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).
Thursday, April 14, 2011
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).
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:
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
"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:
- Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
- Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
- 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.
- Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
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).
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).
Friday, April 8, 2011
Biotech/ Biodefense Sector Trading Alert Stocks Include; (OTCBB: AEMD), (NASDAQ GM: DYSL), (NYSE Amex: PIP), (AMEX: PLX ), (NasdaqGM: SIGA
Point Roberts, WA- April 8, 2011 - Investorideas.com, a leader in investor sector research
including Biotech and Biodefense Stocks issues a trading alert on the sector for morning trading
April 8th. Stocks Include; (OTCBB: AEMD), (NASDAQ GM: DYSL), (NYSE Amex: PIP), (AMEX:
PLX and (NasdaqGM: SIGA ).
The iShares Nasdaq Biotechnology Index (NasdaqGM: IBB ) is trading up at 102.37, up 0.19
(0.19%).
Biotech/ Biodefense Stocks Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at$0.12, up 0.01 (4.35%)
Dynasil Corporation (NASDAQ GM: DYSL) trading at$ 4.35, up 0.02 (0.46%)
Emergent Biosolutions, Inc. Com (NYSE: EBS ) trading at $24.70, down 0.04 (0.16%)
PharmAthene, Inc. (NYSE Amex: PIP) trading at $3.21, down 0.07 (2.12%)
Protalix BioTherapeutics, Inc. (AMEX: PLX ) trading at $6.63, up 0.20 (3.11%)
Siga Technologies (NasdaqGM: SIGA ) trading at $13.39, up 0.08 (0.60%) 10:32AM EDT
Research more Biodfense stocks at Investorideas.com
http://www.investorideas.com/bds/stock_list.asp
Research Biotech Stocks at Investorideas.com
http://www.investorideas.com/BIS/Stock_List.asp
Daily Finance’s recent article, “Inside Wall Street: Looking to the Bio-Defense Sector as
Nuclear Fears Mount”, notes - The sector attracted a lot of interest after 9/11 and a number of
companies emerged to develop protective biodefense drugs and products. But with the waning of
dark headlines about terrorist threats, investors have tended to put them on their low-priority list.
That may be about to change
Full article: http://www.dailyfinance.com/story/stock-picks/inside-wall-street-looking-to-bio-defense-sector-as-
nuclear-fea/19880106/
Biotech/ Biodefense Company Snapshots; Aethlon Medical (OTCBB: AEMD), Protalix
BioTherapeutics, Inc. (AMEX: PLX )
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
Recent News: Shareholder Letter
http://www.investorideas.com/CO/AEMD/news/2011/04061.asp
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
Protalix BioTherapeutics, Inc. (AMEX: PLX )
Protalix is a biopharmaceutical company focused on the development and commercialization of
recombinant therapeutic proteins expressed through its proprietary plant cell based expression
system, ProCellEx™. Protalix's unique expression system presents a proprietary method for
developing recombinant proteins in a cost-effective, industrial-scale manner in an environment
free of mammalian components and viruses. Protalix's lead compound taliglucerase alfa,
an enzyme replacement therapy for the treatment of Gaucher disease, completed Phase III
development. To date, marketing applications have been submitted for taliglucerase alfa in the
United States, European Union, Brazil and Israel. Protalix's development pipeline also includes:
PRX-105, a pegylated recombinant human acetylcholinesterase in development for several
therapeutic and prophylactic indications, a biodefense program and an organophosphate-based
pesticide treatment program; PRX-102, a modified version of the recombinant human alpha-GAL-
A protein for the treatment of Fabry disease; an orally-delivered glucocerebrosidase enzyme that
is naturally encased in carrot cells, also for the treatment of Gaucher disease; and pr-antiTNF, a
biosimilar version of etanercept (Enbrel™) for the treatment of rheumatoid arthritis.
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.
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
including Biotech and Biodefense Stocks issues a trading alert on the sector for morning trading
April 8th. Stocks Include; (OTCBB: AEMD), (NASDAQ GM: DYSL), (NYSE Amex: PIP), (AMEX:
PLX and (NasdaqGM: SIGA ).
The iShares Nasdaq Biotechnology Index (NasdaqGM: IBB ) is trading up at 102.37, up 0.19
(0.19%).
Biotech/ Biodefense Stocks Sector Snapshot
Aethlon Medical (OTCBB: AEMD) trading at$0.12, up 0.01 (4.35%)
Dynasil Corporation (NASDAQ GM: DYSL) trading at$ 4.35, up 0.02 (0.46%)
Emergent Biosolutions, Inc. Com (NYSE: EBS ) trading at $24.70, down 0.04 (0.16%)
PharmAthene, Inc. (NYSE Amex: PIP) trading at $3.21, down 0.07 (2.12%)
Protalix BioTherapeutics, Inc. (AMEX: PLX ) trading at $6.63, up 0.20 (3.11%)
Siga Technologies (NasdaqGM: SIGA ) trading at $13.39, up 0.08 (0.60%) 10:32AM EDT
Research more Biodfense stocks at Investorideas.com
http://www.investorideas.com/bds/stock_list.asp
Research Biotech Stocks at Investorideas.com
http://www.investorideas.com/BIS/Stock_List.asp
Daily Finance’s recent article, “Inside Wall Street: Looking to the Bio-Defense Sector as
Nuclear Fears Mount”, notes - The sector attracted a lot of interest after 9/11 and a number of
companies emerged to develop protective biodefense drugs and products. But with the waning of
dark headlines about terrorist threats, investors have tended to put them on their low-priority list.
That may be about to change
Full article: http://www.dailyfinance.com/story/stock-picks/inside-wall-street-looking-to-bio-defense-sector-as-
nuclear-fea/19880106/
Biotech/ Biodefense Company Snapshots; Aethlon Medical (OTCBB: AEMD), Protalix
BioTherapeutics, Inc. (AMEX: PLX )
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
Recent News: Shareholder Letter
http://www.investorideas.com/CO/AEMD/news/2011/04061.asp
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
Protalix BioTherapeutics, Inc. (AMEX: PLX )
Protalix is a biopharmaceutical company focused on the development and commercialization of
recombinant therapeutic proteins expressed through its proprietary plant cell based expression
system, ProCellEx™. Protalix's unique expression system presents a proprietary method for
developing recombinant proteins in a cost-effective, industrial-scale manner in an environment
free of mammalian components and viruses. Protalix's lead compound taliglucerase alfa,
an enzyme replacement therapy for the treatment of Gaucher disease, completed Phase III
development. To date, marketing applications have been submitted for taliglucerase alfa in the
United States, European Union, Brazil and Israel. Protalix's development pipeline also includes:
PRX-105, a pegylated recombinant human acetylcholinesterase in development for several
therapeutic and prophylactic indications, a biodefense program and an organophosphate-based
pesticide treatment program; PRX-102, a modified version of the recombinant human alpha-GAL-
A protein for the treatment of Fabry disease; an orally-delivered glucocerebrosidase enzyme that
is naturally encased in carrot cells, also for the treatment of Gaucher disease; and pr-antiTNF, a
biosimilar version of etanercept (Enbrel™) for the treatment of rheumatoid arthritis.
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.
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
Wednesday, April 6, 2011
Biotech/Biodefense Stock News; Aethlon Medical (OTCBB: AEMD) Releases Shareholder Letter
SAN DIEGO - April 6, 2011 (Investorideas.com newswire) Aethlon Medical, Inc. (OTCBB: AEMD) disclosed today that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
To our Shareholders:
On April 1st, we submitted a contract response to the Defense Advanced Research Projects Agency (DARPA) related to the Dialysis Like Therapeutics (DLT) program referenced in my last shareholder letter. In our submission, we proposed to leverage our technology platform to deliver a dialysis-like therapy that would address precursors to sepsis, including bacterial toxins, viral pathogens, and disease enhancing particles transported by exosomes. We believe our proposal meets goals underlying the DLT program as the resulting device would target to reduce the occurrence of sepsis and would provide decision-free and life saving medical care for the wounded warfighter. Additionally, we introduced an innovative strategy to deliver our dialysis-like therapy without the need for anticoagulants, as well as a novel approach to selectively clear whole bacteria from circulation.
If selected for an award, several larger organizations and industry thought leaders have agreed to partner with us to advance our program proposals. It is anticipated that the DLT program awards will be announced in the next 120 days. We are now collaborating with our advisors to determine the next contract or grant opportunity to pursue. Beyond non-dilutive bioterror and pandemic threat funding opportunities, we are also evaluating potential responses to new government programs in Hepatitis-C, HIV, and Cancer.
In addition to navigating government funding opportunities, we are actively advancing research and clinical initiatives in both infectious disease and cancer. On the clinical front, I am pleased to disclose that we our close to submitting our updated IDE to the FDA. The goal of our submission is approval from the FDA to initiate Hemopurifier� human studies in the UnitedStates
. Details regarding our FDA communications and clinical site locations can be expected through forthcoming news disclosures.
In regards to our HCV treatment study inIndia , we initiated treatment of our first patient at the Medanta Medicity Institute, which was observed by our President, Rod Kenley. In previous studies, we demonstrated significant viral load reductions in health compromised dialysis patients that were infected with either HCV or HIV. In this study, we are leveraging those results to demonstrate that our Hemopurifier� can accelerate viral load reduction when administered to non-dialysis patients in combination with drug therapy. Based on a prior clinical validation, we are confident in our capabilities and recognize the potential significance of our Hemopurifier� as viral load depletion rates in the earliest stages of therapy are considered predictive of patients who achieve long-term clinical benefit. In the treatment of our first patient, it was recognized early on that that we needed to modify our protocol to administer anticoagulants in dosages specific to our therapy, and not in amounts normally administered to dialysis patients. Regardless, there was no harm to this patient, although the anticoagulant miscalculation did not allow him to successfully complete his entire treatment. While causing a delay of several weeks, our protocol has been formally amended and we are now ramping up patient enrollment. We are also seeking to open up our study to those residing outside of India, based on worldwide inquiries from infected individuals.
In closing, I also wish to disclose that Jeff Richardson has agreed to rejoin our team on a part-time basis. While you may or may not recall Jeff, he was responsible for originating national news coverage our technology through multiple media outlets, including Popular Science, CNN, and Readers Digest. As the former communications director at Amgen, Jeff provides tremendous insight on advancing the awareness of innovative medical therapies through the national media.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, 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, including obtaining government grants, 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 ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company's ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, 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
To our Shareholders:
On April 1st, we submitted a contract response to the Defense Advanced Research Projects Agency (DARPA) related to the Dialysis Like Therapeutics (DLT) program referenced in my last shareholder letter. In our submission, we proposed to leverage our technology platform to deliver a dialysis-like therapy that would address precursors to sepsis, including bacterial toxins, viral pathogens, and disease enhancing particles transported by exosomes. We believe our proposal meets goals underlying the DLT program as the resulting device would target to reduce the occurrence of sepsis and would provide decision-free and life saving medical care for the wounded warfighter. Additionally, we introduced an innovative strategy to deliver our dialysis-like therapy without the need for anticoagulants, as well as a novel approach to selectively clear whole bacteria from circulation.
If selected for an award, several larger organizations and industry thought leaders have agreed to partner with us to advance our program proposals. It is anticipated that the DLT program awards will be announced in the next 120 days. We are now collaborating with our advisors to determine the next contract or grant opportunity to pursue. Beyond non-dilutive bioterror and pandemic threat funding opportunities, we are also evaluating potential responses to new government programs in Hepatitis-C, HIV, and Cancer.
In addition to navigating government funding opportunities, we are actively advancing research and clinical initiatives in both infectious disease and cancer. On the clinical front, I am pleased to disclose that we our close to submitting our updated IDE to the FDA. The goal of our submission is approval from the FDA to initiate Hemopurifier� human studies in the United
In regards to our HCV treatment study in
In closing, I also wish to disclose that Jeff Richardson has agreed to rejoin our team on a part-time basis. While you may or may not recall Jeff, he was responsible for originating national news coverage our technology through multiple media outlets, including Popular Science, CNN, and Readers Digest. As the former communications director at Amgen, Jeff provides tremendous insight on advancing the awareness of innovative medical therapies through the national media.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, 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, including obtaining government grants, 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 ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company's ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, 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
Effective March 15, 2011
Monday, April 4, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) to Host LibiGel® R&D Event in New York City
LINCOLNSHIRE, Ill. - April 4, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) will host a review of female sexual dysfunction (FSD) and the safety of testosterone in women by independent experts, as well as an update of the LibiGel (testosterone gel) development program, for institutional investors and analysts on Thursday, April 7, 2011 in New York City. LibiGel is in Phase III clinical development for the treatment of FSD, specifically, hypoactive sexual desire disorder (HSDD) in menopausal women. Data from both LibiGel Phase III efficacy trials is expected in Fall 2011.
The LibiGel R&D Event will include presentations by independent experts in the fields of FSD and testosterone therapy, and BioSante�s management will speak about the LibiGel Phase III clinical development progress. The independent experts� presentations include:
"Hypoactive Sexual Desire in Postmenopausal Women," by Sheryl Kingsberg, PhD � Chief, Division of Behavioral Medicine, University Hospitals Case Medical Center, MacDonald Women's Hospital; Professor of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio.
"Update on Testosterone Safety in Women," by Glenn D. Braunstein, MD � Chairman, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
Interested parties may access the presentation slides and an audio recording after the event on BioSante�s website at www.biosantepharma.com.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). Enrollment has been completed in the two on-going Phase III efficacy trials which are double-blind, placebo-controlled trials of approximately 500 surgically menopausal women each. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
BioSante also is conducting a Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled over 3,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
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).
The LibiGel R&D Event will include presentations by independent experts in the fields of FSD and testosterone therapy, and BioSante�s management will speak about the LibiGel Phase III clinical development progress. The independent experts� presentations include:
"Hypoactive Sexual Desire in Postmenopausal Women," by Sheryl Kingsberg, PhD � Chief, Division of Behavioral Medicine, University Hospitals Case Medical Center, MacDonald Women's Hospital; Professor of Reproductive Biology and Psychiatry, Case Western Reserve University School of Medicine, Cleveland, Ohio.
"Update on Testosterone Safety in Women," by Glenn D. Braunstein, MD � Chairman, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
Interested parties may access the presentation slides and an audio recording after the event on BioSante�s website at www.biosantepharma.com.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). Enrollment has been completed in the two on-going Phase III efficacy trials which are double-blind, placebo-controlled trials of approximately 500 surgically menopausal women each. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p<0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
BioSante also is conducting a Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled over 3,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
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
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