POINT ROBERTS, November 25, 2011 - www.InvestorIdeas.com, a global investor research portal for independent investors, issues a biotech/pharma investor snapshot for stocks involved in the treatment of Hepatitis C Virus (HCV). Over 170 million people worldwide are chronically infected with Hepatitis C. The sector made headlines earlier this week as Pharmasset, Inc. (Nasdaq:VRUS), traded up over 84% on acquisition news.
Gilead Sciences, Inc. (Nasdaq:GILD) and Pharmasset, Inc. (Nasdaq:VRUS) reported the companies have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash.
What does this mean for the sector? Are there other potential acquisitions? Some say this acquisition makes Vertex Pharmaceuticals Inc (VRTX) look relatively cheap.
Pharmasset (Nasdaq:VRUS) has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company's lead product candidate, PSI-7977, an unpartnered uracil nucleotide analog, has recently been advanced into two Phase 3 studies in genotype 2 and 3 patients. Both studies will utilize 12 weeks of treatment with PSI-7977 in combination with ribavirin. One study will compare this all-oral regimen against 24 weeks of the standard-of-care pegylated interferon/ribavirin in treatment-naïve patients, and the second study will compare the all-oral regimen to placebo in interferon-intolerant/ineligible patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1-infected patients. If successful, this strategy could lead to an initial U.S. regulatory approval of PSI-7977 in 2014. PSI-938, an unpartnered guanosine nucleotide analog, is being tested in a Phase 2b interferon-free trial as monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analog, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.
Gilead's research and development portfolio includes seven unique molecules in various stages of clinical development for the treatment of HCV.
James A. Joyce, Chairman and CEO of Aethlon Medical, Inc. (OTCBB: AEMD) recently updated shareholders on November 16 th, "Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy."
Full news: http://finance.yahoo.com/news/Aethlon-Medical-Releases-prnews-4279719933.html?x=0&l=
Vertex Pharmaceuticals Inc (VRTX) announced earlier in November its interim results from ZENITH, an ongoing Phase 2 study designed to assess the safety, tolerability and efficacy of multiple 12- and 24-week response-guided treatment regimens with VX-222 (100mg or 400mg), its lead polymerase inhibitor in development, in combination with INCIVEK™ (telaprevir) tablets, pegylated-interferon and ribavirin in people with genotype 1 chronic hepatitis C who were new to treatment. On the basis of the results announced today and previously announced data from other treatment arms of the ZENITH study, Vertex intends to start a Phase 3 study to evaluate a total treatment duration of 12 weeks with this four-drug regimen in treatment naïve and relapser patients with genotype 1 chronic hepatitis C.
More about Aethlon Medical (OTCBB: AEMD)
The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. For more information, please visit www.aethlonmedical.com.
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BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Source - www.Investorideas.com
Friday, November 25, 2011
Monday, November 21, 2011
Biotech and Pharma stocks News; BioSante Pharmaceuticals (NASDAQ: BPAX) Added to NASDAQ Biotechnology Index
LINCOLNSHIRE, Ill. - November 21, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced that it has been added to the NASDAQ Biotechnology Index� (Symbol: NBI), effective prior to the stock market open today, November 21, 2011.
The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is a modified market capitalization-weighted index, and the index securities are evaluated semi-annually in May and November.
"We are delighted that BioSante has been added to the NASDAQ Biotechnology Index, as it recognizes our established role in the biotechnology industry, adds greater visibility for our company and could lead to a broader stockholder base,� stated Phillip Donenberg, BioSante�s senior vice president of finance and chief financial officer.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante, Investorideas.com
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The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ-listed securities that are classified as either biotechnology or pharmaceutical according to the Industry Classification Benchmark (ICB). The NASDAQ Biotechnology Index is a modified market capitalization-weighted index, and the index securities are evaluated semi-annually in May and November.
"We are delighted that BioSante has been added to the NASDAQ Biotechnology Index, as it recognizes our established role in the biotechnology industry, adds greater visibility for our company and could lead to a broader stockholder base,� stated Phillip Donenberg, BioSante�s senior vice president of finance and chief financial officer.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Wednesday, November 16, 2011
Trading Alert: PositiveID (OTCBB:PSID) Trades up over 50% on FDA News
POINT ROBERTS - November 16, 2011 - www.InvestorIdeas.com, a global investor
research portal for independent investors issues a trading alert for medical technology stock, PositiveID Corporation (OTCBB:PSID), following news of its FDA clearance for iglucose(TM) mobile health system for diabetes. The stock has moved up over 52% on news with volume of over two million shares in morning trading.
PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
iglucose is a First-of-its-Kind Wireless Communication System for Diabetes Management
PositiveID to Begin Commercialization Efforts in First Quarter 2012
Full news: http://www.investorideas.com/news/2011/main/11161.asp
About PositiveID Corporation (OTCBB:PSID),
PositiveID Corporation, based in Delray Beach, Florida, is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
For more information on iglucose, please visit www.iglucose.com.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411
Source - www.Investorideas.com
PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
iglucose is a First-of-its-Kind Wireless Communication System for Diabetes Management
PositiveID to Begin Commercialization Efforts in First Quarter 2012
Full news: http://www.investorideas.com/news/2011/main/11161.asp
About PositiveID Corporation (OTCBB:PSID), PositiveID Corporation, based in Delray Beach, Florida, is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
For more information on iglucose, please visit www.iglucose.com.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
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Investor Research Tools;
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Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.asp
BC Residents and Investor Disclaimer: Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Source - www.Investorideas.com
Biotech Stock Alert; Aethlon Medical (OTC: AEMD) Releases Shareholder Letter
SAN DIEGO - November 16, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce , has issued the following letter to shareholders.
To our Shareholders:
Earlier this year, we introduced and began marketing the Aethlon ADAPT™ system, a technology platform that intersects the medical device and drug world to establish a new class of therapeutics that allow for the selective subtraction of disease-enhancing particles from patient circulation without adding drug toxicity. Not long ago, the medical community consensus was that it would not be possible for a medical device to remove harmful particles from circulation without also stripping out essential elements required for health. Well, as Walt Disney once stated, "Its kind of fun to do the impossible." I would add immensely challenging as well. Therapies that evolve from our platform hold the potential to alter the healthcare industry by unlocking the ability to attack disease survival mechanisms that are beyond the reach of drugs. Today, we are advancing ADAPT-based endeavors to address unmet medical needs in cancer, infectious disease, and now sepsis.
On October 3rd , we proudly disclosed that the first sale of our Aethlon ADAPT™ system occurred when we signed a $6.8 million contract with the UnitedStates of America . The contract resulted from our response to a "Dialysis-Like Therapeutics" (DLT) program offered through the Defense Advanced Projects Agency (DARPA). DARPA is a primary engine for innovation in our country and we are honored to be working with them on a project whose mission includes saving the lives of wounded soldiers. Under the DLT program, the Aethlon ADAPT™ system will be tested as a core technology component of a therapeutic device that would prevent sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers. In this application, the open architecture of our technology platform provides a therapeutic template to immobilize a combination of affinity compounds to selectively target sepsis-enabling factors in circulation.
DARPA estimates the successful development of this device would save thousands of lives and billions of dollars in the UnitedStates each year. In regards to the global opportunity, more than 18 million cases of sepsis are reported each year, with more than six million resulting in death. We have also been tasked by DARPA to advance a novel blood pump design that seamlessly integrates with therapeutic devices, yet reduces or eliminates the systemic administration of anticoagulants normally required during extracorporeal therapies.
Last week, we received our first milestone payment under the DARPA award, which officially transitioned our corporate status from development-stage to revenue stage organization. Now that we are contract proven, we plan to increase our efforts to market the Aethlon ADAPT™ system to government health and military agencies that seek innovative strategies to address life-threatening or debilitating disease conditions.
With each subsequent sale of the Aethlon ADAPT™ system, we reinforce the value of our therapeutic vision, reduce our reliance on the capital markets, and further establish a unique business model that allows us to generate revenue as we clinically advance pipeline therapies to market. Our technology platform also provides a basis to establish collaborative business relationships with biotechnology and pharmaceutical organizations that might have interest in pursuing a medical device regulatory and commercialization pathway for their affinity drug agents. As toxicity eliminates a majority of affinity drug agents from entering the market, we provide the opportunity to repurpose clinical stage affinity drugs as well as previous clinical dropouts.
On September 21st , we again leveraged the Aethlon ADAPT™ system to introduce a targeted breast cancer therapy known as HER2osome™ and enlisted clinical support from thought leaders in the cancer field. In this application, HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Our therapeutic goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer.
When we first initiated research into tumor-secreted exosomes, the consensus thought was that exosomes were nothing more than cellular garbage bags having no meaningful function. Today, exosomes have emerged to become an important new therapeutic target in cancer care, yet remain unaddressed with drug therapy. In a forthcoming disclosure, we will discuss some of our other exosome related endeavors. However, as it relates to breast cancer, research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin®, a leading monoclonal antibody treatment against the HER2+ breast cancer. Quite simply, we are developing HER2osome™ because we believe the resulting device will enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks. In this regard, the Aethlon ADAPT™ system provides a therapeutic template to immobilize both an anti-HER2 antibody and an exosome targeted affinity agent as a basis to simultaneously clear both targets from the circulatory system of HER2+ breast cancer patients. Like all Aethlon ADAPT™ derived therapies, HER2osome™ is designed for utilization on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
While this is certainly an exciting time for our organization, there is something else I want to address before concluding my letter. That is the treatment of Hepatitis C (HCV) infected individuals with our Hemopurifier®, which is the lead product in our ADAPT product pipeline. Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.
Our HCV treatment results led us to ask the question, what if we administered Hemopurifier® therapy to non-dialysis patients when they initiated HCV drug therapy? To find the answer, we initiated our first clinical study in non-dialysis patients at the Medanta Medicity Institute in India . We already knew that rapid viral load depletion in the first few days of therapy correlated with patients who achieve a sustained viral response, the clinical definition for cure. Confidence in our study plan was further driven by knowledge that the Japanese Ministry of Health and Welfare had approved a non-specific dual plasmapheresis configuration that was shown to improve patient outcomes when administered in the first three days of HCV drug therapy. Based on these factors, our prior treatment outcomes, and the magnitude of HCV opportunity, we believed the Medanta study would contribute to improving shareholder value. We were wrong. Study delays, including protocol changes, patient recruitment challenges, and other mishaps instead contributed to an erosion of shareholder value. That said, I want to reinforce that there has been no indication that our Hemopurifier® isn't performing in the manner we had expected.
Certain delays may prove to be beneficial. On July 19 th, we met with FDA to discuss a proposal to initiate Hemopurifier® clinical studies in the U.S. During our meeting, we were asked if it was possible to measure the quantity of virus captured within the Hemopurifier® during treatment? Our answer was yes, as our science team had measured this data point on three previous occasions. Normally, our focus is to measure viral load changes in patient blood to quantify the potential for benefit. In response to FDA's question, we modified our Medanta study protocol so that we could incorporate this secondary data point in a revised IDE submission to FDA. With this change in place, our protocol is now being administered to enrolled patients at the Medanta Medicity Institute. Our primary endpoint goal remains to demonstrate that our Hemopurifier® improves both immediate and rapid viral response rates when combined with interferon versus interferon alone. We remain convinced that our Hemopurifier® will offer an enduring opportunity to improve current and future iterations of HCV drug therapies. However, with the advent of the Aethlon ADAPT™ system, we have transitioned to being revenue stage organization whose value should no longer be attributed to one product application. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company�s clinical programs or provide market clearance of the company�s products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier�s® ability to capture exosomes and the impact it may have on disease conditions, the ability to successfully complete the Medanta HCV study and achieve positive results, the company�s ability to raise capital when needed, the Company�s ability to complete the development of its planned products, the Company�s ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
To our Shareholders:
Earlier this year, we introduced and began marketing the Aethlon ADAPT™ system, a technology platform that intersects the medical device and drug world to establish a new class of therapeutics that allow for the selective subtraction of disease-enhancing particles from patient circulation without adding drug toxicity. Not long ago, the medical community consensus was that it would not be possible for a medical device to remove harmful particles from circulation without also stripping out essential elements required for health. Well, as Walt Disney once stated, "Its kind of fun to do the impossible." I would add immensely challenging as well. Therapies that evolve from our platform hold the potential to alter the healthcare industry by unlocking the ability to attack disease survival mechanisms that are beyond the reach of drugs. Today, we are advancing ADAPT-based endeavors to address unmet medical needs in cancer, infectious disease, and now sepsis.
On October 3rd , we proudly disclosed that the first sale of our Aethlon ADAPT™ system occurred when we signed a $6.8 million contract with the United
DARPA estimates the successful development of this device would save thousands of lives and billions of dollars in the United
Last week, we received our first milestone payment under the DARPA award, which officially transitioned our corporate status from development-stage to revenue stage organization. Now that we are contract proven, we plan to increase our efforts to market the Aethlon ADAPT™ system to government health and military agencies that seek innovative strategies to address life-threatening or debilitating disease conditions.
With each subsequent sale of the Aethlon ADAPT™ system, we reinforce the value of our therapeutic vision, reduce our reliance on the capital markets, and further establish a unique business model that allows us to generate revenue as we clinically advance pipeline therapies to market. Our technology platform also provides a basis to establish collaborative business relationships with biotechnology and pharmaceutical organizations that might have interest in pursuing a medical device regulatory and commercialization pathway for their affinity drug agents. As toxicity eliminates a majority of affinity drug agents from entering the market, we provide the opportunity to repurpose clinical stage affinity drugs as well as previous clinical dropouts.
On September 21st , we again leveraged the Aethlon ADAPT™ system to introduce a targeted breast cancer therapy known as HER2osome™ and enlisted clinical support from thought leaders in the cancer field. In this application, HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. Our therapeutic goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer.
When we first initiated research into tumor-secreted exosomes, the consensus thought was that exosomes were nothing more than cellular garbage bags having no meaningful function. Today, exosomes have emerged to become an important new therapeutic target in cancer care, yet remain unaddressed with drug therapy. In a forthcoming disclosure, we will discuss some of our other exosome related endeavors. However, as it relates to breast cancer, research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin®, a leading monoclonal antibody treatment against the HER2+ breast cancer. Quite simply, we are developing HER2osome™ because we believe the resulting device will enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks. In this regard, the Aethlon ADAPT™ system provides a therapeutic template to immobilize both an anti-HER2 antibody and an exosome targeted affinity agent as a basis to simultaneously clear both targets from the circulatory system of HER2+ breast cancer patients. Like all Aethlon ADAPT™ derived therapies, HER2osome™ is designed for utilization on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
While this is certainly an exciting time for our organization, there is something else I want to address before concluding my letter. That is the treatment of Hepatitis C (HCV) infected individuals with our Hemopurifier®, which is the lead product in our ADAPT product pipeline. Our Hemopurifier® has demonstrated broad-spectrum capabilities against viral pathogens, including HCV, the human immunodeficiency virus (HIV), and a variety of tested bioterror and pandemic threats. Specific to treating HCV, we previously conducted studies that demonstrated the safe administration of our Hemopurifier® in HCV-infected dialysis patients whose average viral load reductions exceeded 50% during each four-hour treatment. These results were obtained in the absence of any drug therapy.
Our HCV treatment results led us to ask the question, what if we administered Hemopurifier® therapy to non-dialysis patients when they initiated HCV drug therapy? To find the answer, we initiated our first clinical study in non-dialysis patients at the Medanta Medicity Institute in India . We already knew that rapid viral load depletion in the first few days of therapy correlated with patients who achieve a sustained viral response, the clinical definition for cure. Confidence in our study plan was further driven by knowledge that the Japanese Ministry of Health and Welfare had approved a non-specific dual plasmapheresis configuration that was shown to improve patient outcomes when administered in the first three days of HCV drug therapy. Based on these factors, our prior treatment outcomes, and the magnitude of HCV opportunity, we believed the Medanta study would contribute to improving shareholder value. We were wrong. Study delays, including protocol changes, patient recruitment challenges, and other mishaps instead contributed to an erosion of shareholder value. That said, I want to reinforce that there has been no indication that our Hemopurifier® isn't performing in the manner we had expected.
Certain delays may prove to be beneficial. On July 19 th, we met with FDA to discuss a proposal to initiate Hemopurifier® clinical studies in the U.S. During our meeting, we were asked if it was possible to measure the quantity of virus captured within the Hemopurifier® during treatment? Our answer was yes, as our science team had measured this data point on three previous occasions. Normally, our focus is to measure viral load changes in patient blood to quantify the potential for benefit. In response to FDA's question, we modified our Medanta study protocol so that we could incorporate this secondary data point in a revised IDE submission to FDA. With this change in place, our protocol is now being administered to enrolled patients at the Medanta Medicity Institute. Our primary endpoint goal remains to demonstrate that our Hemopurifier® improves both immediate and rapid viral response rates when combined with interferon versus interferon alone. We remain convinced that our Hemopurifier® will offer an enduring opportunity to improve current and future iterations of HCV drug therapies. However, with the advent of the Aethlon ADAPT™ system, we have transitioned to being revenue stage organization whose value should no longer be attributed to one product application. On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including the ability to introduce a targeted breast cancer therapy known as HER2osome™, there is no assurance that FDA will approve the initiation of the company�s clinical programs or provide market clearance of the company�s products, the ability to achieve the goals set out in the DARPA contract, future human studies of the Aethlon Hemopurifier® as an adjunct therapy to improve patient responsiveness to established cancer therapies, the Hemopurifier�s® ability to capture exosomes and the impact it may have on disease conditions, the ability to successfully complete the Medanta HCV study and achieve positive results, the company�s ability to raise capital when needed, the Company�s ability to complete the development of its planned products, the Company�s ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman and CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
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Pharma and Biotech stocks News; BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Positive LibiGel® Pharmacokinetic Study Results
LINCOLNSHIRE, Ill. - November 16, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced additional results from its principal LibiGel (testosterone gel) pharmacokinetic (pK) study. Top line data from this study were announced on September 12, 2011. The pK study results indicate that LibiGel increases levels of free testosterone (the active testosterone component) in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in postmenopausal women, for which there is no FDA-approved product.
The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 grams daily, the same dose as included in the two LibiGel pivotal safety and efficacy trials and safety study. The mean free testosterone level at baseline was 1.4 pg/ml. During the study, subjects in the pK study demonstrated a mean free testosterone of approximately 3.5 pg/ml on day 14, and 4.1 pg/ml on day 21 (at the end of study period 1) and approximately 4.5 pg/ml on study day 42 (at the end of 21 days of transdermal estradiol co-therapy in period 2). During study period 3, the mean free testosterone level was approximately 3.7 pg/ml. Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued.
The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase II efficacy trial which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively. In a recent publication, it was shown that serum testosterone concentrations in normally cycling 30-year-old pre-menopausal women range from 1.2 pg/ml to 6.4 pg/ml. However, generally, blood levels are not compared between studies because different studies performed at different times with different assays can produce varying testosterone blood levels.
In the LibiGel Phase III clinical studies, baseline testosterone levels, although collected, are not an inclusion or exclusion criterion, per FDA suggestion, since therapy for HSDD is meant for symptomatic treatment of HSDD and not testosterone levels. BioSante plans to present the full pK study results at an upcoming medical meeting. The LibiGel pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study will continue for a total of five years; however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to demonstrate the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of efficacy trials and the safety study, BioSante intends to submit an NDA to the FDA, requesting approval of LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
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Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
The pK study was conducted in 24 surgically postmenopausal subjects in three contiguous 21 day periods for a total of 63 days, in the absence of estrogen therapy (study period 1), with a concomitant transdermal estradiol patch (study period 2) and finally with concomitant oral estrogen (study period 3). LibiGel was dosed at 0.22 grams daily, the same dose as included in the two LibiGel pivotal safety and efficacy trials and safety study. The mean free testosterone level at baseline was 1.4 pg/ml. During the study, subjects in the pK study demonstrated a mean free testosterone of approximately 3.5 pg/ml on day 14, and 4.1 pg/ml on day 21 (at the end of study period 1) and approximately 4.5 pg/ml on study day 42 (at the end of 21 days of transdermal estradiol co-therapy in period 2). During study period 3, the mean free testosterone level was approximately 3.7 pg/ml. Free testosterone returned to baseline levels within 24 hours after the last dose of LibiGel, indicating effective elimination after dosing is discontinued.
The levels of free testosterone in the LibiGel pK study were similar to those seen in the BioSante LibiGel Phase II efficacy trial which ranged from 2.8 pg/ml to 3.6 pg/ml. These levels also were similar to those reported in the two pivotal testosterone patch (Intrinsa) studies which showed efficacy in treating HSDD in estrogen-treated surgically menopausal women, which were 4.0 pg/ml at 12 weeks and 3.1 pg/ml at week 24 and 4.0 pg/ml at week 24, respectively. In a recent publication, it was shown that serum testosterone concentrations in normally cycling 30-year-old pre-menopausal women range from 1.2 pg/ml to 6.4 pg/ml. However, generally, blood levels are not compared between studies because different studies performed at different times with different assays can produce varying testosterone blood levels.
In the LibiGel Phase III clinical studies, baseline testosterone levels, although collected, are not an inclusion or exclusion criterion, per FDA suggestion, since therapy for HSDD is meant for symptomatic treatment of HSDD and not testosterone levels. BioSante plans to present the full pK study results at an upcoming medical meeting. The LibiGel pK study was conducted as part of the FDA-requested studies to be submitted in the LibiGel new drug application (NDA) which is anticipated in the fourth quarter of 2012.About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy, approximately half of whom were taking concomitant estrogen therapy and half of whom took no concomitant estrogen therapy. The completed efficacy trials were conducted according to an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued over 5,100 women-years of exposure, to date. The study will continue for a total of five years; however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to demonstrate the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of efficacy trials and the safety study, BioSante intends to submit an NDA to the FDA, requesting approval of LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the fourth quarter of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
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About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
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Medical Technology Stock Alert: U.S FDA Clears PositiveID's (OTCBB:PSID) iglucose System for Diabetes Management
DELRAY BEACH, Fla. - November 16, 2011 (Investorideas.com Newswire) - PositiveID Corporation (OTCBB:PSID), a developer of medical technologies for diabetes management and clinical diagnostics, announced today it has received clearance from the U.S. Food and Drug Administration ("FDA") for its iglucose(TM) mobile health system for diabetes management. iglucose uses mobile technology to revolutionize the way individuals with diabetes manage their condition. By seamlessly communicating glucose readings from data-capable glucometers to the iglucose diabetes management portal, this important data can be shared with family members, caregivers and healthcare professionals. This makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes.
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual's data-capable glucometer to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan.
The iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes.; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose and receive insurance reimbursement; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
William J. Caragol, Chief Executive Officer of PositiveID stated, "iglucose is a safe, flexible, convenient, cost-effective and straightforward solution that we believe will revolutionize the way people with diabetes manage their condition. iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance. This FDA clearance is an important validation of our product offering for PositiveID and we will work diligently to make iglucose available to everyone affected by diabetes in the near future."
PositiveID believes that marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers. The business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base. Over the coming months, PositiveID expects to launch initial roll-outs with several partners that it believes can lead to large orders of iglucose. PositiveID already has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada , and will look to add additional wireless partners.
For years the American Diabetes Association and U.S. Centers for Disease Control and Prevention ("CDC") have recommended that individuals with diabetes self-monitor and take a record of their glucose readings to their healthcare professionals. An American Association of Diabetes Educators ("AADE") positioning statement revealed that self-monitoring is the best way for people with diabetes, as well as healthcare professionals, to assess the ongoing efficacy of all aspects of the diabetes management regimen, including medication and patient behavior. The problem is that most people do not keep consistent and accurate logbooks.
iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition. iglucose uses mobile technology to seamlessly communicate blood glucose readings from an individual's data-capable glucometer to the iglucose diabetes management portal, where, with the user's consent, glucose readings can be shared automatically with family members, caregivers and healthcare professionals via text message, email or fax. iglucose does not require the use of a cell phone or a wireless plan.
The iglucose system collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan(R) OneTouch(R), marketed by Johnson & Johnson, and Nipro Diagnostic(TM) True(TM) monitoring systems to a secure database via wireless cellular technology. A wireless data plan is not required. The Company is continually adding to this list of supported glucose meters.
PositiveID surveyed healthcare professionals at the AADE annual conference regarding the Company's iglucose mobile health communication system to facilitate diabetes management and survey results showed 83 percent of diabetes educators believe using iglucose would improve patient outcomes; 82 percent of diabetes educators believe using iglucose would improve patient consults; and 76 percent of diabetes educators would recommend iglucose to their patients.
More than 25 million children and adults in the U.S. have diabetes, or over 8 percent of the population, according to the 2011 National Diabetes Fact Sheet. The CDC predicts that nearly 30 percent of children born after the year 2000 will develop diabetes. Worldwide, the number of adults with diabetes has doubled over the last three decades to nearly 350 million and increased nearly three-fold in the U.S. , according to a study published in the British journal Lancet. The lifetime risk of developing diabetes for those born in the year 2000 is 35 percent. The total cost of diagnosed diabetes in the U.S. is estimated at $200 billion.
For more information on iglucose, please visit www.iglucose.com.
About PositiveID Corporation
PositiveID Corporation, based in Delray Beach , Florida , is a technology development company with two divisions: HealthID and MicroFluidic Systems. HealthID develops unique medical devices, focused primarily on diabetes management, and MicroFluidic Systems develops molecular diagnostic systems, focused primarily on bio-threat detection products. For more information on PositiveID, please visit www.PositiveIDCorp.com.
Statements about PositiveID's future expectations, including the likelihood that iglucose makes it possible to improve care in a cost-effective manner and help loved ones manage their diabetes; the likelihood that iglucose is a safe, flexible, convenient, cost-effective and straightforward solution for people with diabetes to revolutionize the way they manage their condition; the likelihood that iglucose represents an opportunity to help decrease costs to our healthcare system by helping to improve disease management and patient compliance; the likelihood that this FDA clearance is an important validation of the Company's product offering and the Company will work diligently to successfully make iglucose available to everyone affected by diabetes in the near future; the likelihood that the marketplace adoption for iglucose will be led by healthcare insurers and home-healthcare providers; the likelihood that the business model in this market will begin with initial roll-outs, followed by an evaluation period, and leading to broad scale adoption within the patient base; the likelihood that over the coming months, the Company will launch initial roll-outs with several partners that can lead to large orders of iglucose; the likelihood that PositiveID has the wireless infrastructure in place through partnerships with AT&T in the U.S. and Rogers Communications in Canada and will look to add additional wireless partners; the likelihood that iglucose eliminates the burden of keeping manual logbooks and empowers individuals with diabetes to be more engaged in the self-management of their condition; the likelihood that the Company is continually adding to this list of supported glucose meters; the likelihood that diabetes educators believe using iglucose would improve patient outcomes; the likelihood that diabetes educators believe using iglucose would improve patient consults; the likelihood that diabetes educators would recommend iglucose to their patients; the likelihood that nearly 30 percent of children born after the year 2000 will develop diabetes.; the likelihood that the lifetime risk of developing diabetes for those born in the year 2000 is 35 percent; the likelihood that the total cost of diagnosed diabetes in the U.S. is $200 billion; and all other statements in this press release other than historical facts are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Litigation Reform Act of 1995. Such forward-looking statements involve risks and uncertainties and are subject to change at any time, and PositiveID's actual results could differ materially from expected results. These risks and uncertainties include PositiveID's ability to successfully commercialize iglucose and receive insurance reimbursement; as well as certain other risks. Additional information about these and other factors that could affect the Company's business is set forth in the Company's various filings with the Securities and Exchange Commission, including those set forth in the Company's 10-K filed on March 25, 2011, and 10-Qs filed on May 13, 2011, August 15, 2011, and November 14, 2011, under the caption "Risk Factors." The Company undertakes no obligation to update or release any revisions to these forward-looking statements to reflect events or circumstances after the date of this statement or to reflect the occurrence of unanticipated events, except as required by law.
Contact:
Allison Tomek
PositiveID Corporation
561-805-8000
atomek@positiveidcorp.com
Published at Investorideas.com Newswire
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Disclaimer: Our sites do not make recommendations. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. We attempt to research thoroughly, but we offer no guarantees as to the accuracy of information presented. All Information relating to featured companies is sourced from public documents and/ or the company and is not the opinion of our web sites. This site is currently compensated by featured companies, news submissions and online advertising. Investorideas.com was compensated fifteen hundred to publish and distribute PositiveID Corporation press release by third party IR www.InvestorIdeas.com/About/Disclaimer.asp
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
Tuesday, November 15, 2011
Biotech News Alert; Investor Update for BioSante Pharmaceuticals (NasdaqGM: BPAX); Jefferies Initiating at Buy: Positive Ahead of Phase III LibiGel Data
Point Roberts, WA - November 15, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues an investor update for BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). Jefferies & Company, Inc. has initiated a buy rating on the stock with a price target of $5.00, driven by Phase III LibiGel testosterone gel.
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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Source - Investorideas.com 800-665-0411
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
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About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under an FDA-agreed special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX)
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sectors. Sectors we cover include; water stocks, gold and mining stocks, China stocks, oil and gas stocks, renewable energy stocks, coal stocks, tech stocks, biotech stocks, defense stocks, nanotech, agriculture and gaming.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. BioSante is a paid advertising biotech stock on Investorideas.com (six thousand five hundred for three months)
Source - Investorideas.com 800-665-0411
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
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