LINCOLNSHIRE, Ill. - July 26, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced its financial results for the second quarter of 2011.
The Company's cash and cash equivalents as of June 30, 2011 were approximately $37.1 million. BioSante incurred a net loss of approximately $15.0 million or ($0.16) per share for the quarter ended June 30, 2011, compared to a net loss of $10.8 million or ($0.17) per share for the same period in 2010. This expected increase in net loss was due primarily to the conduct of the three ongoing LibiGel� (testosterone gel) Phase III clinical studies to support submission of a new drug application (NDA) for U.S. Food and Drug Administration (FDA) approval.
As a result of this focus on LibiGel development and the Company's planned conduct of the LibiGel program, research and development expenses increased to approximately $11.1 million and $26.0 million for the three and six month periods ended June 30, 2011 from $8.7 million and $18.1 million for the three and six month periods ended June 30, 2010.
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.
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
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Tuesday, July 26, 2011
Friday, July 22, 2011
Biotech/Pharma Trading Alert for BioSante (NASDAQ: BPAX)
Point Roberts, WA, LINCOLNSHIRE, Ill - July 22, 2011 - Investorideas.com, a leader in sector stock research for independent investors , issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for July 22 nd . The stock traded as high as $3.73 on July 21 st following news of the exclusive worldwide license of its Melanoma Vaccine to The John P. Hussman Foundation.
The stock is on an upward trend based on recent analyst coverage and bullish price targets, gaining almost 40% in the past month.
3 Month Chart
News Excerpt: BioSante Pharmaceuticals (NASDAQ: BPAX) Signs Melanoma Vaccine License
"LINCOLNSHIRE , Ill. - July 21, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced an exclusive worldwide license of its Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities. BioSante received $100,000 on signing the license and is eligible for up to $39 million in milestone payments, plus royalties on sales. Additionally, the Hussman Foundation has committed up to approximately $11 million in Melanoma Vaccine clinical development funding. Also, BioSante will receive between 15 and 33 percent of any sublicense payments received by the Hussman Foundation depending on the timing of any sublicense by the Foundation to a corporate sub-licensee.
BioSante's Melanoma Vaccine is one of a portfolio of BioSante cancer vaccines in development including vaccines for leukemia, breast and pancreatic cancer. BioSante's Melanoma Vaccine was granted Orphan Drug designation by the FDA earlier this year.
"We are excited by the Melanoma Vaccine license with the Hussman Foundation since the Foundation's funding will allow for the first human clinical trial of our Melanoma Vaccine," said Stephen M. Simes, BioSante's president & CEO. "Importantly, the Foundation intends to move rapidly into human clinical trials. Assuming a successful outcome of the first Phase I clinical trial, the Foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence and engaging a corporate sponsor for Phase III clinical trials."
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will," “continue," “could," “believe," “intends," “continue," “expects," “anticipates," “estimates," “may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
The stock is on an upward trend based on recent analyst coverage and bullish price targets, gaining almost 40% in the past month.
3 Month Chart
News Excerpt: BioSante Pharmaceuticals (NASDAQ: BPAX) Signs Melanoma Vaccine License "LINCOLNSHIRE , Ill. - July 21, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced an exclusive worldwide license of its Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities. BioSante received $100,000 on signing the license and is eligible for up to $39 million in milestone payments, plus royalties on sales. Additionally, the Hussman Foundation has committed up to approximately $11 million in Melanoma Vaccine clinical development funding. Also, BioSante will receive between 15 and 33 percent of any sublicense payments received by the Hussman Foundation depending on the timing of any sublicense by the Foundation to a corporate sub-licensee.
BioSante's Melanoma Vaccine is one of a portfolio of BioSante cancer vaccines in development including vaccines for leukemia, breast and pancreatic cancer. BioSante's Melanoma Vaccine was granted Orphan Drug designation by the FDA earlier this year.
"We are excited by the Melanoma Vaccine license with the Hussman Foundation since the Foundation's funding will allow for the first human clinical trial of our Melanoma Vaccine," said Stephen M. Simes, BioSante's president & CEO. "Importantly, the Foundation intends to move rapidly into human clinical trials. Assuming a successful outcome of the first Phase I clinical trial, the Foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence and engaging a corporate sponsor for Phase III clinical trials."
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will," “continue," “could," “believe," “intends," “continue," “expects," “anticipates," “estimates," “may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
Thursday, July 21, 2011
Pharma and Biotech News; BioSante Pharmaceuticals (NASDAQ: BPAX) Signs Melanoma Vaccine License
LINCOLNSHIRE, Ill. - July 21, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced an exclusive worldwide license of its Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities. BioSante received $100,000 on signing the license and is eligible for up to $39 million in milestone payments, plus royalties on sales. Additionally, the Hussman Foundation has committed up to approximately $11 million in Melanoma Vaccine clinical development funding. Also, BioSante will receive between 15 and 33 percent of any sublicense payments received by the Hussman Foundation depending on the timing of any sublicense by the Foundation to a corporate sub-licensee.
BioSante's Melanoma Vaccine is one of a portfolio of BioSante cancer vaccines in development including vaccines for leukemia, breast and pancreatic cancer. BioSante's Melanoma Vaccine was granted Orphan Drug designation by the FDA earlier this year.
"We are excited by the Melanoma Vaccine license with the Hussman Foundation since the Foundation's funding will allow for the first human clinical trial of our Melanoma Vaccine," said Stephen M. Simes, BioSante's president & CEO. "Importantly, the Foundation intends to move rapidly into human clinical trials. Assuming a successful outcome of the first Phase I clinical trial, the Foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence and engaging a corporate sponsor for Phase III clinical trials."
"We at the Hussman Foundation have very personal family reasons for wanting to fund work in melanoma research," said John P. Hussman, PhD, director of the Hussman Foundation. "In our ongoing partnership with leading melanoma and cancer specialists, we are increasingly encouraged that targeting the immune system using BioSante's cancer vaccine may be a viable treatment approach for this most immunogenic of cancers. We chose to license and fund BioSante's Melanoma Vaccine based on its potential to enhance the effective treatment options that are available to melanoma patients in need," Dr. Hussman added.
The first Phase I clinical trial of the Melanoma Vaccine is expected to begin within the next several months. The clinical trial protocol is being finalized at this time and Melanoma Vaccine has been produced for the trial.
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.
About the Hussman Foundation
The mission of the John P. Hussman Foundation is to provide life-changing assistance through medical research, education, and direct aid to vulnerable individuals having urgent needs or significant disabilities. The Hussman Foundation seeks to �tip the balance� in critical areas where research or intervention can significantly alter the course of individual lives, and where resources would otherwise not be available. Additional information is available online at: www.hussmanfoundation.org.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
BioSante's Melanoma Vaccine is one of a portfolio of BioSante cancer vaccines in development including vaccines for leukemia, breast and pancreatic cancer. BioSante's Melanoma Vaccine was granted Orphan Drug designation by the FDA earlier this year.
"We are excited by the Melanoma Vaccine license with the Hussman Foundation since the Foundation's funding will allow for the first human clinical trial of our Melanoma Vaccine," said Stephen M. Simes, BioSante's president & CEO. "Importantly, the Foundation intends to move rapidly into human clinical trials. Assuming a successful outcome of the first Phase I clinical trial, the Foundation will fund a Phase II clinical trial with the objective of obtaining further clinical evidence and engaging a corporate sponsor for Phase III clinical trials."
"We at the Hussman Foundation have very personal family reasons for wanting to fund work in melanoma research," said John P. Hussman, PhD, director of the Hussman Foundation. "In our ongoing partnership with leading melanoma and cancer specialists, we are increasingly encouraged that targeting the immune system using BioSante's cancer vaccine may be a viable treatment approach for this most immunogenic of cancers. We chose to license and fund BioSante's Melanoma Vaccine based on its potential to enhance the effective treatment options that are available to melanoma patients in need," Dr. Hussman added.
The first Phase I clinical trial of the Melanoma Vaccine is expected to begin within the next several months. The clinical trial protocol is being finalized at this time and Melanoma Vaccine has been produced for the trial.
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.
About the Hussman Foundation
The mission of the John P. Hussman Foundation is to provide life-changing assistance through medical research, education, and direct aid to vulnerable individuals having urgent needs or significant disabilities. The Hussman Foundation seeks to �tip the balance� in critical areas where research or intervention can significantly alter the course of individual lives, and where resources would otherwise not be available. Additional information is available online at: www.hussmanfoundation.org.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Wednesday, July 20, 2011
Biotech/Pharma Stocks Investor News Alert: AEMD, CAPS, ONTY, ANX, REGN
Point Roberts, WA - July 20, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for July 19, 2011.
Biotech/Pharma Sector Snapshot Trading July 19 th
Aethlon Medical (OTCBB: AEMD ) traded lower by 0.0041 (-4.14%) to $0.0949. Last week, the stock moved up following a letter to shareholders discussing its Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies.
The Aethlon ADAPT™ system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT™ system being the impetus for industry collaborations that offer new channels of early revenue generation.
Capstone Therapeutics Corp. (NASDAQ:CAPS) was one of the biggest gainers among the biotech companies and soared 44% to $0.36 on technical signal. The stock had corrected about 60% in the previous three-month before resumed its uptrend and over the past one week it has risen over 51%.
Oncothyreon Inc. (NASDAQ:ONTY ) shares also climbed 9.81% to $8.84 after a positive article released by seekingalpha.com.
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) climbed 8.40% to $3.49 on high volume. Last week, it has secured work worth at roughly $165 million for numerous new projects and extensions to present projects in the Latin America, Asia-Pacific, EAME and North America areas.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN ) added 6.02% to $59.16. Last week, the company announced results from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab (REGN88/SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R).
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the AEMD showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get biotech news and stock alerts
http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
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 - cvanzant@investorideas.com
Source - Investorideas.com
Biotech/Pharma Sector Snapshot Trading July 19 th
Aethlon Medical (OTCBB: AEMD ) traded lower by 0.0041 (-4.14%) to $0.0949. Last week, the stock moved up following a letter to shareholders discussing its Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies.
The Aethlon ADAPT™ system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT™ system being the impetus for industry collaborations that offer new channels of early revenue generation.
Capstone Therapeutics Corp. (NASDAQ:CAPS) was one of the biggest gainers among the biotech companies and soared 44% to $0.36 on technical signal. The stock had corrected about 60% in the previous three-month before resumed its uptrend and over the past one week it has risen over 51%.
Oncothyreon Inc. (NASDAQ:ONTY ) shares also climbed 9.81% to $8.84 after a positive article released by seekingalpha.com.
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) climbed 8.40% to $3.49 on high volume. Last week, it has secured work worth at roughly $165 million for numerous new projects and extensions to present projects in the Latin America, Asia-Pacific, EAME and North America areas.
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN ) added 6.02% to $59.16. Last week, the company announced results from Phase 2b trials in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) with sarilumab (REGN88/SAR153191), a novel, high-affinity, subcutaneously administered, fully-human antibody targeting the interleukin-6 receptor (IL-6R).
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the AEMD showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get biotech news and stock alerts
http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
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, $five thousand per month in 144 stock)Effective March 15, 2011
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Disclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) is a paid advertising client ($one thousand five hundred per month, $five thousand per month in 144 stock)
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Monday, July 18, 2011
Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Management Team Additions
LINCOLNSHIRE, Ill. - July 18, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX), today announced the appointment of Sandra Croak-Brossman, MS, Ph.D., as Vice President, Regulatory Affairs and Quality Assurance, and Patricia M. Adams, MS as Vice President, Human Resources. Dr. Croak-Brossman assumed this new role effective today. Ms. Adams assumed her new role effective in May 2011.
Dr. Croak-Brossman joins BioSante with over 24 years of experience in the pharmaceutical industry. She has held a variety of regulatory positions and has led operations at both a U.S. and global level. Dr. Croak-Brossman�s work experience includes positions at Boehringer Ingelheim, Pfizer and Abbott Laboratories. Importantly, while at Pfizer, Dr. Croak-Brossman was the worldwide regulatory lead for Viagra�. Her experience as a regulatory lead in the sexual dysfunction therapeutic market makes her uniquely qualified to manage regulatory projects as BioSante progresses towards the NDA submission for LibiGel� (testosterone gel). Dr. Croak-Brossman earned her MS and Ph.D. in Quantitative Genetics and Animal Breeding from Purdue University and conducted her Post-Doctoral Fellowship at Cornell University.
Ms. Adams has over 20 years of experience in the pharmaceutical industry. From 2009 through May 2011, Ms. Adams was with Lundbeck Inc. (the U.S. subsidiary of H. Lundbeck A/S based in Copenhagen, Denmark) where she most recently served as the Vice President of Human Resources. Prior to joining Lundbeck, Ms. Adams was employed by Takeda Pharmaceuticals North America from 1998 � 2009. While at Takeda, Ms. Adams held positions of increasing responsibility in both Human Resources and Sales Operations and created foundational policies and procedures to support the launch of Takeda�s North American headquarters. Ms. Adams� previous work experiences also include time at both TAP Pharmaceuticals and Abbott Laboratories. Ms. Adams earned her MS in Human Resources from Loyola University Chicago and her Senior Professional in Human Resources certification from The Human Resources Certification Institute.
"We are very pleased to have both Sandra Croak-Brossman and Patricia Adams joining us at this exciting time for BioSante," said Stephen M. Simes, BioSante�s president and chief executive officer. "Sandy�s experience and expertise, particularly in leading Pfizer�s Viagra to an FDA approval, will be invaluable in view of the excellent progress we have made in the development of LibiGel for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product. Patty has a clear vision for where HR needs to go and how to help BioSante recruit, retain and develop the best talent in the pharmaceutical industry. We remain dedicated to our objective of maximizing stockholder value and believe Sandy and Patty will be integral to this endeavor."
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Dr. Croak-Brossman joins BioSante with over 24 years of experience in the pharmaceutical industry. She has held a variety of regulatory positions and has led operations at both a U.S. and global level. Dr. Croak-Brossman�s work experience includes positions at Boehringer Ingelheim, Pfizer and Abbott Laboratories. Importantly, while at Pfizer, Dr. Croak-Brossman was the worldwide regulatory lead for Viagra�. Her experience as a regulatory lead in the sexual dysfunction therapeutic market makes her uniquely qualified to manage regulatory projects as BioSante progresses towards the NDA submission for LibiGel� (testosterone gel). Dr. Croak-Brossman earned her MS and Ph.D. in Quantitative Genetics and Animal Breeding from Purdue University and conducted her Post-Doctoral Fellowship at Cornell University.
Ms. Adams has over 20 years of experience in the pharmaceutical industry. From 2009 through May 2011, Ms. Adams was with Lundbeck Inc. (the U.S. subsidiary of H. Lundbeck A/S based in Copenhagen, Denmark) where she most recently served as the Vice President of Human Resources. Prior to joining Lundbeck, Ms. Adams was employed by Takeda Pharmaceuticals North America from 1998 � 2009. While at Takeda, Ms. Adams held positions of increasing responsibility in both Human Resources and Sales Operations and created foundational policies and procedures to support the launch of Takeda�s North American headquarters. Ms. Adams� previous work experiences also include time at both TAP Pharmaceuticals and Abbott Laboratories. Ms. Adams earned her MS in Human Resources from Loyola University Chicago and her Senior Professional in Human Resources certification from The Human Resources Certification Institute.
"We are very pleased to have both Sandra Croak-Brossman and Patricia Adams joining us at this exciting time for BioSante," said Stephen M. Simes, BioSante�s president and chief executive officer. "Sandy�s experience and expertise, particularly in leading Pfizer�s Viagra to an FDA approval, will be invaluable in view of the excellent progress we have made in the development of LibiGel for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product. Patty has a clear vision for where HR needs to go and how to help BioSante recruit, retain and develop the best talent in the pharmaceutical industry. We remain dedicated to our objective of maximizing stockholder value and believe Sandy and Patty will be integral to this endeavor."
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "continue," "could," "believe," "intends," "continue," "expects," "anticipates," "estimates," "may," other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Friday, July 15, 2011
Biotech/Medical Technology Stock News; Aethlon Medical (OTCBB: AEMD) Releases Shareholder Letter
SAN DIEGO – July 15, 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:
Last December, I authored a shareholder letter which referenced the viewpoint of healthcare leaders who felt a need for innovative new therapeutic strategies to evolve as escalating regulatory costs, challenges and uncertainties made it nearly impossible for small to mid-size organizations to commercialize their drug candidates. In response, we introduced the Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies. The Aethlon ADAPT™ system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT™ system being the impetus for industry collaborations that offer new channels of early revenue generation.
On May 25th, we introduced our Aethlon ADAPT™ system to the drug industry at the C21 Life Sciences Partnering Conference. However, we had already begun to leverage our ADAPT™ system on April 1st, through a response to a government contract opportunity offered by the Defense Advanced Research Projects Agency (DARPA) entitled, "Dialysis-Like Therapeutics." Included within our response was a proposal to develop a device that would reduce the incidence of sepsis in wounded war-fighters. I am pleased to inform you that our submitted program was chosen for funding by a panel of experts assembled by DARPA. While it is an honor to be chosen to receive a contract award, I ask that you curb any assumption that we have won a contract based on information that may be published on the Internet. A contract that leads to funding of our proposed program is predicated on the successful completion of a detailed contracting process. On June 29th, we again leveraged the capabilities of our ADAPT™ system through a response to a U.S. Army initiative to create a device that would meet the objective of a program entitled "Blood Purification for Organ Failure."
The genesis of the Aethlon ADAPT™ system is our Hemopurifier®, a device that has demonstrated broad-spectrum activity against infectious viral pathogens, immunosuppressive proteins and exosomes secreted by cancer. Increasingly, exosomes are being discovered to have implications in other life-threatening diseases. Next Tuesday (July 19th), we will meet with FDA officials to discuss a proposed clinical program to support the regulatory advancement of our Hemopurifier® as a treatment countermeasure against bioterror and pandemic threats. Based on data collected from clinical programs conducted in India, we will also seek permission from the FDA to expand our treatment indications to include Hepatitis C virus (HCV). Formal FDA feedback to next week's meeting would likely occur in early fall. Should the FDA grant permission to initiate our U.S. clinical studies, we have already submitted (on May 31st of this year) a request to the Biomedical Advanced Research and Development Authority (BARDA) to fund clinical programs specific to bioterror and pandemic threats. In the meantime, we continue to advance our HCV treatment program at the Medanta Medicity Institute. As previously communicated, positive clinical outcomes from this study will lead to commercialization of our Hemopurifier® in India. Regardless of the many challenges we have confronted, we continue to advance our mission to create innovative devices that address unmet medical needs in cancer, infectious disease and other life-threatening conditions. On behalf of your dedicated team at Aethlon Medical, I again thank you for your continued support and belief in our endeavors.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the ability for the Company to derive business partnerships or future revenue streams using the Aethlon ADAPT™ system including consummating government contracts or grants, the FDA's willingness to allow the Company to proceed with the clinical trials proposed in the re-initiation of an Investigational Device Exemption (IDE) study, or the FDA's willingness to meet with company officials to discuss Emergency Use Authorization (EUA) for the Hemopurifier® as a broad-spectrum countermeasure against untreatable viral threats, the Company's ability to conduct clinical trials in Europe or to achieve regulatory approval in Europe, the Company's ability to commercialize its Hemopurifier® in India, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
Jody Cain
Senior Vice President, Lippert/Heilshorn & Associates
310.691.7100
jcain@lhai.com
Jim Frakes
Chief Financial Officer
858.459.7800 x300
jfrakes@aethlonmedical.com
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Disclosure/Disclaimer: AETHLON MEDICAL INC (OTC BB: AEMD) is a paid advertising client ($one thousand five hundred per month, $five thousand per month in 144 stock)
Visit the AETHLON MEDICAL INC (OTC BB: AEMD) showcase profile page
Interview with Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), Discusses the Potential of Future Partners or Acquisition
Point Roberts, WA, LINCOLNSHIRE, Ill – July 15, 2011 –(Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals, as industry buzz builds on talk of partners or acquisition with value up to $1 Billion.
As BioSante's lead product LibiGel ® (transdermal testosterone gel), for the treatment of female sexual dysfunction gets closer to market, the company is now on the radar as a biotech company to watch.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, there is an old saying in the market, that the trading tells the story. The activity and interest in your stock is building from both analysts and retail investors. Can you give us some insight to the key points of the recent analyst coverage and what the industry is saying about your company?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We have been in development of LibiGel for quite a number of years. Finally the finish line is in site. We have completed enrollment of women into our three LibiGel Phase III clinical studies and efficacy data should be available in the fourth quarter of this year. Safety data should be available in the third quarter of 2012 and our objective is to submit the LibiGel new drug application (NDA) to the FDA in the fourth quarter of 2012. All of these dates are near-term opportunities in the biotech/pharma world. Analysts and investors are taking note of the progress we have made with LibiGel.
Q: Investorideas.com
Can you discuss the potential dollar value for a female sexual dysfunction drug hitting the market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market for a drug for female sexual dysfunction is potentially bigger than the market for erectile dysfunction drugs, a $2 billion market if the U.S., and male testosterone, a $1.3 billion market in the U.S. Our belief is based on current off-label use of products to treat female sexual dysfunction as well as publications that indicate the potential size of the market for treatment of female sexual dysfunction. It has been over 13 years since Viagra was approved and we believe strongly that women deserve an FDA-approved therapeutic choice for their sexual health issues.
Q: Investorideas.com
With LibiGel ® getting closer to market, how will the process of potential partners or acquisition play out in the pharma industry?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our focus is on completing the LibiGel Phase III clinical work and submitting an NDA in 2012. Our LibiGel partnering strategy from the beginning has been and remains to develop LibiGel as far as we can since we believe the best way to maximize our stockholder value is to bring LibiGel to the latest stage of product development and regulatory status possible. Although we would entertain a license/partnership at this time, we believe the value of LibiGel will increase as new efficacy and safety data become available and these data will be available beginning in the coming months.
Q: Investorideas.com
With other players abandoning the female sexual dysfunction market, your company stayed through the long process and is now postured to be first to market. How significant is it that you have no current competition?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Assuming positive safety and efficacy data, we believe LibiGel will be the first product approved by the FDA for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder. In our primary market research with prescribing physicians, they tell us that there is a great need for an FDA-approved product and that they are dissatisfied with their choices for off-label use. If and when LibiGel is approved we believe it will be a very successful product and result in a very attractive choice for prescribers and women in need, and continued increasing value for our stockholders.
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, 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.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued 4,000 women-years of exposure. The study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to 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. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the second half of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
As BioSante's lead product LibiGel ® (transdermal testosterone gel), for the treatment of female sexual dysfunction gets closer to market, the company is now on the radar as a biotech company to watch.
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Stephen, there is an old saying in the market, that the trading tells the story. The activity and interest in your stock is building from both analysts and retail investors. Can you give us some insight to the key points of the recent analyst coverage and what the industry is saying about your company?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We have been in development of LibiGel for quite a number of years. Finally the finish line is in site. We have completed enrollment of women into our three LibiGel Phase III clinical studies and efficacy data should be available in the fourth quarter of this year. Safety data should be available in the third quarter of 2012 and our objective is to submit the LibiGel new drug application (NDA) to the FDA in the fourth quarter of 2012. All of these dates are near-term opportunities in the biotech/pharma world. Analysts and investors are taking note of the progress we have made with LibiGel.
Q: Investorideas.com
Can you discuss the potential dollar value for a female sexual dysfunction drug hitting the market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We believe the market for a drug for female sexual dysfunction is potentially bigger than the market for erectile dysfunction drugs, a $2 billion market if the U.S., and male testosterone, a $1.3 billion market in the U.S. Our belief is based on current off-label use of products to treat female sexual dysfunction as well as publications that indicate the potential size of the market for treatment of female sexual dysfunction. It has been over 13 years since Viagra was approved and we believe strongly that women deserve an FDA-approved therapeutic choice for their sexual health issues.
Q: Investorideas.com
With LibiGel ® getting closer to market, how will the process of potential partners or acquisition play out in the pharma industry?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
Our focus is on completing the LibiGel Phase III clinical work and submitting an NDA in 2012. Our LibiGel partnering strategy from the beginning has been and remains to develop LibiGel as far as we can since we believe the best way to maximize our stockholder value is to bring LibiGel to the latest stage of product development and regulatory status possible. Although we would entertain a license/partnership at this time, we believe the value of LibiGel will increase as new efficacy and safety data become available and these data will be available beginning in the coming months.
Q: Investorideas.com
With other players abandoning the female sexual dysfunction market, your company stayed through the long process and is now postured to be first to market. How significant is it that you have no current competition?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Assuming positive safety and efficacy data, we believe LibiGel will be the first product approved by the FDA for the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder. In our primary market research with prescribing physicians, they tell us that there is a great need for an FDA-approved product and that they are dissatisfied with their choices for off-label use. If and when LibiGel is approved we believe it will be a very successful product and result in a very attractive choice for prescribers and women in need, and continued increasing value for our stockholders.
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that have enrolled over 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials, which have completed enrollment, 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.
In addition, BioSante is conducting the Phase III LibiGel safety study, a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has completed enrollment of 3,656 women and has accrued 4,000 women-years of exposure. The study will continue for a total of five years, however, BioSante will use the safety study data as part of an NDA submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to 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. The study represents the largest data base of the safety of testosterone in women.
Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women. The NDA submission is targeted for the second half of 2012.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Subscribe to:
Posts (Atom)