BDSI = Kurzfristig 100-200% Potential möglich !!! - 500 Beiträge pro Seite
eröffnet am 08.11.11 23:12:28 von
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ISIN: US09060J1060 · WKN: 766464
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Letzter Kurs 22.03.22 Tradegate
Werte aus der Branche Biotechnologie
Wertpapier | Kurs | Perf. % |
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6,5000 | +83,62 | |
3,1600 | +56,44 | |
20,400 | +55,25 | |
3,9700 | +37,85 |
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3,4800 | -11,67 | |
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3,6350 | -13,45 | |
2,1100 | -18,53 |
BDSI wurde übertrieben runtergeprügelt nachdem ein Phase3 kandidat nicht übrzeugen konnte .
Was die meisten übersehen ist das BDSI bereits ein Produkt(Onsolis) gegen Krebsschmerzen auf den Markt hat .
Onsolis ist bereits in USA und Kanada erhältich EU folgt nächstes Jahr ,Onsolis hat ca 200 Million dollar potential .
In kürze stehen einige News an die BDSI abheben lassen könnte
FDA Zulassung -- REMS (Risk Evaluation and Mitigation Strategies) in Dezember 2011
BEMA® Buprenorphine/Naloxone PK Daten in Dezember 2011
Partnerdeal für BEMA® Buprenorphine 1Q 2012
Die Aktie notiert fast auf Cash niveau und auf Allzeittief was BDSI äusserst attraktiv macht .
Biodelivery Science (BDSI)
Marktkap: 28 M
Cash: 22 M
Kurs: 0.95
Shares Out: 29 M...(Insider + Institutions halten knapp 15 Million zusammen)
Neue Präsentation
http://www.bdsi.com/siteres.aspx?resid=8793c1c0-fd1b-4130-a8…
http://www.dailyfinance.com/quote/nasdaq/biodelivery-science…
Key BDSI Milestones
BEMA® Buprenorphine/Naloxone for opioid dependence
–Data from 2nd PK study in December 2011 (study to ensure proper dosing and blood-levels for pivotal BE study)
–Pivotal bioequivalence study January 2012; Data March 2012
–NDA submission target 1Q 2013
BEMA® Buprenorphine for chronic pain
–Late-stage commercial partnership discussions ongoing
–Initiation of 2nd Phase 3 trial in 1H 2012
ONSOLIS® (transmucosal fentanyl) - approved/marketed product
–Launched in U.S. in October 2009 by Meda Pharmaceuticals
–Launched in Canada August 2011; EU in 2H 2012
Late stage pipeline provides an opportunity for significant growth
–BEMA® Buprenorphine/Naloxone
Pivotal bioequivalence study data March 2012; NDA target 1Q 2013
–BEMA® Buprenorphine chronic pain
Phase 3 study initiation planned for 1H 2012; NDA target 1H 2013
Was die meisten übersehen ist das BDSI bereits ein Produkt(Onsolis) gegen Krebsschmerzen auf den Markt hat .
Onsolis ist bereits in USA und Kanada erhältich EU folgt nächstes Jahr ,Onsolis hat ca 200 Million dollar potential .
In kürze stehen einige News an die BDSI abheben lassen könnte
FDA Zulassung -- REMS (Risk Evaluation and Mitigation Strategies) in Dezember 2011
BEMA® Buprenorphine/Naloxone PK Daten in Dezember 2011
Partnerdeal für BEMA® Buprenorphine 1Q 2012
Die Aktie notiert fast auf Cash niveau und auf Allzeittief was BDSI äusserst attraktiv macht .
Biodelivery Science (BDSI)
Marktkap: 28 M
Cash: 22 M
Kurs: 0.95
Shares Out: 29 M...(Insider + Institutions halten knapp 15 Million zusammen)
Neue Präsentation
http://www.bdsi.com/siteres.aspx?resid=8793c1c0-fd1b-4130-a8…
http://www.dailyfinance.com/quote/nasdaq/biodelivery-science…
Key BDSI Milestones
BEMA® Buprenorphine/Naloxone for opioid dependence
–Data from 2nd PK study in December 2011 (study to ensure proper dosing and blood-levels for pivotal BE study)
–Pivotal bioequivalence study January 2012; Data March 2012
–NDA submission target 1Q 2013
BEMA® Buprenorphine for chronic pain
–Late-stage commercial partnership discussions ongoing
–Initiation of 2nd Phase 3 trial in 1H 2012
ONSOLIS® (transmucosal fentanyl) - approved/marketed product
–Launched in U.S. in October 2009 by Meda Pharmaceuticals
–Launched in Canada August 2011; EU in 2H 2012
Late stage pipeline provides an opportunity for significant growth
–BEMA® Buprenorphine/Naloxone
Pivotal bioequivalence study data March 2012; NDA target 1Q 2013
–BEMA® Buprenorphine chronic pain
Phase 3 study initiation planned for 1H 2012; NDA target 1H 2013
Der gescheiterte Phase 3 Kandidat wird nicht aufgegeben, eine neue P3-Studie die 9 monate dauert beginnt bald .
Daselbe spiel lief damals auch bei Onsolis erst kamen negative daten und dann positive daten und die Zulassung .
http://www.minyanville.com/businessmarkets/articles/biotech-…
BioDelivery Sciences just lost more than half it market value by announcing its improvement over an existing drug doesn’t actually work. The company says its Bema buprenorphine for chronic pain worked no better than placebo. The drug, considered a lower risk for abuse some other painkillers, is administered through a film placed inside the mouth.
The company has said it expects the product may generate more than $500 million in annual sales -- if it works and if it can be approved for sale. The company also says it’s not giving up on the drug. In fact, it plans to conduct another study in the near future -- a trial that will take another nine months to complete. So certain are company execs, they’re reiterating their sales prediction and seem confident they’ll find a development partner.
“Our previously announced market projections for the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively,” CEO Mark A. Sirgo says.
The trial results were supposed to show that the drug worked in a mix of patients who either were taking other painkillers or those receiving none (aka opioid naive or opioid experienced). The trial showed a “near statistically significant difference” between the company’s drug and placebo in the “opioid experienced” group. That’s one of the key findings that gives the company hope for the potential of this drug.
“While there is disappointment over missing the primary efficacy endpoint of this study, the many positive findings we observed gives us great confidence in our ability to ultimately bring this product to market for the treatment of chronic pain in a variety of patient types,” Sirgo says. He adds that a partner may help the company refine the design of its next study.
Daselbe spiel lief damals auch bei Onsolis erst kamen negative daten und dann positive daten und die Zulassung .
http://www.minyanville.com/businessmarkets/articles/biotech-…
BioDelivery Sciences just lost more than half it market value by announcing its improvement over an existing drug doesn’t actually work. The company says its Bema buprenorphine for chronic pain worked no better than placebo. The drug, considered a lower risk for abuse some other painkillers, is administered through a film placed inside the mouth.
The company has said it expects the product may generate more than $500 million in annual sales -- if it works and if it can be approved for sale. The company also says it’s not giving up on the drug. In fact, it plans to conduct another study in the near future -- a trial that will take another nine months to complete. So certain are company execs, they’re reiterating their sales prediction and seem confident they’ll find a development partner.
“Our previously announced market projections for the product of $500 million in annual peak sales should not change based on the delay this outcome creates, and we will continue our ongoing partnering discussions in earnest, including the sharing of these results, which we believe should be viewed positively,” CEO Mark A. Sirgo says.
The trial results were supposed to show that the drug worked in a mix of patients who either were taking other painkillers or those receiving none (aka opioid naive or opioid experienced). The trial showed a “near statistically significant difference” between the company’s drug and placebo in the “opioid experienced” group. That’s one of the key findings that gives the company hope for the potential of this drug.
“While there is disappointment over missing the primary efficacy endpoint of this study, the many positive findings we observed gives us great confidence in our ability to ultimately bring this product to market for the treatment of chronic pain in a variety of patient types,” Sirgo says. He adds that a partner may help the company refine the design of its next study.
Und auf gehts trotz schlechten Marktumfeld ...
20:51
.BioDelivery Services: ONSOLIS profitiert von FDA-Genehmigung für "Risk Evaluation Mitigation Strategy" (REMS) für alle Transmucosal-Fentanyl-Produkte.
.BioDelivery Services: ONSOLIS profitiert von FDA-Genehmigung für "Risk Evaluation Mitigation Strategy" (REMS) für alle Transmucosal-Fentanyl-Produkte.
Verdammt guter Deal den da BDSI abgeschlossen hat riecht nach kursfeuerwerk heute
Financial terms of the agreement include:
$30 million upfront payment to BDSI upon execution of the definitive agreement;
$95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
$55 million in potential sales milestones upon achievement of designated sales levels; and
Tiered, mid to upper teen royalty on U.S. net sales
Financial terms of the agreement include:
$30 million upfront payment to BDSI upon execution of the definitive agreement;
$95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
$55 million in potential sales milestones upon achievement of designated sales levels; and
Tiered, mid to upper teen royalty on U.S. net sales
BioDelivery Sciences Announces Worldwide License and Development Agreement with Endo Pharmaceuticals for BEMA Buprenorphine
http://finance.yahoo.com/news/BioDelivery-Sciences-prnews-42…
Financial terms of the agreement include:
$30 million upfront payment to BDSI upon execution of the definitive agreement;
$95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
$55 million in potential sales milestones upon achievement of designated sales levels; and
Tiered, mid to upper teen royalty on U.S. net sales
Financial terms of the agreement include:
$30 million upfront payment to BDSI upon execution of the definitive agreement;
$95 million in potential milestone payments based on achievement of pre-defined intellectual property, clinical development and regulatory events;
$55 million in potential sales milestones upon achievement of designated sales levels; and
Tiered, mid to upper teen royalty on U.S. net sales
BioDelivery Sciences Announces Worldwide License and Development Agreement with Endo Pharmaceuticals for BEMA Buprenorphine
http://finance.yahoo.com/news/BioDelivery-Sciences-prnews-42…
Antwort auf Beitrag Nr.: 42.559.085 von Biohero am 06.01.12 12:35:18ja da hast du recht!
Hätte so etwas nicht gedacht!!!So ist die Börse!
Hoffe, ich bekomme heute zur Eröffnung an der NASDAQ noch günstig ein paar Stücke
Hätte so etwas nicht gedacht!!!So ist die Börse!
Hoffe, ich bekomme heute zur Eröffnung an der NASDAQ noch günstig ein paar Stücke
Herzlichen Glückwunsch an die Investierten!
Ich bin leider nicht mehr dabei.
So ist es nunmal, wenn man nicht schnell genug ist
bzw. zu spät kommt.
Zum Glück gibt es immer wieder Chancen an der Börse.
BDSI steht jedenfalls auf meiner Watchlist.
Viel Glück, Erfolg und vor allen Dingen Gesundheit
wünsche ich allen BDSI-Fans!
diegutefee
Ich bin leider nicht mehr dabei.
So ist es nunmal, wenn man nicht schnell genug ist
bzw. zu spät kommt.
Zum Glück gibt es immer wieder Chancen an der Börse.
BDSI steht jedenfalls auf meiner Watchlist.
Viel Glück, Erfolg und vor allen Dingen Gesundheit
wünsche ich allen BDSI-Fans!
diegutefee
Hört sich sehr sehr vielversprechend a
Das könnte ein sehr schöner Zock werden
Zitat von Biohero: BDSI wurde übertrieben runtergeprügelt nachdem ein Phase3 kandidat nicht übrzeugen konnte .
Was die meisten übersehen ist das BDSI bereits ein Produkt(Onsolis) gegen Krebsschmerzen auf den Markt hat .
Onsolis ist bereits in USA und Kanada erhältich EU folgt nächstes Jahr ,Onsolis hat ca 200 Million dollar potential .
Da kann es einem den Magen umdrehen, an den Krebsschmerzen der Patienten
zu verdienen.
Eine Heilung von Krebs ist dann gegen diese "Geschäftsidee".
Antwort auf Beitrag Nr.: 42.580.771 von Goldbaba am 11.01.12 19:51:18Was soll dieses Posting hier jetzt sein ?
Antwort auf Beitrag Nr.: 42.580.885 von Wohnwunsch am 11.01.12 20:07:36sorry, wenn ich irgendwas in Dir berührt habe.
Was mich betrifft, möchte ich mit einer solchen Anlage kein Geld verdienen.
Mein Depot soll mir Freude machen.
Was mich betrifft, möchte ich mit einer solchen Anlage kein Geld verdienen.
Mein Depot soll mir Freude machen.
!
Dieser Beitrag wurde von CloudMOD moderiert. Grund: auf eigenen Wunsch des Users
sauber lohnt sich ja doch, wenn man später einsteigt...
charttechnisch ist noch Luft nach oben!
Halte auf jeden Fall die Perle!
charttechnisch ist noch Luft nach oben!
Halte auf jeden Fall die Perle!
Antwort auf Beitrag Nr.: 42.585.397 von sebirem am 12.01.12 16:11:40hier der Chart !!
USD / die genauen Werte kann jeder selber nachschauen und die
potenzielle Unterstützung in rot eingezeichnet, aber wer weiß ob die bei solchen fulminalen Anstiegen und daraus resultierenden/folgenden Rücksetzer hält...mal schauen,hauptsache dabei
USD / die genauen Werte kann jeder selber nachschauen und die
potenzielle Unterstützung in rot eingezeichnet, aber wer weiß ob die bei solchen fulminalen Anstiegen und daraus resultierenden/folgenden Rücksetzer hält...mal schauen,hauptsache dabei
Jetzt wäre es auch gut wenn mal wieder eine News kommen würde um den Kurs etwas zu beflügeln
In der Pipeline steht ja genug an
In der Pipeline steht ja genug an
Gibt es hier einen Grund für den heutigen Anstieg ?
Antwort auf Beitrag Nr.: 42.762.729 von Wohnwunsch am 16.02.12 19:04:33Also dieser Wert hat schon was, sie läuft kontinuierlich nach oben
AUCH wenn es nur kleine Schritte sind. Sehr schön anzusehen
Ich bleib hier erstmal Long...
AUCH wenn es nur kleine Schritte sind. Sehr schön anzusehen
Ich bleib hier erstmal Long...
Antwort auf Beitrag Nr.: 42.984.715 von Wohnwunsch am 31.03.12 19:49:36Diese Aktie macht wirklich Spaß, kontinuierlich mit kleinen Schritten immer weiter nach oben.
Das nenn ich mal weiterhin einen gesunden Anstieg
SCHÖN
Das nenn ich mal weiterhin einen gesunden Anstieg
SCHÖN
Antwort auf Beitrag Nr.: 42.991.841 von Wohnwunsch am 02.04.12 20:42:09Ja solange "Endo P." an Board ist ,kanns auch nur nach oben gehen ;-)
Viel Glück ALLEN!!!
Viel Glück ALLEN!!!
Antwort auf Beitrag Nr.: 42.991.942 von sebirem am 02.04.12 21:02:30Hier werden wir noch Kurse weit über der 3$ Marke sehen.
Ich geh bis Mitte des Jahres von einem Kurs von 4,70$ aus
Hier bleibe ich erstmal
LONG
Wie ist deine Meinung zu dem Wert bzw der Entwicklung ?
Ich geh bis Mitte des Jahres von einem Kurs von 4,70$ aus
Hier bleibe ich erstmal
LONG
Wie ist deine Meinung zu dem Wert bzw der Entwicklung ?
Das gute hier scheint wohl zu sein das den Anstieg scheinbar kaum jemand mitbekommt
Gut dann bleibt der Thread ruhig, auf weitere grüne Tage/Wochen
Gut dann bleibt der Thread ruhig, auf weitere grüne Tage/Wochen
Antwort auf Beitrag Nr.: 42.992.101 von Wohnwunsch am 02.04.12 21:39:08Und wieder in kleinen Schritten hoch, das ist ja besser wie Kino mit
Biodelivery
Weiter so
Stay cool
Biodelivery
Weiter so
Stay cool
Heute wieder schön nach oben, läuft schön und kontinuierlich
Ist hier noch jemand ausser mir investiert ?
Ist hier noch jemand ausser mir investiert ?
Antwort auf Beitrag Nr.: 43.021.914 von Wohnwunsch am 10.04.12 22:38:24Unsere Biodelivery, sie steigt und steigt und steigt
Also diese Aktie macht richtig Spass, nich auf einmal nen Rössern Hype aber schön kontinuierlich nach oben
Also diese Aktie macht richtig Spass, nich auf einmal nen Rössern Hype aber schön kontinuierlich nach oben
ja stimmt!Bin hier "long" bis zum Ende drin!!
Kursziel kann ich dir im Moment nicht sagen,abwarten ;-)
Kursziel kann ich dir im Moment nicht sagen,abwarten ;-)
Antwort auf Beitrag Nr.: 43.038.441 von sebirem am 14.04.12 00:42:15Ich bin mit Biodelivery sehr überrascht, diesen Verlauf in der kurzen Zeit hätte ich nicht erwartet.
Das gute ist das wir hier keinen übertriebenen Hype haben, sondern schön langsam
nach oben laufen.
Ich gehe bis Ende des Jahres von Kursen um die 10$ aus, an meinem Ziel bis Mitte des Jahres
von 4,70$ halte ich weiterhin fest.
Mich überrascht das Biodelivery hier bei WO überhaupt nicht auf dem Radar zu sein scheint
Naja mir soll's recht sein, ich bin gut investiert und das seit längerem
Das gute ist das wir hier keinen übertriebenen Hype haben, sondern schön langsam
nach oben laufen.
Ich gehe bis Ende des Jahres von Kursen um die 10$ aus, an meinem Ziel bis Mitte des Jahres
von 4,70$ halte ich weiterhin fest.
Mich überrascht das Biodelivery hier bei WO überhaupt nicht auf dem Radar zu sein scheint
Naja mir soll's recht sein, ich bin gut investiert und das seit längerem
BioDelivery Sciences to Host Opioid Dependence Investor Event and Webcast on April 11, 2012
Event will focus on the treatment of Opioid Dependence and the BNX development program
Apr 5, 2012
RALEIGH, N.C., April 5, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced that the Company will host a special event entitled "Treatment of Opioid Dependence: The Future Role of BEMA Buprenorphine/Naloxone" for investors and analysts on Wednesday, April 11, 2012 at 12:30 p.m. in New York City. This event will include insightful discussion from medical experts with extensive experience in the management of opioid dependence and treatment with buprenorphine.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
In addition to presentations by independent experts in the management of opioid dependence, BDSI's management will speak about the clinical progress of BEMA Buprenorphine/Naloxone (BNX) for the potential treatment of opioid dependence.
The expert presentations at this event will include:
"Understanding Opioid Dependence" by Gregory Sullivan, M.D. – Board certified in Addiction Medicine and Medical Director of Parkway Medical Center in Birmingham, Alabama. For twenty years, Dr. Sullivan has been actively involved in government and pharmaceutical research on the mechanism, biology and treatment of addiction and pain.
"Buprenorphine in the Successful Management of Opioid Dependence" by Aafaque Akhter, M.D. – Former instructor of Psychiatry at Harvard Medical School and Board certified in Psychiatry and Neurology. Dr. Akhter is the founder and CEO of New England Counseling & Treatment Center, and Norton Health Care, which is one of the few clinics in the country exclusively focused on opiate addiction.
BDSI plans on initiating a pivotal pharmacokinetic study and the safety study for BNX in the third quarter of 2012. Results of the pivotal pharmacokinetic study are anticipated to be available late in the third quarter of this year. If positive, this would allow for an anticipated New Drug Application (NDA) filing in the first half of 2013.
For more information on the event, please contact Brian Korb at bkorb@troutgroup.com. Interested parties may also view the presentation live via the BioDelivery Sciences website at www.bdsi.com. A recording of the presentation will be accessible shortly following the live event and will be archived for 30 days.
About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence
BNX is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.
Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone (buprenorphine/naloxone), which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer. BDSI believes that BNX, which uses BDSI's proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could seize a meaningful share of this rapidly growing market.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals (NASDAQ: ENDP). Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron). BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the investor event described herein and any statements of presenting physicians as well as representatives and partners of BioDelivery Sciences International, Inc. (the "Company") in connection with or related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of (i) future non-clinical or clinical trials for BNX, (ii) the timing for the filing of or the results of the FDA's review of BNX or (iii) future sales results of BNX, if any, as well as the potential benefits of BNX) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com or; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc.,+1-919-582-9050, amedwar@bdsi.com
Event will focus on the treatment of Opioid Dependence and the BNX development program
Apr 5, 2012
RALEIGH, N.C., April 5, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) today announced that the Company will host a special event entitled "Treatment of Opioid Dependence: The Future Role of BEMA Buprenorphine/Naloxone" for investors and analysts on Wednesday, April 11, 2012 at 12:30 p.m. in New York City. This event will include insightful discussion from medical experts with extensive experience in the management of opioid dependence and treatment with buprenorphine.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
In addition to presentations by independent experts in the management of opioid dependence, BDSI's management will speak about the clinical progress of BEMA Buprenorphine/Naloxone (BNX) for the potential treatment of opioid dependence.
The expert presentations at this event will include:
"Understanding Opioid Dependence" by Gregory Sullivan, M.D. – Board certified in Addiction Medicine and Medical Director of Parkway Medical Center in Birmingham, Alabama. For twenty years, Dr. Sullivan has been actively involved in government and pharmaceutical research on the mechanism, biology and treatment of addiction and pain.
"Buprenorphine in the Successful Management of Opioid Dependence" by Aafaque Akhter, M.D. – Former instructor of Psychiatry at Harvard Medical School and Board certified in Psychiatry and Neurology. Dr. Akhter is the founder and CEO of New England Counseling & Treatment Center, and Norton Health Care, which is one of the few clinics in the country exclusively focused on opiate addiction.
BDSI plans on initiating a pivotal pharmacokinetic study and the safety study for BNX in the third quarter of 2012. Results of the pivotal pharmacokinetic study are anticipated to be available late in the third quarter of this year. If positive, this would allow for an anticipated New Drug Application (NDA) filing in the first half of 2013.
For more information on the event, please contact Brian Korb at bkorb@troutgroup.com. Interested parties may also view the presentation live via the BioDelivery Sciences website at www.bdsi.com. A recording of the presentation will be accessible shortly following the live event and will be archived for 30 days.
About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence
BNX is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.
Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone (buprenorphine/naloxone), which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer. BDSI believes that BNX, which uses BDSI's proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could seize a meaningful share of this rapidly growing market.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals (NASDAQ: ENDP). Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron). BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the investor event described herein and any statements of presenting physicians as well as representatives and partners of BioDelivery Sciences International, Inc. (the "Company") in connection with or related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of (i) future non-clinical or clinical trials for BNX, (ii) the timing for the filing of or the results of the FDA's review of BNX or (iii) future sales results of BNX, if any, as well as the potential benefits of BNX) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com or; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc.,+1-919-582-9050, amedwar@bdsi.com
das Geld fließt ;-)
heute +11,68%!!
BDSI to receive $15M milestone payment
Triangle Business Journal
Date: Tuesday, April 17, 2012, 7:38am EDT
BioDelivery Sciences International Inc. said Tuesday that the U.S. Patent and Trademark Office has awarded the company a patent that will result in a $15 million milestone payment from Endo Pharmaceuticals. BDSI is a Raleigh-based specialty pharmaceutical company.
heute +11,68%!!
BDSI to receive $15M milestone payment
Triangle Business Journal
Date: Tuesday, April 17, 2012, 7:38am EDT
BioDelivery Sciences International Inc. said Tuesday that the U.S. Patent and Trademark Office has awarded the company a patent that will result in a $15 million milestone payment from Endo Pharmaceuticals. BDSI is a Raleigh-based specialty pharmaceutical company.
Antwort auf Beitrag Nr.: 43.050.966 von sebirem am 17.04.12 18:43:23Wir werden hier bald wieder das letzte 3Jahreshoch sehen, Kurse von bis zu 10$ bis
Ende des Jahres sollte hier durchaus möglich sein.
Bei WO scheint Biodelivery kaum jemand auf dem Radar zu haben, bin mal gespannt
wenn hier noch einige auf den Zug aufspringen.
Zum Glück treiben sich hier keine Zocker rum
Ende des Jahres sollte hier durchaus möglich sein.
Bei WO scheint Biodelivery kaum jemand auf dem Radar zu haben, bin mal gespannt
wenn hier noch einige auf den Zug aufspringen.
Zum Glück treiben sich hier keine Zocker rum
Es wundert mich das diese Aktie hier keiner auf dem Schirm hat ?
Antwort auf Beitrag Nr.: 43.072.790 von Wohnwunsch am 22.04.12 21:33:45Was ist hier los mit Biodelivery ? Die Aktie steigt und steigt und steig...
Keine Aufmerksamkeit bei WO und nichts zu der Aktie
Hat Biodelivery irgendjemand hier noch im Depot oder warum ist es hier so extrem still ?
Es ist unheimlich was hier abgeht
Keine Aufmerksamkeit bei WO und nichts zu der Aktie
Hat Biodelivery irgendjemand hier noch im Depot oder warum ist es hier so extrem still ?
Es ist unheimlich was hier abgeht
Antwort auf Beitrag Nr.: 43.088.752 von Wohnwunsch am 25.04.12 21:49:21es steigen hier weiterhin die "Großen" ein
am 23 und 24. z.B. die Fonds
-Shares Russell Microcap Index
-Wilshire Micro-Cap ETF
und sicherlich noch andere, wo man aber noch keine Meldung sehen kann...
freuen sich alle später,falls es zum Buyout kommt.
Aber bis dahin abwarten und genießen ;-)
(freu dich doch, dass im Allgemeinen Biotech's auf German Boards nicht so viel diskutiert werden.)
am 23 und 24. z.B. die Fonds
-Shares Russell Microcap Index
-Wilshire Micro-Cap ETF
und sicherlich noch andere, wo man aber noch keine Meldung sehen kann...
freuen sich alle später,falls es zum Buyout kommt.
Aber bis dahin abwarten und genießen ;-)
(freu dich doch, dass im Allgemeinen Biotech's auf German Boards nicht so viel diskutiert werden.)
Antwort auf Beitrag Nr.: 43.089.530 von sebirem am 26.04.12 06:59:25Mal sehen ob es heute kurz vor Börsenschluss wieder einen kleinen Hype in
den USA gibt
Vorstellen kann ich mir das bei Biodelivery sehr gut
den USA gibt
Vorstellen kann ich mir das bei Biodelivery sehr gut
Antwort auf Beitrag Nr.: 43.093.604 von Wohnwunsch am 26.04.12 19:48:33na ja, denke eher der Kurs mal korrigieren oder konsolidieren...
BDSI ist overbought...
mir solls egal sein, hier bleibe ich dabei !!
BDSI ist overbought...
mir solls egal sein, hier bleibe ich dabei !!
Antwort auf Beitrag Nr.: 43.095.096 von sebirem am 27.04.12 07:32:59Unsere Perle läuft sehr schön immer weiter nach oben
Ich bin hier sowas von Long, gehe mal davon aus das wir hier erstmal bis 4,25$ laufen
bevor wir konsolidieren und dann gehen wir weiter bis 4,70$ bis Ende Juni.
Ich bleib dabei das wir hier bis Dezember ein TOP NEWS bezgl. Zulassung bekommen und Kurse um
die 10$ sehen.
Ich bin hier sowas von Long, gehe mal davon aus das wir hier erstmal bis 4,25$ laufen
bevor wir konsolidieren und dann gehen wir weiter bis 4,70$ bis Ende Juni.
Ich bleib dabei das wir hier bis Dezember ein TOP NEWS bezgl. Zulassung bekommen und Kurse um
die 10$ sehen.
Antwort auf Beitrag Nr.: 43.099.352 von Wohnwunsch am 27.04.12 22:10:37Ich könnte mir gut vorstellen, das Biodelivery heute bis Börsenschluss nochmal
schön hochgekauft wird und morgen da bei uns kein Handel stattfindet eine
schöne News veröffentlicht wird
Ich bin auf jedenfall dabei
schön hochgekauft wird und morgen da bei uns kein Handel stattfindet eine
schöne News veröffentlicht wird
Ich bin auf jedenfall dabei
Antwort auf Beitrag Nr.: 43.104.679 von Wohnwunsch am 30.04.12 15:49:53Mal sehen ob wir bereits im Mai die 4,70$ bei Biodelivery sehen
Sie läuft schön mit kleinen Umsätzen nach oben, leider wurde der Ausbruch
mit dem größten Kauf abgeblockt. Allerdings fast wieder auf Tageshoch.
Die Aktie sollte längst konsolidieren aber nichts davon zu spüren, siecläuft weiter
ohne Druck nach Norden.
Das könnte eine zweite INFINION werden, INFINION kam auch mal von 0,40€
auf jetzt weit über 7,xx€
Sie läuft schön mit kleinen Umsätzen nach oben, leider wurde der Ausbruch
mit dem größten Kauf abgeblockt. Allerdings fast wieder auf Tageshoch.
Die Aktie sollte längst konsolidieren aber nichts davon zu spüren, siecläuft weiter
ohne Druck nach Norden.
Das könnte eine zweite INFINION werden, INFINION kam auch mal von 0,40€
auf jetzt weit über 7,xx€
Kaum geschrieben rutscht unsere Biodelivery ins Minus
Wie verhext
Wie verhext
Antwort auf Beitrag Nr.: 43.105.712 von Wohnwunsch am 30.04.12 20:15:27Naja TH wird es heute wohl nicht werden aber ein kleines PLUS ist immerhin ein PLUS
Scheint aktuell fast wie gedeckelt zu sein ?
Sie wird heute irgendwie untergehalten, stehen da morgen etwa
News bei Biodelivery an ?
Wäre nicht das erste mal das bei den Amis was kommt wenn in DE
kein Handel stattfindet
Sie wird heute irgendwie untergehalten, stehen da morgen etwa
News bei Biodelivery an ?
Wäre nicht das erste mal das bei den Amis was kommt wenn in DE
kein Handel stattfindet
Antwort auf Beitrag Nr.: 43.105.936 von Wohnwunsch am 30.04.12 21:31:59Naja SK auf 3,80$ zumindest nicht im Minus geschlossen, allerdings
muss man sagen Biodelivery läuft seit längerem phantastisch.
Es wundert mich nur das ich hier mittlerweile Alleinunterhalter bin, ob ich bei wo
auch als winzigster gut verdiene ?
Für mich bleibt Biodelivery ein klares Langfristinvest, mit einem Kursziel von 4,70$
bis Ende Juli 2012
muss man sagen Biodelivery läuft seit längerem phantastisch.
Es wundert mich nur das ich hier mittlerweile Alleinunterhalter bin, ob ich bei wo
auch als winzigster gut verdiene ?
Für mich bleibt Biodelivery ein klares Langfristinvest, mit einem Kursziel von 4,70$
bis Ende Juli 2012
Antwort auf Beitrag Nr.: 43.106.070 von Wohnwunsch am 30.04.12 22:10:34Heute scheint es wenig Kaufinteresse zu geben, mini Volumen wird aktuell
hier gehandelt. Mal sehen ob wir im Plus schlissen oder heute ins Minus rutschen
hier gehandelt. Mal sehen ob wir im Plus schlissen oder heute ins Minus rutschen
Antwort auf Beitrag Nr.: 43.107.673 von Wohnwunsch am 01.05.12 17:05:00Heute sieht es nicht so gut aus bei Biodelivery, wenig Umsatz und viele rote Balken,
leider auch grössere rote jetzt dabei.
Es scheint fast so das heute doch einige Gewinne mitnehmen, mal sehen wie
es bei Börsenschluss aussieht.
Hoffen wir das es wenigstens ein Null-Summenspiel wird
leider auch grössere rote jetzt dabei.
Es scheint fast so das heute doch einige Gewinne mitnehmen, mal sehen wie
es bei Börsenschluss aussieht.
Hoffen wir das es wenigstens ein Null-Summenspiel wird
Antwort auf Beitrag Nr.: 43.107.775 von Wohnwunsch am 01.05.12 17:47:04Jetzt bräuchten wir ein bisschen Volumen damit die Kiste hoch kommt..
Go Biodelivery go
Go Biodelivery go
Das ist die falsche Richtung, kaufen nicht verkaufen
WIR wollen keine Konso.......
WIR wollen keine Konso.......
SK 3,72$ einn MIANUS von knapp 2%
"kleine Erholung" vom Hype
"kleine Erholung" vom Hype
Antwort auf Beitrag Nr.: 43.108.475 von Wohnwunsch am 01.05.12 22:04:52Unsere Biodelivery läuft und läuft und läuft, diese Perle kennt nur eine nachhaltige
Richtung und zwar nach Norden
Und das ohne gezockelt, sondern schön ruhig
Börse kann so schön sein
Richtung und zwar nach Norden
Und das ohne gezockelt, sondern schön ruhig
Börse kann so schön sein
Antwort auf Beitrag Nr.: 43.137.805 von Wohnwunsch am 08.05.12 20:53:36Biodelivery hat heute über der magischen 4,00$ Marke geschlossen.
Das heisst wir sind aktuell sehr bullish, ich gehe jetzt davon aus das
wir die 4,70$ noch im Mai sehen werden.
Aufgrund der aktuellen Entwicklung sehe ich den Kurs bis Ende 2012
bei 12,25$.
Sollte hier ein Übernahmeangebot kommen kann der Kurs bis 23,xx$ laufend
Hier ist für mich ganz klar das Invest auf eine LONG Strategie ausgelegt
P.S. Rücksetzer im Verlauf sollte jeder einplanen
Das heisst wir sind aktuell sehr bullish, ich gehe jetzt davon aus das
wir die 4,70$ noch im Mai sehen werden.
Aufgrund der aktuellen Entwicklung sehe ich den Kurs bis Ende 2012
bei 12,25$.
Sollte hier ein Übernahmeangebot kommen kann der Kurs bis 23,xx$ laufend
Hier ist für mich ganz klar das Invest auf eine LONG Strategie ausgelegt
P.S. Rücksetzer im Verlauf sollte jeder einplanen
so hab heute meine Posi komplett abverkauft...ist schon gut gelaufen!
waren bei mir ja auch nur 1k
Mein Finger hat gejuckt und bin doch woanders heute rein ;-),
@ein Übernahmeangebot >20 kann ich mir nicht vorstellen, denke eher wenn überhaupt >10
dir viel Glück & auf noch höhere Kurse!!
waren bei mir ja auch nur 1k
Mein Finger hat gejuckt und bin doch woanders heute rein ;-),
@ein Übernahmeangebot >20 kann ich mir nicht vorstellen, denke eher wenn überhaupt >10
dir viel Glück & auf noch höhere Kurse!!
Antwort auf Beitrag Nr.: 43.141.967 von sebirem am 09.05.12 16:24:27Also ich gehe bei Biodelivery noch von weit höheren Kursen
aus, diese Perle läuft und läuft
Meiner Meinung nach ist ein Ausstieg jetzt noch zu früh
aus, diese Perle läuft und läuft
Meiner Meinung nach ist ein Ausstieg jetzt noch zu früh
Antwort auf Beitrag Nr.: 43.143.417 von Wohnwunsch am 09.05.12 20:33:19Und wieder einmal hat unsere Biodelivery mit einem PLUS geschlossen
:
SK 4,09$, wenn wir die 4,15$ knacken Gent es erstmal weiter gehen Norden, allerdings wird
die 4,15$ nach eine harte Nuss
:
SK 4,09$, wenn wir die 4,15$ knacken Gent es erstmal weiter gehen Norden, allerdings wird
die 4,15$ nach eine harte Nuss
Antwort auf Beitrag Nr.: 43.149.853 von Wohnwunsch am 10.05.12 22:25:57Auch heute sieht es wieder gut aus bei Biodelivery.
Mein Tipp zum SK 4,22$
Auf eine grüne Woche
Mein Tipp zum SK 4,22$
Auf eine grüne Woche
Antwort auf Beitrag Nr.: 43.163.360 von Wohnwunsch am 14.05.12 18:48:57Sehen wir die 4,75$ bei Biodelivery schon diese Woche ?
BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its First Quarter 2012 Financials
Signed licensing agreement with Endo Pharmaceuticals for BEMA Buprenorphine for chronic pain worth up to $180 million plus royalties
Received $45 million in upfront cash and milestone payments from Endo to date
Hosted investor/analyst opioid dependence and BNX forum - available for viewing at www.bdsi.com
May 10, 2012
RALEIGH, N.C., May 10, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012 and an update on business operations and upcoming milestones for the balance of 2012.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)
At March 31, 2012, BDSI had $32.1 million in cash compared to $10.8 million at March 31, 2011. This includes the upfront payment of $30 million in connection with the signing of a license and development agreement with Endo Pharmaceuticals, Inc. (NASDAQ: ENDP) (Endo), for BEMA Buprenorphine for the treatment of chronic pain. Such cash balance excludes a $15 million milestone payment received in May 2012 associated with the recently announced granting by the United States Patent and Trademark Office (USPTO) of a patent extending the exclusivity of BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) through 2027.
"Already, 2012 has been a very exciting year for BDSI, highlighted by the significant signing of our Endo Pharmaceuticals partnership in January," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We are working closely with Endo to initiate Phase 3 studies for BEMA Buprenorphine for chronic pain, which we expect to begin in the third quarter of this year."
Dr. Sirgo continued, "We have also made substantial progress with the BNX program for opioid dependence following a meeting earlier this year with the FDA, and we expect to initiate our pivotal pharmacokinetic study this summer with data anticipated before the close of the third quarter. We believe BNX has the opportunity to be the first branded transmucosal buprenorphine/naloxone product to compete with Suboxone, which achieved sales in excess of $1.2 billion in 2011 and continues to grow."
2012 Corporate Update
The following are key events that occurred at BDSI since the beginning of 2012:
Endo License and Development Agreement. Signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing and a tiered mid- to upper-teen royalty on net sales in the U.S.
BNX - Opioid Dependence. Held meeting with the FDA and reached agreement on the development program for BNX that is anticipated to result in the first half of 2013 submission of a New Drug Application (NDA) for the treatment of opioid dependence. Key data results from the pivotal pharmacokinetic study versus Suboxone are due in late third quarter of this year. BDSI held an investor/analyst forum in April titled, "Treatment of Opioid Dependence: The Future Role of BEMA Buprenorphine/Naloxone" with a video webcast available for viewing at www.bdsi.com.
BEMA Exclusivity Patent. Allowance by the USPTO of a patent application extending the exclusivity of BDSI's BioErodible MucoAdhesive (BEMA) technology for BEMA products containing buprenorphine from 2020 to 2027, triggering a milestone payment from Endo in the amount of $15 million, which was received in May 2012.
ONSOLIS. BDSI announced that a U.S. re-launch of ONSOLIS would be delayed until the product formulation can be modified to address certain appearance issues recently noted by FDA. Significant and positive progress has subsequently been made that has led to an initial follow-up discussion with the U.S. Food and Drug Administration (FDA). With this FDA feedback, reformulation work is expected to be complete prior to the end of the second quarter of 2012, at which time BDSI expects to immediately request a meeting with FDA to discuss final results and next steps.
Progress with MonoSol litigation. Progress was made in defense of the process patent infringement lawsuit served against BDSI and its partners for ONSOLIS by MonoSol Rx, LLC (MonoSol). In February 2012, based on the patent reexamination proceedings that had been requested by BDSI on all of the patents asserted by MonoSol against BDSI, the USPTO rejected all claims in the second patent asserted by MonoSol (the '292 patent), and in March 2012, the USPTO notified BDSI of rejection of all claims in the third asserted patent (the '891 patent). These actions followed the November 2011 rejection of the first patent asserted by MonoSol against BDSI (the '588 patent). As a result of the USPTO's actions to reject all claims in all patents asserted by MonoSol, the judge in the case placed a stay on further litigation pending a final judgment by the USPTO. Empirical evidence from previous re-examination proceedings would suggest that amended claims will likely be filed by MonoSol during the proceedings that significantly narrow the scope of their patents. The USPTO could allow such revised patents; however, BDSI believes that its assertion that its products and technologies do not infringe on MonoSol's original patents would only be strengthened based on any narrowing of the claims in such patents.
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
Initiation of two Phase 3 studies for BEMA Buprenorphine. In the third quarter of 2012, BDSI and Endo expect to initiate two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups.
Progress concerning BNX registration studies. BDSI will advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and initiation of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated in late third quarter of 2012.
Launch of BREAKYL in Europe. BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the second half of 2012. Such launch would result in a milestone payment to BDSI of $5 million.
"We look forward to the continuation of a highly productive year for BDSI," said Dr. Sirgo. "Our product pipeline remains strong with both BEMA Buprenorphine and BNX in the substantial and growing pain and opioid dependence markets. We are excited with our plans to have all pivotal studies for both BEMA Buprenorphine and BNX underway in the third quarter of 2012."
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's 2012 initiatives described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Signed licensing agreement with Endo Pharmaceuticals for BEMA Buprenorphine for chronic pain worth up to $180 million plus royalties
Received $45 million in upfront cash and milestone payments from Endo to date
Hosted investor/analyst opioid dependence and BNX forum - available for viewing at www.bdsi.com
May 10, 2012
RALEIGH, N.C., May 10, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012 and an update on business operations and upcoming milestones for the balance of 2012.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)
At March 31, 2012, BDSI had $32.1 million in cash compared to $10.8 million at March 31, 2011. This includes the upfront payment of $30 million in connection with the signing of a license and development agreement with Endo Pharmaceuticals, Inc. (NASDAQ: ENDP) (Endo), for BEMA Buprenorphine for the treatment of chronic pain. Such cash balance excludes a $15 million milestone payment received in May 2012 associated with the recently announced granting by the United States Patent and Trademark Office (USPTO) of a patent extending the exclusivity of BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) through 2027.
"Already, 2012 has been a very exciting year for BDSI, highlighted by the significant signing of our Endo Pharmaceuticals partnership in January," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We are working closely with Endo to initiate Phase 3 studies for BEMA Buprenorphine for chronic pain, which we expect to begin in the third quarter of this year."
Dr. Sirgo continued, "We have also made substantial progress with the BNX program for opioid dependence following a meeting earlier this year with the FDA, and we expect to initiate our pivotal pharmacokinetic study this summer with data anticipated before the close of the third quarter. We believe BNX has the opportunity to be the first branded transmucosal buprenorphine/naloxone product to compete with Suboxone, which achieved sales in excess of $1.2 billion in 2011 and continues to grow."
2012 Corporate Update
The following are key events that occurred at BDSI since the beginning of 2012:
Endo License and Development Agreement. Signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing and a tiered mid- to upper-teen royalty on net sales in the U.S.
BNX - Opioid Dependence. Held meeting with the FDA and reached agreement on the development program for BNX that is anticipated to result in the first half of 2013 submission of a New Drug Application (NDA) for the treatment of opioid dependence. Key data results from the pivotal pharmacokinetic study versus Suboxone are due in late third quarter of this year. BDSI held an investor/analyst forum in April titled, "Treatment of Opioid Dependence: The Future Role of BEMA Buprenorphine/Naloxone" with a video webcast available for viewing at www.bdsi.com.
BEMA Exclusivity Patent. Allowance by the USPTO of a patent application extending the exclusivity of BDSI's BioErodible MucoAdhesive (BEMA) technology for BEMA products containing buprenorphine from 2020 to 2027, triggering a milestone payment from Endo in the amount of $15 million, which was received in May 2012.
ONSOLIS. BDSI announced that a U.S. re-launch of ONSOLIS would be delayed until the product formulation can be modified to address certain appearance issues recently noted by FDA. Significant and positive progress has subsequently been made that has led to an initial follow-up discussion with the U.S. Food and Drug Administration (FDA). With this FDA feedback, reformulation work is expected to be complete prior to the end of the second quarter of 2012, at which time BDSI expects to immediately request a meeting with FDA to discuss final results and next steps.
Progress with MonoSol litigation. Progress was made in defense of the process patent infringement lawsuit served against BDSI and its partners for ONSOLIS by MonoSol Rx, LLC (MonoSol). In February 2012, based on the patent reexamination proceedings that had been requested by BDSI on all of the patents asserted by MonoSol against BDSI, the USPTO rejected all claims in the second patent asserted by MonoSol (the '292 patent), and in March 2012, the USPTO notified BDSI of rejection of all claims in the third asserted patent (the '891 patent). These actions followed the November 2011 rejection of the first patent asserted by MonoSol against BDSI (the '588 patent). As a result of the USPTO's actions to reject all claims in all patents asserted by MonoSol, the judge in the case placed a stay on further litigation pending a final judgment by the USPTO. Empirical evidence from previous re-examination proceedings would suggest that amended claims will likely be filed by MonoSol during the proceedings that significantly narrow the scope of their patents. The USPTO could allow such revised patents; however, BDSI believes that its assertion that its products and technologies do not infringe on MonoSol's original patents would only be strengthened based on any narrowing of the claims in such patents.
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
Initiation of two Phase 3 studies for BEMA Buprenorphine. In the third quarter of 2012, BDSI and Endo expect to initiate two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naive patient groups.
Progress concerning BNX registration studies. BDSI will advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and initiation of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated in late third quarter of 2012.
Launch of BREAKYL in Europe. BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the second half of 2012. Such launch would result in a milestone payment to BDSI of $5 million.
"We look forward to the continuation of a highly productive year for BDSI," said Dr. Sirgo. "Our product pipeline remains strong with both BEMA Buprenorphine and BNX in the substantial and growing pain and opioid dependence markets. We are excited with our plans to have all pivotal studies for both BEMA Buprenorphine and BNX underway in the third quarter of 2012."
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's 2012 initiatives described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Readers are cautioned that peak sales and market size estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such estimates are accurate or that such sales levels will be achieved, if at all.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Antwort auf Beitrag Nr.: 43.163.836 von Wohnwunsch am 14.05.12 20:32:15Heutiger SK 4,48$, unsere Biodelivery ist einfach eine goldene Gans
Antwort auf Beitrag Nr.: 43.164.346 von Wohnwunsch am 14.05.12 22:11:59Und wieder ein Plus bei Biodelivery, heutiger SK 1,49$
Hier werden wir bereits Ende Mai die 4,75$ sehen
Hier werden wir bereits Ende Mai die 4,75$ sehen
Beginnt heute etwa der freie Fall ?
Es wird doch wohl keine Abzock Nummer gewesen sein bei Biodelivery
Es wird doch wohl keine Abzock Nummer gewesen sein bei Biodelivery
BioDelivery Sciences Receives $2.5 Million Milestone from Meda for BREAKYL in E.U.
RALEIGH, N.C., May 21, 2012 /PRNewswire/ --BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL (tradename for ONSOLIS in the E.U). A last milestone payment related to the E.U. of $2.5 million is payable at the time of commercial launch, which is anticipated in late 2012. BREAKYL will be commercialized in the E.U. by Meda.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
RALEIGH, N.C., May 21, 2012 /PRNewswire/ --BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL (tradename for ONSOLIS in the E.U). A last milestone payment related to the E.U. of $2.5 million is payable at the time of commercial launch, which is anticipated in late 2012. BREAKYL will be commercialized in the E.U. by Meda.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
Sieht aktuell nicht so gut aus
BioDelivery Sciences Receives $2.5 Million Milestone from Meda for BREAKYL in E.U.
Milestone payment received in conjunction with granting of first country registration and pricing approval
May 21, 2012
RALEIGH, N.C., May 21, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL (tradename for ONSOLIS in the E.U). A last milestone payment related to the E.U. of $2.5 million is payable at the time of commercial launch, which is anticipated in late 2012. BREAKYL will be commercialized in the E.U. by Meda.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Milestone payment received in conjunction with granting of first country registration and pricing approval
May 21, 2012
RALEIGH, N.C., May 21, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL (tradename for ONSOLIS in the E.U). A last milestone payment related to the E.U. of $2.5 million is payable at the time of commercial launch, which is anticipated in late 2012. BREAKYL will be commercialized in the E.U. by Meda.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
BioDelivery Sciences to Present at the Jefferies 2012 Global Healthcare Conference
May 31, 2012
RALEIGH, N.C., May 31, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the Jefferies 2012 Global Healthcare Conference in New York City. The presentation is scheduled for Thursday, June 7 at 3:30 P.M. Eastern Time.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
Dr. Sirgo will focus on the clinical development program and timeline for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence, as well as BDSI's worldwide licensing and development agreement with Endo Pharmaceuticals for BEMA Buprenorphine for the treatment of chronic pain.
The presentation will be webcast live and can be accessed at www.bdsi.com. For those who are not available to listen to the live broadcast, a replay of the webcast will be available on the BDSI website.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com, or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
May 31, 2012
RALEIGH, N.C., May 31, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, will present at the Jefferies 2012 Global Healthcare Conference in New York City. The presentation is scheduled for Thursday, June 7 at 3:30 P.M. Eastern Time.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
Dr. Sirgo will focus on the clinical development program and timeline for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence, as well as BDSI's worldwide licensing and development agreement with Endo Pharmaceuticals for BEMA Buprenorphine for the treatment of chronic pain.
The presentation will be webcast live and can be accessed at www.bdsi.com. For those who are not available to listen to the live broadcast, a replay of the webcast will be available on the BDSI website.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com, or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
FORM 4
[ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES
OMB APPROVAL
OMB Number: 3235-0287
Estimated average burden
hours per response... 0.5
Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934, Section 17(a) of the Public
Utility Holding Company Act of 1935 or Section 30(f) of the Investment Company Act of 1940
1. Name and Address of Reporting Person *
ODONNELL FRANCIS E JR 2. Issuer Name and Ticker or Trading Symbol
BIODELIVERY SCIENCES INTERNATIONAL INC [ BDSI ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
__ X __ Director __ X __ 10% Owner
_____ Officer (give title below) _____ Other (specify below)
(Last) (First) (Middle)
C/O BIODELIVERY SCIENCES INTL, INC., 801 CORPORATE CENTER DRIVE, SUITE 210 3. Date of Earliest Transaction (MM/DD/YYYY)
6/22/2012
(Street)
RALEIGH, NC 27607
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 6/22/2012 6/22/2012 J 100000 D $0 (1) 3175490 I By HCG II LLC (1)
Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities)
1. Title of Derivate Security
(Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Trans. Date 3A. Deemed Execution Date, if any 4. Trans. Code
(Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date 7. Title and Amount of Securities Underlying Derivative Security
(Instr. 3 and 4) 8. Price of Derivative Security
(Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
( 1) These shares are owned by Hopkins Capital Group II, LLC, of which the Reporting Person is the Manager. The distribution was made to an investment member of Hopkins Capital Group II, LLC, who is not an affiliate of the issuer and for no consideration.
Reporting Owners
Reporting Owner Name / Address
Relationships
Director 10% Owner Officer Other
ODONNELL FRANCIS E JR
C/O BIODELIVERY SCIENCES INTL, INC.
801 CORPORATE CENTER DRIVE, SUITE 210
RALEIGH, NC 27607 X X
Signatures
/s/ Francis E. O'Donnell 6/22/2012
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4(b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations. See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
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[ ] Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES
OMB APPROVAL
OMB Number: 3235-0287
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Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934, Section 17(a) of the Public
Utility Holding Company Act of 1935 or Section 30(f) of the Investment Company Act of 1940
1. Name and Address of Reporting Person *
ODONNELL FRANCIS E JR 2. Issuer Name and Ticker or Trading Symbol
BIODELIVERY SCIENCES INTERNATIONAL INC [ BDSI ] 5. Relationship of Reporting Person(s) to Issuer (Check all applicable)
__ X __ Director __ X __ 10% Owner
_____ Officer (give title below) _____ Other (specify below)
(Last) (First) (Middle)
C/O BIODELIVERY SCIENCES INTL, INC., 801 CORPORATE CENTER DRIVE, SUITE 210 3. Date of Earliest Transaction (MM/DD/YYYY)
6/22/2012
(Street)
RALEIGH, NC 27607
(City) (State) (Zip)
4. If Amendment, Date Original Filed (MM/DD/YYYY)
6. Individual or Joint/Group Filing (Check Applicable Line)
_ X _ Form filed by One Reporting Person
___ Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1.Title of Security
(Instr. 3) 2. Trans. Date 2A. Deemed Execution Date, if any 3. Trans. Code
(Instr. 8) 4. Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s)
(Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Common Stock 6/22/2012 6/22/2012 J 100000 D $0 (1) 3175490 I By HCG II LLC (1)
Table II - Derivative Securities Beneficially Owned ( e.g. , puts, calls, warrants, options, convertible securities)
1. Title of Derivate Security
(Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Trans. Date 3A. Deemed Execution Date, if any 4. Trans. Code
(Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D)
(Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date 7. Title and Amount of Securities Underlying Derivative Security
(Instr. 3 and 4) 8. Price of Derivative Security
(Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form of Derivative Security: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
( 1) These shares are owned by Hopkins Capital Group II, LLC, of which the Reporting Person is the Manager. The distribution was made to an investment member of Hopkins Capital Group II, LLC, who is not an affiliate of the issuer and for no consideration.
Reporting Owners
Reporting Owner Name / Address
Relationships
Director 10% Owner Officer Other
ODONNELL FRANCIS E JR
C/O BIODELIVERY SCIENCES INTL, INC.
801 CORPORATE CENTER DRIVE, SUITE 210
RALEIGH, NC 27607 X X
Signatures
/s/ Francis E. O'Donnell 6/22/2012
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4(b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations. See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB control number.
BioDelivery Sciences Announces Positive Results from BEMA Buprenorphine/Naloxone (BNX) Pharmacokinetic Study
Results of the FDA recommended trial demonstrate dose proportionality ahead of the forthcoming pivotal pharmacokinetic study versus Suboxone
NDA on track for submission in the first half of 2013
Jun 28, 2012
RALEIGH, N.C., June 28, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced positive results of a recently completed pharmacokinetic study (BNX-106) examining the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a New Drug Application (NDA) for BNX.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered, meaning that as doses of BNX increased, there was a corresponding increase in the amount of buprenorphine in the plasma. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.
Overall, these results provide additional confidence that the doses selected for BDSI's upcoming pivotal pharmacokinetic study for BNX will produce similar buprenorphine pharmacokinetics as the reference product, Suboxone. This pivotal pharmacokinetic study is a critical component of the NDA.
"We are pleased to have again demonstrated the ability of our BEMA drug delivery technology to provide solid dose proportionality," said Dr. Andrew Finn, Executive Vice President of Product Development. "The outcome of this study not only satisfies the FDA's request for a multiple film evaluation, but it also enhances the probability of success for BNX in our upcoming pivotal pharmacokinetic study versus Suboxone."
BDSI expects to have key data results from the pivotal pharmacokinetic study versus Suboxone in late third quarter of this year after a mid-summer initiation. The final clinical requirement for the NDA, an open-label safety study, will initiate on time in the third quarter allowing BDSI to remain on track for an NDA filing in the first half of 2013.
About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence
BNX is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.
Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone (buprenorphine/naloxone), which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer. BDSI believes that BNX, which uses BDSI's proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could seize a meaningful share of this rapidly growing market.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Results of the FDA recommended trial demonstrate dose proportionality ahead of the forthcoming pivotal pharmacokinetic study versus Suboxone
NDA on track for submission in the first half of 2013
Jun 28, 2012
RALEIGH, N.C., June 28, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced positive results of a recently completed pharmacokinetic study (BNX-106) examining the effects of multiple BEMA Buprenorphine/Naloxone (BNX) films administered concurrently. This study was part of the U.S. Food and Drug Administration (FDA) recommended program for a New Drug Application (NDA) for BNX.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered, meaning that as doses of BNX increased, there was a corresponding increase in the amount of buprenorphine in the plasma. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.
Overall, these results provide additional confidence that the doses selected for BDSI's upcoming pivotal pharmacokinetic study for BNX will produce similar buprenorphine pharmacokinetics as the reference product, Suboxone. This pivotal pharmacokinetic study is a critical component of the NDA.
"We are pleased to have again demonstrated the ability of our BEMA drug delivery technology to provide solid dose proportionality," said Dr. Andrew Finn, Executive Vice President of Product Development. "The outcome of this study not only satisfies the FDA's request for a multiple film evaluation, but it also enhances the probability of success for BNX in our upcoming pivotal pharmacokinetic study versus Suboxone."
BDSI expects to have key data results from the pivotal pharmacokinetic study versus Suboxone in late third quarter of this year after a mid-summer initiation. The final clinical requirement for the NDA, an open-label safety study, will initiate on time in the third quarter allowing BDSI to remain on track for an NDA filing in the first half of 2013.
About BEMA Buprenorphine/Naloxone (BNX) and Opioid Dependence
BNX is being developed for the treatment of opioid dependence and contains the same drug components as Suboxone, the only currently marketed formulation of buprenorphine and naloxone. Buprenorphine reduces the craving and withdrawal effects from the dependent opioid, and the opioid antagonist, naloxone, is present to deter abuse.
Opioid dependence is a significantly undertreated condition in the U.S., with nearly 2 million people dependent on prescription opioids according to the 2010 National Survey on Drug Use and Health, conducted by the U.S. Department of Health and Human Services. Suboxone (buprenorphine/naloxone), which was approved for the treatment of opioid dependence in 2002, has been shown to be a highly effective treatment option and, as a result, currently generates annual sales of more than $1.2 billion, growing over 20% in 2011 according to data from Wolters Kluwer. BDSI believes that BNX, which uses BDSI's proprietary BEMA delivery technology, has the potential to offer advantages over Suboxone and could seize a meaningful share of this rapidly growing market.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
JMP Securities Starts BioDelivery Sciences International (BDSI) at Market Outperform
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Barclays (BCS) CEO Diamond Resigns; Cites LIBOR Manipulation Inquiries
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July 3, 2012 7:34 AM EDT
BDSI Hot Sheet
Rating Summary:
3 Buy, 0 Hold, 0 Sell
Rating Trend: Up
Today's Overall Ratings:
Up: 10 | Down: 25 | New: 12
JMP Securities initiates coverage on BioDelivery Sciences International (NASDAQ: BDSI) with a Market Outperform. PT $9.00.
For an analyst ratings summary and ratings history on BioDelivery Sciences International click here. For more ratings news on BioDelivery Sciences International click here.
Shares of BioDelivery Sciences International closed at $4.50 yesterday, with a 52 week range of $0.77-$
FREE Breaking News Alerts from StreetInsider.com!
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Top News
Most Read
Highlighted
Barclays (BCS) CEO Diamond Resigns; Cites LIBOR Manipulation Inquiries
From Botched IPOs to Libor Manipulation: Goldman Sachs Isn't the Only Bank Labeled as a Vampire Squid
June Auto Sales Better Than Expected as Incentives Push Car Buyers (GM) (F) (TM)
Chesapeake (CHK) Attracts a New Activist, This One May Not Be So Nice
Iran's Saber Rattling Lifts Oil
July 3, 2012 7:34 AM EDT
BDSI Hot Sheet
Rating Summary:
3 Buy, 0 Hold, 0 Sell
Rating Trend: Up
Today's Overall Ratings:
Up: 10 | Down: 25 | New: 12
JMP Securities initiates coverage on BioDelivery Sciences International (NASDAQ: BDSI) with a Market Outperform. PT $9.00.
For an analyst ratings summary and ratings history on BioDelivery Sciences International click here. For more ratings news on BioDelivery Sciences International click here.
Shares of BioDelivery Sciences International closed at $4.50 yesterday, with a 52 week range of $0.77-$
Antwort auf Beitrag Nr.: 43.348.853 von Wohnwunsch am 03.07.12 18:49:51Heute ist ein sehr komischer Handel, sehr sehr lange absolut geringer Handel...
Wird hier gesammelt oder will man den Kurs noch unten halten
Die News heute war sehr positiv
Wird hier gesammelt oder will man den Kurs noch unten halten
Die News heute war sehr positiv
Naja für heute und morgen hat es sich in den USA mit dem Handel erstmal
erledigt.
Bis Donnerstag, dann in GANZ neue Höhen
erledigt.
Bis Donnerstag, dann in GANZ neue Höhen
Antwort auf Beitrag Nr.: 43.349.138 von Wohnwunsch am 03.07.12 20:12:14Sehr schöner Verlauf heute wieder bei unserer Biodelivery,
es wundert mich wie stabil diese Aktie bei diesem schlechten Marktumfeld
läuft..
es wundert mich wie stabil diese Aktie bei diesem schlechten Marktumfeld
läuft..
Jul 12, 2012 (Close-Up Media via COMTEX) -- BioDelivery Sciences International,
Inc.'s Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI,
presented at this year's JMP Securities Healthcare Conference.
According to a release, the presentation was scheduled for July 13, at 1 p.m.
Eastern Time, at The Peninsula Hotel in New York City.
Dr. Sirgo focused on BDSI's progress with the clinical development program and
the market opportunity for BEMA Buprenorphine/Naloxone (BNX) for the treatment
of opioid dependence. Additionally, Dr. Sirgo discussed BDSI's worldwide
licensing and development agreement with Endo Pharmaceuticals for BEMA
Buprenorphine for the treatment of chronic pain and the forthcoming initiation
of the two Phase 3 studies.
The presentation was webcast live and can be accessed for replay at
www.bdsi.com.
BioDelivery Sciences International is a specialty pharmaceutical company that is
leveraging its drug delivery technologies to develop and commercialize, either
on its own or in partnerships with third parties, new applications of
therapeutics.
More information:
www.bdsi.com
Inc.'s Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI,
presented at this year's JMP Securities Healthcare Conference.
According to a release, the presentation was scheduled for July 13, at 1 p.m.
Eastern Time, at The Peninsula Hotel in New York City.
Dr. Sirgo focused on BDSI's progress with the clinical development program and
the market opportunity for BEMA Buprenorphine/Naloxone (BNX) for the treatment
of opioid dependence. Additionally, Dr. Sirgo discussed BDSI's worldwide
licensing and development agreement with Endo Pharmaceuticals for BEMA
Buprenorphine for the treatment of chronic pain and the forthcoming initiation
of the two Phase 3 studies.
The presentation was webcast live and can be accessed for replay at
www.bdsi.com.
BioDelivery Sciences International is a specialty pharmaceutical company that is
leveraging its drug delivery technologies to develop and commercialize, either
on its own or in partnerships with third parties, new applications of
therapeutics.
More information:
www.bdsi.com
Antwort auf Beitrag Nr.: 43.387.337 von Wohnwunsch am 15.07.12 10:29:10Der Hype bei Biodelivery scheint wohl vorerst beendet zu sein
BioDelivery Sciences and Endo Health Solutions Announce Initiation of Enrollment in the Phase 3 Program for BEMA Buprenorphine for Chronic Pain
RALEIGH, N.C. and CHADDS FORD, Pa., Aug. 2, 2012 /PRNewswire-FirstCall/ --BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Endo Health Solutions Inc. (Nasdaq: ENDP) today announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The Phase 3 program will consist of two efficacy studies, one in opioid naive and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014.
Both studies are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. The studies have been designed through a cooperative effort between BDSI and Endo, along with input from the U.S. Food and Drug Administration (FDA). These two studies, along with an open-label safety study, comprise the Phase 3 program and the basis fora New Drug Application (NDA).
Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the NDA by the FDA. These payments will total $30 million.
"We are very pleased to be back in the clinic with these two important pivotal studies and to have enrolled our first patient," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "This has been a tremendous cooperative effort between the teams at BDSI and Endo since January that we believe gives us the best chance of obtaining a positive clinical outcome. We continue to believe that BEMA Buprenorphine has the potential to address some of the important unmet needs in the treatment of chronic pain and look forward to expeditiously progressing the program forward."
"With a long-standing history and success in developing innovative solutions for pain management, BEMA Buprenorphine represents a significant asset and a high priority program to Endo as we continue our commitment to serving as an integrated health solutions provider," said Dr. Ivan Gergel, M.D., Executive Vice President, R&D and Chief Scientific Officer, Endo. "We are pleased to have the Phase 3 program now underway."
About Endo
Endo Health Solutions Inc. (Endo) is a U.S.-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Endo Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
BioDelivery Sciences International Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE Endo Health Solutions Inc.; BioDelivery Sciences International, Inc.
RALEIGH, N.C. and CHADDS FORD, Pa., Aug. 2, 2012 /PRNewswire-FirstCall/ --BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Endo Health Solutions Inc. (Nasdaq: ENDP) today announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The Phase 3 program will consist of two efficacy studies, one in opioid naive and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014.
Both studies are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain. The studies have been designed through a cooperative effort between BDSI and Endo, along with input from the U.S. Food and Drug Administration (FDA). These two studies, along with an open-label safety study, comprise the Phase 3 program and the basis fora New Drug Application (NDA).
Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the NDA by the FDA. These payments will total $30 million.
"We are very pleased to be back in the clinic with these two important pivotal studies and to have enrolled our first patient," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "This has been a tremendous cooperative effort between the teams at BDSI and Endo since January that we believe gives us the best chance of obtaining a positive clinical outcome. We continue to believe that BEMA Buprenorphine has the potential to address some of the important unmet needs in the treatment of chronic pain and look forward to expeditiously progressing the program forward."
"With a long-standing history and success in developing innovative solutions for pain management, BEMA Buprenorphine represents a significant asset and a high priority program to Endo as we continue our commitment to serving as an integrated health solutions provider," said Dr. Ivan Gergel, M.D., Executive Vice President, R&D and Chief Scientific Officer, Endo. "We are pleased to have the Phase 3 program now underway."
About Endo
Endo Health Solutions Inc. (Endo) is a U.S.-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Through our operating companies: AMS, Endo Pharmaceuticals, HealthTronics and Qualitest, Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services that creates maximum value for patients, providers and payers alike. Learn more at www.endo.com.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Endo Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
BioDelivery Sciences International Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to clinical development program and timeline for BEMA Buprenorphine) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE Endo Health Solutions Inc.; BioDelivery Sciences International, Inc.
BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of its Second Quarter 2012 Financials
Pivotal clinical studies underway for BEMA Buprenorphine for chronic pain and BNX for opioid dependence
Aug 9, 2012
RALEIGH, N.C., Aug. 9, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012, as well as an update on business operations and upcoming milestones for the balance of the year.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
At June 30, 2012, BDSI had $43.0 million in cash compared to $10.8 million at June 30, 2011. Contributions to BDSI's cash balance during the second quarter included a milestone payment of $15 million associated with the licensing and development agreement with Endo Health Solutions (Endo) for BEMA Buprenorphine. The milestone was triggered by the granting of a patent extending the exclusivity for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) by seven years to 2027.
BDSI also received a milestone payment from Meda in the amount of $2.5 million following the first E.U. country registration and pricing approval for BREAKYL (trade name for ONSOLIS in the E.U.). Meda is BDSI's worldwide commercial partner for ONSOLIS/BREAKYL, outside of Taiwan and South Korea, where the product is separately partnered.
Last week, BDSI and Endo announced initiation of enrollment in the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. Additionally, data is anticipated to be available by the end of September for the pivotal bioavailability study for BNX, which is currently ongoing.
"We are extremely pleased to have both of our key assets, BEMA Buprenorphine for chronic pain and BNX for opioid dependence, move into pivotal registration trials," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We announced a number of exciting achievements in the first quarter of this year, including the signing of the licensing and development agreement for BEMA Buprenorphine with Endo and a positive meeting with FDA on our BNX development program. Since the first quarter, we have built on these prior accomplishments by progressing both BEMA Buprenorphine and BNX into registration studies. These are significant achievements and have ushered in a very exciting period of time at BDSI. As it relates to the BNX clinical development program, we look forward to the availability of data from our pivotal pharmacokinetic study in late September."
Corporate Update
The following are key events that occurred at BDSI since the start of the second quarter of 2012:
BEMA Buprenorphine - Chronic Pain. BDSI and Endo announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The Phase 3 program will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014. Both are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.
Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the New Drug Application (NDA) by the FDA. These payments will total $30 million.
In January 2012, BDSI signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing, the recently received $15 million triggered by the granting of a patent extending exclusivity of BEMA products containing buprenorphine and a tiered mid- to upper-teen royalty on net sales in the U.S.
BNX - Opioid Dependence. Positive results were obtained from a pharmacokinetic study (BNX-106) examining the effects of multiple BNX films administered concurrently. The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.
Results of the aforementioned study allowed for initiation of both the pivotal pharmacokinetic study and the safety study, both of which are currently underway. Results of the pivotal pharmacokinetic study are anticipated by the end of September. The current study timeline supports the filing of an NDA for BNX in the first half of 2013.
ONSOLIS/BREAKYL. BDSI announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL. A last milestone payment related to the E.U. of $2.5 million, is payable at the time of commercial launch, which is anticipated in late 2012.
In the U.S., as previously announced, the re-launch of ONSOLIS is delayed until the product formulation can be modified and agreement reached with FDA to address certain appearance issues noted by FDA. Reformulation work has been completed and final test results are being compiled for an expected August submission of a formal meeting request to FDA.
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
Recruitment of two Phase 3 studies for BEMA Buprenorphine. BDSI and Endo expect to continue recruitment in two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups.
Reporting of pivotal pharmacokinetic study results for BNX. BDSI will advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and full recruitment of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated by the end of September 2012.
Launch of BREAKYL in the E.U. BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the fourth quarter of 2012. This launch would result in a milestone payment to BDSI of $2.5 million.
Exploration of Potential New Products and Technologies. In addition to supporting its marketed product and advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals. Furthermore, BDSI has been investigating potential new products or technologies to compliment its existing portfolio.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's 2012 initiatives described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Pivotal clinical studies underway for BEMA Buprenorphine for chronic pain and BNX for opioid dependence
Aug 9, 2012
RALEIGH, N.C., Aug. 9, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that it has filed its Quarterly Report on Form 10-Q for the quarter ended June 30, 2012 with the U.S. Securities and Exchange Commission. In connection therewith, BDSI is providing a review of its recent achievements in 2012, as well as an update on business operations and upcoming milestones for the balance of the year.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
At June 30, 2012, BDSI had $43.0 million in cash compared to $10.8 million at June 30, 2011. Contributions to BDSI's cash balance during the second quarter included a milestone payment of $15 million associated with the licensing and development agreement with Endo Health Solutions (Endo) for BEMA Buprenorphine. The milestone was triggered by the granting of a patent extending the exclusivity for BEMA Buprenorphine and BEMA Buprenorphine/Naloxone (BNX) by seven years to 2027.
BDSI also received a milestone payment from Meda in the amount of $2.5 million following the first E.U. country registration and pricing approval for BREAKYL (trade name for ONSOLIS in the E.U.). Meda is BDSI's worldwide commercial partner for ONSOLIS/BREAKYL, outside of Taiwan and South Korea, where the product is separately partnered.
Last week, BDSI and Endo announced initiation of enrollment in the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. Additionally, data is anticipated to be available by the end of September for the pivotal bioavailability study for BNX, which is currently ongoing.
"We are extremely pleased to have both of our key assets, BEMA Buprenorphine for chronic pain and BNX for opioid dependence, move into pivotal registration trials," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI. "We announced a number of exciting achievements in the first quarter of this year, including the signing of the licensing and development agreement for BEMA Buprenorphine with Endo and a positive meeting with FDA on our BNX development program. Since the first quarter, we have built on these prior accomplishments by progressing both BEMA Buprenorphine and BNX into registration studies. These are significant achievements and have ushered in a very exciting period of time at BDSI. As it relates to the BNX clinical development program, we look forward to the availability of data from our pivotal pharmacokinetic study in late September."
Corporate Update
The following are key events that occurred at BDSI since the start of the second quarter of 2012:
BEMA Buprenorphine - Chronic Pain. BDSI and Endo announced the initiation of the Phase 3 clinical program for BEMA Buprenorphine for the treatment of moderate to severe chronic pain. The Phase 3 program will consist of two efficacy studies, one in opioid naïve and one in opioid experienced subjects. Both studies are anticipated to be completed by late 2013 or early 2014. Both are double-blind, randomized, placebo-controlled, enriched-enrollment studies in patients with chronic lower back pain.
Based on the licensing agreement for BEMA Buprenorphine, BDSI will receive milestone payments from Endo at completion of study enrollment and database lock for each trial, and subsequently, for the acceptance of filing of the New Drug Application (NDA) by the FDA. These payments will total $30 million.
In January 2012, BDSI signed a worldwide license and development agreement with Endo for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain. The agreement, worth up to $180 million to BDSI if all milestones are met, included an upfront payment of $30 million at signing, the recently received $15 million triggered by the granting of a patent extending exclusivity of BEMA products containing buprenorphine and a tiered mid- to upper-teen royalty on net sales in the U.S.
BNX - Opioid Dependence. Positive results were obtained from a pharmacokinetic study (BNX-106) examining the effects of multiple BNX films administered concurrently. The study confirmed that the buprenorphine pharmacokinetics were nearly identical following multiple BNX films applied at one time compared to an equivalent dose administered as a single film. Additionally, there was a linear relationship in buprenorphine pharmacokinetics across the dose range of BNX administered. Regarding the naloxone component of BNX, the study demonstrated that the exposure of naloxone is similar to the reference standard, Suboxone.
Results of the aforementioned study allowed for initiation of both the pivotal pharmacokinetic study and the safety study, both of which are currently underway. Results of the pivotal pharmacokinetic study are anticipated by the end of September. The current study timeline supports the filing of an NDA for BNX in the first half of 2013.
ONSOLIS/BREAKYL. BDSI announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL. A last milestone payment related to the E.U. of $2.5 million, is payable at the time of commercial launch, which is anticipated in late 2012.
In the U.S., as previously announced, the re-launch of ONSOLIS is delayed until the product formulation can be modified and agreement reached with FDA to address certain appearance issues noted by FDA. Reformulation work has been completed and final test results are being compiled for an expected August submission of a formal meeting request to FDA.
Anticipated 2012 Milestones
In 2012, BDSI is focusing its resources on achievement of the following key milestones:
Recruitment of two Phase 3 studies for BEMA Buprenorphine. BDSI and Endo expect to continue recruitment in two Phase 3 efficacy studies for BEMA Buprenorphine for chronic pain, one in opioid experienced and one in opioid naïve patient groups.
Reporting of pivotal pharmacokinetic study results for BNX. BDSI will advance the development of BNX for the treatment of opioid dependence through completion of the pivotal pharmacokinetic study and full recruitment of the safety study, allowing for a potential NDA submission in the first half of 2013. The data from the pivotal pharmacokinetic study is anticipated by the end of September 2012.
Launch of BREAKYL in the E.U. BDSI expects its commercial partner, Meda, to launch BREAKYL (brand name for ONSOLIS in the E.U.) in the E.U. during the fourth quarter of 2012. This launch would result in a milestone payment to BDSI of $2.5 million.
Exploration of Potential New Products and Technologies. In addition to supporting its marketed product and advancing its lead products in development, BDSI is also, as in the past, exploring the application of its BEMA drug delivery technology to additional pharmaceuticals. Furthermore, BDSI has been investigating potential new products or technologies to compliment its existing portfolio.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's 2012 initiatives described herein) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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BioDelivery Sciences Announces Completion of Enrollment in Pivotal Pharmacokinetic Study of BEMA Buprenorphine/Naloxone Compared to Suboxone
Results on target to be released in September
Aug 20, 2012
RALEIGH, N.C., Aug. 20, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)
As agreed with the U.S. Food and Drug Administration (FDA) in February 2012, the study, referred to as BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone from BNX with the reference product Suboxone. Meeting those requirements will represent a positive outcome of that study. All subjects have been dosed and the analytical work (i.e., plasma sample analysis) is in process. BDSI expects to report results from this pivotal pharmacokinetic study before the end of September.
The open-label safety study, which is the last clinical requirement for this program, is expected to complete by year-end. Availability of the necessary product stability data for BNX in the first quarter of 2013 will be followed by submission of the NDA in the second quarter.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYLTM is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to timing and prospects for the clinical development program for BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences, International, Inc., 919-582-9050, amedwar@bdsi.com
Results on target to be released in September
Aug 20, 2012
RALEIGH, N.C., Aug. 20, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)
As agreed with the U.S. Food and Drug Administration (FDA) in February 2012, the study, referred to as BNX-103, was designed to compare the relative bioavailability of buprenorphine and naloxone from BNX with the reference product Suboxone. Meeting those requirements will represent a positive outcome of that study. All subjects have been dosed and the analytical work (i.e., plasma sample analysis) is in process. BDSI expects to report results from this pivotal pharmacokinetic study before the end of September.
The open-label safety study, which is the last clinical requirement for this program, is expected to complete by year-end. Availability of the necessary product stability data for BNX in the first quarter of 2013 will be followed by submission of the NDA in the second quarter.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYLTM is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, with respect to timing and prospects for the clinical development program for BEMA Buprenorphine/Naloxone) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences, International, Inc., 919-582-9050, amedwar@bdsi.com
Was ist denn das heute wieder ?
Erst wurde Biodelivery hochgezogen und jetzt wird sie fallen
gelassen ?
Muss man heute nicht verstehen den Kursverlauf
Erst wurde Biodelivery hochgezogen und jetzt wird sie fallen
gelassen ?
Muss man heute nicht verstehen den Kursverlauf
Antwort auf Beitrag Nr.: 43.568.617 von Wohnwunsch am 04.09.12 21:42:41Unsere Biodelivery will wieder massiv nach oben.......
Mir kommt es fast so vor als hatt diese Aktie kaum jemand
auf seinem Radar...
Es ist schon zu sehen das die Aktie nach der Konsolidierung
jetzt wieder ganz ohne Zocker nach oben läuft.
Hier werden wir noch sehr viel Freude mit Biodelivery haben
Ich bleibe hier Long...
Mir kommt es fast so vor als hatt diese Aktie kaum jemand
auf seinem Radar...
Es ist schon zu sehen das die Aktie nach der Konsolidierung
jetzt wieder ganz ohne Zocker nach oben läuft.
Hier werden wir noch sehr viel Freude mit Biodelivery haben
Ich bleibe hier Long...
Es ist genauso eingetreten wie es damals in meinem zweiten posting in diesen thread gesagt habe ,erst schlechte daten die später also jetzt positiv sind .
BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
http://finance.yahoo.com/news/biodelivery-sciences-announces…
BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
http://finance.yahoo.com/news/biodelivery-sciences-announces…
Zitat von Biohero: Es ist genauso eingetreten wie es damals in meinem zweiten posting in diesen thread gesagt habe ,erst schlechte daten die später also jetzt positiv sind .
BioDelivery Sciences Announces Positive Results of Pivotal Pharmacokinetic Study Comparing BEMA Buprenorphine/Naloxone (BNX) to Suboxone
http://finance.yahoo.com/news/biodelivery-sciences-announces…
Und das heißt jetzt was für uns ?
Antwort auf Beitrag Nr.: 43.601.574 von Wohnwunsch am 13.09.12 18:29:34Unsere Biodelivery läuft wie ein Uhrwerk, mein Kursziel Ende 2012 war bei 7,45€
das werden wir viel früher erreichen
Biodelivery scheint eine goldene Gans zu sein / werden
das werden wir viel früher erreichen
Biodelivery scheint eine goldene Gans zu sein / werden
Hallo, mal ne Frage zu Biodelivery:
wie hoch sind die Umsätze von Onsolis und die Royalties aus der Onsolis-Auslizensierung? Das sind ja die einzigen regelmäßigen Einnahmen der Firma, soweit ich das verstehe.
Im annual report 2011 sieht die Entwicklung von income, cash flow und loss per share ja nicht sehr vielversprechend aus (bin allerdings kein Betriebswirt).
GRuß
me_2
wie hoch sind die Umsätze von Onsolis und die Royalties aus der Onsolis-Auslizensierung? Das sind ja die einzigen regelmäßigen Einnahmen der Firma, soweit ich das verstehe.
Im annual report 2011 sieht die Entwicklung von income, cash flow und loss per share ja nicht sehr vielversprechend aus (bin allerdings kein Betriebswirt).
GRuß
me_2
Sollte bei Biodelivery die Luft nach oben jetzt erstmal raus sein ?
Wer ist hier noch investiert und wie sind eure Meinungen dazu ?
Wer ist hier noch investiert und wie sind eure Meinungen dazu ?
Na hoffentlich laufen wir heute nach dem schönen Anstieg
am Vormittag nicht noch ins Minus in den USA
am Vormittag nicht noch ins Minus in den USA
Was ist mit dem Kurs los ? Sind das Gewinnmitnahmen oder
liegt es nur am Gesamtmarkt ?
Oder ist der Kurs rückläufig ?
liegt es nur am Gesamtmarkt ?
Oder ist der Kurs rückläufig ?
BioDelivery Sciences Reaffirms its Strengthened Position Following Reexamination of MonoSol Patents
Oct 18, 2012
RALEIGH, N.C., Oct. 18, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today reaffirmed its continued strong position and ongoing progress made in its defense of a process patent infringement lawsuit previously served against BDSI and its partners for ONSOLIS, by MonoSolRx, LLC (MonoSol). BDSI reaffirms that its products and technologies do not infringe on MonoSol's original patents, and BDSI believes that its position in this matter has only been strengthened by the recent actions of the U.S. Patent Office that significantly narrow or fully reject the claims in MonoSol's patents.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
As expected, in Ex Parte Reexamination proceedings before the U.S. Patent Office brought by BDSI relating to two of MonoSol's patents in the case (US Patent No. 7,357,891 ('891 Patent) and US Patent No. 7,425,292 ('292 Patent)), MonoSol amended the associated claims several times and made multiple declarations and arguments in an attempt to overcome the rejections made by the U.S. Patent Office. Through the proceedings, MonoSol was forced to significantly narrow its claims in order to obtain allowance, demonstrating that the original claims were invalid. These claim amendments, as well as declarations and other statements regarding the claim language, have significantly narrowed the scope of their patents.
Regarding MonoSol's third patent in this case, US 7,824,588, the reexamination brought by BDSI continues, and to date, all 191 claims have now twice been rejected by the U.S. Patent Office, including most recently in an Action Closing Prosecution. BDSI expects a notice to be issued by the U.S. Patent Office concluding the reexamination in the next few months.
BDSI remains confident in its position and intends to continue its aggressive defense of this matter. In the meantime, BDSI remains focused on developing its pipeline of promising products utilizing its patent protected BioErodible MucoAdhesive (BEMA) technology to bring to market important new products, including BEMA Buprenorphine for chronic pain and BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's litigation with MonoSol and related proceedings before the U.S. Patent Office) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Oct 18, 2012
RALEIGH, N.C., Oct. 18, 2012 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) today reaffirmed its continued strong position and ongoing progress made in its defense of a process patent infringement lawsuit previously served against BDSI and its partners for ONSOLIS, by MonoSolRx, LLC (MonoSol). BDSI reaffirms that its products and technologies do not infringe on MonoSol's original patents, and BDSI believes that its position in this matter has only been strengthened by the recent actions of the U.S. Patent Office that significantly narrow or fully reject the claims in MonoSol's patents.
(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO )
As expected, in Ex Parte Reexamination proceedings before the U.S. Patent Office brought by BDSI relating to two of MonoSol's patents in the case (US Patent No. 7,357,891 ('891 Patent) and US Patent No. 7,425,292 ('292 Patent)), MonoSol amended the associated claims several times and made multiple declarations and arguments in an attempt to overcome the rejections made by the U.S. Patent Office. Through the proceedings, MonoSol was forced to significantly narrow its claims in order to obtain allowance, demonstrating that the original claims were invalid. These claim amendments, as well as declarations and other statements regarding the claim language, have significantly narrowed the scope of their patents.
Regarding MonoSol's third patent in this case, US 7,824,588, the reexamination brought by BDSI continues, and to date, all 191 claims have now twice been rejected by the U.S. Patent Office, including most recently in an Action Closing Prosecution. BDSI expects a notice to be issued by the U.S. Patent Office concluding the reexamination in the next few months.
BDSI remains confident in its position and intends to continue its aggressive defense of this matter. In the meantime, BDSI remains focused on developing its pipeline of promising products utilizing its patent protected BioErodible MucoAdhesive (BEMA) technology to bring to market important new products, including BEMA Buprenorphine for chronic pain and BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ: BDSI) is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. BDSI is focusing on developing products to meet unmet patient needs in the areas of pain management and oncology supportive care. BDSI's pain franchise currently consists of two products utilizing the patented BEMA technology. ONSOLIS (fentanyl buccal soluble film) is approved in the U.S., Canada, and the E.U. (where it will be marketed as BREAKYL), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights are licensed to Meda for all territories worldwide except for Taiwan (licensed to TTY Biopharm) and South Korea (licensed to Kunwha Pharmaceutical Co.). BDSI's second pain product, BEMA Buprenorphine, is being developed for the treatment of moderate to severe chronic pain and is in development in a high dose formulation with naloxone for the treatment of opioid dependence. BEMA Buprenorphine for chronic pain is licensed on a worldwide basis to Endo Pharmaceuticals. BDSI's headquarters is located in Raleigh, North Carolina. For more information, visit www.bdsi.com.
BDSI® and BEMA® are registered trademarks of BioDelivery Sciences International, Inc. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL is registered trademark of Meda Pharma GmbH & Co. KG.
Cautionary Note on Forward-Looking Statements
This press release, the conference presentation described herein, and any statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential" or similar expressions. These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results (including, without limitation, the results of the Company's litigation with MonoSol and related proceedings before the U.S. Patent Office) may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
SOURCE BioDelivery Sciences International, Inc.
For further information: Brian Korb, Senior Vice President, The Trout Group LLC, +1-646-378-2923, bkorb@troutgroup.com; or Al Medwar, Vice President, Marketing and Corporate Development, BioDelivery Sciences International, Inc., +1-919-582-9050, amedwar@bdsi.com
Sieht heute gleich zu Beginn sehr schlecht aus, sattes Minus
Mich stimmt die Situation schon sehr nervös
Mich stimmt die Situation schon sehr nervös
Antwort auf Beitrag Nr.: 43.737.751 von Wohnwunsch am 22.10.12 15:31:56Jetzt schon ein fettes MINUS von >3% das sieht nach Kursverfall aus,
wenn man denkt wir kommen von über 6,2x $
Schei....... was ist mit der Aktie los, schon extrem der Verfall.
Nur wegen dem Verfahren kann es ja nicht sein, das ist ja schon länger
bekannt
wenn man denkt wir kommen von über 6,2x $
Schei....... was ist mit der Aktie los, schon extrem der Verfall.
Nur wegen dem Verfahren kann es ja nicht sein, das ist ja schon länger
bekannt
Antwort auf Beitrag Nr.: 43.737.784 von Wohnwunsch am 22.10.12 15:39:10Jetzt scheint es aber richtig down zu gehen ein Minus von >4%
Weiss einer genauer was den enormen Kursverfall in den letzten
Tagen rechtfertigt ?
Weiss einer genauer was den enormen Kursverfall in den letzten
Tagen rechtfertigt ?
Antwort auf Beitrag Nr.: 43.737.856 von Wohnwunsch am 22.10.12 15:51:55Was ist hier los ???????
MINUS 7%
MINUS 7%
Antwort auf Beitrag Nr.: 43.737.907 von Wohnwunsch am 22.10.12 15:58:17Also wenn hier einige überrascht sind bezgl. des Patentenrechtstreit wundert
mich der doch extreme Kursverfall schon sehr stark.
mich der doch extreme Kursverfall schon sehr stark.
Und schom sind es 7,4% MINUS, schaffen wir heute noch die 10% MINUS ?
Antwort auf Beitrag Nr.: 43.738.735 von Wohnwunsch am 22.10.12 18:55:13Heute ist SCHLACHTFEST bei Biodelivery angesagt, massiver Abverkauf
der Aktien scheint hier seit einigen Tagen zu laufen.
Schade das sich die Firma nicht zu Wort meldet, das sieht nicht gut aus
ENDE des Hyp ?
der Aktien scheint hier seit einigen Tagen zu laufen.
Schade das sich die Firma nicht zu Wort meldet, das sieht nicht gut aus
ENDE des Hyp ?
Ist hier keiner mehr investiert ?
Oder hat zu der Aktie keiner eine Meinung ?
Oder hat zu der Aktie keiner eine Meinung ?
Ok der Kursverfall von Biodelivery ist weiterhin in Takt
GANZ TOLL was hier läuft
GANZ TOLL was hier läuft
ZUM KOTZEN WAS HIER LÄUFT
Und das Management hat ja nicht nötig auf Nachfragen zu reagieren
Und das Management hat ja nicht nötig auf Nachfragen zu reagieren
Haben alle grossen bereit ihre Aktien geworfen oder was ist dieses
mickrige Volumen ?
Warum knallen wir nicht einfach 30% nach unten und gut ist ?
mickrige Volumen ?
Warum knallen wir nicht einfach 30% nach unten und gut ist ?
Genau so soooo ist es gut, kaum geschrieben und ab in den Keller
mit dem Dreck....
Und jetzt die News das es eine Patentverletzung gibt und dann passt es
Auf eine TIEF ROTE ZEIT in dem Schrott
mit dem Dreck....
Und jetzt die News das es eine Patentverletzung gibt und dann passt es
Auf eine TIEF ROTE ZEIT in dem Schrott
Und weiter nach unten, mein lieber man heute stehen die Chancen
aber sehr sehr gut um am Ende des Tages ein FETTES MINUS von 10%
zu bekommen
WEITER SO FLEISSIG VERKAUFEN
aber sehr sehr gut um am Ende des Tages ein FETTES MINUS von 10%
zu bekommen
WEITER SO FLEISSIG VERKAUFEN
Und da sind 50% von den MINUS 10% des heutigen Tages erreicht......
Weiterhin stabil auf dem Abwärtstrend, weiter so Biodelivery
Wir schaffen eine Halbierung des Aktienkurses in 2 Wocehn
Weiterhin stabil auf dem Abwärtstrend, weiter so Biodelivery
Wir schaffen eine Halbierung des Aktienkurses in 2 Wocehn
Jeder kleinere Anstieg wird hier sofort zum Verkauf genutzt, das ist ein sehr schlechtes
Zeichen, wer weiß ob an dem Patentstreit nicht doch wirklich ein Missbrauch von Biodelivery vorliegt.
Ansonsten kann ich mir den massiven Kursverfall nicht erklären, das Anlegervertrauen
scheint völlig weg zu sein
Zeichen, wer weiß ob an dem Patentstreit nicht doch wirklich ein Missbrauch von Biodelivery vorliegt.
Ansonsten kann ich mir den massiven Kursverfall nicht erklären, das Anlegervertrauen
scheint völlig weg zu sein
Nach jedem kleinen Hoch wird SOFORT ABVERKAUFT, das wahrscheinlich dann
wohl mit Biodelivery
Schade das ich nicht auf Jahreshoch verkauft habe
wohl mit Biodelivery
Schade das ich nicht auf Jahreshoch verkauft habe
Wie gesagt, jeder Anstieg wird hier sofort zum Verkauf genutzt
Antwort auf Beitrag Nr.: 43.743.053 von Wohnwunsch am 23.10.12 18:14:27hör auf zu jammern!Gesunde Korrektur!
Hätte deiner Stelle eh viel früher verkauft!
Hätte deiner Stelle eh viel früher verkauft!
Antwort auf Beitrag Nr.: 43.743.420 von sebirem am 23.10.12 19:22:05Aha 30% Kursverlust sind deiner Meinung nach in einer Woche eine gesunde Korrektur,
ja ich weiß wann du ausgestiegen bist und ich kann verstehen das du dich darüber ärgerst
Aber das hat aktuell mit einer Korrektur nichts mehr zu tun, auch wenn ich noch weit über 100%
im Plus bin, ist der Verfall nicht nachzuvollziehen.
Denn nur allein die Nachricht bezüglich des Patentstreit kann es nicht sein, denn das war
länger bekannt.
Also ????
ja ich weiß wann du ausgestiegen bist und ich kann verstehen das du dich darüber ärgerst
Aber das hat aktuell mit einer Korrektur nichts mehr zu tun, auch wenn ich noch weit über 100%
im Plus bin, ist der Verfall nicht nachzuvollziehen.
Denn nur allein die Nachricht bezüglich des Patentstreit kann es nicht sein, denn das war
länger bekannt.
Also ????
Kein Volumen mehr nichts, haben denn ALLE hier das Vertrauen
in Biodelivery verloren ?
in Biodelivery verloren ?
Und wie sollte es auch änderst sein..........
.....der kleine Anstieg wurde sofort zum Verkauf genutzt.
Das ist ein Zeichen hier die Reisleine zu ziehen, der Kurs wird
wohl weiter massiv fallen
.....der kleine Anstieg wurde sofort zum Verkauf genutzt.
Das ist ein Zeichen hier die Reisleine zu ziehen, der Kurs wird
wohl weiter massiv fallen
Jetzt hat ein grosser mal schnell 50.000Stk geworfen,
das war das Zeichen um Biodelivery endgültig ins AUS
zu setzen....
Was für eine Scheisse hier
das war das Zeichen um Biodelivery endgültig ins AUS
zu setzen....
Was für eine Scheisse hier
Und wieder abwärts, auf zu alten Tiefen....
Mist
Mist
Wieder einmal ein schöner Kursverfall heuteczu sehen
Zum kotzen was hier läuft
Zum kotzen was hier läuft
!
Dieser Beitrag wurde von CloudMOD moderiert. Grund: Spam, Werbung
Ist hier außer mir noch jemand in der Aktie investiert ?
Hatte sie jetzt lange nicht auf dem Schirm, ist sehr sehr gut gelaufen seit
dem letzten Kursverfall.
Was ist hier im Busch das die Aktie so stark gestiegen ist ?
Weiss hier jemand mehr ?
Hatte sie jetzt lange nicht auf dem Schirm, ist sehr sehr gut gelaufen seit
dem letzten Kursverfall.
Was ist hier im Busch das die Aktie so stark gestiegen ist ?
Weiss hier jemand mehr ?
hey wohnwunsch, bin seit letzten dienstag auch investiert. hab den ausbruch vom ath gehandelt.
deine fragen kann ich aber leider nicht beantworten, mein kaufgrund war nur auf grund trendfolgestrategie.
die bewegung sieht aber momentan sehr vielversprechend aus. ich bleibe dabei.
deine fragen kann ich aber leider nicht beantworten, mein kaufgrund war nur auf grund trendfolgestrategie.
die bewegung sieht aber momentan sehr vielversprechend aus. ich bleibe dabei.
Antwort auf Beitrag Nr.: 47.657.460 von steven_trader am 31.08.14 19:03:37Bekommt diesen Anstieg bei Biodelivery überhaupt jemand mit ?
Was ist los bei Biodelivery, ich kann keine News finden.
Hat hier jemand was neues ?
Was ist los bei Biodelivery, ich kann keine News finden.
Hat hier jemand was neues ?
Antwort auf Beitrag Nr.: 47.723.730 von Wohnwunsch am 08.09.14 16:29:49sei doch nicht so aufgeregt. erst folgt der kursanstieg, die guten news werden nachgereicht. so läufts doch meistens an der börse oder?
das es niemand mitbekommt, ist immer ein gutes zeichen.
je höher die postingfrequenz, desto schlechter die performanceaussichten.
das es niemand mitbekommt, ist immer ein gutes zeichen.
je höher die postingfrequenz, desto schlechter die performanceaussichten.
Warum heute dieser extreme Verfall, gab es negative News ??
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