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Monday, April 18, 2011

Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Pancreatic and Prostate Cancer Vaccine License

LINCOLNSHIRE, Ill. - April 18, 2011 (Investorideas.com newswire) - Pharma stock news; BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced it has licensed its Pancreas Cancer Vaccine and Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes (Lm).
BioSante will receive milestone and royalty payments after commercialization of combination cancer vaccines using BioSante's cancer vaccine technology. Aduro also has an option to additional BioSante Cancer Vaccine indications, all for use in combination with Aduro's proprietary vaccine platform.
"We hope that this license agreement will be the first of many that can result in bringing improved cancer treatments to patients and increased value to our stockholders," said Stephen M. Simes, president and CEO of BioSante. "In addition to BioSante's Pancreas and Prostate cancer vaccines, our cancer vaccine portfolio extends into breast, colorectal, leukemia, melanoma and multiple myeloma vaccines," Simes continued.
Aduro plans to initiate a Phase II trial in the fourth quarter of 2011 with approximately 90 late-stage pancreatic cancer patients, using a novel sequential vaccine regimen of BioSante's Pancreas Cancer Vaccine and CRS-207.
CRS-207 is Aduro's lead Lm-based therapeutic and has been engineered to express the tumor-associated antigen, mesothelin. CRS-207 was evaluated in a Phase I trial in 17 end-stage patients with cancers known to express mesothelin: mesothelioma, non-small-cell lung, ovarian and pancreatic. Analysis after the completion of the trial revealed a mesothelin-specific T cell response in multiple patients and despite an expected survival of three-five months for all subjects, six out of 17 subjects lived 15 months or longer.
BioSante cancer vaccines are based on human cancer cell lines that are genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune-stimulatory cytokine. BioSante has a portfolio of cancer vaccines, including Pancreas Cancer Vaccine and Prostate Cancer Vaccine. The Pancreas Cancer Vaccine has been evaluated in more than 120 patients and shown to be well tolerated and able to induce mesothelin-specific T cell responses.
Sequential administration of BioSante Pancreas Cancer Vaccine followed by CRS-207 was first shown by Aduro to be synergistic in mouse models, demonstrating enhanced tumor-specific T cell and anti-tumor responses. Because BioSante Pancreas Cancer Vaccine and CRS-207 target the tumor-associated antigen mesothelin, the sequential administration is a heterologous prime-boost regimen. Lm is known to be especially effective in this regimen.
Based on the synergy in preclinical animal models, Drs. Elizabeth Jaffee and Dung Le of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins included three pancreatic cancer patients, in the CRS-207 Phase 1 clinical trial who had previously received the BioSante Pancreas Cancer Vaccine, as part of separate clinical trials. All three late-stage patients who received sequential therapy lived 15 months or longer.
Drs. Jaffee and Le have been instrumental in collaborating with Aduro to design the Phase II trial, which is expected to initiate in the fourth quarter of 2011 and enroll a total of 90 late-stage pancreatic cancer patients. In addition, Dr. Jaffee is one of the original inventors of the BioSante Cancer Vaccines and has many years of experience developing the vaccines.
"The synergy from the sequential administration of BioSante's Pancreas Cancer Vaccine and CRS-207 has the potential to significantly extend and improve the lives of a patient population where progress has historically been measured by extra weeks of survival," said Stephen Isaacs, chairman and chief executive officer of Aduro BioTech. "This partnership may very well represent the future of immunotherapy in which combination therapy becomes the standard."
About Aduro BioTech
Aduro BioTech is a clinical-stage immunotherapy company with a platform technology for therapeutic and prophylactic vaccines for cancer and infectious diseases. The platform of attenuated and targeted vaccines based on Listeria monocytogenes has been in development for nine years and has been validated by 20 major publications and more than $20 million in federal and private grant and contract funding. The company's lead therapeutic, CRS-207, is in clinical development for the treatment of mesothelin-expressing tumors, including pancreatic and non-small-cell lung cancer, and has completed Phase 1.
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," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning 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 reports 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).

Thursday, April 14, 2011

Biotech/ Biodefense Stock Trading Alert; Emergent Biosolutions (NYSE: EBS) Hits 52 Week High Biodefense Stocks Sector Snapshot; (OTCBB: AEMD), (NASDAQ GM: DYSL), (NYSE Amex: PIP), (AMEX: PLX ), (NasdaqGM: SIGA)

Point Roberts, WA - April 14, 2011 - Investorideas.com, a leader in sector stock research including biotech and biodefense stocks issues a trading alert on Emergent Biosolutions, Inc. (NYSE: EBS) as it hit a 52 week high in Wednesday’s trading. The Company reported its chairman and chief executive officer, has been recognized as Biotech CEO of the Year during the Vaccine Industry Excellence (ViE) Awards at the World Vaccine Congress.
Biotech/ Biodefense Stocks Sector Snapshot ( as of close April 14 th)
  • Aethlon Medical (OTCBB: AEMD) closed at $0.1036 on over 242,000 shares, with its 52 week range of $0.096 - 0.35
  • Dynasil Corporation (NASDAQ GM: DYSL) ended at $4.14, with a 52 week range of $ 2.35 - 7.48
  • Emergent Biosolutions, Inc. (NYSE: EBS ) closed at $24,68 hitting its 52 week high; $14.11 - 25.24
  • PharmAthene, Inc. (NYSE Amex: PIP) finished trading at $3.17, its 52 week range of $1.25 - 4.96
  • Protalix BioTherapeutics, Inc. (AMEX: PLX ) closed at $7.24, up 0.15 (2.12%)
  • Siga Technologies (NasdaqGM: SIGA ) ended trading at $13.4, up 0.48 (3.71%) on over 437,000 shares
Recent News:
Emergent BioSolutions Chairman and CEO Fuad El-Hibri Named Biotech CEO of the Year at the World Vaccine Congress
ROCKVILLE, Md.--- Emergent BioSolutions Inc. (NYSE: EBS ) announced that Fuad El-Hibri, its chairman and chief executive officer, has been recognized as Biotech CEO of the Year during the Vaccine Industry Excellence (ViE) Awards at the World Vaccine Congress. The ViE awards showcase excellence and honor accomplishments of both individuals and companies in the global vaccine industry.
"This award is a testament to the collective efforts of the Emergent BioSolutions team, who on a daily basis and all over the world, lives out the corporate mission – to protect life,” said Mr. El-Hibri. "Our team shares a passion and commitment to make vital contributions to address unmet and underserved medical needs. It is an honor to be recognized for the work that we do.”
In selecting the winner for this category, the distinguished panel of judges evaluated the finalists based on their commitment to disease prevention and treatment, leadership, contribution to company performance, communication, and vision, industry influence, and achievements in company positioning and status.
Aethlon Medical (OTCBB: AEMD) Announces Multi-Target Exosome Assay Validation
SAN DIEGO - April 12, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) announced today that its wholly owned subsidiary Exosome Sciences, Inc. (ESI) has validated the ability of its Enzyme Linked Lectin Specific Assay (ELLSA) to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal. In July 2010, ESI disclosed that it filed a patent relating to the development of an assay that would allow researchers to detect exosomes in blood and other fluids. In addition to research opportunities, Aethlon Medical plans to test ELLSA as a diagnostic to quantify the therapeutic capabilities of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the circulatory system of those afflicted with cancer. ESI is now preparing a market survey that will be provided to researchers to determine market demand and pricing for ELLSA as a research tool.
Full news: http://www.investorideas.com/CO/AEMD/news/2011/04121.asp
Biodefense Company Snapshots; Aethlon Medical (OTCBB: AEMD),
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.
More: www.aethlonmedical.com
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Visit the Aethlon Medical (OTCBB: AEMD) showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
Emergent Biosolutions, Inc. (NYSE: EBS )
Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease. Emergent's marketed and investigational products target infectious diseases, oncology and autoimmune disorders. www.emergentbiosolutions.com

About www.InvestorIdeas.com
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more Biodfense stocks at Investorideas.com
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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, $five thousand per month in 144 stock)Effective March 15, 2011     
Aethlon Medical ( OTCBB:AEMD) :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.  
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com

A Broad-Spectrum Treatment Strategy to Address HIV, Hepatitis-C (HCV) and other Infectious Disease Conditions; Q&A with Aethlon Medical (OTCBB: AEMD) CEO, Jim Joyce

Point Roberts, WA. - April 14, 2011 � Investorideas.com, a leader in sector stock research presents a new interview in its series of biotech Q&A's, featuring Jim Joyce, CEO of Aethlon Medical (OTCBB: AEMD).
The Hemopurifier® from Aethlon Medical is a first-in-class medical device candidate to treat infectious disease. Human studies have documented that the Hemopurifier® can significantly reduce viral load in Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients in the absence of antiviral drugs. A study is currently underway to demonstrate the benefit of the Hemopurifier® as an adjunct to HCV drug therapy. Additional details can be accessed online at www.aethlonmedical.com
Q&A Interview
InvestorIdeas: How does your Hemopurifier® differ from drug therapies to treat infectious disease?
Mr. Joyce: Well, our approach is a complete departure from the consensus approach of introducing drug agents into the body to inhibit viral replication. As you are likely aware, these agents can have countering side effects or mechanisms of action that may not be fully understood. So, instead of adding agents into the body, our Hemopurifier® subtracts or removes viruses and other harmful particles from circulation without drug-related side effects. We think our therapeutic filtration approach could redefine the premise of how to treat infectious disease and we believe our strategy is far more innovative than another me-too drug inhibitor.
InvestorIdeas: Is a device that removes harmful particles from the body really considered to be innovative?
Mr. Joyce: The idea of a therapeutic filtration device that can remove harmful particles from circulation is not original. The basis of kidney dialysis, which keeps individuals with renal disease alive, is based on therapeutic filtration. However, like dialysis, previous therapeutic filtration strategies have sought to remove particles from circulation by molecule size, which is an indiscriminate approach that can also remove elements from circulation that are required for health. This factor has primarily limited the use of therapeutic filtration to niche markets. Our Hemopurifier® is truly innovative in the sense that we discriminate to selectively remove infectious viruses and other harmful particles from the entire circulatory system. It is this advancement that allows us to pursue opportunities in the much larger infectious disease and cancer markets.
InvestorIdeas: So it would seem your Hemopurifier® is positioned as a competitor to drug therapies.
Mr. Joyce: That is certainly not our intent. In fact, we expect to be an ally to the drug industry for several compelling reasons. First, if you really want to enhance or extend the benefit of drug therapies, you remove the strains of viruses that are causing drugs to fail and you do it without adding drug toxicity or interaction risks. But to fully unlock the capability of drug therapies you need to provide other complementary mechanisms that are beyond the reach of drugs. In that regard, we provide a strategy to address the toxins shed from viral surfaces to kill immune cells and particles known as exosomes that allow viruses to transport other disease-enhancing particles below the surveillance of the immune system. So our device in combination with drug therapy would seem to be a win-win scenario.
InvestorIdeas: What if a virus is not treatable with drug therapy?
Mr. Joyce: In reality, a vast majority of the viruses that are known to be infectious to man are not treatable with drugs. In scenarios that are life threatening, our Hemopurifer® is likely to be the sole strategy to address viral infections that are not treatable with drugs. For this reason, our Hemopurifier® is immensely valuable as new viruses like the coronavirus underlying the SARS outbreak of 2003 will emerge naturally in the future. We also face the looming threat of biological weapons purposely designed to defeat drug therapies. In either case, our Hemopurifier® provides a decision free first response that can augment the body's own immune response to such exposures, which is certainly more logical than an post-exposure strategy comprised of first identifying the virus that is killing people, and then establishing post-death research programs that may or may not yield a viable treatment candidate years after the fact.
InvestorIdeas: Thank you.
About Aethlon Medical ( OTCBB: AEMD )
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
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
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks with its portal BiotechIndustryStocks.com.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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, $five thousand per month in 144 stock) Effective March 15, 2011       
800-665-0411 - dvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011

Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Teva New Drug Application (NDA) for Testosterone Gel, Bio-T-Gel™ New Drug Application (NDA) Accepted for filing by FDA

LINCOLNSHIRE, Ill. - April 13, 2011 (Investorideas.com newswire) - Pharma stock news; BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) reports a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion.
"We are extremely excited by Teva's NDA filing of Bio-T-Gel," said Stephen M. Simes, BioSante's president & CEO. "We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched. We look forward to receiving milestone payments and royalties on Bio-T-Gel after approval and launch."
About Male Hypogonadism
Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone can be caused by a signaling problem that occurs between the brain and the testes that causes the production of testosterone to drop below normal. Low testosterone also can occur when the body can't make normal levels of testosterone and can lead to a medical condition known as hypogonadism that has many symptoms including fatigue, decreased energy, reduced sexual desire and depressed mood.
It is estimated that low testosterone affects more than 4 to 5 million men in the U.S. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.
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," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning 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 reports 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).

Wednesday, April 13, 2011

Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Teva New Drug Application for Bio-T-Gel™

LINCOLNSHIRE, Ill. - April 13, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion.
"We are extremely excited by Teva's NDA filing of Bio-T-Gel," said Stephen M. Simes, BioSante's president & CEO. "We are confident that Teva has the expertise and resources to capture significant market share once Bio-T-Gel is launched. We look forward to receiving milestone payments and royalties on Bio-T-Gel after approval and launch."
About Male Hypogonadism
Typically, a man's testosterone level is considered low if it's below a level of approximately 300 ng/dL. Low testosterone can be caused by a signaling problem that occurs between the brain and the testes that causes the production of testosterone to drop below normal. Low testosterone also can occur when the body can't make normal levels of testosterone and can lead to a medical condition known as hypogonadism that has many symptoms including fatigue, decreased energy, reduced sexual desire and depressed mood.
It is estimated that low testosterone affects more than 4 to 5 million men in the U.S. Common symptoms include reduced sex drive, decreased energy, loss of body hair or reduced shaving, and depressed mood. There is no cure for hypogonadism. It is a medical condition that usually requires ongoing treatment.
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," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning 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 reports 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).

Tuesday, April 12, 2011

Biotech/Biodefense Stock News; Aethlon Medical (OTCBB: AEMD) Announces Multi-Target Exosome Assay Validation

SAN DIEGO - April 12, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) announced today that its wholly owned subsidiary Exosome Sciences, Inc. (ESI) has validated the ability of its Enzyme Linked Lectin Specific Assay (ELLSA) to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal. In July 2010, ESI disclosed that it filed a patent relating to the development of an assay that would allow researchers to detect exosomes in blood and other fluids. In addition to research opportunities, Aethlon Medical plans to test ELLSA as a diagnostic to quantify the therapeutic capabilities of the Aethlon Hemopurifier� to remove immunosuppressive exosomes from the circulatory system of those afflicted with cancer. ESI is now preparing a market survey that will be provided to researchers to determine market demand and pricing for ELLSA as a research tool.
"We are grateful to those organizations that collaborated in beta-testing the capabilities of ELLSA to detect exosomes, which are increasingly being recognized as particles that deplete immune cells or provide a mechanism to transport disease-enhancing factors below the surveillance of the immune system,� stated Aethlon CEO, Jim Joyce. "Additionally, the ESI ELLSA provides the potential for a near-term revenue stream that complements the therapeutic programs we are actively advancing at Aethlon Medical"
About Aethlon Medical
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
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

Monday, April 11, 2011

Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present at Future Leaders in the Biotech Industry Conference

LINCOLNSHIRE, Ill. - April 11, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will be presenting at Future Leaders in the Biotech Industry Conference at the Millennium Broadway Hotel & Conference Center in New York City. The conference is sponsored by BioCentury and Thomson Reuters, among others.
Stephen M. Simes, BioSante's president & CEO, will speak on April 15, 2011 at 10:00 am EDT. He will provide an overview of the company, as well as an update on the LibiGel� (testosterone gel) Phase III clinical development program. A live audio webcast of Mr. Simes' remarks may be accessed at: http://www.corporate-ir.net/ireye/confLobby.zhtml?ticker=BPAX&item_id=3847287. The webcast will be archived approximately one hour after the live event and will be available for one year.
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," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning 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 reports 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).