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For Those That Missed the Press Release
Hemispherx Biopharma to Provide Update On Global Pandemic Influenza Prevention / Treatment Initiatives
PHILADELPHIA, July 20, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE AMEX:HEB) will provide an update on its Influenza research initiatives via teleconference on Wednesday, July 22, 2009, at 10:00 AM EDT. Initiatives to be discussed will include experimental programs planned or underway in Pacific Rim countries, Australia, South America and the United States. Background information may be sourced at Wall Street Journal.
Hemispherx's Medical Director, CEO, and the Managing Director of the Sage Group, a health care consulting firm retained by Hemispherx, will participate. Investigational products and protocols to be discussed will include Hemispherx's Ampligen(r) (poly I: poly C12U), Alferon N (a natural cocktail of alpha 2 type interferons, FDA approved for treatment of refractory HPV) and Alferon LDO, an experimental formulation of Alferon-N for oral delivery.
To access the conference call:
U.S. Callers: 800-346-7359
International Callers: 973-528-0008
Conference Entry Code: 27781
This call will be webcast via the Company's website at: http://www.hemispherx.net.
Interested if we have any contracts with Japan and or Italy along with FDA update...hmmm
I plan to be on the call!
Investor 100
HOD @ DDSS
What a come back from this morning closing at $2.00!
Lots of MOMO going into tomorrow..what a day.
GLTA
Investor 100
Solid Call on this Sheff!
Another new high @ .0345 before the close!
GLTA
Investor 100
HOD @ BIEL
Stock moved to .034 (+21%) on 43M shares traded.
GLTA
Investor 100
Interesting Opinion on HEB
Hemispherx Biopharma, Inc. (HEB) - HEB had a nice pop Monday and is now back on a lot of stock trader radar's. As long as HEB can continue to close over the 50 day moving average ( which is now $2.12 ) it will be ok. Keep in mind that at any moment we could receive an FDA approval decision on their CFS drug ampligen. This would be a huge market moving event one way or the other. If HEB can break $2.85, I think it could take off again. If HEB somehow does receive FDA approval on their CFS drug, it could pull a HGSI type move or greater.
http://daytradingstockblog.blogspot.com/2009/07/stocks-to-buy-july-21-2009-72109.html
GLTA
Investor 100
FDA Registration link for BIEL
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=209328&lpcd=ILX
Investor 100
Short Stock Stat's @ BIEL
http://shortsqueeze.com/?symbol=biel&submit=Short+Quote%99
Investor 100
Stockcharts.com @ BIEL
http://stockcharts.com/charts/gallery.html?s=biel
The chart looks strong Sheff!
GLTA
Investor 100
I joined you Sheff @ 100K shares .031!
Thanks for the DD on this company that looks positive given the information you posted!
GLTA
Investor 100
Article News @ BIEL
http://biomedreports.com/articles/most-popular/2085-bioelectronics-corporation-otcbiel-poised-for-major-revenue-growth.html
Looks like some real opportunity Sheff!
GLTA
Investor 100
Sheff-Thant is confidence!
Wow, that is a huge announcement Sheff and curious as to your decision to go in big time?
Interested in your decision on this one and much success that some news comes up and moves the PPS!
Investor 100
Solid Day @ HEB fourkids.
Thanks for the update...looks steady as she goes.
GL
Investor 100
NSPH...$4.66
Sheff, any news to add as the PPS looks attractive.
GLTA
Investor 100
HOD @ HEB
Trading over 4.7M shares @ 2.49.
Lots of MOMO this morning.
GLTA
Investor 100
News @ HEB
HEMISPHERX BIOPHARMA TO PROVIDE UPDATE ON GLOBAL PANDEMIC
INFLUENZA PREVENTION / TREATMENT INITIATIVES
Stock moving up 13% this morning.
Could an approval be around the corner..interesting story continues as it awaits for FDA announcement.
Philadelphia, PA, Monday, July 20, 2009: Hemispherx Biopharma (NYSE AMEX: HEB) will provide an update on its Influenza research initiatives via teleconference on Wednesday, July 22, 2009, at 10:00 AM EDT. Initiatives to be discussed will include experimental programs planned or underway in Pacific Rim countries, Australia, South America and the United States. Background information may be sourced at Wall Street Journal, July 18/19, 2009, p. A3.
Hemispherx’s Medical Director, CEO, and the Managing Director of the Sage Group, a health care consulting firm retained by Hemispherx, will participate. Investigational products and protocols to be discussed will include Hemispherx’s Ampligen® (poly I: poly C12U), Alferon N (a natural cocktail of alpha 2 type interferons, FDA approved for treatment of refractory HPV) and Alferon LDO, an experimental formulation of Alferon-N for oral delivery.
To access the conference call:
U.S. Callers: 800-346-7359
International Callers: 973-528-0008
Conference Entry Code: 27781
This call will be webcast via the Company’s website at: http://www.hemispherx.net.
A digital replay of the call will be available until August 5, 2009 by calling:
U.S. Callers: 800-332-6854
International Callers: 973-528-0005
Conference Entry Code: 27781
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics, Ampligen® and Oragens. Ampligen® and Oragens represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
HOD @ DDSS.
Chart looks good and solid MOMO moving up!
Bought 2500 shares on the dip at $1.65.
Me, 5000 shares.
GL
Investor 100
Good morning @ HEB
Lots of MOMO moving on this stock today..over 4M shares!
Holding until news comes out!
Investor 100
Lots of Shaking @ DDSS!
The news of not getting approved with a f/up on the 24th of July provides a window of opportunity for approval that I accept and have chosen to add another 2500 shares on this dip.
Me. 5000 shares.
GLTA
Investor 100
That is confirmed @ DDSS
http://www.nasdaqtrader.com/Trader.aspx?id=Tradehalts
T.1 Halt - News Pending
Trading is halted pending the release of material news.
( Sheff: Hope the news is positive )
GLTA
Investor 100
Zacks .com review @ BDSI
BioDelivery Sciences International (BDSI-NASDAQ)
Current Recommendation Buy
Prior Recommendation N/A
Date of Last Change 04/16/2009
Current Price (07/17/09) $6.07
Six- Month Target Price $9.00
OUTLOOK
SUMMARY DATA
Risk Level Very High Risk
Type of Stock Small-Growth
Industry Med-Biomed/Gene
Zacks Rank in Industry 1 of 138
On July 16, 2009, BDSI received approval from the U.S.
FDA for Onsolis for the management of breakthrough pain
(BTP). This is transformational event for the company.
Approval brings $27 million in cash from commercialization
partner, Meda AB, and allows management to begin
collecting royalties on sales of the product post-launch in the
fourth quarter 2009.
We think the shares are significantly undervalued based on
the potential ramp in Onsolis and the ability that
management now has to fund the rest of the pipeline, which
includes two $500 million ideas in BEMA Buprenorphine and
Bioral Amphotericin B. Our target is $9 per share.
52-Week High $6.94
52-Week Low $1.97
One-Year Return (%) 180.82
Beta 1.17
Average Daily Volume (sh) 677,059
Shares Outstanding (mil) 21
Market Capitalization ($mil) $128
Short Interest Ratio (days) 1.03
Institutional Ownership (%) 6
Insider Ownership (%) 33
Annual Cash Dividend $0.00
Dividend Yield (%) 0.00
5-Yr. Historical Growth Rates
Sales (%) N/A
Earnings Per Share (%) N/A
Dividend (%) N/A
P/E using TTM EPS N/A
P/E using 2008 Estimate N/A
P/E using 2009 Estimate N/A
Zacks Rank 1
BDSI: Onsolis Approved!
Maintain Buy Rating, Raising Target.
ZACKS ESTIMATES
Revenue
(In millions of $)
Q1 Q2 Q3 Q4 Year
(Mar) (Jun) (Sep) (Dec) (Dec)
2008 0.1 A 0.9 A 0.0 A 0.1 A 0.3 A
2009 0.0 A 0.2 E 30.2 E 0.6 E 32.2 E
2010 23.4 E
2011 35.2 E
Earnings per Share
(EPS is operating earnings before non recurring items)
Q1 Q2 Q3 Q4 Year
(Mar) (Jun) (Sep) (Dec) (Dec)
2008 -$0.14 A -$0.13 A -$0.14 A -$0.45 A -$0.90 A
2009 -$0.24 A -$0.23 E $0.79 E -$0.13 E $0.23 E
2010 $0.04 E
2011 $0.34 E
Zacks Investment Research
Onsolis Approved
On July 16, 2009, the U.S. Food and Drug Administration approved Onsolis for the management of breakthrough
pain (BTP) in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock
(opioid tolerant) and who need and are able to safely use high doses of an additional opioid medicine. Approval
triggers a $15 million milestone ($12 million cash) payment from U.S. partner, Meda AB to BioDelivery Sciences
(BDSI). BioDelivery also expects to receive a $15 million launch-stock cash milestone from Meda AB for the
commercial supply. Meda plans to launch the product early in the fourth quarter 2009. For 2009, we see sales of
$6 million, resulting in $1.2 million in royalties (20%). We think peak sales in the U.S. under the current label are
around $250 million, with upside in the future if management can eventually gain approval for non-cancer patients.
Onsolis was approved with a Risk Evaluation and Mitigation Strategy ( REMS ) that is a required plan for managing
risks associated with a drug or biological product. As part of the REMS, Onsolis will only be available through a
restricted distribution program called the FOCUS (Full Ongoing Commitment to User Safety) program. The drug
contains fentanyl, a DEA schedule II controlled substance. As such, the goal of the FOCUS Program for Onsolis is
to mitigate the risk of overdose, abuse, addiction, and serious complications due to medication errors Under this
program, only those prescribers, patients and pharmacies registered with the program will be able to prescribe,
dispense, and receive Onsolis. The FOCUS program will provide training and educational materials to prescribers
and pharmacy personnel, and a counseling call will be placed to patients prior to dispensing to ensure they have
been adequately educated about the appropriate use of the drug. The REMS guideline was in-line with our
expectations.
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, or on an
as needed basis. It also warns that the drug should be kept out of the reach of children. Again, this was as we
expected, and should not limit uptake for the drug. Our only concern from the label was the boxed warnings that
stats Onsolis should not be used as a substitute for other fentanyl products. We think this has the potential to
create some confusion around patients and prescribers, and Meda AB will need to educate as part of the FOCUS
program early on in the launch to mitigate the hiccups.
Approval is a transformational event for BDSI. Not only will it bring about a $30 million milestone payment from
worldwide commercialization partner, Meda AB, but BDSI will also receive double-digit royalties (we estimate 20%)
on sales of Onsolis when the product launches in the fourth quarter. The breakthrough cancer pain (BTP) market is
highly competitive, and there are several formulations of fentanyl already on the market, with several more in latestage
development, but we believe that BDSI s BEMA technology offers significant advantages over existingdelivery technologies.
We note that BioDelivery Science is currently planning a phase III study in non-cancer painthat could greatly expand the label and remove one of the black box warnings limiting the current product use.
Maintain Buy Rating / Target Now $9
At the current price of only $6.08, the market capitalization is approximately $115 million. Now that Onsolis is
approved, we believe this undervalues the company substantially. Risk has been dramatically reduced and the
financial position is now dramatically improved. Management now has enough cash on hand to fund operations
well into 2010, at which time they will probably seek to sign another lucrative collaboration with a development and
commercialization partner for BEMA Buprenorphine. The improved cash position now affords management the
ability to move both BEMA Buprenorphine and Bioral Amphotericin B, each with $500 million sales potential,
forward in clinical development.
Our $9 price target is based on 20x our 2013 EPS estimate of $0.85, discounted back to present day at 15%. We
note our financial model assumes no contribution from off-label uses of Onsolis in non-cancer pain, or does it is
factor in any contribution from BEMA Buprenorphine and Bioral Amphotericin B.
Good news has been released @ BDSI
This time yesterday the FDA announced its approval that sent the stock over $7 and then within a short period of time fell below $6 closing at $6.15.
Yesterdays news has taken four years of hard work so given all the positives going forward I see a bright future with upward movement as progress continues.
I think it is a solid long term play more so than a short term given the big news is out.
Me, I am holding for bigger movements in the next 6+ months.
GL
Investor 100
Conference Call Notes @ BDSI
Collective effort to get most of the details.
Summary: The future is very upbeat given the relationship with FDA, large pool of cash $27M coming ASAP, and other drugs in the pipeline that extend beyond cancer. Also, a partnership agreement interest mentioned for 2010...no details.
Impressed with the CEO's level of confidence in running the company to knowing his products!
Noted: They normally wouldn't announce news in mid-trading day.
FDA went live within 30 minutes of their notifying the company...(was
not happy with this)
Lets not let it distract from the accomplishment of the company, and
"Most significant milestone in company's history"
Being the 1st pharma to have REMS approal - very important
Major accomplishment for company size - ONLY THE BEGINNING
BEMA platform and future BEMA products, and amplifies future pipeline.
We have capability, pipeline and finances to build ....
Commended MEDA pharma, will help go forward with launch and
commercialization
Went over the payments from the Onsolis approval...27 million from
MEDA
double digit royalties, potential to receive another milestone payment
of 30 million.
Expect to close out 09 cash flow positive
Allows to dedicate for aggressively advancing the other products in
pipeline, substantial future value for our shareholders
Onsolis: currently only 2 brands of fentanyll for cancer breakthrough
pain....with many limitations, it is 700 million industry, expected to
become a 1.3 billion in few years. There is much untapped market
potential
majority of patients are given oral tablets to treat rapid onset pain,
takes up to 60 minutes. But Onsolis is rapid acting...
Want to educate key end users to use the product for breakthrough
cancer pain.
Onsolis is high priority for MEDA
Tagline for Onsolis: "adheres, dissolves and delivers"
The delievery system, uses proprieteary BEMA which works quickly.
> Easy, convenient
> There are 5 strengths of the drug - broad range.
> There is predictability for linear dose increase
> well tolerated in oral cavity.
Will launch Onsolis in early 4th qtr of this year, with help from
MEDA.
Meda is ideal commercial partner, one of the fasted growing companies
in pharma.
Not an unrecognized name in the pain arena - good for physicians, etc.
In addition to sales effort, their clinical devlpt team is looking to
find uses outside of cancer for Onsolis. Clinic set up Jan of next
year, if approved, this will contribute substantially to future sales
of onsolis.
They have validated this platform (bema).
POSITIVELY TALKED ABOUT OTHER PRODUCTS IN PIPELINE...ESPECIALL BEMA
BUPENORPHINE
Bema bupenorphine...acute and chronic pain....class 3 narcotic. Less
abuse and addiction, a significant attribute. Similar to morphine, but
less abuse.
Can get it to market more quickly, like they did with Onsolis.
Have an established working relationship with this division with the
FDA - very important.
On track for Phase 3 for Bema Bupemorphine for early next year...
Importantly partnership announcement expected next year. Driven by
Phase 2 clinical data of Bema Buphemorphine.
Company believes market will be 500million to 1billion range (massive)
GAME CHANGING OPPORTUNITY.
Also in early stages of evaluating treatments migraine, nausea
vomiting, expect forumlated and clinic next year (?)
Bioral amphotericin Phase 2 sometime in 2010.
Could become 1st oral fungicide in the world?
Look forward to have new data on pipeline later this year.
Pain and supportive care, sustained future growth, value for future
sharefholders.
We can aggressively move pipeline for first time in company's history.
1)bema technology
2)financial
3)pipeline
Join the call @ BDSI.
Starts in a few minutes..perhaps you will hear something you did not read.
Trading over $6.
GL
Investor 100
BDSI competitor CEPH
http://www.cephalon.com/about-us/
Reviewing this company I wonder Sheff if a buyout or partnership might be in order down the road...hmmm
GLTA
Investor 100
Good Friday to Sheff and board.
Bank stocks providing stronger results bodes well for the market so lets see what happens.
GLTA
Investor 100
Conference Call @ BDSI this morning.
CEO holding conference call this morning 10 am (EST)
http://www.bdsinternational.com/
Investor 100
Perspective on BDSI
( Pulled from another board )
Not only $30 million milestone payment from worldwide commercialization partner but BDSI would also receive double-digit royalties
Not only would it bring about a $30 million milestone payment from worldwide commercialization partner, Meda AB, but BDSI would also receive double-digit royalties (we estimate 20%) on sales of Onsolisupon launch.
The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development. But we believe that BDSI'sBEMA technology offers significant advantages over existing delivery technologies, and could allow for Onsolis to be at least a $250million peak sales drug.
A $6 price yields a market capitalization of approximately $115
million. This more fairly values the company based on the pending
approval of Onsolis. Post-approval, we would not be surprised to see the shares head towards $10 per share due to the dramatically improved financial situation, and the ability it provides for management to now move two pipeline candidates, BEMA Buprenorphine and Bioral Amphotericin B, each with $500 million sales potential, forward in clinical development.
Next thing to watch for - and something that should be arriving soon -is the multi-dose trials for BEMA Buprenorphine... What do the haters have to say on this one? A drug using same base delivery technology as the now APPROVED Onsolis, an active ingredient that the FDA should really like with an emphasis on safety/reducing addiction risks, good initial PK results, a company behind it that is awash in cash, etc.
Come on haters, explain your position using facts related to BEMA
Buprenorphine...
See: BDSI PR Department for details, but in short:
Typically, the FDA notifies a company by fax. They will remain silentafter that for 72hrs (may be 48, I forget), thus giving the companythe opportunity to mobilize their PR machinery.
Most companies get a PR out afterhours and arrange a cc the day of theannouncement to get the biggest PR bang for the buck.
However, BDSI chose to sit on their hands, let the FDA silent periodlapse and allow the market to hear it from a reuters blurb and FDAwebsite.
The lack of pre announcement by the company created a atmosphere orrumor and doubt which spooked the hell out of investors. Once the bigdive was in motion, that chart spike and dive gave any new investors a sense of "ewww, must be something wrong, better stay away", hence only leaving sellers.
Way to go BDSI! If the board has any sense at all they'd fire the CEOand PR people for TOTALLY mismanaging what should have been a bannerday.
The 2% gain is definitely very embarrassing for a FDA approval, thinkabout those people who got in around $7 hoping an approval will fire it up to $10+. Anyway, approval is not end of the story, With the upcoming milestone payment and residual income, and the pipeline of drugs, I think this is actually a pretty good entry point.
Here's what I see
-BDSI has about 50 mil in debt
-BDSI gets 27 mil in milestone payments
-Onsolis will generate 133mil(BDSI #) to 200mil(Zach's #), so let's say 160mil for argument sake
-BDSI gets 20% roaylties (32mil) (Zach's number)
-There's 21mil shares, that's 1.52 per share
-Reuters has BDSI industry averaging a 6p/e
So there ya have it about 9.12 per share.
Of course there's a few minor expenses but nothing a 6.5p/e or 170mil in sales won't adjust for. And for fun pick your P/E
6-9.12
9-13.68
12-18.64
20-30.4
AH Up @ BDSI
Stock up $6.30 ( +.15 or 2.44% )
GLTA
Investor 100
Finding the Prime Target | Acquisition Ideas for the New Pharma Business Model
http://www.nerac.com/nerac_insights.php?category=articles&id=218
Very interesting perspective!
Author:Avis Bridgers
http://www.nerac.com/meet_our_analysts.php?id=77
Impressive credentials indeed!
Mentions HEB in the middle of the column...hmm
Happen to find this from another board.
Investor 100
Finding the Prime Target | Acquisition Ideas for the New Pharma Business Model
http://www.nerac.com/nerac_insights.php?category=articles&id=218
Very interesting perspective!
Author:Avis Bridgers
http://www.nerac.com/meet_our_analysts.php?id=77
Impressive credentials indeed!
HEB mentioned in the middle of the paragraph..hmmm
Happen to find this from another board.
Investor 100
AH Up @ HEB!
http://finance.yahoo.com/q?s=heb
AH @ $2.16 (+.12 or +5.88% )
Some positive MOMO going into tomorrow lets hope!
Investor 100
Reuters: UPDATE 1-US FDA OKs new painkiller for cancer patients
Thu Jul 16, 2009 2:52pm EDT
* Drug cleared for use in certain cancer pain
* Distribution will be restricted to prevent misuse - FDA
WASHINGTON, July 16 (Reuters) - U.S. health officials approved a new opioid drug to relieve severe flare-ups of pain that occur in cancer patients despite treatment with other pain medications.
The drug, called Onsolis, is made by Aveva Drug Delivery Systems and marketed by Meda AB (MEDAa.ST) under a license from BioDelivery Sciences International Inc (BDSI.O), the Food and Drug Administration said on Thursday.
BioDelivery Sciences said it would receive about $27 million in milestone payments under the terms of its agreement with Meda.
Shares of BioDelivery were up 6.7 percent to $6.40 in afternoon trading on Nasdaq.
Onsolis delivers the opioid fentanyl via an absorbable film that sticks to the inside of the cheek, the FDA said.
The drug was cleared for adult cancer patients who already use opioid pain medication around the clock and who need, and can safely use, an additional opioid to treat "breakthrough" flare-ups of pain. Such patients are considered "opioid tolerant."
For patients who are not opioid tolerant, Onsolis "can lead to overdose, sudden serious breathing difficulties and death," Bob Rappaport, head of the FDA division that reviewed the drug, said in a statement.
The FDA said it was requiring safeguards, including distribution limits, to prevent misuse. The drug will only be available through prescribers and pharmacies enrolled in a training program, and the medication will be sent directly to patients' homes.
Meda and BioDelivery Sciences said they expected the drug would be available in the fourth quarter of 2009. (Reporting by Lisa Richwine; Editing by Tim Dobbyn)
Trading Statistics @ BDSI
http://ih.advfn.com/p.php?pid=trades&cb=1247768164&symbol=N^BDSI&java_vm=sun&java_vm_ver=1.6.0_12
Looking forward to joining conference call tomorrow morning.
Investor 100
I agree!
Gaining some MOMO after lunch!
Investor 100
BioDelivery Sciences and Meda Announce FDA Approval of ONSOLIS
July 16, 2009 1:48 PM EDT
RALEIGH, N.C.--(BUSINESS WIRE)-- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) and Meda AB today announced approval from the U.S. Food and Drug Administration (FDA) to market ONSOLIS(TM) (fentanyl buccal soluble film), formerly referred to as BEMA(TM) Fentanyl, for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ONSOLIS is the first product to utilize the company'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).
"The approval of ONSOLIS is a landmark and transformational event for BDSI and represents the culmination of an extraordinary and focused effort by a determined group of BDSI and Meda employees," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "All of us at BDSI, along with our partner Meda, are very pleased to provide healthcare practitioners and their patients suffering from breakthrough cancer pain with a new treatment option for this serious and debilitating condition."
"Importantly, with the approval of ONSOLIS, we have validated the utility of the BEMA drug delivery technology and demonstrated our ability to move a product through clinical development and the regulatory requirements set by FDA," said Dr. Andrew Finn, Executive Vice President of Product Development. "We now look forward to replicating our performance and regulatory achievements as we progress our pipeline."
"Having worked on the clinical development of ONSOLIS, it is exciting to see it reach approval," said Dr. Richard L. Rauck, Executive Director of the Carolinas Pain Institute and for the Center for Clinical Research, a site that participated in the Phase 3 trials for ONSOLIS. "Many patients with cancer suffer from these sharp spikes in pain referred to as breakthrough pain. These patients can benefit from a product like ONSOLIS with its onset of action and oral tolerability profile. We look forward to having this important option available for our patients with cancer breakthrough pain."
ONSOLIS is anticipated to be available in the fourth quarter of 2009 and will be commercialized in the U.S. by Meda Pharmaceuticals, the U.S. subsidiary of Meda AB. Meda is the company's commercialization partner for the product worldwide, with the exception of Taiwan and South Korea, the rights to which remain with BDSI. "We are very excited to launch ONSOLIS in the U.S. and make this product available to patients and healthcare providers," said Anders Lonner, Chief Executive Officer of Meda AB. "The introduction of ONSOLIS has high priority for us, and we are well positioned to be successful."
Under the terms of its commercialization agreement with Meda, BioDelivery Sciences will receive an aggregate of approximately $27 million in milestone payments. The first is based upon FDA approval of ONSOLIS which is in the amount of approximately $12 million. Meda had already advanced the company $3 million in January 2009 against the $15 million milestone payment. A second payment of $15 million will be received following the manufacture of launch stocks of ONSOLIS, a target the company has also achieved. In addition, BDSI will receive a double-digit royalty on net sales as well as the potential for up to another $30 million in milestone payments upon the achievement of certain sales thresholds.
"We are also announcing launch of the FOCUS(TM) (Full Ongoing Commitment to User Safety) Program for ONSOLIS, the first opioid Risk Management and Evaluation Strategy (REMS)," said Dr. David Wright, Director of Regulatory Affairs at BDSI. "The goal of the FOCUS Program for ONSOLIS is to mitigate the risk of ONSOLIS overdose, abuse, addiction, and serious complications due to medication errors. The program was created in accordance with the FDA's requirements to help ensure that the benefits outweigh the risks of ONSOLIS. The program will facilitate appropriate use of ONSOLIS and provide healthcare practitioners, patients, and caregivers support through training and education."
BDSI will hold a webcast to discuss the approval of ONSOLIS on Friday, July 17, 2009 at 10:00 a.m. Participants are invited to access the live webcast or obtain a dial-in number from the company's website at www.biodeliverysciences.com.
About Breakthrough Pain
Breakthrough Pain (BTP) is a common, debilitating feature of chronic pain, particularly in patients with cancer. It is a transitory, severe, or excruciating pain flare-up that "breaks through" the relief provided by around-the-clock analgesics. Unlike persistent cancer pain, BTP is generally rapid in onset (within three minutes) and lasts up to two hours. Patients with cancer may experience between two and seven episodes of BTP a day. A large multicenter survey conducted by pain specialists in twenty-four countries found that 65% of 1,095 cancer patients had BTP1. It is estimated that over a half-million people in the U.S. with cancer suffer from breakthrough pain, however, only about twenty thousand receive a treatment approved for the condition.
1 Caraceni A, Martini C, Zecca E, et al. Breakthrough pain characteristics and syndromes in patients with cancer pain.
An international survey. Palliative Medicine. 2004;18:177-183.
About ONSOLIS
ONSOLIS consists of a small, dissolvable, polymer film, formulated with the opioid narcotic fentanyl for application to the buccal mucosa (inner lining of the cheek). Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. ONSOLIS was evaluated in over 300 patients with over 90,000 doses administered in clinical trials. ONSOLIS adheres to the buccal mucosa in seconds, starts to dissolve in minutes and delivers fentanyl across the mucosa for relief of BTP in opioid tolerant patients with cancer.
IMPORTANT SAFETY INFORMATION
ONSOLIS is an opioid analgesic indicated only for the management of breakthrough pain in patients with cancer, 18 years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
ONSOLIS is contraindicated in opioid non-tolerant patients; acute or postoperative pain, including headache/migraine, dental pain, or use in the emergency room; and patients with intolerance or hypersensitivity to fentanyl, ONSOLIS, or its components. Life-threatening respiratory depression could occur in patients not taking chronic opiates.
ONSOLIS contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics.
Clinically significant respiratory and CNS depression can occur; patients should be monitored accordingly. ONSOLIS films contain medicine in an amount that can be fatal to a child. Keep out of the reach of children and dispose of unneeded films properly. Use with other CNS depressants or CYP3A4 inhibitors may increase depressant effects including hypoventilation (which may lead to potentially fatal respiratory depression), hypotension, and profound sedation; dosage adjustments may be warranted. ONSOLIS may impair ability for the performance of potentially dangerous tasks (e.g., driving a car or operating machinery). ONSOLIS should be titrated cautiously in patients with chronic obstructive pulmonary disease or preexisting medical conditions predisposing them to hypoventilation. ONSOLIS should be administered with extreme caution in patients susceptible to intracranial effects of CO2 retention.
Substantial differences exist in the pharmacokinetic profile of ONSOLIS compared to other fentanyl products that result in clinically important differences in the extent of absorption of fentanyl. As a result of these differences, the substitution of ONSOLIS for any other fentanyl product may result in fatal overdose.
The most common adverse reactions (frequency >=10%) seen in ONSOLIS clinical trials were: nausea, vomiting, dizziness, dehydration, dyspnea, and somnolence.
Safety and efficacy below age 18 years have not been established. ONSOLIS should be administered with caution to patients with renal or hepatic impairment.
ONSOLIS is available only through a restricted distribution program called the FOCUS Program and requires prescriber, pharmacy, and patient enrollment.
About BioDelivery Sciences International
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a specialty pharmaceutical company that is focused on developing innovative products to address growing market opportunities, including conditions such as pain. The company utilizes its owned and licensed patented drug delivery technologies to develop, partner, and commercialize new products using proven therapeutics. BDSI's pain franchise utilizes the Company's patented BEMA buccal soluble film technology and currently consists of: ONSOLIS (fentanyl buccal soluble film) a treatment for "breakthrough" pain in opioid tolerant patients with cancer, and BEMA Buprenorphine, a second analgesic in development with at least one potential target indication for the treatment of moderate to severe pain. The company is working with its BEMA and Bioral technologies on products targeted at conditions common to oncology and surgical patients such as pain and infections. The company headquarters is located in Raleigh, North Carolina, and its principal laboratory is located in Newark, New Jersey. For more information please visit www.biodeliverysciences.com.
About Meda AB
MEDA AB (publ) is a leading international specialty pharma company. The company specializes in marketing and pharmaceutical development in late clinical stage. Acquisitions and long-term partnerships drive the company's strategy. Meda is represented by its own organizations in about 40 countries. Meda's products are sold in 120 countries worldwide. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.
Cautionary Note on Forward-Looking Statements
This press release and the statements of representatives and partners of BioDelivery Sciences International, Inc. (the "Company") related thereto contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "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, those relating to the timing for completion, and results of, scheduled or additional clinical trials and the FDA's or other regulatory review and/or approval and commercial launch and sales results (if any) of the Company's formulations and products and regulatory filings related to the same, and receipt by the Company of milestone payments, may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control).
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FDA approved Onsolis (fentanyl buccal soluble film)
Questions and Answers about Onsolis (fentanyl buccal soluble film)
* About Today's FDA Action
* About Onsolis
* About the Onsolis Risk Evaluation and Mitigation Strategy (REMS)
* Brief Summaries of REMS Elements
About Today's FDA Action
What action did FDA take today?
FDA approved Onsolis (fentanyl buccal soluble film), a new dosage form for fentanyl. Onsolis will be available under an approved Risk Evaluation and Mitigation Strategy or REMS. The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. Opioid medicines such as Onsolis have benefit when used properly and are a necessary component of pain management for certain patients. Opioid medicines also have serious risks when used improperly. The REMS for Onsolis is intended to help reduce these risks, while still ensuring that patients who need these drugs to treat pain will continue to have access to them.
What is a REMS?
A REMS is a tool to help ensure that the benefits of a drug continue to outweigh its risks. For background information on REMS go to http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163655.htm
Why did FDA approve Onsolis before the finalization of a single-system REMS for extended-release (prolonged action) and high-potency opioids?
Onsolis is not an extended- release opioid and is only for opioid-tolerant patients. Onsolis is an oral transmucosal fentanyl product, which is a highly potent opioid that is safe and effective in a much more limited patient population than extended-release and long-acting opioids. Therefore FDA’s approval of Onsolis, including the Onsolis REMS, is independent of FDA’s effort to develop REMS for extended-release and high potency opioids.
Is FDA still taking into consideration the recommendations that were made at the public meeting May 27th and 28th asking for input on the development of a REMS for certain extended-release opioids?
Yes, all of the comments heard at the public meetings and received through submission to the public docket, number FDA-2009-N-0143 will be reviewed. This docket can be accessed at: http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2009-N-0143 and is open for comments until June 30, 2009. FDA believes this is valuable information that will lead to practical and effective solutions for development of a REMS and for appropriate use of opioid drug products. The approval of Onsolis is independent of the larger extended-release and high potency opioid REMS effort.
About Onsolis
What is Onsolis?
Onsolis contains fentanyl, an opioid pain reliever, in a small film (about the size of a dime or nickel) that sticks to the inside of your cheek and eventually dissolves within 15 to 30 minutes after it is applied. Onsolis is used to manage breakthrough pain (flare-up of pain occurring in patients with otherwise stable, constant pain) in patients with cancer, 18 years of age and older, who are already using another opioid pain medicine around-the-clock and whose body is used to the medicine (opioid-tolerant). Onsolis comes in a foil package and is available in differing dosage strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg and 1200 mcg.
Is Onsolis a generic version of other transmucosal (delivered through the mucous membrane) fentanyl products? Can it be substituted for other similar pain drugs?
NO. Onsolis is NOT a generic version of any other transmucosal fentanyl product. Onsoliscannot be substituted for any other fentanyl product. Substantial differences exist in how Onsolis is absorbed compared to other oral transmucosal fentanyl products. Substitution of Onsolis for any other oral transmucosal fentanyl product may result in fatal overdose.
How will Onsolis be supplied?
As part of the REMS for Onsolis, the drug will only be available through a restricted distribution program called the FOCUS Program. The FOCUS Program prescription process includes the following steps:
* Each patient, prescriber, distributor, and pharmacy completes the enrollment process to become enrolled in the FOCUS Program.
* Prescriber faxes the initial prescription information for Onsolis to the FOCUS Program to start the verification process.
* Prescriber sends the original, hardcopy prescription for Onsolis to a FOCUS pharmacy via courier using the supplied, shipping label for a FOCUS Program courier.
* While the original, hardcopy prescription is in transit the FOCUS pharmacy confirms that the patient and prescriber are active in the FOCUS Program database, the patient counseling call has been successfully completed, prepares the medication; and schedules Onsolis delivery to the patient.
* Upon receipt of the original, hardcopy prescription, the FOCUS pharmacy dispenses Onsolis and delivers the medication directly to the patient via a secure, traceable courier (with adult signature required).
What should a patient do with unused Onsolis?
Patients are directed to dispose of unopened Onsolis films as soon as they are no longer needed:
1. Remove the Onsolis film from its foil package.
2. Drop the Onsolis film into the toilet.
3. Repeat steps 1 and 2 for each Onsolis film. Flush the toilet after all unneeded films have been put into the toilet.
The Onsolis foil packages or cartons are not to be flushed down the toilet.
About the Onsolis REMS
What are the components of the Onsolis REMS?
The name of the Onsolis REMS is FOCUS (Full Ongoing Commitment to User Safety) Program. As part of the FOCUS program, Onsolis will only be available through a restricted distribution program with prescriber, pharmacy, distributor, and patient enrollment. The FOCUS program will provide training and educational materials to prescribers and pharmacies, and patient education and counseling. Orders will only be filled from participating pharmacies that courier the product directly to the patients’ homes.
Why does Onsolis have a patient enrollment program?
Oral transmucosal fentanyl products are highly potent opioids that are highly effective in treating pain, but also have a very high risk of death when they are administered incorrectly, especially to patients who are not opioid tolerant. They are therefore safe and effective in a much more limited patient population than extended-release and long-acting opioids. Experience with other transmucosal fentanyl products, Actiq and Fentora, has shown that ensuring the appropriate use of oral transmucosal fentanyl products cannot be accomplished by labeling and prescriber and patient education alone. Therefore, FDA is requiring REMS that include restricted distribution programs for the class of transmucosal fentanyl products, which includes Onsolis, Actiq, and Fentora. FDA is approving a REMS for Onsolis now and intends to approve REMS for Actiq and Fentora in the coming months. Patient enrollment programs are a key element of these REMS because:
* The indications for the transmucosal fentanyl products are unique. Onsolis, Actiq and Fentora are indicated for breakthrough cancer pain in patients who are on around-the-clock opioids and are considered opioid-tolerant. The misuse and abuse of these drugs in opioid nontolerant patients or patients who are not taking opioids daily has led to deaths.
* These products are not absorbed in the body the same way, and as a result, cannot be substituted for one another. Medication errors have been reported with Fentora being substituted for Actiq, even though it is stated in a boxed warning not to do so. This experience in light of a third oral transmucosal fentanyl coming onto the market warrants additional steps to reduce the likelihood of inappropriate substitution of these drugs.
* Fentanyl has become highly sought after by abusers. There is concern that as more of these products reach the market, failure to anticipate and prevent misuse and abuse could result in a substantially large number of deaths.
Does this mean all opioids will be required to have a patient enrollment program?
Onsolis is not the same as the extended-release opioids and therefore, we do not see the specific items in the Onsolis REMS setting a precedent for other types of opioids. The REMS for Onsolis is independent of the larger REMS efforts under discussion for extended-release and high potency opioids.
What is the goal of the FOCUS Program?
The goal of the FOCUS Program for Onsolis is to lessen the risk of fentanyl overdose, abuse, misuse, addiction, and serious complications due to medication errors by:
* Helping to assure proper patient selection, including avoidance of the use of Onsolis in opioid non-tolerant patients;
* Reducing the risk of exposure to Onsolis in persons for whom it was not prescribed, including accidental exposure in children; and
* Training prescribers, pharmacists, and patients about proper dosing and administration.
How will FDA know if the FOCUS program is achieving its goal?
The company that makes Onsolis is required to submit a six month and one year assessment of the FOCUS Program as well as information from different data sources that monitor drug overdose, abuse, misuse, addiction and medication errors.
Will the elements of the Onsolis REMS create a precedent for elements to be included in the extended-release opioids REMS?
As noted above, Onsolis is not the same as the extended-release opioids and therefore, we do not see the specific items in the Onsolis REMS setting a precedent for other types of opioids.
Will FDA evaluate the potential limitations of timely patient access?
The Onsolis program is designed so that once a valid prescription is received in the pharmacy and there is confirmation that the physician and patient are properly enrolled, Onsolis will be delivered by courier to the patient’s home in most cases within 24 hours, but no longer than 5 business days for any patient. Therefore, no undue delays are expected. In some cases, this could result in availability of Onsolis sooner for patients compared to use of a community pharmacy which may not always have Onsolis in stock. The FOCUS Program will distribute to all regions of the United States.
Will FDA evaluate the need for prescribers to substitute another opioid analgesic for Onsolis because of the Onsolis REMS?
This is a concern, particularly when the program is started because patients and prescribers will lack familiarity with the program. However, once familiarity is gained, we do not expect that prescribers will refrain from prescribing Onsolis to appropriate patients.
Once the manufacturers of extended-release opioids establish their REMS, will the Onsolis REMS be included, or will it always remain separate?
As the programs are expected to be quite different, it is not expected that the Onsolis REMS will be modified to be equivalent to the REMS for the extended-release opioids.
What REMS elements does the FOCUS Program include?
The FOCUS Program includes the following elements:
* Medication Guide
* Communication Plan
* Elements to Assure Safe Use
* Implementation System
* Timetable for Submission of Assessments
Brief Summaries of REMS Elements
Medication Guide:
What is a Medication Guide?
A Medication Guide is a paper handout that is provided to patients with many prescription medicines, for example anti-depressants and NSAIDs (non-steroidal anti-inflammatory drugs). The guide addresses safety concerns that are specific to a particular drugor drug class. The purpose of a Medication Guide is to provide FDA-approved information to patients when FDA determines that it is necessary to patients’ safe and effective use of drug products. FDA will require the distribution of a Medication Guide for a drug if FDA determines that it could help prevent serious adverse events, or if the drug has serious risks relative to benefits that patients should be made aware of because it could affect patients’ decision to use or continue to use the drug, or if the drug is important to health and patient adherence to directions for use is crucial to the drug’s effectiveness.
Communication Plan:
What is the Onsolis Communication Plan?
The company that makes Onsolis, BioDelivery Sciences International, Inc. (BDSI), will execute a communication plan to healthcare providers. This includes letters to prescribers telling them about Onsolis and about the FOCUS Program.
Elements to Assure Safe Use:
The FOCUS Program includes safe use conditions described below to manage the risks of Onsolis. The program is directed to prescribers, patients, distributors, and pharmacies. The FOCUS Program database maintains an enrollment list and the status of enrollees (i.e., active or inactive).
Prescriber enrollment will include mandatory review of the educational material and enrollment renewal on a periodic basis. Prescribers are required to review the information in the prescribing information and to:
* Ensure appropriate patient selection, including that the patient is opioid tolerant
* Provide the Medication Guide for patient review
* Complete the FOCUS Program prescriber enrollment form (including prescriber knowledge assessment); sign and fax the form to the FOCUS Program
* Obtain the patient’s signature on the patient enrollment form; sign and fax the form to the FOCUS Program
* Follow FOCUS Program-specific procedures for prescribing Onsolis
Patients are counseled by their prescriber on the Medication Guide.
* The prescriber and patient complete and sign the Patient Enrollment Form and the prescriber faxes it to the FOCUS Program.
* The patient receives a FOCUS counseling call with the initial prescription to review the safe use conditions.
Focus Pharmacies - Pharmacies will be enrolled in FOCUS, and Onsolis will be dispensed only by the enrolled pharmacies via courier to the patient. Onsolis will not be available in other health care settings, such as retail outlet pharmacies or hospitals. Pharmacy enrollment must be renewed every 2 years or when there have been substantial changes to the program. The enrolled pharmacies will have a Call Center for all pharmacist-patient interactions. FOCUS Pharmacies that dispense Onsolis must:
* Review the educational materials (Website Educational Materials or Printed Educational Materials).
* Document that all pharmacy staff dispensing Onsolis have been trained on the FOCUS Program procedures and have reviewed the program educational materials.
* Complete and sign the Pharmacy Enrollment Form and fax it to the FOCUS Program.
Implementation System:
In order to keep the FOCUS program running, BDSI is required to develop an implementation system to:
* Ensure that wholesalers/distributors who distribute Onsolis are specially certified. To become certified, wholesalers/distributors will be enrolled in the FOCUS Program. Wholesaler/distributor renewal will occur every 2 years or when there have been substantial changes to the program. Wholesalers/distributors that ship Onsolis to the specialty pharmacies must review the REMS document and complete and sign the Distributor Enrollment Form and fax it to the FOCUS Program.
* Maintain a database of all enrolled entities (including patients, pharmacies and prescribers) to monitor and evaluate implementation of the elements of the program regarding patient and pharmacy enrollment in the FOCUS Program.
* Monitor the distribution of Onsolis to ensure that the drug is only shipped to active FOCUS pharmacies, and that only active patients are receiving Onsolis and only active prescribers are prescribing Onsolis.
* Monitor, audit, and evaluate all active FOCUS pharmacies, distributors, and the FOCUS Program vendor at the initiation of the program to ensure they implement the program as directed.
* Monitor and evaluate the elements to assure safe use regarding patient and pharmacy enrollment in the FOCUS Program in the manner described in the REMS Supporting Document, and take reasonable steps to work to improve implementation of these elements.
Timetable for Submission of Assessments:
BDSI will be required by FDA to submit an assessment of the FOCUS Program for review 6 months and 1 year after the approval date for Onsolis and once a year thereafter. There will be a number of areas assessed as part of a program to monitor the effectiveness of the FOCUS program. The FDA will be interested in measuring the FOCUS Program’s ability to ensure safe use conditions such as controlling drug overdose, abuse, misuse, addiction and medication errors. Other areas of interest will be evaluating the timeliness of patient access.
Rumor of Approval for BDSI.
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Swine flu scares up multibillion-dollar windfall
July 16, 2009 — 10:30am ET | By John Carroll
Swine flu has turned out to be far milder than once feared, but it's lethal enough to scare up billions of dollars in new vaccine orders.
France is the latest European country to put in its order, spending $1.4 billion to gain enough new vaccine from three of the world's largest manufacturers to inoculate three quarters of the country's population. Germany and the U.K. have ordered their own stockpiles while officials at the CDC contemplate a fall campaign that will provide anywhere from 40 million to 160 million doses. And health officials say that children may have to look forward to four jabs after school begins as they line up for shots for both seasonal as well as H1N1 flu.
The multibillion-dollar windfall has pushed vaccine makers to work around the clock to push new jabs into the clinic. Novartis says it expects to begin human testing on its new vaccine later this month--with plans to use both traditional egg-based as well as faster cell-based manufacturing technology. And other manufacturers insist they're also close to having the data they need to get an approval.
Much of the current focus is on outbreaks reported in the southern hemisphere, in particular Argentina, Chile and Australia. But new cases are also popping up all over the northern hemisphere, while health officials brace for a second wave of swine flu in the fall that they fear could prove more lethal than the strain now circulating around the globe.
We've assembled the latest swine flu news over at FierceVaccines.
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