NanoCrystal (TM) Technology - 500 Beiträge pro Seite

[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

[MrRipley]

Bioverfügbarkeit - das A und O

[Cyberhexe]

Pfizer Earns Up, Warns of Patent Lapses
Wednesday October 20, 11:05 am ET
By Ransdell Pierson
...
The world`s largest drugmaker, which forecast 2004 earnings in line with Wall Street expectations, said the four medicines facing patent expirations collectively have U.S. annual sales of more than $5 billion that will be endangered.


5Mrd Umsatzpotenzial mit auslaufendem Patentschutz, dies ist auch für Pfizer kein Pappenstiel.
Mit der NanoCrystal (TM) Technology hätte PFE die Möglichkeit den Patentschutz durch neue Formulierungen zu verlängern.

Würde mich nicht wundern, wenn Pfizer eines Tages versuchen würde, Elan zu schlucken !


http://biz.yahoo.com/rb/041020/health_pfizer_earns_5.html

[Cyberhexe]

Abkommen zwischen Elan und Entremed bzgl. Produktion von Panzem NCD (NanoChrystalDispersion) mit Hilfe der NanoChrystalTechnology. Panzem NCD ist der grosse Hoffnungsträger von Entremed in der Onkologie. In der Anwendung hat diese für den Patienten den Vorteil, dass sie über den Tag in flüssiger Form einzunehmen ist und somit einerseits kontinuierliche PLasmaspiegel ermöglicht und zum anderen nicht gespritzt oder via Infusion verabreicht werden.

http://biz.yahoo.com/prnews/040929/dcw010_1.html

EntreMed Presents Additional Panzem(R) (2ME2) Preclinical Data at EORTC-NCI-AACR Symposium
Wednesday September 29, 10:00 am ET
...
Elan Drug Delivery, Inc. is manufacturing Panzem NCD® for EntreMed using its proprietary NanoCrystal® technology.

[Cyberhexe]

es gibt Gerüchte, dass Elan die NanoChrystal Tech ausgliedern könnte (spin off) - dies würde eigentlich Sinn machen: Fokussierung auf Kernkompetenz und günstig hinsichtlich einer verbesserten shareholder value

[Cyberhexe]

Roche hat nun die Möglichkeit Elans NanoChrystal-Technologie auf breiter Basis anzuwenden. Ich habe das Roche-Portfolio jedoch noch nicht genau studiert, um sagen zu können, welche Kandidaten hierfür in Frage kommen - dies sind vor allem die schwer wasserlöslichen Wikrkstoffe.

Elan and Roche Expand Nanocrystal Technology License
Friday January 7, 2:35 am ET
Proprietary Elan Technology Helps Improve Drug Delivery by Transforming Drugs into More Effective and "User Friendly" Dosage Forms to Increase Patient Convenience and Compliance


DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 7, 2005-- Elan Corporation, plc today announced a broad license agreement with Roche around Elan`s proprietary NanoCrystal® technology. The agreement will provide Roche with access to NanoCrystal technology and the right to apply it to a number of proprietary drug candidates. Elan will receive development milestones and royalties on sales of any product incorporating the use of NanoCrystal technology.
Paul Breen, Executive Vice President, Global Services & Operations, Elan said, "We are very pleased to broaden our license agreement with Roche. This agreement highlights the robustness of the technology and the interest of pharmaceutical companies to use this technology. This past year saw the third product launched in the US incorporating our NanoCrystal technology. This agreement brings to a close a very successful year for Elan`s drug delivery efforts."

"We are pleased to add this technology to our formulation development options and are enthusiastic about its drug delivery potential," said Ursula Redeker, Roche`s Global Head of Safety & Technical Sciences. "This agreement further strengthens our ability to deliver value for patients as we continue to develop innovative, differentiated medicines."

[Cyberhexe]

... und schon wieder hat Elan mit seiner NanoChrystal-Technologie eine mögliche Geldquelle erschlossen - falls der Wirkstoff zugelassen wird. Und wiederum ist mit Johnson&Johnson ein Platzhirsch der Kooperationspartner.
Allerdings findet man nichts über die Höhe der möglichen Lizenzzahlungen. Weiss da jemand etwas. Bei den MABs sind dies normalerweise 3 bis 5% der Umsätze, welche den "Entdecker-Firmen" mit den patentierten Technologien (z.B. PDLI) abzugeben sind. Ich weiss jedoch nicht, ob diese Technologie der Miniaturisierung ähnlich hohe Lizenzgebühren ermöglicht. Weiss jemand mehr?

Elan`s Proprietary NanoCrystal-R- Technology is Used by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. -J&J PRD- in Phase III Clinical Trial of Paliperidone Palmitate
Wednesday January 12, 2:30 am ET


DUBLIN, Ireland--(BUSINESS WIRE)--Jan. 12, 2005--Elan Corporation, plc today announced that its proprietary NanoCrystal® technology is being used by Johnson & Johnson Pharmaceutical Research & Development (J&J PRD) in a Phase III clinical trial of a long acting injectable formulation of its paliperidone palmitate in patients with Schizophrenia. NanoCrystal technology can improve the bioavailability of drugs by transforming them into nanometer-sized particles that can be used to create more effective and convenient dosage forms such as tablets, capsules, liquids, and powders.
"For more than 30 years, Elan has been working to meet the challenges of drug delivery and enhance the performance of drugs. This important milestone further reinforces the strength of our NanoCrystal technology," said Paul Breen, Executive Vice President, Global Services & Operations, Elan. "Having already launched three products in the U.S. using our NanoCrystal technology, we hope that these Phase III trials will be successful in bringing yet another product to market."

[Gbix]

Press Release Source: Elan Corporation, plc

Japanese Patent Office Issues Patent Certificate to Elan for Its NanoCrystal-TM- Technology
Thursday February 3, 2:30 am ET

DUBLIN, Ireland--(BUSINESS WIRE)--Feb. 3, 2005--Elan Corporation, plc today announced that Japan`s Patent Office has issued a patent certificate for Elan`s proprietary NanoCrystal(TM) Technology. Japanese Patent Number 36020546, which expires January 24, 2012, protects intellectual property related to Elan`s NanoCrystal technology.

"This is a significant milestone in the development of new applications of our NanoCrystal technology and may facilitate the expansion of our activities in Japan, one of the world`s most significant pharmaceutical markets. The patent may allow us to work more closely with Japanese companies to help them develop and commercialise compounds that exhibit poor water-solubility," said Paul Breen, Executive Vice President, Global Services & Operations, Elan.

Three pharmaceutical products have been commercialised in the U.S. incorporating NanoCrystal Technology to date, with several additional product launches anticipated over the next two years.

About Elan`s NanoCrystal Technology

NanoCrystal technology may enhance the clinical performance of poorly water-soluble drugs by transforming them into nanometer-sized particles. 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. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, sterile forms for injection, with the potential for substantial improvements to clinical performance. Elan`s NanoCrystal Technology is protected by more than 130 U.S. and foreign patents and patent applications. More information about Elan`s NanoCrystal technology is available at www.elan.com/drugdelivery.

About Elan

Elan is a neuroscience-based biotechnology company that is focused on discovering, developing, manufacturing, selling and marketing advanced therapies in neurodegenerative diseases, autoimmune diseases and severe pain. Elan`s (NYSE:ELN - News) shares trade on the New York, London and Dublin Stock Exchanges.

NanoCrystal(TM) Technology is a registered trademark owned by Elan Pharma International Limited Corporation, Ireland

Contact:

Elan Corporation, plc
Investors:
Emer Reynolds,
353-1-709-4000
800-252-3526
or
Media:
Anita Kawatra
212-407-5740
800-252-3526


Source: Elan Corporation, plc

[Cyberhexe]

zur Erinnerung...Elans Nanotechnologie-Patente generieren bereits enorme Lizenzzahlungen, welche mit einem hohen Deckungsbeitrag in das Gesamtergebnis einfliessen.
Anbei die Zahlen aus dem letzten Quartalsbericht:

Contract manufacturing and royalties

Contract manufacturing and royalty revenue from Elan`s Drug Technology business comprises revenue earned from products Elan manufactures for third parties and royalties Elan earns on sales by third parties of products that incorporate Elan`s technologies.

Contract manufacturing and royalty revenue was $43.5 million in the first quarter of 2005, an increase of 45% over the $30.0 million recorded in the first quarter of 2004. The increase in revenue reflects increased sales by third parties of products that incorporate Elan`s technologies and increased manufacturing activity.

Mittlerweile gibt es Verbindungen zu fast allen Grössen in der Pharmabranche:

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

[Cyberhexe]

anbei eine Aufstellung von den Produkten, die mit Elans NanoChrystal Technology bereits vermarktet werden

Avinza® - once-daily, novel dual release morphine sulphate (Ligand Pharma)
Cardizem® SR – twice-daily, sustained-release diltiazem (Biovail Pharma)
Cardizem® CD – once-daily, sustained-release diltiazem (Biovail Pharma)
Emend® – oral table form of aprepitant, a poorly water soluble compound (Merck)
Focalin XR(TM) - extended-release capsules for (ADHD) (Novartis)
Megace ES - oral suspension for the treatment of anorexia, cachexia and weight loss (Par Pharma)
Naprelan® - once-daily, sustained-release naproxen sodium (Wyeth-Ayerst Lab)
Rapamune® - oral tablet form of poorly water soluble compound (Wyeth-Ayerst Lab)
Ritalin® LA – once-daily, pulsatile release of methylphenidate (Novartis)
Theo-Dur® - twice-daily, sustained-release theophylline (Schering)
TriCor – (Abbott Lab)
Verelan® - once-daily, sustained-release verapamil (Schwarz Pharma)
Verelan® PM – modified release, chronotherapeutic verapamil (Schwarz Pharma)

zusätzlich existieren Abkommen mit weiteren Grössen der Branche:

Aventis Pharma S.A., a subsidiary of Aventis S.A.
Bristol-Myers Squibb Company (NYSE: BMY)
Janssen Pharmaceutica N.V. (Janssen)
Johnson & Johnson – Paliperidone Palmitate P3
Roche

Da dürfte zukünftig noch einiges zu erwarten sein, da mit neuen Formulierungen und Spezialitäten die Möglichkeit besteht, sich von den Nachahmern fernzuhalten!

[Cyberhexe]

Elan ist bereits in einigen Nanotechnologiefonds ein Schwergewicht. Warum? Hier ist die Begründung:


NanoCrystal Technology
Elan’s NanoCrystal technology to create nano-sized particles of drugs without changing their chemical properties
was actually developed by Kodak and is based on a simple idea. Smaller particles = more surface area = more
chemical reactions = better bioavailability. More of the drug is actually used by the body and less is available to
cause side effects. To see how this works, think of how long it takes for a piece of rock candy to dissolve in water.
The same quantity in table sugar form dissolves much faster because the particles are smaller. If you took the same
quantity and pulverized it into nano-sized sugar particles they would almost instantly dissolve.
Elan acquired the technology from Kodak in 1998 for $150 million; but then tried to sell the business in 2002 when
Elan was trying to reduce its debt. Fortunately, they were not successful because this technology is a hidden gem.
I think there is a huge opportunity for Elan’s NanoCrystal technology to improve the safety and efficacy of a wide
range of new and existing drugs. Alza never had anything like this.
So far, Elan has used this technology to partner with major drug companies to improve their partner’s existing drugs.
Elan typically earns royalties in the 5% - 8% range on these deals. But I think Elan should be able to do much
better. All that the partner brings to the table is a blockbuster drug with a soon to be expired patent. Elan brings the
technology to create an improved drug with renewed patent protection that can compete well against other generic
versions for years to come. Why should Elan settle for 5% - 8% of revenues? What’s to stop Elan from using this
technology to come out with their own generic versions of these blockbuster drugs after they go off-patent?
This is a much better way to build a stable of blockbuster drugs. Instead of funding R&D and working on pre-clinical
compounds that might take a decade to bring to market IF they prove to be effective Elan could be working on the
NanoCrystal versions of blockbuster drugs that will soon be off-patent. These are drugs that have already proven to
be a success. And the FDA approval process is streamlined: generic drug manufacturers need only show chemical
equivalence. That is much easier to prove than efficacy, helping make this a faster and more certain path to build
a big pharmaceutical company.

[Cyberhexe]

Die Zusammenarbeit mit Roche und anderen Pharmagrössen mit Elans NanoChrystalTechnology ist allerdngs nichts Neues. Aufgrund der bereits bestehenden Übereinkünfte mit einigen Pharmariesen kann zukünftig mit Neuigkeiten gerechnet werden und zwar vor allem im Bereich von schlecht wasserlöslichen Aktivsubstanzen, die demnächst ihren Patentschutz verlieren. Durch Verwendung von Elans patentierter Technologie wird eine erhöhte Bioverfügbarkeit realisiert, wodurch die Möglichkeit besteht sich nach Ablauf des Patentschutzes von generischen Anbietern abzugrenzen.
Es wäre darüber hinaus noch spannend zu wissen, in welcher Höhe die Lizenzzahlungen vereinbart werden. Da nach Ablauf des Patentschutzes Elan durchaus auch ohne den eigentlichen Patentinhaber aktiv werden könnte, ist die Ausgangslage für Elan bei der Verhandlung der Lizenzzahlungen gar nicht so schlecht. Und es gilt zu beachten, dass derartige Lizenzzahlungen fast vollständig in den Deckungsbeitrag eingehen, da so gut wie keine Kosten anfallen.

nachfolgend die Pressemitteilungen zur 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