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Buy-Rating (Dundee)
26 May 2010
BIONICHE – BLADDER CANCER UPSIDE, BASE BUSINESSPROTECTS DOWNSIDE
Bioniche has 3 businesses with diversified risk/rewardprofiles: 1) Animal Health, which is expected to generate $27-$28 million insales in fiscal 2010; 2) Human Health, with lead product, Urocidin, in Phase 3testing for bladder cancer (results expected mid-2010); 3) Food Safety, with anapproved (in Canada) vaccine for reducing E. coli 0157 in cattle feces (U.S.conditional license pending) and a pipeline of other vaccines. The commonelement linking most of the company’s products and development programs isimmune stimulation.
Animal Health
We view Animal Health as a stable business and a value backstop for the higher risk/rewardopportunities. Our estimated F2010 sales of $27-$28 million would be lower Y/Yvs F2009 (sales $33 million) due mainly to foreign exchange impact and softnessin some end markets due to the economic turndown. However, 2011 could be abetter year with the economy recovering and potential for geographic expansionof Folltropin.
Urocidin
Urocidin (Mycobacterial Cell Wall-DNA Complex, or MCC)provides the biggest upside potential forBNC investors, with Phase 3 results expected mid-2010. MCC is a DNA/proteinisolate from non-pathogenic mycobacterium, phlei. Its main action is tostimulate direct pro-apoptotic and indirect immune-mediated killing of cancercells in patients with non-invasive bladder cancer.
Our initial diligence suggests that Urocidin has arelatively high overall probability of approval, although the first of twoplanned Phase 3 trials has a moderate level of risk – the refractory patientsenrolled in the first Phase 3 are a “tougher-to-treat” population than wasenrolled in Phase 2. Mitigating the risk to a degree, is the 20% completeresponse (CR) hurdle for Phase 3 – in Phase 2, patients achieved a 46.4% CRrate at 26 weeks in a population that was mainly relapsed, but also included afew naïve patients (Figure 8).
Figure8: Urocidin Phase 2 Complete Response Rate (%)
Week12 Week 26 Month 12Month 18 (for MCC 4 mg / MCC 8 mg)
27 / 46 27/ 46 32 / 64 23 / 73 (rounded %ages)
A second planned Phase 3 trial will testUrocidin head-to-head against the current standard of care, baccilusCalmette-Guerin (BCG) in first-line treatment, where we expect Urocidin todemonstrate better efficacy based on prior data, and superior safety and tolerability– BCG is a live pathogen, carrying with it risk of contamination, fatalinfection and frequent painful bladder inflammation.
In July 2009, Bioniche licensed U.S. Urocidincommercial rights to Endo Pharmaceuticals (ENDP-Q; unrated). Bioniche receivedan up-front cash payment of $20 million with the potential for as much as $110million in additional payments based on future clinical, regulatory, andcommercial milestones. Subsequently, in February 2010, Endo exercised an optionto license the remaining global commercial rights for Urocidin, paying Bionichea further $8 million, and taking on the remaining Phase 3 development costs.Bioniche will manufacture the product and receive a transfer price for supply.After COGS, we estimate the net to Bioniche will be approximately 20%-25% ofsales. Bioniche currently operates a cGMP facility capable of manufacturing~35,000 Urocidin doses annually, with plans to build a million dose facility ata cost of approximately $30 million (planned funding to be provided bygovernment loans and grants) contingent on success of the upcoming Phase 3trial.
Bladder cancer is the fourth most common cancer in men,and the ninth most common in women. About 500,000 people in the U.S. currentlyhave bladder cancer, and the number of new cases each year is about 70,000 (ofwhich 50,000 have the non-muscle invasive form of the cancer that is eligiblefor Urocidin treatment). Two thirds of patients (33,330) typical do not respondto BCG or relapse within a year. Globally, it is estimated that 80,000 bladdercancer patients become refractory each year.
Based on these estimates, the global market opportunityfor Urocidin in the refractory population would be $800 million – this assumesa per dose cost of $1,000 ($21,000 for a full course of 21 doses, supported bythe $22,000 cost for a full course of Valstar), and assumes that eachrefractory patient receives an average of 10 doses (based on 25% receiving afull course and 75% receiving only the first 6 induction doses). If the secondPhase 3 trial expands the Urocidin label to first line treatment, the marketopportunity would grow to the estimated 2 million doses of BCG sold globallyeach year, or $2 billion. 25% penetration of this market would represent $500million in annual sales, and an estimated $112.5 million in gross profit forBioniche.
Food Safety
Food Safety, the third Bioniche business, is primarilyfocused on development and commercialization of a vaccine for cattle whichlowers the fecal load of pathogenic 0157 E. coli bacteria. The product islicensed in Canada,where the primary market, upscale cattle farms, is very small. The company ishopeful it will receive conditional approval to sell the vaccine in the U.S. this year,where there are many more cattle farms, and a higher percentage (20% vs. 2% bymanagement’s estimate) produce upscale, branded beef.
Near-term Hurdle for Value Inflection
The key hurdle for BNC value inflection will be Phase 3Urocidin results expected mid-2010. We believe there is a moderate-to-goodchance of success for this trial, and we believe with the base Animal Healthbusiness, that downside risk is limited.
Key risks:
Clinical risk –While we believe Urocidin has demonstrated strong indications of superiority(safety and efficacy) vs BCG in prior clinical testing, the hurdle is high forthe upcoming results for the first Phase 3 trial for the bladder cancer drug.Mitigating this risk is the base business of Bioniche, the deep-pocketedpartner for Urocidin, and our view that the long term probability of approvalof the drug is high.
Urocidin pricing - The expected pricing for Urocidin (~$1,000 per dose) is substantiallyhigher than for BCG (~$50 per dose). We believe higher pricing can bejustified, but it will be necessary to continue to demonstrate substantialefficacy and safety benefits in Phase 3.
Base business risk - The base businessis on track for lower sales in F2010 vs F2009. F2011 may see an uptick on theback of better economic growth and specific Animal Health product initiatives,and we believe Urocidin will be the bigger driver of BNC stock in the nearterm.
BSDM..FDA Approval in JUNE !!!!!!!!!!!!!!
This stock has tremendous upside potential ..Please do your own DD !!!
2 Approvals (BSD-2000 and MTX-180) within 2 Months !!!
BSD MEDICAL (BSDM)
Market Cap : 31 Million$
Cash : 8 Million$
Price : 1,32 $
BSDM filed a 510K for the MTX-180 with the FDA on March 22. Review period is usually 90 days OR LESS. That puts approval on or before June 22, 2010. About 3-4 weeks from today at the latest.
About the MTX-180
The MTX-180 will work well, and will the be-all, end-all of the ablation market. Every doctor doing ablations will end up with one.
Remember BSDM has done it before, with the device they built for treating BPH. The TherMatrx100.
That device dominated the market, put Urologix (competitor) out of business, and became the system of choice when treating BPH. I believe BSDM sold the rights to it to American Medical Devices Inc. for about 40 million dollars, and that is how they have funded themselves, and the development of the MTX-180 over the last 5 years.
The MTX-180 should be, by all accounts, a cash cow that puts BSDM back on the map, and will draw much attention to their other more expensive hyperhtermia products.
MTX-180 is cheap (maybe 25,000 $$$ ?) but the replaceable parts for surgeries are $900-$3,200 PER SURGERY, and those parts will be sold by BSDM at a 50-60 percent margin. A "razor blade" business if you will.
You do the math.
If BSDM gets just one hundred MTX-180's out there, just 2 for every state in America, and each one does 5 ablations a day, 30 per week, that's 1,560 per year for each one. Multiply by 100 systems, that's, 156,000 ablations per year in the U.S. alone.
At $900-$3,200 x 156,000 you get 140 million to 561 million dollars in revenues generated in 1 year from 100 machines. That's some serious revenues! For a company with just 22 million shares outstanding!
Getting the picture now? What if they end up selling 500 MTX-180's???
Over 600 of the TherMatrx100 BPH treatment systems were sold in the last 6 years. BSDM can do it agian, and the MTX-180 is expected to dominate the marketplace and sell MORE.
MTX-180 could be all this company needs to get the stock into the double digits. Any sales from BSD-2000 is just gravy on top of the meat, the MTX-180.
June will be here in 2 weeks.
All those revenues will now be spread out over just 23 million shares, 11 million of them closely held.
No debt, cash rich now (7.5 million $$) and a new product launch in June. That is the reality. And don't forget, China is buying BSD-2000's, there is an ongoing clinical trial for Thermodox combined with the BSD-500, and the HDE submission for the BSD-2000 can be approved any day now.
This stock can triple in ONE day.
2 Approvals (BSD-2000 and MTX-180) within 2 Months .
BSD Medical (Nasdaq : BSDM )
Market cap 32 Million $
Price 1,40 $
BSD Medical Corporation Reports Continuation of FDA Review of BSD-2000 Hyperthermia System
----
BSD Medical Files FDA 510(k) Submission to Market Phase II MicroThermX Ablation System
Press Release Source: BSD Medical Corporation On Monday March 22, 2010, 8:00 am EDT
SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ:BSDM - News) (Company or BSD) today announced that the Company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA) for premarket clearance of the Company's Phase II MicroThermX® Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of the 510(k) Premarket Notification submission will authorize commercial distribution of the MTX-180 in the United States.
BIG NEWS VERY SOON !!!!!!!!!!!
IntelGenx Acquires Full Ownership of High Dose Bupropion (CPI-300)
http://finance.yahoo.com/news/IntelGenx-Acquires-Full-iw-119536655.html?x=0&.v=1
"We are very excited to have acquired full control and ownership of CPI-300 at this critical juncture in the product's development," said Dr. Horst G. Zerbe, President and Chief Executive Officer of IntelGenx. "The manufacturing site change for the product has progressed as planned and engineering scale-up batches at Pillar5 have already been manufactured. In addition, we have a meeting scheduled with FDA in early June to address their complete response letter and clarify the required steps to obtain product approval. Finally, the Markman hearing in respect of the Biovail litigation is also scheduled for early June, and we remain optimistic for a positive outcome. The timing of this acquisition should yield substantial value to the company and its shareholders because we believe it is an excellent product that will become commercialized in the near future."
Good News ......
Medifocus Inc. Announces That It Has Received Approval for Its Amended Phase III Clinical Trial for Treatment of Breast Cancer from Health Canada
The Approval Allows the Company to Pool Patient Data from Canada and the USA for Use towards Obtaining Commercial Approval from Both Countries
Press Release Source: Medifocus, Inc. On Thursday May 13, 2010, 10:00 am EDT
http://finance.yahoo.com/news/Medifocus-Inc-Announces-That-bw-562436674.html?x=0&.v=1
More good news
FDA ACCEPTS ANDA FILING FOR DEPRESSION DRUG ..
Good news is coming very soon .GLTA
Medifocus, Inc. Announces Acceptance at Two Medical Society Meetings: Posters and Oral Presentations on Past Clinical Trial Results and the Upcoming Phase III Pivotal Study will be Given
COLUMBIA, Md.--(BUSINESS WIRE)--Medifocus Inc. (OTC:MDFZF.PK and TSXV:MFS) is pleased to announce that clinical presentations of the Company’s breast cancer treatment system, the Microfocus APA-1000, will be made at two medical society Annual Meetings in March and April 2010.
Poster presentations reviewing clinical progress for the Company’s APA-1000 system will be made at the National Consortium of Breast Centers 2010 Annual Meeting in Las Vegas, NV, March 20-24, 2010, and at the Society for Thermal Medicine 2010 Annual Meeting in Clearwater, Florida, April 23-26, 2010. In addition, at the Society for Thermal Medicine Meeting, an oral presentation reviewing the results of four clinical trials will be made. The title of the oral presentation is “Adaptive Phased Array Focused Microwave Thermotherapy for Invasive Breast Carcinomas: An Updated Review of Four Clinical Studies” by William C. Dooley, MD, Hernan I. Vargas, MD, Alan J. Fenn, PhD, Mary Beth Tomaselli, MD, Jay K. Harness, MD, and Robert A. Gardner, MD.
On March 9, 2010, Medifocus announced that it had received from the Food and Drug Administration (FDA) an Investigational Device Exemption (IDE) approval to initiate a pivotal Phase III clinical trial upon obtaining institutional review board (IRB) approval from the clinical sites, using the Company's Microfocus APA 1000 System for the treatment of breast cancer. Medifocus had previously announced on June 9, 2009 that Health Canada had granted full Investigational Testing Authorization (ITA) approval to allow the initiation of the same pivotal Phase III study in Canada. The regulatory approvals allow for Phase III clinical trial testing of the APA-1000 system to begin this year in North America.
Medifocus' pivotal Phase III clinical trial design is based on results from four (4) clinical studies performed at ten medical institutions in the USA with the Company's Microfocus APA 1000 Breast Cancer Thermotherapy System. The patient data leading to the design of the pivotal trial were summarized and published online December 22, 2009 in the journal Annals of Surgical Oncology by William C. Dooley, MD, et al. As summarized in the review article, the clinical data showed that when the Medifocus focused heat treatment was added to Standard of Care (SoC) chemotherapy, the median tumor shrinkage in the thermo-chemotherapy arm was 88.4% while for chemotherapy alone, the median tumor shrinkage was only 58.8%. This increase in median tumor shrinkage was statistically significant with a P value equal to 0.048. In addition, the data indicated that for the thermo-chemotherapy treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for the chemotherapy alone. The Company's focused heat treatment, once commercialized, may be in a position to help these patients to improve their chance of breast conservation thus reducing the need for mastectomy.
The pivotal Phase III clinical trial is designed to assess the safety and improvement in efficacy, as measured by increased tumor shrinkage, using the Company’s focused microwave heat energy in combination with neo-adjuvant (pre-operative) chemotherapy over chemotherapy alone on large breast cancer tumors. A total of 238 patients will be entered into the pivotal study at six medical institutions in the USA and Canada as approved by the FDA. Institutional Review Board (IRB) approval will be required at the participating USA medical institutions.
BiotechMaster is online now Add to BiotechMaster's Reputation Report Post Edit/Delete Message
US approval is coming this Q
TIME TO BUY
(RCW Cancer) US approval this Year !!!!!
Medifocus is still flying under Radar ...
Great Presentation ..
http://www.medifocusinc.com/files/power_point_for_Sept_2009.pdf
Early Revenue Opportunity –
Recurrent Chest Wall (RCW) Cancer
Unmet Medical Need
16,000 new patients per year affected
in North America
Much larger patient population world-wide
Use System to treat RCW in
combination with Radiation
Supplemental PMA Approval in 2010
RAALLLYYYYYYYYYYYYYYYYYYYYYYYYYYYYy
http://de.advfn.com/p.php?pid=staticchart&s=TSE%3ABNC&p=0&t=37&vol=1
RAALLLYYYYYYYYYYYYYYYYYYYYY
http://de.advfn.com/p.php?pid=staticchart&s=TSE%3ABNC&p=0&t=37&vol=1
Bid & Ask up ..This stock will explode with more Volume !!!
http://www.otcmarkets.com/pink/quote/quote.jsp?symbol=pmbs
Realtime-Chart
http://ih.advfn.com/p.php?pid=staticchart&s=NB%5EPMBS&p=0&t=19&vol=1
BUY ON BARCHART
http://www.barchart.com/quotes/PMBS
Outlook 2010.........
http://www.puramedbioscience.com/PuraMed%20ppt-4.2010.ppt
Go To Market Timeline
2nd Quarter 2010:
Continue to run the LipiGesic™ M direct response commercial
Begin retail introduction with individual retailer meetings and attend NACDS in June
Complete clinical trial transcript
Submit clinical trial results for publication
Complete product build of LipiGesic™ M for retailer roll-out
3rd Quarter 2010:
Publish clinical results in peer reviewed medical journal
Initiate PR effort to promote clinical trial results
Begin retail distribution nationally to U.S chain direct response drug stores and national drug wholesalers
Build initial LipiGesic™ PM inventory to make available for sale
Continue to run the LipiGesic™ M direct response commercial
4th Quarter 2010:
Initiate Phase II retail roll-out to include U.S. food and mass merchandiser channels
Start the production of the LipiGesic™ PM direct response commercial
Initiate production run of LipiGesic™ PM inventory for direct response campaign
PMBS will go over 5$ very very soon .Better get in before its too late ..
Huge Pipeline ..
LipiGesic™ M
LipiGesic™ M provides acute relief from migraine headaches, and contains the herbs feverfew and ginger as principal ingredients. PuraMed believes that its specific formulation of these herbs for its migraine remedy is unique and proprietary, providing relief from these severe headaches in minutes. The Company believes it will capture a material segment of the huge migraine headache remedy market. We believe that Americans spend in excess of $6 billion annually on headache pain relievers, and that over half of sufferers of migraine headaches rely exclusively on non-prescription medications.
We believe that at least 30 million Americans suffer from chronic migraine headaches with over 20 million of them having “severe” migraine conditions. Thus migraine headaches constitute a severe and disabling condition for millions of people. We further believe that the economic burden alone to the U.S. economy is in excess of $20 billion annually.
LipiGesic™ M is effective, available as a non-prescription remedy, without any known side effects, and affordable compared to more expensive migraine drugs based on prescription chemical formulations.
LipiGesic™ PM
LipiGesic™ PM is a new class of non-prescription sleep aid without any known side effects, and contains a proprietary blend of natural ingredients including Valerian, St. John’s Wort, and Chamomile. We believe that the proprietary blend of these ingredients provides an effective remedy for insomnia and other sleep disorders. The sleep aid market features products based primarily on chemical antihistamines.
Accordingly, the LipiGesic™ PM product provides a wide open market opportunity for an effective, natural alternative to prescription medications, which are somewhat addictive and often cause withdrawal symptoms and other side effects. We have priced LipiGesic™ PM as a premium sleep aid product, which provides us with a projected gross margin of approximately 80%. This large margin should leave us substantial room for ample introductory promotion, product allowances and other incentives conducive to achieving rapid market penetration.
Similar to the migraine remedy market, the market for sleep aid products represents a very large segment of the overall healthcare products marketplace. We believe that over half of all adults in the U.S. suffer from sleep disorders, and that many of them experience persistent insomnia. The National Center on Sleep Disorders has reported that there are as many as 70 million problem sleepers in the U.S. with many of them suffering from chronic sleep disorders. We believe that insomnia is second only to pain as a healthcare complaint.
Future LipiGesic™ Products
We have completed development of additional non-prescription products, which we intend to launch commercially over the next couple years after establishing a solid market for our initial two products. These other PuraMed products include:
LipiGesic™ H – provides relief for common tension headaches which afflict a majority of American adults from time to time. This remedy provides headache relief features a unique proprietary formulation of St. John’s Wort and common aspirin.
LipiGesic™ Smoker’s Pal – provides relief from the symptoms associated with nicotine withdrawal with the added benefit of an appetite suppressant.
LipiGesic™ RLS – provides relief of problematic leg cramps associated with Restless Leg Syndrome affecting a large segment of the population in the U.S.
LipiGesic™ GI – provides relief of symptoms associated with nighttime reflux disorders.
LipiGesic™ CS – provides fast relief for canker sore outbreaks.
PMBS will go over 5$ very very soon .Better get in before its too late ..
Huge Pipeline ..
LipiGesic™ M
LipiGesic™ M provides acute relief from migraine headaches, and contains the herbs feverfew and ginger as principal ingredients. PuraMed believes that its specific formulation of these herbs for its migraine remedy is unique and proprietary, providing relief from these severe headaches in minutes. The Company believes it will capture a material segment of the huge migraine headache remedy market. We believe that Americans spend in excess of $6 billion annually on headache pain relievers, and that over half of sufferers of migraine headaches rely exclusively on non-prescription medications.
We believe that at least 30 million Americans suffer from chronic migraine headaches with over 20 million of them having “severe” migraine conditions. Thus migraine headaches constitute a severe and disabling condition for millions of people. We further believe that the economic burden alone to the U.S. economy is in excess of $20 billion annually.
LipiGesic™ M is effective, available as a non-prescription remedy, without any known side effects, and affordable compared to more expensive migraine drugs based on prescription chemical formulations.
LipiGesic™ PM
LipiGesic™ PM is a new class of non-prescription sleep aid without any known side effects, and contains a proprietary blend of natural ingredients including Valerian, St. John’s Wort, and Chamomile. We believe that the proprietary blend of these ingredients provides an effective remedy for insomnia and other sleep disorders. The sleep aid market features products based primarily on chemical antihistamines.
Accordingly, the LipiGesic™ PM product provides a wide open market opportunity for an effective, natural alternative to prescription medications, which are somewhat addictive and often cause withdrawal symptoms and other side effects. We have priced LipiGesic™ PM as a premium sleep aid product, which provides us with a projected gross margin of approximately 80%. This large margin should leave us substantial room for ample introductory promotion, product allowances and other incentives conducive to achieving rapid market penetration.
Similar to the migraine remedy market, the market for sleep aid products represents a very large segment of the overall healthcare products marketplace. We believe that over half of all adults in the U.S. suffer from sleep disorders, and that many of them experience persistent insomnia. The National Center on Sleep Disorders has reported that there are as many as 70 million problem sleepers in the U.S. with many of them suffering from chronic sleep disorders. We believe that insomnia is second only to pain as a healthcare complaint.
Future LipiGesic™ Products
We have completed development of additional non-prescription products, which we intend to launch commercially over the next couple years after establishing a solid market for our initial two products. These other PuraMed products include:
LipiGesic™ H – provides relief for common tension headaches which afflict a majority of American adults from time to time. This remedy provides headache relief features a unique proprietary formulation of St. John’s Wort and common aspirin.
LipiGesic™ Smoker’s Pal – provides relief from the symptoms associated with nicotine withdrawal with the added benefit of an appetite suppressant.
LipiGesic™ RLS – provides relief of problematic leg cramps associated with Restless Leg Syndrome affecting a large segment of the population in the U.S.
LipiGesic™ GI – provides relief of symptoms associated with nighttime reflux disorders.
LipiGesic™ CS – provides fast relief for canker sore outbreaks.
RALLY ..GET IN NOW !!!
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 5$ WITHIN 2 WEEKS !!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 5$ WITHIN 2 WEEKS !!!
GET IN NOW BEFORE THE STOCK GETS DISCOVERED . THIS IS A 10 BAGGER EASILY !!!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 2$ WITHIN 2 WEEKS !!!
GET IN NOW BEFORE THE STOCK GETS DISCOVERED . THIS IS A 10 BAGGER EASILY !!!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
RAAALLLLYYYYYYYYYYYYY
RAALLLLYYYYYY HAS JUST BEGUN ..WE COULD SEE 2$ WITHIN 2 WEEKS !!!
THIS IS A 10 BAGGER EASILY !!!!
Puramed (PMBS.OB)
Market Cap: 8,9 Mio$
Price: 0,67 $
Shares Out : 12,6 M ( 8,6 M Shares held by Insider)
Float : 2,6 Million
PuraMed Bioscience, Inc. (PMBS.OB) Targets Two Market Opportunities
PuraMed Bioscience, Inc., a non-prescription pharmaceutical company, believes it has identified huge and largely untapped market opportunities, and has laid out a solid plan to capture them. The company, based in Schofield, Wisconsin, was established with two specific goals in mind, representing these two OTC (over-the-counter) product opportunities.
The first objective is to rapidly build a substantial and profitable business based upon three OTC products already developed by the company founders. The products, designed for headache and insomnia relief, are each unique in their own class, and collectively target a $2 billion American market.
LipiGesic MTM is a proprietary formulation created for the acute relief of migraine headaches within minutes. LipiGesic HTM is designed to dramatically increase the speed and levels of relief of tension headaches, effective at low doses and with the fewest potential side effects. LipiGesic PMTM is a new class of OTC sleep aid containing a proprietary blend of ingredients for the quick and natural relief of insomnia.
The second, longer term objective is to establish a leadership position in the highly fragmented OTC natural and alternative health remedy market by introducing a new kind of product line. By applying hard science to natural products, PuraMed believes it can deliver products providing better performance while having fewer side effects.
The company also believes their products will benefit from the kind of effective opportunity identification and marketing that is largely absent in the natural OTC market. Promising research in the field often goes overlooked for years by large pharmaceutical companies. Through the effective use of clinical trials in conjunction with carefully timed and aggressive marketing, PuraMed is convinced that it can better reach a major part of the OTC market.
The two founders of PuraMed, Russ Mitchell and Jim Higgins, both have extensive experience in the successful sale and distribution of new health products, with novel strategies that have proven highly effective over multiple applications. Through the use of outside production and other third party resources, they plan to rapidly build their position, and consider marketing to be key to the new company’s success.
About the Company
PuraMed was established to capture two unique opportunities. The first is to build a substantial and profitable business, rapidly, beginning with three products developed by its founders: LipiGesic™ M (for acute relief of migraine headaches), LipiGesic™ H(for acute relief of tension headaches) and PuraMed™ PM (for insomnia). Each of these is effective and addresses a very large OTC consumer market, collectively well over $2 billion in the U.S. Each product will be unique in its class .
US APPROVAL WILL PUSH THIS STOCK TO 8$+ .IPCI IS FLYING UNDER RADAR !! GLTA
IntelliPharmaceutics (IPCI)
Market Cap: 27 Mio$
Cash: 8 Mio$
Price: 2,40 $
Shares Out: 10,9 M.. (CEO OWNS 6 MIO SHARES )
UPCOMING MILESTONES 2010 ::
FOCALIN XR (ADHD) (Sales 350M$) MARKET APPROVAL IN 2Q 2010
EFFEXOR XR (DEPRESSION) (Sales 3,9 B$) PIII RESULTS + US PARTNERSHIP in 2Q/3Q 2010
FILE AND HAVE ACCEPTED FOR REVIEW BY THE FDA
, TWO ADDITIONAL ANDA APPLICATION IN 2010
Intellipharmaceutics International Inc. (IPCI) engages in the research, development and commercialization of controlled-release drug technologies. The Company has 15 drug programs in development that address various therapeutic areas, including neurology, cardiovascular, Gastro-Intestinal Tract (GIT), pain and infection. Partnered with Par Pharmaceutical Companies Inc., the Company's lead drug product, a generic form of Focalin XR, is under review by the Food and Drug Administration for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Another one of the Company's leading drug candidate is Rexista, a competing drug to Oxycodone, developed to alleviate pain.
"With the development of its four leading drug products, including Generic Focalin XR, Generic Effexor XR, Rexista (Oxycodone) and Generic Coreg CR, the Company attempts to capture a portion of a combined market of more than $6.0 billion in annual revenue. Presently, revenue derived from its competitors' proprietary drugs Focalin XR, Effexor XR, Coreg CR and Oxycodone RX total $350 million, $3.9 billion, $300 million and $2.0 billion, respectively.
"The novel approach of manipulating the delivery of the above-named drug therapies via the Company's novel Hypermatrix(TM) concept allows the Company a margin of competitive advantage within the pharmaceutical space. Its Hypermatrix delivery system concept is designed to optimize Nature's hyper-dimensionality as it relates to drug therapies."
PIII Results within 6 Weeks !!!
Urocidin (Bladder cancer) PIII results in April 2010 .Urocidin has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
PIII RESULTS WILL BE POSITIVE ..MARK THIS POST !!!
Bioniche Life Science (BNC.TO) or (BNHLF.PK)
Market Cap: 86 Mio $
Cash: 30 Mio $
Price: 0,96 $
Bioniche Life Sciences Inc. (“Bioniche”; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating UrocidinTM in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy – Bacillus Calmette-Guérin (BCG).
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche “continue the trial unmodified until the next scheduled or triggered meeting.” The next scheduled meeting of the Committee is scheduled to occur in October.
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
Big News within 6 Weeks !!!!
Urocidin (Bladder cancer) PIII results in April 2010 .Urocidin has BLOCKBUSTER POTENTIAL (1-1,5 Billion Dollar Market Potential )
PIII RESULTS WILL BE POSITIVE ..MARK THIS POST !!!
Bioniche Life Science (BNC.TO) or (BNHLF.PK)
Market Cap: 86 Mio $
Cash: 30 Mio $
Price: 0,96 $
Bioniche Life Sciences Inc. (“Bioniche”; TSX: BNC), a research-based, technology-driven Canadian biopharmaceutical company, today provided an update on its Phase III clinical program evaluating UrocidinTM in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy – Bacillus Calmette-Guérin (BCG).
The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche “continue the trial unmodified until the next scheduled or triggered meeting.” The next scheduled meeting of the Committee is scheduled to occur in October.
Upcoming Milestones
2009/2010 Conditional license for E. coli cattle vaccine in the U.S.
2009/2010 Achievement of pre-commercialization milestone payments for
UrocidinTM
2010 First U.S. sales of E. coli cattle vaccine
2010 Results of refractory Phase III NMI bladder cancer trial
2011 Belleville, ON vaccine manufacturing centre operational
Final PIII in Breast Cancer// Mcap 7 M$
This stock is definitely flying under Radar ..Get in now before the stock gets discovered ..
Medifocus will HIT 10$+ within 12-15 Months .
Medifocus
Market-Cap: 7 Mio $
Price: 0,28 $
Shares Out : 24,3 Mio
Medifocus, Inc. Announces That It Has Received Approval to Initiate Its Pivotal Phase III Clinical Trial for Treatment of Breast Cancer from the Food and Drug Administration (FDA), Investigational Device Exemption (IDE) Application
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_newsreleases.asp%3Fsymbol%3DV.MFS%26newsid%3D7657794
Medifocus, Inc. Announces Positive Clinical Results of Its Breast Cancer Treatment Studies Published in Annals of Surgical Oncology: Planning to Begin Phase III In Early 2010
1/12/2010 9:30:01 AM - Business Wire
http://www.stockhouse.com/tools/?page=%2FFinancialTools%2Fsn_newsreleases.asp%3Fsymbol%3DV.MFS%26newsid%3D7591353
Fact Sheet
http://www.medifocusinc.com/files/medifocus_fs_Oct2009.pdf
Homepage
http://www.medifocusinc.com/company.asp
Market Potential
It is projected that invasive breast cancer cases in the US will have increased to 213,000 new cases in 2006 (National Cancer Institute). This is expected to increase to 480,000 new cases a year by 2017. This market is growing dramatically as the North American population ages.
Management believes that Medifocus’ technology can be useful in the treatment of the entire range of breast cancers. The first indication, large breast cancers, represents 20% of the total incidence of breast cancer. Medifocus is initially targeting 20% of that market.
The Medifocus system will be the first-to-market with its APA solution in 2010 - 2011, when experts suggest that the rate of diagnosis of large breast tumors will reach 76,000.
LAST CHANCE TO BUY UNDER 4$ !!!
IntelliPharmaceutics (IPCI)
Market Cap: 33 Mio$
Cash: 8 Mio$
Price: 3 $
Shares Out: 10,9 M.. (CEO HOLDS 6 M SHARES )
UPCOMING MILESTONES 2010 ::
FOCALIN XR (ADHD) (Sales 350M$) MARKET APPROVAL IN 1H 2010
EFFEXOR XR (DEPRESSION) (Sales 3,9 B$) PIII RESULTS + US PARTNERSHIP in 2Q/3Q 2010
FILE AND HAVE ACCEPTED FOR REVIEW BY THE FDA
, TWO ADDITIONAL ANDA APPLICATION IN 2010
Intellipharmaceutics International Inc. (IPCI) engages in the research, development and commercialization of controlled-release drug technologies. The Company has 15 drug programs in development that address various therapeutic areas, including neurology, cardiovascular, Gastro-Intestinal Tract (GIT), pain and infection. Partnered with Par Pharmaceutical Companies Inc., the Company's lead drug product, a generic form of Focalin XR, is under review by the Food and Drug Administration for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Another one of the Company's leading drug candidate is Rexista, a competing drug to Oxycodone, developed to alleviate pain.
"With the development of its four leading drug products, including Generic Focalin XR, Generic Effexor XR, Rexista (Oxycodone) and Generic Coreg CR, the Company attempts to capture a portion of a combined market of more than $6.0 billion in annual revenue. Presently, revenue derived from its competitors' proprietary drugs Focalin XR, Effexor XR, Coreg CR and Oxycodone RX total $350 million, $3.9 billion, $300 million and $2.0 billion, respectively.
"The novel approach of manipulating the delivery of the above-named drug therapies via the Company's novel Hypermatrix(TM) concept allows the Company a margin of competitive advantage within the pharmaceutical space. Its Hypermatrix delivery system concept is designed to optimize Nature's hyper-dimensionality as it relates to drug therapies."
Approval soon =10$+ is coming
Dont miss the train
IntelliPharmaceutics (IPCI)
Market Cap: 35 Mio$
Cash: 8 Mio$
Price: 3,23 $
Shares Out: 10,9 M (CEO HOLDS 6 M SHARES )
UPCOMING MILESTONES 2010 ::
FOCALIN XR (ADHD) (Sales 350M$) MARKET APPROVAL IN 1H 2010
EFFEXOR XR (DEPRESSION) (Sales 3,9 B$) PIII RESULTS + US PARTNERSHIP in 2Q/3Q 2010
FILE AND HAVE ACCEPTED FOR REVIEW BY THE FDA
, TWO ADDITIONAL ANDA APPLICATION IN 2010
Intellipharmaceutics International Inc. (IPCI) engages in the research, development and commercialization of controlled-release drug technologies. The Company has 15 drug programs in development that address various therapeutic areas, including neurology, cardiovascular, Gastro-Intestinal Tract (GIT), pain and infection. Partnered with Par Pharmaceutical Companies Inc., the Company's lead drug product, a generic form of Focalin XR, is under review by the Food and Drug Administration for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Another one of the Company's leading drug candidate is Rexista, a competing drug to Oxycodone, developed to alleviate pain.
"With the development of its four leading drug products, including Generic Focalin XR, Generic Effexor XR, Rexista (Oxycodone) and Generic Coreg CR, the Company attempts to capture a portion of a combined market of more than $6.0 billion in annual revenue. Presently, revenue derived from its competitors' proprietary drugs Focalin XR, Effexor XR, Coreg CR and Oxycodone RX total $350 million, $3.9 billion, $300 million and $2.0 billion, respectively.
"The novel approach of manipulating the delivery of the above-named drug therapies via the Company's novel Hypermatrix(TM) concept allows the Company a margin of competitive advantage within the pharmaceutical space. Its Hypermatrix delivery system concept is designed to optimize Nature's hyper-dimensionality as it relates to drug therapies."
IPCI IS STILL FLYING UNDER RADAR !!
US APPROVAL IS COMING VERY SOON .IPCI WILL GO OVER 10$ EASILY !!
IntelliPharmaceutics (IPCI)
Market Cap: 35 Mio$
Cash: 8 Mio$
Price: 3,23 $
Shares Out: 10,9 M (CEO HOLDS 6 M SHARES )
UPCOMING MILESTONES 2010 ::
FOCALIN XR (ADHD) (Sales 350M$) MARKET APPROVAL IN 1H 2010
EFFEXOR XR (DEPRESSION) (Sales 3,9 B$) PIII RESULTS + US PARTNERSHIP in 2Q/3Q 2010
FILE AND HAVE ACCEPTED FOR REVIEW BY THE FDA
, TWO ADDITIONAL ANDA APPLICATION IN 2010
Intellipharmaceutics International Inc. (IPCI) engages in the research, development and commercialization of controlled-release drug technologies. The Company has 15 drug programs in development that address various therapeutic areas, including neurology, cardiovascular, Gastro-Intestinal Tract (GIT), pain and infection. Partnered with Par Pharmaceutical Companies Inc., the Company's lead drug product, a generic form of Focalin XR, is under review by the Food and Drug Administration for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Another one of the Company's leading drug candidate is Rexista, a competing drug to Oxycodone, developed to alleviate pain.
"With the development of its four leading drug products, including Generic Focalin XR, Generic Effexor XR, Rexista (Oxycodone) and Generic Coreg CR, the Company attempts to capture a portion of a combined market of more than $6.0 billion in annual revenue. Presently, revenue derived from its competitors' proprietary drugs Focalin XR, Effexor XR, Coreg CR and Oxycodone RX total $350 million, $3.9 billion, $300 million and $2.0 billion, respectively.
"The novel approach of manipulating the delivery of the above-named drug therapies via the Company's novel Hypermatrix(TM) concept allows the Company a margin of competitive advantage within the pharmaceutical space. Its Hypermatrix delivery system concept is designed to optimize Nature's hyper-dimensionality as it relates to drug therapies."
RAALLLLLYYYYYYYYYYYYYYYY
APPROVAL IS COMING = NEXT SOMX
Get the f outta here losers
This stock is a GIFT at this rpice .Market cap is only 29 Million$ .
MARKET MAKERS ARE BUYING HEAVY...WEAK HAND ARE SELLING
STRONG BUY AT THIS PRICE ...
The Long And Short Of Intellipharmaceutics International
3/15/2010 5:59 AM ET
Canada-based Intellipharmaceutics International Inc. (IPCI) (I.TO) has become the latest defendant to settle a long-standing patent spat involving ADHD (Attention Deficit Hyperactivity Disorder) drug Focalin-XR spread between two courts and multiple plaintiffs.
Intellipharmaceutics International is a specialty pharmaceutical company focused on developing controlled-release generic and branded drugs. Intellipharmaceutics International was formed in October 2009 by the merger of publicly traded Vasogen Inc. and privately held Intellipharmaceutics. The shares of Intellipharmaceutics International began trading on the Toronto Stock Exchange and Nasdaq on October 22, 2009.
In May 2007, Intellipharmaceutics, which was then a private firm, and its development partner, Par Pharmaceutical Companies Inc. (PRX), filed an ANDA for a generic Focalin XR product with the FDA. Intellipharmaceutics had also filed paragraph IV certification indicating that it believed its generic versions of Focalin XR did not infringe patents pertaining to the drug and/or that the patents are invalid or unenforceable. The application was accepted by the FDA for filing in August 2007.
Focalin and the longer-acting Focalin XR are refined versions of Celgene Corp.'s (CELG) Ritalin. Focalin-XR was developed using Elan Corp.'s (ELN) proprietary Spheroidal Oral Drug Absorption System technology. In April 2000, Celgene granted Novartis AG (NVS) an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Focalin XR.
Following the FDA's acceptance for filing of the ANDA for generic Focalin-XR, Elan filed a patent infringement lawsuit on October 1, 2007 against Par Pharma and its development partner, IntelliPharmaCeutics in the United States District Court for the District of Delaware, while Celgene and Novartis filed a lawsuit against IntelliPharmaCeutics in the United States District Court for the District of New Jersey on October 5, 2007.
Actavis South Atlantic LLC , Abrika Pharmaceuticals, Inc. and KV Pharmaceutical Co. (KV-A) are the other companies that are defendants in the Focalin-XR patent suit.
After nearly two-and-a-half years, the plaintiffs - Novartis, Celgene and Elan have now settled the patent infringement lawsuits against Intellipharmaceutics over the generic version of Focalin-XR. The terms of the settlements are confidential and remain subject to regulatory and court approval. In 2009, sales of Focalin, including Focalin-XR, totaled $343 million in the U.S., a slight decline from $347 million in 2008. Global sales of Focalin, including Focalin-XR in 2009 were $449 million, slightly up from $440 million reported in 2008.
Intellipharmaceutics is not the only company to have settled the patent dispute over generic Focalin-XR. Last month, Teva Pharmaceutical Industries Ltd. (TEVA) signed an agreement with Novartis and Celgene to settle patent infringement suits related to the marketing of a generic version of Focalin-XR. Terms of the settlement are yet to be disclosed.
With the conclusion of the litigation process over the generic Focalin-XR, Intellipharmaceutics is now awaiting FDA approval.
Intellipharmaceutics executed the license and commercialization agreement for the development of a generic Focalin XR with Par Pharmaceutical in November 2005. Under the agreement, Intellipharmaceutics is responsible for some development costs and Par is responsible for certain costs including bio-equivalence costs, API costs, and scale up / stability costs. Par is also responsible for costs associated with litigation. Intellipharmaceutics has a ten year profit-sharing agreement with Par from commercial launch of the product, which is expected to fetch $35 million in sales (combined share).
The company's generics pipeline also includes Venlafaxine HCI, a generic version of antidepressant Effexor XR, and Carvedilol CR, a generic version of Coreg CR prescribed to lower blood pressure. Effexor XR is developed and marketed by Wyeth, now part of Pfizer Inc. (PFE), while Coreg CR is marketed by GlaxoSmithKline plc (GSK).
Intellipharmaceutics expects its ANDA filing for generic Effexor XR to be accepted by the FDA this year.
In addition to generic products, the company also has a key non-generic product in development , Rexista, an abuse-and alcohol-resistant, controlled-release oral oxycodone formulation. The company expects to complete phase I studies with Rexista this year.
In addition to the drug candidates mentioned above, the company has 11 more products at varying stages of development.
Shares of Intellipharmaceutics exploded to a new intraday high of $5.05 on Friday, an increase of 232% from the previous day's close price of $1.52, before closing the day's trade at $4.14 on a volume of 2.5 million shares.
DONT MISS THE BIG OPPORTUNITY .IPCI WILL GO OVER 10$ EASILY !!
IntelliPharmaceutics (IPCI)
Market Cap: 44 Mio$
Cash: 8 Mio$
Price: 4,12 $
Shares Out: 10,9 M (CEO HOLD 6 M SHARES )
UPCOMING MILESTONES 2010 ::
FOCALIN XR (ADHD) (Sales 350M$) MARKET LAUNCH IN 1H 2010
EFFEXOR XR (DEPRESSION) (Sales 3,9 B$) PIII RESULTS + US PARTNERSHIP in 2Q/3Q 2010
FILE AND HAVE ACCEPTED FOR REVIEW BY THE FDA, TWO ADDITIONAL ANDA APPLICATION IN 2010
RRAAALLLLYYYYYYYYYYYYYYYYYYYYYYYYYY
STILL WAYYYYYYYYY UNDERVALUED ...BOOOOOOOOOOOOOOOM
GET IN NOW BEFORE ITS TOO LATE
BIG News out for IPCI = MEANS US APPROVAL !!!!!
LOAD UP THE TRUCK WHILE ITS VERY VERY CHEAP !!
http://finance.yahoo.com/news/Intellipharmaceutics-pz-2496926109.html?x=0
Intellipharmaceutics Announces Settlement for its Generic Version of Focalin XR(R)
Press Release Source: Intellipharmaceutics International Inc. On Thursday March 11, 2010, 5:00 pm EST
TORONTO, March 11, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI - News) (TSX:I - News) today announced that Novartis Pharmaceuticals Corporation and Celgene Corporation have settled their patent suit in the U.S. District Court for the District of New Jersey, and Elan Pharma International Ltd. has settled its patent suit in the U.S. District Court for the District of Delaware, with Intellipharmaceutics Corp., a wholly-owned subsidiary of Intellipharmaceutics International, and its licensee Par Pharmaceutical, Inc. over a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR(R) (dexmethylphenidate hydrochloride). The terms of the settlements are confidential and remain subject to regulatory and court approval.
APPROVALLLL..IPCI WILL EXPLODE TODAY
Intellipharmaceutics Announces Settlement for its Generic Version of Focalin XR(R)
Press Release Source: Intellipharmaceutics International Inc. On Thursday March 11, 2010, 5:00 pm EST
TORONTO, March 11, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI - News) (TSX:I - News) today announced that Novartis Pharmaceuticals Corporation and Celgene Corporation have settled their patent suit in the U.S. District Court for the District of New Jersey, and Elan Pharma International Ltd. has settled its patent suit in the U.S. District Court for the District of Delaware, with Intellipharmaceutics Corp., a wholly-owned subsidiary of Intellipharmaceutics International, and its licensee Par Pharmaceutical, Inc. over a generic version of the Attention Deficit Hyperactivity Disorder drug Focalin XR(R) (dexmethylphenidate hydrochloride). The terms of the settlements are confidential and remain subject to regulatory and court approval.
US APPROVAL IN 2Q 2010 = 10 BAGGER !!!
GET IN NOW BEFORE THE STOCK GETS DISCOVERED .....
BSD MEDICAL (BSDM)
Market Cap: 38 Mio$
Price: 1,78 $
Shares Out: 22 M
News
http://www.bsdmedical.com/more-press.php
BSD Medical Corporation Reports Continuation of FDA Review of BSD-2000 Hyperthermia System
SALT LAKE CITY -- November 18, 2009
http://www.bsdmedical.com/press_view.php?press_id=317
http://www.cancerdecisions.com/content/view/285/2/lang,english/
A Victory for Hyperthermia in Bladder Cancer
Sunday, 15 November 2009
There was another victory for the use of regional deep hyperthermia in the treatment of cancer. The latest victory occurred in the treatment of high-risk bladder cancer. Heat treatment, delivered via the BSD 2000 machine, improved such patients' five-year survival rate from 67 to 80 percent. The local tumor control rate went from 63 to 81 percent. In addition, the disease-specific survival was 88 percent, metastasis-free survival was 89 percent, and the bladder-preserving rate was 96 percent at three years.
The median number of weekly hyperthermia treatments that patients received was five (with a range of 1-7). So some of the patients received just a single hyperthermia treatment, yet their results were averaged with the rest. Not surprisingly, there was a correlation between the number of hyperthermia treatments patients received and their overall survival rate -simply put, those who received more frequent treatments did better (Wittlinger 2009).
The study was published in Radiotherapy and Oncology by Dr. Michael Wittlinger of the Department of Radiation Oncology at Erlangen University Medical School in Germany and seven colleagues. Radiotherapy and Oncology is the official publication of the European Society for Therapeutic Radiology and Oncology.
Other Studies Show the Same Effect
This is not the only study to demonstrate improved results when hyperthermia is added to conventional treatment for bladder cancer. Thus, Renzo Columbo, MD, of Milan, Italy, reported on a multi-center trial in which 83 patients with intermediate or high-risk bladder tumors who were randomized to receive either the drug mitomycin-C alone or the same drug plus hyperthermia (following bladder-sparing surgery). The recurrence rate for those receiving mitomycin C alone was 57.5 percent, but it plummeted to 17.1 percent in those who also received hyperthermia. That study appeared in the Journal of Clinical Oncology (Colombo 2003).
In addition, Jacoba van der Zee, MD, and colleagues at the Erasmus Medical Center in Holland reported on a prospective, randomized trial that included 101 bladder cancer patients. The addition of hyperthermia to radiotherapy significantly increased the complete tumor response rate (the disappearance of all local tumor) from 51 percent for those treated with radiotherapy alone to 73 percent in patients also treated with hyperthermia, a 22 percent improvement. The duration of local control was also significantly longer. That study was published in the Lancet (van der Zee 2000).
For the record, the same trial also included patients with cervical or rectal cancer patients. The treatment worked in all cancer types, but the response was even greater in cervical cancer, where hyperthermia increased the complete response (CR) rate from 57 to 83 percent, a 26 percent difference. The three-year survival rate went from 27 to 51 percent (Van der Zee 2000). As I reported in my newsletter of June 15, 2009, hyperthermia has now become part of standard treatment for cervical cancer in Holland and has been recommended as such by the German Cancer Society (Frankena 2008 and Frankena 2009). By contrast, the device used in the latest German trial, the BSD 2000, although made in the United States, is restricted to investigational use by the Food and Drug Administration (FDA).
The accumulating data on the benefits of hyperthermia gives the lie to the idea that American oncologists will adopt any therapeutic measure, provided that it is proven effective in clinical trials. In my opinion, a great many American patients will die needlessly before the cancer establishment wakes up to the fact that hyperthermia is a relatively harmless way of prolonging the lives of many cancer patients.
RALLLLYYYYYYYYYYYYYYYYYYYYYYYYYYYY
Two Final-Studies in Breast & Liver Cancer .This Undiscovered stock is the next DNDN.Market Cap of 50 M$ is wayyyyyy Undervalued ...
Celsion (CLSN)
Market Cap: 50,7 Mio$
Cash: 12,6 Mio$
Price: 4,18 $
Shares Out: 12,1 M
First drug, ThermoDox®, is in 2 registrational trials with near term commercialization
•
ThermoDox addresses $ billion market potential
•
Strong IP patent protection to 2018 with extension potential, Orphan Drug designation in US
•
Commercialization plans maximize shareholder value
•
US strategy is to market and sell directly
•
Ex-US strategy is through license agreements with Pharma partners
Key Events Through 2010
Sign 2nd license agreement for ThermoDox Q2/3Q 2010
600 patients in Phase 3 HCC Trial Q2 2010
Interim Analysis Phase III Q4 2010
1st data set analysis from RCW Phase I/II trial 12/2010
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
INSIDER BUYING ...
Small float, Nice pipeline and a great story if you do your DD.
http://www.secform4.com/insider-trading/749647.htm
http://finance.yahoo.com/q/it?s=CLSN
5$ is coming next week !!!!!!!
RALLYY HAS JUST STARTED.........
Two Final-Studies in Breast & Liver Cancer .CLSN is the next DNDN.
Big US-PartnerShip is coming soon ....
Celsion (CLSN)
Market Cap: 45 Mio$
Cash: 14,1 Mio$
Price: 3,85 $
Shares Out: 12,1 M
Key Events Through 2010
Sign 2nd license agreement for ThermoDox Q2/3Q 2010
Complete 600 patients in Phase 3 HCC Trial Q2 2010
Interim Analysis Phase III Q4 2010
1st data set analysis from RCW Phase I/II trial 12/2010
"We continue to make substantive progress in our Phase III HEAT trial for ThermoDox with over 45% of the 600 patients now enrolled in the study," said Michael Tardugno, President and CEO of Celsion. "With the recent addition of China, Thailand, Malaysia, Philippines and additional sites in Korea, Taiwan and Italy, we expect enrollment completion within the next 2 quarters. We have achieved our goal of opening enrollment at 60 clinical trial sites world-wide, and we anticipate initiating the trial at an additional 10 sites by the end of this month. Additionally, our pivotal Phase recurrent chest wall breast cancer trial, the Dignity Study, has enrolled a sufficient number of patients in the Phase I portion to warrant a dose escalation review by the DSMB. Assuming there will be no adverse events suggesting dose limiting toxicity, the Dignity Study may be allowed to increase dosage to the therapeutic dose as early as March of this year."
Data Monitoring Committee Recommends Continuation of Celsion's Phase III ThermoDox(R) Study for Primary Liver Cancer
270 patients treated in Phase III trial at 60 sites in 11 countries
COLUMBIA, Md., Feb 10, 2010 /PRNewswire via COMTEX News Network/ -- Celsion Corporation (Nasdaq: CLSN) announced today that after reviewing safety data from 120 patients enrolled in the pivotal Phase III ThermoDox(R) clinical trial ("HEAT" trial) for primary liver cancer, the Data Monitoring Committee (DMC) has recommended that Celsion continue to enroll patients in the trial.
The DMC for the HEAT study is comprised of an independent group of medical and scientific experts who are responsible for reviewing and evaluating patient safety and efficacy data. The DMC reviews safety data at regular intervals with the mandate to ensure patient safety and monitor the quality and overall conduct of the study. The study design and statistical plan for the Phase III ThermoDox trial also incorporates a pre-planned interim efficacy analysis by the DMC after patient enrollment is complete, with the intent to stop the study if there is overwhelming evidence of treatment benefit or an extremely low probability of treatment success.
"We are pleased that the DMC has recommended continuation of the study based on its review of the safety data," stated Michael H. Tardugno, President and Chief Executive Officer of Celsion. "We currently have 60 sites enrolling patients in 11 countries and plan to have 70 sites with patients by the end of February. With recent acceleration in patient recruitment, and the study now nearly 50% enrolled, we project that the trial will be fully enrolled within the next two quarters."
Celsion's global Phase III ThermoDox study for primary liver cancer is enrolling 600 patients and is being conducted under a FDA Special Protocol Assessment (SPA). The study is designed to evaluate the efficacy of ThermoDox in combination with radiofrequency ablation (RFA) when compared to patients who receive RFA alone as the control. The primary endpoint for the study is progression-free survival.
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Key Events Through 2010
Sign 2nd license agreement for ThermoDox Q2/3Q 2010
Complete 600 patients in Phase 3 HCC Trial Q2 2010
Interim Analysis Phase III Q4 2010
1st data set analysis from RCW Phase I/II trial 12/2010