ZGNX nächster Turnaroundwert mit großem Potential

Zogenix, Inc. Earnings Conference Call (Q4 2011)
Scheduled to start Thu, Mar 8, 2012, 4:30 pm Eastern  

hört das Federn lassen hier auf :D!

 

 

ZGNX 2.03 NDA filing 04/30/2012  

ZGNX $1.96 ready for gap fill @$2.48 next week!  

Neues Tageshoch $2.18  

Zogenix and Battelle Ink Marketing Agreement for DosePro(R) Drug Delivery Technology

Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, and Battelle, the world's largest independent research and development organization, today finalized their previously announced collaborative agreement to advance out-licensing opportunities and development of Zogenix's DosePro® drug delivery technology. Battelle and Zogenix will co-market DosePro technology to potential pharmaceutical and government clients with the objective of licensing the system for use with innovative therapeutics that would be enabled or enhanced by DosePro's unique needle-free delivery system.

DosePro offers increased safety and convenience compared to needle-based injection via syringes or auto-injectors by providing a pre-filled, single-use, disposable, needle-free drug delivery system that is easy to use and preferred by patients. Compared to other delivery technologies, DosePro has the potential to solve the significant challenges of delivering viscous drug formulations, such as high concentration biologics, which cannot be delivered with traditional needle-based injection.

The DosePro drug delivery technology is covered by more than 46 internationally issued patents extending through 2026. Zogenix has produced in excess of 1.5 million units of the company's migraine therapy, SUMAVEL® DosePro®, which has received approval in the United States and Europe using the DosePro technology. Patient experience has demonstrated that patients will switch from oral to injectable formulations when provided the option of using SUMAVEL DosePro, despite the availability of a needle-based product for over a decade.

John Turanin, Vice President and General Manager, DosePro Technology, at Zogenix, states, "Battelle has a strong reputation for product development that has earned them a 'who's who' client list in the pharmaceutical industry. Collaborating on DosePro provides additional support of our technology and the backing of a significant technical business partner. We expect the out-licensing effort to accelerate now that we are working with Battelle. We have already trained their business development team and are expanding laboratory capabilities to begin working on DosePro product candidates."

Barbara Kunz, President of Battelle Health and Life Sciences Global Business, said, "This collaboration enables Battelle to expand our platform of innovative drug delivery solutions to our pharmaceutical customers. We believe DosePro will be able to assist our clients with addressing many of the challenges they face today, in particular, the delivery of highly viscous drug formulations."

Battelle's business development professionals responsible for life and health sciences will market DosePro to their customers in strategic product planning meetings, at conferences, in trade publications, and through other marketing communications. The technical teams from both Battelle and Zogenix are working together to create a center of excellence for DosePro technology development and testing within Battelle's laboratories. Battelle has the option to enter into an agreement with Zogenix to jointly develop and commercialize an iteration of the DosePro technology which delivers a larger dose (1.2mL) than the current dose size of 0.5mL.

For more information on licensing opportunities using the DosePro platform contact Michael Chansler from Battelle at (206) 588-9827 or chanslerm@battelle.org.

About DosePro®

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 liquid drug, subcutaneously, without a needle. The platform is currently used by Zogenix's first commercial product, SUMAVEL DosePro®, and its investigational candidate, Relday. The Company believes that DosePro offers several benefits to patients compared to other subcutaneous delivery methods, and that it has the potential to become a preferred delivery option for patients and physicians. These benefits include 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 process, no need to fill or manipulate the device, 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. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ (hydrocodone bitartrate), is a novel, oral, 12-hour extended-release formulation of hydrocodone without acetaminophen for the treatment of moderate to severe chronic pain requiring around the clock opioid therapy which has recently completed Phase 3 clinical trials. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

About Battelle

As the world's largest independent research and development organization, Battelle provides innovative solutions to the world's most pressing needs through its four global businesses:  Laboratory Management; National Security; Health and Life Sciences; and Energy, Environment and Material Sciences. It advances scientific discovery and application by conducting $6.5 billion in global R&D annually through contract research, laboratory management and technology commercialization.  Headquartered in Columbus, Ohio, Battelle oversees 22,000 employees in more than 130 locations worldwide, including seven national laboratories which Battelle manages or co-manages for the U.S. Department of Energy and the U.S. Department of Homeland Security and a nuclear energy lab in the United Kingdom.

Battelle also is one of the nation's leading charitable trusts focusing on societal and economic impact and actively supporting and promoting science, technology, engineering and mathematics (STEM) education.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding the ability to successfully out-license the DosePro technology and the timing thereof, the ability of DosePro to solve the significant challenges of delivering viscous drug formulations, Battelle's exercise of the DosePro 1.2 mL option, the expected duration of patent protection for the DosePro technology and the likelihood that patients will switch from oral to injectable formulations when provided the option. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to DosePro and obtaining regulatory approval for other DosePro products; risks associated with the development of a larger volume, second generation version of the DosePro technology to accommodate drug formulation volumes greater than 0.5 mL; and the scope, validity and duration of patent protection and other intellectual property rights for DosePro; and other risks described in the company's prior press releases and filings with the Securities and Exchange Commission.

You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.

CONTACT: ZOGENIX MEDIA:
        Victoria Aguiar | The Ruth Group
        646.536.7013 | vaguiar@theruthgroup.com
       
        BATTELLE:
        Katy Delaney
        614.424.7208 | delaneyk@battelle.org
       
        T.R. Massey
        614.424.5544 | masseytr@battelle.org  

ZGNX $2.00 - gap to fill @$2.48  

ZGNX news - Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain

SAN DIEGO, May 2, 2012 /PRNewswire/ -- Zogenix, Inc. (ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Zohydro™ (hydrocodone bitartrate extended-release capsules), Zogenix's lead investigational product candidate for the treatment of chronic pain.

Zohydro is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. If approved, Zohydro could be the first hydrocodone product to offer the benefit of less frequent dosing and the ability to treat patients with chronic pain without the risk of acetaminophen-related liver injury. Currently, hydrocodone is only available in immediate-release, combination products, most commonly with the analgesic acetaminophen, and requires dosing every 4 to 6 hours. Zohydro, classified as a Drug Enforcement Agency (DEA) Schedule II drug product, would carry more strict prescription and dispensing rules as compared to the currently available hydrocodone combination products. In addition, Zogenix has included in the NDA a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is consistent with current FDA and industry-wide guidelines for extended-release opioid products. The REMS is intended to control inappropriate prescribing, misuse and abuse of extended-release opioids while maintaining patient access to essential pain medications.

"The NDA submission for Zohydro is a significant milestone, bringing us another step closer to making this important acetaminophen-free hydrocodone treatment option available to patients in need of around the clock therapy for chronic pain," said Stephen Farr, Ph.D., president and chief operating officer of Zogenix. "Hydrocodone is often a physician's first opioid recommendation for treating acute, moderate or moderately severe pain. However, many patients are being treated with hydrocodone combination products that include acetaminophen and, when used in high dosages or over long periods of time, put themselves at risk for developing liver injury. Zohydro could provide a significant new treatment alternative that does not contribute to this health risk."

The NDA submission is based on data from over 1,100 patients with chronic pain participating in the pivotal Phase 3 efficacy study (Study 801), and an open-label Phase 3 safety study (Study 802) of Zohydro. Study 801 successfully met its primary efficacy endpoint, demonstrating that Zohydro resulted in significantly (p=0.008) improved chronic pain relief compared to placebo. The two key secondary endpoints in this study - the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication - were also met. Additional study endpoints were supportive of the efficacy of Zohydro compared to placebo. The study demonstrated that Zohydro was generally safe and well tolerated. Overall, the most commonly reported adverse events (greater than or equal to 2%) in the placebo-controlled pivotal Phase 3 efficacy Study 801 in opioid-experienced patients were consistent with those typically seen with chronic opioid therapy and were constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting and pruritus. Study 802, in which patients received Zohydro for up to 12 months, further demonstrated that Zohydro was generally safe and well tolerated, and the incidence of adverse events was consistent with that seen in the pivotal Phase 3 efficacy study.

In conjunction with Zohydro's NDA submission, Zogenix is required to make a milestone payment of $1.0 million to Alkermes Pharma Ireland Limited (APIL), a subsidiary of Alkermes, plc, under the Company's exclusive license agreement with APIL in the U.S. for Zohydro.

About Zohydro

Zohydro is a novel, oral, single-entity extended-release formulation of hydrocodone without acetaminophen for the management of moderate to severe chronic pain in patients requiring around the clock opioid therapy. If approved, Zohydro could be the first single-entity hydrocodone therapy, avoiding the potential for liver injury associated with the use of acetaminophen in high doses or over long periods of time.

Zohydro uses APIL's patented Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.

About Chronic Pain

Chronic pain is defined as ongoing or recurrent pain that adversely affects an individual's well-being. An estimated 116 million people in the United States are burdened with chronic pain, at an estimated national economic cost of $560 to $635 billion annually.

Chronic pain can be treated with both immediate-release and extended-release opioids. Currently marketed hydrocodone products are only immediate-release and contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver injury when used in high dosages, over long periods of time or in accidental overdoses due to multiple acetaminophen products being taken at once.

About Zogenix

Zogenix, Inc. (ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release formulation of various strengths of hydrocodone intended for administration every 12 hours for around the clock management of moderate to severe chronic pain. Zogenix submitted an NDA to the FDA for Zohydro in May 2012. Zogenix's second DosePro investigational product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.

For additional information, please visit www.zogenix.com.

Forward Looking Statements

Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the potential for Zohydro to be the first approved oral, single-entity extended-release formulation of hydrocodone; and the size of the chronic pain market and the potential of Zohydro to provide a significant new treatment alternative and be well positioned in that market. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the top-line data Zogenix has reported for Zohydro is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial, and may also change in connection with the continued review of such data as part of Zogenix's submission and the FDA's review of the NDA for Zohydro; the potential for delays associated with any additional data required to be submitted by Zogenix in support of the NDA; the potential for Zohydro to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Zohydro to delay or prevent regulatory approval or commercialization; the impact of any inability to raise sufficient capital to fund ongoing operations; the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates and the ability to operate its business without infringing the intellectual property rights of others; and other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

SODAS® is a trademark of Alkermes Pharma Ireland Limited.

SUMAVEL ®, DosePro ®, Relday™ and Zohydro™ are trademarks of Zogenix, Inc.

INVESTORS:


MEDIA:

Zack Kubow | The Ruth Group


Emily Poe | WCG

646.536.7020 | zkubow@theruthgroup.com


212.301.7183 | epoe@wcgworld.com

http://ih.advfn.com/...pid=nmona&article=52246581&symbol=ZGNX  

$2.04 sieht doch mal wieder ganz nett aus  

Item 1.01 Material Definitive Agreement

On June 6, 2012, Zogenix, Inc. (“Zogenix”) and Mallinckrodt LLC (“Mallinckrodt”) entered into a co-promotion agreement. Under the terms of the co-promotion agreement (the “Agreement”), Mallinckrodt was granted a co-exclusive right (with Zogenix) to promote Sumavel DosePro to a mutually agreed prescriber audience in the United States. Under the Agreement, Mallinckrodt’s sales team will begin selling Sumavel DosePro to its customer base of prescribers no later than August 20, 2012. Mallinckrodt has committed to a minimum number of sales representatives for the initial term of the Agreement, which runs through June 30, 2014, and can be extended by mutual agreement of the parties in additional six month increments. Zogenix remains responsible for the manufacture, supply and distribution of commercial product for sale in the United States. In addition, Zogenix will supply product samples to Mallinckrodt at an agreed upon transfer price and Mallinckrodt will reimburse Zogenix for all other promotional materials used.

In partial consideration of Mallinckrodt’s sales efforts, Zogenix will pay Mallinckrodt a service fee on a quarterly basis that represents a specified fixed percentage of net sales of prescriptions generated from Mallinckrodt’s prescriber audience over a baseline amount of net sales to the same prescriber audience (the “Baseline Net Sales”). In addition, upon completion of the co-promotion term in June 30, 2014 (unless otherwise extended), and only if the Agreement is not terminated as a result of certain circumstances, Zogenix will be required to pay Mallinckrodt an additional tail payment calculated as a fixed percentage of the Mallinckrodt net sales over the Baseline Net Sales during the first full twelve (12) months following the last day of the term.

Mallinckrodt may terminate the Agreement with sixty (60) days notice in the event a material change is made to the net sales price of Sumavel DosePro that would result in a material adverse effect to Mallinckrodt’s financial return (as defined in the Agreement). Mallinckrodt may also terminate the Agreement if its request for the inclusion on its call list of a certain number of additional prescribers is not mutually agreed upon. Lastly, Mallinckrodt may terminate the Agreement if a governmental authority takes action or raises an objection that prevents or would reasonably be expected to make it unlawful for Mallinckrodt to perform, or subject Mallinckrodt to any penalty or claim, investigation or similar action related to, its obligations under the Agreement, in the event of Zogenix’s inability to meet trade demand for commercial product or where a third party files an action alleging that the making or selling of Sumavel DosePro infringes the intellectual property rights of such third party.

Zogenix may terminate the Agreement with sixty (60) days notice if Mallinckrodt does not achieve an agreed-upon minimum sales effort. Either party may terminate the agreement if certain minimum net sales thresholds are not met for any quarter ending after December 31, 2012 or certain levels of prescriptions are not met in a specified period. In addition, either party may terminate the Agreement related to safety concerns, in the event of a change of control of itself or the other party (excluding with respect to Mallinckrodt, any public spin-off of Mallinckrodt from its corporate parent Covidien plc), upon the introduction of a generic product, in connection with the material breach of the other party’s obligations or if a bankruptcy event occurs under certain circumstances.

* * *
http://www.otcmarkets.com/edgar/GetFilingHtml?FilingID=8662035  

das wars dann erstmal....

http://www.streetinsider.com/Corporate+News/...reat+Pain/7932966.html

http://www.streetinsider.com/Corporate+News/...anel+Says/7933061.html

mal sehen wie sehr die Zogenix-Aktie am montag nach diesem negativen panel fällt...  

Hoch 1,44 $
Tief 1,11 $

http://www.fool.com/investing/general/2012/12/10/...-thumbs-down.aspx  

So, mit kleiner Posi rein... am 1.3.2013 ist hier "Roulette-Tag"... bis dahin rechne ich mit Kursen um 2$.. mal gucken, Turnaround-play =)

 

FDA-Entscheidung... Könnte allerdings auch jederzeit die news dazu geben.. ob positiv oder negativ, sehr spannend!

 

Persönlich halte ich die zwar knappe Entscheidung  für eine Zulassung  nach dem negativen Panel für relativ sehr gering.  Nach einer negativen Entscheidung wird es noch mal 20% -30% runter rauschen. Mit Vorsicht ist das zu geniesen.  Ich würde vor einem Einstieg vor der  Entscheidung in diesem Fall abwarten.. und das Ergebniss abwarten.

Zogenix (NASDAQ: ZGNX) Zohydro ER effective to treat pain, FDA says. The vote was tight at 7 - 6.  

Deswegen meine ich ja: die negative Entscheidung ist bereits stark eingepreist... bei anderen Biotechs würde nach ner negativen FDA der Kurs um ca.70% einbrechen...

Hingegen, eine Überraschung würde hier schnell einige 100% bringen... aber ist nur meine Meinung...

Die negativen Stimmen im Dezember kamen ja nur, weil einige von denen Angst haben, dass Zohydro illegal eingesetzt werden könnte... aber welches Medikament wird nicht nicht illegal eingesetzt :D??

Mal gucken, ich gehe von einem Approval aus...

 

Von ca. -9% auf + 2%... bisher... der Tag ist noch lang und Freitag ist Tag "X"... lets go =)!

 

http://www.nasdaq.com/symbol/zgnx/real-time#.USuwIjc_e6o

 

                       

Und das wird heut noch nichts das Ende sein imo =)

 

und der FDA-Termin wurde verschoben! Imo ein sehr gutes Zeichen! Heute holen wir uns die 2,00 $ zurück! Erstes persönliches Kursziel: 2,38 $

Weeeee =)!!!

 

für seine Shares... mhhhh, schwierig! War kurz davor, zu verkaufen! Aber wenn Zohydro zugelassen wird, dann ist das hier 'ne Goldgrube! 5-10 Bagger! Auf Ihub wird sogar von 60$/ share in den nächsten 5 Jahren gesprochen! Oh man, schwierige Entscheidungen!

 

Ich danke dir.

Beste Grüsse,
Oki-Wan 2.0  

 

Ich musste zweimal zuschlagen, da vor mir jemand schön den Preis hochgetrieben hat. Beim ersten Kauf ging es noch.
Meine persönliche Meinung dazu: Hier ist noch viel Potential. Die Zeit vor der FDA-Bekanntgabe wird heiss.
Beste Grüsse und auf ein erfolgreiches Gelingen,
Oki-Wan 2.0

P.S.: Ich habe mir den IHUB-Artikel auch durchgelesen, aber nirgendwo die xxUSD gefunden; würde mich aber nicht wenig freuen, wenn die Aktie auf 10 USD steigt ;-)