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    Zogenix - den Schmerzen an den Kragen - 500 Beiträge pro Seite

    eröffnet am 18.09.11 16:16:40 von
    neuester Beitrag 19.03.14 19:03:42 von
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      Avatar
      schrieb am 18.09.11 16:16:40
      Beitrag Nr. 1 ()
      Zum Einstieg meine Einleitung aus dem Run Up Thread:

      "Wieso habe ich eigentlich dieses Perlchen nicht früher entdeckt??? Es geht um Zogenix...

      Im Laufe von Q3 werden Phase 3 - Ergebnisse von Zohydro erwartet. Zohydro ist eine
      Hydrocodon-Version, die bei mittelschweren bis schweren chronischen Schmerzen verabreicht werden soll.
      Der Vorteil von Zohydro ist, dass es nicht mit einem weiteren Analgetikum kombiniert werden muss.
      Mit diesem einzigartigen Ansatz adressiert man einen 3,2 Mrd Dollar Markt.

      Darüberhinaus soll in diesem Jahr bereits ein Umsatz von 46-52 Mio Dollar mit dem im letzten Jahr
      eingeführten nadellosen SUMAVEL DoesPro (Sumatriptan) erwirtschaftet werden."

      Was hat sich in der Zwischenzeit ereignet?

      Der Kurs ist um 60% gefallen! Warum?

      ZGNX hat zu den Halbjahreszahlen Cash in Höhe von $ 7,7 Mio ausgewiesen. Bei einem Cashburn
      von 20 Mio pro Quartal war abzusehen, dass dringend neue Mittel beschafft werden mussten.
      Eine 30 Mio Finanzierungszusage hat hier nur kurz für Entlastung gesorgt. Um eine stabile
      finanzielle Lage zu gewährleisten wurde im August eine Kapitalerhöhung angekündigt.
      Dies wurde zum Anlass genommen den Kurs in den freien Fall zu bringen. Leider hat sich das
      Management bei der Durchführung der Kapitalerhöhung nicht gerade mit Ruhm bekleckert. Letzte
      Woche wurde nun die Platzierung von 30 Mio Anteilen zu 2 Dollar verkündet. Dies verschafft
      Zogenix den nötigen Spielraum um Zohydro bis zur Zulassung zu bringen. Der Cashburn wird
      in den nächsten Quartalen durch das Auslaufen der Phase 3 Studien zu Zohydro und des
      Umsatzwachstums bei SUMAVEL Dosepro rückläufig sein.

      Was spricht für Zogenix?

      1. Zogenix verfügt bereits über ein zugelassenes Produkt namens SUMAVEL Dosepro zur Behandlung
      von Migräne. Für 2011 wird ein Umsatz in Höhe von 45 Mio erwartet, was einem Umsatzwachstum
      von mehr als 100% im Vergleich zum Vorjahr entsprechen würde. Das letzte ausgewiesene Quartalswachstum
      betrug 16%.

      2. Mit Zohydro befindet sich ein noch aussichtsreicherer Produktkandidat in der Pipeline.
      Die ersten positiven Phase 3 Ergebnisse zur Wirksamkeit wurden im August berichtet.
      Die Ergebnisse hinsichtlich der Sicherheit werden in den nächsten Wochen erwartet. Bei
      gutem Verlauf könnte bereits Anfang 2012 ein Zulassungsantrag für Zohydro eingereicht werden.

      3. Einer Marketcap von knapp 130 Mio stehen nun Cashreserven in Höhe von 80-90 Mio
      entgegen. Produkte und Pipeline werden derzeit mit nicht einmal 50 Mio bewertet. Lachhaft!

      4. Zogenix hat die Pipeline mit der Einlizensierung von Relday eindrucksvoll gestärkt.
      Das zugrunde liegende Ausgangsprodukt risperidone erreicht weltweite Umsätze von 1,5 Mrd
      Dollar. Ein verbessertes Produkt könnte hier einen gehörigen Anteil des Kuchens ergattern.

      Meine langfristigen Umsatzschätzungen für Zogenix:

      SUMAVEL Dosepro 100 Mio Dollar
      Zohydro 150 Mio Dollar
      Relday 150 Mio Dollar

      Alleine die Umsätze aus den ersten beiden Produkten würden nach meinen Schätzungen
      eine Marktkapitalisierung von mindestens 400-500 Mio rechtfertigen.

      Bei Kursen um 2 Dollar überwiegen m.E. die Chancen bei einem Investment in ZGNX.

      Dieser Beitrag ist nicht als Kauf- oder Verkaufsempfehlung zu verstehen.
      Zogenix hat allerdings einen eigenen Thread verdient... ;)
      Avatar
      schrieb am 18.09.11 18:21:52
      Beitrag Nr. 2 ()
      Zitat von Der.Eroberer: Zum Einstieg meine Einleitung aus dem Run Up Thread:

      "Wieso habe ich eigentlich dieses Perlchen nicht früher entdeckt??? Es geht um Zogenix...

      Im Laufe von Q3 werden Phase 3 - Ergebnisse von Zohydro erwartet. Zohydro ist eine
      Hydrocodon-Version, die bei mittelschweren bis schweren chronischen Schmerzen verabreicht werden soll.
      Der Vorteil von Zohydro ist, dass es nicht mit einem weiteren Analgetikum kombiniert werden muss.
      Mit diesem einzigartigen Ansatz adressiert man einen 3,2 Mrd Dollar Markt.

      Darüberhinaus soll in diesem Jahr bereits ein Umsatz von 46-52 Mio Dollar mit dem im letzten Jahr
      eingeführten nadellosen SUMAVEL DoesPro (Sumatriptan) erwirtschaftet werden."

      Was hat sich in der Zwischenzeit ereignet?

      Der Kurs ist um 60% gefallen! Warum?

      ZGNX hat zu den Halbjahreszahlen Cash in Höhe von $ 7,7 Mio ausgewiesen. Bei einem Cashburn
      von 20 Mio pro Quartal war abzusehen, dass dringend neue Mittel beschafft werden mussten.
      Eine 30 Mio Finanzierungszusage hat hier nur kurz für Entlastung gesorgt. Um eine stabile
      finanzielle Lage zu gewährleisten wurde im August eine Kapitalerhöhung angekündigt.
      Dies wurde zum Anlass genommen den Kurs in den freien Fall zu bringen. Leider hat sich das
      Management bei der Durchführung der Kapitalerhöhung nicht gerade mit Ruhm bekleckert. Letzte
      Woche wurde nun die Platzierung von 30 Mio Anteilen zu 2 Dollar verkündet. Dies verschafft
      Zogenix den nötigen Spielraum um Zohydro bis zur Zulassung zu bringen. Der Cashburn wird
      in den nächsten Quartalen durch das Auslaufen der Phase 3 Studien zu Zohydro und des
      Umsatzwachstums bei SUMAVEL Dosepro rückläufig sein.

      Was spricht für Zogenix?

      1. Zogenix verfügt bereits über ein zugelassenes Produkt namens SUMAVEL Dosepro zur Behandlung
      von Migräne. Für 2011 wird ein Umsatz in Höhe von 45 Mio erwartet, was einem Umsatzwachstum
      von mehr als 100% im Vergleich zum Vorjahr entsprechen würde. Das letzte ausgewiesene Quartalswachstum
      betrug 16%.

      2. Mit Zohydro befindet sich ein noch aussichtsreicherer Produktkandidat in der Pipeline.
      Die ersten positiven Phase 3 Ergebnisse zur Wirksamkeit wurden im August berichtet.
      Die Ergebnisse hinsichtlich der Sicherheit werden in den nächsten Wochen erwartet. Bei
      gutem Verlauf könnte bereits Anfang 2012 ein Zulassungsantrag für Zohydro eingereicht werden.

      3. Einer Marketcap von knapp 130 Mio stehen nun Cashreserven in Höhe von 80-90 Mio
      entgegen. Produkte und Pipeline werden derzeit mit nicht einmal 50 Mio bewertet. Lachhaft!

      4. Zogenix hat die Pipeline mit der Einlizensierung von Relday eindrucksvoll gestärkt.
      Das zugrunde liegende Ausgangsprodukt risperidone erreicht weltweite Umsätze von 1,5 Mrd
      Dollar. Ein verbessertes Produkt könnte hier einen gehörigen Anteil des Kuchens ergattern.

      Meine langfristigen Umsatzschätzungen für Zogenix:

      SUMAVEL Dosepro 100 Mio Dollar
      Zohydro 150 Mio Dollar
      Relday 150 Mio Dollar

      Alleine die Umsätze aus den ersten beiden Produkten würden nach meinen Schätzungen
      eine Marktkapitalisierung von mindestens 400-500 Mio rechtfertigen.

      Bei Kursen um 2 Dollar überwiegen m.E. die Chancen bei einem Investment in ZGNX.

      Dieser Beitrag ist nicht als Kauf- oder Verkaufsempfehlung zu verstehen.
      Zogenix hat allerdings einen eigenen Thread verdient... ;)


      ich rate dir,steige ein mit allem was du hast :rolleyes:
      Avatar
      schrieb am 18.09.11 18:31:36
      Beitrag Nr. 3 ()
      Interessante Präsentation:

      http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9M…

      Seite 16 zeigt die Umsatzerwartung bei nur 1%-iger Penetration der Märkte
      Avatar
      schrieb am 18.09.11 20:44:40
      Beitrag Nr. 4 ()
      Avatar
      schrieb am 18.09.11 23:27:46
      Beitrag Nr. 5 ()
      Für einen BioTech hört es sich für einen der von BioTechs keine Ahnung hat jedenfalls erstmal schon interessant an. ;)


      An DIESEM Punkt/"EV" liegen aber oft meine Problemchen:

      Zitat von Der.Eroberer: Einer Marketcap von knapp 130 Mio stehen nun Cashreserven in Höhe von 80-90 Mio entgegen. Produkte und Pipeline werden derzeit mit nicht einmal 50 Mio bewertet. Lachhaft!


      Weil:

      Zitat von Der.Eroberer: Bei einem Cashburn von 20 Mio pro Quartal


      Wart mal viere Derer.



      Habe hier keine Absichten, nur eine Bemerkung zu diesem Punkt.

      Gruß
      P.

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      Avatar
      schrieb am 19.09.11 12:25:40
      Beitrag Nr. 6 ()
      Danke für deinen Hinweis.

      Allerdings wird sich der Cashburn mit dem Auslaufen der Phase3 Studien und dem wachsenden Umsatz für
      SUMAVEL Dosepro zwangsläufig in den kommenden Quartalen nach unten bewegen. Dann sind es schnell mal
      6-8 Quartale. Bis dahin wird Zohydro auf dem Markt sein.

      Dass es bis zur Zulassung von Zohydro zu einer weiteren Kapitalerhöhung kommen wird scheint fast sicher.
      Dennoch fällt die Bewertung der derzeitigen Pipeline dürftig aus. Zumal für Zohydro vereinzelt Blockbuster-
      potenzial gesehen wird. Empfehlung von heute folgt...
      Avatar
      schrieb am 19.09.11 12:33:07
      Beitrag Nr. 7 ()
      Heutige Empfehlung aus Seeking Alpha:

      Buy Zogenix Inc. (ZGNX): ZGNX is a five-year old San Diego-based biotech company engaged in the development and commercialization of therapeutics to treat central nervous system (CNS) disorders and pain. Its only commercial product is the SUMAVEL DosePro™ system, which offers needle-free subcutaneous administration of sumatriptan for acute treatment of migraine and cluster headache.

      In addition, ZGNX recently announced in mid-August positive phase 3 results for its lead product candidate Zohydro, a controlled release formulation of hydrocodone, for the treatment of severe chronic pain in patients requiring around-the-clock opioid therapy, and plans to submit a New Drug Application to the FDA by early 2012 with potential approval and product launch in 2013.

      The stock was down severely by 30.6% last week after the firm announced that it was increasing its secondary offering to up to 34.5 million shares (at $2.00 per share) from the 13.8 million shares announced at the end of August, a significant dilution to the company’s existing share count of 34.1 million.

      We believe that ZGNX is a buy here. The 30 million shares offering is to raise funds for bringing its new drug candidate Zohydro to market, which could be a blockbuster drug as it would be the first extended-release hydrocodone treatment available without acetaminophen, which if taken in high quantities can cause liver toxicity.

      In addition, Zohydro utilizes Elan Plc’s (ELN) proprietary Spheroidal Oral Drug Absorption System or SODAS® technology, which modifies the release profile of hydrocodone to provide consistent 12-hour pain relief relative to immediate-release combination formulations. Hydrocodone is currently the most prescribed drug in the U.S. with over 131.2 million prescriptions written in 2010. If approved, Zohydro with its improved long-term safety profile would fill an important niche in this large market, and we believe ZGNX at a current market cap of less than $150 million (even after the dilution from the secondary offering) is an attractive speculative buy at these levels.

      http://seekingalpha.com/article/294363-small-cap-biotech-top…
      Avatar
      schrieb am 19.09.11 23:31:54
      Beitrag Nr. 8 ()
      Ein anderes ausgezeichnetes Schmerzmittel Nyloxin und Cobroxin,
      mit dessen Hilfe hat kürzlich Mr.Gottfurcht, der an euner schmerzhaften reumatische Arthritis leidet, den Mount Everst bestiegen.

      Trotzdem notiert die Aktie des Erzeugers Nutra Oharm nur 0,06 €.

      Es sieht so aus, als ob die kleinen Pharmas nicht genug verdienen.
      Avatar
      schrieb am 21.09.11 19:00:02
      Beitrag Nr. 9 ()
      Massive Insiderkäufe im Rahmen der Kapitalerhöhung:

      www.openinsider.com

      Symbol: ZGNX
      Avatar
      schrieb am 01.10.11 15:27:07
      Beitrag Nr. 10 ()
      Und wieder einen Schritt weiter:

      SAN DIEGO, Sept. 30, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has obtained the required long-term clinical exposure data from its Phase 3 open label safety study (Study 802) of Zohydro(TM) (hydrocodone bitartrate) extended-release capsules. The safety database of at least 300 patients on therapy with Zohydro for six months and at least 100 patients on therapy with Zohydro for one year is a requisite component of the 505(b)(2) New Drug Application (NDA) for Zohydro to the U.S. Food and Drug Administration (FDA), which remains on track for submission in early 2012.

      Roger Hawley, Chief Executive Officer of Zogenix, said, "Following on the recent announcement of positive top-line results from our pivotal Phase 3 efficacy study (Study 801) for Zohydro, we are pleased to announce that we have now obtained the long-term safety dataset required for the Zohydro NDA submission. We are now focused on analyzing the results of the two Phase 3 studies and preparing the data for submission to the FDA. We have our pre-NDA meeting scheduled with the FDA during the fourth quarter and we believe we remain on track to submit the Zohydro NDA in early 2012. In addition, our recently priced secondary offering provides us with the resources to advance Zohydro through potential FDA approval."

      Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.

      Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to consistently deliver hydrocodone over an extended period of time, without exposure to acetaminophen, will position the product well in this large market.
      Avatar
      schrieb am 21.12.11 18:46:45
      Beitrag Nr. 11 ()
      So, nach meinem schmerzhaften Ausstieg, werde ich mich jetzt wieder in ZGNX engagieren.
      Die Verluste müssen wieder reinkommen... ;)

      Den entscheidenden Anstoss gab die heutige Meldung:

      Zogenix Reviews Positive Sales Trends and 2012 Commercial Initiatives for SUMAVEL(R) DosePro(R)

      Evaluating New Co-Promotion Opportunities to Supplement Zogenix U.S. Sales Team

      Zogenix to Host Conference Call Today at 9:00 am ET

      SAN DIEGO, Dec. 21, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced earlier today with Astellas Pharma US, Inc. (Astellas), a U.S. subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo:4503) that the co-promotion of SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System currently in place will end on March 31, 2012. SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System, was launched with Astellas in January 2010 for the acute treatment of migraine and cluster headache. Beginning in the second quarter of 2012, Zogenix will assume full responsibility for the continued commercialization of the brand, with a focus on headache specialists, neurologists and primary care physicians who treat a significant number of migraine patients. Zogenix is also evaluating potential co-promotion partners who could complement the Zogenix sales force efforts.

      Based on current sales trends and the economics of the co-promotion agreement, Zogenix expects minimal impact on brand cash flow in 2012 as highlighted by the following:
      During the third quarter 2011, Zogenix generated 63% of SUMAVEL DosePro unit demand from specialists within its segment; combined with institutions within the Zogenix segment plus unit demand from the jointly-called on Astellas segment of primary care practices, Zogenix's responsibility totals 71% of the unit demand
      Much of the remaining primary care prescription activity is concentrated with approximately 500 physicians prescribing 14% of unit demand in the third quarter. These physicians will become a key priority for the Zogenix sales force. Combined with currently called on physicians, the Zogenix sales force will be calling upon physicians who prescribe 85% of the total SUMAVEL DosePro unit demand
      By February 1, 2012, a detailed transition plan will be agreed to by Zogenix and Astellas to ensure uninterrupted access and service to physicians within the Astellas segment
      Growth in the third quarter was driven primarily by continued performance of the Zogenix sales force.
      The Zogenix sales force expansion from 80 to 95 representatives was recently completed
      Zogenix will leverage its existing strong relationships with neurologists and headache specialists to create more brand awareness among primary care physicians. Sales tools deployed by the Zogenix sales force have proved effective in driving prescriptions for SUMAVEL DosePro and will now be introduced to primary care physicians. This includes the new Migraine Toolbox, a comprehensive patient starter kit, and the published Phase 4 clinical data
      Meeting expectations for the brand, prescription refill rate for SUMAVEL DosePro remained consistent at 38% for the third quarter.
      During the first ten weeks of the fourth quarter, total prescriptions were up 16% over the first ten weeks in the third quarter.
      Payer coverage for SUMAVEL DosePro continues to expand and additional contracts have been signed in the third and fourth quarters.
      The co-promotion agreement calls for tail payments which are estimated to be approximately $3.6 million in July 2013 and $2.1 million in July 2014. These amounts are estimates and actuals will be based on the final sales results for the 12 months ending March 31, 2012

      Roger Hawley, chief executive officer of Zogenix, said, "The conclusion of our co-promotion agreement with Astellas starting in the second quarter will lower expenses as a result of the elimination of the service fee. We are evaluating a number of potential pharmaceutical company partners who have expressed interest in promoting SUMAVEL DosePro within their prescriber audiences. Alternatively, we will explore a modest expansion of our sales force. We expect to provide an update on these activities by the end of the first quarter."

      Hawley continues, "Our long-term goal with SUMAVEL DosePro is unchanged. The unmet patient need is significant. We have a clear objective to get more physicians to treat the varying intensity of the attacks with the right form of triptan therapy and focus on pain-free outcomes as the acute treatment goal."
      Avatar
      schrieb am 21.12.11 18:49:36
      Beitrag Nr. 12 ()
      Gestern bereits gab es ein Update zu dem FDA-Zulassungsantrag zu Zohydro:

      Zogenix Completes Zohydro(TM) Pre-NDA Meetings With FDA
      Zohydro NDA Submission on Track

      SAN DIEGO, Dec. 20, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX - News), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has concluded its pre-New Drug Application (NDA) meetings with the U.S. Food & Drug Administration (FDA) related to its lead investigational product candidate, Zohydro(TM) (hydrocodone bitartrate extended-release capsules). The purpose of the meetings was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Zohydro, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. After a detailed review of the submission timeline, Zogenix plans to submit the NDA for Zohydro early in the second quarter of 2012.

      Stephen Farr, PhD, president and chief operating officer of Zogenix, said, "The completion of our pre-NDA meetings with the FDA brings us one more important step closer to potentially gaining approval for Zohydro. We appreciate the informative interactions, timeliness, and clarity provided by the FDA, as well as the full support of Alkermes, our CMC partner, in the pre-NDA meeting process."

      Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.

      Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to provide consistent 12-hour pain relief, without exposure to acetaminophen, will position the product well in this large market.
      Avatar
      schrieb am 21.12.11 21:08:37
      Beitrag Nr. 13 ()
      Ein etwas aufgedrehter Yahoo-Board Teilnehmer, der allerdings die Situation von
      Zogenix auf den Punkt bringt:


      "Tax loss selling ending soon in fact don't look now but almost 80,000 shares traded after hours in 9 blocks. If you are new to the game rest assured every December crazy things happen especially to stocks near 52 week lows & with the proper DD makes for excellent next year $$$$$$ makers...

      Almost at Cash Insiders bought 7.1 mill shares @ $2 now $1.49 DD on ZGNX 95 Mill $$$ Mkt Cap 71 Mill in Cash & approved Migraine drug doing 40 mill in sales 2011 & projected to do 80 mill in 2012 BUT their big dollar drug has phase 3 trials completed & positive on their ( First to Market ) Extended release Hydrocodone drug & also ( First to Market ) APAP free or Acetaminophen free ( causes Liver Toxicity) & FDA cracking down on it. ZGNX according to last CC has already been approached by Pharmas looking to partner up on drug & will make a decision in early 2012 whether to partner or go alone. Why go alone ??? Huge market for Hydrocodone ( Over 6 Billion Dollars a Year ) & Oppenhiemer has opined that ZGNX drug will do around 500 Million a year in sales. Insiders know the potential & have bought over 56% of the total outstanding shares 36.4 Million shares including the 7.1 Million shares purchased in September. Coupled with the 18 Million shares just purchased in the last 3 months by Institutions which now totals over 25 million shares & growing . BTW 18 million shares bought 11 thousand shares sold ???? FLOAT is around 4 Million shares 4 MILLION ...This is a sure shot double/triple/??? easily could be another INHX $2 to $10 quickly on FDA or Partner news or a straight buyout..INSANE Valuation here though


      Oppenheimer anticipates positive top-line Phase III results from ZGNX's Zohydro by the end of August, potentially driving the shares to the ~$5-6 range. As a reminder, Zohydro is ZGNX's novel, oral, single-entity controlled-release formulation of hydrocodone, intended to treat moderate to severe chronic pain. Our positive bias on Phase III results is based on strong phase II data, as well as the well-understood safety/efficacy profile of the hydrocodone class. If approved, they estimate Zohydro's relative advantages in safety and dosing convenience could help garner a meaningful portion of the branded hydrocodone market, resulting in peak sales of ~$500 mln. On positive data, they anticipate ZGNX to file an NDA in 2012, followed by an acceleration in partnership discussions later in 2012.


      No dilution till 2013 & that's IF they go it alone if they partner they will have 100's of millions of dollars....

      From S.E.C. filing of latest 10Q

      As of September 30, 2011, we had cash and cash equivalents of $70.8 million. We believe that our cash and cash equivalents as of September 30, 2011, together with future revenue and borrowings available under our $10.0 million revolving credit facility, will be sufficient to fund our operations into the second quarter of 2013."

      http://messages.finance.yahoo.com/Stocks_(A_to_Z)/Stocks_Z/t…
      Avatar
      schrieb am 23.12.11 15:12:50
      Beitrag Nr. 14 ()
      Um ZGNX bewertungstechnisch fassen zu können, vergleiche ich die Situation mit
      bereits bekannten Verhaltensmustern anderer Aktien. Ich nehme hier mal
      Adolor und Pacira zum Vergleich:

      Adolor
      Zugelassenes Produkt Entereg soll in 2011 um die 40 Mio Umsatz machen. Damit
      ist der Umsatz absolut vergleichbar mit SUMAVEL von ZGNX. Weiterhin hatte man
      eine Pipeline, die nicht höherwertiger als die von ZGNX war. Ich spreche von "war",
      weil Adolor von Cubist für einen Gegenwert von 221 Mio Dollar übernommen wurde.
      Weitere 200 Mio Dollar fließen, wenn die Pipeline sich positiv entwickelt.
      ZGNX ist mit 107 Mio bewertet...

      Pacira
      Pacira hat es in diesem Jahr geschafft die Zulassung für ein Schmerzmittel zu erhalten. Aktuell
      bringt es Pacira auf eine Marketcap von 200 Mio bei Kursen um 8,50 Dollar. Spitzen-
      kurse von über 15 Dollar wurden im Vorfeld des FDA-Entscheids für Pacira bezahlt.
      Dies würde einer Bewertung von über 300 Mio gleichkommen.
      ZGNX ist mit 107 Mio bewertet...

      Pacira ist für mich das beste Vorbild für eine mögiche Entwicklung von ZGNX.
      Ich rechne damit, dass stärkere Verkaufszahlen von SUMAVEL und die nahende
      Zulassung von Zohydro eine Bewertung von 200-300 Mio Dollar zulassen werden.
      Dies bedeutet, dass Kurse oberhalb von 3 Dollar in 2012 ohne Probleme vertretbar
      wären.

      Anfang des Jahres 2011 wurde ZGNX bereits mit über 200 Mio Dollar bewertet. Nun
      haben wir positive Ergebnisse zu Zohydro in der Tasche und die Umsätze von
      SUMAVEL Dosepro haben sich respektabel entwickelt. Warum sollte ZGNX dieses
      Bewertungsniveau nicht wieder in 2012 erreichen? ZGNX ist ein potenzieller
      Verdoppler, der die Tiefs bereits gesehen haben könnte.

      Keine Kauf- oder Verkaufsempfehlung
      1 Antwort
      Avatar
      schrieb am 23.12.11 17:15:25
      Beitrag Nr. 15 ()
      Antwort auf Beitrag Nr.: 42.518.314 von Der.Eroberer am 23.12.11 15:12:50

      Ich finde es immer bissl tricky bei Entwicklern Bewertungsvergleiche untereinander zu machen. Vor allem da -einerseits:

      1) unterscheiden sie sich i.d.R., bei allen "Ähnlichkeiten", schlussendlich doch sehr

      2) andererseits wird als Projektion/Masstab ein Unternehmen herangezogen dass sich selber noch in der Entwicklung befindet(i.e. bei dem selber eine "faire" Bewertung/Einschätzung der Aussichten kaum vernünftig vorzunehmen ist)


      Somit fängt man irgendwie mit n´em Kartenhaus an, bei dem schon gleich die ersten 5/20 weggezogen wurden -und jetzt viel Spaß beim stapeln. ;)

      Gruß
      P.
      Avatar
      schrieb am 24.12.11 11:33:33
      Beitrag Nr. 16 ()
      Da gebe ich dir grundsätzlich Recht. Bewertungsvergleiche sind "tricky", allerdings
      ist es meine Art Unternehmen zu vergleichen. Bleibt die Gefahr, dass man diesen
      Vergleich als Einziger so sieht.
      Avatar
      schrieb am 27.12.11 19:59:22
      Beitrag Nr. 17 ()
      Zogenix macht bei hohem Volumen innerhalb von 3 Handelstagen +30%. Ziehe meinen Stopkurs
      nach. Somit kann die Position nicht mehr ins Minus laufen. Weiterhin erwarte ich Kurse von
      deutlich über 2 Dollar für 2012.
      Avatar
      schrieb am 28.12.11 18:18:39
      Beitrag Nr. 18 ()
      Welch ein Aufwärtsdruck! :D

      Habe die Hälfte meiner Anteile mit +45% verkauft. Nicht schlecht für 5 Handelstage...
      Avatar
      schrieb am 30.12.11 15:56:41
      Beitrag Nr. 19 ()
      Rest raus mit knapp über 50% Gewinn. Dieser Trade hat noch zu einem positiven
      Jahresausklang geführt. Im 1. Quartal konzentriere ich mich auf die Run-Ups.
      Avatar
      schrieb am 03.01.12 20:55:40
      Beitrag Nr. 20 ()
      Top Biotech Pick For 2012: Zogenix

      Tis the season to look for top picks for maximum gains in 2012. In the biotech space, one needs to look no further than the San-Diego based specialty pharmaceutical company, Zogenix (ZGNX). What began as a small, private start-up in 2006 has developed into a thriving public company focused on treating central nervous system disorders and pain. Key ZGNX developments and assets include:
      FDA approved drug, Sumavel DosePro, with triple digit year-over-year U.S. sales growth.
      Positive Phase 3 results for a second drug, Zohydro, seeking FDA approval.
      New Drug Application (NDA) for Zohydro to be submitted to FDA in Q2 2012.
      Licensing deal agreement for a third drug, Relday, seeking FDA approval.
      $70 million in cash on balance sheet
      Huge insider buying at 2010 IPO and at September 2011 follow-on offering
      Institutional ownership increased by 18,109,313 shares in Q3 2011.

      What also makes Zogenix so attractive as a top biotech stock pick for 2012 is the likelihood that ZGNX’s depressed stock price ($2.19 at time of this writing) will return to the valuation it commanded just a year ago at $6.90 (52-week high reached shortly after IPO) when it had only one (#1) of the seven bullish attributes listed above.

      So let’s take a look at the three things that make Zogenix an undervalued biotech gem for 2012: top management, valuable drug assets, and major insider & institutional funding.

      1. Zogenix’s Top Management

      A big key to Zogenix’s early success is its founder, Cam Garner. Garner is one of the best in the business at creating and growing specialty pharmaceutical companies into attractive acquisition targets for bigger pharma. His track record of success is legendary as illustrated by taking his profitable business model to tiny Dura Pharmaceuticals (valued at $5 million when Garner took the helm) and executing a strategy that resulted in Dura being acquired a decade later by Irish drugmaker Elan Corp. (ELN) in a stock deal worth $1.8 billion.

      That Dura business model has been replicated in multiple Garner creations in the years since his 2000 Dura transformation resulting in similar outcomes - premium takeovers greatly benefitting early investors. Examples include Cam Garner-founded companies DJ Pharma (sold to Biovail Corp. for $212M), and Xcel Pharmaceuticals (sold to Valeant Pharmaceutical for $282M).

      Garner’s successful model is built upon picking a strong management team first. Second is finding a niche market and product to sell. And, third is focusing your sales efforts on doctor specialists (instead of primary care physicians) who work in your niche market.

      The top seats of management at Zogenix are filled with many trusted, former Elan Pharmaceutical alums that worked alongside Garner at Elan after the Dura acquisition. The first recruits were pharmaceutical industry executive sales veteran, Richard Hawley (Zogenix CEO since August 2006), and drug development expert Stephen J. Farr (Zogenix President since May 2006). Later on, more management seats were filled by top-notch Elan alums Mark Thompson (VP, Sales and Managed Markets), Stephen Jenner (VP, Marketing), and Cynthia Robinson (Chief Development Officer).

      After Zogenix got venture capital from founding investors Cam Garner, Jim Blair (Domain Associates), Scott Glenn (Windamere Ventures), David Hale (Hybritech Founder), Clarus Ventures, Thomas, McNerney & Partners, Abingworth Management, Chicago Growth Partners, and Scale Venture Partners, the team identified the products to acquire and sell.

      2. Zogenix’s Valuable Drug Assets

      Sumavel DosePro (Drug Asset #1)

      The choice of Stephen Farr as the first President of Zogenix was a big clue to what product and niche market Cam Garner and company had their eye on. Farr was recruited from Aradigm Corporation where he served as Senior Vice President and Chief Scientific Officer. In 2003, Farr led the effort at Aradign to identify and acquire the novel drug delivery technology now called DosePro. He also led the development of DosePro’s application for the drug, sumatriptan, for the treatment of migraines.

      Just three months after its May 2006 founding, Zogenix acquired the product, Intraject Needle Free Technology (later to be renamed DosePro) and related assets from Aradigm Corporation for $4 million.

      In just 18 months after acquiring this technology, a New Drug Application (NDA) for sumatriptan DosePro was submitted to the FDA. Just over a year later, the FDA approved Sumavel DosePro needle-free delivery system to treat migraine headaches.

      As of January 2010, Sumavel DosePro is now being commercially sold in the U.S. and Europe as the first single use, needle-free product for treating acute migraine and cluster headaches. Sumavel unit sales and prescription sequential growth have been very robust in this $3.5B market.

      Sales growth of Sumavel DosePro since FDA approval:

      Q1 2010: $1.9M

      Q2 2010: $4.2M

      Q3 2010: $5.7M

      Q4 2010: $6.8M

      Q1 2011: $7.5M

      Q2 2011: $8.7M

      Assuming that Sumavel DosePro can gain a conservative 1% share of the 12.2 million triptan prescriptions per year, this translates into annual Sumaval revenue of $59 million according to Zogenix’s projections. Regulatory approval to market Sumavel DosePro has also been granted in Germany, United Kingdon, Denmark, Sweden, and Norway.

      Zohydro, Deal With Elan (Drug Asset #2)

      While Sumavel DosePro was undergoing clinical trials in 2007, Zogenix was moving forward on its second drug development opportunity. Thanks to the familiarity of Elan’s drug pipeline by Zogenix’s founder and management, Zogenix moved to strike a license agreement deal with Elan Corporation to develop and commercialize a late stage, controlled-release opioid (now called Zohydro) for the treatment of pain. This drug opportunity was attractive because hydrocodone is the most widely prescribed drug in the United States representing a $13B market opportunity.

      Pivotal phase 3 clinical trials began in March of 2010, which resulted in positive efficacy and safety results. We are now one quarter away from Zogenix’s second New Drug Application (NDA) submission scheduled for early Q2 2012. If Zohydro is approved, it would become the first acetaminophen-free, oral, single-entity hydrocodone, 12-hour extended release formulation on the market.

      The likelihood of FDA approval for Zohydro is high for the following reasons:

      Positive Phase 3 Trial Results, expressed this way by Chief Executive Officer Hawley of Zogenix, "These positive results represent an important step forward in the commercialization of our extended-release hydrocodone. Adding Zohydro as our second commercial product would be transformational for Zogenix's business, given the number of chronic pain patients and the growing physician demand for an acetaminophen-free hydrocodone product.

      Acetaminophen-free formulation. The FDA is very concerned with the liver toxicity acetaminophen (APAP) can cause. In January 13, 2012, the FDA asked all drug manufacturers to limit acetaminophen in drugs on liver health concerns.

      Zohydro will be the first acetaminophen-free hydrocodone product if approved. It will also be the first extended release (12 hours) single-entity hydrocodone.

      Assuming that Zohydro can gain 1% market share of the 128 million hydrocodone prescriptions per year, this translates into annual Zohydro revenue of $248 million, according to Zogenix’s projections. Zogenix would enter the largest prescription drug category in the United States, hydrocodone pain products. Over 128 million prescriptions were filled in this drug category in 2010 representing a $7.5 billion market opportunity.

      Relday, Deal with DURECT (Drug Asset #3)

      And if Zogenix was not busy enough with the Zohydro New Drug Application and growing Sumavel DosePro sales this year, it has also recently inked another deal with DURECT Corporation to develop and commercialize a proprietary, long-acting injectable formulation of risperidone using DURECT’s SABER controlled-release formulation in combination with Zogenix’s DosePro needle-free drug delivery system.

      Zogenix will initiate clinical studies for this new product candidate (Relday) in early 2012 after it files its third NDA since the inception of the company in 2006. The combined market opportunity for oral and injectable antipsychotic products is estimated at more than $16B in 2010.

      Relday is an example of the unlimited partner licensing opportunities available with the DosePro technology.

      3. Huge Insider Ownership and Recent Buying

      This may seem like a remarkable achievement for a start-up company in such a short amount of time, but that is exactly how Cam Garner and company have planned and executed management recruitment, product identification and acquisition, and commercial sales growth many times over. It is a winning formula.

      This successful model has attracted a loyal insider investor base who have continued to add to their Zogenix holdings at every opportunity and without selling a single share to date. In addition to the early Series A & B rounds of funding when Zogenix was still privately held, these same insider founding funders have added more to their positions in two subsequent public offerings.

      The first public offering was in November 2010 when Zogenix held an IPO resulting in the sale of 14, 436,493 shares priced at $4.00 for gross proceeds of $57.7 million. The early investors’ preferred shares were converted to common stock in the deal yet they also continued to add to their positions by buying nearly half of the offering at $4.00/share. Most notable insider (board members) buys at this IPO were:

      Domain Partners (Jim Blair, Director); 2,349,999 shares bought at $4.00

      Scale Venture Partners (Louis Bock, Director); 1,839,645 shares bought at $4.00

      Clarus Ventures (Kurt Wheeler, Director); 1,750,000 shares bought at $4.00

      Chicago Growth Partners (Arda Minacherhomjee, Director); 550,000 shares bought at $4.00

      Cam Garner (Chairman of Board); 30,000 shares bought at $4.00

      And most recently in September 2011, Zogenix raised more capital via a follow-in offering of 30,000,000 shares priced at $2.00. The $56.9 million in proceeds would fund the regulatory approval of Zohydro, the initial clinical trial of Relday, and the ongoing commercialization of Sumavel DosePro.

      In this recent offering, the committed insiders (board members and executive management team) again added to their ZGNX holdings by buying 9,165,000 shares out of the 30,000,000 shares offered. Most notable insider buys at $2.00 were as follows:

      Domain Partners (Jim Blair, Director); 3,500,000 shares bought at $2.00

      Clarus Ventures (Kurt Wheeler, Director); 3,500,000 shares bought at $2.00

      Scale Venture Partners (Louis Bock, Director); 1,250,000 shares bought at $2.00

      Ann Rhoads (CFO, Zogenix); 100,000 shares bought at $2.00

      Richard Hawley (CEO, Zogenix); 50,000 shares bought at $2.00

      And if those insider buys were not enough validation to the 2012 potential of Zogenix’s growth and stock price appreciation, institutional ownership in ZGNX skyrocketed in Q3 2011 by 18,109,313 shares to reach 25,250,372 shares, or 38% of outstanding shares.

      The future looks very bright for Zogenix in 2012 due to the strong execution of management, near-term catalysts with drug assets (NDA submission for Zohydro, sales growth of Sumavel DosePro, new partner agreements, etc.) and strong funding support. These fundamental strengths along with likely buyout speculation should propel ZGNX stock back over $6.00 for a healthy 3-bagger gain.

      For those reasons (and more to come in a second ZGNX article), Zogenix is my top biotech pick for 2012.

      Disclosure: I am long ZGNX.

      http://seekingalpha.com/article/317105-top-biotech-pick-for-…
      Avatar
      schrieb am 04.01.12 18:32:32
      Beitrag Nr. 21 ()
      So schnell kann es gehen. Vor wenigen Tagen noch unter 1,50 - jetzt bei über 2,50.
      Leider schon draußen, aber dennoch bemerkenswerte Entwicklung.
      Avatar
      schrieb am 06.01.12 16:36:02
      Beitrag Nr. 22 ()
      Heute kratzt ZGNX bereits an der 3 Dollar-Marke. Das sind 100% innerhalb
      von knapp 2 Wochen. Eine solch krasse Bewegung hätte selbst ich nicht für möglich
      gehalten. Nun sollte es langsam gut sein. Kann mir nicht vorstellen, dass diese
      Bewegung in diesem Tempo weitergeht.
      Avatar
      schrieb am 20.12.12 13:40:24
      Beitrag Nr. 23 ()
      Wer dabei bei ZGNX? Ich bin nach folgenden News spekulativ um USD 1.20 rein:

      NEW YORK (AP) -- Shares of Zogenix tumbled to an all-time low on Monday after U.S. government health experts overwhelmingly voted against a stronger version of hydrocodone.

      THE SPARK: On Friday the Food and Drug Administration's panel of pain specialists voted 11-2 with one abstention against Zohydro for moderate to severe chronic pain. The drug was developed as a long-acting pain reliever by San Diego-based Zogenix Inc.

      The panelists acknowledged that the pill would likely reduce pain, but worried it would exacerbate the U.S. epidemic of prescription painkiller abuse.

      The FDA is not required to follow the group's recommendation, though it often does so. It is scheduled to make its decision on the drug by March 1.

      THE ANALYSIS: Oppenheimer's Christopher Holterhoff downgraded Zogenix to "Perform" from "Outperform" and removed its $3 price target.

      The analyst said in a client note that he does not anticipate Zogenix will receive FDA approval. He anticipates that the company will continue to work with the FDA on matters of concern in an effort to potentially receive approval for Zohydro in the future.

      SHARE ACTION: Zogenix Inc.'s stock fell $1.10, or 46.6 percent, to $1.26 in afternoon trading. Earlier in the session the stock dropped to $1.25, its lowest level since the shares went public in November 2010.

      http://finance.yahoo.com/news/zogenix-hits-time-low-panel-17…
      Avatar
      schrieb am 27.10.13 18:38:46
      Beitrag Nr. 24 ()
      Zogenix Wins U.S. Approval for Pure Hydrocodone Pain Pill

      Zogenix Inc. (ZGNX) won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.

      The Food and Drug Administration cleared the San Diego-based company’s Zohydro for the management of pain severe enough to require continuous, long-term treatment, the agency said today in a statement. Zohydro is intended as an alternative to drugs including Vicodin that mix hydrocodone with less-potent medicines such as aceteminophen.

      Zogenix is counting on the painkiller to boost its $44 million in 2012 revenue from sales of a migraine treatment Sumavel. FDA advisers recommended in December that Zohydro not gain market clearance until the agency examined greater measures to curb opioid abuse. The medicine doesn’t contain tamper-proof technology that other drugmakers are using to prevent crushing and snorting of their pills, such as closely held Purdue Pharma LP’s OxyContin.

      http://www.bloomberg.com/news/2013-10-25/zogenix-wins-u-s-ap…
      Avatar
      schrieb am 14.11.13 14:37:14
      Beitrag Nr. 25 ()
      Oppenheimer upgraded Zogenix with a $5 price target citing its encouraging physician survey relating to the company's recently approved chronic pain drug Zohydro.

      http://finance.yahoo.com/news/zogenix-upgraded-outperform-pe…
      Avatar
      schrieb am 07.12.13 15:58:14
      Beitrag Nr. 26 ()
      Zogenix and Battelle Expand DosePro Technology Business Agreement

      SAN DIEGO and COLUMBUS, Ohio, Dec. 3, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (ZGNX) and Battelle today announced that they have entered into a new long-term collaborative agreement regarding co-marketing of Zogenix's DosePro(R) needle-free drug delivery technology, advancing potential out-licensing opportunities for DosePro with biopharmaceutical clients, and expanding the application of the technology to higher-dose biologic therapies.

      The new five-year contract also establishes Battelle as the preferred provider of development services for the DosePro technology. Zogenix plans to leverage the substantial technical resources and capabilities of Battelle's drug delivery business for expertise in self-injection system design, human factors and device engineering as the companies further develop DosePro targeting dose volumes in excess of 1mL to accommodate a greater number of biopharmaceutical drug candidates.

      The companies began co-marketing and product testing in March 2012, and the agreement builds on the success of the companies' relationship since then. During this period, the companies launched the "Less is More" marketing campaign, completed and presented studies supporting the use of DosePro with biologics, and presented patient research demonstrating preference for needle-free injection technology. The research, which queried 300 rheumatoid arthritis patients, demonstrated a significant 30 percent increase in patient acceptance of self-injected medication when a needle-free option was offered. In addition, the companies completed a study that demonstrated the ability of the DosePro technology to effectively deliver a monoclonal antibody therapeutic, AbbVie Inc.'s Humira(R) (adalimumab). The in vitro study showed that DosePro can deliver Humira without incremental risk to protein denaturation and equivalent biological integrity as compared to delivery by pre-filled syringe.

      John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, said, "Through our co-marketing agreement with Battelle, we have expanded awareness of the DosePro needle-free drug delivery system. Battelle has proved to be a strong technical and business development ally and interest in the DosePro technology from biopharmaceutical companies has significantly increased because of Battelle's support. We are pleased with our progress and continue to believe there is significant potential to out-license DosePro for the delivery of biologics. Our new 5-year agreement with Battelle underscores both companies' commitment to achieving this goal, which includes executing on near-term and future opportunities."

      "The DosePro technology offers the opportunity to solve major challenges in self-administration of important biologic therapies," added William Dunlevy, Vice President and General Manager, Process and Product Development at Battelle. "DosePro's advantages in delivery of highly viscous formulations and its attributes which support protein stability are unmatched by standard autoinjector technology, and offer valuable options to our biopharmaceutical clients."

      About DosePro(R)

      The DosePro system is a first-in-class, easy-to-use drug delivery system designed for self-administration of a pre-filled, single dose of sterile liquid drug, subcutaneously, without a needle. The platform is currently used by Zogenix's first commercial product, SUMAVEL(R) DosePro(R). The Company believes that DosePro offers several benefits to patients compared to other subcutaneous needle-based delivery methods, and that it has the potential to become a preferred delivery option for patients and physicians. These benefits include instantaneous automatic delivery, less anxiety or fear due to the lack of a needle, easier disposal without the need for a sharps container, no risk of needle stick injury or contamination, an easy-to-use three step administration process, no need to fill the device prior to use, reliable performance, discreet use and portability. In several clinical trials and market research studies, DosePro has been shown to be preferred by patients over conventional needle-based systems.

      About Zogenix

      Zogenix, Inc. (ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with central nervous system disorders and pain-related conditions who need innovative treatment alternatives to help them return to normal daily functioning. Zogenix recently received FDA approval for Zohydro ER (hydrocodone bitartrate) extended-release capsules, the first extended-release oral formulation of hydrocodone without acetaminophen. Zogenix developed and commercialized the first needle-free subcutaneous injection, SUMAVEL(R) DosePro(R) (sumatriptan injection) for migraine and cluster headache. The development pipeline for Zogenix includes a once-monthly subcutaneous injection for schizophrenia.

      About Battelle

      Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

      http://finance.yahoo.com/news/zogenix-battelle-expand-dosepr…
      Avatar
      schrieb am 08.12.13 17:05:04
      Beitrag Nr. 27 ()
      Zitat von Aurum2010: Wer dabei bei ZGNX?


      Meine Meinung ? Schrott !!

      Für Schmerzen gibt's besseres !
      Avatar
      schrieb am 09.12.13 11:23:40
      Beitrag Nr. 28 ()
      Zitat von lunatics:
      Zitat von Aurum2010: Wer dabei bei ZGNX?


      Meine Meinung ? Schrott !!

      Für Schmerzen gibt's besseres !


      Sehr schön :) Ich wette dagegen.
      KZ bis zur Marktlancierung im März 2014 mind. USD 5.00
      Avatar
      schrieb am 09.12.13 21:18:04
      Beitrag Nr. 29 ()
      Zitat von Aurum2010: Sehr schön :) Ich wette dagegen.
      KZ bis zur Marktlancierung im März 2014 mind. USD 5.00


      Ich wette nur mit Profis ! :D
      Avatar
      schrieb am 09.12.13 22:47:03
      Beitrag Nr. 30 ()
      Wie Du meinst... Was disqualifiziert mich um in deiner Liga mitzuspielen?
      Avatar
      schrieb am 10.12.13 14:40:27
      Beitrag Nr. 31 ()
      Zogenix Announces FDA Approval of 4 mg SUMAVEL(R) DosePro(R) (sumatriptan injection) Needle-Free Delivery System

      SAN DIEGO, Dec. 10, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system (CNS) disorders and pain, announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for a 4 mg dose of SUMAVEL DosePro (sumatriptan injection) Needle-free Delivery System. SUMAVEL DosePro has been available in a 6 mg dose for the treatment of acute migraine and cluster headache. The 4 mg dose of SUMAVEL DosePro can be used to help migraine sufferers who require management of side effects. The 4 mg dose of SUMAVEL DosePro is expected to be available approximately June 2014.

      SUMAVEL DosePro is the first and only needle-free delivery system for subcutaneous sumatriptan for the treatment of acute migraine and cluster headache. Clinical data has shown that the current 6 mg dose of SUMAVEL DosePro can provide migraine pain relief within 10 minutes for some patients (16% of patients versus 4% for placebo). The product was launched in January 2010, reaching over 225,000 total prescriptions at the end of the third quarter 2013.1

      "Having a lower dose option of SUMAVEL DosePro will allow physicians to use another tool in the management of migraine and cluster headache," said Roger K. Cady, M.D., director of the Headache Care Center in Springfield, Mo. Cady continued, "The well-established efficacy of sumatriptan injection with the benefit of increasing patient satisfaction using needle-free technology, supports the goal of optimizing migraine treatment."2

      Roger L. Hawley, chief executive officer of Zogenix, said, "We are pleased to be able to provide treatment solutions to help patients better manage their migraine and cluster headache attacks. We continue to improve our product and educational resources based on the feedback we receive from headache specialists who are experts in the treatment of migraine."

      According to the National Headache Foundation, acute migraine attacks affect nearly 30 million Americans, primarily women between the ages of 25 and 40, who are treated by primary care physicians, neurologists and headache specialists. Tablets are a treatment option for some of these migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed, particularly for those who experience migraine attacks associated with sudden onset, waking, nausea or vomiting. The U.S. Headache Consortium endorses migraine treatment guidelines which support a "toolbox" approach to providing treatment options for improved outcomes.

      About SUMAVEL DosePro

      INDICATION and IMPORTANT LIMITATIONS

      Sumavel DosePro (sumatriptan injection) is a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and the acute treatment of cluster headache in adults.

      Limitations of Use

      SUMAVEL DosePro is intended for use only if a clear diagnosis of migraine or cluster headache has been established. If a patient has no response to the first migraine attack treated with SUMAVEL DosePro, reconsider the diagnosis of migraine before SUMAVEL DosePro is administered to treat any subsequent attacks. SUMAVEL DosePro is not indicated for the prevention of migraine attacks.

      Dosage and Administration

      The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. SUMAVEL DosePro is intended for subcutaneous use only. SUMAVEL DosePro is intended for use as an acute treatment of migraine or an acute treatment of cluster headache. For the treatment of cluster headache, the efficacy of a lower dose has not been established. The maximum cumulative dose of SUMAVEL DosePro in a 24-hour period is 12 mg, with doses separated by at least 1 hour. SUMAVEL DosePro is intended to be administered only to the abdomen or thigh.

      http://ir.zogenix.com/phoenix.zhtml?c=220862&p=irol-newsArti…
      Avatar
      schrieb am 17.03.14 19:14:38
      Beitrag Nr. 32 ()
      Zitat von Aurum2010: Wie Du meinst... Was disqualifiziert mich um in deiner Liga mitzuspielen?


      Deine Unwissenheit ??
      Wo steht ZGNX im März ??...sei froh habe ich deine Wette nicht angenommen. :D
      Avatar
      schrieb am 17.03.14 19:47:29
      Beitrag Nr. 33 ()
      Zitat von lunatics:
      Zitat von Aurum2010: Wie Du meinst... Was disqualifiziert mich um in deiner Liga mitzuspielen?


      Deine Unwissenheit ??
      Wo steht ZGNX im März ??...sei froh habe ich deine Wette nicht angenommen. :D


      Ich bin zu Kursen über USD 5.00 mitte Februar 14 raus - mein KZ war erreicht.
      Avatar
      schrieb am 19.03.14 19:03:42
      Beitrag Nr. 34 ()
      Vielleicht auch besser so. Ich glaube nicht dass ZGNX beim momentanen Umfeld noch grosse Sprünge gegen Norden macht.


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