NanoChrystalTechnology (Elan Corp.) - 500 Beiträge pro Seite

[Cyberhexe]

....und schon wieder eine bemerkenswerte Vereinbarung mit Elans patentierter Nanotechnologie....und das Potential ist riesig, da alle nicht wasserlöslichen Wirkstoffe als potenzielle Kandidaten in Frage kommen.



Elan and EntreMed Execute License Agreement for Proprietary NanoCrystal(R) Technology
Tuesday January 10, 2:30 am ET


DUBLIN, Ireland & ROCKVILLE, Md.--(BUSINESS WIRE)--Jan. 10, 2006--Elan Corporation, plc (NYSE: ELN - News) and EntreMed, Inc. (NASDAQ: ENMD - News) today announced that they have entered into a License Agreement in which EntreMed has been granted rights to utilize Elan`s proprietary NanoCrystal Technology to develop the oncology product candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol). Under the terms of the License Agreement, Elan is eligible to receive payments upon the achievement of certain clinical, manufacturing, and regulatory milestones. Additionally, Elan will receive royalty payments based on sales of Panzem® NCD.



Under the License Agreement and corresponding Services Agreement, Elan will manufacture EntreMed`s Panzem® NCD, a NanoCrystal Technology formulation with improved bioavailability and absorption. Other marketed pharmaceutical products in the United States utilizing Elan`s NanoCrystal Technology include TriCor® (marketed by Abbott), Megace® ES (marketed by Par Pharmaceuticals), and Rapamune® (marketed by Wyeth). In 2004, the parties signed a Clinical Supply Agreement covering the supply of Panzem® NCD for Phase 1 trials. These Agreements extend the Panzem® NCD supply arrangement to Phase 2 and later trials. Panzem® NCD is currently in Phase 1b clinical studies in patients with advanced cancer. EntreMed expects to announce the commencement of multiple Phase 2 trials in early 2006.

Paul V. Breen, Executive Vice President, Elan Drug Technologies, said, " We are pleased to extend our relationship with EntreMed. We hope that these agreements will lead to the launch of a new product with unique benefits to cancer patients."

EntreMed President and Chief Executive Officer, James S. Burns commented, " These agreements continue our relationship with Elan for further development and manufacturing of Panzem® NCD, our lead clinical drug candidate. Interim results from our Phase 1b studies demonstrated that daily dosing with the Elan formulation maintains blood levels of 2ME2 within the desired therapeutic range, allowing us to move forward with Phase 2 clinical trials."

Mr. Burns further commented, " Expanding the Elan relationship is a logical next step for EntreMed that provides us with access to process improvements and continuity of supply for further scale-up and clinical development. We look forward to working closely with Elan to meet our development goals and move Panzem® NCD towards commercialization."




http://biz.yahoo.com/bw/060110/20060109006149.html?.v=1


wallstreet:club

[Cyberhexe]

About Elan`s NanoCrystal(R) Technology

Elan`s NanoCrystal Technology is a novel drug delivery technology that offers
superior results when coupled with poorly water-soluble compounds. An increasing
number of the drug candidates synthesized each year by pharmaceutical companies
are poorly water-soluble. Many of these potentially innovative drug candidates
are often abandoned because of poor pharmacokinetic properties including
absorption, distribution, metabolism, and excretion. NanoCrystal Technology has
the potential to rescue a significant percentage of these chemical compounds.

Elan`s NanoCrystal Technology is part of a suite of technologies which Elan`s
Drug Technologies business offers to third party clients. Elan Drug Technologies
offers its` technology based solutions to the global pharmaceutical industry.
With over 30 products launched in 40 countries, it has a proven track record of
delivering success to third party clients. More information about Elan Drug
Technologies broad range of technologies, patent estate and range of services is
available at www.elan.com/EDT.

[Cyberhexe]

mit der von Elan Corp. patentierten NanoCrystal Technology arbeiten bereits die Grossen wie z.B. EliLilly, Roche, Aventis, BMS, Merck

http://www.elan.com/DrugDelivery/Announcements/

http://www.elan.com/DrugDelivery/drug_delivery/

Hintergrund: mit Hilfe der Technologie soll die Bioverfügbarkeit derart verbessert werden, dass geringere Dosen die bisherige Wirksamkeit garantieren, jedoch dadurch das Risiko der Nebenwirkungen entsprechend verringert wird. Hiermit soll auch eine Möglichkeit geschaffen werden, den Patentschutz von Wirkstoffen zu verlängern. Elan erhält hierfür natürlich entsprechende Lizenzgebühren. Da das Anwendungsgebiet bei den wasserunlöslichen Wirkstoffen nahezu unermesslich ist, scheint hier eine weitere Elan success story möglich zu sein.

14 June 2004 Announcement on the establishment of new Sterile Biopharmaceuticals Plant at its Athlone, Ireland facility
10 June 2004 Elan Announces Manufacturing Agreement with Lilly
21 April 2004 Elan NanoSystems licenses NanoCrystal™ technology to Roche
20 Jan 2004 Elan NanoSystems licenses NanoCrystal™ technology to Aventis
13 Oct 2003 Elan`s NanoSystems licenses NanoCrystal® to Janssen
30 Sep 2003 Elan`s NanoSystems and Bristol-Myers Squibb sign license
20 May 2003 Merck and Elan Announce NanoCrystal® Technology is Formulation for Merck’s Emend® (aprepitant)
30 Aug 2000 Elan announces first U.S. approval for its NanoCrystal™ technology

[Cyberhexe]

...und ausserdem noch die Zusammenarbeit mit Roche:



21st April 2004
Elan Licenses Its NanoCrystal Technology to Roche
http://www.elan.com/News/2004/04-21-2004-eln_licenses.asp

7 January 2005
Elan and Roche Expand Nanocrystal Technology License
Proprietary Elan Technology Helps Improve Drug Delivery by Transforming Drugs into More Effective and " User Friendly" Dosage Forms to Increase Patient Convenience and Compliance

http://www.elan.com/News/full.asp?ID=660276


http://www.roche.com/de/sci_coll_phar_part

[Poppholz]

Jetzt auch auf Deutsch:

Business Wire
Elan und EntreMed schließen Lizenzvereinbarung über die geschützte NanoCrystal(R)-Technologie
Dienstag 10. Januar 2006, 18:56 Uhr

DUBLIN, Irland & ROCKVILLE, Maryland 10. Januar 2006 Elan Corporation, plc (NYSE: ELN) und die EntreMed, Inc. (NASDAQ:ENMD) gaben heute bekannt, dass sie eine Lizenzvereinbarung geschlossen haben. Durch diesen Vertrag ist EntreMed berechtigt, die geschützte NanoCrystal-Technologie von Elan zur Entwicklung des onkologischen Wirkstoffkandidaten Panzem(R) NCD (2ME2 oder 2-Methoxyestradiol) einzusetzen. Der Vertrag sieht vor, dass Zahlungen an Elan zu leisten sind, sobald bestimmte Fortschritte bei der klinischen Forschung, der Herstellung und dem Zulassungsverfahren verzeichnet werden. Des Weiteren erhält Elan anteilig zu den Umsätzen ANZEIGE

mit Panzem(R) NCD Nutzungsgebühren.
In der Lizenzvereinbarung und der entsprechenden Leistungsvereinbarung wurden festgelegt, dass Elan den Wirkstoffkandidaten Panzem von EntreMed, eine Rezeptur, die auf der NanoCrystal basiert und eine bessere Bioverfügbarkeit und Resorption aufweist, produzieren kann. Weitere, in den USA vermarktete pharmazeutische Produkte, die auf der NanoCrystal-Technologie von Elan basieren, sind TriCor(R) (Vermarkter: Abbott), Megace(R) ES (Vermarkter: Par Pharmaceuticals) und Rapamune(R) (Vermarkter: Wyeth). In 2004 unterzeichneten die Parteien einen Liefervertrag für klinische Studien, der die Bereitstellung von Panzem(R) NCD für Phase I-Studien vorsah. Mit den aktuellen Verträgen werden die Liefervereinbarungen auf Phase II- und nachfolgende Studien ausgeweitet. Panzem(R) NCD wird derzeit in Phase Ib-Studien an Patienten mit fortgeschrittenem Krebs klinisch getestet. EntreMed rechnet damit, die Einleitung verschiedener Phase II-Studien Anfang 2006 bekannt geben zu können.

Paul V. Breen, Executive Vice President der Elan Drug Technologies, erklärte: "Wir freuen uns darauf, unsere Beziehungen mit EntreMed auszuweiten, und hoffen, dass diese Vereinbarungen zur Markteinführung eines neues Produktes führen, das sich für Krebspatienten als segensreich erweist".

James S. Burns, Vorsitzender des Vorstandes von EntreMed, kommentierte den Vertragsschluss wie folgt: "Durch diese Verträge werden unsere Geschäftsbeziehungen mit Elan mit dem Ziel fortgesetzt, unseren klinischen Wirkstoffkandidaten Panzem(R) NCD weiterzuentwickeln und herzustellen. Die vorläufigen Ergebnisse unserer Phase Ib-Studien zeigen, dass eine tägliche Gabe mit der Rezeptur von Elan den Pegel von 2-Methoxyestradiol im Blut auf dem therapeutisch gewünschten Niveau hält. Somit können wir jetzt mit den klinischen Phase II-Studien beginnen.

Burns sagte des Weiteren: "Die Ausweitung der Geschäftsbeziehungen mit Elan ist für EntreMed der nächste logische Schritt. Wir können auf diese Weise von Prozessverbesserungen und einer Lieferkontinuität profitieren, um eine weitere nachfolgende und klinische Entwicklung voranzutreiben. Wir freuen uns auf die enge Zusammenarbeit mit Elan, damit wir unsere Entwicklungsziele erreichen und Panzem(R) NCD der Vermarktung näher bringen können".

Über die NanoCrystal(R)-Technologie von Elan

Bei der NanoCrystal-Technologie von Elan handelt es sich um eine neuartige Technologie zur Freisetzung von Medikamenten, die in Kombination mit schwer wasserlöslichen Präparaten hervorragende Ergebnisse erzielt. Mehr und mehr Wirkstoffkandidaten, die jedes Jahr von pharmazeutischen Unternehmen synthetisch hergestellt werden, sind schwer wasserlöslich. Viele dieser möglicherweise innovativen Wirkstoffkandidaten werden oftmals aufgegeben, weil sie geringe pharmakokinetische Eigenschaften u. a. bei der Resorption, Verteilung, dem Stoffwechsel und der Ausscheidung aufweisen. Die NanoCrystal-Technologie könnte einen beträchtlichen Teil dieser chemischen Verbindungen retten.

Diese Technologie von Elan ist Teil einer Reihe von Technologien, die das Unternehmen dritten Parteien überlässt. Elan Drug Technologies stellt seine technologisch-basierten Lösungen der pharmazeutischen Industrie weltweit zur Verfügung. Mit mehr als 30 Produkten, die in 40 Ländern eingeführt wurden, hat das Unternehmen gezeigt, dass sich seine Technologien erfolgreich von Drittkunden vermarkten lassen. Weitere Informationen über das breite Spektrum der Technologien, den Bestand an Patenten und die Bandbreite der Dienstleistungen von Elan Drug Technologies sind unter www.elan.com/EDT abrufbar.

Über Elan

Elan ist ein im Bereich der Neurowissenschaft tätiges Biotechnologieunternehmen, das sich auf die Entdeckung, Entwicklung, Herstellung, den Verkauf und die Vermarktung hoch entwickelter Therapien für neurodegenerative Erkrankungen, Autoimmunerkrankungen sowie die Linderung großer Schmerzen spezialisiert hat. Die Aktien von Elan (NYSE:ELN) werden an den Börsen in New York, London und Dublin gehandelt.

Über Panzem(R) NCD

2-Methoxyestradiol ist ein oral aktives kleines Molekül, das mittels verschiedener Wirkungsmechanismen Tumorzellen angreift und die Entwicklung neuer Blutgefäße, die Tumorzellen mit verschiedenen Stoffen versorgen, behindert. Panzem(R) Nanocrystal Colloidal Dispersion (Panzem(R) NCD), eine flüssige, orale Rezeptur, hat in vorklinischen Studien ihr Potential, die Bioverfügbarkeit des Stoffes beträchtlich zu erhöhen, unter Beweis gestellt. Auf diese Weise wird der Pegel von 2ME2 im Blut der Patienten erhöht.

Über EntreMed

EntreMed, Inc. (NASDAQ: ENMD) ist ein Pharmazieunternehmen, das sich auf die klinische Forschung und Entwicklung von therapeutischen Wirkstoffkandidaten zur Behandlung von Krebs und Endzündungen spezialisiert hat. Panzem(R) (2-Methoxyestradiol oder 2ME2), ein Wirkstoffkandidat des Unternehmens, wird derzeit in klinischen Studien für die Behandlung von Krebs getestet. In der präklinischen Forschung und Entwicklung wird der Wirkstoff auch für weitere Indikationen geprüft. EntreMed gab kürzlich bekannt, dass es Miikana Therapeutics, Inc. übernehmen wird, ein auf die klinische Krebsforschung spezialisiertes Unternehmen mit Sitz in Fremont im US-Bundesstaat Kalifornien. Ziel von EntreMed ist, neue Verbindungen zu entwickeln und vermarkten. Ausgangspunkt dafür ist das Fachwissen seiner Forschungsabteilungen in den Bereichen Angiogenese, Steuerung des Zellzyklus und Entzündungen, die als Prozesse für die Behandlung von Krebs und anderen Krankheiten wie der rheumatoiden Arthritis von ausschlaggebender Bedeutung sind. Weitere Informationen über EntreMed sind auf der Website des Unternehmens unter www.entremed.com abrufbar oder können in den bei der US-Börsenaufsichtsbehörde verschiedentlich eingereichten Unterlagen eingesehen werden.

Die NanoCrystal(R)-Technologie ist eine eingetragene Handelsmarke und Eigentum der Elan Pharma International Limited Corporation aus Irland.

Panzem(R) ist eine eingetragene Handelsmarke und Eigentum der EntreMed, Inc.

TriCor(R) ist eine eingetragene Handelsmarke und Eigentum der Abbott Laboratories Corporation.

Megace(R) ist eine eingetragene Handelsmarke der Bristol-Myers Squibb Company. Lizenznehmer ist die Par Pharmaceutical, Inc.

Rapamune(R) ist eine eingetragene Handelsmarke und Eigentum der Wyeth Pharmaceuticals.

Vorausschauende Aussagen

Diese Pressemitteilung enthält vorausschauende Aussagen im Sinne des "Private Securities Litigation Reform Act", die sich auf die Realisierung zukünftiger finanzieller und geschäftlicher Ziele, Strategien, Erwartungen und Zielsetzungen beziehen. Vorausschauende Aussagen unterliegen zahlreichen Voraussetzungen, Risiken und Unwägbarkeiten, die sich kontinuierlich wandeln. Die vorausschauenden Aussagen beziehen sich nur auf den Zeitpunkt, an dem sie abgegeben werden. Es wird keine Verpflichtung zu ihrer Aktualisierung übernommen. Die tatsächlichen Ergebnisse können sich aufgrund zahlreicher Faktoren maßgeblich von den derzeit vorhergesagten Ergebnissen unterscheiden. Einige dieser Faktoren sind in den bei der US-Börsenaufsichtsbehörde "Securities and Exchange Commission" eingereichten Unterlagen unter der Bezeichnung "Risikofaktoren" aufgeführt. Andere Faktoren beziehen sich auf die Risiken in Verbindung mit dem Bedarf an zusätzlichem Kapital und die Unsicherheit in Verbindung mit einer zusätzlichen Kapitalausstattung, die Produkte, die sich in einem frühen Stadium der Entwicklung befinden, die Tatsache, dass präklinische Modellierungsergebnisse nicht unbedingt aussagekräftig sind in Bezug auf klinische Ergebnisse, die Unsicherheiten in Verbindung mit der präklinischen und klinischen Forschungsphase, den Erfolg bei der klinischen Entwicklung der Produkte, die Abhängigkeit von dritten Parteien, den zukünftigen Kapitalbedarf und schließlich die Risiken in Verbindung mit der Vermarktung der vorgestellten Produkte des Unternehmens, sollte diese realisiert werden (wie beispielsweise Unwägbarkeiten in Bezug auf Marketing, Sicherheit, Zulassung, Patente, Produkthaftung, Belieferung, Wettbewerb und andere Unwägbarkeiten).

Kontakt

Elan Corporation
Kapitalanleger:
Emer Reynolds, [phone]
800-252-3526
Chris Burns, 800-252-3526
ODER
Medien:
Davia Temin, [phone]
Elizabeth Headon, [phone]
ODER
EntreMed, Inc.
Communications/IR
Ginny Dunn, [phone]

[[KERN]Codex]

[Poppholz]

ELAN wurde von der International Association of Nanotechnology zu einem der Top 100 Nanotechnologie-Unternehmen ernannt


http://www.ianano.org/Fortune-Nanotech.pdf

(der Artikel bezieht sich hauptsächlich auf MIV, aber ELAN ist eben mit in der Liste aufgeführt)

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April 27, 2006 Health care's nanotechnology hopes Marketwatch

Elan has had particular success using its NanoCrystal technology to reformulate drugs and make them easier for patients to take. For example, the company uses its nanotechnology in the antirejection agent Rapamune, which the body is better able to absorb than previous treatments, said Paul Breen, head of Elan's drug technologies in Dublin, Ireland.
"We eliminated the need to make a complicated mixture and the patient was able to take a tablet," Breen said.
The company is testing more than 70 compounds with nanotechnology, he said.
"We make the particles so small that they easily cross over the biological barriers," Breen said. "Particles of that size tend to want to clump together to go back to bigger particles. Part of our technology is not only reducing the size to an extremely nanoscale, but also stabilizing them there so they can easily pass through the cell wall and into the bloodstream."

http://www.marketwatch.com/News/Story/Story.aspx?guid={A393F…

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http://www.entremed.com/download/press/Elan-EntreMed_Joint_P…

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Welche Faktoren beeinflussen unser Anlageverhalten?
In erster Linie, die Aussicht auf Gewinn, also die Chance, und zweitens das damit verbundene Risiko.

Nun bei unserem elanvollen Favoriten sind die Chancen nahezu gigantisch, denn sollte sich auf Ende Jahr beim Alzheimer-Projekt eine Phase III- Studie abzeichnen, sind steigende Kurse nicht nur in Cent-Beträgen vorprogrammiert.
Die kurzfristigen Schlagzeilen werden jedoch von der Tysabri-Wiederzulassung bestimmt. Sollte Tysabri kurzfristig (von den Analysten zumindest) unerwartete Marktanteile sichen - und davon gehe ich aus-, dann wird dies den Kurs ebenfalls beflügeln.
Verbunden mit der hochinteressanten Nanotechnolgie für wasserunlösliche Aktivsubstanzen - über 70 Wirkstoffe werden getestet, 5 sind bereits zugelassen, für welche Elan bereits Lizenzeinnahmen erhält (und dies ohne Kosten zu generieren!) - ergeben einen überaus interessante Kombination mit riesigem Kurspotential.

Nun, demgegenüber steht momentan ein, wie ich finde, relativ kleines Risiko.
Tysabri wurde in den letzten 15 Monaten nicht appliziert, weshalb von dieser Seite vorerst keine negativen Schlagzeilen zu erwarten sind.
Die in der Klinik getesteten Alzheimer-Aktivsubstanzen (AAB-001 und ACC-001) hatten bereits eine Vorläufer-Substanz (AN-1792), mit welcher der "proof-of-concept" bereits erbracht wurde.
Die bei AN-1792 aufgetretenen Nebenwirkungen (Hirnhautentzündung) sind jedoch zumindest bei AAB-001 nicht zu erwarten, da es sich hierbei nicht um eine aktive Immunisierung sondern um einen passiven Schutz durch Injektion des Antikörper handelt.
Und bei der Nanotechnologie ist sowieso jede weitere Zulassung ein Volltreffer, der nur Einnahmen und keine Kosten verursacht.

Das Chance/Risiko-Verhältnis scheint mir deswegen momentan einzigartig, weshalb man nicht ungeduldig werden sollte.

[Cyberhexe]

Diese Zeilen sind beeindruckend , und erinnern mich wieder daran, dass es hier nicht nur um (m)ein Investment geht, sondern für viele Tausende von existenzieller Bedeutung ist. Einer meiner Arbeitskollegen ist an MS gestorben (dies ist eigentlich das falsche Wort, es war viel schlimmer!), so dass es mir bewusst ist, welche Konsequenzen mit MS möglich sind.

http://www.mspatientsforchoice.org/


OPEN LETTER TO THE FDA

To the FDA,

When I left Washington with other team members of MSpatientsforchoice after testifying at the open hearing on March 7th, I was elated that we were going to see the return of Tysabri. The months since the recall of the drug have been difficult for all. For many in the MS community, the withdrawal of Tysabri has meant the advancement of disability. For many it has meant there are NO options against intolerable pain. Almost all who came to Washington, and the thousands they represent, have seen decline in their quality of life.


We had hoped with our very personal stories of what it\'s like to live with this horrendous disease, that it would be readily understood why we\'re ready to manage the risks associated with this drug. Enough reviews, surveys, and studies have been done on Tysabri. The risks are understood well enough that a percentage can even be attached to the risk. And over and over again individuals with MS are begging for this drug to be back as an option in their care. Tysabri is THE ONLY THING ON THE HORIZON THAT OFFERS A FUTURE FOR MANY WITH MS. It is unkind, unnecessary and intolerable to keep the drug away from the thousands of us with MS who are in such desperate need. Please remove this latest 90 day waiting period and begin making a positive change in the lives of so many with MS.

Sincerely yours,

MSpatientsforchoice

[Cyberhexe]

Elans Fortschritte bei der Anwendung der Nanotechnologie-Patente:

es werden intern zu 30 Komponenten Machbarkeitsstudien vorbereitet sowie mit einem halben Dutzend Pharmafirmen über Kooperationen gesprochen...

Newsflow on drug technology division in H2
Elan’s drug technology division remains focussed on developing internal and partnership projects for its
Nanosystems delivery technology. The division is currently preparing feasibility studies on 30 compounds
internally, and half a dozen discussions with prospective pharma partners are also ongoing. Newsflow
on some of these initiatives is expected in the second half of 2006.
Elan is also exploring angles to co-promote products that use Nanosystems technology. This may be one
way of filling the potential gap in revenues that will be created by the genericisation of Maxipime and
Azactam.

Spätestens zum 28. Juni hat die FDA ihre Entscheidung über die Wiederzulassung von Tysabri bekannt zu geben. An einer erneuten Zulassung gibt es keine Zweifel, lediglich spannend bleibt die Frage, ob als "fist line" oder "second line treatment"! Die europäische Arzneimittelbehörde EMEA sollte im Anschluss daran ebenfalls die Zulassung zur Behandlung von MS erteilen. Die Zulassung bei der Indikation MorbusCrohn wird erst später (Ende 2006) erwartet.

By the end of June, Elan is on track to receive approval for
Tysabri in both the US and EU (preliminary approval has
already been granted for the latter). A decision on its
Crohn’s indication in Europe could also occur in the second
half of 2006.

Aber der absolute Hammer wäre, wenn man mit Bapineuzumab (AAB-001) auf Ende Jahr in die klinische phase 3 eintreten könnte....dann würde der Kurs sehr wahrscheinlich explodieren!

On AD, the company line remains that Phase
II data on AAB-001 will be available towards the end of the
year. A decision will also be made on Phase III at that time.
We still believe that interim analyses may allow Elan to
make this decision earlier.

Upbeat on prospects in AD
Management continues to demonstrate strong underlying confidence in the progress of its AD pipeline.
The company line remains that it will be the end of the year before Phase II data on lead product AAB-
001 (bapineuzumab) are available.
We continue to believe that interim analyses may allow Elan to interpret data earlier in 2006. There are
several endpoints being analyzed – cognition, memory, quality of life and imaging. Statistically significant
results are not required; strong signals will be sufficient for the product to progress to Phase III. Specific
patient subgroups are also being analyzed.
Although Phase III studies would most likely last 18 months, existing AD therapies have been approved
for symptomatic use on the basis of just six months of data. That Phase III on AAB-001 is also likely to
include interim analyses could provide Elan with the potential to accelerate development, even as a superior
symptomatic treatment in the first instance.
We were very encouraged by the recently released Phase I data on AAB-001. Although a small 30-patient
study, several dosage levels demonstrated absolute improvements in MMSE scores (a measure of language
and short-term memory used in AD trials).

...und man besitzt aus dem Alzheimer-Programm immerhin 40 Patente, die meines Wissens teilweise an andere Pharma-Riesen weiter lizenziert wurden (Eli Lilly).

A strong message was also given regarding intellectual property. With 40 issued patents in the AD
immunotherapy area already, Elan is likely to be in the enviable position of defending its IP rights rather
than infringing on the rights of others.

[Cyberhexe]

Elan Signs License Agreement with Abbott for Elan's Proprietary NanoCrystal(R) Technology


http://biz.yahoo.com/bw/060706/20060705005965.html?.v=1


...und wieder ein Abkommen, welches für die Zukunft noch einiges verspricht!

[Cyberhexe]

wohl nur der Anfang einer langen Liste von nanotechnologischen Erfolgsmeldungen. Mit Hilfe Elans Technologie haben die Pharmagrössen die Möglichkeit, ihre Erfolgsprodukte von generischen Anbietern abzugrenzen. Und dies gilt für alle wasserunlöslichen Wirkstoffe.

http://www.drugresearcher.com/news/ng.asp?n=68996-abbott-ela…

[Cyberhexe]

...da könnten, sogar rückwirkend, weitere Lizenzeinnahmen für Elans patentierte Nanotechnologie fällig werden. Letztes Jahr berugen dei Verkaufserlöse für Abraxane 134 mio$, wofür normalerweise zwischen 5 und 10% an Lizenzgebühren zu zahlen sind. Das wären immerfhin ca. 10 Mio$/Jahr, die ohne einen Aufwand zu generieren voll in den Deckungsbeitrag von Elan eingehen würden.
Mit fast allen Grossen der Pharmabranche bestehen bereits entsprechende Abkommen, so dass das zukünftige Potential Riesiges verspricht.

http://biz.yahoo.com/fool/060728/115411003215.html?.v=1

Tiny Particles Cause a Big Storm for Abraxis
Friday July 28, 2:07 pm ET
By Jack Uldrich


The news of yet another lawsuit being filed in Delaware is easy to overlook, especially in today\'s society, where such filings are about as common -- and, I would argue, bothersome -- as pigeon droppings.
ADVERTISEMENT


Yet Elan\'s (NYSE: ELN - News) decision last week to sue Abraxis Bioscience (Nasdaq: ABBI - News) -- over claims that Abraxis had infringed on its patent for nanoparticle formulation by selling the breast cancer treatment, Abraxane -- could have serious long-term implications for Abraxis.

Abraxane isn\'t just any new drug. In January 2005, it became the first drug using nanoparticles to receive FDA approval. Due to their small size, the nanoparticles have a number of unique attributes. Specifically, they helped improve the effectiveness of Taxol (the active molecule in Abraxane is the same as in Taxol) by lowering toxicity and opening up the possibility that the drug could be used by some patients for whom Taxol had lost its efficacy.

As a result of the FDA approval, the company\'s stock soared in early 2005. Much of the run-up was not directly attributable to Abraxane -- even though the drug recorded $134 million in sales in the past year and Abraxis agreed to a partnership with AstraZeneca (NYSE: AZN - News) to co-promote the drug. Instead, many investors -- myself included -- were excited about the company\'s ability to apply the nanoparticle formulation to improve and rejuvenate its long list of generic drugs.

And it is here that the Elan lawsuit could have the most chilling affect on Abraxis\' long-term prospects. Until the legal issues are resolved, a dark, menacing cloud will linger over the company\'s head.

Abraxis\' stock, which has fallen nearly 60% from its 52-week high, might make a compelling buy for more risk-tolerant investors, but my personal recommendation is to stay indoors and take a wait-and-see approach.

This is not because I have any unique knowledge of the patent in question. Rather, it is because if Abraxis Biosciences is found guilty, the company may well have to pay sizeable retributions to Elan. Moreover, the future value of its other drugs may also be greatly reduced. On the other hand, if it is found innocent, it simply has Elan\'s lawyers off its back. It must still seek FDA approval for those other applications in which it hopes to use the nanoparticle formulation -- and this can often be a long process.

To put it another way, my forecast for Abraxis reads like a cautious weather report. "A cool front appears to have settled in for the foreseeable future, bringing with it cloudy skies and a good chance of rain."

[Cyberhexe]

http://www.elan.com/EDT/nanocrystal%5Ftechnology/

NanoCrystal® Technology
For poorly water soluble compounds, Elan's proprietary NanoCrystal technology can enable formulation and improve compound activity and final product characteristics. The NanoCrystal technology can be incorporated into all dosage forms both parenteral and oral, including solid, liquid, fast-melt, pulsed release and controlled release dosage forms.

Poor water solubility correlates with slow dissolution rate, and decreasing particle size increases the surface area, which leads to an increase in dissolution rate. This can be accomplished predictably and efficiently using NanoCrystal technology. NanoCrystal particles are small particles of drug substance, typically less than 1000 nanometers (nm) in diameter, which are produced by milling the drug substance using a proprietary, wet-milling technique. The NanoCrystal particles of the drug are stabilized against agglomeration by surface adsorption of selected GRAS (Generally Regarded As Safe) stabilizers. The result is an aqueous dispersion of the drug substance that behaves like a solution - a NanoCrystal colloidal dispersion, which can be processed into finished dosage forms for all routes of administration.

To learn more about key properties of Elan’s NanoCrystal technology, please click the following:


Enhanced oral bioavailability
NanoCrystal technology enhances discovery effectiveness
Enhanced rate of absorption
Reduction in fed/fasted variability
Orally Disintegrating Tablet
Injectable route of administration
Inhaled delivery
Commercial Approvals for NanoCrystal® Technology

The first United States approval of a product produced incorporating the NanoCrystal technology occurred in August 2000: Wyeth’s first solid-dose formulation of the immunosuppressant Rapamune® (sirolimus) received marketing approval from the U.S. Food & Drug Administration (FDA). Rapamune was previously available only as an oral solution in bottles or sachets. The oral solution requires refrigeration storage, and must be mixed with water or orange juice prior to administration. The new tablet developed with NanoCrystal technology provides patients with more convenient administration and storage than Rapamune oral solution. The development of a NanoCrystal dispersion of sirolimus enabled the preparation of a solid dose formulation.

Emend® (aprepitant, MK 869) was approved by the FDA in March 2003 and launched in the United States by Merck in April 2003. Emend is a capsule containing 80 or 125 mg of aprepitant formulated as NanoCrystal drug particles. Whereas the first commercial product that utilized NanoCrystal technology (Rapamune) was a reformulation of an already marketed drug, Emend was developed as an NCE in a NanoCrystal formulation.

TriCor® (fenfibrate) was launched in December 2004 by Abbott in the U.S. following FDA approval. The new formulation of TriCor provides the benefits of a simplified, flexible dosing regime and allows for administration with or without food. The old formulation had to be taken with a meal.

Megace® ES (megestrol) was approved in July 2004 by the FDA and subsequently launched in the U.S. Megace ES utilizes Elan’s NanoCrystal technology delivery system to improve the rate of dissolution and bioavailability of the original megesterol acetate oral suspension. Patients taking Megace ES are able to take a one-teaspoon daily dose, or one-fourth of the volume of the original product. Megace ES is also 16 times less viscous than the original formulation, which may make it easier to swallow.


An Enabling Technology

NanoCrystal technology represents both an enabling technology for evaluating new chemical entities that exhibit poor water solubility and also a valuable tool for optimizing the performance of established drugs. NanoCrystal technology is of particular benefit for drugs with poor solubility in water. The process is also useful for moderately soluble drugs when a high concentration of drug in a low volume of fluid is desired.

Oral Administration

NanoCrystal technology can be incorporated in a variety of oral dosage presentations including:

Tablets – immediate-release film coated, modified-release, Orally Disintegrating Tablet
Capsules – immediate-release, modified-release
Liquid dispersions
Powders
NanoCrystal particles of active drug substance have rapid dissolution rates, and may then enable the following differentiated advantages:

Increased oral bioavailability
More rapid absorption of active drug substance
Elimination of fed-fasted effects

Parenteral Administration

NanoCrystal dispersions of poorly water-soluble drugs can also provide improved performance characteristics for intravenous, subcutaneous or intramuscular dosage forms.

NanoCrystal dispersions are low in viscosity and aqueous based, and may then enable the following differentiated advantages:

Higher dose loading with smaller dose volume
No organic solvents or pH extremes
Capability for sterile filtering
Longer dose retention in blood and tumors for some compounds
Typically, NanoCrystal dispersions are formed with concentrations between 50 mg/mL and 400 mg/mL. The size of NanoCrystal particles (typically less than 200 nanometers (nm) in diameter) allows for safe and effective passage through capillaries.

[bernie55]

Tuesday, November 14, 2006
Berube ON FDA (A draft)

WHAT FOLLOWS IS A DRAFT OF A PART OF AN ARTICLE THAT I AM WRITING.

The first nanotechnologies that will have an impact on public perception with be those associated with medical care. Quite simply, necrophobia is a powerful fear, and drugs and devices which can delay death will be treated favorably. The primary source materials for the following came from Nakissa Sadrieh of the FDA’s Office of Pharmaceutical Science.

The first problem will be the “…difficult[y] for the FDA to maintain adequate scientific expertise in the field.” This has always been the case with the FDA given the wages available for its personnel should they decide to relocate into the business of pharmaceutical and medical innovation.

Strangely enough, two areas posing the greatest difficulties for the FDA are food supplements and cosmetics, two sets of products which have the weakest legislative history of the entire set of products which might be intuited as under the FDA’s purvey.

Recently, there have been some indications nanoscience will make intrusions into the supplement market according to Ann Dowling, of the Royal Society. There seems to be concern that supplements using nanoparticles are on the Woodrow Wilson inventory though I have not verified this claim at this time.

As we learned from the Magic Nano fiasco not all products claiming to include nanotechnology actually do.

The best example of a nano0supplement to date might be Neosino AG’s Nanosilimagna™ allegedly containing calcium, silicon, and magnesium in the form of nanoparticles. It is marketed as a nutrition supplement for athletes under the name Neosino Sport Nano-Liquid™. Both the German Sports Federation, footballer Roy Makaay, and biking champion Michael Themann endorse it. In addition, it is also used in cosmetics as Neosino Spray-Forte™. Having reviewed one of the studies on its efficacy, there seems little doubt that product claims have been hyperbolized. Of course, the supplements industry does not have to go through clinical trials as required for pharmaceuticals and it is unclear whether any toxicity testing was undertaken. The supplements market is enormous and we can expect more examples to surface.

We know that nanoparticles have been used for over a decade in cosmetics especially sunscreens. This observation was made by ICTG and seven other groups when they filed a petition with the FDA in 2006. They claimed there were at least 116 sunscreens, cosmetics and personal care products currently on the market and warned about the production of free radicals and dermal penetration especially through broken skin. Additional fears about the use of nanoparticles in cosmetics can be found on the Friends of the Earth website.

The ICTA petition calls for a formal opinion on nanotechnology especially in regards to the concept of equivalence and the fast lane approval process. In addition, concerns over health and safety serve as the basis for demands for definitions and characterization, nanomaterials toxicity testing paradigms, and labeling. In addition, the petition calls for nano-specific product regulation much like those advocated by Davies and calls upon the FDA to comply with the National Environmental Policy Act (NEPA). The NEPA can demand a programmatic environmental impact statement as part of its regulatory powers and could serve as the basis of future legal action.

The FDA can only regulate when they have been empowered to regulate and some areas such as food supplements and over-the-counter sunscreens may need legislative activity. Actually, the ICTA complaint demands the FDA amend the OTC sunscreen Drug Monograph to reconsider sunscreens with nanoparticles as “new drugs” which would require the manufacturers submit a “new drug application” (NDA).

New medical nanoproducts will probably be subject to the same rigorous review given current pharmaceutical drugs though the FDA may need additional training in understanding the differences between a medical device, a drug, a biological or chemical entity, especially when a product looks like food but acts like medicine.

It has been difficult determining exactly what the FDA has been doing. Consider the following anecdote from Rick Weiss of the Washington Post (I am not defending its validity at this time). Norris Alderson, director of the FDA, reported in 2004 “the agency had so far approved six nano-based products: two drugs, two medical devices, and two sunscreen lotions. But [when questioned] he did not know whether special safety tests had been required. When pressed for details, an agency representative called back to report that, in fact, no nano-based products have been approved. No explanation for the confusion was offered.” This was a little embarassing. Clearly things have improved. Nonetheless, it is unsurprising that there have been many concerns expressed about the FDA’s regulatory authority and efforts.

These concerns led the 2004 Swiss Re report to conclude that both the FDA in the USA and the EC’s Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers have not established viable hazard guidelines. This complaint was amplified in the previously mentioned petition.

Even without explicit guidelines per se, the FDA seems to have the machinery and a track record that might make them especially viable as a government regulator for many nano-products though the breadth of their current mandate, especially considering advances at the nanoscale, might make their mission unmanageable.

In general, the FDA has a set of centers that deal with particular types of products. For example while the Center for Drug Evaluation and Research (CDER) is responsible for drugs, the Center for Devices and Radiological Health (CDRH) deals with devices. This brings us to the first issue. There are times when it becomes problematic determining when a nanoproduct is a drug, a device, or even a biologic because it has characteristics of all three classes.

Following on the heals of the FDA Modernization Act on 1997, two initiatives, the Tissue Reference Group in 1998 and the Device Action Plan in 1999, helped streamline jurisdictional issues. Today, when there is a question about jurisdiction, the Office for Combination Products resolves it. To help, the FDA has a Nanotechnology Interest Group (NTIG) with representatives from each center. Generally, the decision is based on the primary mode of action of the combination product. A ruling on the primary role of action of a combination product has been defined as “the most important therapeutic action” and this definition has been published in the Federal Register. In addition, the NTIG will facilitate inter-center communications. Kudos to the FDA.

Both devices and materials used in vivo undergo rigorous trials. For drugs, it begins with an Investigational New Drug (IND) application which generally involves small-scale clinical studies and animal testing. The next step requires clinical studies which follow a NDA. There are three phases. In Phase I, safety data is obtained from human subjects. Phase II generates data on effectiveness. Phase III expands on phase I and II by increasing the sample of subjects. A NDA review follows.

Here’s a review of some action to date.

Using technology developed by Elan Drug Delivery, Wyatt, Merck, Abbott, and American Pharmaceutials all developed nanoparticulate drugs and received FDA approval. Elan developed a milling technique which increases the bioavailability of some of these companies' products.

The IND-NDA three phase process described above was the route taken by Merck, Wyeth and American Pharmaceuticals. The FDA approved Abraxane™ in January 2005 for treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Abraxane™ is touted in the literature as the first approved nano-drug per se.

Merck proceeded with Emend®, the nanoparticulate drug aprepitant. Wyeth brought their drug sirolimus to Elan for development of a nanoparticulate formulation of sirolimus called Rapamune® which successfully obtained approval as well.

Instead of pursuing the clinical trail route, a company may elect to claim bio-equivalence as was done by Abbott in the case of TriCor® which was claimed as equivalent to fenofibrate. This seems the best place to begin the discussion on new versus existing.

In terms of devices, NanoOss® is a nanocrystaline version of hydroxyatite that is less likely to crack, hence is “has the strength of steel.” NanoOss® was considered as a Class II device and Angstrom Medica got FDA approval.

Devices are classified into three categories by the CDRH. Class I devices are subject to general controls and include band-aids and crutches. Class II devices need to show substantial equivalence, much like bio-equivalence above and include items like wheelchairs and tampons. Class III devices involve the “introduction of a new material, procedure, or device without a substantial equivalent in the marketplace.” “In the eyes of the FDA, NanoOss® was just calcium phosphate.” Hence, we see another instance when a nanoproduct is viewed as equivalent to its more bulk chemical equivalent for purposes of regulation.

Another device, CardioMEMS’ EndoSure Wireless AAA Pressure Measurement System, was designed to treat an aneurism of the lower abdominal aorta and it received FDA approval in February 2004. According to CardioMEMS’ CEO Davis Stern had to prove the materials it used were bio-compatible and stable. As a Class III device, clinical tests began in March 2004 in Brazil and eventually included populations in Argentina, Canada, and the USA.” If there is an area that the ETC Group should begin to question, it might be the use of developing countries' citizens [thought I would not classify Argentina and Brazil as developing countries per se] as test subjects in the approval process.

Immunicon received FDA approval for its CellSearch Circulating Tumor Cell Kit, Immunicon CellTracks AutoPrep System, and Immunicon CellSpotter Analyzer Cell Analyzer using magneto-nanoparticles called ferrofluids in August 2004.

In another case reported by Small Times’ David Forman, AcryMed’s product known as SilvaGard® got approval. SilvaGard® is an antibacterial nanoparticle coating for medical devices. As such, AcryMed’s customers file for FDA approval rather than AcryMed. In December 2005, I-Flow Corp.’s ON-Q SilverSoaker® antimicrobial catheter using SilvaGard® was approved.

The FDA cites that it has traditionally regulated many products with particulate materials in the nano-size range and that the current pharmacotoxicity tests are sufficiently adequate for most nanotechnology products that it will regulate.” In case, where current tests are inadequate, the FDA can require the petitioner to meet higher burdens of proof.

The FDA also has authority for post-market surveillance. While some consumer confidence has eroded after the heart damage problems associated with Vioxx and other Cox 2 inhibitors, Congress is anticipating internal reforms and there is some support for new legislation as well.


http://nanohype.blogspot.com/2006/11/berube-on-fda-draft.htm…