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  

So,Leute,wie komme ich auf den Vergleich mit Cephalon ? Ganz einfach: Onsolis von BDSI erreicht bereits Umsätze von 60 miln dollar und hat BDSI 50 mln Gewinn beschert,daher auch das aktuelle KGV 1,35 für BDSI ! Der witz an der sache: Cephalon ist 4 MRD wert und BDSI nur 66 Millonen !  

The BEMA® drug delivery technology is a buccal soluble film consisting of a small, bioerodible polymer film for application to the mucosal membranes (inner lining of cheek). BEMA® films were designed to rapidly deliver a dose of drug across the mucous membranes for time sensitive conditions.

BEMA® films are designed to:

◦Adhere to oral mucosa in less than 5 seconds
◦Optimize delivery across the oral mucosa
◦Completely dissolve within 15 to 30 minutes
The first product use of the BEMA® technology is Onsolis® (fentanyl buccal soluble film). The BEMA® technology may also be developed with other active drugs, particularly in conditions where rapid delivery of drug is important, oral dosing is not optimal, or where intravenous lines or injections are unavailable or not practical. BDSI® owns the worldwide rights to the BEMA® drug delivery technology.  

Bioral® is a novel drug delivery system, based upon cochleate technology. Bioral® encapsulates and protects a drug without chemically bonding to it and may facilitate oral dosing of drugs that typically need to be given by intravenous administration. Alternating layers of lipids spiral around a drug molecule, encapsulating it and potentially protecting it from degradation by acid or digestive enzymes in the stomach. The Bioral® technology is being evaluated as a new means of overcoming the poor oral absorption of drugs, such as the antifungal drug Amphotericin B and in programs involving siRNAs. Several pre-clinical studies have demonstrated the potential value of agents delivered using the Bioral® technology.1, 2, 3

The Bioral® drug delivery technology was developed in collaboration with the University of Albany and the University of New Jersey Medical and Dental School, each of which has granted BDSI® exclusive worldwide licenses under applicable patents. Collaboration with the National Institutes of Health has supported, in part, the Bioral® preclinical program, and a collaboration with the Walter Reed Army Institute of Research is currently exploring the use of Bioral® technology in difficult to treat parasitic infections  

was ist passiert? O_o  

And, shares of BioDelivery Sciences are plummeting today after the company announced the primary endpoint in its phase 3 clinical study of a pain drug was not reached.
In the study of BEMA Buprenorphine for the treatment of moderate to severe pain in a mixed opioid nave and opioid experienced population, the overall pain intensity difference of the drug versus a placebo was not achieved.

However, the company said, it believes the totality of the study results favor the drug, including a near statistically significant difference in the opioid experienced patients.

The company said it will initiate a second efficacy study in the near future.  

20:51
.BioDelivery Services: ONSOLIS profitiert von FDA-Genehmigung für "Risk Evaluation Mitigation Strategy" (REMS) für alle Transmucosal-Fentanyl-Produkte.  

 

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.

 

 machen die Amis das GAP bei 3 Dollar noch zu.

Nahc solchen NEWS ist alles möglich meiner Meinung.

 

 

 Komisch das es hier so ruhig ist obwohl der Thread ja erst vor kurzem eröffnet wurde.

Ich dachte es sind hier welche investiert.

 

.... das es bei Ariva offensichtlich kein Interesse an wirklich guten Aktien gibt,hat einer die 700 % seit Kursen unter 1€ mitgenommen ????

MFG
Chali  

http://de.advfn.com/...0&height=600&min_pre=0&min_after=0  

... 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  

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..  

Belbuca return expected to push BDSI to profitability sooner
Feb 1, 2017, 3:09pm EST Updated Feb 1, 2017, 4:18pm EST

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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.  

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 ...  

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/

 

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

 

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$.

 

ist durchaus wert mal hineinzuschauen.
https://ir.bdsi.com/events-presentations  

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  

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).  

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)?  

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.









































































































 

Das sind gute Nachrichten. Mal sehen wo die Aktie von BDSI heute schließt.