Counting my change
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Alert TDLP News...Transdel Pharmaceuticals Close to Signing Lucrative Pharma Partnership Deals
LOS ANGELES, CA, Jul 27, 2010 (MARKETWIRE via COMTEX) -- According to a newly
published report, Transdel Pharmaceuticals' (TDLP) proprietary transdermal cream
drug delivery platform is an asset that pharmaceutical companies have taken
notice of and the company may be on the verge of announcing some significant
news.
Transdel has developed their topical anti-inflammatory cream, called
Ketotransdel(R), for the treatment of acute pain.
"Basically our technology utilizes a combination of penetrator enhancers to take
the drug through the skin barrier and delivering it to the affected tissues,"
explains John Lomoro, CEO and CFO of Transdel.
What makes the company so interesting to investors right now are the rumors that
Transdel is very close to a deal with one or two companies and that could mean a
$10 million upfront cash deal as well as the expenses for an additional FDA trial
being paid for by those partners.
BioMedReports today is reporting that the company could receive royalty payments
in excess of 25%.
"Yes, we will partner this product," explains Lomoro. "When I signed on with the
company I was given a mandate by the board that we wanted to be a fully
integrated specialty pharma company and to accomplish that the goal we need to
partner out the Ketoprofen program, either on a global basis or on regional
deals, and we have pursued those partnerships aggressively.
"We are in late stage discussions with potential regional partners and with a
global partner. The idea being that we would set it up where we would sit back a
clip coupons and have a joint development committee where they would participate
in the development and exercise of the Phase 3 studies and registration process,
meaning they would pay for it."
Investors can read the complete report complete with more comments from John
Lamoro today at BioMedReports.Com:
http://biomedreports.com/articles/most-popular/48598-transdermal-drug-delivery-platform-on-the-verge-of-something-big.html
In addition, Biotech investors interested in accessing the news portal's complete
BIEL NEWS..BioElectronics and YesDTC Holdings Receive Japanese Regulatory Review Date
FREDERICK, Md., July 27, 2010 /PRNewswire via COMTEX/ -- BioElectronics Corp.
(Pink Sheets: BIEL), manufacturers of innovative pain relieving medical devices,
today announced its distribution partner for Japan, YesDTC Holdings, Inc. (YESD)
has received notification from its legal staff of the pending review by Japanese
government medical device regulators for the ActiPatch(TM) and Allay(TM)
Menstrual Relief products. This review will take place on Wednesday, July 28th.
The initial analysis by YesDTC's attorneys has been very favorable toward the
Company's ability to begin marketing in Japan as several similar devices are
already on the market. This regulatory review is designed to verify that Japanese
regulatory agencies will place ActiPatch and Allay in the same category as these
currently marketed devices or if additional information and or testing will be
required.
BioElectronics and YesDTC recently announced several important product line
enhancements specifically tailored to suit the needs of the highly discerning and
quality conscious Japanese marketplace. Additionally, upon release,
BioElectronics will make the recently announced back pain belt available to the
Japanese marketplace.
Andrew Whelan, CEO of BioElectronics, commented, "We view the Japanese market as
being significant to our future success. There is a history of Japanese
regulators closely mirroring the medical device classifications that had earlier
occurred within the European Union, where we are a Class IIa device. This pending
review, which will take place this week, should offer us a great deal of
information about the timing in what we believe will be a highly profitable
market."
About BioElectronics Corporation
BioElectronics Corporation is the maker of ActiPatch(R) Therapy, RecoveryRx(TM)
Devices, HealFast(TM) Therapy (http://www.healfasttherapy.com) and the Allay(TM)
family of inexpensive, disposable drug-free anti-inflammatory devices. For more
information please see http://www.bielcorp.com.
SOURCE BioElectronics Corp.
Copyright (C) 2010 PR Newswire. All rights reserved
Biotech stocks got a boost Monday as Sanofi-Aventis
SA's (SNY) possible acquisition of drug maker Genzyme Corp. (GENZ) lifted
sentiment in the sector.NEW YORK (Dow Jones)--
France's Sanofi has made an informal acquisition approach to Genzyme, people
familiar with the matter told The Wall Street Journal. Since news of Sanofi's
interest in the struggling biotech became public Friday, investors and bankers
have been scrambling to find out whether Sanofi's rivals could also be
interested in making a play for Genzyme, which makes drugs for rare, inherited
disorders.
Britain's GlaxoSmithKline PLC (GSK) and New Jersey-based Johnson & Johnson
(JNJ) are seen as the most logical suitors for Genzyme, bankers and analysts
said.
Genzyme's shares closed up 15% Friday on the news and continued the climb
Monday. They were recently up 7.6% to $67.27 and they set a 52-week high of
$67.69 earlier in the session.
Zacks Investment Research analyst Jason Napodano said hope for a bidding war
for Genzyme was exciting investors.
"Any time there's a deal between pharma and biotech, people seem to remember
M&A is a driving force for biotech stocks," Napodano said.
He added that big pharmaceutical companies need biotechs as they're facing
slowing top lines and drugs going off patent protection.
"And there are lots of biotechs with lots of drugs and no sales force to
promote them," Napodano said. "It's a perfect marriage."
Needham & Co.'s Mark Monane said M&A speculation is definitely increasing
attention on the biotech sector. "There's a lot of exciting things going on in
the sector and if you're looking for growth, biotech is the place to be," he
said.
The NYSE Arca Biotechnology Index (BTK) recently climbed 2.7% and the Nasdaq
Biotechnology Index (NBI) recently grew 2.5%. That compares with a 0.48% gain
in the S&P 500 and a 0.59% climb in the Nasdaq Composite.
Among the biotech companies trading higher Monday was Biogen Idec Inc.
(BIIB), up 5.9% to $56.64, after dropping Friday on news of the potential
Genzyme deal. Biogen and Allergan Inc. (AGN) got a boost earlier this month
after a report Sanofi was considering a U.S. deal of up to $20 billion.
Other gainers in the sector were BioMarin Pharmaceutical Inc. (BMRN), up 5.1%
to $21.01, Seattle Genetics Inc. (SGEN), up 3.9% to $12.97, and Amylin
Pharmaceuticals Inc. (AMLN), up 3.5% to $19.78. Dendreon Corp. (DNDN), which
has often been the target of takeover speculation, rose 4.3% to $36.13, and
Regeneron Pharmaceuticals Inc. (REGN) was up 4.2% to $25.01.
RBC Capital Markets' Michael Yee said that while Regeneron shares were likely
getting a boost from hopes Sanofi could be looking for other acquisitions,
"it's a misconception for Regeneron to be bid up on that" as Sanofi already
holds about 20% of the company and they have existing partnerships.
Meanwhile, Arena Pharmaceutical Inc. (ARNA) continued its upward
trajectory--recently climbing 8.5% to $6.42 after setting a 52-week high of
$6.75 earlier in the session. Shares have soared about 65% since the U.S. Food
and Drug Administration rejected an obesity drug by rival Vivus Inc. (VVUS).
Investors have been scooping up Arena shares on hopes its obesity drug's
relatively clean safety profile and long-term data may aid its review.
Orexigen Therapeutics Inc. (OREX), which also has an obesity drug in
development, was recently up 9.7% to $4.77.
WBB Securities analyst Stephen Brozak said given Vivus' setbacks, investors
interested in the obesity-drug sector have only two choices--Arena or Orexigen.
He said the critical key in getting approval for an obesity drug is having
enough safety data, and Arena's drug seems to fit the bill.
"Investing in health care right now is the least bad choice people can make
in investing," Brozak said.
-By Shara Tibken and Caitlin Nish, Dow Jones Newswires; 212-416-2189;
shara.tibken@dowjones.com
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary:
http://www.djnewsplus.com/nae/al?rnd=QvP5fzJ0giciLPhsoxNi8A%3D%3D. You can use
this link on the day this article is published and the following day.
(END) Dow Jones Newswires
07-26-10 1453ET
Copyright (c) 2010 Dow Jones & Company, Inc.
14:53 072610
Alert EVRN Update... Spoke with Paul....Both shows went extremely well, the have orders coming and a lot of leads. They are gearing up to send sample packs to numerous distributors.
They have signed up a new logistics/fulfillment partner to handle internet orders.This will make web sales flow easier. All previous orders will ship prior to August 15th.
Paul will be in further communication with Whole Foods this week to check on progress which is going good. All indications that Whole foods will expand distribution to other regions by year end.
It is a bio bonanza today!! Lets keep it going.....
ALERT POZN...moving strong up 5.20%
I own TDLP... This stock is totally under radar.
Alert TDLP....Anti-inflammatory drug delivered through skin set to net $10 million upfront deal
Written by M.E.Garza
Thursday, 22 July 2010 16:07
1diggdigg
As we told our subscribers on Thursday morning, this company's innovative-patented cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier.
In essence it is a topical cream delivery system that is among the most elegant and effective and now, sources are telling us that there is a significant event on the horizon which could impact share prices significantly, especially given the size of the tightly held share float.
The company is Transdel Pharmaceuticals Inc (OTC: TDLP) and it has a product called Ketotransdel® which is Ketoprofen in their delivery system.
Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAIDs).
Prescription ketoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).
Nonprescription ketoprofen is used to relieve minor aches and pain from headaches, menstrual periods, toothaches, the common cold, muscle aches, and backaches. Ketoprofen works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Ketotransdel®, the Company's lead late stage pain product, utilizes the Transdel™ technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (“NSAID”), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects.
We do know that the market for NSAIDs delivered transdermally has been growing rapidly and that there are two competitive products from King Pharma- the flector patch which is a patch of Volataren (Diclofenac) and one by the old Ciba company which is a gel.
Ketoprofen is a more effective product when dermally delivered and their system allows 10x more drug to be used.
The prior two products have grown to over $300 million in three years and the market is estimated at over $4.5 billion in the US alone.
Transdel had good Phase 3 results but as typical with pain products, they find themselves in a position in which they need to duplicate those Phase 3 trials.
Sources tell us it will cost $7 mill and take at least 1 year, but already the company has been negotiating with several pharmaceutical companies, including a good sized private one and several big international ones.
Those same industry sources indicate that Transdel is very close to a deal with one or two companies that could mean a $10 million upfront cash deal as well as the expenses for the trial being paid for by the partner. In addition, there are indications that the company could recieve a royalty payment in excess of 25%.
Interestingly, on the company's own website, they indicate that they are seeking a commercial partner for Ketotransdel®, and are actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
Industry sources are telling us that they are expecting this news sometime in the next 10-20 days. In the meantime, we fully expect to reach out to company officials for more informaiton and/or an interview in hopes of learning more details as we chase this story.
Disclosure: No Positions
This stock has been under radar.
This huge news
TDLP Alert...Anti-inflammatory drug delivered through skin set to net $10 million upfront deal
Written by M.E.Garza
Thursday, 22 July 2010 16:07
1diggdigg
As we told our subscribers on Thursday morning, this company's innovative-patented cream formulation technology is designed to facilitate the effective penetration of a variety of products through the tough skin barrier.
In essence it is a topical cream delivery system that is among the most elegant and effective and now, sources are telling us that there is a significant event on the horizon which could impact share prices significantly, especially given the size of the tightly held share float.
The company is Transdel Pharmaceuticals Inc (OTC: TDLP) and it has a product called Ketotransdel® which is Ketoprofen in their delivery system.
Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAIDs).
Prescription ketoprofen is used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints).
Nonprescription ketoprofen is used to relieve minor aches and pain from headaches, menstrual periods, toothaches, the common cold, muscle aches, and backaches. Ketoprofen works by stopping the body's production of a substance that causes pain, fever, and inflammation.
Ketotransdel®, the Company's lead late stage pain product, utilizes the Transdel™ technology to deliver the active drug, ketoprofen, a non-steroidal anti-inflammatory drug (“NSAID”), through the skin directly into the underlying tissues where the drug exerts its well-known anti-inflammatory and analgesic effects.
We do know that the market for NSAIDs delivered transdermally has been growing rapidly and that there are two competitive products from King Pharma- the flector patch which is a patch of Volataren (Diclofenac) and one by the old Ciba company which is a gel.
Ketoprofen is a more effective product when dermally delivered and their system allows 10x more drug to be used.
The prior two products have grown to over $300 million in three years and the market is estimated at over $4.5 billion in the US alone.
Transdel had good Phase 3 results but as typical with pain products, they find themselves in a position in which they need to duplicate those Phase 3 trials.
Sources tell us it will cost $7 mill and take at least 1 year, but already the company has been negotiating with several pharmaceutical companies, including a good sized private one and several big international ones.
Those same industry sources indicate that Transdel is very close to a deal with one or two companies that could mean a $10 million upfront cash deal as well as the expenses for the trial being paid for by the partner. In addition, there are indications that the company could recieve a royalty payment in excess of 25%.
Interestingly, on the company's own website, they indicate that they are seeking a commercial partner for Ketotransdel®, and are actively pursuing discussions with U.S. and foreign based potential partners with sales and marketing infrastructures.
Industry sources are telling us that they are expecting this news sometime in the next 10-20 days. In the meantime, we fully expect to reach out to company officials for more informaiton and/or an interview in hopes of learning more details as we chase this story.
Disclosure: No Positions
You are correct.....
Remember Swine Flu? It's Likely Officially Over
the tickerspy.com Staff, On Tuesday July 20, 2010, 9:54 am EDT
According to Bloomberg, the WHO is likely to announce an end to the H1N1 'swine flu' pandemic sometime this month. The news may come as a surprise, largely because a recent lack of media coverage likely led most to believe the threat ended months ago. All in all, $14 billion was spent on vaccines and antivirals for what Bloomberg described as little more than a fever and a cough in a majority of patients. If there's one thing investors learned from the H1N1 scare, it's that demand for preparedness can send stocks soaring despite an unclear ultimate impact of a viral outbreak.
A look at the Swine Flu and Bird Flu Stocks Index's performance chart shows the vaccine and antiviral market's near vertical ascent to huge gains starting in the summer of 2009. However, as media hype subsided and fears waned, shares tumbled sharply.
As of this writing, seven biotechs are more than -60% from their highs at the peak of the H1N1 scare last fall. Volatile micro-cap Hemispherx Biopharma (AMEX: HEB - News) has lost nearly -90% of its value, followed by Inovio Biomedical (AMEX: INO - News), Novavax (NASDAQ: NVAX - News), and Generex Biotech (NASDAQ: GNBT - News). Even Biocryst Pharmaceuticals (NASDAQ: BCRX - News), whose Peramivir antiviral won emergency use authorization from the FDA, and Sinovac Biotech (NASDAQ: SVA - News), the first vaccine firm to win Chinese approval, have slipped by more than -50% from their respective 52-week highs.
Large-cap swine flu plays were the safest bets for investors, and while their gains weren't as impressive as the small-caps last summer, massive portfolios of existing drugs kept stocks like Novartis AG (NYSE: NVS - News), GlaxoSmithKline (NYSE: GSK - News), and Roche (OTC: RHHBY - News) from getting slammed when hype subsided.
There's no telling when the next potentially expansive viral outbreak will occur, but a number of Swine Flu and Bird Flu Stocks Index components could be beneficiaries as traders look to vaccine stocks and antiviral small-caps to get rich amidst the public scare and media blitz. Investors can track the Index for performance trends,
Remember Swine Flu? It's Likely Officially Over
the tickerspy.com Staff, On Tuesday July 20, 2010, 9:54 am EDT
According to Bloomberg, the WHO is likely to announce an end to the H1N1 'swine flu' pandemic sometime this month. The news may come as a surprise, largely because a recent lack of media coverage likely led most to believe the threat ended months ago. All in all, $14 billion was spent on vaccines and antivirals for what Bloomberg described as little more than a fever and a cough in a majority of patients. If there's one thing investors learned from the H1N1 scare, it's that demand for preparedness can send stocks soaring despite an unclear ultimate impact of a viral outbreak.
A look at the Swine Flu and Bird Flu Stocks Index's performance chart shows the vaccine and antiviral market's near vertical ascent to huge gains starting in the summer of 2009. However, as media hype subsided and fears waned, shares tumbled sharply.
As of this writing, seven biotechs are more than -60% from their highs at the peak of the H1N1 scare last fall. Volatile micro-cap Hemispherx Biopharma (AMEX: HEB - News) has lost nearly -90% of its value, followed by Inovio Biomedical (AMEX: INO - News), Novavax (NASDAQ: NVAX - News), and Generex Biotech (NASDAQ: GNBT - News). Even Biocryst Pharmaceuticals (NASDAQ: BCRX - News), whose Peramivir antiviral won emergency use authorization from the FDA, and Sinovac Biotech (NASDAQ: SVA - News), the first vaccine firm to win Chinese approval, have slipped by more than -50% from their respective 52-week highs.
Large-cap swine flu plays were the safest bets for investors, and while their gains weren't as impressive as the small-caps last summer, massive portfolios of existing drugs kept stocks like Novartis AG (NYSE: NVS - News), GlaxoSmithKline (NYSE: GSK - News), and Roche (OTC: RHHBY - News) from getting slammed when hype subsided.
There's no telling when the next potentially expansive viral outbreak will occur, but a number of Swine Flu and Bird Flu Stocks Index components could be beneficiaries as traders look to vaccine stocks and antiviral small-caps to get rich amidst the public scare and media blitz. Investors can track the Index for performance trends,
How do you know about the 2 shifts in production?
**I called and talked to the CEO and he told me.
How long do you think it takes before the audits are finished?
** Less than 30 days
It cost a lot of money to promote and enter the distribution agreements imo, hope we soon hear some sales figures.
**We will see in audits coming up.
If we move to a bigger board, OTC BB or higher, what do you think will happen with the shares we are holding
** Not sure on this one
Talked to corp. inquiring on my order.
TZPC News..ThermaFreeze Announces Availability of Video Interview with Chairman Rich Bolton and CFO Rich Falcone
Date : 07/20/2010 @ 9:30AM
Source : PR Newswire
Stock : ThermaFreeze Products Corp (OTC) (TZPC)
Quote : 0.36 0.0 (0.00%) @ 8:09AM
ThermaFreeze Announces Availability of Video Interview with Chairman Rich Bolton and CFO Rich Falcone
ThermaFreeze Products Corp (OTC) (USOTC:TZPC)
Intraday Stock Chart
Today : Tuesday 20 July 2010
Click Here for more ThermaFreeze Products Corp (OTC) Charts.
ThermaFreeze Products Corporation (Pink Sheets: TZPC), the maker of patented, innovative refrigerant products designed for use in the commercial shipment of perishables and for use as a consumer compress and chiller product, announced today that a new two-part video interview with the Company's Chairman, Rich Bolton, and Chief Financial Officer, Rich Falcone, is now available at the following links: http://vimeo.com/12829377 and http://vimeo.com/12831055.
In the interview, Mr. Bolton and Mr. Falcone discuss ThermaFreeze's business strategy and growth opportunities for 2010 and beyond. The management team also provides an overview of the Company's unique ice replacement product and the strong sales and interest they are receiving from retailers and consumers all over the United States.
"We believe our products are superior to any other ice replacement products in the market and our prices are very competitive. We have also established low cost manufacturing here in Alabama and retailers from coast to coast are buying our ThermaFreeze products. In addition, larger retailers have already started to put in sizable orders for 2011. We are very excited about our prospects for the second half of 2010 and 2011," commented Rich Bolton, Chairman of ThermaFreeze Products Corporation.
About ThermaFreeze Products Corporation
ThermaFreeze(TM) Products Corporation manufactures and markets a patented, innovative refrigerant product designed for use in the commercial shipment of perishables and for use as a consumer compress and chiller product. ThermaFreeze(TM) refrigerant is flat, lightweight and flexible even when frozen, making it more convenient and cost-effective than ice, gel packs, ice bricks and dry ice.
Safe Harbor for Forward-Looking Statements
Statements made in this release with the respect to the Company's current plans, estimates, strategies and beliefs and other statements that are not historical are forward-looking statements. Forward-looking statements include, but are not limited to, those statements using words such as "believe," "expect" and "plans" and words of similar meaning in connection with a discussion of future operations, financial performance, events or conditions. Statements are based on management's assumptions and beliefs in light of the currently available information. The Company cautions that a number of important risks and uncertainties could cause actual results to materially differ from those discussed in the forward-looking statements, and therefore, undue reliance should not be placed on them.
SOURCE ThermaFreeze Products Corporation
You are right about the positive EBIT and cash flow.
They are absolutely working on moving to a bigger board,what they are working on is their audits and getting all of that together,then they will be ready.
As far as sales figures,i am not aware of any,I do know the last QVC shipment was around $160,000.
This company is pumping out product like crazy,they have been running 2 shifts 24hrs. a day.
Update....Grocer sample packs and internet orders should be filled by August 15th. Also, Sample packs have been just now shipped to Source One, as they have meetings with distributors coming up soon.
I did not catch this one...Thanks!
They are in process
Added...AVNR and ALXA on forward moving events and are both way under valued.
SPPI News...Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a biotechnology company with fully integrated commercial and drug development operations, with a primary
focus in hematology and oncology, today announced the appointment of George Tidmarsh, M.D., Ph.D., to the position of Senior Vice President, Chief Scientific Officer and Head of Research and Development Operations. Dr.
Tidmarsh will report directly to the Chief Executive Officer and will provide the strategic planning and leadership necessary for managing all of the company's scientific operations, including clinical research, medical and
regulatory affairs, biostatistics and data management, and pharmaceutical
operations.
"During the past several years, we have laid the groundwork for significant
growth in 2010 and beyond and, I believe, we now stand on the cusp of great
commercial and clinical success," said Rajesh C. Shrotriya, M.D., Chairman of
the Board of Directors, Chief Executive Officer, and President of Spectrum
Pharmaceuticals. "It is more important now than ever for us to strengthen our
team with professionals who meet exceedingly higher performance standards and
who can help us maximize the potential of our two marketed cancer drugs, as
well as our development-stage portfolio comprised of many novel drugs. I have
known George for more than eight years as a dedicated and passionate scientist
who works diligently with the uncanny ability of remaining focused on the
mission at hand while keeping the big picture in mind. During the short period
that he has been at Spectrum he has already demonstrated his excitement,
passion and qualities for thoroughness. I am confident that Dr. Tidmarsh, a
successful biotechnology leader with more than 20 years of experience in our
industry including FDA drug approvals, has the requisite qualities to enable us
to accomplish the objective of helping improve the quality of life of cancer
patients while increasing shareholder value for Spectrum stockholders."
"I am pleased to be working with Dr. Shrotriya and the team he has assembled
at Spectrum Pharmaceuticals," said Dr. Tidmarsh. "Spectrum's two marketed
cancer drugs, ZEVALIN(R) and FUSILEV(R), are complemented by a promising
diversified portfolio of novel drugs, two of which, apaziquone and belinostat,
are in registrational trials poised for New Drug Applications within the next
two years. I am looking forward to working diligently towards helping
accomplish corporate goals and helping improve the quality of life of cancer
patients."
Dr. Tidmarsh founded Horizon Pharma and Threshold Pharmaceuticals, taking
Threshold public in 2005 and guiding Horizon to successful completion of its
Phase 3 program. Dr. Tidmarsh has also held various positions at Coulter
Pharmaceuticals, including its Chief Medical Officer. During that time, he
played a key role in the landmark $142 million co-development deal with
SmithKline for its radiopharmaceuticals product, Bexxar, for the treatment of
non-Hodgkin's lymphoma. Prior to Coulter Pharmaceuticals, he held scientific
and clinical positions at Sequus Pharmaceuticals, Gilead Sciences, and
SyStemix. Dr. Tidmarsh led fundamental scientific discovery efforts at SyStemix
and Gilead Sciences and played a key role in the FDA approval process of Doxil,
including the successful presentation to the FDA Oncology Drug Advisory
Committee. Prior to joining Spectrum, Dr. Tidmarsh founded Metronome
Therapeutics, a privately held biopharmaceutical company focused on novel
cancer drug development. Dr. Tidmarsh served as a consultant to Spectrum prior
to his appointment.
Dr. Tidmarsh, received his B.S. in Microbiology from Stanford University and
his M.D. and Ph.D. from the Stanford University School of Medicine, where he
also completed fellowships in Pediatric Oncology and Neonatal Intensive Care.
In addition, he has been a clinical staff member at Stanford Children's
Hospital and El Camino Hospital. He has authored over 20 peer-reviewed
scientific papers published in leading journals.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated
commercial and drug development operations with a primary focus in hematology
and oncology. The Company's strategy is comprised of acquiring, developing and
commercializing a broad and diverse pipeline of late-stage clinical and
commercial products. The Company markets two oncology drugs, FUSILEV and
ZEVALIN and has two drugs, apaziquone and belinostat, in late stage development
along with a diversified pipeline of novel drug candidates. The Company has
assembled an integrated in-house scientific team, including clinical
development, medical research, regulatory affairs, biostatistics and data
management, formulation development, and has established a commercial
infrastructure for the marketing of its drug products. The Company also
leverages the expertise of its worldwide partners to assist 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 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 our employees
and partners around the world to assist us in the execution of our strategy,
and any statements that relate to the intent, belief, plans, abilities, 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.(R), ZEVALIN(R), and FUSILEV(R) are registered
trademarks of Spectrum, REDEFINING CANCER CARE(TM) and the Spectrum
Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. All
other trademarks and trade names are the property of their respective owners
(c) 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
CONTACT: Spectrum Pharmaceuticals, Inc.
Paul Arndt, Senior Manager, Investor
Relations
949-788-6700 x216
SOURCE: Spectrum Pharmaceuticals, Inc.
Copyright Business Wire 2010
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary:
http://www.djnewsplus.com/nae/al?rnd=27YxZ%2FvAjoVhgpDfzJPHCQ%3D%3D. You can
use this link on the day this article is published and the following day.
(END) Dow Jones Newswires
07-19-10 0700ET
07:00 071910
HEB News..The Indian Drugs Controller General Approves Start of Clinical Study of Hemispherx Biopharma's Natural Interferon Product, Alferon N Injection(R), in
Hospitalized Flu Patients
Clinical Sites Expected to Enroll Subjects During Monsoon Season
PHILADELPHIA, July 19, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc.
(NYSE Amex:HEB), an advanced specialty pharmaceutical company engaged in the
clinical development of new drug entities for treatment of seriously
debilitating disorders, and Max Neeman International, one of the leading and
largest clinical research organizations ("CROs") in India, jointly announce
that the collaborative Phase II clinical research effort for one of Hemispherx'
flagship products, Alferon N Injection(R) (interferon Alfa-n3) was approved by
the Indian Drugs Controller General on July 13, 2010 and is expected to start
enrolling patients right away.
The clinical research platform is designed to improve the quality of care for
treatment of seriously ill patients hospitalized with either seasonal influenza
or pandemic influenza. The CRO targeted clinical sites that will be enrolling
subjects in the current monsoon season. According to various expert
epidemiological sources, strains of influenza are becoming progressively
resistant to currently available commercial antiviral drugs (including
so-called neuraminidase inhibitors) and death rates are expected to increase
globally without the development of new effective treatment strategies.
The monsoon season in India is from July through mid October, with the peak
expected in August. With this in mind, a company spokesperson commented that
the study was well positioned to enroll the patients necessary to complete this
clinical study on a timely basis.
The Alferon N Phase II study is closely modeled on the successful clinical
performance of neuraminidase inhibitors drugs, one of which was recently (yr.
2010) commercialized in Japan largely based on a single well-controlled study
in hospitalized patients suffering from influenza. Unpublished pre-clinical
studies, including animal studies, suggest that Alferon N may have a
substantially improved protective effect on pulmonary tissue over that provided
by zanamivir, a neuraminidase inhibitor. However, animal experimentation does
not necessarily predict clinical outcomes.
Alferon N Injection(R) is an FDA approved product presently for a category of
sexually-transmitted diseases. Hemispherx has invested several million dollars
in improvements to the Alferon N production facility in New Brunswick, New
Jersey. The goal is to increase the annual yields of Alferon N. Should the
forthcoming clinical trials be successful, Hemispherx will examine application
to expand the existing commercial authorization to allow Alferon N Injection(R)
as an approved drug for treatment of hospitalized flu patients in India and
elsewhere.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company
engaged in the clinical development of new drug entities for treatment of
seriously debilitating disorders. Hemispherx' flagship products include Alferon
N Injection(R) (FDA approved for a category of sexually transmitted diseases)
and the experimental therapeutics Ampligen(R) and Alferon LDO. Ampligen(R)
represents experimental RNA nucleic acids being developed for globally
important debilitating diseases and disorders of the immune system. Hemispherx'
platform technology includes agents for potential treatment of various severely
debilitating and life threatening diseases. Hemispherx has an extensive number
of 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.
About Max Neeman International
Max Neeman International is one of the leading and largest CROs in India. Its
specialty is that it offers services for the successful conduct of Phase I-IV
clinical and device trials for small and mid-sized international and national
Pharmaceutical, Biotechnology, Medical Device and Nutraceutical companies in
compliance with ICH GCP standards. Operational since 2001, Max Neeman is an ISO
9001:2000 certified CRO for Monitoring, Site Management and Data Management
Services. The company is presently active in 22 cities with five regional
offices. Contact Donald Swankie, Vice President for more information
(donald.swankie@neeman-medical.com / +1.919.424.3345).
http://www.neeman-medical.com
About Max Healthcare
With 13 hospitals, 1,500 physicians and 3,000 support staff - Max Healthcare
is one of a leading chain of hospitals in India. Its state of the art
infrastructure, over 225 ICU beds and most advanced technologies makes it one
of the best hospitals in India. http://www.maxhealthcare.in
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) and Alferon(R)
LDO) 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. Further, the commencement of clinical trials in June, 2010 by Max
Neeman in India is its target date but cannot be guaranteed due to a variety of
risk factors outside of the parties control and should be regarded only as a
forward looking estimate.
CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518.398.6222
ir@hemispherx.net
Max Neeman International
Company/Investor Contact:
Donald Swankie
919.424.3345
donald.swankie@neeman-medical.com
Click here to go to Dow Jones NewsPlus, a web front page of today's most
important business and market news, analysis and commentary:
http://www.djnewsplus.com/nae/al?rnd=27YxZ%2FvAjoVhgpDfzJPHCQ%3D%3D. You can
use this link on the day this article is published and the following day.
(END) Dow Jones Newswires
07-19-10 0802ET
08:02 071910
I have witnessed In-Store Product Tasting and Demonstrations and they work great...This is what Paul was doing in Chicago and was very successful with it.
KngmAz, I don't totally disagree with you.There are things I would like to see happen. However, As I been closely researching and personally meeting Paul and his partners,I feel confident in my investment.Nobody, should be in this company or any other company if they do not believe in what they are doing and how they are doing it.
Here is the link to the interview...Some very good information!!
Why would you say that?...Start ups take time, they are not quick buck type of stocks. From my DD they are running this perfectly. These guys are pros in what they do.
I have called E-Trade numerous times and they have no knowledge of any restructuring.
Great day over-all...We shall see more news soon per my conversations with Corp. The solar arena is definitely heating up.
I think any positive exposure is good.
The solar industry is gaining massive speed with the new available financing options
This company is setting up perfectly.
You are spot on with SPPI, This stock is way undervalued and insider buying has increased recently.
NVLT..NOVELOS THERAPEUTICS ANNOUNCES POSITIVE PHASE 2 RESULTS
IN NOV-002 NEOADJUVANT BREAST CANCER TRIAL AT SYLVESTER
COMPREHENSIVE CANCER CENTER, AT THE UNIVERSITY OF MIAMI
- - -
Tumor Response Target Achieved – Detailed Results Submitted for Presentation at
SABCS in December 2010
NEWTON, Mass., July 12, 2010 – Novelos Therapeutics, Inc. (OTCBB: NVLT), a
biopharmaceutical company developing therapeutics to treat cancer and hepatitis, today
announced positive results in a Phase 2 trial of NOV-002 in combination with neoadjuvant
chemotherapy treatment in patients with stage IIB-IIIC HER-2/neu negative invasive breast
cancer, conducted by the Braman Family Breast Cancer Institute at Sylvester Comprehensive
Cancer Center at the University of Miami Miller School of Medicine. Alberto Montero, MD,
Assistant Professor of Medicine at the Miller School and medical oncologist at Sylvester, is the
Principal Investigator.
This Phase 2 open-label, single-arm, Simon 2-Stage trial was designed to determine if
preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide
followed by docetaxel (AC-T) results in at least a doubling in the rate of pathologic complete
response (pCR) compared to a historical control. For NOV-002 to be declared active at the end
of the trial, a minimum of 12 patients must achieve a pCR. This criterion of 12 pCRs has been
met prior to all patients completing the trial. Patient enrollment continues and some patients are
still in the NOV-002 treatment stage. Trial results have been submitted for presentation to the
AACR Breast Cancer Symposium taking place in San Antonio, TX, in December 2010. The
Phase 2 trial design can be found on www.clinicaltrials.gov – ID: NCT00499122, or via a link at
www.novelos.com ‘Clinical Trials’ section.
New Life in HEB....up 6.5% on great news
I e-mailed Paul...Checking on next distribution,Whole Foods sales and new company status. I will let you all know,as soon,as I here back.
I like it,more exposure....
I Watched both QVC ThermaFreeze segments and sales were extremely strong. I sure we will see news to this affect.
J&J sales plunge as new drug recall announced
By LINDA A. JOHNSON, AP
Thu Jul 8, 11:51 PM EDT
TRENTON, N.J. — Sales of Johnson & Johnson pain relievers are collapsing as a string of recalls appears to have made consumers wary of once-sterling brands such as Tylenol and Benadryl.
An eighth recall, announced Thursday, could worsen consumer reaction. That wariness and the huge amount of products pulled off store shelves together look to be costing J&J tens of millions of dollars a month.
Thursday's recall by Johnson & Johnson's McNeil consumer health care unit covers 21 lots of products, including Children's Tylenol. Those were recalled because of a musty or moldy smell, extending a large Jan. 15 recall tied to a nauseating chemical on shipping pallets.
The company said the new lots were added to the recall as a precaution after an internal review found those lots, shipped and stored before Jan. 15, had been on the same type of wooden pallets.
An April 30 recall of more than 130 million bottles of children's and infants' liquid medicines involved products J&J said "may not meet required quality standards," may contain tiny metal particles or may have too much active ingredient.
The string of recalls is an embarrassment for a company that set the standard on how to do it correctly when it rushed to pull bottles of Tylenol — deliberately poisoned by someone who was never caught — off store shelves in the early 1980s.
This time, the culprit appears to be a lack of internal quality control. That's harder to forgive, particularly given that the public has little tolerance for mistakes or carelessness involving products for children, said analyst Steve Brozak of WBB Securities.
"This is pain by a thousand cuts," Brozak said of the repeated recalls.
Erik Gordon, a professor and analyst at the University of Michigan's Ross School of Business, said J&J has been too conservative about replacing those responsible.
"Heads should have rolled" and longtime CEO Bill Weldon should be taking responsibility, Gordon said. "If I were on the board, I think I would be looking for his resignation."
Weldon has turned the gold standard for handling an unsafe product "into the tin standard," he added.
Data from market research firm SymphonyIRI you Group show sales of New Brunswick, N.J.-based J&J's pain reliever pills fell 56 percent in the four weeks ending June 13, compared to a year earlier.
Its figures show that U.S. sales of pain-relieving tablets, gelcaps and other types of pills, including multiple strengths of Tylenol and Motrin, plunged to $20.9 million in that four-week period, putting the company behind rivals Bayer Consumer Health and Wyeth Labs. Sales of private-label, or store brands, benefited the most from Johnson & Johnson's fall, jumping 23 percent to $51.9 million.
Meanwhile, sales in the smaller category of liquid pain relievers, such as Children's Tylenol, fell 96 percent, to just $630,000. Those figures do not include sales at Walmart, gas station stores and club stores.
Together, that amounts to tens of millions of dollars in revenue lost in just one month — and a big hit to the reputation of the maker of iconic products such as Johnson & Johnson's baby shampoo and Band-Aids. Gordon said sales of any product with Johnson & Johnson on it will be hurt.
CathyJo Andrews threw out 10 bottles of children's medicines earlier this summer after a prior recall.
"It scared me," she said. "It's my kids."
Since then the mother of two, who lives in the Chicago suburb of Oak Lawn, has received coupons from Johnson & Johnson to reimburse her, but doesn't plan to use them soon.
Andrews said when her 6-year-old developed a fever and had an allergic reaction, she opted instead to take a trip to the pediatrician.
"I'd much rather pay for a doctor's visit and a prescription from the pharmacy than have to freak out and worry about it," the 28-year-old said.
A Johnson & Johnson spokeswoman said the company had no comment beyond its announcement of the latest recall.
Food and Drug Administration spokeswoman Elaine Gansz Bobo said the agency continues to work with McNeil on all the product recalls.
"We do not see any serious health risk to the public from this additional recall," she said.
Gansz Bobo said she did not know of any other company that had eight medicine recalls in less than a year.
"It certainly is quite a few, and something that we hope is not repeated by other companies," she told The Associated Press.
The repeated recalls are particularly surprising at a company where executives regularly repeat the 67-year-old corporate credo, which begins: "We believe our first responsibility is to the doctors, nurses and patients, to mothers and fathers and all others who use our products and services."
Gordon noted that besides the announced recalls, congressional investigators say J&J paid another company to quietly buy up packages of Motrin with potency problems in 2008.
"I think it's unfathomable that a longtime J&J guy could do something so un-J&J-like," he said of Weldon.
Gordon said he sees parallels to the repeated recalls by Toyota, another company "renowned for quality having quality problems. You have to wonder if global cost pressures have changed the game even for the best of the best."