Counting my change
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Heb News-Carter bought 30,000 at $0.569
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Part II: MedClean Team Sees Opportunity to Emerge as Breakout Player in the Market
Written by M.E.Garza
Sunday, 06 December 2009 12:55
On Friday, shares of MedClean Technologies (OTC:MCLN) consolidated after two sessions of double digit percentage gains. The stock looks poised to take another run at the $.04 resistance level and beyond after investors digested news that the company is set to receive up to $7.5 million from a sale of up to 750 shares of its Series "C" preferred stock.
Part I: One Man's Trash Is Another Man's Treasure - MedClean Technologies
Department of Justice Demand for Open Playing Field in Medical Waste Likely to Help MedClean Technologies (OTCBB: MCLN)
Some fear of dilution may have impacted the shares, but MedClean officials made clear that the preferred stock purchase agreement will enable the company’s growth and expansion.
Scott Grisanti, Chairman of the Board MCLN was asked about investors' concerns that the company might dilute common shares and thus dilute the value of the company.
"That’s not something that has been discussed," explained Grisanti. "What I can say is that as we continue to seek working capital for the company that equity is one of the two main ways as you know to drive working capital proceeds to a company outside of sales of course and that would acquire more access to authorized shares, but outside of that we have not had any discussions.
After careful analysis of the news of that $7.5 million injection into the company on Friday, one financial analyst told BioMedReports this weekend that "the filing and press release looks like the company has positioned itself with what looks like a line of credit. If we are to assume, as previously reported, that the company has been busy trying to fill orders and install new systems as part of their responsibility to new and existing contracts, then it makes sense that they would need working capital. When you're a company at the commercial stage with a product that you need to build and sell into the market, you're going to need money this credit line certainly gives them that."
Investors in the biotech sector are not used to seeing opportunities like this often because so much of what they invest in is highly speculative. Even the most modest new drug candidate may be years away from commercialization and production, yet we often see these biotech companies dilute shares constantly due to research and development costs.
We know based on the interviews and filings that we've seen on this company that they are growing and thus far doing a good job of securing a position that provides a base for further advancement in this very lucrative, yet equally competitive sector where company shares trade at 14-25x earnings.
We also know that this is a fully reporting company that just turned a year over year profit with a growing number of orders pending for a product that is not only saving hospitals and clinics big money in their processing and handling of regulated medical waste, but that buyers who are placing the orders have a great deal of flexibility on paying for the systems.
As we understand it, the company has arranged deals for leasing, purchase financing and even straight rentals of these innovative systems. That makes product purchases/acquisitions appealing to many more healthcare facilities and it allows them to order these systems knowing they have not only flexibility for payment, but that their cost recoupment opportunities with these systems are very good.
"The bigger the facility and the more medical waste they are producing, the faster the system is going to pay for itself," explained David Laky, President and Chief Executive Officer of MedClean. He pointed out to BioMedReports that many of the traditional and costly processing expenses being charged by competitors are eliminated with the new MedClean Systems. He also reported that his company's rental program has been a very favorable to both the hospitals and to MedClean."
As Chairman Scott Grisanti points out, "The market opportunity in the U.S. medical waste market is two billion dollars a year and that’s about three point one billion pounds, and of that, half a billion dollars a year, one point four billion pounds are what’s called the large quantity generator market, which is principally the hospital market, so that gives you a feel for where we stand. After that, the balance are small quantity generators and the company is keenly interested in that segment and looks to expand its offering in the future." [Watch for our upcoming report on BioMedical Technology Solutions (OTC:BMTL) a company that is very much focused on that sector of "small quantity generators" like private practice doctor and dentist offices.]
Here is a transcript of our interview with company officals:
BiomedReports: One thing that caught our eye about your company was the interest in your group from MedAssets (NASDAQ: MDAS), especially since it’s one of the largest purchasing groups in the country. Can you talk about that contract and what it entails?
Scott Grisanti, Chairman of the Board MCLN: The MedAssets agreement earlier this year was a pretty exciting milestone for us. I think that MedAssets is really setting the bar for what a GPO (group purchasing organization) needs to be and for what a GPO needs to do in the current health care environment in order to deliver value, and I’m talking specifically about the MedAssets differentiated value proposition which counts heavily on domain and business process expertise and technologies to handle things such as revenue cycle management really surrounding the core GPO services. So we see MedAssets as an up and comer in the GPO area and we see their inclusion of our MedClean system available to the members through that contract as yet another example of that forward thinking approach as MedAssets focuses more and more on delivering value to their constituent hospitals that go beyond the basic better price on rubber gloves value proposition that has been their cornerstone of the traditional GPO business.
From the MedClean perspective, of course, being on the MedAssets GPO contracts insures that many participating hospitals can sole source our Medclean system, so that’s a big advantage, especially in the health care market, which as you probably know is often bogged down by a very big decision making processes. So having those pre-negotiated terms of conditions and inclusion on the contract to facilitate transactions more quickly we believe will over time give great value to us.
BioMedReports: Our understanding is the contract is immediate, correct? So anytime they want to start implementing the Medclean system in their MedAssets group purchasing in the hospitals that they can do that immediately, is that correct?
Scott Grisanti, Chairman of the Board MCLN: That’s right. Any hospital can acquire our Medclean system off of its MedAssets GPO contract and there are provisions in that agreement to handle the fact that unlike the rubber gloves example, solutions like ours do require configuration, that almost without exception is specific to the institution. So all of that is taken into account and prepackaged.
BioMedReports: Regarding your management team. There has been a lot of discussion in-house that you guys have a pretty solid team with some great experience growing companies together. You guys share ties from your days at eResearchTechnology, Inc (Nasdaq:ERES). During your tenure there, the company's market valuation grew from $27 million to a peak of $1.5 billion, receiving recognition from Fortune Magazine as the number two fastest growing company in America. Can you talk about that and how all of it came together?
Scott Grisanti, Chairman of the Board MCLN: Sure, we are very proud of our team and the current management team really coalesced around the capitalization of the company over the summer of 2008. As part of that process, I became aware of the Medclean opportunity. The company, at that point was known under a different name- Aduramed- through a gentleman that was working as a consultant for the company. Until recently he served as our chairman and continues to serve as a board member and consultant. I'm speaking about Joe Esposito. Joe has a terrific reputation for driving value for shareholders, for customers, and for employees at a wide variety of companies. He had been working with Medclean for about a year. At the point that I became involved with Medclean, I had just finished a stint with Primavera Systems, which is an enterprise application software provider in the project and program management area. That accompany had been in business for about twenty three years and was recapitalized in 2006 and I became engaged with Primavera as the Executive Vice President of Sales, Marketing and Services as part of that recap process. That enabled me to take on some new opportunities and participate in the recap of the company as an investor and agreed for the next leg of the journey to assume the CEO and present role. What we did soon after that was bring on a couple of key people, including David Lakey (Medclean's current CEO), who u are familiar with and Dave can discuss his background as we have gone down the path over the past year. Dave was at the point where he was able to step into the CEO and President role and as part of our overall succession planning. I now have transitioned into the chairman role and am supporting the team in the further execution of our strategy.
I think that one of the many nice things about this team is not just the level of experience and track record and success but also the fact that from day one at Aduramed, we already had sufficient experience working with each other and that piece of the puzzle was already in place. That’s very important when you’re moving into a new industry, and a new market that is undergoing some rapid changes.
David Laky, President and Chief Executive Officer, MCLN: I came from research technology, where Joe and Scott were members of and Joe was CEO and President there. I was responsible for the electronic data capture division of that company. There was somewhere between seven and nine million dollars there that I was responsible for in that line of business within eResearchTechnology. eResearch had focused on two lines of business, product safety and electronic data capture.
When I saw what was going on with Medclean and the opportunity that Joe and Scott were working there and that I could join back with the team, obviously that was exciting to me from several aspects. I was running a line of business that was not the primary line of business of the company while I could gain great experience and worked closely with Scott and Joe at eResearch. Soon after I left eResearch they actually sold that line of business.so it was time to make that transition. I had joined eResearch in 1999 and worked my way all the way up the ranks including professional services, sales support, sales, and then full p&l responsibility for the line of business and it was time for me to start looking for another opportunity presented itself and I was excited to work back with the team members and step out of the software world. I had been doing software sine ninety one and I wanted to get into a combination of different areas and stay in the health field and this was a good opportunity.
Scott Grisanti, Chairman of the Board MCLN: So what you have here at Medclean is a core management team between us and Joe who understood what it was to drive eResearch from twenty eight million to one hundred nine million in revenue and more importantly deliver shareholder value by increasing market cap. So if you take a management team that can finish each other’s sentences and has a track record like that and place it in this highly fragmented (something) market for onsite treatment of regulated medical waste and confidential document destruction in a hospital market. It creates a real opportunity for Medclean to emerge as a breakout player in the market.
David Laky, President and Chief Executive Officer, MCLN: When we got to the company, we wanted to insure that there were defined processes, defined procedures, defined customer support mechanisms that were in place to insure that we could work with our current customers, plus develop a process and strategy for moving forward where we added value for our customers, but also delivered in a very professional manner and turn the business into a more professionally run and process driven environment, which could result in expanding and growing the business, because we had the repeatable processes in place and not one off type of sales, so we have been spending time developing structure around the business model to support the business model.
BioMedReports: That’s one of the things that made me want to get you guys on our investor community's radar. Some of us had been a past shareholders in eResearch technology and it really struck me when I started looking at the bios of Medclean that basically a lot of the same management team was now at MedClean. We had also seen an article that was written in Fortune Magazine about the growth and so when I was looking here and seeing that there was a unique opportunity in the lucrative regulated medical waste field it suddenly looked very attractive to investors who often don't know if they should even be investing in penny stock level companies. I wondered if you guys could expand upon that. Also, you reached an agreement with the state of New Jersey, which is really difficult because the state of New Jersey is the pharmaceutical capital of the world in terms of drug companies. So to be able to establish a partnership with the state of New Jersey led us to believe that most others would follow suit. Could you talk about that? Do you see that is really going to enhance your partnerships with other states by bringing in additional added value and credibility?
Scott Grisanti, Chairman of the Board MCLN: First of all, the definition of regulated medical waste does not include pharmaceutical waste. Regulated medical waste is typically biohazardous waste, infectious waste. Pharm waste, especially in a hospital environment, is an area that on a state regional and national basis is beginning to get a lot more focus and certainly an area where I can see companies focusing over the coming years bringing solutions to market.
But today, the vast majority of pharm waste goes down the drain and it is actually legal to do so. But I expect that over time that will tighten up a bit as people are asking question about why there are salmon with male and female characteristics swimming around as a result of that waste leeching in the water supply, but that is out of the scope of what medclean currently offers just to clarify.
New Jersey was a very significant milestone because New Jersey is a very careful state when it comes to approving new technologies, especially in the treatment of biohazardous waste.
David Laky, President and Chief Executive Officer, MCLN: Let me talk a little bit about the professional approach from a management and process perspective that we brought to the table based on our experience with the rewards of discipline that we learned at eResearch. That’s really what carried the day in New Jersey. New Jersey had not approved a provider of onsite solutions for regulated medical waste since 2005 so we sat down with the folks at Health and Senior Services and the folks at the State Department of Environmental Protection and provided a very extensive documentation that made them comfortable with moving forward with an approval.
And New Jersey was ironically the only state where we did not have the ability to implement systems, so that was something that we set about pretty immediately and it involved a lot of outreach at the legislative area like the State Assembly and a number of people at the State Senate level.
We were able to retain a leading microbiological expert to vouch for our efficacy. Before folks approve you they want to make sure that your solution is efficacious and in this market that means that it kills the bad stuff in a consistent manner and also the appropriate legal counsel and we worked hand in glove, especially with the folks at the Department of Health and Senior Services in order to make them comfortable with our solution. And our right, that speaks loudly beyond the boundaries of the Garden State because New Jersey is notoriously demanding in regard to what it takes to get a solution approved.
So that, of course is something we are very proud of. Plus because it is a challenging environment to get approved in, the benefit of approval is that it becomes a very rich environment. We are working diligently in the New Jersey market to facilitate adoption of our solutions.
BioMedReports:So you've got a bunch of smart guys coming from the computer world. They decide to get into this field because you guys obviously saw a market opportunity here. Can you talk a little bit about that and give the investors a thumbnail sketch of what this potential marketplace is.. Maybe even talk about your competitors and how you guys are different?
Scott Grisanti, Chairman of the Board MCLN: Well, we are different in a couple of ways. First of all, arguably if you can get a comprehensive survey you would find, I would bet you sixty five to seventy five companies in the U.S. purporting to deliver solutions for onsite treatment of regulated medical waste, and in some cases HIPPA compliant destruction of confidential medical documents- which we do also- you would find that the vast majority of those companies, eighty to eight five percent, I don’t want to say are unprofessional, becuae that’s not for me to say, but it's cottage industry oriented, project oriented corporations.
In other words, these are small private companies while Medclean is a public corporation with a very solid management team. We are a growing public company in a world of small private companies, the same people find the project, sell the project, implement the project. The same people sit on the beach for two months and then they get around to thinking about another project. From a customer perspective, that often doesn’t inspire a lot of confidence, because you are turning over a very important high potential exposure area to a technology that a third party company has provided. So that is one way that we differentiate ourselves.
Through the documentation of our efficacy, which is second to none in the industry. So we really took the discipline with regard to validated systems and repeatable processes that we learned at eResearch and applied that same discipline to this space with regard to not just insuring from an engineering perspective that our systems generate the highest level of efficacy in the industry, but insuring that we have the broadest base of data that proves that conclusively. So that’s another way we differentiate ourselves.
Yet another way that we are different is in our acquisition and deployment options. Folks can buy the systems outright. They can obtain the systems through a compliant operating lease through Green Health Care Financial Solutions, which is a Limited Liability Corporation that we have set up in conjunction with another entity to exclusively serve our customers in the delivery of the Medclean solution in an operating expense manner.
We also have a rental program for folks who are not in a position to commit to long term usage.
Finally, the physical deployment of the systems. Many folks would like the equipment implemented within their facility inside their flow walls. However, we found that hospital space is at a premium, so we have taken our system components that we continue to offer for installation inside a facility, and now offer them preconfigured in a specially equipped industry standard shipping container. This preserves the space within the facility and eases implementation. Worst case scenario, implementation of our system is only two to three weeks, but it can sometimes involve what can be costly and complex at times from a planning perspective modifications inside the facility. If the ceiling isn’t high enough, you might have to dig a pit for a piece of equipment etc. With our on-demand container approach, all of that goes away.
Everything is preconfigured in the container, the container is dropped off. The special utility connections that come with kind of umbilical cord adapters that hook right into the utilities and you’re good to go. So literally, in a half day, you can drop off the system, train the operators and you’re good to go.
Better yet, you don’t have to take up a single square foot of space inside the hospital. As a matter of fact the way that we put together these containers is so unique that it is the subject of a patent that we have filed. In addition to that, the protocol, the software program that drives the sterilization of the treatment cycle that enables us to achieve the consistently high results of efficacy, is also unique that it is also the subject of a patent. So we are different with regard to the extent of the intellectual property aspects that we bring to the table to insure best practice.
So those are just a couple of the ways that we are different from the competition. Underlying all of this is a standard operation procedure based approach to the market and our customers. And that’s one of the things that we were able to bring to the table coming from a highly regulated clinical development environment that we came from coming into this kind of cottage oriented, highly fragmented industry.
BioMedReports: Can you talk about that industry and what opportunities you see there financially?
Scott Grisanti, Chairman of the Board MCLN: Without a doubt, there is tremendous opportunity in this market for onsite treatment of regulated medical waste, even if you set aside for a moment the HIPPA compliant destruction of confidential documents.
Several billion dollars a year are spent in the offsite hauling of regulated medical waste, so there is tremendous market opportunity. So the companies in the market for onsite treatment of waste are small and fragmented. The good news in this is that it is a largely untapped market. So this is a multibillion dollar market opportunity that renews every year. The hospitals never stop making infectious waste. So, it is a very underpenetrated market and no company has emerged with the capability and scalability to be a significant player and we need to be that significant player.
BioMedReports: What sort of milestones have you set for yourself towards becoming that significant player?
Scott Grisanti, Chairman of the Board MCLN: We don’t like to make projections in this public space especially, but the company, for example in 2008 posted a loss of seven point eight million dollars and if you look at our press release for the third quarter, we are happy to report that we are cash flow positive on the gap basis, so that is a very important milestone that we reached.
We also talked about the New Jesery approval, four years running, no new approvals, we were able to come in and get that done.
We conceived and brought to market the on demand container solution that I discussed.
We identified and protected two intellectual properties that I discussed.
We talked about the development and publication of the most extensive body of data in the industry and we capped it off at the end of last year with the rebranding of the company.
We took Aduramed and transformed it into MedClean which had been the name of the product line for a number of years.
We're looking to continue for that to be our strategy.
BioMedReports: The year over year was extremely impressive. You guys basically did that in two quarters correct? Because you went from Aduramed to MedClean in the first week in January
Scott Grisanti, Chairman of the Board MCLN: That was our rebranding. The new management of the company began in early September, the recap was in early august. I joined as CEO a month later in early September and Dave joined about five weeks later. So we’re really talking about what’s transpired in the last twelve months. We’re very excited about what we’re accomplishing. We’re excited about the future. We are careful to make clear that in order to continue to execute the strategy; we required a continued source of working capital.
We continue to work in that regard as we have said in our press releases. We are no different than most small companies these days in that respect and we continue to soldier on because we believe that we are in a position to make a difference.
BioMedReports: Could you talk a little bit about the backlogged orders: I noticed from the 10-Q that you guys have a lot of business coming in and some of the orders are backlogged and I’m curious. Is it because you haven’t been paid on those orders that you got or there was so much business going on that you can’t get to it all?
Scott Grisanti, Chairman of the Board MCLN: Well, we actually took to revenue. A significant amount of our backlog from the third quarter and that represented some systems that were sold earlier this year. And that’s outlined in the filings. In addition, there are a more customers where there are contracts in place, but we are awaiting further instruction on system installations.
BioMedReports: So there shouldn’t be a concern, perhaps from the investors who see that, that you guys can’t keep up with orders:
Scott Grisanti, Chairman of the Board MCLN: Oh, no, no, that should not be a concern at all. If that’s the feeling that that data was leaving you folks with, no. that is not a concern that we have.
BioMedReports: So just to make it clear, you are now able to take orders for these systems from all over the country right?
Scott Grisanti, Chairman of the Board MCLN: Yes, that’s right. And we have systems today ranging from California to Iowa to Texas to Massachusetts to New York to Maryland to Puerto Rico to Illinois. So we actually, for a small company have a pretty widely distributed customer base.
BioMedReports: Can you talk, then, about the manufacturing process at all? What type of bandwidth do you have?
Scott Grisanti, Chairman of the Board MCLN: We have a terrific facility in Connecticut where we can assemble, in parallel up to four of these containerized systems at a time. So we are certainly not bound by any manufacturing constraints because our manufacturing consists of assembling components that our built to our specifications by various suppliers and all of our various suppliers are very well equipped to address any demands that we might put on them. With regard to our second and third tier suppliers, a number of those components are commodity components. So there are physical constraints of course, but no logical constraints for the business.
BioMedReports: Finally, we want your thoughts on this great partnership that you announced in September with a private company called Vastara. Many of our investors wondered if you could talk about them and perhaps touch upon some of the advantages of the partnership. At first glance, it looks like they are in the same industry you guys are in.
Scott Grisanti, Chairman of the Board MCLN: Vastara is a very interesting company. They are really at the forefront of the Pharmaceutical Waste space, and their solutions do not include onsite destruction of pharma waste, but really focus on proper classification of pharm waste. As it turns out, there are many variations of pharma waste and Vastaras solution insures that pharma waste is sorted properly so that the right waste ends up in the right waste streams and we do mention as does the Vastara team, that the partnerships that we have and the associated solutions as we move forward in the future is very symbiotic. I think that the evolution for the market that Vastara serves is earlier on than the one Medclean does. We are very excited for what the future has to hold for that company and our partnership.
Disclosure: Long MCLN
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
Genta to supply gallium nitrate injection for new cystic fibrosis trial
Sat. December 05, 2009; Posted: 05:17 AM
Dec 05, 2009 (Datamonitor via COMTEX) -- GETA News | PowerRating -- Genta, a biotechnology company, has reported that it will supply Ganite, a gallium nitrate injection, for a new clinical trial that will be initiated in patients with cystic fibrosis who may develop serious infections.
The initial clinical trial using a gallium compound for this purpose will involve patients with cystic fibrosis (CF) who will be treated at the University of Washington in Seattle, Washington and the University of Iowa, Iowa City, Iowa.
If initial results are promising, additional trials will be conducted with additional medical centers and a larger number of patients. Genta has provided cross-reference to its investigational new drug exemption for Ganite, and the company will supply the drug at no cost to patients in the trial. The study is also supported by grants awarded by the orphan products division of the FDA and by the Cystic Fibrosis Foundation.
Ganite is exclusively marketed by Genta and is approved in the US for the treatment of cancer-related hypercalcemia that is resistant to hydration.
Raymond Warrell, Jr, Genta's CEO, said: "This trial represents the rapid clinical translation of enormously promising observations. Initial results from our first CF patient showed that systemic treatment achieved target gallium levels in sputum, and that these levels could be sustained for a prolonged duration.
"Pseudomonas infections in CF are exceptionally difficult to eradicate. If initial results of the intravenous drug in this trial are promising, future patients might also benefit from extended therapy that could be afforded by one of our oral gallium compounds."
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Santarus (NASDAQ: SNTS) Caps off Strong Week with Second FDA Approval
Written by Mike Havrilla
Friday, 04 December 2009 16:44
Santarus (NASDAQ: SNTS) capped off a strong week with its second FDA approval announced AH today.
Following approval of Zegerid OTC earlier in the week, the FDA approved the Company's immediate-release omeprazole / sodium bicarbonate / magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD. The Agency has not yet approved a trade name for the new product.
Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days, at which time the Company plans to launch the product.
Disclosure: No positions
SAN DIEGO--(BUSINESS WIRE)--Santarus, Inc. (NASDAQ:SNTS - News), a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for immediate-release omeprazole/sodium bicarbonate/ magnesium hydroxide tablets in 40 mg and 20 mg dosage strengths of omeprazole. Santarus submitted the NDA for this tablet product in January 2009.
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The NDA for the new prescription tablet product was approved for all indications the company was seeking, including for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease, or GERD; however, the FDA has not yet approved a trade name for the new product. Santarus has submitted an NDA supplement requesting approval of a proposed trade name that includes the “ZEGERID®” brand name and anticipates that the FDA will complete its review of this NDA supplement within 180 days.
“We are pleased to receive FDA approval for our new immediate-release prescription tablet product and our current plans are to launch in 2010 following approval of our NDA supplement,” said Gerald T. Proehl, president and chief executive officer. “With its dual buffering system and convenient tablet dosage form, we believe this new immediate-release omeprazole product will be an attractive addition to our ZEGERID family of prescription products for the treatment of GERD and certain other upper GI conditions.”
The new dual buffer tablet product is an immediate-release proton pump inhibitor (PPI) that combines omeprazole with the antacids sodium bicarbonate and magnesium hydroxide. The antacids protect the omeprazole from acid degradation and facilitate its rapid absorption. Santarus also promotes ZEGERID® (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension to gastroenterologists and other selected physicians. Santarus reported net product sales for ZEGERID of $87 million for the nine months ended September 30, 2009.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets are indicated for the treatment of heartburn and other symptoms associated with GERD, for the short-term treatment of erosive esophagitis diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months), and for short-term treatment of active benign gastric ulcer and active duodenal ulcer.
Important Safety Information
The most frequently reported adverse events with omeprazole/sodium bicarbonate/magnesium hydroxide tablets are headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. For more information about these and other events, please see Section 6 of the full Prescribing Information. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets contain 750 mg (9 mEq) of sodium bicarbonate (equivalent to 209 mg of Na+) and 343 mg (12 mEq) of magnesium hydroxide (equivalent to 143 mg of Mg2+).
The sodium content of this product should be taken into consideration when administering to patients on a sodium-restricted diet or at risk of developing congestive heart failure (CHF).
Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. Increased sodium intake can cause swelling and weight gain.
Magnesium content increases risk of hypermagnesemia and magnesium toxicity in the elderly and in patients with renal impairment or renal disease.
Omeprazole/sodium bicarbonate/magnesium hydroxide tablets are contraindicated in patients with known hypersensitivity to any component of the formulation.
Since both 20 mg and 40 mg omeprazole/sodium bicarbonate/magnesium hydroxide tablets contain the same amount of sodium bicarbonate and magnesium hydroxide, two 20 mg tablets are not equivalent to, and should not be substituted for, one 40 mg tablet. This would result in taking twice the amount of sodium bicarbonate and magnesium hydroxide.
About Santarus
Santarus, Inc. is a specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address the needs of patients treated by gastroenterologists and other physicians. The company’s current commercial efforts are focused on ZEGERID® (omeprazole/sodium bicarbonate), which is indicated for the treatment of certain upper GI diseases and disorders, and on GLUMETZA® (metformin hydrochloride extended release tablets), which is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Santarus is also developing two late-stage lower GI product candidates, budesonide MMX® and rifamycin SV MMX®, for the U.S. market. Budesonide MMX is being investigated in two multicenter Phase III clinical trials for the induction of remission of mild or moderate active ulcerative colitis. Rifamycin SV MMX has been investigated in a Phase II clinical program in travelers’ diarrhea. More information about Santarus is available on the company’s Web site at www.santarus.com.
Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the timing for the FDA’s review of the NDA supplement and for the anticipated launch of the immediate-release omeprazole tablet product, and whether the new tablet product will be an attractive addition to the ZEGERID family of products.
The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans or objectives will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus’ business, including, without limitation: the timing for and outcome of the FDA’s review of the NDA supplement requesting approval of a proposed trade name for the new immediate-release omeprazole tablet product; timing for commercial availability of the new tablet product; whether Santarus is able to generate market demand and acceptance for the new tablet product; the scope and validity of patent protection for the new tablet product and Santarus’ other ZEGERID products, including the outcome and duration of the pending patent infringement lawsuit against Par Pharmaceutical, Inc., and Santarus’ ability to commercialize the new tablet product and its other ZEGERID products without infringing the patent rights of others; other difficulties or delays in development, testing, manufacturing and marketing of, and obtaining and maintaining regulatory approvals for, Santarus’ products; and other risks detailed in Santarus’ prior press releases as well as in public periodic filings with the Securities and Exchange Commission.
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 Santarus undertakes no obligation to revise or update this news 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.
Santarus® and ZEGERID® are registered trademarks of Santarus, Inc. GLUMETZA® is a registered trademark of Biovail Laboratories International S.r.l. licensed exclusively in the United States to Depomed, Inc. MMX® is a registered trademark of Cosmo Technologies Limited.
Contact:
Company Contact:
Santarus, Inc.
Martha L. Hough, 858-314-5824
VP Finance & Investor Relations
Debra P. Crawford, 310-691-7100
Chief Financial Officer
or
Investor Contact:
Lippert/Heilshorn & Associates, Inc.
Jody Cain (jcain@lhai.com), 858-314-5708
Bruce Voss (bvoss@lhai.com), 858-314-5708
News
for 'HESG' - (Health Sciences Group in Negotiations to Joint Venture and Acquire Two Montana Marijuana Growers and Caregivers Companies)
INDIAN HARBOR BEACH, FL, Dec 04, 2009 (MARKETWIRE via COMTEX) -- Health
Sciences Group, Inc. (PINKSHEETS: HESG) would like to announce that it is in
strong negotiations to acquire a minority stake in two separate Montana-based
marijuana growing, distribution and care giving operations.
"This is part of our strategy, acquiring existing operations as well as starting
new operations. We feel that the profits in Medical Marijuana are in growing and
transportation of marijuana," states Thomas Gaffney, CEO of Health Sciences
Group.
Gaffney continues, "We are still working with Medical Marijuana, Inc. on doing
business in California and we are also exploring operation businesses in
Colorado."
The deals would more or less be partnerships. HESG would fund the operations for
expansion and growth of the existing business. The negotiations are moving
quickly and we expect them to close no later than the end of December 2009 or
the first of the year.
"With these acquisitions, HESG would be the first public company with actual
operation of a Medical Marijuana business," states Gaffney. "Once the
preliminary documents are decided and signed we will announce the names; until
then we are keeping the names of the Companies under wraps. The public can
expect the names of the companies to be exposed by the middle of next week."
In the State of Montana you must be licensed as an actual caregiver to grow
marijuana. Combined, each of these operations have approximately 100 patients
combined.
Below is a portion of the Montana medical Marijuana Act.
Montana Medical Marijuana Act
INITIATIVE NO. 148
NEW SECTION. Section 1. Short title. [Sections 1 through 9] may be cited as
the "Medical Marijuana Act".
NEW SECTION. Section 2. Definitions. As used in [sections 1 through 9], the
following definitions apply:
(1) "Debilitating medical condition" means: (a) cancer, glaucoma, or
positive status for human immunodeficiency virus, acquired immune
deficiency syndrome, or the treatment of these conditions; (b) a
chronic or debilitating disease or medical condition or its treatment
that produces one or more of the following:
(i) cachexia or wasting syndrome;(ii) severe or chronic pain;(iii)
severe nausea;(iv) seizures, including but not limited to seizures
caused by epilepsy; or(v) severe or persistent muscle spasms,
including but not limited to spasms caused by multiple sclerosis or
Crohn's disease; or
(c) any other medical condition or treatment for a medical condition
adopted by the department by rule. (2) "Department" means the
department of public health and human services. (3) "Marijuana" has the
meaning provided in 50-32-101. (4) "Medical use" means the acquisition,
possession, cultivation, manufacture, use, delivery, transfer, or
transportation of marijuana or paraphernalia relating to the
consumption of marijuana to alleviate the symptoms or effects of a
qualifying patient's debilitating medical condition. (5) "Physician"
means a person who is licensed under Title 37, chapter 3. (6) (a)
"Caregiver" means an individual, 18 years of age or older who has
agreed to undertake responsibility for managing the well-being of a
person with respect to the medical use of marijuana. A qualifying
patient may have only one caregiver at any one time.
(b) The term does not include the qualifying patient's physician. (7)
"Qualifying patient" means a person who has been diagnosed by a physician
as having a debilitating medical condition. (8) "Registry identification
card" means a document issued by the department that identifies a person as
a qualifying patient or caregiver. (9) (a) "Usable marijuana" means the
dried leaves and flowers of marijuana and any mixture or preparation of
marijuana.
(b) The term does not include the seeds, stalks, and roots of the plant.
(10) "Written certification" means a qualifying patient's medical records
or a statement signed by a physician stating that in the physician's
professional opinion, after having completed a full assessment of the
qualifying patient's medical history and current medical condition made in
the course of a bona fide physician-patient relationship, the qualifying
patient has a debilitating medical condition and the potential benefits of
the medical use of marijuana would likely outweigh the health risks for the
qualifying patient.
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to
consumers, physicians and other healthcare professionals through its website,
www.igohealthy.org, and health focused publications. The Health Sciences network
consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The
Company operates in three segments: Online Services, Publishing and Other
Services. The Company is recently exploring options of corporate growth within
the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
Biel Update-Joel Noel
Lots of worried investors here and I don't blame you. Got a Call from Lady V a few minutes ago and she asked to address a few concerns. So, here goes.
First off - Everything is fine. We are adding a few last minute important enhancements to the 510Ks - Here's the story - As of early this week the file was really very good, but it was not 100% perfect. We only want to file an application that is perfect. Over the past week we enhanced the application with a usability study that we just completed. This enhances the OTC part of the application. We could have gone without it, but we have selected to include it. I think it is the right thing to do. We are also adding to the file two medical papers about the affects of ActiPatch on cells. These are written by Genecov and one other MD - both of whom have many years of clinical trial experience. This will further enhance the file. We have made the choice to take a few extra days to add this info - it will make the applications much better. We want to give the FDA reviewer every tool available to give us fast clearance.
We have also taken a few extra days to have our law firm review the application one last time. This too is a wise management decision. The lawyers say this will be a very strong submission - every "I" is being dotted and every "T" crossed. We feel this is too important to rush out the door.
The final product will be a very strong file that we feel willl have very high odds of clearance. In the past, some have critized BEIL management for being a bit careless about procedures and to some extent this was correct. Now, however, we are taking the extra time to make sure everything is perfect and I am confident it will be. We are very confident this application will be successful.
Some will critize us for the delay, but I remind you that BIEL is a very small company - we are not Pfizer or Merck. A good percentage of the team has been pulled away to take care of the information request from pink sheets. The rest of us are finalizing the 510K. It will pop out of BIEL over the next few trading days. Everyone needs to hold on and have some patience. Taking a few extra days makes sense.
I will close by saying that I have been involved with BIEL for well more than a year and know this story well. I have never been more confident in the company's future. I believe the file that will go to FDA will be stellar - we have taken the time to do it right. The clinicals are very strong and safety is 100% I also believe, as do our FDA lawyers, that odds of clearance are extremely high. It's coming - sit tight.
Joe Noel
I suggest everyone listen to the CC. you can go to HEB's website to listen. It was very detailed and concise. I liked what I heard and remain very positive on this company.Everyone is frustrated that FDA approval did not happen now ,but a little more patience, in my option we will win big.
Health Sciences Retires Common Shares
Date : 12/02/2009 @ 11:00AM
Source : MarketWire
Stock : Health Sciences Group, Inc. (HESG)
Quote : 0.001 0.0001 (11.11%) @ 11:01AM
Health Sciences Retires Common Shares
INDIAN HARBOR BEACH, FL -- (Marketwire) -- 12/02/09 -- Health Sciences Group, Inc.
(PINKSHEETS: HESG) would like to announce that as of today December 2, 2009 it has officially cancelled (retired) 2 billion shares of common stock.
This retirement of shares has come from 500,000,000 shares of Thomas Gaffney's personal shares and 1.5 billion shares that the Company set aside for the acquisition of Modus Health Care that never closed.
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other healthcare professionals through its website, www.igohealthy.org, and health focused publications. The Health Sciences network consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties.
Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Health Sciences Group, Inc. to be materially different from the statements made herein.
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By Staff
CONTACT:
Health Sciences Group, Inc.
Thomas Gaffney
President and CEO
(321) 604-1451
Email Contact
FDA Approval Means Millions for Santarus
Written by Terika Ray
Tuesday, 01 December 2009 20:35
Santarus (NASDAQ:SNTS), the specialty biopharmaceutical company focused on acquiring, developing and commercializing proprietary products that address needs within the Gastrointestinal (GI) Industry earned a $20 million milestone and may be entitled to receive up to an additional $37.5 million in sales milestones following a key FDA decision on Tuesday. The company is expecting another FDA decision this Friday.
Thus far, Marketing their two lead products, Zegerid® and Glumetza® has resulted in achieving a 70% Compound Annual Growth Rate (CAGR) (2005 – 2008) and a 23rd rank for the fastest growing company in North America by Deloitte and Touche technology fast 500.
drugClearly SNTS has a proven track record, but can they maintain this successful growth given their key FDA related developments?
On Tuesay afternoon, the U.S. Food and Drug Administration approved Schering-Plough HealthCare Products, Inc.’s, New Drug Application (NDA) for ZEGERID OTC™ Capsules (omeprazole/sodium bicarbonate) with a dosage strength of 20 mg of omeprazole for over-the-counter (OTC) treatment of frequent heartburn. The NDA was submitted by Schering-Plough under the terms of a license agreement for OTC proton pump inhibitor (PPI) products using Santarus’ proprietary technology.
SANTARUS
Quotes delayed at least 20 mins.
Upon approval, Santarus has earned a $20 million milestone and may be entitled to receive up to an additional $37.5 million in sales milestones. Santarus will also be entitled to a low double-digit royalty, subject to adjustment in certain circumstances, on net sales of any ZEGERID OTC products sold by Schering-Plough HealthCare Products under the license agreement. In turn, Santarus will be obligated to pay royalties to the University of Missouri on net sales of any such OTC products.
The OTC heartburn market in the U.S. is estimated at $1.7 billion based on data from Information Resources, Inc., a market research firm, and company estimates. Zegerid®'s over the counter use (OTC) can boost revenue up to ~$1 Billion in the U.S alone.
“We are pleased that Schering-Plough HealthCare Products has achieved this significant regulatory milestone for ZEGERID OTC and we look forward to seeing the product on retail store shelves across the United States in the first half of 2010,” said Gerald T. Proehl, president and chief executive officer of Santarus. “We believe the consumer advertising and publicity associated with the launch of ZEGERID OTC will increase awareness of the ZEGERID® brand.”
The Players
Proton Pump Inhibitors (PPI) are drugs that treat ulcers and Gastro esophageal reflux disease (GERD), which is a common condition in which food or liquid travels backwards from the stomach to the esophagus (the tube from the mouth to the stomach). This action can irritate the esophagus, causing heartburn and other symptoms.
Although the PPI market is saturated, no PPI is currently approved for the prevention of upper GI bleeding (UGI) and as an immediate release PPI. The table below shows the competitive product comparison (Rx=prescription, OTC= over the counter).
The table below shows popularity growth for Zegerid® over 12 months compared to its competitors (prior to Prevacid® OTC launch in Nov. 2009). [NRx=new dispensed prescriptions, TRx=total dispensed prescriptions]
With the OTC heartburn market growing from $1.14 Billion in 2005 to $1.24 Billion in 2008 and competitors like Novartis spending ~ $200 MM to launch Prevacid® OTC, increasing brand equity, Zegerid® OTC is a key contribution to the SNTS portfolio.
The Profitability
Business Strengths
* SNTS' business strategy of licensing technology in niche markets and providing a service of clinical research, development, regulatory and commercialization without a full R&D department enables them to avoid the expense of drug discovery and infrastructure, while generating significant revenue through agreement payments and sales. In other words, efficiency is gained with high return and minimal investment, resulting in high bottom line growth.
* The on-going agreement with Schering Plough (S-P) to develop, manufacture, and commercialize Zegerid® OTC in North America leverages S-P’s expertise and success with transferring Claritin® Rx to OTC to build brand equity, optimizing sales
* The recent merger of Schering-Plough (S-P) and Merck may strengthen the S-P commercialization force of Zegerid® OTC in North America
* The on-going agreement with GSK to develop, manufacture, and commercialize both Zegerid® Rx and OTC in the International PPI markets worth $2.6 Billion should contribute significantly to revenue growth, given the FDA approval in some countries (excludes Europe, Australia, Japan and Canada)
* The agreement with Norgine to launch Zegerid® Rx in Europe leverages Norgine’s GI expertise without attracting attention from the more powerful competitors. Additional gains could be obtained via the Euro exchange rate conversion to the US Dollar
* Exclusive agreement with Depomed enables SNTS to promote Glumetza® and receive a fee payment ranging from 75% to 80% of the gross margin associated with net sales of Glumetza®. SNTS will be responsible for all costs associated with its sales force and for all other marketing expenses associated with its promotion of Glumetza®.
* Strong product differentiation, value positioning and brand equity. Zegerid® is the only PPI immediate release & UGI bleeding prevention drug. In fact, “74% of frequent heart burn sufferers indicated that they prefer an immediate release product over a delayed release product…”. Glumetza® grew to be the #1 prescribed metformin drug in July 2009 and is growing in popularity as the only extended release technology that accomplishes the ADA recommended titration levels without the competitor side effects.
* SNTS constantly tracks and monitors ROI to manage finances. For example, SNTS exited out of Medicaid and terminated its contract with Otsuka pharmaceuticals due to low ROI and to maintain efficiency. The $7.6 MM net income through Sept. 30 2009 and net positive cash flow are indicators of a healthy financial status
Marketing Opportunities
* SNTS seeks to increase current product sales penetration and expand its product portfolio by including Zegerid® OTC, Zegerid® tablet line extension, along with new diverse products Budesonide and Rifamycin that treat ailments affecting a total of 13.5 million patients a year, protected by patents from 2016 to 2025, pending some approvals
* SNTS 2010 revenue potential, considering only Zegerid® RX and OTC sales & agreements, totals up to ~ $2.67 Billion plus additional royalty payments plus additional sales from SNTS commercialization of Zegerid® Rx
* Zegerid® Rx indications are different from that of Zegerid® OTC, enabling SNTS to maximize sales for Zegerid® OTC without significantly reducing Zegerid® Rx sales. In fact, “Prevailing theory holds that switched products hold onto a good portion of existing prescription patients. However, that may only apply to first-in-class switches. Last year, Wolters Kluwer Health and The Nielsen Co. followed McNeil Consumer Healthcare's switch of Zyrtec, the second second-generation antihistamine to reach the market, finding that a full 84% of those who switched to Zyrtec OTC weren't former Zyrtec prescription users, but former Claritin® and Benadryl users. That suggests a lower carryover from the base of prescription users.”
* Proctor & Gamble sought a petition to prevent Zegerid® from claiming the powerful position as an “immediate release PPI”, which was rejected by the FDA. This is an opportunity for Zegerid® OTC to dominate PPI market sales
Business Weaknesses
* Agreements can be terminated and constant effort must be exerted to seek new business developments. For example, TAP terminated the agreement to commercialize Zegerid® Rx. But, SNTS overcame the challenge and partnered with GSK and S-P.
* If Zegerid® OTC is approved, SNTS/ S-P face the challenge of persuading consumers to switch to Zegerid® OTC brand. Strong brand equity and value positioning, along with S-P success and expertise with OTC drugs should facilitate the persuasion, optimizing sales
* Managing growth with rapid expansion in multiple, diverse markets may pose a challenge. But licensing agreements with powerful resources like GSK and S-P should facilitate management
External Threats
* Healthcare reform changes could impact revenue. Zegerid® OTC would be a positive move potentially offsetting any negative health care reform effects. In fact, “Consumer use of OTC heartburn medications saves the U.S. healthcare system $757 million annually, and saves the average consumer $174 annually. (CHPA and The Nielsen Company, 2009)”
* A recent FDA notice could negatively impact sales. 19 Nov 2009: “Federal health officials said a popular variety of heartburn medications [PPI drug class] can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke.” The FDA recommends a non-PPI from the H-2 blocker family for these patients.
* The judge has ruled Par Pharmaceutical infringed on the Zegerid® patent, but has yet to enforce it which would prevent Par from manufacturing a generic Zegerid®. Final ruling is expected in 2010 or later
* Threat of competition is high: The PPI drug market is saturated with powerful competitors. Merck was granted patent licensing rights to Depomed’s metformin technology in July 2009 to market the competitor Januvia® to treat diabetes type 2 and Teva Pharmaceuticals promotes the generic competitor Glucophage XR® as of April 2008. However, SNTS does not expect a significant impact on sales. Another law suit is pending with Lupin Pharmaceuticals for patent infringement on Glumetza®
* Threat of substitutes is moderate: As Diet & exercise and Obesity drugs promote a healthier lifestyle, they can negatively impact future sales, but not likely in the near future. In fact, “A number of studies suggest that obesity contributes to gastro esophageal reflux [GERD]. For instance, the Nurses Health Study found that being overweight or obese significantly increased reflux symptoms in women. (Women who lost weight in the study, meanwhile, had fewer symptoms.)” The recent FDA notice regarding PPI interference with Plavix, may drive sales away from PPI’s to H-2 blockers, depending on the percentage of the PPI target market taking Plavix
The Zegerid® Product (How it works)
The antacid, sodium bicarbonate neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption, reducing relief time to within 30 minutes.
The Verdict
SNTS has a strong Track record of growth despite challenges and successful business management, indicating promising future performance, assuming the same management team exists.
Zegerid® OTC is a strong competitive product as the first and only PPI immediate release OTC drug AND the key product for significant net income growth for SNTS..
Terika Ray, PMP, M.S is a new contributor to BioMedReports who brings an expertise in Marketing/ Product Management, Portfolio Management, Engineering & Biomedical Sciences
Disclosure: Long SNTS
BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read at the bottom of / About Us / Section
Health Sciences Makes Progress on Medical Marijuana Endeavors
* Press Release
* Source: Health Sciences Group, Inc
* On 1:05 pm EST, Tuesday December 1, 2009
Companies:
o Health Sciences Gr
INDIAN HARBOR BEACH, FL--(Marketwire - 12/01/09) - Health Sciences Group, Inc. (Pinksheets:HESG - News) would like to announce that:
Related Quotes
Symbol Price Change
HESG.PK 0.0008 -0.0002
Chart for HEALTH SCIENCES GR
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1. It has had positive feedback from Medical Marijuana, Inc. (MJNA) about the expansion and revenue producing areas allowed within the United States pertaining to marijuana collectives versus marijuana dispensaries. The revenues to be generated through collectives (the grow end) is much more lucrative than entering into management fees non-profit marijuana dispensaries. On a side note it is estimated that the growing end of marijuana through collectives in California can exceed revenue of $400,000 per month. Therefore the Company will be immediately seeking opportunities within the "growing and transportation" end of legalized marijuana licensing.
2. The Company has entered into preliminary negotiations with Greenway University for joint venture / consulting agreements for Colorado operations pertaining to growing, transportation and dispensaries.
3. The Company has been in preliminary talks with growers and dispensaries in Montana and Oregon for possible joint ventures or acquisitions.
We believe that we-Health Sciences have entered this industry at the right time. We believe that if we continue to make progress and develop relationships with people within the movement of using marijuana for medical purposes we will all succeed.
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other healthcare professionals through its website, www.igohealthy.org, and health focused publications. The Health Sciences network consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Health Sciences Group, Inc. to be materially different from the statements made herein.
Contact:
By Staff
CONTACT:
Health Sciences Group, Inc.
Thomas Gaffney
President and CEO
(321) 604-1451
Email Contact
Rodman and Renshaw Upcoming PDUFA Dates
11/26/2009, Theravance, Inc. (THRX, Not Rated), Telavancin, Nosocomial Pneumonia (Hospital-Acquired
Pneumonia) Caused By Gram-Positive Bacteria, Such As Methicillin-Resistant Staphylococcus aureus (MRSA)
(Confirmed)
12/01/2009, Dyax Corp. (DYAX, Not Rated), DX-88 (Ecallantide), Hereditary Angioedema (HAE) (Confirmed)
12/09/2009, Santarus, Inc. (SNTS, Not Rated)/ Schering-Plough Corporation (SGP, Not Rated), Zegerid OTC
(Omeprazole/Sodium Bicarbonate), Frequent Heartburn (Estimated)
12/11/2009, Vion Pharmaceuticals, Inc. (VION, Not Rated), Onrigin (Laromustine)/Formerly Cloretazine, De Novo
Poor-Risk Acute Myeloid Leukemia (AML) In Patients Sixty Years Of Age Or Older
12/18/2009, Schering-Plough Corporation (SGP, Not Rated), Saphris (Asenapine), Schizophrenia, Bipolar
Disorder. (estimated)
Dec 2009, Genzyme Corporation (GENZ Not Rated), Genzyme Oncology Clolar (Clofarabine), Acute
Myelogenous Leukemia (AML) In Previously Untreated Adults Aged 60 years Or Older (Confirmed)
Fall 2009, Hemispherx BioPharma, Inc (HEB, Not Rated), Ampligen (Double Stranded RNA Toll-Like Receptor-3
Agonist), Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis(ME)
01/16/2010, MannKind Corporation (MNKD, Market Outperform), Afresa (Technosphere Inhaled Insulin System),
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes, Insulin Dependent Diabetes Mellitus
(IDDM)/Type 1 Diabetesv (estimated)
01/22/2010, SkyePharma PLC (ADR) (SKYEY, Not Rated)/ Abbott Laboratories (ABT, Not Rated), Flutiform
(Formoterol/Fluticasone), Maintenance Treatment Of Asthma In Patients 12 Years Of Age and Older (estimated)
02/09/2010, GlaxoSmithKline plc (ADR) (GSK. Not Rated)/ XenoPort, Inc. (XNPT, Market Outperform), Solzira
(Gabapentin Prodrug)/XP13512, Restless Leg Syndrome (RLS) (Estimated)
Upcoming Scientific
Rodman and Renshaw Upcoming PDUFA Dates
11/26/2009, Theravance, Inc. (THRX, Not Rated), Telavancin, Nosocomial Pneumonia (Hospital-Acquired
Pneumonia) Caused By Gram-Positive Bacteria, Such As Methicillin-Resistant Staphylococcus aureus (MRSA)
(Confirmed)
12/01/2009, Dyax Corp. (DYAX, Not Rated), DX-88 (Ecallantide), Hereditary Angioedema (HAE) (Confirmed)
12/09/2009, Santarus, Inc. (SNTS, Not Rated)/ Schering-Plough Corporation (SGP, Not Rated), Zegerid OTC
(Omeprazole/Sodium Bicarbonate), Frequent Heartburn (Estimated)
12/11/2009, Vion Pharmaceuticals, Inc. (VION, Not Rated), Onrigin (Laromustine)/Formerly Cloretazine, De Novo
Poor-Risk Acute Myeloid Leukemia (AML) In Patients Sixty Years Of Age Or Older
12/18/2009, Schering-Plough Corporation (SGP, Not Rated), Saphris (Asenapine), Schizophrenia, Bipolar
Disorder. (estimated)
Dec 2009, Genzyme Corporation (GENZ Not Rated), Genzyme Oncology Clolar (Clofarabine), Acute
Myelogenous Leukemia (AML) In Previously Untreated Adults Aged 60 years Or Older (Confirmed)
Fall 2009, Hemispherx BioPharma, Inc (HEB, Not Rated), Ampligen (Double Stranded RNA Toll-Like Receptor-3
Agonist), Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis(ME)
01/16/2010, MannKind Corporation (MNKD, Market Outperform), Afresa (Technosphere Inhaled Insulin System),
Non-Insulin Dependent Diabetes Mellitus (NIDDM)/Type 2 Diabetes, Insulin Dependent Diabetes Mellitus
(IDDM)/Type 1 Diabetesv (estimated)
01/22/2010, SkyePharma PLC (ADR) (SKYEY, Not Rated)/ Abbott Laboratories (ABT, Not Rated), Flutiform
(Formoterol/Fluticasone), Maintenance Treatment Of Asthma In Patients 12 Years Of Age and Older (estimated)
02/09/2010, GlaxoSmithKline plc (ADR) (GSK. Not Rated)/ XenoPort, Inc. (XNPT, Market Outperform), Solzira
(Gabapentin Prodrug)/XP13512, Restless Leg Syndrome (RLS) (Estimated)
Upcoming Scientific
Part I: One Man's Trash Is Another Man's Treasure - MedClean Technologies (OTC:MCLN)
Written by M.E.Garza
Tuesday, 01 December 2009 04:26
Let's start with the worst kept secret on the Internet. Yesterday, our subscribers were issued a trade alert about this week's profiled company, MedClean Technologies (OTC:MCLN).
The company enables hospitals
and other medical facilities to treat and dispose of their regulated medical waste and provide HIPAA-compliant destruction of confidential documents in an efficient, compliant, safe and cost-effective manner. If you haven't seen the video if their state-of-the-art on-site treatment system, please take a look at it on the right before reading further.
Within minutes of our posted alert, some of those subscribers among you began to post messages about the pick on forums and message boards across the web.
This happens every time we post an alert, regardless of when the information is released, but because this stock has so many eye-balls on it, the palpable excitement grew into something we had never really seen before.
Prices gapped up significantly as the market prepared to open and as the echo of the opening bell faded, the strength of the stock grew in not only momentum and incredible volume, but price as well.
It started out like many of our other profiled picks- reaching a morning high of nearly eight cents- almost double where it had closed on Friday, but instead of trading out before the "overbought" equity turned, investors held on as the price polarity shifted.
At the end of the day, according to many of the angry e-mails and messages that were passed along, our "over-hyped pick was pure garbage."
As writers who cover the sector, some claim that we can control many things, but two of the things we definitely can't control are the buy and sell buttons of our readers.
If we could, perhaps there would be more winners than losers among us, but then again we must remember that it's called a trade and almost by definition, someone will always walk away more happy than another. In the market, someone always holds longer than they could have and someone always sells before they should have.
Was Monday's incredible trading action that saw over a quarter of a billion shares change hands garbage or greed?
If you were one of the ones who feels you got caught holding the bag, then the answer may seem obvious- yet the matter is definitely quite debatable. Some hands, without question, were even shaken out of their shares by fear of a mad rush to cash out huge profits.
Amazingly, Monday's scoreboard showed that the stock closed mere fractions of a cent from where it closed on Friday's previous market session (-$.0073), but in the world of pennies, even the slightest percentages losses can quickly add up.
We understand that in today's market, most investors are in for a quick buck. These days, the impatient investor is more common that anyone would like to acknowledge in the biotech sector- a sector that had historically been home to some of the most patient investors on the street.
At the end of the day, the score card shows something else, however.
Some among you, who had been holding shares since they were priced at tenths of a cent made their money and moved on with big smiles on their face. They're in for a very merry holiday season, it would seem.
Others, added even more shares to their portfolio on today's dip and smiled into the evening sunset.
Self included.
Why, after all, should they sell their significantly vast amounts of MCLN shares at a vastly undervalued six, seven, or even eight cents?
As I mentioned in my alert to subscribers, this is a stock that just emerged from sub-penny levels, yet to some it may come as a shock that I continue to stand firmly behind my estimated a short term value target of $.40 per share.
"You've lost all credibility," writes another.
Maybe so, but those of us who carefully researched this company, spoke to their management group at length and looked carefully through their books and track record still feel not only bullish about this company, but extremely so.
If this were a glorified pump and dump scheme, then there are many of us who are still enthusiastically waiting to for the perfect opportunity to dump- and that is more along the lines of driven, calculated investing, we think.
Maybe we have lost our marbles, but the fact that paid subscribers feel compelled to share our picks is a two sided issue that we are wrestling with. On the one hand, if the information were worthless, then no one would care or even give the shortsighted and simple-minded actions a second thought. On the other, that brings me- in my own long winded way- to tell you about MCLN. This is rare penny level OTC entity that, we can assure you, is a real company, selling a real product, with real value and income, run by a real management team with tremendous experience that are all working hard together to fulfill real orders and contracts in a sector of the market still looking for a real leader to meet a pent up demand.
"Most of our competitors are mom and pop type shops," says Scott Grisanti who recently transitioned from CEO to Chairman of the Board of Directors for MedClean.
Even more compelling is the fact that this sub-sector (regulated medical waste) features companies whose market cap and trade values are most often based not on three or four times trailing twelve months (TTM) revenue and earnings, but actually fourteen to twenty five times those figures!
See sector leader Stericycle, Inc. (NASDAQ:SRCL) for a high mark example of that valuation analysis. SRCL's shares trade at over $54 per share. On the low end, you may want to examine Sharps Compliance Corp. (OTC:SMED) whose shares trade at over $9 per share.
Are you understanding the undervalued message yet? If you control a million shares or more of this company, you are in very good company.
This isn't the bottom of the final inning with two strikes and two outs. This ballgame is just getting started. Pitch number one just zoomed by. For some it became a home run. For others things are just getting warmed up.
The MedClean story, itself, gets better.
Through a recently announced partnership with the privately held Vestara, the Irvine, CA based provider of technology to automatically identify, sort, and segregate hazardous and non-hazardous pharmaceutical waste into proper streams, MedClean Technologies is showing some tells that they may be looking to establish a strong presence in the equally lucrative and under-served pharmaceutical waste management sector as well.
Already MedClean's solutions provide significant advantages for hospital customers compared to other approaches. These include lower costs, reduced risk and protection of host communities and overall better environmental solutions.
A single MedClean Container system can treat 1 million pounds of regulated medical waste per year, in addition to handling confidential document destruction (such as medical records), with a smaller footprint compared to multiple vendors handling different tasks for a hospital.
As one might imagine, the sales and orders for these cost, time and money saving systems are piling up.
Earlier this year in fact, MedAssets, Inc. (NASDAQ: MDAS), the $23 per share company whose group purchasing organization partners with hospitals and health systems to help improve quality and lower costs within the U.S. healthcare system awarded a contract to this penny stock company, and while specific financial details of the lucrative contract have yet to be completely revealed, it's safe to assume that the contract has enhanced the company's financial strength. After all, MedAssets runs one of the nation's largest group purchasing organizations (GPOs) and it helps to facilitate not only sales but leases of the equipment.
"Our manufacturing and installation bandwidth is running at full capacity," says David Laky, President and Chief Executive Officer of the company, "but that's a nice problem to have and we're actively making changes to accommodate more orders."
"We're excited about the collaboration with MedAssets and they have definitely enabled us to provide our solutions to an expanding base customers,” adds Chairman Grisanti.
The leaders appear particularly proud that their system meets the stringent and rigorous requirements of MedAssets as well as the tough regulatory requirements for processing medical waste in many states, including New Jersey- where customers in both the pharmaceutical and medical fields are required to minimize liability and protect the environment more strictly than just about any other state in the country.
In May, following a joint authorization issued by the state Department of Environmental Protection and Department of Health and Senior Services, MedClean was approved to provide New Jersey state hospitals with their systems following one of the most rigorous review processes and the first such approval for an on-site hospital system granted since 2005.
This was yet another in a series of victories for the group since their official launch of the company’s integrated business plan to emerge as the leader in the 2 billion market while transforming themselves into MedClean Technologies from their previously named Aduromed brand.
As part of that transformation, earlier this month, the company announced a restructuring of their management team. Laky was promoted to President and CEO as Grisanti transitioned to Chairman of the Board. Joseph Esposito, a key figure and accomplished leader of the group MedClean's past Chairman, remains on the board as a director and continues to serve as a consultant to the Company. Since that time, the company went from posting a loss of $7.8 million in 2008 to becoming cash flow positive on an EBIDTA basis in the 3rd quarter of 2009- marking impressive Third Quarter Revenue Increases 108% Year-Over-Year.
Tomorrow, in part two of our special report on the company, we're going to dive much further into our conversation with the unique management team- who actually share ties from their days at eResearchTechnology, Inc (Nasdaq:ERES). During their tenure there, the company's market valuation grew from $27 million to a peak of $1.5 billion, receiving recognition from Fortune Magazine as the number two fastest growing company in America and helping the company become the industry leader in safety drug research for biopharmaceutical, Contract Research Organizations (CROs) and medical device companies.
In the meantime, let's take a closer look at yesterday's trading action.
At first glance, it appears that the parabolic moves in share price for the stock may have signaled and end of the trend, but we have not really seen a verifiable sharp reversal in direction here.
Every stock has to breathe and there is no doubt that share prices which rise faster and faster can not sustain that sharp upward rise, since profits are being made very quickly and must be at some point taken.
The jury, in fact, is still out and how quickly this stock will grow another set of legs to take it up further will become more clear by the end of today's session, it may even become quite clear in the first thirty minutes of trading.
Fundamentally, the stock is very sound. Technically, we leave you with two different looks at the chart analysis. Click here to study the first one and here to view the second.
Remember also that MCLN has been on the SEC's Regulation SHO compliance tool list for over 20 consecutive days and is now high on the market maker's "buyin imminent" list. In our opinion, continued volume will finally force the market makers to cover and help fuel prices as demand exceeds supply. See this link for more information: http://www.buyins.net/tools/short_list.php?dys=%3E12
As always, we urge you to do your own research and wish you only the best in your trading and investing.
Batter up!
Disclosure: Long MCLN
HEB Job Postings
Position: QC Chemist II
Location: New Brunswick, NJ
Job responsibilities will include, but are not limited to:
· Performing QC testing for product lot release and stability studies for Ampligen® and the single stranded RNA raw materials, Poly I and Poly C12U. Testing methodologies such as HPLC, ultracentrifugation, UV/Visible spectroscopy, circular dichroism, gel permeation chromatography and wet chemistry.
· Performing HPLC testing release and stability studies to support production of Alferon N Injection ®.
· Participating in validation of manufacturing processes that include testing of raw materials and in-process materials. Development and Validation of analytical methods as required.
· Interacting with Manufacturing, QC and QA to coordinate the sampling schedules, sample preparations.
· Independently completing required daily activities in the QC labs in compliance with the company’s SOPs as well as appropriate health authority regulations and guidance.
· Reviewing documents and preparing data reports.
Requirements/Education:
* BS with a minimum of 5 years of pharmaceutical industry experience or MS degree with a minimum of 2 years experience.
* Knowledge of protein chemistry, DNA, and RNA is a plus.
* Strong oral and written communication skills and ability to work in teams and multitask are needed.
* Familiarity with GMP, GLP, and FDA regulations is preferred.
Position: QC Biochemist II
Location: New Brunswick, NJ
Responsibilities:
*
Perform cell based bioassays such as Cytopathic Effect Inhibition assay for product lot release and stability testing.
* Prepare media and solutions, and maintain cell lines. Evaluate human leukocytes and perform qualification for biological components used in manufacturing of interferon product.
* Perform biochemical assays such as gel electrophoresis, protein and ELISA assays.
* Participate in environmental monitoring for manufacturing facilities that includes sampling, testing, and data analysis.
* Interact with manufacturing, QC and QA to coordinate the sampling schedules.
* Independently complete required daily activities in the QC labs in compliance with company’s SOPs as well as appropriate health authority regulations and guidance. Review documents and prepare data reports.
Requirements/Education:
*
BS with a minimum of 5 years of pharmaceutical industry experience or MS degree with a minimum of 2 years experience.
* Hands-on experience in biochemical testing and tissue culture is required.
* Knowledge of protein chemistry, DNA, and RNA is a plus.
* Strong oral and written communication skills and ability to work in teams and multitask are needed.
* Familiarity with GMP, GLP, and FDA regulations is preferred.
Position: Manufacturing Technician
Location: New Brunswick, NJ
Job Description and Responsibilities:
* Perform unit operations in the manufacture of blood derived alpha interferon and a synthetic RNA species.
* Operations in the manufacture of the interferon include but are not limited to cell isolation and culture, solution formulation, sterile component preparation, cell harvesting, bulk liquid concentration, preparative chromatography and related operations.
* Operations in the manufacture of the RNA include but are not limited to RNA synthesis, extraction, precipitation, diafiltration and freeze-drying.
* Both processes require compliance to cGMPs.
Job Requirements:
* A minimum of 2 years experience in a cGMP manufacturing environment or a BS in life science, chemistry, or related field is required.
* Experience in at least some of the operations listed above would be preferable.
* Experience with bio-hazardous materials and/or hazardous solvents is important.
* Must be willing to work in a team environment.
Please forward resumes:
*
Via US Mail:
Hemispherx Biopharma, Inc.
Director of Human Resources
783 Jersey Avenue
New Brunswick, NJ 08901
*
Via Facsimile: (215) 988-1739
*
Via E-mail: hr@hemispherx.net.
HEB Major Accumulation!Check This Out!
HEB : AMEX
Industry: Biotechnology
HOLDINGS SUMMARY
Shareholders
Top Shareholders
Large Block Owners 183
Total Number of Shares Held 46.5M
% Change in Ownership 0%
% Shares Owned 88%
Monthly Rotation Number
of Shares Value of
Change (MM) % of Shrs.
Outstanding
Buyers 11/29/09 17,516,099 $35.55 22.2%
Sellers 11/29/09 3,521,766 $5.08 0.7%
Holdings chart
Institutions:
57 Holders
$44,558,958 Value
17.5% Owned of O/S
Mutual Funds:
67 Holders
$13,900,106 Value
4.3% Owned of O/S
Other Major Holders:
59 Holders
$44,673,400 Value
17.5% Owned of O/S
Institutions 57 Holders
Mutual Funds 67 Holders
Other Major Holders 59 Holders
I called Robert Oppenheimer to get an update .I will inform as soon as he calls me back.
Lifeline Biotechnologies Reports on an Update to the First Warning System's(TM) Advanced Analytical Capabilities
Last update: 11/30/2009 8:30:01 AM
RENO, Nev., Nov 30, 2009 (BUSINESS WIRE) -- Lifeline Biotechnologies, Inc. (Pink Sheets: LLBO) today reported that management has recently returned from Singapore where meetings were conducted with Nanyang Technological University's (NTU) School of Mechanical & Aerospace Engineering to receive the final report on the software development of Lifeline's First Warning System(TM).
Jim Holmes, Lifeline's CEO said, "This final report is the result of a two year contract we've had with NTU and their successful effort to improve the capabilities of our First Warning System(TM) to accurately interpret patient data and classify the physiological condition of a woman's breast. Our system has been designed and developed to assist in the early detection of breast cancer."
Dr. Louis Keith, Lifeline's Vice President and Medical Director said, "The report clearly displayed that the system of obtaining physiological measurements of the dynamic changes in the breasts of women was valid, and that such data could be efficiently and effectively classified into four reproducible classes which then could be transmitted to examining physicians for use as an adjunct to the early detection of breast cancer. Of equal importance, the report showed that the noninvasive First Warning System(TM) was more efficient than mammography without exposure to radiation and compression while providing indications of tissue irregularities at much earlier stages."
Lifeline filed with the FDA in July, 2009 and is anticipating a response. Once the FDA's response is received, the Company will issue a press release, as well as post the response on Lifeline's website.
The Company has received many questions concerning the prospect of a reverse split of the common stock. Though the outstanding common stock is increased from time to time, there are no plans for a reverse split. Lifeline competes in the money markets for funds to continue the development of its products as well as supporting operating and administrative expenses. The cost of funds, for companies such as Lifeline, is expensive and the terms have been and may continue to be dilutive. The Company continues to seek alternative sources of financing in an effort to reduce the dilutive aspects.
Safe Harbor: This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 27E of the Securities Act of 1934. Statements contained in this release that are not historical facts may be deemed to be forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain. Actual performance and results may differ materially from that projected or suggested herein due to certain risks and uncertainties including, without limitation, the ability to obtain financing, successful development of the Company's product or market acceptance of the product and regulatory and shareholder approval for anticipated actions.
SOURCE: Lifeline Biotechnologies, Inc.
Lifeline Biotechnologies, Inc. Jim Holmes, 775-324-1933 Jholmes@lbti.com
Copyright Business Wire 2009
Next Big Mover in Medical Small Caps
Written by M.E.Garza
Sunday, 29 November 2009 15:46
We have been keeping an eye on this stock for a little over 3 weeks. Last week, just as it emerged from sub-penny trading levels, we finally reached out to the management team and interviewed them at length about their plans, expectations and current limitations. After an inital lengthy discussion with them, we feel confident that our readers will like this company for many of the same reasons that initially caught our eye.
MedClean Technologies, Inc. (OTC: MCLN) engages in the design, sale, installation, and servicing of onsite turnkey systems to treat regulated medical waste. It provides MedClean systems to hospitals and clinics as a solution to incineration or off site hauling of untreated medical waste. The company?s MedClean system employs various equipment and machinery, including an autoclave vessel to sterilize the medical waste; a shredding device, the MedClean Shredder, to convert sterilized waste material into confetti-like material qualifying the end product as municipal solid waste (See the comprehensive video on the right).
We believe the product is a game changer in the Regulated Medical Waste space and it has already begun saving hospitals and clinics millions of dollars by affecting not only how they handle the often times hazardous waste material, but also in regulatory compliance fees and reporting requirements.
As we mentioned earlier this weekend, we feel that the potential moves for this equity will make our now infamous BioElectronics (OTC:BIEL) pick look like child's play. Some of you may recall that we did help call attention to BIEL's technology at the sub penny level before it moved to $.12 before stalling and becoming a "buy on rumor sell on news" penny stock. Things may change for BIEL if they ever finally get their FDA approval, but even then, the billion shares of trading float have become a huge anchor to the stock.
Investors who invested in American Scientific Resources, Inc's (Pink Sheets: ASFX) FDA approved home needle destruction device, the Disintegrator(TM) and Disintegrator Plus(TM) should also get very excited about this medical waste play. ASFX.PK ran from .003 to .08 based on a needle dispenser (one product) called the Disintegrator. They traded millions of shares churning through the shares to get that to the .08 level w/o the transparency of the share structure.
Another one of our recently profiled companies, Viking Systems, Inc. (OTCBB:VKNG) recently ran from $.003 to $1.10 on news regarding a contract with the U.S. Army over a period of four days. VKNG also appeared on the SEC's Regulation SHO compliance tool list (like MCLN does today [more on that below]).
MedClean Technologies, Inc. (OTC: MCLN) looks more bullish and attractive to small cap investors than any of these other companies, but don't take our word for it. Look at the chart.
Our published report on the company Tuesday will mark the first time any publication or news portal will call attention to the company and their product. The management team does not believe in hiring penny-stock pumpers and promoters an have never one so. This will be the first comprehensive report on the company with quotes and information from the actual management team.
Here are just a few of the bullet points that will be discussed in more detail in our special report on Tuesday morning:
* MCLN's stock has just emerged from the sub-penny trading level and our own short-term trading target of $.40 is based on our own in-depth technical, fundamental and financial analysis of the company. A six month trading target of $1+ is very much possible, but not likely sustainable without future growth and reported income variables which may or may not be part of the company's immediate plans.
* MCLN has been on the SEC's Regulation SHO compliance tool list for 19 consecutive days and is now high on the market maker's "buyin imminent" list. In our opinion, continued volume will force the market makers to cover and help fuel prices during the next 48-72 hours- exploding higher as demand exceeds supply.
* In 2008, MCLN posted a loss of 7.8 million and in the 3rd qrtr of 2009 they were cash flow positive on an EBIDTA basis. Third Quarter Revenue Increases 108% Year-Over-Year.
* MCLN was recently awared a substantial MedAssets Supply Chain Systems Contract. MedAssets (Nasdaq: MDAS) trades at over $23 per share and they partner with healthcare providers to improve their financial strength by implementing integrated spend management and revenue cycle solutions. MedAssets serves more than 125 health systems, 3,300 hospitals and 30,000 non-acute carehealthcare providers.
* Thanks to orders from hospitals and clinics like those, MCLN's management team has informed us that they are running at full capacity and still experiencing an accumulation of unfilled orders.
* MCLN's management team helped take their previous company to the NASDAQ and they identified and protected intellectual property w/ patent application entitled “Containerized Medical Waste Treatment System and Related Method.” The group previously worked together at eResearchTechnology, Inc- where they helped grow the company's market valuation from $27 million to a peak of $1.5 billion, receiving recognition from Fortune Magazine as the number two fastest growing company in America. They recognized a fantastic new market opportunity with MCLN and are building that vision now.
While we certainly hope you get as excited as we are about MCLN, we urge you to do your own research and wish you only the best in your trading and investing.
This report is intended for paid subscribers of BioMedReports. Paid subscriptions are what monetize BioMedReports, so please be aware that any unauthorized dissemination, review, distribution or copying of this report is strictly prohibited. We will work with the owners of public forums or websites where this information is posted without permission to provide us with the IP address an/or identity of any individuals who post this or any other subscription based information from this site.
Disclosure: Long MCLN
I have talked to Robert a couple of times also and he has always been spot on.
HEB - A letter from a CFS patient
http://www.hhs.gov/advcomcfs/meetings/pr...
I am writing to you as a patient. Nobody has asked me to send this to you and I am not
acting on anybody's behalf other than my own personal interest and health. Please DO
NOT share this information with Hemispherx Biopharma or any of their representatives, I
do not want them to know that I am writing to you. I merely want to ask if you will
please expedite the approval of Ampligen for the treatment of Chronic Fatigue
Syndrome.
XMRV retrovirus has been discovered, as published in Science Magazine in the that the
2.5 RNase L antiviral pathway (which is what Ampligen repaired in my body) is involved
in the repair of the antiviral pathway and that is what is broken in my body and others
with this same illness.
I have struggled, suffered, and been debilitated by Chronic Fatigue Syndrome for 23
years. One year before I first became ill, I was a classified top-secret word processor for
the Physical Science Laboratory at New Mexico State University. I was responsible for
typing large proposals of government contracts. Then, after that, I was working at a law
firm in Denver as a Word Processor. I became ill with the "flu" in 1986, and I had to quit
working.
I was a patient on the FDA cost-recovery program, AMP-511 study for 8 years, taking
ampligen by i.v. 400 mg. twice per week and I became incredibly well after being on this
medicine. It improved my health, my labs, and my life. I did not retain the same level of
health after discontinuing the medicine in 2004, and my life has been very difficult being
so ill since then.
I am delighted that the scientists and researchers have discovered such medical
breakthroughs as the XMRV retrovirus and it's correlation with the 2.5 RNaseL antiviral
pathway and now want you to please consider approving this drug for this disease that
has a specific ability to treat the problems with the anti-viral pathway and make so many
people better and able to return to work.
I am only 47 years old and although I have significant neurological damage and and
immune compromised system. At times I can hardly walk, cook dinner, or fight
infection. I have lost six teeth and hardly have any left in my mouth to chew, due to bone
infections. My gastrointestinal system does not digest food properly, and I have a painful
irritated bladder that does not empty correctly. I have headaches, body aches, and
inflammation disorder, even in the brain. But I can still type (given that I rest before and
after) and I want to plead for your help in approving this drug.
I will not benefit from the approval of Ampligen in any other way than to say that now
there is a therapy for a disease that exists. A retrovirus that took away my right to health
and infected many millions of people around the world. Please help America to be the
first to recognize and treat this horrendous virus and end the horror by approving
Ampligen.
with respect and admiration for all that you do,
HEB - A letter from a CFS patient
http://www.hhs.gov/advcomcfs/meetings/pr...
I am writing to you as a patient. Nobody has asked me to send this to you and I am not
acting on anybody's behalf other than my own personal interest and health. Please DO
NOT share this information with Hemispherx Biopharma or any of their representatives, I
do not want them to know that I am writing to you. I merely want to ask if you will
please expedite the approval of Ampligen for the treatment of Chronic Fatigue
Syndrome.
XMRV retrovirus has been discovered, as published in Science Magazine in the that the
2.5 RNase L antiviral pathway (which is what Ampligen repaired in my body) is involved
in the repair of the antiviral pathway and that is what is broken in my body and others
with this same illness.
I have struggled, suffered, and been debilitated by Chronic Fatigue Syndrome for 23
years. One year before I first became ill, I was a classified top-secret word processor for
the Physical Science Laboratory at New Mexico State University. I was responsible for
typing large proposals of government contracts. Then, after that, I was working at a law
firm in Denver as a Word Processor. I became ill with the "flu" in 1986, and I had to quit
working.
I was a patient on the FDA cost-recovery program, AMP-511 study for 8 years, taking
ampligen by i.v. 400 mg. twice per week and I became incredibly well after being on this
medicine. It improved my health, my labs, and my life. I did not retain the same level of
health after discontinuing the medicine in 2004, and my life has been very difficult being
so ill since then.
I am delighted that the scientists and researchers have discovered such medical
breakthroughs as the XMRV retrovirus and it's correlation with the 2.5 RNaseL antiviral
pathway and now want you to please consider approving this drug for this disease that
has a specific ability to treat the problems with the anti-viral pathway and make so many
people better and able to return to work.
I am only 47 years old and although I have significant neurological damage and and
immune compromised system. At times I can hardly walk, cook dinner, or fight
infection. I have lost six teeth and hardly have any left in my mouth to chew, due to bone
infections. My gastrointestinal system does not digest food properly, and I have a painful
irritated bladder that does not empty correctly. I have headaches, body aches, and
inflammation disorder, even in the brain. But I can still type (given that I rest before and
after) and I want to plead for your help in approving this drug.
I will not benefit from the approval of Ampligen in any other way than to say that now
there is a therapy for a disease that exists. A retrovirus that took away my right to health
and infected many millions of people around the world. Please help America to be the
first to recognize and treat this horrendous virus and end the horror by approving
Ampligen.
with respect and admiration for all that you do,
Until 1:00pm
Lets not forget...Ampligen(r) is also authorized for Emergency (compassionate) Cost Recovery Sales Authorization by the FDA and has a ``promising'' designation by the Agency on Health Research Quality (AHRQ):
Spectrum Pharmaceuticals and Handok Pharmaceuticals Announce Collaboration Agreement for Apaziquone in South Korea
* Spectrum Completes Asia Partnerships For Apaziquone
* Total Deal Value For South Korea Could Exceed $19 Million
* Spectrum to Receive an Upfront Payment, Milestones, and Royalties
* Handok Responsible for 100% of Development and Commercial Expenses
Companies:
o Spectrum Pharmaceuticals, Inc.
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI - News), a commercial stage biotechnology company with a primary focus in oncology, and Handok Pharmaceuticals Co., Ltd., a fully integrated Korean pharmaceutical company, today announced a collaboration for the development and commercialization of apaziquone in South Korea. Apaziquone is an antineoplastic agent currently being investigated for the treatment of non-muscle invasive bladder cancer by intravesical instillation.
Related Quotes
Symbol Price Change
SPPI 4.74 0.00
Chart for Spectrum Pharmaceuticals, Inc.
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Spectrum Pharmaceuticals has previously entered into a strategic collaboration with Allergan, Inc. (NYSE: AGN - News) for North America, Europe, and other key markets and Nippon Kayaku Co., Ltd. for Asian countries excluding South Korea.
“This collaboration with Handok completes the Company’s stated objective of achieving solid strategic partnerships that are aimed at fully exploiting developmental goals for apaziquone on a worldwide basis,” said Rajesh C. Shrotriya, MD, Chairman of the Board, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Handok Pharmaceuticals is one of South Korea’s most progressive pharmaceutical companies and we are delighted to partner apaziquone with an established Korean company.”
“Apaziquone is a strategic fit for Handok,” said Young-Jin Kim, Chief Executive Officer and Chairman of Handok. “Urology is one of the areas where we are trying to expand and we believe Spectrum’s apaziquone will strengthen our presence in the field. We look forward to working with Spectrum in developing apaziquone for non-muscle invasive bladder cancer in South Korea.”
Under the terms of the agreement, Handok will pay Spectrum an upfront payment and potential milestone payments totaling over $19MM. The potential milestones will be based on the achievement of certain regulatory and commercialization milestones. Handok received rights to apaziquone for the treatment of non-muscle invasive bladder cancer in South Korea. Handok will conduct the apaziquone clinical trials pursuant to a development plan and will be responsible for all expenses relating to the development and commercialization of apaziquone in South Korea.
Spectrum is currently conducting two Phase 3 clinical trials to investigate apaziquone’s safety and efficacy in non-muscle invasive bladder cancer. Spectrum’s goal is to complete enrollment in both Phase 3 studies by year-end 2009.
About Non-Muscle Invasive Bladder Cancer
Non-muscle invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder and is commonly treated with intravesical therapies. Approximately 70% of all patients newly diagnosed with bladder cancer have non-muscle invasive bladder cancer.1 More than one million patients in the United States, Europe and Japan are estimated to be affected by the disease, which is treated predominantly by urologists.2
About Apaziquone
Apaziquone, an anti-cancer agent that becomes activated by reductase enzymes found in cancer cells, is formulated for administration directly into the urinary bladder. Phase 2 data has confirmed anti-tumor activity in patients with multiple, recurrent non-muscle invasive bladder cancer, as evidenced by 31 of 46 patients (67%) showing a complete response after receiving six weekly treatments with 4 mg of apaziquone instilled into the urinary bladder in a marker lesion study. In another Phase 2 study, apaziquone instilled into the bladder following surgery was well tolerated and was not absorbed in any detectable amount from the bladder wall into the bloodstream and therefore, is expected to carry a low risk of systemic toxicity, if any.
The apaziquone registration plan, which the U.S. Food and Drug Administration (FDA) concurred with under a Special Protocol Assessment, calls for two double blind, placebo-controlled, randomized Phase 3 clinical studies, each with 562 patients with Ta G1 or G2 low risk non-invasive bladder cancer. Patients are randomized in a one-to-one ratio to apaziquone or placebo. Under the protocol, the patients are given a single 4 mg dose following surgical removal of the tumors. The primary endpoint is a statistically significant difference (p<0.05) in the rate of tumor recurrence between the two treatment groups by year two. The FDA has granted Fast Track Designation for the investigation of apaziquone for the treatment of non-muscle invasive bladder cancer. Spectrum also received scientific advice from the European Medicines Agency (EMEA) whereby the EMEA agreed that the two Phase 3 studies as designed should be sufficient for a regulatory decision regarding European registration.
About Handok Pharmaceuticals Co., LTD.
HANDOK Pharmaceuticals Co., Ltd., (002390 KS), based in Seoul, Korea, is a company posting 275B KRW in pharmaceutical, diagnostic, and OTC sales in 2008. HANDOK, founded in 1954, is the pharmaceutical company in Korea with a distinguished and successful track record in various types of strategic partnerships. HANDOK is known to have leading expertise in various therapeutic categories including diabetes, CV, Urology and respiratory system and is planning to expand into additional categories such as oncology and CNS. HANDOK maintains a world class GMP manufacturing facility and was the first local Korean company to incorporate clinical research capabilities with medical directors on staff. For more information, visit the HANDOK website at www.handok.co.kr/english.
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 Statements – This press release may also 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 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 Spectrum’s approved drugs, continuing to build Spectrum’s team, leveraging the expertise of partners around the world to assist Spectrum in the execution of its strategy, the safety and efficacy of apaziquone, that enrollment will be completed by year-end 2009, that apaziquone is expected to carry a low risk of systemic toxicity, if any 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 Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that Spectrum’s 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 Spectrum’s existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that Spectrum’s efforts to acquire or in-license and develop additional drug candidates may fail, Spectrum’s lack of revenues, limited marketing experience, dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in Spectrum’s reports filed with the Securities and Exchange Commission. Spectrum does 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.
Information regarding Handok Pharmaceuticals has been obtained from Handok Pharmaceuticals and not independently verified by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum, TURNING INSIGHTS INTO HOPE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
1 Kirkali Z, et al. Bladder Cancer: Epidemiology, Staging and Grading, and Diagnosis. Urology 66 (Suppl 6A): 4-34, 2005.
2 For U.S. see National Cancer Institute. Bethesda, MD, http://seer.cancer.gov/statfacts/html/urinb.html accessed 10-23-2008; For Europe see Globocan 2002 database, http://www-dep.iarc.fr/ accessed 10-23-2008.
Contact:
Spectrum Pharmaceuticals, Inc.
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Interesting! Did U.S. make mistake in skipping vaccine additive?
Reuters
A nurse prepares a H1N1 flu vaccine shot at a hospital in Budapest Reuters – A nurse prepares a H1N1 flu vaccine shot at a hospital in Budapest November 20, 2009. REUTERS/Karoly …
* Shortage Forces Doctors To Pick Who Gets H1N1 Shot Play Video Video:Shortage Forces Doctors To Pick Who Gets H1N1 Shot CBS 5 San Francisco
* Priority Groups Urged To Get H1N1 Vaccine Play Video Video:Priority Groups Urged To Get H1N1 Vaccine KDKA Pittsburgh
* Has Swine Flu Peaked? Play Video Video:Has Swine Flu Peaked? ABC News
By Maggie Fox, Health and Science Editor Maggie Fox, Health And Science Editor – Fri Nov 20, 12:36 pm ET
WASHINGTON (Reuters) – As U.S. health officials struggle to vaccinate tens of millions of Americans against the pandemic of swine flu, some are looking regretfully at one easy way to instantly double or triple the number of doses available -- by using an immune booster called an adjuvant.
These additives, often as simple as an oil and water mixture, broaden the body's response to a vaccine, reducing the amount of active ingredient called antigen needed.
They are widely used in European flu vaccines as well as in Canada. But not in the United States -- even though the federal government has spent nearly $700 million buying them.
The reason -- people might not trust them.
"If we really do want pregnant women to trust this vaccine or even parents, we have to think about what is acceptable to them," Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention said in an interview.
"We have so much vaccine hesitancy in this country," agreed Jeff Levi of the non-profit Trust For America's Health. "To add ... a new element could well have undermined the efficacy of this campaign," Levi told a hearing this week before a Congressional subcommittee.
This frustrates the World Health Organization, which says the global capacity to make influenza vaccines is about 3 billion doses a year -- not enough to cover the population of 6.8 billion people. WHO has hoped rich countries would donate leftover H1N1 vaccine to others.
The U.S. Health and Human Services Department was ready to try adjuvants had the pandemic been worse. H1N1 swine flu has infected an estimated 22 million Americans and killed 3,900, but it so far does not appear to be any deadlier than seasonal influenza.
The worry is that it is affecting younger adults and children instead of the elderly usually targeted by flu, and has the potential to mutate into something more deadly.
"If things had been worse and this would have been a more severe pandemic, we may well have needed to go that way anyway," Levi said.
TRIED AND TRUE
Instead, the United States has stuck with what CDC director Dr. Thomas Frieden has repeatedly called the "tried and true" approach -- the same formulation used in seasonal flu vaccines. Five companies have contracts -- Sanofi-Aventis, CSL, Novartis, AstraZeneca unit MedImmune and GlaxoSmithKline.
Polls show that only about half of Americans plan to be vaccinated against H1N1. Of those who do not, about half say they worry about safety.
Even so, long lines have formed as people try to get the 50 million or so swine flu doses that have rolled out of factories. Drug companies have struggled with an unpredictable virus that does not grow well in eggs, as well as changes to U.S. orders that slowed down packaging.
Studies suggest the supply that is out now could have been tripled.
In September, GlaxoSmithKline found a single shot of its H1N1 vaccine protected 98 percent of volunteers, using an adjuvant and just 5.25 micrograms of antigen. A standard dose without adjuvant takes 15 micrograms of antigen.
Vaccine makers urged Congress this week to help federal agencies find ways to approve the use of adjuvants, and to assure skeptical Americans about their safety.
Dr. Vas Narasimhan, president of Novartis Vaccines USA, noted adjuvants had been licensed for use in Europe for 10 years and tested in 200,000 people.
"Adjuvanted vaccines produce higher immune response than unadjuvanted vaccines particularly in the elderly and young children," Narasimhan told a hearing this week.
He said they may protect better than standard vaccines against viruses that have drifted a little -- the single biggest reason that flu vaccines must be re-formulated every year.
They may also eventually help require less vaccination. "Adjuvanted vaccines have been shown to more broadly prime patients' immune response (up to seven years later), requiring fewer vaccinations to the newly circulating strain," he said.
The National Institute of Allergy and Infectious Diseases is intrigued. Last month it awarded $60 million to researchers and companies to develop new adjuvants.
(Editing by Philip Barbara)
Related Searches:
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* pandemic
* influenza vaccines
60 to 90 days from production they will be on shelves.
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Health Sciences Group Quest to be Listed on the OTCBB[color=red][/color]
* Press Release
* Source: Health Sciences Group, Inc.
* On 2:08 pm EST, Thursday November 19, 2009
INDIAN HARBOUR BEACH, Fla., Nov. 19, 2009 (GLOBE NEWSWIRE) -- Health Sciences Group, Inc. (Pink Sheets:HESG - News) would like to announce that its lawyer Mr. Robert Young is aggressively seeking realtors in the Los Angeles area to open up Health Sciences offices. The company intends on pursuing with new consultant agreement under Marijuana Inc. a joint venture to market management services. "We are still in negotiations with Marijuana Inc. (MJNA) to complete a joint venture or merger or rolling up into a reporting OTCBB shell. We have all intentions of bringing on the best legal team possible and to make medical marijuana acceptable to the public. I can not say it enough -- we are not about legalizing pot for recreational purposes-we are against it! We are here for the millions of ill people that could and will greatly benefit from medical marijuana. I have first hand experience with medical marijuana and it works, it eases pain, anxiety, and increases appetite. I witnessed it first hand with the passing of my own father. This is personal to me," said Thomas Gaffney, President and CEO of Health Sciences Group, Inc.
Gaffney continues, "As far as the companies are concerned, we are in preliminary talks about moving to the OTCBB to provide transparency to the public. Health Sciences' chief priority is sustainable economic success -- a priority shared by all of our employees and management and by me especially. By providing the best possible transparency into our business by joining forces with Medical Marijuana, Inc. and other medical marijuana based companies, this will give us the growth and strength to increase shareholder value. Health Sciences will continue to operate iGoHealthy.org and our magazine iGoHealthy."
We would appreciate any shareholders opinion or ideas at info@igohealthy.org
ABOUT HEALTH SCIENCES GROUP, INC.
Health Sciences Group, Inc. is a provider of health and wellness services to consumers, physicians and other
healthcare professionals through its website, www.igohealthy.org, and health focused publications. The Health Sciences network consists of its public website, www.igohealthy.org, and iGoHealthy Magazine. The Company operates in three segments: Online Services, Publishing and Other Services. The Company is recently exploring options of corporate growth within the Legal Medical Marijuana Industry.
FORWARD-LOOKING DISCLAIMER
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. This material contains statements about
expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Health Sciences Group, Inc. to be materially different from the statements made herein.
InvestorSoup.com issues Technical Trading Outlook for Health Sciences Group Inc.
* Press Release
* Source: InvestorSoup
* On 6:50 am EST, Wednesday November 18, 2009
Companies:
o Express Scripts Inc.
o Health Sciences Gr
o Healthways Inc.
DALLAS, Nov. 18, 2009 (GLOBE NEWSWIRE) -- InvestorSoup.com announces an investment report featuring Health Sciences Group Inc. (Pink Sheets:HESG - News). The report includes financial, comparative and investment analyses, and pertinent industry information you need to know to make an educated investment decision.
Related Quotes
Symbol Price Change
ESRX 86.09 0.00
The investment report on Health Sciences Group Inc. (Pink Sheets:HESG - News) should be of particular interest to other drug retailers: Healthways Inc. (Nasdaq:HWAY - News), Express Scripts Inc. (Nasdaq:ESRX - News) and VYTA Corp. (Pink Sheets:VYTC - News).
It is available at: http://www.investorsoup.com/lp/HESG
Get our alerts BEFORE the rest of the market. Follow us on Twitter: www.twitter.com/investorsoup
Health Sciences Group Inc. (HESG) identifies, develops and commercializes products and functional food ingredients derived from natural sources to provide consumers and healthcare professionals with preventive healthcare alternatives. The Company has two operating subsidiaries: BioSelect Innovations, Inc. and Swiss Research, Inc. BioSelect Innovations has developed a number of product formulations. These patents address the integration of selective traditional over-the-counter generic drugs with complementary alternative medications, such as vitamins, herbs and other natural nutraceutical supplements.
Message Board Search for HESG: http://www.boardcentral.com/boards/HESG
In the report, the analyst notes:
"HESG announced in late October the appointment of Dr. Fred Aserati to spearhead the company's interest in exploring either applying for licensing of distribution of medical marijuana in California or seeking acquisition or partnership of existing medical businesses. Dr. Aserati has an extensive background in studying the government's policy on the growing and distribution of medical Cannabis/Marijuana.
"HESG recently announced that in addition to finalizing a consulting agreement with Medical Marijuana, Inc. in its pursuit to enter the Medical Marijuana business it has also contacted several law firms in California and Colorado for purposes of licensing requirements for dispensaries. Thomas Gaffney, Health Sciences CEO, states, 'That in addition to entering into a consulting agreement with Medical Marijuana Inc. we have contacted several law firms in Colorado and California pertaining to medical marijuana laws -- basically the requirements of licensing. We have all intentions of entering the world of medical marijuana in the near future. We have also been in contact with some operating dispensaries about possible acquisitions.'"
To read the entire report visit: http://www.investorsoup.com/lp/HESG
See what investors say about these stocks at: http://www.stockhideout.com/
InvestorSoup.com is a small-cap research and investment commentary provider. InvestorSoup.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on InvestorSoup.com, please visit http://www.InvestorSoup.com
InvestorSoup.com Disclosure
InvestorSoup.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. InvestorSoup.com is a Web site wholly owned by BlueWave Advisors, LLC. Please read our report and visit our Web site, InvestorSoup.com, for complete risks and disclosures.
Contact:
InvestorSoup.com
Jeffrey Brown, Editor
(469)-252-3505
info@investorsoup.com
Insider Buying
Re: Update from Joe Noel 16-Nov-09 06:55 pm
leemajors:
What I will tell you however is that I recently bought BIEL shares. 2,763,00o to be exact.
Joe Noel
Update from Joe Noel 16-Nov-09 06:47 pm
Here is the latest update:
FDA Meeting - I did not attend the meeting so I have not wanted to provide the update. Have been told by management that management and the lawyers were at FDA on Friday. Was a short meeting to discuss reclassification from Class III to Class II. FDA asked for additional information concerning power levels. Another meeting has been set in about a week and a half where management is going to provide data from a scientific study that was done by Dr. McLoud out of Stoney Brook University. Sorry I do not have the date - management is in europe working on a distro contract so I do not have all the details. The scientific study should provide additional info to support reclassification. Everyone thinks the fact that the parties are talking is a very good sign - if FDA was not going to consider we do not feel we would get in front of them.
Study - What can I say about the study that has not been said. I think the result speak volumes about how effective ActiPatch is - I know as I have used the device myself after my skin cancer surgery. The study data is being sent to FDA and will probably be used as the basis for an additional filing for muscle soreness. There are now four studies showing safety and efficacy.
We feel things are progressing well at BIEL. The next stage of the company will be revenue generation. I think all of you wil be impressed with the upcoming marketing plan. Thanks for all your support.
We can argue over this and that ....Bottom line Biel's product works.Nobody has ever posted any proof that is does not work.It is that simple.
Anyone can question any study. What basis does any of us have on what type of study should have been done? Try to find any bad reviews from people using the product.I can't.It apparently works,bottom line.
I can't believe it! What is the doom and gloom? This is very significant.I am sure they will follow up with an FDA update.
The writing is on the wall!
BioElectronics Technology More Effective Than Extra Strength Tylenol(R) in Reducing Muscle Soreness in Clinical Study
ActiPatch Proved 50 Percent More Effective Than Acetaminophen
* Press Release
* Source: BioElectronics Corporation
* On 4:10 pm EST, Monday November 16, 2009
Companies:
o Bioelectronics Corporation
FREDERICK, MD--(Marketwire - 11/16/09) - BioElectronics Corp. (Pinksheets:BIEL - News) today announced that its disposable drug-free anti-inflammatory devices proved to be significantly more effective than acetaminophen in a clinical study of Delayed Onset Muscle Soreness (DOMS).
The study tested the effectiveness of ActiPatch� Therapy versus acetaminophen in reducing the pain of Delayed Onset Muscle Soreness, a condition associated with increased physical exertion.
"We now have an additional Institutional Review Board (IRB) supervised and National Institutes of Health (NIH) registered clinical study that demonstrates what our customers have been saying for years," said Andrew Whelan, CEO, BioElectronics Corp. "Our products give fast, localized relief from pain and swelling without the danger of drug side effects. We plan to use this additional study to further support our pending 510(K) applications on file at FDA as well as possibly using them in additional applications."
"In the study more than 100 healthy male and female college athletes and trainers were given a vigorous resistance exercise regimen to induce DOMS. They were then randomly divided into three groups; a group that used ActiPatch for two days, a control group that received no treatment, and a third group that was to be treated with acetaminophen," commented Sheena Kong, M.D. the principal investigator. "All participants returned approximately 48 hours after the exercise regime. Upon return those in the ActiPatch and control groups immediately rated their levels of muscle pain and soreness using the Visual Analogue Scale. Participants in the acetaminophen group were given one gram of acetaminophen in the form of Extra Strength Tylenol� and then 90 minutes later rated their levels of muscle pain and soreness using the same scale."
Dr. Kong continued, "The study was conclusive showing that the ActiPatch treated volunteers had significantly less pain than those in either the acetaminophen or control groups. Also of note was the fact that some of the participants assigned to the acetaminophen group were eliminated from the results because they expressed reservations about consuming the drug."
The report notes that there was a highly significant difference between the control group and the group using the ActiPatch, with the control group indicating an average VAS pain level of 3.179 compared to 1.500 for the ActiPatch group where lower numbers indicate lower pain levels. This difference between the two groups was found to be significant at the .001 level. The difference between the acetaminophen group and the ActiPatch group was also highly significant with the acetaminophen group indicating an average pain level of 2.507, i.e., over one point higher than the ActiPatch group. This difference was found to be significant at the .05 level.
ActiPatch technology truncates the human body's natural inflammatory response by breaking the cycle of chronic inflammation. ActiPatch does this by delivering sensation-free pulsed electromagnetic energy and RF waves directly to the affected area and driving out the edematous fluid along with byproducts of the damaged tissue. The effect is well documented and results in a significant overall improvement in the restorative and recovery process following a soft tissue injury. This speedier healing results in a significant reduction in the pain associated with the injury. ActiPatch has been used by thousands of people throughout the world and maintains a 100% safety profile.
The study is Institutional Review Board (IRB) supervised and has been registered with the National Institutes of Health. The principal investigator, Sheena Kong, M.D. holds no financial position in any form in the study's sponsor, BioElectronics Corp., and has not and will not receive financial compensation of any kind for the administration or completion of the study. The acetaminophen used in the study was Extra Strength Tylenol� in 1 gram doses.
A complete copy of the study results and protocol is available on the BioElectronics Corp. web site: http://www.bioelectronicscorp.com.
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.
*Tylenol is a registered trademark of McNeil, PPC. Inc.
Contact:
For media enquiries, please contact:
Joe Noel
BioElectronics Corp.
(925) 922-2560
Level 2 update 3x.0006
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