax level with Megace ES was
1,517 ng/mL in fed patients and 1,041 ng/mL in unfed patients. Further, in unfed
patients Megace ES achieved 5 times greater peak plasma levels than megestrol
acetate oral suspension. Additionally, the study demonstrated that a lower
volume of Megace ES achieved maximum blood concentration more rapidly than the
currently available oral suspension products.
About Unintended Weight Loss
Anorexia (a persistent lack of appetite), unintended weight loss, and cachexia
(significant weight loss that involves depletion of both fat and lean body mass)
represent a serious risk in patients with AIDS. Significant weight loss and
cachexia are associated with worsening illness, physical impairment, decreased
tolerance of some therapeutic agents, and increased susceptibility to infection.
Important Safety Information About Megace ES
Megace ES and megestrol acetate oral suspension are contraindicated in patients
with a history of hypersensitivity to megestrol acetate or any component of the
formulation, or patients with known or suspected pregnancy.
Evidence of adrenal suppression has been observed in patients receiving
megestrol acetate oral suspension. The glucocorticoid activity of megestrol
acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre- existing
diabetes mellitus, and overt Cushing's Syndrome have been reported in
association with the chronic use of megestrol acetate.
The most common adverse events (less than or equal to 1% and > than placebo)
associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800
mg/20 mL are impotence, flatulence, rash, hypertension, insomnia, fever,
decreased libido, dyspepsia and hyperglycemia.
Women who participated in studies (n=10) reported breakthrough bleeding;
however, it is unknown if these events are drug -- or disease-related. For more information on Megace ES, or for complete prescribing information, visit
http://www.MegaceES.com.
About NanoCrystal Technology
Megace ES was developed with NanoCrystal Technology, a nanoparticulate drug
delivery system of Elan Pharma International Limited, a subsidiary of Elan
Corporation, plc (NYSE: ELN). NanoCrystal Technology is applied exclusively to poorly water-soluble drugs, and has been applied successfully to several dosage forms to overcome many of the problems created by low levels of water
solubility. An extensive patent estate protects Elan's NanoCrystal Technology.
More information about Elan's NanoCrystal Technology is available at
http://www.elan.com/EDT.
About Par Pharmaceutical Companies
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic
pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc., and
its recently acquired subsidiary, Kali Laboratories, Inc. The company also is
developing an additional line of branded pharmaceutical products for specialty
markets, the first of which is Megace ES. Par currently manufactures, markets or
licenses 90 prescription drugs. The trade name Megace was licensed from
Bristol-Myers Squibb Company. For press releases and other company information,
visit http://www.parpharm.com.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward- looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange
Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
* NanoCrystal Technology is a trademark of Elan Pharma International
Limited. Page 2
** Cmax: Maximum drug concentration in blood plasma.
Contacts:
Stephen Mock
+1-201-802-4000
smock@parpharm.com
Cecelia C. Heer
+1-201-802-4000
cheer@parpharm.com
SOURCE Par Pharmaceutical Companies, Inc.
CONTACT: Stephen Mock, +1-201-802-4000, smock@parpharm.com, or Cecelia C. Heer,
+1-201-802-4000, cheer@parpharm.com, both of Par Pharmaceutical Companies, Inc.
URL: http://www.prnewswire.com
http://www.parpharm.com
www.prnewswire.com
Copyright (C) 2005 PR Newswire. All rights reserved.
<!--StartFragment -->Ja meinte den vom 6.7. aber heute geht es auch nach oben in USA
ELAN CORP PLC - New York Stock Exchange: ELN (NEW charting help)
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