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[nostradamus]

Teva Wins Generic Uceris® Patent Trial


JERUSALEM--(BUSINESS WIRE)--Oct. 31, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that the United States District Court for the District of Delaware has ruled in the Company’s favor in patent litigation involving Teva’s abbreviated new drug application (ANDA) directed to a generic version of Valeant’s Uceris® (budesonide ER) tablets. At trial in May, the Court found that Plaintiffs did not meet the threshold to establish infringement, and the Court has now issued its written decision confirming that Teva’s ANDA product does not infringe the asserted patent.

“We are pleased to have another legal win on one of our first-to-file PIV patent challenges brought in through the Actavis Generics acquisition.” said Dipankar Bhattacharjee, President and CEO, Global Generic Medicines, Teva. “This presents another first generic opportunity for Teva and we look forward to offering this product to our customers when otherwise able to.”

Based on available information, Teva believes it is a "first applicant" to file an ANDA for the generic version of Uceris®. Should its ANDA be approved, Teva may be entitled to 180 days of generic market exclusivity.

Uceris® had annual sales of approximately $191 million in the U.S., according to IMS data as of September 2017.

With nearly 600 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market. Teva has over 300 product registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over 100 pending first-to-files in the U.S. Currently, one in seven generic prescriptions dispensed in the U.S. is filled with a Teva generic product.

[Hebi55]

Aus diesen und anderen Gründen kauft Novaris AAA und nicht Cosmo Pharma. Ein Trauerspiel hier.

[kosh]

Wie passt das Urteil zur Verlängerung des US-Patentschutzes bis 2031 für Uceris?
-> https://www.nzz.ch/wirtschaft/newsticke ... 1.18399456

Das Pharmaunternehmen Cosmo hat in den USA eine Verlängerung des Patentschutzes für sein Magendarm-Medikament Uceris von 2020 bis ins Jahr 2031 erhalten.
... In dem Patent würden die Hauptcharakteristiken der MMX-Technologie erstmals «reflektiert und integriert», heisst es weiter.

Nebenbei bemerkt:
-> http://www.cosmopharma.com/news-and-med ... 7/20171023

FDA GRANTS COSMO PHARMACEUTICALS BOTH QIDP AND FAST TRACK DESIGNATIONS FOR AEMCOLO (RIFAMYCIN SV MMX®)
Home /News & Media /Press Releases & Company News / 2017

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Aemcolo Eligible for Additional Market Exclusivity and Priority Review in the United States

Drug Candidate Offers Significant Anti-Infective Properties and
Unique Delivery Mechanism for Treatment of Travelers’ Diarrhea



Dublin – October 23, 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced that the U.S. Food and Drug Administration has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for Aemcolo (Rifamycin SV MMX®), formerly Zemcolo, for the treatment of patients with travelers’ diarrhea.

“There have not been any new chemical entities approved to treat colonic infections in years, so resistance to current available drugs is a serious issue. The QIDP and Fast Track designations highlight the importance of treating colonic infections with new chemical entities and Aemcolo’s potential to address this unmet medical need,” said Alessandro Della Chà, Chief Executive Officer of Cosmo Pharmaceuticals. “We look forward to productive interactions with the FDA as we work to bring Aemcolo to patients.”

If approved, Aemcolo will be eligible for an additional five years of market exclusivity based on the QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. With Fast Track designation, Aemcolo is now eligible for priority review. Fast track is a process the FDA designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The program’s purpose is to get important new drugs to the patient earlier.

Phase III clinical trials of Aemcolo in traveler's diarrhea have been completed in the US and EU. The Phase III program demonstrated Aemcolo’s superiority as compared to placebo (p-value= 0.0008) and its non-inferiority as compared to Ciprofloxacin.

New Drug and Marketing Authorization Applications are currently being prepared for submission to the FDA and European Medicines Agency (EMA), respectively.

About Aemcolo
Aemcolo is a pharmaceutical product candidate employing rifamycin SV engineered with Cosmo Pharmaceuticals’ MMX® technology. Aemcolo is a broad spectrum, semi-synthetic, orally non-absorbable antibiotic which can be used for the treatment of bacterial infections of the colon such as traveler’s diarrhea. The application of MMX® technology to rifamycin SV allows the antibiotic to be delivered directly into the colon, avoiding unwanted effects on the beneficial bacterial flora living in the upper portions of the gastro-intestinal tract. The specific dissolution profile of Aemcolo tablets is thought to increase the colonic disposition of the antibiotic so that an optimized intestinal concentration is achieved thus abating its systemic absorption in the small intestine.

Grüsse
kosh

[jheimi]

Das würde mich auch intetessieren..

[kosh]

Update zur Klage betreffend Patent-Verletzung von Uceris®
Dublin – 1. November 2017 – Cosmo Pharmaceuticals N.V. (SIX: COPN) gab bekannt, dass das US-Bezirksgericht von Delaware entschieden hat, dass es sich bei Actavis’ (Teva) Produkt im verkürzten Zulassungsverfahren (Abbreviated New Drug Application, ANDA) für die generische Version von Valeant’s Uceris® nicht um eine Patentverletzung handelt.

«Wir sind überzeugt, dass wir eine gute Grundlage für eine Berufung haben und werden unsere Patentrechte an Uceris® auch weiterhin nachdrücklich verteidigen." sagte Alessandro Della Chà, Chief Executive Officer von Cosmo Pharmaceuticals.

-> http://www.cosmopharma.com/~/media/File ... urt_GE.pdf

Delaware, also die US-Steueroase wo das Bankgeheimnis vom US-Justizministerium weiterhin geduldet wird, bekundet man am Gericht offensichtlich auch Mühe mit dem US-Patentrecht. Ich hoffe, die Berufung findet vor einem weniger korrumpierbaren Gericht in einem anderen Bundesstaat statt und Della Chà lässt schon mal Kanonen aufstellen, um auf Spatzen zu schiessen - die Sprache der Anwälte. Allzu naiv sollte man nicht in ein US-Gerichtsverfahren eintreten und die Frage nach der Befangenheit eines Richters nicht ausgeschlossen werden.

Die Amis auf Kurs
Grüsse
kosh

[Dilbert]

Rechtliches Hick-Hack in/mit USA - um Patente - ohjemine, das tönt nach Nerven-, Kräfte- und Geld-Raub.


Aber hier dafür noch ein "Anti-Depressivum" by Cosmo:
http://www.cosmopharma.com/~/media/File ... MMX_GE.pdf


Gruss
Dilbert

[jheimi]

Auf dem aktuellen Niveau weist Cosmo eine Marktkap. von ca.2Mia.CHF auf.
Zum Vergleich, Idorsia hat eine Markkap. von aktuell 2.4Mrd.CHF, dabei noch kein Produkt weiter als Phase 2.

Irgendwie stimmen die Relationen überhaupt nicht. Das Potential von Cosmo wird entweder total falsch eingeschätzt oder wir sind alles Träumer.

[hampistravelservice]

Nachbörslich:
668 17:31:27 141.60 17'000

ergibt eine Transaktion über 2'400'000

wünsche ein schönes Weekend

[jheimi]

Das war nicht nachbörslich, sondern in der Schlussauktion und hat wohl nicht viel zu bedeuten.

[hampistravelservice]

Richtig, aber trotz allem in einem Trade gleich viel Umsatz wie den ganzen Tag