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Biosante - Potential zum Tenbagger??
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Wäre es nicht klüger auf USA zu warten?
BioSante Pharmaceuticals, Inc. to Present at Roth Health Care Conference
2012-03-09 07:55 ET - News Release
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the Roth Health Care Conference to be held at Ritz Carlton Laguna Niguel in Dana Point, CA (March 12-14, 2012), on Tuesday, March 13, 2012 at 12:30 pm PT.
A live audio webcast of remarks by Mr. Simes may be accessed at wsw.com/webcast/roth26/bpax/. The webcast will be archived for 90 days.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante’s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.
Contacts:
For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary, (312) 506-5220
azachary@harrisdmckinney.com
Source: BioSante Pharmaceuticals, Inc.
2012-03-09 07:55 ET - News Release
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the Roth Health Care Conference to be held at Ritz Carlton Laguna Niguel in Dana Point, CA (March 12-14, 2012), on Tuesday, March 13, 2012 at 12:30 pm PT.
A live audio webcast of remarks by Mr. Simes may be accessed at wsw.com/webcast/roth26/bpax/. The webcast will be archived for 90 days.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante’s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante's licensee. Additional information is available online at: www.biosantepharma.com.
Contacts:
For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary, (312) 506-5220
azachary@harrisdmckinney.com
Source: BioSante Pharmaceuticals, Inc.
Übernahme und Short-Squeeze-Gerüchte auf investorshub. Mal sehen, ob der Kurs reagiert.
was wird denn heute bekanntgegeben oder um was geht es bei der konferenz?
aktiviert :-) Prima!
BioSante Pharmaceuticals Reports Financial Results for 2011 and Corporate Highlights
2012-03-13 17:04 ET - News Release
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the year ended December 31, 2011 and additional corporate highlights.
As of December 31, 2011, BioSante’s cash balance was approximately $57.2 million as compared to $38.2 million at December 31, 2010. BioSante’s net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010. The net losses for 2011 were primarily due to expenses associated with the clinical development of LibiGel®.
BioSante’s corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel’s path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study. It is BioSante’s objective to meet with the U.S. Food and Drug Administration (FDA) to determine the best path forward, and to make a decision during the second quarter of 2012 whether to continue the LibiGel Phase III safety study. Management also has expanded efforts to explore new product development projects through in-licensing and mergers and acquisitions. In addition, a full review of the GVAX cancer vaccine portfolio is underway.
The current projected cash burn rate for 2012 is approximately $2.5 million per month, assuming the LibiGel safety study continues per protocol. If the safety study is halted, the monthly cash burn rate will decline to approximately $1.5 million per month, pending other product development and activities.
Additional Corporate Highlights
BioSante’s GVAX cancer vaccines are in 17 Phase I and Phase II cancer clinical trials, most of which are being conducted in cooperation with The Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded by others at no cost to BioSante. During 2011, BioSante announced two licensing agreements for the cancer vaccines. In April 2011, BioSante licensed its GVAX Pancreas Cancer Vaccine and GVAX Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes. Additionally, in July 2011, BioSante licensed the GVAX Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities, and which has committed $10.9 million to GVAX Melanoma Vaccine Phase I and Phase II studies.
Last month, BioSante announced that on February 14, 2012 the FDA approved its testosterone gel for male hypogonadism, which BioSante has licensed to Teva Pharmaceuticals USA, Inc. Teva is responsible for all regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of the product.
BioSante also has a licensing agreement with Pantarhei Bioscience B.V. for the development of its patented Pill-Plus™ oral contraceptive. Pantarhei is engaged in several Phase II clinical studies with this product from which BioSante hopes to share additional clinical data later this year.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante´s licensee. 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 its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante’s decision whether to continue the safety study, BioSante’s future burn rate, its clinical and corporate development activities and the activities of its licensees and sublicensees, including the timing of BioSante’s announcement of clinical data for the Pill-Plus™,and other statements identified by words such as "anticipates," "will," "continue," "could," "believe," "intends," "expects," "plans," “hopes,” "may," "potential," other words of similar meaning, derivations of such words and 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante´s actual results are described in BioSante´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
2012-03-13 17:04 ET - News Release
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced financial results for the year ended December 31, 2011 and additional corporate highlights.
As of December 31, 2011, BioSante’s cash balance was approximately $57.2 million as compared to $38.2 million at December 31, 2010. BioSante’s net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010. The net losses for 2011 were primarily due to expenses associated with the clinical development of LibiGel®.
BioSante’s corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel’s path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study. It is BioSante’s objective to meet with the U.S. Food and Drug Administration (FDA) to determine the best path forward, and to make a decision during the second quarter of 2012 whether to continue the LibiGel Phase III safety study. Management also has expanded efforts to explore new product development projects through in-licensing and mergers and acquisitions. In addition, a full review of the GVAX cancer vaccine portfolio is underway.
The current projected cash burn rate for 2012 is approximately $2.5 million per month, assuming the LibiGel safety study continues per protocol. If the safety study is halted, the monthly cash burn rate will decline to approximately $1.5 million per month, pending other product development and activities.
Additional Corporate Highlights
BioSante’s GVAX cancer vaccines are in 17 Phase I and Phase II cancer clinical trials, most of which are being conducted in cooperation with The Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded by others at no cost to BioSante. During 2011, BioSante announced two licensing agreements for the cancer vaccines. In April 2011, BioSante licensed its GVAX Pancreas Cancer Vaccine and GVAX Prostate Cancer Vaccine to Aduro BioTech, a clinical-stage immunotherapy company, solely for use in combination with Aduro's proprietary vaccine platform based on Listeria monocytogenes. Additionally, in July 2011, BioSante licensed the GVAX Melanoma Vaccine to The John P. Hussman Foundation, a charitable foundation that supports research to address life-threatening medical conditions and significant disabilities, and which has committed $10.9 million to GVAX Melanoma Vaccine Phase I and Phase II studies.
Last month, BioSante announced that on February 14, 2012 the FDA approved its testosterone gel for male hypogonadism, which BioSante has licensed to Teva Pharmaceuticals USA, Inc. Teva is responsible for all regulatory and marketing activities. BioSante will receive royalties and may receive certain milestone payments upon commercialization of the product.
BioSante also has a licensing agreement with Pantarhei Bioscience B.V. for the development of its patented Pill-Plus™ oral contraceptive. Pantarhei is engaged in several Phase II clinical studies with this product from which BioSante hopes to share additional clinical data later this year.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante´s licensee. 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 its products and the LibiGel development program, including in particular the LibiGel safety study and the anticipated timing of BioSante’s decision whether to continue the safety study, BioSante’s future burn rate, its clinical and corporate development activities and the activities of its licensees and sublicensees, including the timing of BioSante’s announcement of clinical data for the Pill-Plus™,and other statements identified by words such as "anticipates," "will," "continue," "could," "believe," "intends," "expects," "plans," “hopes,” "may," "potential," other words of similar meaning, derivations of such words and 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante´s actual results are described in BioSante´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
Heute wieder Bärchenstimmung !!!
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FAST Act to Modernize Approval Process -- Cardium and BioSante Poised to Benefit
2012-03-19 08:20 ET - News Release
NEW YORK, NY -- (MARKET WIRE) -- 03/19/12
Biotechnology stocks continue to be some of the strongest performers in the markets as favorable legislation out of Washington boosts the sector's reach. The iShares NASDAQ Biotechnology Index (IBB) is currently up more than 16 percent year to date, reflecting an uptick in investor sentiment. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Cardium Therapeutics Inc. (NYSE Amex: CXM) & BioSante Pharmaceuticals Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:
www.paragonreport.com/CXM
www.paragonreport.com/BPAX
Earlier this month the Biotechnology Industry Organization applauded the Faster Access to Specialized Treatments (FAST) Act. According to BIO the legislation will modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases.
BIO President and CEO Jim Greenwood says the FAST act will speed access to innovative new therapies and cures to patients living with debilitating and life-threatening diseases such as Parkinson's, Alzheimer's, diabetes and numerous rare diseases for which there is currently no treatment or cure.
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Earlier this month the company reported that it is making its MedPodium Nutra-Apps products available across the United States by working with Nutritional Products International (NPI) and InHealth Media.
BioSante is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). Earlier this month the company reported that its net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at www.paragonreport.com/disclaimer
2012-03-19 08:20 ET - News Release
NEW YORK, NY -- (MARKET WIRE) -- 03/19/12
Biotechnology stocks continue to be some of the strongest performers in the markets as favorable legislation out of Washington boosts the sector's reach. The iShares NASDAQ Biotechnology Index (IBB) is currently up more than 16 percent year to date, reflecting an uptick in investor sentiment. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Cardium Therapeutics Inc. (NYSE Amex: CXM) & BioSante Pharmaceuticals Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:
www.paragonreport.com/CXM
www.paragonreport.com/BPAX
Earlier this month the Biotechnology Industry Organization applauded the Faster Access to Specialized Treatments (FAST) Act. According to BIO the legislation will modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases.
BIO President and CEO Jim Greenwood says the FAST act will speed access to innovative new therapies and cures to patients living with debilitating and life-threatening diseases such as Parkinson's, Alzheimer's, diabetes and numerous rare diseases for which there is currently no treatment or cure.
The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.
Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Earlier this month the company reported that it is making its MedPodium Nutra-Apps products available across the United States by working with Nutritional Products International (NPI) and InHealth Media.
BioSante is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). Earlier this month the company reported that its net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010.
The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at www.paragonreport.com/disclaimer
hier noch ,
bis sich die bude ausgekotzt hat...
eine zulassung fda und dann sowas
bis sich die bude ausgekotzt hat...
eine zulassung fda und dann sowas
schau dir mal DSCO an... da genau das gleiche! Bin froh, dass ich da noch mit Gewinn raus war!
BioSante Pharmaceuticals Announces Positive Pill-Plus™ Data Presentation
2012-03-20 07:55 ET - News Release
Improvements reported in sexual desire, arousal, responsiveness and activity
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that data from studies of the Pill-Plus “triple component” oral contraceptive were presented on March 10, 2012 by Pantarhei Bioscience at the World Congress of Gynecological Endocrinology in Florence, Italy. The title of the Pantarhei presentation was, “Clinical effects of normalizing testosterone levels during oral contraception.” The United States patents for oral use of the Pill-Plus are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.
To date, six prospective, randomized controlled (placebo or active) Phase II clinical studies of the Pill-Plus have been completed in 355 subjects. In these studies, use of the Pill-Plus has been shown to increase frequency of sexual activity, arousal, responsiveness to partner, genital sensations and vaginal lubrication. In addition, improvements were seen in quality of life scores. No significant androgenic effects were noted.
“We are pleased with the results to date in the clinical work being carried out by Pantarhei Bioscience,” said Stephen M. Simes, BioSante’s president & CEO. Herjan J.T. Coelingh Bennink, Pantarhei’s president and CEO added, “With these positive clinical results in hand, Pantarhei’s current objective is to seek a development partner to move the Pill-Plus concept into Phase III clinical development.”
BioSante will receive royalty payments on sales of the Pill-Plus in the U.S., if and when introduced. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party. BioSante has retained all rights under the BioSante-licensed patents to the transdermal delivery of triple component contraceptives.
The Pill-Plus concept, also known as Androgen Restored Contraception (ARC), is to create an oral contraceptive that protects against androgen loss which occurs with current oral contraceptives, potentially causing reduced arousal, orgasms, pleasure and less frequent satisfying sexual activity in oral contraceptive users. The restoration of testosterone levels is achieved by adding the natural human adrenal steroid DHEA to current estrogen/progestogen combination oral contraceptives. DHEA restores testosterone levels by metabolic conversion to testosterone.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. Its management has an extensive track record in the pharmaceutical industry. Pantarhei develops patent protected new medical uses of existing compounds (hormones, biologicals and approved drugs) in Women’s Health and Endocrine Cancer. Pantarhei operates by outsourcing all activities with the objective to obtain patent protection of concepts and demonstrate proof of concept (phase II) in the human. For development and commercialization into the final phase III, Pantarhei will generally seek partnerships with pharmaceutical companies. Additional information is available online at: www.pantarheibio.com.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante´s licensee. 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 and Pantarhei’s plans, objectives, expectations and intentions with respect to its products and other statements identified by words such as "anticipates," "will," "continue," "could," "believe," "intends," "expects," "plans," “hopes,” "may," "potential," other words of similar meaning, derivations of such words and 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. 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. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com
2012-03-20 07:55 ET - News Release
Improvements reported in sexual desire, arousal, responsiveness and activity
LINCOLNSHIRE, Ill. -- (Business Wire)
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that data from studies of the Pill-Plus “triple component” oral contraceptive were presented on March 10, 2012 by Pantarhei Bioscience at the World Congress of Gynecological Endocrinology in Florence, Italy. The title of the Pantarhei presentation was, “Clinical effects of normalizing testosterone levels during oral contraception.” The United States patents for oral use of the Pill-Plus are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.
To date, six prospective, randomized controlled (placebo or active) Phase II clinical studies of the Pill-Plus have been completed in 355 subjects. In these studies, use of the Pill-Plus has been shown to increase frequency of sexual activity, arousal, responsiveness to partner, genital sensations and vaginal lubrication. In addition, improvements were seen in quality of life scores. No significant androgenic effects were noted.
“We are pleased with the results to date in the clinical work being carried out by Pantarhei Bioscience,” said Stephen M. Simes, BioSante’s president & CEO. Herjan J.T. Coelingh Bennink, Pantarhei’s president and CEO added, “With these positive clinical results in hand, Pantarhei’s current objective is to seek a development partner to move the Pill-Plus concept into Phase III clinical development.”
BioSante will receive royalty payments on sales of the Pill-Plus in the U.S., if and when introduced. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party. BioSante has retained all rights under the BioSante-licensed patents to the transdermal delivery of triple component contraceptives.
The Pill-Plus concept, also known as Androgen Restored Contraception (ARC), is to create an oral contraceptive that protects against androgen loss which occurs with current oral contraceptives, potentially causing reduced arousal, orgasms, pleasure and less frequent satisfying sexual activity in oral contraceptive users. The restoration of testosterone levels is achieved by adding the natural human adrenal steroid DHEA to current estrogen/progestogen combination oral contraceptives. DHEA restores testosterone levels by metabolic conversion to testosterone.
About Pantarhei Bioscience B.V.
Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. Its management has an extensive track record in the pharmaceutical industry. Pantarhei develops patent protected new medical uses of existing compounds (hormones, biologicals and approved drugs) in Women’s Health and Endocrine Cancer. Pantarhei operates by outsourcing all activities with the objective to obtain patent protection of concepts and demonstrate proof of concept (phase II) in the human. For development and commercialization into the final phase III, Pantarhei will generally seek partnerships with pharmaceutical companies. Additional information is available online at: www.pantarheibio.com.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s 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. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. 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 Jazz Pharmaceuticals, BioSante´s licensee. 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 and Pantarhei’s plans, objectives, expectations and intentions with respect to its products and other statements identified by words such as "anticipates," "will," "continue," "could," "believe," "intends," "expects," "plans," “hopes,” "may," "potential," other words of similar meaning, derivations of such words and 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, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. 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. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contacts:
For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com
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#498 
@st
die meisten leute , die sich als wohl erzogen
fuehlen,
haben nicht mal ne genaue satzstellung
um sich gegen irgendwas
im staat ...oder sonstwo ..firma
durchzusetzen..
die meisten leute , die sich als wohl erzogen
fuehlen,
haben nicht mal ne genaue satzstellung
um sich gegen irgendwas
im staat ...oder sonstwo ..firma
durchzusetzen..
oder wie....?
da oben um 2 dollar ist noch ein offnes gap...
vllt machen sich da mal einige dran ..das zu schliessen
da oben um 2 dollar ist noch ein offnes gap...
vllt machen sich da mal einige dran ..das zu schliessen
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