Eagle Pharma - fly like an Eagle - 500 Beiträge pro Seite

[BiotechHype]

Mit Eagle Pharmaceuticals (EGRX) habe ich einen Wert ausfindig gemacht, der in den nächsten Monaten vor wichtigen Meilensteinen steht. Im Juli stehen gleich 2 PDUFA-Termine an, die die Unterbewertung des Unternehmens aufzeigen werden. Derzeit fliegt dieser Adler unter dem Radar. Das IPO ging sichtlich daneben. Zu 15 Dollar an den Markt gekommen, fristet der Wert nun unter 10 Dollar ein unbeachtetes Dasein. Damit ist EGRX mit 135 Millionen Dollar bewertet. Zwei Produkte sind bereits zugelassen und 2 weitere könnten im Juli hinzukommen. Von besonderem Interesse sollte die Entscheidung am 06.07. zu Bendamustine RTD sein. Dies ist eine verbesserte Version des von TEVA vermarkteten Produkts Treanda, welches im Jahr 2012 Umsätze in Höhe von $ 600 Millionen bescherte. Sobald das Patent abläuft kann Eagle mit seiner verbesserten Version in direkte Konkurrenz eintreten. Dies könnte spätestens Anfang 2016 der Fall sein. Sollten die Gerichte schon vorher positiv im Sinne von EGRX entscheiden, dann könnte ein früherer Markteintritt in den USA bewerkstelligt werden. Eine zweite PDUFA-Entscheidung erwartet EGRX am 22.07. zu Ryanodex OH. Das Umsatzpotenzial ist überschaubar, allerdings würde das die Fähigkeit des Unternehmens untermauern Produkte erfolgreich durch die Entscheidungsinstanzen zu bringen.

Das Geschäftsmodell des Unternehmens ist es, vermarktete und zugelassene Produkte zu verbessern. Nach Ablauf des Patentschutzes des Originalpräparats versucht EGRX mit dem eigenen Produkt in den Markt einzutreten. Hierbei startet man nicht mit einem Nachahmerpräparat, sondern direkt mit einer verbesserten Version. Somit erhofft man sich einen Vorteil gegenüber konkurrierenden Generikaherstellern.

EGRX verlässt sich allerdings nicht auf die Vermarktung von verbesserten Nachahmerprodukten. Mit Ryanodex EHS versucht man in einer bisher unberührten Inidikation (extertional heat stroke) Fuß zu fassen. Allerdings befindet man sich hier noch in einer frühen Entwicklungsphase.

Zum IPO wurden über 50 Mio Dollar eingesammelt, die das Unternehmen auf solide Beine stellen.

Pipeline:

[gengpengy]

!

Dieser Beitrag wurde von CloudMOD moderiert. Grund: Spam, Werbung

[BiotechHype]

Am 08. Mai stellt das Unternehmen seine Strategie auf der Deutsche Bank Health Care Conference vor. Dies ist die erste Unternehmenspräsentation nach dem IPO. Ist die erstklassige Chance auf sich aufmerksam zu machen.

Eagle Pharmaceuticals, Inc. ("Eagle") (EGRX) announced that the Company will present at the 39th Annual Deutsche Bank Health Care Conference on May 7 – 8, 2014 at the InterContinental Hotel in Boston, MA.

Scott Tarriff, President and Chief Executive Officer, and David E. Riggs, Chief Financial Officer, will host the presentation on Thursday, May 8, 2014 at 3:30 p.m. EDT.

http://finance.yahoo.com/news/eagle-pharmaceuticals-present-…

[Oberlaendler]

Teva and Eagle Pharmaceuticals Announce Teva’s License to Commercialize Eagle’s Bendamustine Rapid Infusion Product
Eagle has Submitted NDA for Bendamustine Rapid Infusion to FDA

JERUSALEM & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--

Teva Pharmaceutical Industries Ltd. (TEVA) and Eagle Pharmaceuticals, Inc. (EGRX) today announce that the companies have entered into an exclusive license agreement for EP-3102, Eagle’s bendamustine hydrochloride (HCl) rapid infusion product for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL). Teva will be responsible for all U.S. commercial activities for the product including promotion and distribution. Eagle has responsibility for obtaining all regulatory approvals, conducting post-approval clinical studies, if required, and initially supplying drug product to Teva.

Eagle has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Eagle has requested Priority Review of the NDA; this product candidate has received Orphan Drug Designations for both CLL and indolent B-cell NHL, and therefore may be eligible for seven years of exclusivity upon approval. The NDA is supported by data from Eagle’s recently-completed clinical trials demonstrating that the rapid infusion bendamustine HCl product can be administered in ten minutes in a low-volume, 50 mL admixture.

“Since 2008, Teva’s bendamustine HCl product, TREANDA®, has played a valuable role in the treatment of patients with CLL or indolent B-cell NHL that has progressed,” stated Paul Rittman, Vice President and General Manager, Teva Oncology. “With a substantially shorter infusion time, Eagle’s rapid infusion bendamustine HCl represents an important and improved benefit to both patients and healthcare providers. By adding this product to Teva’s Oncology portfolio, we are furthering our commitment to enhancing treatment options for patients affected by cancer and executing on a business development strategy to pursue opportunities in therapeutic areas where we can apply our expertise, commercial infrastructure and experience.”

“We are very pleased to partner with Teva for the commercialization of our rapid infusion bendamustine product,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “Given their strong presence and unsurpassed knowledge of this market, we believe there is no better company than Teva to optimize the market potential of this product.”

As part of the agreement, Teva will waive its orphan drug exclusivities for NHL and CLL with respect to EP-3102, which should allow the product to come to market more quickly. Under the terms of the exclusive license agreement, Eagle will receive an upfront cash payment of $30 million and is eligible to receive up to $90 million in additional milestone payments. In addition, Eagle will receive double-digit royalties on net sales of the product, assuming FDA approval.

The companies will also settle the pending patent infringement action between them in the United States District Court for the District of Delaware involving Teva’s U.S. Patent No. 8,791,270.

http://finance.yahoo.com/news/teva-eagle-pharmaceuticals-ann…

Gruß Oberländler

[Oberlaendler]

Kleine Nachrichtensammlung der letzten Zeit:

Eagle Pharmaceuticals, Inc. Reports First Quarter 2015 Results
Business Wire Eagle Pharmaceuticals, Inc. May 12, 2015 6:50 AM

WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--

Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq: EGRX) today announced its financial results for the three-month period ended March 31, 2015. Highlights of and subsequent to the first quarter of 2015 include:
• Entered into an Exclusive License Agreement (the “License Agreement”) and a Settlement and License Agreement (the “Settlement Agreement”) for our bendamustine hydrochloride (HCl) rapid infusion product (the “rapid infusion” product) with Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA). Under the terms of the License Agreement, Eagle received an upfront cash payment of $30 million and is currently eligible to receive up to $90 million in additional milestone payments. In addition, Eagle is entitled to receive double digit percentage royalties on future net sales of the product, if approved by the U.S. Food and Drug Administration (the “FDA”);
•Our New Drug Application (“NDA”) for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regime was accepted for filing by the FDA with a December 13, 2015 PDUFA date;
• The U.S. Patent and Trademark Office granted a new patent pertaining to the rapid infusion bendamustine product; this patent expires in March 2033;
• RYANODEX® (dantrolene sodium) for Injectable Suspension was granted seven years of U.S. market exclusivity for the treatment of malignant hyperthermia (MH) by the FDA;
• Product sales increased to $3.1 million compared to $1.2 million for the first quarter of 2014;
• Total revenue was $36.3 million, which includes the $30 million upfront payment from Teva under the License Agreement. Total revenue was $5.0 million for the first quarter of 2014;
• Net income was $19.7 million, or $1.38 per basic and $1.31 per diluted share, compared to a net loss attributable to common stockholders of $(3.2) million, or $(0.36) per basic and diluted share, for the first quarter of 2014;
• Cash, cash equivalents and short-term investments were $115.9 million at March 31, 2015, including $54.3 million in net proceeds from an underwritten follow-on offering of EGRX common stock, including exercise of the underwriter's over-allotment option (less the underwriter discount). ...
http://finance.yahoo.com/news/eagle-pharmaceuticals-inc-repo…


New Patent Issued for Eagle Pharmaceuticals’ Bendamustine Rapid Infusion ProductBusiness Wire(Tue, May 19)
http://finance.yahoo.com/news/patent-issued-eagle-pharmaceut…


und von heute:
6:50 am Eagle Pharma announces it has submitted an NDA to the US FDA for its ready-to-use Bivalirudin product Briefing.com(Wed 6:50AM EDT)
http://finance.yahoo.com/news/inplay-briefing-com-055139997.…

Gruß Oberländler