BioDelivery Sciences International
WKN: 766464 / ISIN: US09060J1060Entdeckt:Neue Cephalon mit KGV 1 2000% Chance
| eröffnet am: | 14.12.10 16:41 von: | Chalifmann3 |
| neuester Beitrag: | 14.02.22 18:30 von: | Biotecfan |
| Anzahl Beiträge: | 29 | |
| Leser gesamt: | 20511 | |
| davon Heute: | 6 | |
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14.12.10 16:41
#1
Chalifmann3
Entdeckt:Neue Cephalon mit KGV 1 2000% Chance
BioDelivery Sciences Announces Enrollment of the First Patient in the Phase 3 BEMA Buprenorphine Clinical Program
Phase 3 data anticipated in third-quarter of 2011
RALEIGH, N.C.--(BUSINESS WIRE)-- BioDelivery Sciences International, Inc. (Nasdaq:BDSI - News) today announced the enrollment and dosing of the first patient in its Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.
“Enrollment of the first patient into the BEMA Buprenorphine Phase 3 program marks our continued progress in making this novel treatment available for patients with moderate to severe chronic pain,” said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. “We believe that with our experienced and enthusiastic investigators, we can progress this program expeditiously and have results available by the third quarter of next year. Positive findings from this study would then allow for an NDA filing in the first half of 2012.”
According to Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, “BEMA Buprenorphine could play an important future role in the treatment of chronic pain and may offer distinct advantages over other marketed opioid analgesics including oxycodone, hydrocodone, and morphine. These advantages would in part come from the fact that we anticipate it being classified as a Schedule III product, meaning there is a potential for less abuse than Schedule II products. With overall sales of opioid analgesics in the U.S. approaching nearly $10 billion, we believe this represents a significant opportunity for BDSI.”
BEMA Buprenorphine utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek) to deliver the opioid analgesic buprenorphine.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ:BDSI - News) 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 EU (where it is 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 for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”). 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.
Weitere Infos folgen ...
MFG
Chali
Phase 3 data anticipated in third-quarter of 2011
RALEIGH, N.C.--(BUSINESS WIRE)-- BioDelivery Sciences International, Inc. (Nasdaq:BDSI - News) today announced the enrollment and dosing of the first patient in its Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.
“Enrollment of the first patient into the BEMA Buprenorphine Phase 3 program marks our continued progress in making this novel treatment available for patients with moderate to severe chronic pain,” said Dr. Andrew Finn, Executive Vice President of Product Development at BDSI. “We believe that with our experienced and enthusiastic investigators, we can progress this program expeditiously and have results available by the third quarter of next year. Positive findings from this study would then allow for an NDA filing in the first half of 2012.”
According to Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, “BEMA Buprenorphine could play an important future role in the treatment of chronic pain and may offer distinct advantages over other marketed opioid analgesics including oxycodone, hydrocodone, and morphine. These advantages would in part come from the fact that we anticipate it being classified as a Schedule III product, meaning there is a potential for less abuse than Schedule II products. With overall sales of opioid analgesics in the U.S. approaching nearly $10 billion, we believe this represents a significant opportunity for BDSI.”
BEMA Buprenorphine utilizes BDSI’s proprietary BioErodible MucoAdhesive (BEMA) drug delivery technology, which consists of a small, dissolvable, polymer film for application to the buccal mucosa (inner lining of the cheek) to deliver the opioid analgesic buprenorphine.
About BioDelivery Sciences International
BioDelivery Sciences International (NASDAQ:BDSI - News) 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 EU (where it is 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 for the treatment of opioid dependence. Additional product candidates are being developed utilizing the BEMA technology for conditions such as nausea/vomiting (BEMA Granisetron) and migraine (BEMA “Triptan”). 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.
Weitere Infos folgen ...
MFG
Chali
3 Postings ausgeblendet.
06.01.12 17:17
#5
anmelden76
BDSI bekommt bis zu 180 Millionen Dollar
BDSI to receive up to $180 million plus royalties
http://www.prnewswire.com/news-releases/...prenorphine-136798643.html
Die Aktie hat deutliches Potential nach NORDEN trotz des bisherigen Anstiegs.Wartet die nächsten Tage ab ob sich die Aktie abkühlt und überlegt dann einzusteigen.
Mein Kursziel binnen der nächsten 12 Monate liegt bei 8 Dollar.
27.01.14 17:10
#9
knippsand
merkwürdiges Teil..........
http://de.advfn.com/...0&height=600&min_pre=0&min_after=0
15.05.14 21:57
#10
Roboterotze
Keiner investiert ?
... in BDSI ??
Nur noch 3 Wochen hin bis zum FDA-Termin am 07. Juni 2014 (was aber 'n Samstag ist ??).
Wie ich die Ami's kenne, werden in den nächsten 2 Wochen ein paar "Experten"-Meinungen gestreut werden (z.B. Seeking Alpha), die Aktie stetig steigen, es aber auch Kursschwankungen (im intraday) fabriziert werden, um SL-fishing zu betreiben.
Auf 9 - 9.50 USD gehen die m.E. locker, Übertreibungen sind aber auch möglich, a la IntelgenX oder Exact Scienes.
Viele Grüße
RobO
Nur noch 3 Wochen hin bis zum FDA-Termin am 07. Juni 2014 (was aber 'n Samstag ist ??).
Wie ich die Ami's kenne, werden in den nächsten 2 Wochen ein paar "Experten"-Meinungen gestreut werden (z.B. Seeking Alpha), die Aktie stetig steigen, es aber auch Kursschwankungen (im intraday) fabriziert werden, um SL-fishing zu betreiben.
Auf 9 - 9.50 USD gehen die m.E. locker, Übertreibungen sind aber auch möglich, a la IntelgenX oder Exact Scienes.
Viele Grüße
RobO
20.05.14 09:48
#11
Roboterotze
Wollte keiner hören ;-)
Durchschnittskurs 15.05. ~ 8.40 USD
Schlusskurs 19.05. 9.07 USD + 8%
Ich hoffe mal die 9.00 USD halten heute, da es ja gestern doch ziemlich rasant hoch ging.. - aber wie geschrieben, die Ami's sind immer für Übertreibungen (nach oben und unten) gut..
Schlusskurs 19.05. 9.07 USD + 8%
Ich hoffe mal die 9.00 USD halten heute, da es ja gestern doch ziemlich rasant hoch ging.. - aber wie geschrieben, die Ami's sind immer für Übertreibungen (nach oben und unten) gut..
02.02.17 08:05
#12
Chalifmann3
news
Belbuca return expected to push BDSI to profitability sooner
Feb 1, 2017, 3:09pm EST Updated Feb 1, 2017, 4:18pm EST
Industries & Tags
Health Care
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Following the reacquisition of licensing rights to its pain management product Belbuca from Endo Pharmaceuticals last month, BioDelivery Sciences International anticipates profitability sooner than originally anticipated.
“On Jan. 6, we inherited a product on very favorable financial terms that ended the year with a $30 million gross sales run rate” BDSI President and CEO Mark Sirgo said Wednesday during an investor event in New York.
Pain treatment Belbuca, developed by Raleigh-based BioDelivery Sciences International (Nasdaq: BDSI) and its partner, Ireland-based Endo International (Nasdaq: ENDP)
“This added revenue growth will allow us to bring our commercial business to profitability by the end of the first quarter,” he said, noting that the company previously said it expected profitability by the end of the year with its opioid dependence drug Bunavail.”
He further noted that Belbuca is more than twice as profitable as Bunavail per prescription.
While Endo “primed the pump” in terms of Belbuca, Sirgo said at the event that BDSI’s commercialization efforts will need to be more focused going forward.
Scott Plesha, senior vice president of sales and marketing at BDSI, said at the event that the company has worked with the roughly 28 percent of current Belbuca prescribers that account for more than 40 percent of prescriptions to identify more similar and potential prescribers.
In addition to an existing BDSI sales force that knows the buprenorphine molecule, he said that BDSI had hired 14 sales representatives from Endo. BDSI began its field efforts for Belbuca last week, he said, and will dedicate about 80 percent of sales time to Belbuca.
In an interview in December, Sirgo said that, while its reacquisition from Endo wasn’t what the company had anticipated for Belbuca, it did present opportunities like an increased focus on selling Belbuca outside the U.S.
Endo placed “a heavy emphasis on the product in the [largest] U.S. market,” he said at the time.
In terms of raising additional capital in 2017, Sirgo said at the investor event that the company had “sufficient capital” through the end of the third quarter and possibly beyond given certain adjustments. He said the company would look to debt markets and potential licensing arrangements before considering an equity raise in the coming year.
Feb 1, 2017, 3:09pm EST Updated Feb 1, 2017, 4:18pm EST
Industries & Tags
Health Care
Share
Order Reprints
Save Article
Print
Following the reacquisition of licensing rights to its pain management product Belbuca from Endo Pharmaceuticals last month, BioDelivery Sciences International anticipates profitability sooner than originally anticipated.
“On Jan. 6, we inherited a product on very favorable financial terms that ended the year with a $30 million gross sales run rate” BDSI President and CEO Mark Sirgo said Wednesday during an investor event in New York.
Pain treatment Belbuca, developed by Raleigh-based BioDelivery Sciences International (Nasdaq: BDSI) and its partner, Ireland-based Endo International (Nasdaq: ENDP)
“This added revenue growth will allow us to bring our commercial business to profitability by the end of the first quarter,” he said, noting that the company previously said it expected profitability by the end of the year with its opioid dependence drug Bunavail.”
He further noted that Belbuca is more than twice as profitable as Bunavail per prescription.
While Endo “primed the pump” in terms of Belbuca, Sirgo said at the event that BDSI’s commercialization efforts will need to be more focused going forward.
Scott Plesha, senior vice president of sales and marketing at BDSI, said at the event that the company has worked with the roughly 28 percent of current Belbuca prescribers that account for more than 40 percent of prescriptions to identify more similar and potential prescribers.
In addition to an existing BDSI sales force that knows the buprenorphine molecule, he said that BDSI had hired 14 sales representatives from Endo. BDSI began its field efforts for Belbuca last week, he said, and will dedicate about 80 percent of sales time to Belbuca.
In an interview in December, Sirgo said that, while its reacquisition from Endo wasn’t what the company had anticipated for Belbuca, it did present opportunities like an increased focus on selling Belbuca outside the U.S.
Endo placed “a heavy emphasis on the product in the [largest] U.S. market,” he said at the time.
In terms of raising additional capital in 2017, Sirgo said at the investor event that the company had “sufficient capital” through the end of the third quarter and possibly beyond given certain adjustments. He said the company would look to debt markets and potential licensing arrangements before considering an equity raise in the coming year.
11.08.19 21:10
#13
Biotecfan
jetzt ist
ein guter Zeitpunkt zum einsteigen, sind jetzt am Breakeven dran und sie haben mit Belbuca ein Medikament das sich gut verkauft . Mit einer Kapitalerhöhung wurde für 30 Millionen die Vermarktungsrechte ein weiteres Medikament gekaut, das sich eventuell als ...
13.07.21 16:42
#14
Vassago
BDSI 3.68$
Zahlen für Q1/21
- Umsatz 41 Mio. $
- Gewinn 5 Mio. $
- EPS 0,05$
- Cash 116 Mio. $
- MK 363 Mio. $
" The Company reiterates its 2021 financial guidance, with full year 2021 total Company net sales of $170 - $180 million, including full year 2021 BELBUCA net sales of $155 - $165 million. Total operating expenses are expected to be in the range of $115 - $120 million, as the Company continues to invest to support the growth of its brands, and EBITDA is expected to be in the range of $40 - $50 million in 2021."
https://ir.bdsi.com/news-releases/...ports-first-quarter-2021-results
https://www.fool.com/investing/2021/07/13/...nny-stock-could-soon-do/
05.08.21 13:36
#15
Vassago
BDSI 3.75$
Zahlen für Q2/21
- Umsatz 41 Mio. $
- Gewinn 9 Mio. $
- EPS 0,09$
- Cash 120 Mio. $
- MK 369 Mio. $
Announces Agreement to Acquire ELYXYB TM for the Acute Treatment of Migraine
https://ir.bdsi.com/news-releases/...orts-second-quarter-2021-results
08.11.21 16:20
#16
Vassago
BDSI 3.39$
Zahlen für Q3/21
- Umsatz 41 Mio. $
- Gewinn 6,7 Mio. $
- EPS 0,07$
- Cash 101 Mio. $
- MK 335 Mio. $
"For 2021 financial guidance, the Company is lowering its full year 2021 total net revenue guidance range to $162 - $167 million from $170 - $180 million previously communicated. The situation with Alvogen is a factor contributing to our amended guidance. BDSI now expects BELBUCA net sales for 2021 to be in the range of $144 - $148 million dollars"
- Closed acquisition of ELYXYB, the first FDA-approved, ready-to-use oral solution for acute migraine with potential long-term peak sales opportunity of $350 - $400 million
https://ir.bdsi.com/news-releases/...solid-third-quarter-2021-results
Auf der ersten Blick würde ich sagen, hier ist noch Luft nach oben bis mindestens 4,15$.
13.11.21 15:12
#17
Biotecfan
Die aktuelle Presentation
ist durchaus wert mal hineinzuschauen.
https://ir.bdsi.com/events-presentations
https://ir.bdsi.com/events-presentations
24.11.21 21:05
#18
Vassago
BDSI 3.00$
Das die Umsatzprognose für FY21 gesenkt werden musste ist natürlich ärgerlich. Was hat es mit dem Patentstreit auf sich?
https://seekingalpha.com/article/...rent-lows-could-be-an-opportunity
https://seekingalpha.com/article/...rent-lows-could-be-an-opportunity
25.11.21 22:12
#19
Biotecfan
Zu einsteigen
aber super, sie haben auch günstig ein neues Medikament einlizensiert, im nächsten Jahr beginnen sie mit der Vermarktung, Die risiken im Patenstreit sind für mich im Kurs schon enthalten und es gab auch bei Kursen um die 3 Dollar reichlich Inseiderkäufe.
Under the terms of the agreement, ELYXYB will be acquired for an upfront payment of $6 million, plus an additional $9 million on August 3, 2022. BDSI
will make tiered quarterly earn-out payments on potential net sales ranging from the high single digits to the low double digits. Additional payments will
be made contingent upon the achievement of certain regulatory and sales milestones. The impact of the acquisition is estimated to be cash flow
accretive within approximately 24 months of commercial launch, currently planned for Q1 2022. The closing of the transaction is subject to satisfactory
completion of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976
(HSR Act).
Under the terms of the agreement, ELYXYB will be acquired for an upfront payment of $6 million, plus an additional $9 million on August 3, 2022. BDSI
will make tiered quarterly earn-out payments on potential net sales ranging from the high single digits to the low double digits. Additional payments will
be made contingent upon the achievement of certain regulatory and sales milestones. The impact of the acquisition is estimated to be cash flow
accretive within approximately 24 months of commercial launch, currently planned for Q1 2022. The closing of the transaction is subject to satisfactory
completion of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976
(HSR Act).
04.12.21 18:15
#20
Vassago
BDSI 2.58$ (neues 52WT)
MK 255 Mio. $, Risiken eines Patentstreits sind selten komplett im Kurs eingepreist. Das würde ja bedeuten, dass die Aktie +/- 0% auf eine mögliche Niederlage im Patentstreit reagieren würde. Das halte ich für unrealistisch. Daher muss die Frage gestellt werden, wieviel BDSI wert wäre, wenn sie den Rechtsstreit verlieren würden (Bear-Case)?
20.12.21 18:40
#21
Biotecfan
Jetzt wirds wieder besser
BioDelivery Sciences stieg um bis zu 11%, nachdem es ein Gerichtsurteil gewonnen hatte, das die Gültigkeit von zwei seiner Patente auf das Schmerzmittel Belbuca bestätigte und Alvogen für ein Jahrzehnt daran hindern wird, eine generische Version des Medikaments zu verkaufen.
20.12.21 22:30
#23
Biotecfan
Ja das sind sehr gute nachrichten
und sie haben ja auch ein weiteres Medikament hinzugekauft, in der Presentation wurde das Potenzial auf 350-400 <,Millionen Dollar angegeben, ein Umsatz von 100 Millionen würden schon die jetzige Marktkapitalisierung rechtfertigen.
ELYXYB Expands BDSI’s Presence in Neurology in Attractive Deal
* Results of 2Pivotal studies comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving MBS freedom at 2 hours post dose being significantly greater than patients receiving placebo
** Results of Pivotal study 2 comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving headache pain freedom at 2 hours post dose being significantly greater than patients receiving placebo
1. Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)
Potential long-term peak sales opportunity of $350 - $400M
ELYXYB Expands BDSI’s Presence in Neurology in Attractive Deal
* Results of 2Pivotal studies comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving MBS freedom at 2 hours post dose being significantly greater than patients receiving placebo
** Results of Pivotal study 2 comparing patients receiving ELYXYB to patients receiving placebo with the percentage of patients achieving headache pain freedom at 2 hours post dose being significantly greater than patients receiving placebo
1. Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)
Potential long-term peak sales opportunity of $350 - $400M
20.12.21 22:41
#24
Biotecfan
Die offizielle Meldung
ist nun da, Kurs wird morgen wohl weiter steigen.
RALEIGH, NC, 20. Dezember 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), ein wachsendes Spezialpharmaunternehmen, das sich Patienten mit schweren und komplexen chronischen Erkrankungen widmet, gab heute bekannt, dass das US-Bezirksgericht of Delaware hat im Patentstreit des Unternehmens gegen Alvogen Group, Inc. und ihre verbundenen Unternehmen, die am 23. Mai 2018 einen abgekürzten Zulassungsantrag (ANDA) für das BELBUCA®-Produkt von BDSI eingereicht haben, eine Stellungnahme zugunsten von BDSI abgegeben Prozessrichter bestätigt die Gültigkeit der Ansprüche in den BDSI-Patenten 8.147.866 (das '866-Patent), das 2027 abläuft, und 9.901.539 (das '539-Patent), das 2032 abläuft. Alvogen räumte die Verletzung dieser Ansprüche ein. Dementsprechend erwartet BDSI eine Marktexklusivität von BELBUCA gegenüber Alvogen bis 2032.
„Wir freuen uns über die Entscheidung des Gerichts und freuen uns darauf, Patienten mit chronischen Schmerzen kontinuierlich BELBUCA zur Verfügung zu stellen“, sagte Jeff Bailey, CEO von BDSI. „Wir danken unseren Aktionären für ihre Unterstützung während der langen Prozessdauer. Mit der Beseitigung
RALEIGH, NC, 20. Dezember 2021 (GLOBE NEWSWIRE) -- BioDelivery Sciences International, Inc. (NASDAQ: BDSI), ein wachsendes Spezialpharmaunternehmen, das sich Patienten mit schweren und komplexen chronischen Erkrankungen widmet, gab heute bekannt, dass das US-Bezirksgericht of Delaware hat im Patentstreit des Unternehmens gegen Alvogen Group, Inc. und ihre verbundenen Unternehmen, die am 23. Mai 2018 einen abgekürzten Zulassungsantrag (ANDA) für das BELBUCA®-Produkt von BDSI eingereicht haben, eine Stellungnahme zugunsten von BDSI abgegeben Prozessrichter bestätigt die Gültigkeit der Ansprüche in den BDSI-Patenten 8.147.866 (das '866-Patent), das 2027 abläuft, und 9.901.539 (das '539-Patent), das 2032 abläuft. Alvogen räumte die Verletzung dieser Ansprüche ein. Dementsprechend erwartet BDSI eine Marktexklusivität von BELBUCA gegenüber Alvogen bis 2032.
„Wir freuen uns über die Entscheidung des Gerichts und freuen uns darauf, Patienten mit chronischen Schmerzen kontinuierlich BELBUCA zur Verfügung zu stellen“, sagte Jeff Bailey, CEO von BDSI. „Wir danken unseren Aktionären für ihre Unterstützung während der langen Prozessdauer. Mit der Beseitigung
14.02.22 12:54
#25
Vassago
BDSI 5.52$ (vorbörslich +52%)
Collegium Pharmaceuticals übernimmt BDSI
- in einem All-Cash Deal für 5,60$ je Aktie
- 54% Premium auf den SK vom Freitag
- 65% Premium auf den 30-Tage Durchschnitt
https://ir.bdsi.com/news-releases/...odelivery-sciences-all-cash-deal
Wer Anfang Dezember gekauft hat, kann sich sogar über 100% Kursgewinn freuen.