Counting my change
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Just Talked to Robert Oppenheimer - Great call! He just came back from New York,which had to do with financing. He said it was a success,he could not give out details,but we should all hear about it in about 2 days in the form of a PR. They were seeking 1 million in financing which he said would start their production.
They have some orders already waiting to get filled as soon as possible.The excitement of the product has been overwhelming with distributors calling for updates when the product will go into production.He said Walmart wants to carry the product ,but Everock wants to systematically move their product and not make promises of production they cannot keep.He estimates they will be ready for Walmart and the discount chains by summer of 2010.As you all may know the have already designed the packaging.
Everock is also looking for strategic partner(Large food Company) to expand there product line in the future.
One more thing....Everock is not diluting shares and website sales will start following financing and production.
I agree
IF the FDA needed these new information for approval
they would have issued a COMPLETE RESPONSE LETTER TO HEB.They have never done this.Also,the NDA is not necessarily contingent on these filings.
Not True...Approval can come any day. The FDA does not necessarily need this information to approve.
It is a joke the link they are providing is from May. Total scam
Must Listen CC SPPI
This stock is golden!
http://cc.talkpoint.com/bcom001/102609a_me/?entity=16_0EXPPQ2
Q&A: Is BIEL still worth it?
Biomed Report
Written by Vinny Cassano
Friday, 30 October 2009 03:24
Contributing columnists Vinny Cassano and Peter Depalma respond to a comment about BioElectronics (OTC:BIEL).
BioElectronics Corporation
0.07 +0.00 (+2.86%)
Intraday | 3 Month | 6 Month | 1 Year
Quotes delayed at least 20 mins.
A comment from Shep regarding BioElectronics Corporation:
...says the anonymous poster w/ nothing verifiable to back up the statement. Umm-hmm.
Still loading up on BIEL. A little browsing led me to a story where one of the company top dogs states they are getting ready to move from the trial and development phase to more of a marketing phase. More ads, product recognition; that kind of thing. Coupled with impending FDA approvals (which as far as I can tell are nearly a done deal) and this thing could pop pretty soon. An independent analyst recently projected the company will trade at between .30 and .50 cents w/in 6 mos. (Check InvestorHub for the link). .07 could look like a steal next year. I'm in.
VFC's Take: I like Shep's style, short and to the point; unlike mine, where sometimes I'm long in getting to the point.
As far as BIEL is concerned, I'm with Shep. I'm not here for today's or tomorrow's gains. By this time next year - barring any unexpected setbacks - I think BIEL for 8 cents is going to look a steal that investors look back on and say, "Why didn't I buy?"
BioElectronics is slowly moving from 'Idea' phase to 'reality' phase, and I do believe that as Acetaminophin moves out, ActiPatch has a good opportunity to move in. I'm accumulating while this stock is below seven cents.
Peter's Take: The problem with BIEL is that it is a momentum play with lots of potential that has become somewhat of a joke. Instead of "investing," which is what people did when the stock traded from under a penny to over a dime, people have started "playing the pops" and any time company has good news you'll see it rise, but not stay at the new level any longer than a few hours- if that.
It doesn't help that some of the stocks' cheerleaders are cyber-casting to investors when these pops are coming and even telling people what they plan to do with their shares when good news comes. That's not investing and it's certainly not reassuring. Frankly, it's no better than pumping and dumping and that's really the crux of the problem here. People are having trouble trusting that this is a real company worth putting their money into long term.
Perception is reality in the market and as long as people perceive that this is not a serious company, the stock will keep losing any gains it makes on good news within a day. They started out with a great plan, even had some good media coverage early on, but now they've become just another momentum play. The fact that the technology was a finalist for the Wall Street Journal Innovations Award is fantastic, but until other media outlets start to recognize it, it's going to keep suffering at the lack of what I call "street cred."
The stock would already at fifteen plus cents per share as they await the first of several FDA approvals that are in the works, but people are scared to hold on to the volatile shares fearing that they'll become bag holders.
I love the product, hate the investor education strategy. Still, I do agree with Vinny that some time down the not too distant road, people will regret not investing and holding. For now, I've taken my profits and am waiting on the sidelines for the less educated day traders and rats to lose interest and jump ship.
Disclosure: Vinny Cassano is Long BIEL
Look at the whole company picture not just a piece of it!!!
BIEL Joe Noel’s answers to all Shareholder questions – Oct 28, 2009 from yhb
Thank you for the questions. I will do my best to answer each and every one of them. Before I began, however, I have to tell you that these answers are subject to certain conditions, which I have listed at the end. This is simply a legal requirement that all companies must make when addressing information at this level of detail.
One other item I want to point out to you – this is a very detailed list of questions and answering them is going to take a considerable amount of time. I’m going to type out my answers, but I’m not going to edit as this will take time I simply do not have. Therefore, I can guarantee you there will likely be a few typos in what I have written below. Also, I use speech dictation technology, so sometimes the software mixes up words. If you and the other shareholders can forgive these typos and not rip me apart for these, I will be happy to answer these questions in great detail. Thanks for your understanding relative to this issue. Please see below as I have done the best I can to give you the information you are requesting. And don’t forget these answers are subject to the disclaimers below. (Again, a legal requirement)
1. Currently the A/S count is 1.5B. The O/S is very near that number. Are there any plans to raise the A/S, and if so, does it take a vote of the shareholders, or do insiders control enough stock to make it happen without our vote?
Answer – Yes, BIEL is bumping up against its maximum. The share count has increased recently due to additional debt conversions. Several months ago the convertible debentures were paid off via a conversion to equity. Over the past few weeks the remaining debt has also been converted to equity. This strengthens the company’s balance sheet, but of course the downside is dilution. With most of the debt now converted there should be a significant deceleration in dilution. If additional capital needs to be raised or if there is an acquisition the company wants to make then the number of authorized shares would be increased.
2. We all know approval is between Oct 15 and Dec 30. Do you have any comments on the dates
Answer – There is really no way of telling if the approval date is between October 15 and December 30 as the FDA simply does not operate in this manner. We do believe that this is a fairly accurate “guesstimate”, but we do not have any specific basis to make such an assumption. FDA will act on its own timeframe and there’s nothing we can do to accelerate this – we are going to simply have to be patient.
3. What are the official sales figures /per country around the world.
Answer – We have not released official sales figures on a per country basis. I want to emphasize that revenue production is not the major goal of the company. We have said many times that the priorities at BioElectronics are clinical trials, FDA filings, and building our brands. We believe we are on track to meet these goals. Over the next few weeks you will see us change our emphasis toward revenue production. On Monday, we have a meeting specifically to address this new phase in the company’s life. Our revenue plan for next year is very large and we are currently working very hard to devise strategies to meet this revenue production goal. I think shareholders will be very impressed with the programs we are currently putting in place to produce major revenue growth during full year 2010.
4. What are the plans for increasing marketing efforts in US and around the world?
Answer – I allude to this partially in the answer above. The US marketing effort is of course contingent on FDA clearance, which we believe we will have shortly. The US marketing effort will rely heavily on our direct response television advertising as it is simply the best way to move a lot of product very quickly. Expect an aggressive rollout of this campaign in the first quarter of the year. As soon as FDA clearance is granted we will be making major decisions relative to strategic marketing initiatives. These will center on whether we plan to place the product ourselves to the grocery/drug store chains or if we want to license the technology to a major manufacturer. We have had several conversations with major manufacturers and consumer goods distribution companies and we see many options relative to these. It is a decision that has not been made yet, but will be made as soon as FDA clearance to market in the US is granted.
Relative to international we plan to accelerate our current strategy of creating distribution partnerships for specific countries or regional international geographies. We believe this is the best way to leverage our brands considering our limited marketing and managerial staffs.
5. Are the sales online (like Amazon.com) legal?
Answer – Yes, of course. The online sales are through a separate distribution partnership operated under the direction of medical professionals. All customers who purchase the Allay product must complete a health questionnaire designed by medical professionals in order to qualify to receive the product. Therefore, purchase of the product falls under the practice of medicine. ActiPatch, is not marketed online within the United States. The websites that sell the product are operated by Canadian-based distributors.
6. Without going into specifics, any takeover/partnership negotiations going on?
Answer – This is an area that no company representative or management team member would ever venture into and therefore least must simply say we don’t have any comment relative to this issue. We have made no secret of our long-term desire to sell the products or the entire company to a larger organization.
7. Are you aware that REUTERS UPGRADED BIEL TO OUTPERFORM? Any comments ?
Answer – Yes – I am aware of the upgrade. I placed little value on such upgrades as the staff at Reuters performs very little real research into companies and is not really familiar with our operations. We clearly liked the upgrade, though we feel our shareholders are far more qualified to make an accurate assessment of the overall direction of BioElectronics.
8. On FDA approval, what are the plans to raise money for marketing and manufacturing in USA
Answer – Our ability to raise money is very robust. We get many calls each week from wealthy investors and investment organizations offering us money. We do not have specific plans to raise money for marketing and manufacturing as our balance sheet is in pretty good shape at the current moment. I remind you we also have the guarantee from the export/import bank that will allow us to quickly and inexpensively raise working capital to fund exports. We do not believe our domestic marketing campaigns will be particularly expensive. We have already paid for the production of television advertising spots – rather expensive, but you get what you pay for – all should be very high quality. Media buys (television time) should be self funding in that the short-term investment should be paid back with 4 to 1 revenue to expense ratio.
9. You have mentioned several times that BIEL is not considering Reverse Split. What is your latest stand on this issue?
Answer – I have never heard a discussion at BioElectronics relative to a reverse split.
10. Does BIEL plan to hold any shareholder conference calls?
Answer – Yes – We will without a doubt be holding shareholder conference calls.
11. I’d like to know how BIEL used the money they got from the new O/S shares past months. It might be around 30 to 40 million $ in 3 months. It would be fair to tell us what this amount is and what it was used for ?
Answer – There was not $30 to $40 million raised in the past 3 months. Not even close. The increase in shares was mainly related to the conversion of debt into equity. We will be reporting the actual amount of money raised when our auditing firm produces results for the September quarter. I do not have an actual date as of yet as the audit is ongoing.
12. How is the audit coming along? And what exactly is the purpose. Is it to move to OTC.BB ?
Answer – The auditors were in the BIEL office this week and it is ongoing. We are conducting an audit for several purposes – first is that our investors have asked us for the audit – second, as we have stated previously, we want to move off of the pink sheets and onto a different stock trading venue. We have specific plans to do this, but it is inappropriate at this time to discuss in detail.
13. What’s the status of the Class II petition ?
Answer – We do not know. The FDA has not gotten back to this issue – while we are not sure of the exact reason we suspect it is simply a workload issue on their part as all Class III devices cleared under 510K must either be reclassified to Class II or undergo a time-consuming and expensive PMA process. We, and our law firm, fully expect a reclassification to Class II, but we simply have not heard back from FDA.
14. When do you expect to report Q3 earnings/sales ?
Answer – I cannot provide you a date at this time is the auditors are currently working on the numbers.
15. Are there any future plans to reduce the O/S once revenue starts coming in ?
Answer – There are no specific plans to do this – stock buybacks are usually performed by cash rich companies with limited growth prospects. The theoretical argument is: does the company or the shareholder have better investment uses for the cash. We believe, as we think our shareholders also believe, that we have better uses for the investment of cash. We have a great set of products and we believe demand will be very high.
16. What is the deal with Scottrade? This is very bad for the company that people cannot buy on SC. Also, someone reported the same problem with Charles Schwabb starting today.
Answer – Scottrade limits the trading of many pink sheet stocks, not just BIEL. It is more expensive for brokerage firms to perform back office operations relative to pink sheet stocks. Our understanding is that Scottrade simply does not want to incur these additional costs and therefore chooses not to trade certain securities. There’s really nothing we can do about this – but the situation is not specific just to BioElectronics.
All of us would really appreciate if you answer these questions. This will go a long way in boosting investor confidence as right now lot of longs who entered late are losing confidence.
-Thanks and Regards
Certain statements in the above may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact, included in this release, including, without limitation, statements regarding potential future plans and objectives of the companies, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Factors that could cause actual results to differ materially from those in the forward-looking statements include, among other things, the following: general economic and business conditions; competition; unexpected changes in technologies and technological advances; ability to commercialize and manufacture products; results of experimental studies; research and development activities; changes in, or failure to comply with, governmental regulations; and the ability to obtain adequate financing in the future.
Joe Noel
Emerging Growth Research, LLP
(925) 922-2560
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Color of Money Green Pick of the Day-Aethlon Medical Establishes Exosome Sciences, Inc.
* Press Release
* Source: Aethlon Medical, Inc.
* On 10:30 am EDT, Thursday October 22, 2009
Companies:
o Aethlon Medical Inc.
SAN DIEGO, Oct. 22 /PRNewswire-FirstCall/ -- Aethlon Medical, Inc. (OTC Bulletin Board: AEMD - News) announced today that it has established Exosome Sciences, Inc. (ESI) as a wholly owned subsidiary of the Company. ESI will seek to leverage the recent discovery that the Hemopurifier®, a medical device developed by Aethlon Medical as a broad-spectrum therapy against infectious viral pathogens, is effective in capturing exosomes that are secreted by solid tumors, lymphomas, and leukemia to suppress the immune response in cancer patients. Aethlon Medical, Inc. will contribute into ESI all exosome-related patents and patents pending.
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(Logo: http://www.newscom.com/cgi-bin/prnh/20090325/LA88762LOGO-b)
Jim Joyce, Chairman and Chief Executive Officer of Aethlon Medical, Inc. said, "The ability to reduce circulating exosomes would likely reverse immune suppression and increase patient responsiveness to both immunotherapy and chemotherapy, thus positioning ESI to participate in the $43 billion cancer therapy market. ESI also plans to advance exosome diagnostic and research services, and explore recently discovered opportunities to address exosomes in disease conditions beyond cancer."
In the last year alone, an increasing number of research driven science publications reveal that exosomes have implications in inflammatory conditions including Sepsis, bacterial infections including Tuberculosis (TB), autoimmune conditions such as Rheumatoid Arthritis, and neurological and neurodegenerative diseases such as Alzheimer's disease The growth in the exosome industry is further evidenced by published research and citations increasing from 140 articles in 2001 to 1,160 articles and citations in 2008.
"ESI allows us to leverage the previously unrecognized value of our non-infectious disease research into a new asset that positions us to be an important participant in the emerging exosome industry. We also maintain the option of installing an independent management team at ESI and if appropriate in the future, may spin out part or all of ESI as a means to achieve fuller valuation for Aethlon Medical shareholders," concluded Joyce.
A recent publication entitled, "Exosomes as a Tumor Immune Escape Mechanism: Possible Therapeutic Implications" discusses the potential for the Hemopurifier® to become the first therapeutic strategy to inhibit the immune suppression caused by tumor secreted exosomes. The abstract and complete article is available to be accessed online at: www.translational-medicine.com/content/6/1/37.
About Aethlon Medical
Aethlon Medical creates diagnostic and therapeutic device solutions for infectious disease and cancer. Our Hemopurifier® represents the first-in-class medical device to selectively adsorb viruses and immunosuppressive toxins from the bloodstream. The Hemopurifier® seeks to improve Hepatitis-C treatment outcomes and serves as a broad-spectrum treatment countermeasure against bioterror and pandemic threats. Additional information regarding Aethlon Medical can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier® to reduce viral loads and other disease conditions, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
RedChip Companies, Inc.
Jon Cunningham
1-800-733-2447, Ext. 107
Jon@redchip.com
Jim Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jim Frakes
Senior VP Finance
858.459.7800 x300
jfrakes@aethlonmedical.com
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Always do your own DD!
FSCO News Isolagen: New drug application, new name
by John George Staff Writer Tuesday, October 6, 2009, 12:11pm EDT
A Food and Drug Administration advisory committee will review a new drug application for a wrinkle treatment being developed by FibroCell Science Inc., formerly Isolagen, on Friday.
Isolagen emerged from bankruptcy court protection with its new name and a new board of directors last month. FibroCell (OTCBB:FCSC) is searching for a new CEO.
To further distance itself from its past financial troubles, the Exton-based company has changed the in-house name of its lead product — formerly known as Isolagen Therapy — to azfibrocel-T.
Azfibrocel-T will be the sole topic for discussion at the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee Meeting Friday in Bethesda, Md.
Azfibrocel-T, the proposed brand name for which is Laviv, is a cellular therapy treatment that involves harvesting and multiplying a patient’s own collagen-producing cells, or fibroblasts, into tens of millions of new cells that are returned to a patient’s skin — through injections — to repair the damage that caused wrinkles.
Fibrocell’s new board of directors is led by David Pernock, a GlaxoSmithKline senior vice president who is serving as the board’s chairman. Other members are Paul A. Hopper, managing director of Cappello Group; Kelvin D. Moore, consultant sales director for Seaborne Group; and Robert S. Langer, a professor of chemical and biomedical engineering at the Massachusetts Institute of Technology.
Declan Daly, the CEO at Isolagen, is leading FibroCell as interim CEO. The board intends to name a CEO in the near future. At that time, Daly will continue to serve as the company’s chief operating officer and chief financial officer.
Companies: FibroCell Science Inc., Isolagen
BioElectronics Announces Financial Audit
* Press Release
* Source: BioElectronics Corporation
* On 11:00 am EDT, Tuesday October 20, 2009
Companies:
o BioElectronics Corporation
FREDERICK, MD--(Marketwire - 10/20/09) - BioElectronics Corp. (Pinksheets:BIEL - News), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced it has retained independent accounting firm Berenfeld Spritzer Schechter & Sheer for accounting and auditing services.
"With over 200 accounting and auditing professionals, Berenfeld is highly qualified to manage our accounting and auditing needs. BioElectronics is now reaching the point where a full audit will more fully assist our investors, distributors and business partners to understand our strengthening business operations," commented Rick Staelin, chairman of the board of BioElectronics Corp. "The availability of fully audited financial statements will also allow us increased flexibility relative to movement to other stock trading venues and will enhance our ability to partner with other business entities potentially strengthening our branding and distribution efforts."
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch� Therapy, RecoveryRx(TM) Devices, HealFast� Therapy (www.healfasttherapy.com) and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.
Contact:
For media enquiries, please contact:
Joe Noel
(925) 922-2560
Spectrum Pharmaceuticals, Inc. Ranked #22 Fastest Growing Company in North America on Deloitte's 2009 Technology Fast 500
* Attributes Its 11,034% Revenue Growth to Financial Discipline, Sale of Non-Core Assets, and Sales of Its Proprietary Oncology Drug FUSILEV®
* Product Sales of ZEVALIN® Will Drive Growth in 2009 and Beyond
* Press Release
* Source: Spectrum Pharmaceuticals, Inc.
* On 8:01 am EDT, Tuesday October 20, 2009
Companies:
o Spectrum Pharmaceuticals, Inc.
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGM: SPPI - News), a commercial-stage biotechnology company with a primary focus in oncology, today announced that it ranked #22 on Technology Fast 500™, Deloitte LLP’s ranking of 500 of the fastest growing technology, media, telecommunications, life sciences, and clean technology companies in North America. Rankings are based on percentage of fiscal year revenue growth during the five year period from 2004-2008. Spectrum Pharmaceuticals grew 11,034% during this period.
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{"s" : "sppi","k" : "c10,l10,p20,t10","o" : "","j" : ""}
“We are pleased to be one of the fastest growing companies in North America,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We believe that the sale of our non-core assets in early 2008, as well as sales of FUSILEV in the second half of 2008, contributed greatly to our growth. With the completion of our acquisition of ZEVALIN in early 2009, and the FDA’s approval in September 2009, for the use of ZEVALIN as first-line therapy for NHL, we believe we will be able to continue to grow our business, and remain on the Deloitte Technology Fast 500™ list of growing companies in North America.”
“Technology Fast 500™ recognizes innovative companies that have broken down barriers to success and defied the odds with their remarkable five-year revenue growth,” said Phil Asmundson, Vice Chairman and U.S. technology, Media and Telecommunications leader, Deloitte LLP. “We congratulate Spectrum Pharmaceuticals on this accomplishment.”
“With its impressive 5-year growth, Spectrum Pharmaceuticals has earned its position among the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America,” said Mark Jensen, Managing Partner, Technology and Venture Capital Services, Deloitte & Touche LLP. “Deloitte is proud to honor Spectrum Pharmaceuticals for its achievement.”
Overall, Technology Fast 500™ award winners for 2009 had growth rates ranging from 212% to 146,050% over five years, with an average growth rate of 2,486%.
Technology Fast 500™ Selection and Qualifying Criteria
Technology Fast 500™ provides a ranking of the fastest growing technology, media, telecommunications, life sciences and clean technology companies in North America. This ranking is compiled from nominations submitted directly to the Technology Fast 500™ website, and public company database research conducted by Deloitte. Technology Fast 500™ award winners for 2009 are selected based on percentage fiscal year revenue growth during the five year period from 2004 to 2008.
In order to be eligible for Technology Fast 500™ recognition, companies must own proprietary intellectual property or proprietary technology that contributes to a significant portion of the company’s operating revenues. Using other companies’ technology or intellectual property in a unique way does not satisfy this requirement. Consulting companies, professional service firms, etc. are not eligible unless they have proprietary technology that contributes to a significant portion of their operating revenues.
Technology Fast 500™ award eligibility requirements also include base-year operating revenues of at least $50,000 USD or CD, and current-year operating revenues of at least $5 million USD or CD. These revenues must have more than doubled between 2004 and 2008. Additionally, companies must be in business for a minimum of five years, and be headquartered within North America.
About Deloitte
As used in this document, “Deloitte” means Deloitte LLP. Please see www.deloitte.com/about for a detailed description of the legal structure of Deloitte LLP and its subsidiaries.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a commercial-stage biotechnology company with a primary focus in oncology. The Company’s strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for its approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in its areas of focus; and, leveraging the expertise of partners around the world to assist it in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Forward-looking statement – This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, that product sales of ZEVALIN® will drive growth in 2009 and beyond, that we will be able to continue to grow our business, and remain on the Deloitte Technology Fast 500™ list of growing companies in North America, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® , FUSILEV® and ZEVALIN® are registered trademarks of Spectrum Pharmaceuticals, Inc. TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
BIEL On Today's Study Results
Everyone:
We consider the study data to be very big news. The data is excellent showing strong statistical significance. There is every reason to believe the rest of the data will be just a strong. Showing that ActiPatch works better than Tylenol will strengthen the case for clearance and will be huge relative to marketing claims. All of us at BEIL consider this initial data one of the biggest events in the life of the company. The investigator needs to be conservative in statements until the entire study is completed, but this is really strong data the FDA will have to take into consideration.
Take a look and listen to what the FDA is now saying about Tylenol and then consider its choice relative to a new technology that is shown to work better than Tylenol. We think this data makes our case toward approval significantly stronger. Here is the link to the FDA's official position on Tylenol.
http://www.fda.gov/Drugs/ResourcesForYou...
Listen to the audio clips - we think they are pretty amazing as is this study data. Joe Noel
BioElectronics Announces Results From Pilot Section of Acetaminophen Comparative Study
Initial Data Showing ActiPatch(R) Has Superior Efficacy to Acetaminophen in the Form of Tylenol(R) for Relief of Exercise-Induced Muscle Soreness
* Press Release
* Source: BioElectronics Corporation
* On 11:00 am EDT, Monday October 19, 2009
*
Companies:
o BioElectronics Corporation
FREDERICK, MD--(Marketwire - 10/19/09) - BioElectronics Corp. (Pinksheets:BIEL - News), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the initial results from the pilot section of its ongoing acetaminophen comparison study. The study, which is expected to be complete during early November, compares the effects of ActiPatch� Therapy to acetaminophen in the form of Extra Strength Tylenol� for the treatment of delayed onset muscle soreness (DOMS).
Participants in the pilot section of the study were randomly assigned to one of three groups, 1) a control group, 2) a group that used ActiPatch, and 3) a group that was treated with over-the-counter strength acetaminophen in the form of Extra Strength Tylenol. Each of the group's participants then evaluated their levels of muscle soreness and discomfort 48 hours after vigorous resistance training designed to induce delayed onset muscle soreness.
"Thus far, results from the pilot section of this study seem to be highly statistically significant with the ActiPatch group scoring its average level of muscle soreness and discomfort at much lower levels compared to either the control group or the acetaminophen treatment group," commented principal investigator Sheena Kong, M.D. "For many years physicians, medical researchers and sports trainers attributed this type of muscle soreness to the build up of lactate in muscle tissues after exercise. A significant body of research now shows delayed onset muscle soreness is mainly attributable to damage to the muscle cell membrane, which sets off an inflammatory response leading to the formation of metabolic waste products that act as a chemical stimulus to the nerve endings that directly cause the pain that is experienced after muscle over exertion. While additional research needs to be conducted on the actual mechanism, it appears ActiPatch works to reduce this inflammatory response resulting in a reduction in the formation of metabolic waste products and therefore, what appears, based on these preliminary results, to be a significant reduction in levels of muscle pain and soreness."
The study, which is Institutional Review Board (IRB) supervised, is currently ongoing with full study results expected during early November 2009. Principal investigator, Sheena Kong, M.D., holds no financial position in any form in the study's sponsor, BioElectronics Corporation, and will receive no financial compensation of any kind for the completion of the study.
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch� Therapy, RecoveryRx(TM) Devices, HealFast(TM) Therapy (www.healfasttherapy.com) and the Allay(TM) family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see www.bielcorp.com
Interesting HEB article
http://www.willstar.net/downloads/c3/ThePinkSheet.pdf
Hemispherx drug for chronic fatigue held up by additional FDA demands
Philadelphia Business Journal - by John George Staff Writer
A decision on Hemispherx BioPharma’s new drug application for Ampligen, twice delayed by the FDA earlier this year, is still in limbo.
William A. Carter, CEO of the Center City biotech company, said last week the company is responding to issues raised by the Food and Drug Administration during its review of Ampligen, an experimental treatment for chronic fatigue syndrome.
Hemispherx has spent more than $500 million and more than three decades developing the drug.
Carter last week provided an update on the status of the FDA’s review of Ampligen to BioMedReports, a Web site that provides information on life sciences firms.
“We continue to be in contact with the [FDA] concerning certain requests they have made over the last year that have to do with toxicology,” Carter said. “This is nonclinical work on the drug. We have continued to complete reports and we expect to sometime this quarter, the fourth quarter, complete a set of requirements [from the FDA] that have to do with preclinical toxicology.”
In its latest quarterly report filed with the Securities and Exchange Commission, Hemispherx noted it is working with the Lovelace Respiratory Research Institute in Albuquerque, N.M., on animal toxic studies in support of its Ampligen application.
The August filing noted the studies were requested by the FDA and that the studies were “substantially completed,” with summary reports issued to the agency during the third quarter.
“Data for final FDA reports are presently undergoing internal auditing at Lovelace and Hemispherx with a projected completion of the final report for late 2009 to early 2010,” the company stated in the filing.
Carter told BioMedReports the FDA has also “done a number of audits” of the company’s clinical sites and manufacturing facility during the past 12 months.
“The clinical inspections resulted in no findings that required [major] corrective action by the company,” he said, adding that the agency did note compliance issues at its facility in New Brunswick and at a contract facility in Spokane, Wash.
The manufacturing plant in Spokane is where Ampligen is packaged.
Carter said over this past summer the company addressed the FDA’s compliance issues at its New Jersey facility and submitted a report to the agency for review. He said the company expects to complete remediation efforts at the Spokane facility within the next several weeks.
“Until all those reports are completed and filed, the agency can withhold a final decision on the commercialization of the product,” said Carter.
Earlier this week, the company announced the discovery of a novel retrovirus in chronic fatigue syndrome patients.
A study published in the Oct. 8 issue of Science Express by a consortium of researchers found a new retrovirus in the blood cells of 67 percent of chronic fatigue syndrome patients and in 3.7 percent of healthy control subjects.
Hemispherx is collaborating with the Whittemore Peterson Institute, in Reno, Nev., to evaluate the potential role of Ampligen in the clinical treatment of chronic fatigue syndrome patients who have a specific immune deficiency in cell activity.
The company plans to provide an update on its programs targeting the disorder at a November Health and Human Services Chronic Fatigue Syndrome Advisory Committee meeting in Washington, D.C.
One Additional Item on FDA - Joe Noel 15-Oct-09 11:55 am
The other important item relative to FDA - It appears FDA has assigned the same person to evaluate Allay and ActiPatch. Our lawyers also consider this to be positive in that questions and answers from one will be used for the other. The bottom line here is that ActiPatch and Allay both use a 3 volt battery that hurts no one. We have a 100% safety record. We have proven that the device works. Many of you on this board have used it. We do not believe FDA is going to say we can't sell it for use on your foot when FDA has been saying it is okay to place on your eye, which of course is directly connected to your brain. We have to wait for the FDA process to work its way through. Like I said, we remain very positive - Joe Noel
BIEL Update from Joe Noel 15-Oct-09 11:31 am
Hi Everyone - We have been getting too many calls and e-mails to answer over the past few days, so I thought I would provide everyone with a quick update. First of all, all of the loyal BIEL shareholders should know that there are a considerable number of outright lies posted by some of the bashers on this board. Here are the facts relative to FDA clearance. Don’t let the basher and liars take your shares from you.
FDA status - Last week we heard from FDA on the second set of applications that were filed. They had only two questions for us - one of which was to provide a simple diagram - we and our FDA lawyers consider this to be a very strong sign. Meaning, having only a few questions from FDA indicates there are not major problems with the applications. Many filers get dozens of questions. This strongly reinforces our stance that FDA clearance is highly likely. After all, the FDA has been saying for more than six years that ActiPatch can be used on a plastic surgery patient’s eye. We see no reason that they are going to say that it cannot be sold for someone's knee or back. Safety is 100% and there has never been a single complaint ever raised. Efficacy is very high, which is demonstrated by very strong clinical data generated by Dr. Genecov. We maintain our strong opinion that FDA clearance will be granted. It appears FDA is somewhat backed up on 510K applications after moving their offices and getting a new director of the device unit. We don't have an estimate of when clearance will be granted, but we do believe we are getting very close. Our opinion internally is that we will be able to market the product over-the-counter very soon and we are now shifting gears at the company toward this aim.
The October 15th date that has been thrown around was arbitrarily set by the people at a newsletter called BioMedReports. It was never a date provided by FDA or BIEL. Everyone needs to understand that the FDA will act when they act. The FDA's mission is to make sure that products are both safe and effective. Their mission is also to clear devices. Historically over 80% of all devices are cleared. Being cleared for one indication of use by FDA combined with the strong efficacy and safety data all certainly point to OTC clearance for our products. We continue to believe FDA clearance is right around the corner.
By the way, the Tylenol study continues and we are looking forward to reviewing the data.
Everything is fine. Our confidence level in the future remains sky high.
HEB NEWS!!!Japanese NIH Research Reaffirms and Expands Pandemic Flu Protection by Ampligen(R)
New Data At Recent "Mucosal Immunity" International Workshop in Osaka Suggest Alternative Method to Protect At High Risk Groups
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:15 am EDT, Thursday October 15, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Oct. 15, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced that Dr. H. Hasegawa, Chief, Laboratory of Mucosal Vaccine Development Virus Research Center, Japanese National Institute of Infectious Diseases (JIID), expanded the data on Ampligen(R), an experimental immunotherapeutic, at the "Mucosal Immunity" session of the Japan-France Vaccine and Infectious Diseases Workshop in Osaka, October 10, 2009. (Please see http://www.osaka-u.ac.jp/en/seminar/info/2009/10/594). Dr. Hasegawa is the Principal Investigator on the Ampligen(R)/ Influenza vaccine program under the joint auspices of JIID/ Ministry of Health, Biken Corporation (Osaka) and Hemispherx Biopharma. Dr. Hasegawa provided an overview of intranasal pandemic flu vaccine (H5N1) and nasal immunity mechanisms.
The new data consist of both expanded clinical and anatomical findings in macaque monkeys exposed to the most virulent forms of pandemic influenza (H5N1). Standard human seasonal influenza vaccines -- given alone and having no benefit on H5N1 influenza virus pathology and clinical status -- were nonetheless highly effective against pandemic virus when combined with Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, which was applied intranasally in very small doses, in a prophylactic treatment setting.
According to various sources, pandemic influenza vaccines will be in very limited supply on a global basis. Thus, many countries are not expected to be able to access significant pandemic vaccines stock piles. In contrast, the sources of seasonal human influenza vaccines are much more abundant and readily accessible. Hemispherx's goal is to expand the observations of JIID into other countries including the South American continent where relevant clinical vaccination protocols are being actively developed for the current pandemic H1N1 influenza virus. According to WHO's (World Health Organization) Initiative for Vaccine Research, in some countries only 10% of the population will have access to pandemic vaccine.
According to Dr. Hasegawa's research including that recently published at the Sapporo, Japan, Vaccinology Conference, Ampligen(R) (Poly I : Poly C12U), an experimental immunotherapeutic and centerpiece of a mucosal immunity program, may convey two additional biological properties (in addition to the above referenced cross-protection) when co-administered intranasally with pandemic flu vaccines: 1) the enhancement of immunity with higher IgA and IgG levels which may convey a survival/therapeutic advantage in animal model systems, and 2) the potential to widen the therapeutic (preventative) profile by protecting against a phenomenon known as "antigenic drift" in which the pandemic virus may escape the preventative effect of the vaccine; this phenomenon is well-established with avian H5N1 virus and mitigated the potential effectiveness of various influenza vaccines manufactured several years ago in the U.S.A.
A description of the vaccine manufacturing technology can be accessed on the Hemispherx web site, announcement of October 8, 2009.
Avian influenza (H5N1), endemic in the Pacific Rim countries, has a greater than 60% death rate in human transmissions to date while the current swine flu (H1N1) death rate is much lower (please see www.flucount.org: swine flu count- world wide statistics of the H1N1 Influenza Pandemic). Moreover, H5N1 requires only a mutation to allow primary recognition of human cell receptors for easy transmission. The research in the monkey model suggests that even when the lethality genes are concentrated in the influenza virus (e.g., avian H5N1), Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, continues to conveys an effective preventative regimen.
Animal model experiments do not necessarily predict biological behavior in man. Regulatory agencies are the only governmental entities vested with the authority to determine whether biological products and experimental therapeutics may be deemed safe and effective for use in a human population.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) 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 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). 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.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
Dr. H Says, Push On To Human Clinical Trials! 11-Oct-09 11:19 pm
sew69kid found Dr. Hasegawa's Presentation titled "Development of Nasal Mucosal Flu Vaccine."
The next step is human clinical trials.
In the last paragraph of Dr. Hasegawa's presentation on the "Development of Nasal Mucosal Flu Vaccine"
In the last paragraph(Page 6) Dr. Hasegawa seems to be saying that Ampligen used as an adjuvant has been shown to be effective against influenza viruses. In the future I think we push ahead to clinical trials to study safety.
This was run through Google Translate but it is still pretty rough:
http://translate.google.com/translate?js=y&prev=_t&hl=en&ie=UTF-8&u=http%3A%2F%2Fwww.nibio.go.jp%2Ftopixs%2Fvaccine%2Fimage%2Fpdf%2Fhapyo_hasegawa.pdf&sl=ja&tl=en&history_state0=
Here is the Japanese Version:
http://www.nibio.go.jp/topixs/vaccine/im...
Transdel Pharmaceuticals Appoints Dr. Joachim P.H. Schupp as Chief Medical Officer
* Press Release
* Source: Transdel Pharmaceuticals, Inc.
* On 7:58 am EDT, Tuesday October 13, 2009
Companies:
o Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 13 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced the appointment of industry veteran Joachim P.H. Schupp, MD as Chief Medical Officer.
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{"s" : "tdlp.ob","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Dr. Schupp has almost 25 years of leadership experience in the pharmaceutical industry. He has achieved the professional distinction of leading international project teams that have brought several drugs through the development and the regulatory process and on to the market globally.
Dr. Schupp spent 19 years with Novartis Pharmaceuticals in Switzerland where he held various positions in clinical development and global project management. Dr. Schupp began his pharmaceutical career at Ciba-Geigy, now Novartis, in 1985 where he was appointed to lead international clinical project teams to discover new non steroidal inflammatory drugs (NSAIDs) with improved gastrointestinal tolerability. He provided medical support for the life-cycle management of Ciba-Geigy's lead product Voltaren (diclofenac) and designed and supervised large multinational clinical trials for several indications of inflammation and pain.
"Dr. Schupp's extensive pharmaceutical industry experience is a tremendous asset to Transdel and we are pleased to welcome him to our senior management team," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In particular, his experience in bringing drugs to market in the areas of pain and inflammation are directly relevant to our ongoing clinical development program. Dr. Schupp provided great value and guidance for the successful completion of our Phase 3 study of our lead topical pain drug, Ketotransdel®. He joins Transdel full-time at this important juncture as we continue to advance our Ketotransdel program through the regulatory process. Given his broad experience in multiple therapeutic areas, we look forward to his continuing contributions to our lead program, as well as to other development opportunities, which we intend to pursue with our proprietary transdermal platform technology."
His international team leadership role is credited for the market approval of several drugs, including Femara® in the United States (U.S.) and European Union (EU) for first line and post operative breast cancer; Apligraf®, the first human skin equivalent, in the U.S., Canada and Switzerland for venous and diabetic ulcers; and for the international development and regulatory approval of Exjade®, the first oral iron chelator approved for transfusional hemosiderosis. Dr. Schupp received several prestigious awards at Ciba-Geigy and Novartis for his team leadership contributions.
Most recently, Dr. Schupp has worked as an Executive Consultant for pharmaceutical and biotechnology companies. He held positions as Vice President of Medical Affairs at Adventrx Pharmaceuticals from 2006 to 2008 and Vice President of Clinical Data Services at ProSanos Corporation from 2004 to 2006. Dr. Schupp received his M.D. from the Free University of Berlin in Germany and he served on the faculty at the University of Pretoria, South Africa in Internal Medicine and Rheumatology.
Both Dr. Singh and Dr. Schupp have during the course of their careers provided leadership in bringing several drugs through the regulatory process and on to the market globally. Specifically, Dr. Singh was involved in bringing BOTOX® and recombinant factor VIII to the market.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, has successfully completed a Phase 3 clinical trial and utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel(TM) platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. In June 2009, the Company announced that they entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotransdel(®); the Company's ability to obtain regulatory approval to market Ketotransdel; and the Company's ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the outcome of the final analyses of the data from the Phase 3 clinical trial may vary from the Company's initial conclusions; the FDA may not agree with the Company's interpretation of such results or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial; the FDA may continue to require the Company to complete additional clinical trials for Ketotransdel(®) before the Company can submit a 505(b)2 NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel(®); and the Company's current need to raise additional funding to complete its product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
HEB NEWS New Infectious Retrovirus Detected in Chronic Fatigue Syndrome
May Clarify Mechanism of Action of Hemispherx's Ampligen(R)
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:15 am EDT, Tuesday October 13, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Oct. 13, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") announced today that the discovery of a novel retrovirus in CFS may now shed new light on the potential mechanism of action of Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, in CFS. CFS is a debilitating disease of unknown etiology that is estimated to affect 17 million people worldwide. In the October 8, 2009 issue of Science Express, a consortium of researchers from the Whittemore Peterson Institute, the National Cancer Institute and the Cleveland Clinic report a new retrovirus in the blood cells of 67% of Chronic Fatigue Syndrome (CFS) patients and 3.7% in healthy control subjects. The infectious virus was also greater than 99% identical to that previously detected in prostate cancer. Patients with CFS are known to display various abnormalities in immune system functions and experience both higher cancer rates and neurological pathology, all of which may be associated with several retroviruses such as HIV and HTLV-1.
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{"s" : "heb","k" : "c10,l10,p20,t10","o" : "","j" : ""}
Presently, the Company is actively collaborating with the Whittemore Peterson Institute to evaluate the potential role of Ampligen(R), an experimental therapeutic, in the clinical treatment of CFS patients who have a specific deficiency in Natural Killer (NK) cell activity. Immunosuppression is often seen in CFS patients and may be a feature of many retroviruses in animal and man. Phase III clinical studies have been conducted in CFS and a New Drug Application (NDA) is presently pending before the United States Food and Drug Administration (FDA).
Ampligen(R) (Poly I : Poly C12U), an experimental therapeutic, was in fact originally developed as a broad-spectrum antiviral/immunomodulator, and has previously demonstrated bioactivity against retroviruses in model systems.
The Company stated that an update on its CFS programs will be provided at the upcoming Health and Human Services CFS Advisory Committee in Washington, D.C. in November, 2009.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) 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 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). 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.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
I am with you cccp!!I need this one too if I am going to be able to come to your wedding!!!!
Biel Approved in Australia!!
FREDERICK, Md., Oct. 9 /PRNewswire-FirstCall/ -- BioElectronics Corporation, (Pink Sheets: BIEL), announced today that the Australian Therapeutic Goods Administration has cleared ActiPatch for sale by its distributor, Endotherapeutics Party Limited.
"We are confident that the experienced sales professionals of Endotherapeutics will successfully launch ActiPatch in the Australian market. Endotherapeutics' team has many decades of experience in the medical devices market and their people come from well known established medical devices companies," said Andrew Whelan, President of BioElectronics Corporation.
Ivan Srejber, Managing Director of Endotherapeutics Party Limited, said "We have extensive experience in launching products and establishing significant market share for previously unknown products. We are very excited about the market potential for ActiPatch in Australia and look forward to a mutually beneficial business partnership with BioElectronics Corporation."
About Endotherapeutics Party Limited:
Founded in 1998, Endotherapeutics has provided medical technologies for the health care specialist throughout Australia. Companies represented by Endotherapeutics are leaders in their specific market segments. To learn more about Endotherapeutics Party Limited please visit http://www.endotherapeutics.com.au.
About BioElectronics:
BioElectronics Corporation is the maker of ActiPatch. ActiPatch is a drug-free anti-inflammatory patch with an embedded battery operated microchip that delivers weeks of continuous pulsed therapy for less than a dollar a day. The unique ActiPatch delivery system, using patented technology, provides a cost-effective, patient friendly method to reduce soft tissue pain and swelling.
Spectrum gets FDA response letter on cancer drug
Fri Oct 9, 2009 7:01am EDT
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* Says will request meeting with FDA
* Says FDA did not request changes to current indications
Oct 9 (Reuters) - Spectrum Pharmaceuticals (SPPI.O) said it received a complete response letter from U.S. health regulators regarding its supplementary marketing application for its drug, Fusilev, to treat advanced metastatic colorectal cancer.
Spectrum, which received marketing approval for its another cancer drug last month, said it plans to request a meeting with the U.S. Food and Drug Administration to discuss options for approval of Fusilev.
Fusilev is currently approved by the FDA as a rescue after high dose of methotrexate therapy in patients with osteosarcoma, a type of bone cancer.
Fusilev is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonist, a type of chemotherapy.
Spectrum said the FDA did not request any changes to the currently approved indications and package insert.
Hemispherx's Ampligen Flu Vaccine Program To Be Presented At International Vaccine Workshop In Japan - Update
10/9/2009 3:19 AM ET
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(RTTNews) - At the "Mucosal Immunity" session of the Japan-France Vaccine and Infectious Diseases Workshop in Osaka, Japan on October 10, Hideki Hasegawa, Chief, Laboratory of Mucosal Vaccine Development Virus Research Center, Japanese National Institute of Infectious Diseases will review data on Hemispherx Biopharma Inc.'s (HEB: News ) Ampligen, an experimental immunotherapeutic.
Hemispherx's collaborative influenza vaccine development partner in Japan is Biken Corp. As part of an agreement to develop an effective influenza vaccine for Japan, in December 2007, Biken licensed Hemispherx's experimental drug Ampligen as an immune enhancer to influenza vaccines. BIKEN owns intellectual property rights related to candidate novel influenza vaccines.
In June of this year, Biken announced its plan to invest a total of 35 billion Yen (US $350 million) to expand its Flu production capacity in Kanonji City. The Japanese research teams believe that Ampligen is an essential co-ingredient to provide experimental efficacy with Biken vaccines.
A pandemic influenza vaccine has yet to be approved and distributed in Japan. The shipments of the first swine flu vaccines in the United States began arriving this week, according to reports.
Hemispherx's New Drug Application for Ampligen seeking approval in the treatment of chronic fatigue syndrome, or CFS, is still under FDA review. In February, the regulatory agency extended the review period by three months to May. Again on May 26, the FDA informed the company that it would require up to 1-2 additional weeks to decide on Ampligen. However the new deadline has also passed. According to reports, the company CEO William Carter has informed a news portal about the regulatory status of Ampligen and the report on the status of Ampligen is expected to be released Friday.
Hemispherx's Ampligen Flu Vaccine Program To Be Presented At International Vaccine Workshop In Japan - Update
10/9/2009 3:19 AM ET
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Hemispherx Biopharma To Present At The Maxim Group 3rd Annual Growth Conference; Webcast At 11:30 AM
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Infosys Technologies Q2 Profit Drops; Guides Q3 Above Consensus; Boosts FY10 Outlook - Update
Chinese Yuan Soars To 4-month High Against Dollar
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Japanese Yen Slides Against Majors
(RTTNews) - At the "Mucosal Immunity" session of the Japan-France Vaccine and Infectious Diseases Workshop in Osaka, Japan on October 10, Hideki Hasegawa, Chief, Laboratory of Mucosal Vaccine Development Virus Research Center, Japanese National Institute of Infectious Diseases will review data on Hemispherx Biopharma Inc.'s (HEB: News ) Ampligen, an experimental immunotherapeutic.
Hemispherx's collaborative influenza vaccine development partner in Japan is Biken Corp. As part of an agreement to develop an effective influenza vaccine for Japan, in December 2007, Biken licensed Hemispherx's experimental drug Ampligen as an immune enhancer to influenza vaccines. BIKEN owns intellectual property rights related to candidate novel influenza vaccines.
In June of this year, Biken announced its plan to invest a total of 35 billion Yen (US $350 million) to expand its Flu production capacity in Kanonji City. The Japanese research teams believe that Ampligen is an essential co-ingredient to provide experimental efficacy with Biken vaccines.
A pandemic influenza vaccine has yet to be approved and distributed in Japan. The shipments of the first swine flu vaccines in the United States began arriving this week, according to reports.
Hemispherx's New Drug Application for Ampligen seeking approval in the treatment of chronic fatigue syndrome, or CFS, is still under FDA review. In February, the regulatory agency extended the review period by three months to May. Again on May 26, the FDA informed the company that it would require up to 1-2 additional weeks to decide on Ampligen. However the new deadline has also passed. According to reports, the company CEO William Carter has informed a news portal about the regulatory status of Ampligen and the report on the status of Ampligen is expected to be released Friday.
Subscriber Alert From BioMedReports.Com
On Friday at BioMedReports, Dr. William A. Carter, CEO of Hemispherx BioPharma, Inc. (AMEX:HEB) is expected to share some important news about the company's pending FDA decision and some new information about the company's Alferon LDO (Low Dose Oral) application
Hemispherx's Ampligen(R)/ Intranasal Flu Vaccine Program to be Presented At International Vaccine Workshop in Osaka
Coincides With First Deliveries of Intranasal Pandemic Vaccine in U.S. to High Risk Groups
* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:15 am EDT, Thursday October 8, 2009
Companies:
o Hemispherx Biopharma, Inc.
PHILADELPHIA, Oct. 8, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced that Dr. H. Hasegawa, Chief, Laboratory of Mucosal Vaccine Development Virus Research Center, Japanese National Institute of Infectious Diseases (JIID), will review data on Ampligen(R), an experimental immunotherapeutic, at the "Mucosal Immunity" session of the Japan-France Vaccine and Infectious Diseases Workshop in Osaka, October 10, 2009. (Please see http://www.osaka-u.ac.jp/en/seminar/info/2009/10/594) Dr. Hasegawa is the Principal Investigator on the Ampligen(R)/ Influenza vaccine program under the joint auspices of JIID/ Ministry of Health, Biken Corporation (Osaka) and Hemispherx Biopharma. Dr. Hasegawa will provide an overview of intranasal pandemic flu vaccine and nasal immunity mechanisms.
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According to public sources, the first swine flu vaccines (e.g., "Flu Mist") are scheduled for delivery in the United States this week. As intranasal vaccines, their initial use is targeted for high risk populations. The intranasal vaccine production technology utilized in the referenced mucosal influenza immunity program by JIID is also licensed from the U.S. based manufacturers of "Flu-Mist" (via various license and operating agreements with and between Biken Corporation and the Japanese Ministry of Health). To the Company's knowledge, no pandemic influenza vaccines have yet been approved and distributed in Japan.
According to Dr. Hasegawa's peer reviewed published research including an Abstract recently published at the Sapporo, Japan, Vaccinology Conference, Ampligen(R) (Poly I : Poly C12U) an experimental immunotherapeutic and centerpiece of a mucosal immunity program, may convey two additional biological properties when co-administered intranasally with pandemic flu vaccines: 1) the enhancement of immunity with higher IgA and IgG levels which may convey a survival/therapeutic advantage in animal model systems, and 2) the potential to widen the therapeutic (preventative) profile by protecting against a phenomenon known as "antigenic drift" in which the pandemic virus may escape the preventative effect of the vaccine; this phenomenon is well-established with avian H5N1 virus and mitigated the potential effectiveness of various influenza vaccines manufactured several years ago in the U.S.A.
Animal model experiments do not necessarily predict biological behavior in man. Regulatory agencies are the only governmental entities vested with the authority to determine whether biological products and experimental therapeutics may be deemed safe and effective for use in a human population.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) 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 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). 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.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(R), Alferon(R) LDO and Oragens(R)) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
Labopharm completes distribution and supply agreement with Grunenthal for twice-daily tramadol-acetaminophen for a number of European countries
* Press Release
* Source: Labopharm Inc.
* On 8:02 am EDT, Thursday October 8, 2009
Companies:
o Labopharm Inc.
- The Agreement Includes Up-Front and Milestone Payments of up to
7.5 Million Euros -
LAVAL, QC, Oct. 8 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS - News; NASDAQ: DDSS - News) today announced that its wholly owned subsidiary, Labopharm Europe Limited, has completed a distribution and supply agreement with Grunenthal GmbH for its twice-daily tramadol acetaminophen formulation for a number of countries in Europe.
Under the terms of the agreement, Grunenthal has the exclusive right to market and sell Labopharm's twice-daily tramadol-acetaminophen formulation in a number of European countries. Labopharm will supply Grunenthal with unpackaged tablets and will receive a fixed transfer price inclusive of gross margin.
Labopharm will receive 3.5 million Euros on signature and up to 4 million Euros in milestone payments upon achievement of certain regulatory and product reimbursement approvals prior to the launch of the product.
"We are pleased to have established the first marketing partnership for our twice-daily tramadol-acetaminophen formulation," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "This agreement represents the initial step in the international commercialization plan for our tramadol-acetaminophen product. We are currently in discussion with Grunenthal to potentially expand our agreement to include additional European countries. We are also in discussion with other potential partners to conclude distribution and supply agreements for other jurisdictions around the world."
"We are enthusiastic to have the opportunity to commercialize Labopharm's innovative pharmaceutical formulation of one of our major brand Zaldiar," said Wolfgang Becker, Member of the Executive Board at Grunenthal and in charge of the worldwide Commercial Operations, "and we are convinced that prescribers will welcome this form for the benefit of their patients."
Labopharm is responsible for obtaining regulatory approval in most of the countries covered by the agreement. The Company is pursuing regulatory approval in Europe through the Mutual Recognition Procedure (MRP) and expects to submit its application for marketing authorization to the reference member state (RMS) before the end of 2009.
The estimated Euro sales in the countries covered by the agreement represent approximately 27% of the immediate release tramadol-acetaminophen combination products market in Europe, as per the last 12 months ending June, 2009.
About Grunenthal
Grunenthal is passionate about globally being the preferred partner in pain management for patients, health care professionals, and payors. The corporation drives innovation to expand European market leadership in moderate to severe pain. Grunenthal is an independent, family-owned German corporation with companies in 34 countries all over the world. Founded in 1946, the corporation employs 2,000 people in Germany and 5,200 worldwide. In 2008, Grunenthal achieved revenues of about 864 million Euros. More information: www.grunenthal.com
About Labopharm Inc.
Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S., Canada, major European markets and Australia. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.
This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. Except as required by law, the Company undertakes no obligation and does not intend to update these forward-looking statements.
Transdel Pharmaceuticals Announces Positive Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)
-- Primary Efficacy Endpoint Met
-- Excellent Safety and Tolerability Profile Demonstrated
-- Minimal Systemic Exposure Found in Pharmacokinetic Sub-Study
-- Company to Host Conference Call/Webcast Today at 9:00 a.m., (EDT)
* Press Release
* Source: Transdel Pharmaceuticals, Inc.
* On Tuesday October 6, 2009, 7:30 am EDT
Companies:
o Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 6 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities. Ketotransdel(®) is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company's innovative proprietary Transdel(TM) drug delivery system.
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Top-Line Results and Trial Design
The double-blind, randomized, placebo-controlled, multi-center Phase 3 study enrolled a total of 364 patients with acute soft tissue injuries in 26 centers in the United States.
The primary efficacy endpoint was the difference between Ketotransdel® and placebo in the change from baseline in pain intensity as measured by the 100 mm Visual Analogue Scale (VAS) during daily activities over the past 24 hours on Day 3. The VAS is a well known and validated instrument for pain measurement. The study achieved statistical significance in its primary endpoint in the per protocol analysis. The statistical analysis of those patients that complied with the study requirements (the per protocol (PP) population) included a total of 252 patients and showed a positive and statistically significant outcome in the primary efficacy endpoint between Ketotransdel® and placebo, reaching a p-value of less than 0.05.
Secondary endpoints included safety assessments and other efficacy parameters.
Ketotransdel® demonstrated an excellent safety and tolerability profile similar to the placebo cream. In particular, there were no Ketotransdel® treatment related gastrointestinal, cardiovascular or other clinically relevant adverse events reported, which are commonly observed with oral NSAIDs.
Ketotransdel® was well absorbed through the skin with minimal blood concentrations of ketoprofen detected in a subset of patients who underwent pharmacokinetic (PK) assessments following multiple exposures during the study. These PK results are consistent with the Company's previous clinical study findings.
Analysis of the Intent-to-Treat (ITT) population of the primary efficacy endpoint (which includes all study patients even if they failed to comply with the protocol and study requirements) favored Ketotransdel® compared to placebo but not to a degree that reached statistical significance. We believe that this finding was not due to a lack of effect of Ketotransdel®, but rather due to patient compliance issues, non-adherence to protocol procedures and other potentially confounding factors (e.g., incorrect use of study drugs and/or concomitant use of unallowed drugs).
"Based on these positive top-line clinical results and the excellent safety profile demonstrated, we believe Ketotransdel® is well-positioned to address a critical need in the pain management marketplace. We are committed to continue working closely with the FDA to bring this much needed drug to the marketplace as soon as possible," stated Dr. Juliet Singh, President and Chief Executive Officer of Transdel Pharmaceuticals. "In addition, this clinical study further validates the great potential of our proprietary transdermal drug delivery platform, and we look forward to maximizing the medical and commercial potential of this technology to bring important therapies to patients."
"There is a significant need among healthcare providers and patients for safe and effective therapies for pain management," said lead clinical investigator Evan F. Ekman, M.D. and President of Southern Orthopaedic Sports Medicine and Medical Director of Palmetto Health Parkridge Surgery Center. "The results from this Phase 3 clinical trial are very encouraging. They confirm to me that Ketotransdel® has a valuable role as a potentially safer and effective analgesic and anti-inflammatory treatment compared to available oral pain drugs, including oral NSAIDs, which are associated with gastrointestinal, cardiovascular and other medical problems."
Further detailed analyses are currently ongoing, and the Company intends to present the clinical trial results at upcoming medical conferences and in peer-reviewed journals.
The Company expects that Ketotransdel, if and when approved by the United States Food and Drug Administration (FDA), could become the first topical NSAID cream product available by prescription in the United States for acute pain management. Transdel is seeking a commercial partner for Ketotransdel®, and is actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
About Ketotransdel
Ketotransdel® is comprised of a transdermal formulation of ketoprofen, an NSAID (Non-Steroidal Anti-inflammatory Drug), and the Company's innovative proprietary Transdel(TM) drug delivery system. Ketoprofen was selected as the active ingredient for Ketotransdel® for its proven clinical safety and efficacy track record. In a previous randomized double-blind, placebo controlled Phase 1/2 trial, Ketotransdel® provided effective local delivery of ketoprofen resulting in statistically significant relief of pain and soreness with minimal systemic exposure to the drug. No adverse reactions to Ketotransdel® were reported. The Company also intends to pursue Ketotransdel for other indications, such as osteoarthritis. The drug could address what the Company believes is a significant unmet medical need for patients and physicians seeking a potentially safer alternative to acetaminophen and oral NSAIDS such as ibuprofen and COX-2 inhibitors that have well-known gastrointestinal, cardiac, renal and/or hepatic safety issues.
Acute Musculoskeletal Pain and Pain Market
Acute soft tissue injuries cause musculoskeletal pain that affects the muscles, ligaments, tendons and/or bones. Treatment often includes the administration of oral non-steroidal anti-inflammatory drugs.
The pain market is the third most prescribed class of drugs in the United States. Oral formulations of non-steroidal anti-inflammatory drugs (NSAID) currently are marketed worldwide for the treatment of inflammation and pain, including pain due to musculoskeletal injuries, signs and symptoms of osteoarthritis and rheumatoid arthritis, menstrual cramps, headache and other minor aches and pains. Based on industry estimates, currently more than 30 million people world-wide use NSAIDs daily. According to market research firm BCC Research the global market for pain relievers was worth $19.1 billion in 2008, and is expected to grow to $32.8 billion by 2013. While traditional oral NSAIDs are effective, they can cause serious gastrointestinal and cardiovascular adverse events. Further, the withdrawal of some COX-2 inhibitors, a class of NSAIDs, has removed a major therapeutic option for patients with multiple moderate and severe forms of pain, resulting in a significant market opportunity. These developments have created an important need for a locally administered pain product with a strong safety profile. Based on market research reports, the United States transdermal drug delivery market is projected to increase from $3 billion in 2005 to $4.5 billion in 2012.
Conference Call/Web Cast Information
Transdel will host a conference call/webcast to discuss matters mentioned in this release. The call is scheduled for today, October 6, 2009, at 9:00 a.m., Eastern Time. To participate in this call, dial 888-695-0608, or outside of the United States, dial 719-457-2615 and the confirmation code 4282348, shortly before 9:00 a.m., Eastern Time. A replay of the call will be available for a limited period following the call, beginning at 12:00 p.m. Eastern Time today. The replay number is 719-457-0820, confirmation code 4282348. The audio webcast can be accessed at www.transdelpharma.com.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel(TM) platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. In June 2009, the Company announced that it entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.
Forward-Looking Statements
The Company cautions you that the statements included in this press release that are not a description of historical facts are forward-looking statements. These include statements regarding: the Company's interpretation of the results of its Phase 3 clinical trial for Ketotransdel®; whether the results from the clinical trial, along with any other clinical trials that may be required by the FDA, will be sufficient to support a 505(b)2 New Drug Approval (NDA) submission; the potential indications for use for Ketotransdel®; the market opportunity for the Company's products; and the Company's ability to complete additional development activities for products utilizing its proprietary transdermal delivery platform. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the Company's business, including, without limitation: the outcome of the final analyses of the data from the Phase 3 clinical trial may vary from the Company's initial conclusions; the FDA may not agree with the Company's interpretation of such results or may challenge the adequacy of the Company's clinical trial design or the execution of the clinical trial; the FDA may continue to require the Company to complete additional clinical trials for Ketotransdel® before the Company can submit a 505(b)2 NDA application; the results of any future clinical trials may not be favorable and the Company may never receive regulatory approval for Ketotransdel®; the third parties upon whom the Company relies to conduct its clinical trials may not perform as expected; technological changes or competitive products or pricing may prevent the Company from successfully commercializing its products; and the Company's current need to raise additional funding to complete its product development plans. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Transdel Pharmaceuticals to Host Conference Call and Webcast on Tuesday, October 6, 2009 to Announce Top-Line Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)
* Press Release
* Source: Transdel Pharmaceuticals, Inc.
* On Monday October 5, 2009, 7:58 am EDT
Companies:
o Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News) today announced that it will host a conference call and audio webcast on Tuesday, October 6, 2009 at 9:00 am, eastern, to announce the top-line results of its Phase 3 clinical study for Ketotransdel®, a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain. A press release will be issued on Tuesday, October 6, 2009 at 7:30 am, eastern.
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To participate in the call, dial 888-695-0608, or outside of the U.S., dial 719-457-2615, confirmation code 4282348 shortly before 9:00 am, eastern. The audio webcast can be accessed via the Internet by visiting the Investor Relations section of the Company's Web site at http://www.transdelpharma.com.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel(TM) platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. In June 2009, the Company announced that it entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
Statements made in this release that are not historical in nature constitute forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Please note that forward-looking statements are based on projections, that these projections involve judgment, and that individual judgments may vary. Moreover, these statements are subject to risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the uncertainty of the Company's future financial results and its ability to raise additional funds to support its operations, its ability to complete the required clinical trials and obtain FDA approval for Ketotransdel, the efficacy and the commercial success of any products it develops, the impact of competitive products or pricing, and technological changes. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. All forward-looking statements included in this release are made as of the date of this press release, and the Company assumes no obligation to update any such forward-looking statements.
Transdel Pharmaceuticals to Host Conference Call and Webcast on Tuesday, October 6, 2009 to Announce Top-Line Phase 3 Study Results for Lead Topical Pain Drug Ketotransdel(R)
* Press Release
* Source: Transdel Pharmaceuticals, Inc.
* On Monday October 5, 2009, 7:58 am EDT
Companies:
Transdel Pharmaceuticals, Inc.
LA JOLLA, Calif., Oct. 5 /PRNewswire-FirstCall/ -- Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP - News) today announced that it will host a conference call and audio webcast on Tuesday, October 6, 2009 at 9:00 am, eastern, to announce the top-line results of its Phase 3 clinical study for Ketotransdel®, a topical cream based non-steroidal anti-inflammatory drug ("NSAID") for acute pain. A press release will be issued on Tuesday, October 6, 2009 at 7:30 am, eastern.
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TDLP.OB 1.45 0.00
Chart for TRANSDEL PHARMACTL
{"s" : "tdlp.ob","k" : "c10,l10,p20,t10","o" : "","j" : ""}
To participate in the call, dial 888-695-0608, or outside of the U.S., dial 719-457-2615, confirmation code 4282348 shortly before 9:00 am, eastern. The audio webcast can be accessed via the Internet by visiting the Investor Relations section of the Company's Web site at http://www.transdelpharma.com.
About Transdel Pharmaceuticals, Inc.
Transdel Pharmaceuticals, Inc. (OTCBB: TDLP - News) is a specialty pharmaceutical company developing non-invasive, topically delivered products. The Company's innovative-patented Transdel(TM) cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier. Ketotransdel®, the Company's lead pain product, utilizes the Transdel technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects. The Company intends to leverage its Transdel(TM) platform technology to expand and create a portfolio of topical products for a variety of indications. The Company is actively pursuing partnerships with companies to expand its product portfolio for pharmaceutical and cosmetic/cosmeceutical products. In June 2009, the Company announced that it entered into a license agreement with JH Direct, LLC for the exclusive worldwide rights to Transdel's anti-cellulite cosmeceutical product which utilizes the Company's Transdel(TM) technology. For more information, please visit http://www.transdelpharma.com.
Safe Harbor Statement
Statements made in this release that are not historical in nature constitute forward-looking statements. Forward-looking statements can be identified by the use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Please note that forward-looking statements are based on projections, that these projections involve judgment, and that individual judgments may vary. Moreover, these statements are subject to risks and uncertainties that cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the uncertainty of the Company's future financial results and its ability to raise additional funds to support its operations, its ability to complete the required clinical trials and obtain FDA approval for Ketotransdel, the efficacy and the commercial success of any products it develops, the impact of competitive products or pricing, and technological changes. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q filed with the SEC. Such documents may be read free of charge on the SEC's web site at www.sec.gov. All forward-looking statements included in this release are made as of the date of this press release, and the Company assumes no obligation to update any such forward-looking statements.
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