Point Roberts, WA. –February 14, 2011 (Investorideas.com Energy stocks Newswire) -
www.InvestorIdeas.com and its leading Biotech investor portals, announces a technical stock
trading alert for BioSante Pharmaceuticals Inc (NASDAQ:BPAX). The stock is trading at $2.41,
up 0.10 (4.33%), trading as high as $2.53 in morning trading.
Recent News: BioSante Pharmaceuticals (NASDAQ: BPAX) Reports Positive LibiGel Safety
Data in Phase III Program
“LINCOLNSHIRE, Ill. - February 14, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX),
presented positive safety data in its ongoing LibiGel Phase III clinical development program, at
the annual meeting of ISSWSH on February 12, 2011.
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure
in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17
adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately
0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27
percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-
agreed protocol, without modifications including continued enrollment of new subjects. This was
the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th
unblinded review of all study safety data. LibiGel is in development for the treatment of female
sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal
women, for which there is no FDA-approved product.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02142.asp
Recent News: BioSante Pharmaceuticals, Inc. To Present LibiGel®
Safety Study Update At BIO CEO & Investor Conference
“LINCOLNSHIRE, Illinois (February 14, 2011) – BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the
Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take
place February 14-15, 2011 at the Waldorf-Astoria in New York.
Stephen M. Simes, BioSante’s president & CEO, will speak today, Monday February 14, 2011
at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel®
(testosterone gel) Phase III clinical development program including safety data. A live audio
webcast of Mr. Simes’ remarks may be accessed at: http://www.veracast.com/webcasts/bio/
ceoinvestor2011/16113289.cfm .”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/02141.asp
More info: 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.
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Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
Investorideas.com Disclosure, Disclaimer/ BPAX is a paid advertising client on
Investorideas.com. (one thousand per month)
Disclaimer: The following news is paid for by BPAX (three thousand per month)
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Monday, February 14, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals Reports Positive LibiGel Safety Data in Phase III Program
LINCOLNSHIRE, Ill. - February 14, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), presented positive safety data in its ongoing LibiGel Phase III clinical development program, at the annual meeting of ISSWSH on February 12, 2011.
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
"Once again, the DMC has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. In addition, the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete. The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum."
Subjects have been enrolled in this study for an average of 12.5 months. More than 1,000 subjects have been enrolled in the study for more than a year and over 550 subjects for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight. BioSante's objective is to submit the LibiGel NDA for a product launch in 2012.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante's president & CEO. "We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future," Mr. Simes continued. "With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled 2,869 women, with a maximum of 4,000 patients to be enrolled. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. 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.
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 will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �potential,� �could,� �can,� �believe,� �intends,� �continue,� �plans,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante reported that with 2,869 women enrolled and over 3,000 women-years of exposure in its LibiGel Phase III cardiovascular and breast cancer safety study, there have been 17 adjudicated cardiovascular (CV) events, with a lower than anticipated event rate of approximately 0.57 percent. There have been eight breast cancers reported, a rate of approximately 0.27 percent.
Therefore, the Phase III LibiGel (testosterone gel) safety study will continue as per the FDA-agreed protocol, without modifications including continued enrollment of new subjects. This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
"Once again, the DMC has recommended that the safety study continue as per the FDA-agreed protocol, without modification as there were no general or specific safety issues based on their unblinded review of adverse events. In addition, the low number of CV events to date is consistent with the safety of testosterone in this population," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects will be complete. The protocol allows up to 4,000 women to be enrolled, however, the DMC may recommend completion of enrollment at any time between the current enrollment and the 4,000 women maximum."
Subjects have been enrolled in this study for an average of 12.5 months. More than 1,000 subjects have been enrolled in the study for more than a year and over 550 subjects for more than two years. The periodic reviews by the DMC are based on their mandate in accordance with FDA agreement on protocol-defined study oversight. BioSante's objective is to submit the LibiGel NDA for a product launch in 2012.
"LibiGel remains the only product in the world in Phase III clinical development for the treatment of HSDD," said Stephen M. Simes, BioSante's president & CEO. "We expect to announce completion of enrollment in both Phase III efficacy trials in the near-future," Mr. Simes continued. "With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD, also referred to as FSD, in menopausal women."
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that has enrolled 2,869 women, with a maximum of 4,000 patients to be enrolled. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study. 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.
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 will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p<0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as �will,� �potential,� �could,� �can,� �believe,� �intends,� �continue,� �plans,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Present LibiGel Safety Study Update at BIO CEO & Investor Conference
LINCOLNSHIRE, Ill. - February 14, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) will be presenting at the 2011 BIO CEO & Investor Conference. Hosted by the Biotechnology Industry Organization (BIO), the 13th Annual CEO & Investor Conference will take place February 14-15, 2011 at the Waldorf-Astoria in New York.
Stephen M. Simes, BioSante�s president & CEO, will speak today, Monday February 14, 2011 at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel� (testosterone gel) Phase III clinical development program including safety data. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/bio/ceoinvestor2011/16113289.cfm
A webcast replay will be available for 90 days beginning one hour after conclusion of the live event.
About The BIO CEO & Investor Conference
Now in its thirteen year, the BIO CEO & Investor Conference 2011 is the largest investor conference focused on the biotechnology industry. The conference provides a forum for public and private equity investors, research analysts, investment bankers and senior-level industry executives to learn about and discuss investment trends and investment opportunities in the biotechnology industry. This year�s conference will feature corporate presentations from more than 120 companies, workshops featuring leading experts on specific therapeutic and technology topics, plenary and panel sessions on timely business issues and industry trends, many opportunities to schedule one-on-one meetings, as well as numerous networking opportunities. For more information, visit www.ceo.bio.org.
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
Stephen M. Simes, BioSante�s president & CEO, will speak today, Monday February 14, 2011 at 3:30 pm EST. He will provide an overview of the company, as well as an update on LibiGel� (testosterone gel) Phase III clinical development program including safety data. A live audio webcast of Mr. Simes� remarks may be accessed at: http://www.veracast.com/webcasts/bio/ceoinvestor2011/16113289.cfm
A webcast replay will be available for 90 days beginning one hour after conclusion of the live event.
About The BIO CEO & Investor Conference
Now in its thirteen year, the BIO CEO & Investor Conference 2011 is the largest investor conference focused on the biotechnology industry. The conference provides a forum for public and private equity investors, research analysts, investment bankers and senior-level industry executives to learn about and discuss investment trends and investment opportunities in the biotechnology industry. This year�s conference will feature corporate presentations from more than 120 companies, workshops featuring leading experts on specific therapeutic and technology topics, plenary and panel sessions on timely business issues and industry trends, many opportunities to schedule one-on-one meetings, as well as numerous networking opportunities. For more information, visit www.ceo.bio.org.
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
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Thursday, February 10, 2011
BioSante's Senior V.P. Michael Snabes, MD, PhD, to Discuss Data From LibiGel® Safety Study
LINCOLNSHIRE, Ill. - February 10, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports it will provide a LibiGel safety study update, in addition to supporting two clinical symposia, at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH).
An estimated 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting, hosted at the Doubletree Paradise Valley resort in Scottsdale, Arizona, February 10-13, 2011.
Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, will deliver an oral presentation entitled, "LibiGel� (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events," on February 12, 2011 at 3 pm local time. Dr. Snabes will provide an update on the largest-ever safety study comparing low-dose testosterone treatment to placebo treatment, including the LibiGel safety study's low cardiovascular event rate. To date, this ongoing study has enrolled more than 2,800 menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).
The supported symposia are entitled, "Efficacy of Testosterone in Treating Women with HSDD" and "FSD and the FDA: Past, Present & Future." The first symposium, "Efficacy of Testosterone in Treating Women with HSDD," will feature Susan R. Davis, MBBS, FRACP, PhD, Professor of Women's Health and NHMRC Principal Research Fellow and Director, the Women's Health Research Program, Department of Medicine, Monash University, Vic, Australia, and Glenn Braunstein, MD, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
The second symposium, "FSD and the FDA: Past, Present & Future," will be moderated by Alan Altman, MD, president of ISSWSH. The speakers include Anita H. Clayton, MD, professor of psychiatry and neurobehavioral sciences, and professor of clinical obstetrics and gynecology at the University of Virginia Health Systems; Michael Krychman, MD, medical director of The Sexual Medicine Center in Hoag Hospital in Newport Beach, California; Marianne Brandon, PhD, a clinical psychologist for Wellminds Wellbodies LLC and a diplomat in sex therapy; Julia Heiman, PhD, director of the Kinsey Institute for Research in Sex, Gender, and Reproduction and professor of psychology and clinical psychiatry at Indiana University, as well as Dr. Snabes of BioSante.
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 an FDA Special Protocol Assessment (SPA). 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.
For more information, please contact:
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
An estimated 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting, hosted at the Doubletree Paradise Valley resort in Scottsdale, Arizona, February 10-13, 2011.
Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, will deliver an oral presentation entitled, "LibiGel� (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events," on February 12, 2011 at 3 pm local time. Dr. Snabes will provide an update on the largest-ever safety study comparing low-dose testosterone treatment to placebo treatment, including the LibiGel safety study's low cardiovascular event rate. To date, this ongoing study has enrolled more than 2,800 menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).
The supported symposia are entitled, "Efficacy of Testosterone in Treating Women with HSDD" and "FSD and the FDA: Past, Present & Future." The first symposium, "Efficacy of Testosterone in Treating Women with HSDD," will feature Susan R. Davis, MBBS, FRACP, PhD, Professor of Women's Health and NHMRC Principal Research Fellow and Director, the Women's Health Research Program, Department of Medicine, Monash University, Vic, Australia, and Glenn Braunstein, MD, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
The second symposium, "FSD and the FDA: Past, Present & Future," will be moderated by Alan Altman, MD, president of ISSWSH. The speakers include Anita H. Clayton, MD, professor of psychiatry and neurobehavioral sciences, and professor of clinical obstetrics and gynecology at the University of Virginia Health Systems; Michael Krychman, MD, medical director of The Sexual Medicine Center in Hoag Hospital in Newport Beach, California; Marianne Brandon, PhD, a clinical psychologist for Wellminds Wellbodies LLC and a diplomat in sex therapy; Julia Heiman, PhD, director of the Kinsey Institute for Research in Sex, Gender, and Reproduction and professor of psychology and clinical psychiatry at Indiana University, as well as Dr. Snabes of BioSante.
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 an FDA Special Protocol Assessment (SPA). 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.
For more information, please contact:
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
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Monday, February 7, 2011
Q&A with Josh Levine of MicroCap Investor; Winning Strategy for Stocks in Biotech, Cleantech, and Emerging Technologies
New York, NY, Point Roberts
WA, February 7, 2011 � Investorideas.com, an investor research portal specializing in sector investing including cleantech and biotech, interviews Josh Levine of the MicroCap Investor newsletter to gain insight on his research methodology.
Interview:
Q: Investorideas.com
Josh, your newsletter is unique in that you cover microcap stocks, which most investors associate with day trading -- but you research the space to look for long term wins. Can you tell investors why you look within the microcap space for those opportunities?
A: Josh Levine, MicroCap Investor
I view microcap investing as a long-term process that entails holding stocks one, three, five years and longer. It is endlessly fascinating and rewarding to invest in small companies developing new technologies and innovations, but it does require lots of patience and discipline. Jumping in and out of stocks only creates short term capital gains -- a tax consequence we try to avoid.
Successful microcap investing, above all else, relies on fundamental analysis and not market timing or seasonal variations. As long as investors focus on the market's inefficiencies at this level -- and capitalize on them -- they'll do very well in the long run.
This point about inefficiencies is extremely important. The gaps between the market's perspective and the fundamental realities of a company are vastly wider in smaller stocks than larger ones -- and that's why I‘ve uncovered so many enticing opportunities.
Like the old song goes, "You say potato and I say po-tah-to, you say tomato and I say to-mah-to ..." Similarly, investors in the microsphere seldom agree on the inherent values of these fledgling companies and, more specifically, their potential earnings power several years out.
Of course, that's what makes for a market and that's why there are usually buyers and sellers at almost every price. As they say, one man's trash is another man's treasure. In microcap land, where there are thousands of penny stocks and solid fundamentals are at a premium, there is lots of trash to sift through. Fortunately, I've been around the block enough times to know which neighborhoods hold the real treasures.
Q: Investorideas.com
You have a focus on biotech, cleantech, and other emerging technologies. Can you tell us why those key areas?
A: Josh Levine, MicroCap Investor
Small firms are able to concentrate on high-value-added functions where cutting-edge knowledge and technology are paramount. As a result, the microcaps that execute deliver amazingly high-growth margins and profits -- and fantastic returns to their investors.
By participating in transformational changes in the highest-growth industries, any microcap that successfully navigates the path from R&D to commercialization and beyond will emerge a big winner. There are no better sectors to find these companies than in biotechnology and medical technologies, cleantech and renewableenergy , and advanced IT and networking technologies.
The life sciences is a particularly rich group to explore for exciting microcap opportunities. One reason is that big pharma companies are expected to lose as much as $140 billion in annual sales by 2016, as some of their key product patents expire. These drug giants are desperate for new innovations to revitalize their pipelines and small biotechs are an excellent source.
A surprisingly large number of the best microcap prospects reside in the biopharma and biotech sectors. I have always sought out and discovered bio companies with certain valuable attributes. Indeed, compared to the vast majority of sub-$100-million-market-value firms, the biotechs in our portfolio have seasoned management, big-league experienced boards, sane capital structures, enough cash to operate for more than 12 months, and solid partnerships with big pharmas.
In the energy world, for example, the shift to electric transportation will have far-reaching impact on nearly every industry and sector, from energy producers and suppliers to electrical equipment manufacturers and utilities to developers of the smart grid and numerous other advanced IT and energy technologies. Many small companies are building pieces of the emerging infrastructure and smart grids.
It's notable that one of the big boys in global electric infrastructure equipment, ABB, Inc. recently made a $10 million investment in a tiny company that supplies EV charging systems. Mergers and acquisitions will be happening more frequently among companies developing technologies for the smart grid. What's more, the anticipated IPOs this year for cleantech rising stars like Silver Spring Networks and BrightSource Energy will attract new investors.
Electric networks are the largest, most complex systems around, and it will take massive investments in technology over the next couple of decades to get them into shape to meet soaring demand for ever more efficient and ubiquitous electric power. As a consequence, a multitude of opportunities exist for small, innovative firms to capture lucrative market niches.
Q: Investorideas.com
You have just added a new stock to your watch list I understand. Can you tell us the criteria you have in place when you add a new stock and what you typically look for?
A: Josh Levine, MicroCap Investor
First, I want to point out there are variations in my decision-making process between, for instance, a nanocap listed on the OTC Bulletin Board and an established microcap with a $250 million market cap that's profitable with an institutional following.
For the smallest microcaps, it's essential to spend time with management and look at everything with a magnifying glass. For more seasoned companies, there is already a track record as well as more information available, which makes the due diligence process less of a maze.
Obviously, fundamental stock analysis is central, but I've learned that investing in small advanced-tech firms is as much art as science. It comes down to certain basics that apply across the board, and they are:
I remember hearing old time investors talking about making their big wins in the market by finding the next big thing and holding on for years. In the past few years that mentality has been dismantled by what transpired in 2008. Do you still see that kind of opportunity in the market - and what kind of wins are you seeing in your portfolio?
A: Josh Levine, MicroCap Investor
Yes, the opportunities for returns of 200%, 500%, 1,000% and higher continue to be out there. But to earn the truly life-altering profits, you need to be fully invested in the best microcap stocks prior to any major bull cycle. A big portion of gains are often made in the early phase of a bull market for microcaps, so you've got to be positioned early. Otherwise, by the time the trend takes shape, it's usually too late to build the kind of low-cost positions that ultimately deliver those ten-bagger profits.
Today I believe we're in the early stages of a microcap bull market, but it's difficult to predict the exact timing. Still, ever since the end of 2008 - even before the general market bottomed - the stocks in the MicroCap Investor portfolio have been trending higher.
We ended 2010 on a high note by capturing a 138% profit by selling one-half of our position in a company that's leading the charge, so to speak, in energy solutions for transportation.
Another microcap in our portfolio, a developer of a new class of cancer therapeutics, is up 240% since I first recommended it to subscribers. When I added this stock to our portfolio it was within pennies of its six-year low. The value of this biotech, which has a long-standing partnership with a leading biopharma and a healthy cash hoard, lies in the ability of its drugs to be used in combination therapies and its excellent prospects for attracting licensees. While its gains so far have been good, this stock could soar five to ten times its current price depending on the success of clinical trials for its various drugs.
In general, our biotech positions are looking very, very good. In less than six months, we're up 43% with a stem cell developer which already has two revenue-generating businesses. And a number of others have been regularly hitting new milestones, which eventually will be translated into much higher market valuations.
While all of the stocks in our portfolio are positioned for tremendous upside ahead, the most consistent performers have been what I call the “Mature Microcaps.” For instance, within this group we've got a gain of 109% with a supplier of advanced equipment for large-scale solar projects, and we're up 76% with a designer of 3G/4G wireless chips.
Finally, one of my favorite microcaps today is a company which has developed and is selling advanced mobile services to multi-billion dollar markets worldwide in dire need of its cost-effective and efficient solutions. We've already got a 120% gain, but I believe this one has all the characteristics of rapidly becoming one of the great microcap winners of the decade.
The recent activity in our micros, nice as it's been, hardly measures up to the bonanzas of past microcap bull runs. A big reason is that this bull market lacks the full participation of the public which has remained enormously risk-adverse after the blow-ups, busts and downturns of the past decade.
Depending on the breadth and length of this upturn, individual investors will increasingly come back into the game, and eventually in large numbers. By then, however, the biggest profits will have been registered by those investors positioned far ahead of the herd.
Josh Levine's MicroCap Investorhttp://www.levinesmicrocapinvestor.com
Levine's MicroCap Investor delves deep into the world of small stocks to identify big winners, targeting innovative companies on the path of the new and revolutionary.
About Josh Levine
Levine has 25 years of senior-level experience in analyzing technology trends and investing in top-performing micro- and small-cap stocks. He excels at assessing management teams and evaluating new innovations and their impact on corporate valuations.
More on Levine's bio: http://www.levinesmicrocapinvestor.com/aboutus/
To learn more about this and the other outstanding investment opportunities in the MicroCap Investor portfolio, subscribe now.
http://www.levinesmicrocapinvestor.com/subscriptions/order/
InvestorIdeas.com is partnered with Josh Levine and MicroCap Investor as part of its mission to provide investors with research tools to explore the world of small stocks. The InvestorIdeas.com team operates this web site and manages the administration and marketing for MicroCap Investor.
InvestorIdeas.com is a leading investment and industry research portal, with resources covering high-growth sectors including technology, biotech and cleantech.
Levine's Microcap Investor
Disclaimer and disclosure for Levine's Microcap :
http://www.levinesmicrocapinvestor.com/disclosure/
Disclaimer and disclosure for Investorideas.com
Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. http://www.investorideas.com/About/Disclaimer.asp
Contact us
admin@levinesmicrocapinvestor.com
800 665 0411
Interview:
Q: Investorideas.com
Josh, your newsletter is unique in that you cover microcap stocks, which most investors associate with day trading -- but you research the space to look for long term wins. Can you tell investors why you look within the microcap space for those opportunities?
A: Josh Levine, MicroCap Investor
I view microcap investing as a long-term process that entails holding stocks one, three, five years and longer. It is endlessly fascinating and rewarding to invest in small companies developing new technologies and innovations, but it does require lots of patience and discipline. Jumping in and out of stocks only creates short term capital gains -- a tax consequence we try to avoid.
Successful microcap investing, above all else, relies on fundamental analysis and not market timing or seasonal variations. As long as investors focus on the market's inefficiencies at this level -- and capitalize on them -- they'll do very well in the long run.
This point about inefficiencies is extremely important. The gaps between the market's perspective and the fundamental realities of a company are vastly wider in smaller stocks than larger ones -- and that's why I‘ve uncovered so many enticing opportunities.
Like the old song goes, "You say potato and I say po-tah-to, you say tomato and I say to-mah-to ..." Similarly, investors in the microsphere seldom agree on the inherent values of these fledgling companies and, more specifically, their potential earnings power several years out.
Of course, that's what makes for a market and that's why there are usually buyers and sellers at almost every price. As they say, one man's trash is another man's treasure. In microcap land, where there are thousands of penny stocks and solid fundamentals are at a premium, there is lots of trash to sift through. Fortunately, I've been around the block enough times to know which neighborhoods hold the real treasures.
Q: Investorideas.com
You have a focus on biotech, cleantech, and other emerging technologies. Can you tell us why those key areas?
A: Josh Levine, MicroCap Investor
Small firms are able to concentrate on high-value-added functions where cutting-edge knowledge and technology are paramount. As a result, the microcaps that execute deliver amazingly high-growth margins and profits -- and fantastic returns to their investors.
By participating in transformational changes in the highest-growth industries, any microcap that successfully navigates the path from R&D to commercialization and beyond will emerge a big winner. There are no better sectors to find these companies than in biotechnology and medical technologies, cleantech and renewable
The life sciences is a particularly rich group to explore for exciting microcap opportunities. One reason is that big pharma companies are expected to lose as much as $140 billion in annual sales by 2016, as some of their key product patents expire. These drug giants are desperate for new innovations to revitalize their pipelines and small biotechs are an excellent source.
A surprisingly large number of the best microcap prospects reside in the biopharma and biotech sectors. I have always sought out and discovered bio companies with certain valuable attributes. Indeed, compared to the vast majority of sub-$100-million-market-value firms, the biotechs in our portfolio have seasoned management, big-league experienced boards, sane capital structures, enough cash to operate for more than 12 months, and solid partnerships with big pharmas.
In the energy world, for example, the shift to electric transportation will have far-reaching impact on nearly every industry and sector, from energy producers and suppliers to electrical equipment manufacturers and utilities to developers of the smart grid and numerous other advanced IT and energy technologies. Many small companies are building pieces of the emerging infrastructure and smart grids.
It's notable that one of the big boys in global electric infrastructure equipment, ABB, Inc. recently made a $10 million investment in a tiny company that supplies EV charging systems. Mergers and acquisitions will be happening more frequently among companies developing technologies for the smart grid. What's more, the anticipated IPOs this year for cleantech rising stars like Silver Spring Networks and BrightSource Energy will attract new investors.
Electric networks are the largest, most complex systems around, and it will take massive investments in technology over the next couple of decades to get them into shape to meet soaring demand for ever more efficient and ubiquitous electric power. As a consequence, a multitude of opportunities exist for small, innovative firms to capture lucrative market niches.
Q: Investorideas.com
You have just added a new stock to your watch list I understand. Can you tell us the criteria you have in place when you add a new stock and what you typically look for?
A: Josh Levine, MicroCap Investor
First, I want to point out there are variations in my decision-making process between, for instance, a nanocap listed on the OTC Bulletin Board and an established microcap with a $250 million market cap that's profitable with an institutional following.
For the smallest microcaps, it's essential to spend time with management and look at everything with a magnifying glass. For more seasoned companies, there is already a track record as well as more information available, which makes the due diligence process less of a maze.
Obviously, fundamental stock analysis is central, but I've learned that investing in small advanced-tech firms is as much art as science. It comes down to certain basics that apply across the board, and they are:
- People - starting with the founders and top management, nothing counts more than the quality, experience, track record, and credibility of those running the company.
- Technology - technologies need to perform well but they also must represent a transformational shift or add significant value by improving current products or systems.
- Markets - technologies must address a sizable market, or it's simply not worth the effort. Also, it's essential to monitor market trends and being clued in to what industry leaders are doing. As senior analyst for ChangeWave Research, I am able to track the pace of change across many industries.
- Intangibles - this covers everything under the intellectual property umbrella, from patents to trade secrets, including everything inside the heads of employees. There's nothing tougher to quantify, but it's vital to get as much understanding as you can about these assets.
- Capital Structure - this reveals a whole lot about a company's history and the ability of executives to manage growth and build for the future. Problems in the capital structure often cripple microcaps, so investors need to be very critical in their analysis.
I remember hearing old time investors talking about making their big wins in the market by finding the next big thing and holding on for years. In the past few years that mentality has been dismantled by what transpired in 2008. Do you still see that kind of opportunity in the market - and what kind of wins are you seeing in your portfolio?
A: Josh Levine, MicroCap Investor
Yes, the opportunities for returns of 200%, 500%, 1,000% and higher continue to be out there. But to earn the truly life-altering profits, you need to be fully invested in the best microcap stocks prior to any major bull cycle. A big portion of gains are often made in the early phase of a bull market for microcaps, so you've got to be positioned early. Otherwise, by the time the trend takes shape, it's usually too late to build the kind of low-cost positions that ultimately deliver those ten-bagger profits.
Today I believe we're in the early stages of a microcap bull market, but it's difficult to predict the exact timing. Still, ever since the end of 2008 - even before the general market bottomed - the stocks in the MicroCap Investor portfolio have been trending higher.
We ended 2010 on a high note by capturing a 138% profit by selling one-half of our position in a company that's leading the charge, so to speak, in energy solutions for transportation.
Another microcap in our portfolio, a developer of a new class of cancer therapeutics, is up 240% since I first recommended it to subscribers. When I added this stock to our portfolio it was within pennies of its six-year low. The value of this biotech, which has a long-standing partnership with a leading biopharma and a healthy cash hoard, lies in the ability of its drugs to be used in combination therapies and its excellent prospects for attracting licensees. While its gains so far have been good, this stock could soar five to ten times its current price depending on the success of clinical trials for its various drugs.
In general, our biotech positions are looking very, very good. In less than six months, we're up 43% with a stem cell developer which already has two revenue-generating businesses. And a number of others have been regularly hitting new milestones, which eventually will be translated into much higher market valuations.
While all of the stocks in our portfolio are positioned for tremendous upside ahead, the most consistent performers have been what I call the “Mature Microcaps.” For instance, within this group we've got a gain of 109% with a supplier of advanced equipment for large-scale solar projects, and we're up 76% with a designer of 3G/4G wireless chips.
Finally, one of my favorite microcaps today is a company which has developed and is selling advanced mobile services to multi-billion dollar markets worldwide in dire need of its cost-effective and efficient solutions. We've already got a 120% gain, but I believe this one has all the characteristics of rapidly becoming one of the great microcap winners of the decade.
The recent activity in our micros, nice as it's been, hardly measures up to the bonanzas of past microcap bull runs. A big reason is that this bull market lacks the full participation of the public which has remained enormously risk-adverse after the blow-ups, busts and downturns of the past decade.
Depending on the breadth and length of this upturn, individual investors will increasingly come back into the game, and eventually in large numbers. By then, however, the biggest profits will have been registered by those investors positioned far ahead of the herd.
Josh Levine's MicroCap Investorhttp://www.levinesmicrocapinvestor.com
Levine's MicroCap Investor delves deep into the world of small stocks to identify big winners, targeting innovative companies on the path of the new and revolutionary.
About Josh Levine
Levine has 25 years of senior-level experience in analyzing technology trends and investing in top-performing micro- and small-cap stocks. He excels at assessing management teams and evaluating new innovations and their impact on corporate valuations.
More on Levine's bio: http://www.levinesmicrocapinvestor.com/aboutus/
To learn more about this and the other outstanding investment opportunities in the MicroCap Investor portfolio, subscribe now.
http://www.levinesmicrocapinvestor.com/subscriptions/order/
InvestorIdeas.com is partnered with Josh Levine and MicroCap Investor as part of its mission to provide investors with research tools to explore the world of small stocks. The InvestorIdeas.com team operates this web site and manages the administration and marketing for MicroCap Investor.
InvestorIdeas.com is a leading investment and industry research portal, with resources covering high-growth sectors including technology, biotech and cleantech.
Levine's Microcap Investor
Disclaimer and disclosure for Levine's Microcap :
http://www.levinesmicrocapinvestor.com/disclosure/
Disclaimer and disclosure for Investorideas.com
Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. http://www.investorideas.com/About/Disclaimer.asp
Contact us
admin@levinesmicrocapinvestor.com
800 665 0411
Thursday, February 3, 2011
Biotech/Pharma Profile Update for BioSante Pharmaceuticals, Inc.
Key Highlight: BioSante Pharmaceuticals is Only Company in World In Phase III Clinical Development for Treatment of Female Sexual Dysfunction
Point Roberts, WA, LINCOLNSHIRE, Ill - February 3, 2011 Investorideas.com, a leader in sector research, updates the company profile for BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for investors following biotech and pharma stocks.
Recent News:
"BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Provide Update on LibiGel Safety Study at International Society for the Study of Women's Sexual Health Meeting"
LINCOLNSHIRE, Ill. - February 3, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that it will provide a LibiGel safety study update, and is supporting two clinical symposia at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) being held from February 10-13, 2011 at the Doubletree Paradise Valley resort in Scottsdale, Arizona. More than 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting.
Read the full news release, click here .
Company Overview:
BioSante (NASDAQ: BPAX) 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. www.biosantepharma.com
The BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Read the full BPAX Investor Presentation at: http://www.investorideas.com/CO/BPAX/news/2011/BPAX-Presentation-012111.pdf
Financial Highlights
Full LibiGel Brochure at: http://www.investorideas.com/CO/BPAX/news/2011/LibiGel-Brochure-Jan2011.pdf
LibiGel®* Treatment of Women with
Hypoactive Sexual Desire Disorder (HSDD)
LibiGel® is a gel formulation of testosterone in development that is quickly absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
Regulatory Status
The LibiGel clinical development program, in consultation and agreement with the FDA, has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. BioSante is conducting three Phase III LibiGel clinical studies and BioSante's objective is to submit a new drug application (NDA) to the FDA in 2011 for a potential approval in 2012.
Progress and Plans in Phase III:
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials that are underway are randomized, double blind, placebo-controlled trials which will enroll approximately 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of between 2,750 and
4,000 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, after an average of 12 months' exposure BioSante intends to submit a LibiGel NDA for review and potential approval by FDA.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in the first 2,750 women enrolled comprising approximately 2,700 women-years of exposure, there have been only 14 adjudicated cardiovascular events even though the safety study is enrolling women with a higher risk of cardiovascular events. To date, over 2,750 women have been enrolled.
BioSante's obective is to submit the LibiGel NDA in 2011 for a potential FDA approval in 2012.
Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
To the extent any statements made in this news release deal with information that is not hist orical, 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 and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Disclaimer: This news release is part of a monthly information distribution program for BioSante (BPAX) (one thousand dollars per month). Investorideas.com is a third party publisher of news and research .All information on featured companies is prepared by the company or taken from public filings and news releases. 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.
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/pharma, mining and gold stocks, in addition to global markets including China, India, the Middle East and Australia. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Visit our Biotech investor portal : www.biotechindustrystocks.com
Research more biotech stocks at the Biotech stocks Directory
Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante Pharmaceuticals Inc.
Contact Investorideas.com to become a biotech showcase stock or research biotech stocks
800 665 0411: cvanzant@investorideas.com
Point Roberts, WA, LINCOLNSHIRE, Ill - February 3, 2011 Investorideas.com, a leader in sector research, updates the company profile for BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for investors following biotech and pharma stocks.
Recent News:
"BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) To Provide Update on LibiGel Safety Study at International Society for the Study of Women's Sexual Health Meeting"
LINCOLNSHIRE, Ill. - February 3, 2011 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced that it will provide a LibiGel safety study update, and is supporting two clinical symposia at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) being held from February 10-13, 2011 at the Doubletree Paradise Valley resort in Scottsdale, Arizona. More than 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting.
Read the full news release, click here .
Company Overview:
BioSante (NASDAQ: BPAX) 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. www.biosantepharma.com
The BPAX company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Read the full BPAX Investor Presentation at: http://www.investorideas.com/CO/BPAX/news/2011/BPAX-Presentation-012111.pdf
Financial Highlights
- At December 31, 2010, BioSante had approximately $39M in cash
- Monthly burn rate of approximately $3.5M - $4.0M
- NASDAQ: BPAX
- Recent Price (2/2/11): $1.93
- Market Cap: $150M
- Average Daily Volume: 1.1M
- Common Shares Outstanding: 81.4M
- 52-Week Range: $1.29-$2.50
- Fiscal Year Ends: December 31
- Financial resources to continue corporate strategy
- Late stage pharmaceutical product portfolio with significant growth potential
- LibiGel in three ongoing Phase III safety and efficacy clinical studies
- Elestrin is FDA approved and marketed in the U.S.
- Proprietary cancer vaccines in Phase II clinical trials
- Focused growth strategy
- Management's proven ability to gain FDA approval, implement plans and increase stockholder value
Full LibiGel Brochure at: http://www.investorideas.com/CO/BPAX/news/2011/LibiGel-Brochure-Jan2011.pdf
LibiGel®* Treatment of Women with
Hypoactive Sexual Desire Disorder (HSDD)
LibiGel® is a gel formulation of testosterone in development that is quickly absorbed through the skin after a once-daily application of a pea-sized dose of gel on the upper arm, delivering testosterone to the bloodstream evenly over time and in a non-invasive and painless manner. Though generally characterized as a male hormone, testosterone also is present in women and its deficiency has been found to decrease libido or sex drive. In addition, studies have shown that testosterone therapy can increase bone density, raise energy levels and improve mood, in addition to boosting sexual desire and activity.
Regulatory Status
The LibiGel clinical development program, in consultation and agreement with the FDA, has been designed to show that LibiGel can safely improve women's sexual desire and the frequency of satisfying sexual events and decrease personal distress associated with low sexual desire in women with HSDD. BioSante is conducting three Phase III LibiGel clinical studies and BioSante's objective is to submit a new drug application (NDA) to the FDA in 2011 for a potential approval in 2012.
Progress and Plans in Phase III:
Currently, BioSante is conducting three Phase III clinical studies to demonstrate the safety and efficacy of LibiGel to increase sexual desire and satisfying sexual events and to decrease distress associated with the decreased desire. Two Phase III safety and efficacy trials that are underway are randomized, double blind, placebo-controlled trials which will enroll approximately 500 surgically menopausal women each for six-months of treatment. BioSante is conducting these trials under an FDA agreed special protocol assessment (SPA). In addition, BioSante has another SPA agreement with the FDA related to treatment of naturally menopausal women. The SPA process and agreement confirms the FDA's position that FSD and HSDD are true conditions that women experience, with measurable endpoints, that can be evaluated and which deserve therapeutic options. It also affirms that the FDA agrees that the LibiGel Phase III safety and efficacy clinical trial design, clinical endpoints, sample size, planned conduct and statistical analyses are acceptable to support regulatory approval. Further, it provides assurance that these agreed measures will serve as the basis for regulatory review and the decision by the FDA to approve an NDA for LibiGel.
In addition to the two Phase III safety and efficacy trials covered by the SPA, BioSante is conducting one Phase III cardiovascular and breast cancer safety study of LibiGel, which also is underway. The safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular events and breast cancer study of between 2,750 and
4,000 women exposed to LibiGel or placebo. BioSante will follow the women enrolled in the safety study for a total of 5 years. However, after an average of 12 months' exposure BioSante intends to submit a LibiGel NDA for review and potential approval by FDA.
The LibiGel safety study is tracking a composite of cardiovascular events including cardiovascular death, myocardial infarction and stroke in women with FSD who are 50 years of age or older and have at least two cardiovascular risk factors such as hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of cardiovascular events. The incidence of breast cancer also will be tracked throughout the study.
BioSante has reported that in the first 2,750 women enrolled comprising approximately 2,700 women-years of exposure, there have been only 14 adjudicated cardiovascular events even though the safety study is enrolling women with a higher risk of cardiovascular events. To date, over 2,750 women have been enrolled.
BioSante's obective is to submit the LibiGel NDA in 2011 for a potential FDA approval in 2012.
Contact BioSante Pharmaceuticals
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
To the extent any statements made in this news release deal with information that is not hist orical, 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 and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Disclaimer: This news release is part of a monthly information distribution program for BioSante (BPAX) (one thousand dollars per month). Investorideas.com is a third party publisher of news and research .All information on featured companies is prepared by the company or taken from public filings and news releases. Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
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Wednesday, February 2, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. To Provide Update on LibiGel Safety Study at International Society for the Study of Women's Sexual Health Meeting
LINCOLNSHIRE, Ill. - February 2, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it will provide a LibiGel safety study update, and is supporting two clinical symposia at the Annual Meeting of The International Society for the Study of Women's Sexual Health Meeting (ISSWSH) being held from February 10-13, 2011 at the Doubletree Paradise Valley resort in Scottsdale, Arizona. More than 300 experts and practitioners in women's health and female sexual dysfunction (FSD) are expected to attend the meeting.
Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, will deliver an oral presentation entitled, "LibiGel� (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events," on February 12, 2011 at 3 pm local time. Dr. Snabes will provide an update on the largest-ever safety study comparing low-dose testosterone treatment to placebo treatment, including the LibiGel safety study's low cardiovascular event rate. To date, this ongoing study has enrolled more than 2,800 menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).
The supported symposia are entitled, "Efficacy of Testosterone in Treating Women with HSDD" and "FSD and the FDA: Past, Present & Future." The first symposium, "Efficacy of Testosterone in Treating Women with HSDD," will feature Susan R. Davis, MBBS, FRACP, PhD, Professor of Women's Health and NHMRC Principal Research Fellow and Director, the Women's Health Research Program, Department of Medicine, Monash University, Vic, Australia, and Glenn Braunstein, MD, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
The second symposium, "FSD and the FDA: Past, Present & Future," will be moderated by Alan Altman, MD, president of ISSWSH. The speakers include Anita H. Clayton, MD, professor of psychiatry and neurobehavioral sciences, and professor of clinical obstetrics and gynecology at the University of Virginia Health Systems; Michael Krychman, MD, medical director of The Sexual Medicine Center in Hoag Hospital in Newport Beach, California; Marianne Brandon, PhD, a clinical psychologist for Wellminds Wellbodies LLC and a diplomat in sex therapy; Julia Heiman, PhD, director of the Kinsey Institute for Research in Sex, Gender, and Reproduction and professor of psychology and clinical psychiatry at Indiana University, as well as Dr. Snabes of BioSante.
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 DrugAdministration (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, future market size, acceptance and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Media:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Investors:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Michael Snabes, MD, PhD, BioSante's senior vice president of medical affairs, will deliver an oral presentation entitled, "LibiGel� (testosterone gel) Safety Study Continues with a Low Rate of Cardiovascular and Breast Cancer Events," on February 12, 2011 at 3 pm local time. Dr. Snabes will provide an update on the largest-ever safety study comparing low-dose testosterone treatment to placebo treatment, including the LibiGel safety study's low cardiovascular event rate. To date, this ongoing study has enrolled more than 2,800 menopausal women who suffer from Hypoactive Sexual Desire Disorder (HSDD).
The supported symposia are entitled, "Efficacy of Testosterone in Treating Women with HSDD" and "FSD and the FDA: Past, Present & Future." The first symposium, "Efficacy of Testosterone in Treating Women with HSDD," will feature Susan R. Davis, MBBS, FRACP, PhD, Professor of Women's Health and NHMRC Principal Research Fellow and Director, the Women's Health Research Program, Department of Medicine, Monash University, Vic, Australia, and Glenn Braunstein, MD, Department of Medicine, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California.
The second symposium, "FSD and the FDA: Past, Present & Future," will be moderated by Alan Altman, MD, president of ISSWSH. The speakers include Anita H. Clayton, MD, professor of psychiatry and neurobehavioral sciences, and professor of clinical obstetrics and gynecology at the University of Virginia Health Systems; Michael Krychman, MD, medical director of The Sexual Medicine Center in Hoag Hospital in Newport Beach, California; Marianne Brandon, PhD, a clinical psychologist for Wellminds Wellbodies LLC and a diplomat in sex therapy; Julia Heiman, PhD, director of the Kinsey Institute for Research in Sex, Gender, and Reproduction and professor of psychology and clinical psychiatry at Indiana University, as well as Dr. Snabes of BioSante.
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
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, future market size, acceptance and potential of LibiGel and other statements identified by words such as "will," "potential," "could," "would," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Media:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Investors:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
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