Investorideas.com newswire, breaking biotechnology and pharma news

Monday, June 27, 2011

Biotech/ Pharma Stocks Battle for the Sexual Health Market: BioSante Pharmaceuticals, (NASDAQ: BPAX), Pfizer (NYSE: PFE), Teva Pharmaceutical (Nasdaq: TEVA), Watson (NYSE: WPI)

Point Roberts, WA - June 27th, 2011 - Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features a sector snapshot of biotech/ pharma stocks in the sexual dysfunction and sexual health markets.
The competition is heating up in the men's sexual dysfunction market for Pfizer (NYSE: PFE)'s Viagra but there is only one Biotech/Pharma company postured to be first to market in the women's sexual health market, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), with LibiGel, a testosterone gel in late-stage Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
There is a lot of money on the table in the men's erectile dysfunction market, with Viagra generating revenues of $1.93 billion for Pfizer in 2010. Pfizer Inc (NYSE: PFE) is battling it out in court with Teva Pharmaceutical (Nasdaq: TEVA) and Watson Pharmaceuticals (NYSE: WPI) for generic versions of Viagra. Teva (NASDAQ: TEVA) has announced it plans to make generic versions of Viagra in 2012, when the basic Pfizer patent expires.
More info http://www.fiercepharma.com/story/pfizer-just-might-postpone-viagras-patent-cliff/2011-06-13
Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals (NASDAQ: BPAX), recently commented in an Investorideas.com interview, “We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.”
http://www.investorideas.com/news/2011/main/06073.asp
Investor Spotlight forBioSante Pharmaceuticals (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) which is in Phase III clinical development under 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 using BioSante patented technology. www.biosantepharma.com.
Recent News for LibiGel Product: Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
LINCOLNSHIRE , Ill. - May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
Updates from the LibiGel Brochure:
Progress and Plans in Phase III: Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials, which are underway and have completed enrollment of subjects, are randomized, double-blind, placebocontrolled trials of over 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway and in which enrollment of subjects is complete. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of approximately 3,600 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, BioSante intends to submit a LibiGel NDA for review and potential approval by FDA by the end of 2012.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in 3,550 women enrolled comprising approximately 3,800 women-years of exposure, there have been only 22 adjudicated cardiovascular events, even though the safety study has enrolled women with a higher risk of cardiovascular events. Enrollment in the LibiGel safety study is complete at approximately 3,600 subjects
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
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.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.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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Friday, June 17, 2011

Biotech/Pharma Stocks; (OTCBB: AEMD), (NYSE: BMY ), (NasdaqGS: DNDN , (NYSE: GSK ) Take A New Approach to Cancer

Biotech/Pharma Stocks; (OTCBB: AEMD), (NYSE: BMY ), (NasdaqGS: DNDN , (NYSE: GSK ) Take A New Approach to Cancer



Cancer Immunotherapy Advances Hold New Hope

Point Roberts, WA- June 17, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, reports on advances in Cancer Immunotherapy featuring Aethlon Medical (OTCBB: AEMD), Bristol-Myers Squibb Company (NYSE: BMY ) ,Dendreon Corporation (NasdaqGS: DNDN ) and GlaxoSmithKline (NYSE: GSK ).

Immunotherapy is a treatment that uses the patient’s body immune system to help fight cancer. According to the American Cancer Society, “This can be done in a couple of ways:

stimulating your own immune system to work harder or smarter, or giving you immune system components, such as man-made immune system proteins. “



Biotech/Pharma Sector Snapshot Trading as of Close June 16th

Aethlon Medical (OTCBB: AEMD) closed at $0.10

Bristol-Myers Squibb Company (NYSE: BMY ) closed at $27.47,up 0.05 (0.18%

Dendreon Corporation (NasdaqGS: DNDN ) ended trading at $38.99, up 0.21 (0.54%), followed by additional gains in after hours trading.

GlaxoSmithKline (NYSE: GSK ) closed at $41.18



Aethlon Medical (OTCBB: AEMD) uses technology instead of drugs to help the patient’s immune system. The Hemopurifier®, the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. The company has discovered that the Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer.



Dendreon Corporation (NasdaqGS: DNDN ) was the first to receive FDA approval for its

PROVENGE® (sipuleucel-T) immune cell treatment of cancer. According to the company, it is the first autologous cellular immunotherapy AUTOLOGOUS CELLULAR IMMUNOTHERAPYPROVENGE is classified by the FDA as an autologous cellular immunotherapy. It is designed to be an active cellular immunotherapy. Closeto receive FDA approval for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. PROVENGE is designed to induce an immune response against prostate cancer.



Bristol-Myers Squibb Company (NYSE: BMY ) has (FDA) approval for YERVOY™ (ipilimumab) 3 mg/kg for the treatment of patients with unresectable (inoperable) or metastatic melanoma. YERVOY is the first and only therapy for unresectable or metastatic melanoma to demonstrate a significant improvement in overall survival based on results from a pivotal randomized, double-blind Phase 3 study. Median overall survival was 10 months (95% CI: 8.0-13.8) for YERVOY, 6 months (95% CI: 5.5-8.7) for gp100 and 10 months (95% CI: 8.5-11.5) for YERVOY + gp100, with p-values of 0.0026 (not adjusted for multiple comparisons) for YERVOY and 0.0004 for YERVOY + gp100 vs. gp100, respectively. As published in the New England Journal of Medicine, the Kaplan-Meier estimated survival rate at 1 year was 46% (95% CI: 37.0, 54.1) in the YERVOY arm vs. 25% (95% CI: 18.1, 32.9) in the gp100 arm. The estimated survival rate at 2 years was 24% (95% CI: 16.0, 31.5) in the YERVOY arm vs. 14%2 (95% CI: 8.0, 20.0) in the gp100 arm. YERVOY, which is a recombinant, human monoclonal antibody, is the first FDA-approved cancer immunotherapy that blocks the cytotoxic T- lymphocyte antigen-4 (CTLA-4).

Full News: http://www.investorideas.com/news/2011/main/03281.asp



GlaxoSmithKline (NYSE: GSK ) MAGE-A3 ASCI (Antigen-Specific Cancer Immunotherapeutic)

Is targeting melanoma and lung cancer.



Company Snapshot

About Aethlon Medical (OTCBB: AEMD)



At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.



Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.



Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.



As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:

1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.

2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.

3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.

4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.



The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.



In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.



Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.



Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products 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, CEO

858.459.7800 x301

jj@aethlonmedical.com



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Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp



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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. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, 200,000 144 shares )



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Wednesday, June 8, 2011

Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) to Discuss Recent Progress at the LHA Life Sciences & Medical Technologies Virtual Conference on June 16

SAN DIEGO � June 8, 2011 (Investorideas.com newswire) - Aethlon Medical, Inc. (OTCBB: AEMD) the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announces that Chairman and CEO James A. Joyce will provide a company overview, discuss recent developments and review upcoming milestones at the 5th LHA Life Sciences & Medical Technologies Virtual Conference.
The webcast presentation will be available Thursday, June 16, 2011, at 10:00 a.m. Pacific time (1:00 p.m. Eastern time) by visiting the Company's website at: www.aethlonmedical.com
Aethlon further disclosed that Company President Rodney S. Kenley will discuss the role of the Aethlon Hemopurifier® in the treatment of hepatitis C virus (HCV) in a presentation tomorrow at the 20th International Vicenza Course of Hemodialysis and CKD in Vicenza, Italy. The Aethlon Hemopurifier® is first-in-class therapeutic filtration device that selectively removes infectious viruses and immunosuppressive toxins from the entire circulatory system through the use of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide. Mr. Kenley's presentation, "The Treatment of HCV with Affinity Plasmapheresis on Dialysis Machines," will focus on treating HCV in existing dialysis clinics with no change in infrastructure or capital investments. The Hemopurifier® can be used to treat HCV in dialysis patients, in whom the prevalence of HCV is over 100 times higher than the general population, as well as non-dialysis patients. Access to Mr. Kenley's slide presentation will be provided on the Aethlon Medical website after the conclusion of the event.
About Aethlon Medical
The Aethlon Medical mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. The Aethlon ADAPT� system is an expansive technology platform that converges affinity drug agents and plasma membrane technology to create therapeutic filtration devices that selectively target the removal of harmful particles from the entire circulatory system. Our lead therapeutic candidate is the Aethlon Hemopurifier®, a device with broad-spectrum capabilities against viral pathogens and immunosuppressive cancer exosomes. In human studies, Hemopurifier® therapy has provided significant viral load reductions in HIV and hepatitis C virus infected individuals without the administration of antiviral drugs. We are now focused on advancing our Hemopurifier® as an adjunct strategy to improve the benefit of established infectious disease and cancer treatment regimens. Based on studies conducted by government and non-government research organizations, the Hemopurifier® is also a leading broad-spectrum treatment candidate to address bioterror and pandemic threats. For more information, please visit www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT� system, the Aethlon ADAPT� systems' ability to selectively remove disease-related particles from the entire circulatory system without the loss of essential blood components or its ability to eliminate the need to infuse drug agents into the body, the Company's ability to commercialize its Hemopurifier® in India, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products 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, 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
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011

Tuesday, June 7, 2011

Biotech Q&A; BioSante Announces Completion of Enrollment in LibiGel Safety Study

Point Roberts, WA, LINCOLNSHIRE, Ill - June 7, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview and update with Mr. Stephen M. Simes, president and chief executive officer of BioSante Pharmaceuticals. Mr. Simes discusses the significance of the Company’s completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study.
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, the company has announced completion of the enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. Can you explain to investors how it was determined that the current enrollment is sufficient?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Yes, based on the last unblinded statistical analysis by the independent statistician of the Data Monitoring Committee, it was determined that according to the FDA-agreed sample size analysis enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Q: Investorideas.com
How does this impact the timeline for a new drug application (NDA) submission?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our projected timeline is to submit an NDA to the FDA seeking approval to market LibiGel by the end of 2012.
Q: Investorideas.com
Can you explain to investors the timelines and the next stages of the Phase III LibiGel safety study?
Based on the LibiGel safety study protocol, the primary analysis of data will be conducted in 12 months. This will put us in a position to submit the NDA by the end of 2012.
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Q: Investorideas.com
LibiGel is currently the only product in the world in Phase III clinical development for the treatment of HSDD- Can you explain to new investors the significance of being first to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the potential market for products to treat women's sexual health is well over $1 billion in the U.S. alone. We also believe that LibiGel will be the first product approved for the treatment of menopausal women in this indication. Being first to market will result in gaining the majority of the available market.
Related News Release:
Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in LibiGel® Phase III Safety Study
May 31, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced completion of enrollment in its ongoing LibiGel (testosterone gel) Phase III cardiovascular and breast cancer safety study. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
BioSante has been informed by the LibiGel safety study independent Executive Committee regarding the outcome of the sample size analysis that determines the number of subjects to be enrolled in the LibiGel Phase III safety study. The FDA-agreed sample size analysis indicates that enrollment should stop, based on meeting a minimum 90 percent predictive probability of success of the safety study to show the safety of LibiGel at the primary data analysis. As per the protocol, the safety study will continue for 12 months of therapy from the last subject enrolled before the primary analysis will be conducted by BioSante, which will provide the data for BioSante's new drug application (NDA) submission anticipated to be made in 2012. The study will continue for five years.
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/05311.asp
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) which is in Phase III clinical development under 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 using BioSante patented technology. 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.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com azachary@mckinneychicago.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220; azachary@mckinneychicago.com
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Biotech/Pharma Stocks News; UV Flu Technologies (OTCBB: UVFT) Receives First Order for the Chinese Marketplace

CENTERVILLE, MA – June 7, 2011 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") announced today that it had received its first order of ViraTech UV-400's for test and evaluation for the Chinese marketplace. The units will be manufactured to Chinese electrical standards, and will be shipped for evaluation to 3 hospitals in different Chinese cities.
"This is our first entry into the biggest potential market for our products in the world," said John Lennon, President of UV Flu. "China has approximately 330,000 hospitals, with even greater numbers of clinics, and the spread of airborne bacteria and viruses is epidemic in many areas. Children in many cities are examined before they're allowed on school grounds, and it's not uncommon to see large numbers of people in hospital waiting areas with IVs, providing a fertile environment for the airborne spread of bacteria.
"We have been patiently building our brand over the last several months, and the results are about to be realized. We now have RX-3000s in a significant number of the top hospitals in America, and are currently back-ordered, while a new program we are starting with Hotels later this month is expected to put us in a similar back-order situation on the UV Flu side. We also hope to have our new initiatives in China, along with the Mideast, introduced later this month," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
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Biotech and Pharma News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Jefferies Global Healthcare Conference

LINCOLNSHIRE, Ill. - June 7, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that Phillip B. Donenberg, BioSante’s senior vice president of finance and CFO, will speak on Thursday, June 9, 2011 at 4:00pm eastern time at the Jefferies 2011 Global Healthcare Conference at the Grand Hyatt Hotel in New York City.
Mr. Donenberg will provide an overview of BioSante, as well as an update on the LibiGel® (testosterone gel) Phase III clinical development program.
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) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. 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 products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. 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:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com

Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).

Monday, June 6, 2011

Biotech/Pharma Stocks News; UV Flu Technologies (OTCBB: UVFT) Introduces "RX Air Plus," One of the World's Most Advanced Air Purification Systems

CENTERVILLE, MA � June 6, 2011 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce it has commenced marketing the "RX Air Plus" Air Purification System, which the Company believes could revolutionize the air purification marketplace.
The new system may prove to be the most effective air purification system in the world today, as the "RX Air Plus" System packages the RX-3000, built by the Company's RxAir subsidiary, along with 2 ViraTech UV-400 units. The Company believes this to be the only air purification system in the world utilizing two different FDA cleared Class II Medical devices as an integrated system. RX Air Plus brings together the two technologies, which combine to kill over 99% of bacteria and other contaminants, while reducing all odors and volatile organic compounds, as well as capturing over 99.97 % of all particulates within indoor areas up to 1500 square feet in size.
"No other Company offers a system which matches the capabilities of these combined technologies," said John Lennon, President of UV Flu Technologies. "The 'RX Air Plus' offers two of the most unique and effective products in the air purification marketplace today. The two ViraTech UV-400 units utilize hi-intensity germicidal UV lamps contained within a patented cartridge, which kills organic contaminants while also breaking down odors and concentrations of VOCs. The RX-3000 is one of the finest HEPA based air purifiers, capturing over 99.97% of particulates. The quality of indoor air protected by this system is typically purer than outdoor air while never having to open a window. The Company is offering the system to new customers and distributors immediately. We also plan to approach the over 1000 customer locations already utilizing the RX-3000 as possible upgrade opportunities."
"We also believe this system is going to have numerous applications in the Mideast, where microscopic sand particles are a major issue with respect to poor indoor air quality. To this end, the Company is in talks with several companies with respect to distribution in the Mideast, and expects to have an agreement in place this quarter," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/

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