BDSI

[cpezc]

Hello everyone,

I wanted to point out Biodelivery Sciences and see what you think. I've been watching it for a while now and although it has been gradual it's action has been very positive over the past few months, moving steadily from 1.80 to 3 since I have been watching. Now it is up for FDA approval for their first product on February 28th.

Here's the blurb:

'Patented technology that can orally-deliver drugs that normally require parenteral administration such as insulin. Thus, by using this oral delivery system, BDSI can make an off-patent, generic injectable (eg. Amphotericin B, Vancomycin, calcitonin, etc) an orally delivered, patent-protected branded pharmaceutical. Importantly, the BDSI technology eliminates almost all the risk associated with new drug development. Moreover, many new biotech products are large molecules that normally require parenteral administration. The BDSI delivery system would expand the marketplace for these drugs by eliminating the need for painful injections. Additional applications include gene therapy and vaccine therapy.'

1.The first candidate is an anti nausea drugs for cancer patients - great benefit for mouth absorbtion v. swallowing - due for FDA decision by 28th Feb. 'at the latest'
2.  2nd drug - BEMA(TM) LA for the acute treatment of moderate to severe pain, such as post-operative pain.
3. The CEO heads The Hopkins Capital Group, http://www.hopkinscap.com/personnel.html , which has had some very good success recently whith other small pharmas. This is a top rates VC firm. BDSI has a very small (nano) market cap, but Insiders control 65% (incl. 797K options). Pharmaceutical Product Development owns 10%.
4. Market cap=tiny, but another company the group supported went for $1.6 to equiv. $400 with splits in 5 years. Although the past weeks have shown below average volume Tuesday it was well above average.
5.When I first found this company I looked at their Yahoo message board I noticed that many of the discussions were very technical by doctors. This is NOT typical of The Yahoo boards and most of you must know. lol!


Cheers,
C

[cpezc]

Hi again, still looking for opinions on this. The more I look at it the better it seems. The Hopkins Capital Group is a group of Johns Hopkins alumni VCs, and they have a fantastic track record.
Also, TMTA looking great today after a brillaint CC and report last night... hmm on second thought I got stuck in it before.

[cpezc]

Good volume of Friday things are picking up. Tuesday is the day.  Just to add - the maket for the first drug is not huge - projectedat $25million, and it is licensed for distribution through ABPI, another Hopkins Capital Group supported company. I still expect BDSI to end up between $4-6 this week, a big spread I know, but it really depends on the PR.  It is really a buildup to the BIG one, which is , Fentanyl. It has a market at least 10 times the size and it is coming later in the year. They just received another $2 million installment for development, so it looks to be going very well and on schedule.  BTW, Fentanyl (breakthrough relief of cancer pain) is also one of the drugs GNBT are looking at for their buccal inhaler, but BDSI are way ahead (still I love GNBT  - got in at 1.36 3 months ago and the averaged down at .91 - so I am pretty happy this weekend;-) - Good luck!

[cpezc]

Here's a link to the Wall Street Investors Forum from December:

http://origin.vcall.com/CustomEvent/conferences/wallstreetanalyst/112905/agenda.asp?Day=1

BDSI is on the bottom right of the page. There is audio and a slide show.

Article bout Emezine FDA approval Tusday, 28th Feb 06:

http://biz.yahoo.com/bw/051207/20051207005104.html?.v=1

Article about Bema Fentanyl:

http://biz.yahoo.com/bw/060216/20060216005137.html?.v=1

[cpezc]

Double avg volume today at 147k and an 8.27% gain. not bad. looking for much more tomorow and in days following as the news comes and filters through. High today 3.48. Previous close 3.03.

[cpezc]

Today is the day. New will hopefully come AH or tomorrow morning PM. Keep it on the radar. Also see ABPI and Biovax which are other Hopkins Group companies. ABPI is distributing Emazine so it should get a pop too. Good luck!

[cpezc]

OUCH. Got a non-approvable letter needing more data. Unexpected and a 33% drop after hours. This is Should be pointed out that Emezine is used all over the world already and that some of the clinical data was based on other research. this may have lead to the disapprovable letter. They may be able to remeby this but the question is if it is worth it. BDSI was to get 20% royalty on 25-35 milllion sales, so it was really just and income stream to support the development and promotin of their BEMA tech which is much bigger - first drug at 125 million estimate.  Buy now at bargain prices as Phase III continues for Fentanyl and they move to clarify with the FDA about Emezine. sorry about the bad haircut.

[D&Data]

SO ..... buy on low prices....to profit of the little  rebound....

Ciao ciao

[Ares]

Daily chart of BDSI.

Will it break the 5.70 resistance?
Or will this dip towards the 50ma (3.50 range)
Lately the volume was up when the price went up and the volume down when the price went down.
Indicators look overbought but then again sometimes price still goes up.

[Ares]

BDSI moving

[setravis]

"BDSI" Threads have been Merged.
Please use the search before starting new threads on a Stock Pick.
Chances are a thread already exist.
So why not post whatever you have to comment about on that pick to that thread.
"Simplicity" My fellow traders.                                     
All history on a stock pick in 1 thread is awesome.                                   
Just trying to get threads together,so we don't have a numerous amount floating around on the same stock.                
Thank You....and good luck with all your trades....make some $$$               

[REALDEALS21]

MAJOR MEWS SENDING THIS ONE UP 68 ++ 

Press Release   Source: BioDelivery Sciences International, Inc.

BDSI Announces Positive Phase III Clinical Trial Results for BEMA(TM) Fentanyl
Wednesday April 25, 6:00 am ET
Primary Efficacy Endpoint in Pivotal Trial Demonstrates Statistical Significance Compared to Placebo in Patients with Breakthrough Cancer Pain
Company to Host Conference Call and Webcast at 11am Eastern Time Today to Discuss Results

MORRISVILLE, N.C.--(BUSINESS WIRE)--BioDelivery Sciences International, Inc. (Nasdaq: BDSI - News) announced today statistically significant results with BEMA(TM) Fentanyl in cancer patients with breakthrough pain in its pivotal Phase III efficacy clinical trial for the product. The results are based on achievement of the primary efficacy endpoint of the trial, Summary of Pain Intensity Difference (SPID), compared to placebo.

The results demonstrated that patients treated with BEMA(TM) Fentanyl showed a statistically significant improvement on the primary efficacy endpoint at 30 minutes (SPID 30) compared to placebo (p less than 0.004), meaning a greater reduction in pain. Eighty (80) patients participated in the double-blind, placebo-controlled portion of the study.

BEMA(TM) Fentanyl consists of a small, dissolvable polymer disc, formulated with the opioid narcotic fentanyl, for application to the buccal (inner lining of cheek) membranes. Upon administration, BEMA Fentanyl is designed to deliver a rapid, reliable dose of drug across mucous membranes.

Dr. Andrew Finn, BDSI's Executive Vice President of Product Development, stated "We are obviously very pleased with these efficacy results. Only five patients (approximately 3% of those patients entering the initial titration phase of the study) were unable to achieve adequate pain relief. We believe this high level of pain control is attributable to the efficient, reliable absorption from the buccal mucosa, the ease of application of the BEMA Fentanyl product and the ability to titrate across a wide range of doses up to and including our 1200 mcg dose. Importantly, the results also demonstrated that BEMA(TM) Fentanyl was well-tolerated by patients in the trial, with no reported drug-related changes to the oral mucosa, which is important for cancer patients who may also have oral ulcerations as a result of a weakened immune system."

"Once we have the remainder of the data analyzed, including the secondary efficacy parameters, our plan will be to submit the data to a scientific conference for presentation. We will do that at the first available opportunity and at the most appropriate forum. However, we wanted to be able to share the news that we have achieved the most important endpoint, namely the SPID 30, at this time," concluded Dr. Finn.

Dr. Mark Sirgo, President and CEO of BDSI, commented, "These Phase III results demonstrate that the BEMA(TM) delivery system is effective in delivering a significant level of fentanyl over a range of doses to manage the breakthrough cancer pain that occurred in these patients. The results also demonstrated that the dosage form was convenient and comfortable to use. Importantly, we believe that the dose linearity (i.e. double the dose and double the plasma concentration of the drug) demonstrated in our previously announced pharmacokinetic studies up to the 1200 mcg dose provide the ability to relieve breakthrough cancer pain in a higher percentage of patients. This was demonstrated by the fact that only 3% of patients who entered the titration phase did not proceed to the double blind, placebo controlled phase of the study because they could not achieve adequate pain control. Overall, given the efficacy profile of BEMA(TM) Fentanyl as demonstrated during this Phase III study, along with the apparent ease of use and comfort of the BEMA(TM) disc, we remain confident that BEMA(TM) Fentanyl has the potential to play an important role in the future treatment of breakthrough cancer pain."

In 2006, franchise sales for the market leader in rapid acting fentanyl products were a reported $659 million, while only treating less than 50,000 of the estimated 500,000 cancer patients with breakthrough pain. "We believe that the efficacy and safety profile of BEMA(TM) Fentanyl is well suited to penetrate the 90% of the market that is not served by existing products" commented Dr. Sirgo. "Based on this, and assuming NDA acceptance and approval by FDA and that our development and commercialization activities continue as planned, we continue to believe that we will ultimately reach our annual peak sales projection of $250 million for the treatment of breakthrough cancer pain."

"On behalf of the Board of Directors, I want to congratulate our senior management and our entire BEMA(TM) Fentanyl team for achieving this pivotal milestone in the history of BDSI" said Frank E. O'Donnell Jr., M.D., Chairman of the Board of BDSI. "Since the addition of Drs. Sirgo and Finn to our senior management team in 2004, BDSI has made great strides in its evolution from a drug delivery company into a specialty pharmaceutical company. In that time, under their dedicated, tireless and very able leadership, BDSI has carefully marshaled and focused its resources, faced and overcome many obstacles and stayed true to its pursuit of the capital and time efficient 505(b)(2) regulatory pathway. Our team has brought tangible value to our stockholders, and our board takes this time to state its appreciation and admiration of the efforts of our management team and all of our employees."

Dr. O'Donnell continued, "We are hopeful that this demonstration of the effectiveness of BEMA(TM) Fentanyl augers very well for the potential application of the BEMA(TM) technology to other therapeutics that normally require parenteral administration. While it is true that work remains to be completed in the regulatory and commercial areas for BEMA(TM) Fentanyl, now that we have demonstrated the clinical value of this important delivery technology, we will seek to expand our pipeline of other clinically and economically valuable applications and partnerships."

Patients from the efficacy study were also eligible for entry in the long-term safety study with BEMA(TM) Fentanyl, which is still ongoing. The two studies together will form the foundation of BDSI's New Drug Application (NDA) scheduled for submission during the third quarter of 2007. Prior to this submission, BDSI will conduct a pre-NDA meeting with the FDA on June 28, 2007 to discuss results of this efficacy trial along with the safety data and other requirements for the NDA submission.

BDSI will host a conference call to discuss the results today April 25th at 11:00 AM ET. We invite all those interested in hearing management's discussion to join the call by dialing 1-(877)-407-8033. International participants may access the call by dialing 1-(201)-689-8033. A replay will be available for one week following the call by dialing 1-(877)-660-6853 for domestic participants or 1-(201)-612-7415 for international participants and entering account number 286 plus conference ID code 240056 when prompted. Participants may also access a live webcast of the conference call through the BDSI website at www.biodeliverysciences.com or at http://www.vcall.com/IC/CEPage.asp?ID=116323. The webcast will be archived on the company's website for 7 days.

About the BEMA(TM) Technology

BDSI's BEMA(TM) drug delivery technology consists of a dissolvable, dime-sized polymer disc for application to the mucosal (inner lining of cheek) membrane. BEMA(TM) discs deliver a rapid, reliable dose of drug across mucous membranes for time-critical conditions or trauma cases where intravenous lines or injections are unavailable or not practical.

About BEMA(TM) Fentanyl

BDSI's lead product under development is BEMA(TM) Fentanyl, a treatment for "breakthrough" cancer pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid pain relief. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The transmucosal form of fentanyl is a powerful narcotic used to treat breakthrough cancer pain. BDSI believes that fentanyl applied with its BEMA(TM) disc technology has the potential to meet the market need for new narcotics and, BDSI believes, will be well suited for breakthrough cancer pain in opioid-tolerant patients.

[setravis]

BDSI Sees Positive Cash Flow
from BEMA(TM) Fentanyl
BioDelivery Sciences International, Inc. (BDSI) exercised its option to
acquire the U.S. rights to the BEMA(TM) drug delivery technology that
it licensed from QLT USA, Inc. (QLTI). The acquisition gives BDSI full
ownership of the BEMA(TM) technology. BDSI paid QLT $3 million at
the closing of the acquisition and has issued a promissory note in the
amount of $4 million. The note is payable to QLT in two future $2 million installments
triggered by the occurrence of specific milestones, including the NDA approval of BDSI's
first BEMA product.
The Company has also entered into an exclusive and perpetual license and related supply agreement with
Meda for the U.S., Canadian and Mexican commercialization rights to BDSI's flagship BEMA(TM) Fentanyl
product for the treatment of "breakthrough" cancer pain. Under this agreement, Meda will be responsible for
the marketing and distribution of BEMA Fentanyl in the U.S., whose launch is anticipated in late 2008. In addition,
Meda will be responsible for the management of the post-NDA approval clinical development program.
BDSI anticipates a $30 million non-refundable up front milestone payment from Meda.
Dr. Mark Sirgo, President and CEO of BioDelivery Sciences, told Knobias on Thursday, "We believe this
transaction, coupled with the U.S. licensing partnership with Meda, solidifies our financial position for the
foreseeable future. With the $30 million up front payment from Meda, BioDelivery projects positive cash flow
for 2007. Additionally, the Company expects royalty revenue from Fentanyl by the end of 2008, resulting in
positive cash flow for 2008. "
Fentanyl is an opioid analgesic with a potency eighty times that of morphine. BEMA(TM) Fentanyl utilizes
patented BEMA(TM) oral adhesive disc technology that consists of a dissolvable, dime-sized polymer disc
for application to mucosal (inner lining of cheek) membranes. The discs deliver a rapid, reliable dose of drug
across mucous membranes for time-critical conditions like breakthrough cancer pain. Breakthrough cancer
pain is severe flares of pain that often "break through" daily longer acting pain medicines that are used to
control persistent pain. The best treatment for breakthrough pain is short-acting pain medicines that work
rapidly.
Dr. Sirgo added, "Our Phase III results this year demonstrated that BEMA Fentanyl was highly effective for
the treatment of breakthrough pain in cancer patients."
A direct competitor in the marketplace for BEMA(TM) Fentanyl is Cephalon's (CEPH) Actiq(R), a fentanyl
lozenge on a stick that dissolves slowly in the mouth for absorption across the buccal mucosa. Barr Pharmaceuticals
(BRL) also produces a generic version of this product. Other competition in the market comes from
Cephalon's Fentora(TM), an effervescent tablet formulation of fentanyl.
Dr. Sirgo explained, "Our first clinical trial indicated that our formulations were more bioavailable than Actiq.
Our product produced greater and faster absportion and higher concentrations (60%) of fentanyl when compared
to Actiq. Additionally, there are few taste issues and no "oral" irritation or ulceration which has been
associated with Fentora."
"Additional studies will investigate the use of BEMA Fentanyl in breakthrough pain that is associated with other
non-cancer conditions such as chronic back or neck pain, where a significant unmet need currently exists.
The Company is also working on a second pain product, BEMA(TM) Long Acting Analgesic, or BEMA(TM)
LA. This BEMA formulation of an already approved product in the U.S. may target a broader range of pain
conditions such as post operative and chronic pain due to osteoarthritis, lower back disorders and rheumatoid
arthritis. We submitted an IND on BEMA(TM) LA in December 2005 and have completed the initial Phase I
trial, which demonstrated therapeutic plasma concentrations of the active ingredient."
He continued, "Our lead Bioral(R) formulation is an encochleated version of Amphotericin B, an anti-fungal
treatment for treating systemic fungal infections. A Bioral(R) formulation of Amphotericin B provides the potential
for oral delivery of a drug that is currently only given by intravenous injection. The Bioral technology
encapsulates the selected drug in a nanocrystalline structure termed a "cochleate" cylinder. All of the components
of the cochleate cylinder are naturally occurring substances. We believe that the cochleate cylinder
provides an effective delivery mechanism without forming a chemical bond, or otherwise chemically altering,
the selected drug. We submitted an IND for Bioral Amphotericin B in late 2006 and are progressing to clinical
studies. In addition to our proprietary pipeline, we have conducted significant research utilizing the Bioral(R)
system to deliver nucleic acids for which we are seeking potential partners to create new therapeutics."
"We have also exclusively licensed Emezine(R), a formulation of prochlorperazine, a treatment for nausea
and vomiting. In February 2005, BDSI announced that it completed the clinical studies and an NDA for
Emezine(R) was subsequently submitted to the FDA. However, BDSI received a non approvable letter from
the FDA relating to Emezine in early 2006. BDSI is working with the FDA to determine the next steps in the
development of this product."
BioDelivery Sciences, with both its BEMA(TM) and Bioral(R) technology, will continue to work on products
targeted at other acute treatment opportunities such as insomnia, nausea and vomiting, and infections.

[setravis]

Thursday, July 16, 2009
FDA approval pumps $27M into BDSI pipeline
Triangle Business Journal

Now that BioDelivery Sciences International has won regulatory approval for its first product, CEO Mark Sirgo says the company is in a better position to develop other products in its pipeline.

"It takes a lot of pressure off of everyone here, knowing that we've got the first one behind us," he said.

The U.S. Food and Drug Administration on Thursday formally approved Onsolis, Raleigh-based BDSI's mouth patch that delivers the painkilling drug fentanyl to cancer patients suffering severe "breakthrough pain" that doesn't respond to other medications.

Onsolis is manufactured by Aveva Drug Delivery Systems of Florida and marketed under license from BDSI (Nasdaq: BDSI) by Meda Pharmaceuticals. With FDA approval of Onsolis, BDSI is due about $27 million in milestone payments, which Sirgo said would be directed to the company's drug pipeline.

The company also is developing the product BEMA Buprenorphine, a form of painkilling drug buprenorphine that is often given intravenously to treat chronic pain. Like Onsolis, the product uses the company's BEMA technology, which delivers drugs through mucous membranes in the mouth via a small patch.

Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.

Following news of FDA's approval of Onsolis, BDSI shares soared on Wall Street to as high as $7.25, up almost 19 percent on the day. The stock then steadily slid back down, closing the day at $6.14, up 2.33 pecent. .

The announcement Thursday was a moment of triumph for Sirgo, who survived an investor's attempt to oust him two years ago after Onsolis ran into some hurdles in clinical trials. With the drug back on track for approval, that same investor – private equity firm Elliott International Capital Advisors – recently gained control of enough BDSI shares to become its largest shareholder.

Sirgo said that the Onsolis approval showed that the company could accomplish what it set out to do when given enough time and resources and that in the end, Elliott and venture capital firm Clinical Development Capital were happy shareholders.

BDSI employs 21, most of them in Raleigh. Sirgo said he expects to add another five to six people in the next year in development and manufacturing.