BioDelivery Sciences(Nanostock) - Reboundchance! - 500 Beiträge pro Seite

[Buddah]

massive Insiderkäufe aus aktuellem niveau.
siehe: http://finance.yahoo.com/q/it?s=BDSI

mfg B.

[Buddah]

mehr Infos unter:

http://www.biodeliverysciences.com/

mfg b.

[Hackertom1]

ich muß sagen, die größte verdopplerchance die mir im moment bekannt ist. haben jetzt genug geld. ca. 9-10 mille dollar cash im moment. haben eine "pending NDA" geschichte, ein medikament in phase3, 2 medikamente in phase1 am ende des jahres und das ganze für 20 millionen marktkapitalisierung. wow. nachdem BDSI nur generika macht, sind die zulassungsverfahren deutlich schneller und auch viel wahrscheinlicher als bei anderen medikamenten.

das sollte sich jeder mal anschauen, es lohnt sich. ab 3 denk ich darüber nach zu verkaufen.


Hack

[cripplecreek]

Insider kaufen mehr als 500.000 Aktien des Unternehmens.

http://finance.yahoo.com/q/it?s=BDSI

[dehoim]

[posting]18.442.399 von cripplecreek am 25.10.05 23:24:02[/posting]was hast Du denn da wieder schönes gefunden

[jonathanheart]

@dehoim / cripple

ihr auch hier ?

[cripplecreek]

[posting]18.459.992 von jonathanheart am 26.10.05 20:59:17[/posting]wenn es um aussichtsreiche werte geht haben wir wohl immer das gleiche gespühr...

vor zwei tagen wurde eine unabhängige analystenstudie veröffentlicht. bei launch aller 4 generika werden bei geschätzten 25 Mio an umlaufenden aktien für 2010 mal eben weit über 4$ eps geschätzt. bei einem kgv von 20 wären das 80 dollar pro aktie oder aus 10.000 us$ in nur 5 jahren 400.000 us4. na wenn das keinen genaueren blick auf diese aktie wert ist.

das erste produkt soll bereits anfang 2006 seine fda-zulassung erhalten und wird dann erste umsätze aus lizenzzahlungen von ca. 15 prozent der produktverkäufe generieren. die anderen produkte sind eigenentwicklung - wobei der begriff entwicklung hier nicht ganz richtig ist. schließlich handelt es sich um generika. es geht also nur darum, am markt erfolgreiche und etablierte produkte noch effizienter zu machen, also zu modifizieren. der vorteil liegt auf der hand, die kosten für r/d betragen nur einen bruchteil der ursprünglichen entwicklungskosten und das produkt erhält ein verkürztes zulassungsverfahren durch die fda. also keine 7-10 jahre entwicklung mit kosten von mehreren hunder millionen. das risiko scheint bei diesem kurs und einer bewertung von ca. 20 mio us$ doch sehr gering im vergleich zu dem potenzial. noch ist der markt recht eng, aber insiderkäufe und institutionelle käufe über die letzten wochen weisen in die richtige richtung.

[schakal23]

also die insider hatn ende letztes jahr auch aktien gekauft da war der kurs über 3$ und heute?
kann mir jemand sagen warum diesen kurs verfall dieses jahr und die 4,400,00 neue schars weill die geld brauchten?

[panik]

BDSI Prepares For Phase III with BEMA(TM) Fentanyl Following Positive Results of Comparative Pharmacokinetic Study
Tuesday November 1, 7:30 am ET
Study Demonstrates BEMA(TM) Fentanyl Has Enhanced Absorption Compared to Market Leader Actiq(R)


MORRISVILLE, N.C.--(BUSINESS WIRE)--Nov. 1, 2005-- BioDelivery Sciences International, Inc. (NASDAQ: BDSI - News, BDSIW - News), a specialty pharmaceutical company, today announced the results of a crossover study comparing the pharmacokinetics between equal strengths of BDSI`s oral adhesive disc (known as BEMA(TM)) formulation of the narcotic fentanyl and Actiq®, a lozenge formulation of fentanyl which is the current market leader in fast dissolving fentanyl products in treating breakthrough cancer pain.
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The study was conducted in 12 subjects who used both BEMA(TM) Fentanyl and Actiq®. The results showed that the BEMA(TM) Fentanyl formulation showed greater bioavailability (absorption), higher maximum plasma concentrations (Cmax) and faster concentrations of fentanyl in the plasma (t-first and t-max) compared to Actiq®.

Actiq®, produced by Cephalon Inc. (NASDAQ:CEPH - News), had reported 2004 sales of $345 million and, according to Cephalon`s public statements, projected 2005 sales between $390 to $420 million. BDSI has previously disclosed its belief that BEMA(TM) Fentanyl could potentially achieve annual peak sales of approximately $250 million for the company.

Dr. Andrew Finn, Executive Vice President of Clinical and Regulatory Development for BDSI, stated "Simply put, the results of this study demonstrate that fentanyl can potentially be delivered more effectively and easily from BDSI`s BEMA(TM) delivery system compared to Actiq®. Besides allowing greater absorption of fentanyl, this study demonstrated that the BEMA(TM) disc was easier to use for the subjects in the study as it only required seconds to apply while the Actiq® lozenge required active sucking for up to 30 minutes."

BDSI reported in July 2005 that it had signed a $7 million dollar licensing and development agreement with Princeton, New Jersey based Clinical Development Capital, LLC (CDC) under which CDC, will provide up to $7 million dollars in funding for BDSI`s Phase III program for BEMA(TM) Fentanyl provided certain conditions are met. BDSI has previously reported that it plans to initiate its Phase III BEMA(TM) Fentanyl program for the treatment of "breakthrough" cancer pain prior to the end of 2005.

Dr. Francois Nader, Chief Medical Officer at Clinical Development Capital, stated that "The results of this study continue to indicate a profile of BEMA(TM) Fentanyl that will make it an effective and valuable therapy for the treatment of breakthrough cancer pain and demonstrates BDSI`s ability to execute their development plan."

Dr. Mark A. Sirgo, President and CEO of BDSI stated "We believe that the data from this trial represents another significant milestone for BDSI. These results bolster our confidence that, if approved by the FDA in the future, BEMA(TM) Fentanyl has the potential to be a significant product for the management of breakthrough cancer pain. Moreover, the results further demonstrate the potential viability of the BEMA(TM) drug delivery platform as a whole. We look forward to now commencing our Phase III program for BEMA Fentanyl."

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting and infections. The company`s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" 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 additional clinical trials and FDA review of the Company`s formulations and products, may differ 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).

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.



--------------------------------------------------------------------------------
Contact:
BioDelivery Sciences International, Inc.
Mark A. Sirgo, Pharm.D., 919-653-5160
President and Chief Executive Officer
or
L.G. Zangani LLC
Leonardo Zangani, 908-788-9660
Investor Relations



--------------------------------------------------------------------------------
Source: BioDelivery Sciences International, Inc.

[schakal23]

man ich wollte heute abend in usa einsteigen hätten die mit dem news noch warten können

[jonathanheart]

BDSI has previously disclosed its belief that BEMA(TM) Fentanyl could potentially achieve annual peak sales of approximately $250 million for the company.

das hört sich doch mal super an....und alles bei ner market cap von nichtmal 20Mio Dollar

[dehoim]

BDSI reported in July 2005 that it had signed a $7 million dollar licensing and development agreement with Princeton, New Jersey based Clinical Development Capital, LLC (CDC) under which CDC, will provide up to $7 million dollars in funding for BDSI`s Phase III program for BEMA(TM) Fentanyl provided certain conditions are met. BDSI has previously reported that it plans to initiate its Phase III BEMA(TM) Fentanyl program for the treatment of " breakthrough" cancer pain prior to the end of 2005.

[Hackertom1]

@schakal


ich geh fest davon aus dass du die aktie wieder um 1.90 bekommen wirst in ein paar tagen. vielleicht heute schon. frag mich nicht woher, aber hier ist immer noch riesen verkaufsvolumen im ask, und das jeden einzelnen tag. was weiß ich wer da all die shares auf den markt wirft wo die aktie doch so günstig ist. seltsam ist das alle mal. trotzdem bleibe ich 100% investiert.


Hack

[dehoim]

[posting]18.542.611 von Hackertom1 am 02.11.05 14:11:59[/posting]1,90 €?

[XTrack]

Sieht gut aus im Amiland heute. Könnte die nächsten Tage so weitergehen!

[XTrack]

Wie vorhergesagt
Sehr schöne Entwicklung! BDSI ist eine Perle

[panik]

BDSI Announces its Intention to Proceed with Phase III Trials in 2006 on its Second BEMA(TM) Product Following FDA Meeting
Monday November 28, 8:00 am ET
505(b)(2) Regulatory Pathway to Be Available For BEMA(TM) Long Acting Analgesic, a Treatment for Acute Pain


MORRISVILLE, N.C.--(BUSINESS WIRE)--Nov. 28, 2005--BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News, BDSIW - News) announced today that it met on November 15, 2005 with the U.S. Food and Drug Administration to discuss the regulatory pathway and development plan for BEMA(TM) Long Acting Analgesic (BEMA(TM) LA), the second analgesic to be formulated with BDSI`s BEMA(TM) delivery system. At the meeting, the FDA gave its preliminary indication that BDSI will be able to utilize the FDA`s 505(b) (2) regulations for submission of a New Drug Application for BEMA(TM) LA. As a result, BDSI announced that it intends to enter clinical development with BEMA(TM) LA in the first quarter of 2006 and expects to begin Phase III trials in the second half of 2006.
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BDSI is initially developing BEMA(TM) LA for the acute treatment of moderate to severe pain, such as post-operative pain. BEMA(TM) LA will be a formulation of an analgesic which is already FDA-approved, which is substantially more potent than morphine, but which BDSI believes has a lower risk of opioid related side effects. Notably, this analgesic is considered a Class III narcotic, which means that it has been classified as having less abuse and addiction potential than Class II narcotics such as morphine. BDSI expects BEMA(TM) LA to compete in the $24 billion worldwide pain treatment market.

Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI, stated "Receiving this guidance from the FDA is another essential step forward for BDSI`s drug development pipeline. BEMA(TM) LA represents a broadening of our focus on the pain market and is also the third drug formulation for which we have been granted the use of the 505(b)(2) regulatory pathway by FDA. Although final FDA approval of our products and formulations can not be guaranteed, the FDA`s receptiveness to our regulatory approval strategy is, we believe, a significant validation of a critical component of our business model."

BDSI`s first product, Emezine®, a buccal tablet for treating nausea and vomiting, is presently undergoing 505(b)(2) FDA review, with a decision expected on its approval in the first quarter of 2006. BDSI recently announced that, following positive Phase I clinical results, the company is in the process of ramping up for Phase III trials under the 505(b)(2) process on BEMA(TM) Fentanyl for the indication of "breakthrough" cancer pain.

In availing itself of the FDA`s 505(b)(2) approval process, BDSI is seeking to obtain more timely and efficient approval of new formulations of previously approved therapeutics which incorporate BDSI`s licensed drug delivery technologies, such as BEMA(TM). Because the 505(b)(2) approval process is designed to address new delivery formulations of drugs previously approved by the FDA, BDSI believes it has the potential to be more efficient and less time consuming than other FDA approval methods.

BDSI`s patented BEMA(TM) drug delivery system is exclusively licensed to BDSI on a worldwide basis. The BEMA(TM) delivery technology consists of an easy to use, dissolvable, dime-sized polymer disc that is applied to the mucus membrane (i.e. cheek) of the mouth. The disc dissolves over approximately 20-30 minutes, delivering the drug across the mucus membrane for rapid absorption and onset of effect.

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting and infections. The company`s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" 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 additional clinical trials and FDA review of the Company`s formulations and products, may differ 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).

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.



Contact:
BioDelivery Sciences International, Inc.
Mark A. Sirgo, Pharm.D., 919-653-5160
or
Investor Relations:
L.G. Zangani LLC
Leonardo Zangani, 908-788-9660

--------------------------------------------------------------------------------
Source: BioDelivery Sciences International, Inc.

[panik]

Insiders buying at BDSI
01 Dec 2005

Research advances at BioDelivery Sciences help explain insider buying.


Arguably, no one has better information about a business than the people who work there. So, as part of this week`s Reuters Select Top Down theme concentrating on small- & micro-cap companies, we`re taking a look at biotech company, BioDelivery Sciences International, Inc. (BDSI). The stock caught our attention when it recently appeared on the Reuters Select screen in the Sentiment category for Insider Buying, which seeks companies where the corporate insiders are buying shares.

Insider Buying

There are plenty of reasons insiders sell stock, but it`s widely understood that they buy for one reason, which is that they think the stock will go up. With those two thoughts in mind, it`s clear why many investors track the buying habits of corporate executives when it comes to the stock of their own companies.

This is where the Insider Buying screen comes into play. It looks for those firms where the insiders are picking up shares. The screen begins by requiring that requiring at least three insider purchase transactions, either net of sales or regardless of sales.

When we look at BDSI`s results for the last quarter, we see that there was a lot of buying taking place. Whether we are talking about the chairman of the board of directors, the chief financial officer or the chief executive officer, insiders have been busy buying up shares. For instance, the company`s president and CEO, Mark Sirgo, recently bought 13,800 shares, while the CFO, James McNulty, acquired 2,000, and the chairman, Francis O`Donnell, Jr., picked up 100,000 shares. In fact, looking at the trading record, it does not seem as if any of the insiders ever sold shares. Click here to see more trading activity information.

Of course, we don`t want insiders to hold too many shares, because that could then limit trading and reduce liquidity. Hence, the screen then filters for companies where the percentage of insider ownership is between 25% and 75%, and the stock`s float contains at least 2 million shares, making up for at least 25% of the total number of outstanding shares.

In Absentia

Something that has been noticeably absent from the screen thus far is any mention of more fundamental relationships, such as profit margins or something like that. Remember, many of the fundamental screens are based on historical performance, but the idea underlying the Insider Buying screen is that those who know the company expect good times ahead. This could hold for a company where profit margins have been deteriorating, but, because of some management initiatives, will widen in the future.

That said, any fundamental constraint has to be rather liberal. We proceed by taking a look at the broadest measure of improving business, revenue. The screen filters for companies were revenue growth beats the industry average in either the trailing twelve-month (TTM) or three-year periods, or the company`s own TTM revenue growth rate is better than its three-year pace. (BDSI`s three-year revenue growth rate is 55%, while the industry average is 32%; the pace of the company`s TTM revenue improvement is 8%, versus a peer mean of 25%.) Much of that revenue is the result of license and research fees, royalties, and sponsored research revenue, which is consists of research grants from sources like the National Institutes of Health (NIH).

In looking at BDSI, we see that it is actually a good thing that there are not more stringent fundamental considerations on this screen. Because the company has been operating at a loss, its profit margins are negative, which obviously pales in comparison with the industry averages that are positive and substantial (the industry`s operating profit margin the TTM span was 20.8% and the net profit margin was 14.4%). This also throws a monkey wrench into any valuation comparisons. Sure we have a price to sales figure (9.8 versus the peer norm of 11.5), but we lack P/E or P/Cash Flow figures. Further, the one analyst who covers BDSI expects revenue advances next year, but believes that this will just turn into a smaller per share loss.

Now that we`ve come to the conclusion that we can`t evaluate this firm the way we would most others, the question then arises: if the fundamentals aren`t there, why do the insiders like it so much?

It seems that the key reason for the insider interest goes back to belief in the longer-term prospects of the firm. Although this may not measured right now in terms of the financial statements, it does seem that the future is getting brighter as a result of research advances.

Take a step back for a moment and look at the company.

Products & Research

The company was founded in 1995 to commercialize Bioral technology, and the company uses this technology to help develop enhanced versions of generic drugs.

In addition to the Bioral technology, BDSI`s core emphasis is a bioerodable mucoadhesive (BEMA), which is basically a tab about the size of a coin that attaches to inside of the mouth. The drug on the tab then diffuses through the tissue of the mouth, and then the tab itself dissolves away.

It is based off of these platforms that BDSI is investigating the efficacy of various drugs. For example, the company`s first product, Emerzine, a tablet for treating nausea and vomiting, is currently undergoing FDA review to seek approval for new delivery formulations. The company expects to hear from the FDA in the first quarter of next year. Further, after positive Phase I clinical trials regarding its BEMA Fentanyl product for the treatment of cancer pain, BDSI is getting ready to take this product to later-stage trials, also to test the new delivery system of this product.

Most recently, the company announced that the FDA gave an affirmative nod to the company`s development plan for BEMA Long Acting Analgesic; BDSI plans to enter clinical development early next year, with clinical trials starting sometime in the second half. This product, a new formulation of an already-approved drug, is being developed to treat moderate to severe pain.

When looking at early-stage biotech companies, it is important to look past just the product pipeline and research advances, and to find out with what firms the small biotech has partnered. After all, it spreads the risk and the cost if another company is will to help out.

With that in mind, we see that BDSI has a deal with Aveva Drug Delivery Systems, which is part of the Nitto Denko company, one of the world`s leading manufacturers in transdermal drug delivery systems. Under the terms of this arrangement, Aveva will prepare clinical supplies for BDSI`s phase III clinical trials and also provide commercial manufacturing for BEMA Fentanyl. BDSI looks to conclude these trials in the second half of next year.

Some Thoughts

Smaller biotech and drug companies, with few products on the market or in the pipeline, have a considerably more risk than the larger, more-established firms. Given that the company`s sparse market presence, but still relatively rich pipeline, there is a lot of risk here. As such, BDSI appears to currently be best suited for more risk-tolerant investors.

[panik]

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Press Release Source: BioDelivery Sciences International, Inc.


New Study Shows BDSI`s Emezine(R) Demonstrates More Efficient Absorption Versus Swallowed Form of Prochlorperazine
Wednesday December 7, 8:00 am ET
Plasma Concentrations of Dissolving Tablet Formulation of Anti-Emetic Medication More Than Twice as High as Swallowed Pill Version


MORRISVILLE, N.C.--(BUSINESS WIRE)--Dec. 7, 2005--BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News, BDSIW - News) announced today the publication of a pharmacokinetic (PK) study regarding Emezine®, its investigational buccal tablet formulation of prochlorperazine maleate for the treatment of severe nausea and vomiting. The findings, published in the December 2005 issue of the Journal of Clinical Pharmacology, showed that, in the PK study, plasma concentrations of Emezine®`s active ingredient, prochlorperazine, were more than twice as high and less variable than those obtained from a standard oral tablet. Emezine®, a dissolving tablet placed between the lip and gum (also known as the buccal area), avoids the need for a patient to swallow a product during a period of nausea and, BDSI believes, offers a more patient-friendly alternative to injections and rectal suppositories.
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As previously announced, BDSI submitted a New Drug Application (NDA) on Emezine® to the Food and Drug Administration in April 2005. The FDA has notified BDSI that it will rule on the approvability of the Emezine® NDA no later than February 28, 2006. Prochlorperazine in other dosage forms is already FDA-approved for the treatment of severe nausea and vomiting. This includes, but is not limited to, post-operative nausea and vomiting and nausea and vomiting associated with chemotherapy, as well as viral infections such as flu. Consistent with its business strategy, BDSI submitted Emezine® for FDA review, and the FDA is undertaking such review, via the FDA`s 505(b)(2) regulatory approval process, which permits a company to partially rely on the clinical and non-clinical testing results of previously approved pharmaceuticals in connection with the filing by such companies of NDAs with the FDA.

Dr. Andrew Finn, Pharm.D., Executive Vice President of Clinical Development and Regulatory Affairs of BDSI and an author of the study, said "Prochlorperazine has been widely used for many years for the relief of nausea associated with surgery, narcotic use and cancer treatment, including radiation. Our study in normal volunteers demonstrates the variability of oral prochlorperazine absorption, a situation that is likely even greater in the nauseated patient because of the associated delay in the movement of stomach contents and absorption of a drug that is swallowed orally. The buccal delivery of prochlorperazine with Emezine® addresses these fundamental absorption issues because it is absorbed through the buccal mucosa in the mouth and is not swallowed."

BDSI licenses Emezine® on an exclusive basis in the U.S. from Reckitt Benckiser Healthcare (UK) Limited. If approved, the Emezine® tablets will be manufactured for BDSI by Reckitt Benckiser, which currently distributes Emezine® in the United Kingdom. Also, as BDSI has previously announced, distribution of Emezine® in the U.S. will be handled by TEAMM Pharmaceuticals, a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News).

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting and infections. The company`s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey.

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" 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 clinical trials and FDA review of, and the manufacturing and distribution of, the Company`s formulations and products, may differ 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).

L.G. Zangani, LLC provides financial public relations service to the Company. As such L.G. Zangani, LLC and/or its officers, agents and employees, receives remuneration for public relations and or other services in the form of monies, capital stock in the Company, warrants or options to purchase capital in the Company.



Contact:
BioDelivery Sciences International, Inc.
Mark A. Sirgo, Pharm.D., 919-653-5160
or
Investor Relations:
L.G. Zangani LLC
Leonardo Zangani, 908-788-9660

--------------------------------------------------------------------------------
Source: BioDelivery Sciences International, Inc.

[Kaserer]

Na hier wird bald die Rakete gezündet, wer dabei sein will, sollte baldigst einsteigen. KZ 8 €

[XTrack]

Press Release Source: BioDelivery Sciences International, Inc.

BioDelivery Sciences Files IND for BEMA(TM) LA, a Treatment for Moderate to Severe Pain
Friday January 6, 8:00 am ET

MORRISVILLE, N.C.--(BUSINESS WIRE)--Jan. 6, 2006--BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News) announced today that it has submitted an initial Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for the company`s BEMA(TM) Long Acting Analgesic (LA) product. If and when approved by FDA, BEMA(TM) LA is intended to meet the need for an alternative route of administration of an existing, marketed narcotic for the treatment of moderate to severe pain. BEMA(TM) LA will be formulated using BDSI`s licensed BEMA(TM) technology platform, which consists of a fast dissolving mucoadhesive disc designed to rapidly deliver the active ingredient across the buccal mucosa of the mouth.

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click here
BDSI believes that BEMA LA represents a substantial opportunity to capture market share in a pain market that generated reported 2004 sales of $21 billion and is estimated to grow to $29.8 billion by 2008. Due to the potential for BEMA(TM) LA to be used to treat a variety of pain conditions, BDSI believes that the product could capture a 1-2% share of the total worldwide pain market and potentially generate peak sales of between $250 million and $500 million.

BEMA(TM) LA will be a formulation of an analgesic which is already FDA-approved, which is substantially more potent than morphine, but which BDSI believes has a lower risk of serious adverse reactions and abuse.

As previously announced, BEMA(TM) LA was the subject of a pre-IND meeting with the FDA in November of 2005 and will be developed in adherence to BDSI`s business model of 505(b)(2) NDA submissions. Accordingly, the first human clinical trial will be a pharmacokinetic comparison in normal volunteers with the current formulations of the active ingredient in the reference listed drugs already approved and on the market.

Dr. Andrew Finn, Executive Vice President of Clinical and Regulatory Development for BDSI, stated, "We expect that the results of this initial human study for BEMA(TM) LA will provide additional data supporting the robust performance of the BEMA(TM) delivery technology as well as an alternative delivery of the active ingredient that will potentially benefit patients."

Dr. Mark Sirgo, President and CEO of BDSI, stated, "The filing of this IND further demonstrates the commitment of BDSI to develop a broad portfolio of products in our areas of interest and is additional evidence of BDSI`s ability to execute our announced development plans. This longer acting pain product will complement our first product formulated with the BEMA(TM) technology, BEMA(TM) Fentanyl, which will be used specifically for the treatment of breakthrough cancer pain. BEMA(TM) LA will initially target moderate to severe pain. Needless to say, with our existing NDA for Emezine® (prochlorperazine maleate) under review at FDA; BEMA(TM) Fentanyl entering Phase III and now with our ability to move forward with BEMA(TM) LA into human testing, 2006 has the potential to be an extremely exciting year for BDSI."

BDSI`s patented BEMA(TM) drug delivery system is exclusively licensed to BDSI on a worldwide basis. The BEMA(TM) delivery technology consists of an easy to use, dissolvable, dime-sized polymer disc that is applied to the mucus membrane (between the cheek and gum) of the mouth. The disc dissolves over approximately 20-30 minutes, delivering the drug across the mucus membrane for rapid absorption and onset of effect.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting and infections. The company`s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" 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 clinical trials and FDA review of the Company`s formulations and products, may differ 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).


Contact:

Mark Sirgo, Pharm.D.
President and Chief Executive Officer
BioDelivery Sciences International, Inc.
919-653-5160
or
Investor Relations Group
John Nesbett/Vince Daniels (Investor Relations)
Janet Vasquez/Lynn Granito (Public Relations)
212-825-3210

Source: BioDelivery Sciences International, Inc.

BSDI KÖNNTE EIN TENBAGGER WERDEN!!!!

[XTrack]

3$
Und noch immer eine niedrige Market-Cap von 35Mio$...

[Kaserer]

Ist ja sehr ruhig um Biodelivery. Sollte mir nur Recht sein, solange der Kurs in die Richtung geht wo er hingehört, nähmlich mindestens eine zweistellige Zahl vor dem Komma und das in 2006.

[XTrack]

Ist noch jemand dabei? BDSI macht seinen Weg! Morgen wird wahrscheinlich das Announcement der FDA zu Emezine kommen. Es bleibt also spannend

[cripplecreek]

[posting]20.407.906 von XTrack am 27.02.06 18:30:33[/posting]es macht zumindest den anschein, dass sie die zulassung erhalten. der kurs ist der beste indikator...

die 4 sehen wir kurzfristig...

[panik]

BioDelivery Sciences Receives Non-Approvable Notification from FDA on Emezine(R)
Wednesday March 1, 4:00 pm ET
Company Has Requested a Meeting with the FDA to Gain Clarity on Notification


MORRISVILLE, N.C.--(BUSINESS WIRE)--March 1, 2006--BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News), a specialty biopharmaceutical company, has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) for the company`s new drug application (NDA) for Emezine®, a buccal tablet formulation of prochlorperazine maleate for the treatment of severe nausea and vomiting. The letter was received on February 28, 2006.
ADVERTISEMENT


The non-approvable letter stated that additional information would be required to address remaining questions. BDSI has requested a meeting with the FDA regarding their notification and will use the outcome of this meeting to evaluate the direction it intends to pursue regarding Emezine®.

Dr. Mark A. Sirgo, President and CEO of BDSI, stated, "We are extremely surprised and disappointed by the FDA`s decision in light of the fact that we strictly adhered to the development program that was outlined in our pre-NDA meeting with the FDA in March of 2004. It is clear based on the FDA`s comments that they are now, among other things and contrary to our previous expectations, seeking additional data on the product. We will take the next few days, in conjunction with our licensing and distribution partners, to consider our options in responding to and working with the FDA on this matter. We have put in a meeting request today and plan to act quickly to resolve the situation. In the meantime, we will maintain focus on our flagship BEMA(TM) Fentanyl product, which is now progressing through Phase III, and on the other products and formulations in our pipeline."

Emezine® is an oral transmucosal (drug absorbed directly through the mucosa of the mouth) medication for the treatment of nausea and vomiting. The current alternatives to oral tablets are injections and suppositories. BDSI licenses Emezine® on an exclusive basis in the U.S. from Reckitt Benckiser Healthcare (UK) Limited. The Emezine® tablets are proposed to be manufactured for BDSI by Reckitt Benckiser, which currently distributes a similar product in the United Kingdom. TEAMM Pharmaceuticals, a subsidiary of Accentia Biopharmaceuticals, Inc. (NASDAQ:ABPI - News), has contracted to be BDSI`s distribution partner for Emezine®.

BDSI is also working on BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain, and expects to complete its Phase III BEMA(TM) Fentanyl trials during the second half of 2006. BEMA(TM) Fentanyl is an oral adhesive disc formulation of the narcotic fentanyl. Additionally, BDSI will be conducting Phase I trials with BEMA(TM) LA, its second analgesic in the BEMA(TM) technology, in the first quarter of 2006 and plans to initiate Phase III trials in the second half of 2006.

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company`s drug delivery technologies include: (i) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications, and (ii) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" 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 additional clinical trials and FDA review of the Company`s formulations and products, may differ 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).



Contact:
Investor Relations Group
Investor Relations:
Vince Daniels, 212-825-3210
or
Public Relations
Janet Vasquez, 212-825-3210

--------------------------------------------------------------------------------
Source: BioDelivery Sciences International, Inc.

[cripplecreek]

[posting]20.454.303 von panik am 01.03.06 22:10:09[/posting]Die letzten Handelsminuten haben ja dies bereits vermuten lassen. Leider keine gute Nachricht. Allerdings ist das keine definitive Absage an das erste Produkt. Es sind weitere Unterlagen einzureichen. Man will sich seitens BDSI die nächsten Tage mit FDA und Partner zusammensetzen und das weitere Vorgehen besprechen. Der Kurs wird überzogen reagieren, wie immer in solchen Fällen. Zu berücksichtigen ist, dass für Emezine eh keine signifikanten Umsätze erwartet wurden. Man wollte lediglich mit den Erlösen die weitere Forschung finanziell unterstützen. Dafür sollte allerdings im Zweifelsfall ein Investor gefunden werden.

[XTrack]

Ist natürlich dumm, dass es nicht sofort geklappt hat mit der Zulassung. Trotzdem ist der Abschlag von 30% übertrieben, der Hauptumsatzträger soll BEMA Fetanyl werden. Market Cap somit also wieder unter 30Mio$. Ich werde weiter halten und Phase III bei BEMA sowie die weitere Entwicklung bei Emezine abwarten.

[Ed24]

-35% !!!

Na klasse!

[spencer76]

bin ein neuling. soll ich die aktie jetzt halten oder schnellst möglich verkaufen? hat jemand rat?

[Buddah]

spencer76
Hm.Prinzipiell sollte man immer vor einem Kauf festlegen wieviel mam bereit ist zu verlieren.Bei spekulativen Aktien wie dieser helfen einem,wenn es "dumm kommt",auch keine Stops.Also sollte man am besten nur soviel investieren,wie man bereit ist zu verlieren.Dann schläft es sich besser und man kann stärkere Kursschwankungen einfach aussitzen.Solltest Du das Geld nicht sofort benötigen,würde ich eher drinnenbleiben.

Gruss B.

[spencer76]

ersma vielen dank für deine antwort,
natürlich ist das geld welches ich bei aktien einsetze "übrig". man möchte natürlich soviel wie möglich rausschlagen und wie gesagt bin ich neuling.lese mir ab und zu den aktionär durch und kaufe wenn ich kohle übrig habe ein paar aktien. aber ehlich gesagt hab ich echt wenig ahnung und bin froh hier mir ein par infos rauszupicken.. also vielen dank dir und allen andern die hier tipps rauslassen.

[XTrack]

Press Release Source: BioDelivery Sciences International, Inc.

BioDelivery Sciences Updates Product Development Pipeline Status and 2006 Milestones
Tuesday March 14, 8:30 am ET

MORRISVILLE, N.C.--(BUSINESS WIRE)--March 14, 2006--BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News): Company Has over $1 Billion in Estimated Peak Revenue Potential for

Products under Development; Pain Franchise Products Noted as Key Value

Driver for Company

BioDelivery Sciences International, Inc. (NASDAQ:BDSI - News), a specialty biopharmaceutical company, provided the following update on the portfolio of products in its development pipeline and the company`s 2006 milestones:

Product Development Pipeline

Product Indication Clinical Status Peak Sales*
------- ---------- --------------- ------------
BEMA(TM) Breakthrough Cancer Phase III Clinical $250 million
Fentanyl Pain Trials

BEMA(TM) LA Moderate-Severe Pain IND filed, Phase I: $500 million
2Q 2006

Bioral(R) Fungal Infections Formulation / Pre- $400 million
Amphotericin B Clinical: Phase I:
3Q 2006

BEMA(TM) Anxiety / Insomnia Pre-Formulation $250 million
Zolpidem

Emezine(R) Nausea / Vomiting Status of NDA under $30 million
discussion with FDA**

* BDSI estimates, assuming FDA approval. BDSI to pay royalties to
licensors and partners.
** BDSI preparing response for meeting with FDA based on recent NDA
decision.

2006 Milestones

Product Milestone Quarter
------- --------- -------
BEMA(TM) Fentanyl Report Phase III Data Q4

BEMA(TM) LA Report Phase I Data Q2
Report Phase II Data Q4
Intention to Proceed into Phase III Q4

Bioral(R) Amphotericin B File IND Q2-3
Report Phase I Data Q3
Intention to Proceed into Phase II Q3-4

BEMA(TM) Zolpidem File IND Q4

Emezine(R) FDA meeting to address open items Q2

Dr. Mark A. Sirgo, President and CEO of BDSI, stated, "We have a diversified portfolio of proposed formulations and products in various stages of development that have an estimated combined peak revenue potential of greater than $1 billion per year. Our most significant near term asset, BEMA(TM) Fentanyl, has, we believe, peak sales potential of $250 million dollars and is currently moving through Phase 3. BEMA(TM) Fentanyl will be the first of our two lead pain franchise products which we expect to participate in the large and growing pain therapy area."

As it relates to BDSI`s 2006 milestones, Dr. Sirgo continued, "We are encouraged by our progress and we are determined to achieve a number of significant milestones in the next three quarters, in particular our pain franchise of BEMA(TM) Fentanyl and BEMA(TM) LA, which we believe have the potential to significantly drive stockholder value in BDSI this year."

About BioDelivery Sciences International

BioDelivery Sciences International, Inc. is a specialty biopharmaceutical company that is exploiting its licensed and patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, clinically-significant new formulations of proven therapeutics targeted at "acute" treatment opportunities such as pain, anxiety, nausea and vomiting, and infections. The company`s drug delivery technologies include: (i) the patented BEMA(TM) (transmucosal or mouth) drug delivery technology and (ii) the patented Bioral® nanocochleate technology, designed for a potentially broad base of applications. The company`s headquarters are located in Morrisville, North Carolina and its principal laboratory is located in Newark, New Jersey. For more information please visit www.bdsinternational.com.

Forward-Looking Statements

Note: Except for the historical information contained herein, this press release contains, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve risks and uncertainties. Such statement may include, without limitation, statements with respect to the Company`s plans, objectives, expectations and intentions and other statements identified by words such as "may", "could", "would", "should", "believes", "expects", "anticipates", "estimates", "intends", "plans" 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, actual sales results, if any, or the results of scheduled or additional clinical trials and FDA review of the Company`s formulations and products, may differ 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). Peak sales estimates have been determined on the basis of market research and comparable product analysis, but no assurances can be given that such sales levels will be achieved, if at all.


Contact:

Investor Relations Group
Investor Relations:
Vince Daniels, 212-825-3210
or
Public Relations:
Janet Vasquez, 212-825-3210

Source: BioDelivery Sciences International, Inc.

[spencer76]

hallo zusammen,

hab die schlechte nachricht das das medikament keine zulassung erhielt erhalten. hat jemand ne idee wies weitergeht. ich meine der kurs steigt ja im moment wieder an was ich nicht versteh. wie handhabt ihr die ganze geschichte? verkauft ihr jetzt oder haltet ihr. ich für mich denke ich halte, aber vieleicht wißt ihr mehr?

danke

[XTrack]

Hey Spencer!

Na, das hat aber gedauert, bis Dich die Info erreicht hat

BDSI wird sich nochmal mit der FDA treffen, weil Emezine aufgrund fehlender bzw unzureichender Daten nicht zugelassen wurde. Daher steigt der Kurs auch wieder, weil es Hoffnung gibt, dass Emezine doch noch zugelassen wird. Desweiteren steht dieses Jahr noch eine Menge an, wie Du in meinem letzten Posting lesen kannst. Wenn es mit Emezine nicht klappt, gibts noch genug Action für den Rest des Jahres und damit genug Chancen auf Kurssteigerungen. Ich werde halten und unter 3$ bekommt meine Stücke eh keiner.

[spencer76]

Antwort auf Beitrag Nr.: 21.028.550 von XTrack am 31.03.06 14:59:41

hy xtrack,

vielen dank für deinen beitrag war nämlich echt schon nah dran die dinger zu verkaufen. hätte allerdings fettes minus gamacht da ich die aktien für2,50 gekauft habe. also warten wir mal ab was passiert.

m.f.g

spencer76

[JackHB]

Hi! Ist hier noch jemand?
Sich die letzten 30 Tage anszusehen macht schon Spaß!
Scheint das die schlechten Nachrichten überwunden wurden.

[XTrack]

Naja, die schlechten Nachrichten könnten nochmal zu schlechten Nachrichten werden, wenn Emezine definitiv keine Zulassung erhält. Im Moment spielt das Prinzip Hoffnung eine große Rolle. BDSI wird weiterhin eine hohe Volatilität an den Tag legen und ist damit nichts für schwache Nerven.

Ich werde bis Ende des Jahres halten, da BEMA für mich der eigentliche Grund für das Invest war und nicht Emezine.

[JackHB]

Antwort auf Beitrag Nr.: 21.074.031 von XTrack am 04.04.06 19:24:57

Ohne Phantasie geht doch bei kaum einem Wert etwas.
Werde mal schauen ob die sich am Markt behaupten können. Da ich erst nach dem Knick rein bin, sehe ich bisher natürlich nur schmwerzfreies Grün - sehr Angenehm.

[XTrack]

Antwort auf Beitrag Nr.: 21.075.006 von JackHB am 04.04.06 20:19:35

Ob sie sich am Markt behaupten können, wirst Du erst in mehr als einem Jahr wissen.

Bald sind wir wieder bei 3$

[JackHB]

BioDelivery Sciences Confirms Dose Proportionality with BEMA(TM) Fentanyl

MORRISVILLE, N.C.--(BUSINESS WIRE)--April 24, 2006--

BioDelivery Sciences International, Inc. (Nasdaq: BDSI), a specialty biopharmaceutical company, announced the results of a pharmacokinetic study with BEMA(TM) Fentanyl. The study demonstrated that both peak plasma fentanyl concentrations and overall exposure increase in a linear manner (i.e., in proportion to the dosage amount) across the range of BEMA(TM) Fentanyl doses tested. This result is known as dose proportionality, meaning that a change in the dose results in a proportional change in the maximum circulating concentration of the subject pharmaceutical. Achieving dose proportionality is a key milestone in the clinical testing of a pharmaceutical product.

This study was performed in healthy subjects (not patients) to evaluate the relationship between the dose of fentanyl administered and the plasma concentrations achieved. Plasma fentanyl concentrations are related to the pharmacologic effects of the product and normal volunteers are typically used for these studies. Participating subjects received each of 3 different doses of BEMA(TM) Fentanyl.

Dr. Andrew Finn, BDSI's Executive Vice President of Clinical Development and Regulatory Affairs, said "The results demonstrated that mucosal absorption of fentanyl can be rapid and predictable, without the need for patient effort in the application process. We believe that this ease of administration will distinguish BEMA(TM) Fentanyl as a product for the management of breakthrough cancer pain."

Dr. Mark Sirgo, BDSI's President and Chief Executive Officer, added "While this study was a necessary component of our BEMA(TM) Fentanyl development program for the treatment of breakthrough cancer pain, we believe that the results serve as an important demonstration of the robustness of our patented BEMA(TM) delivery system and its ability to accommodate several different strengths of fentanyl in a dose proportionate fashion. These same dosage strengths are part of our BEMA(TM) Fentanyl Phase III program, which we anticipate completing by the end of 2006. These study results add to the body of evidence we are collecting on BEMA(TM) Fentanyl that support our confidence in the commercial viability of this product in the marketplace."

Within the global market, pain medication generates estimated annual sales of more than $24 billion. An estimated $2 to $4 billion is targeted at breakthrough pain, with BEMA(TM) Fentanyl's indication of breakthrough cancer pain being a subset of this market. BDSI believes that BEMA(TM) Fentanyl maintains a strong potential of securing a significant share of the breakthrough cancer pain market in the U.S. The company estimates that BEMA(TM) Fentanyl will generate minimum annual peak sales of $250 million.