Investorideas.com Newswire - Investor FAQs and Facts for BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX)
Investor FAQs and Facts for BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX)
POINT ROBERTS, August 24, 2001 - www.InvestorIdeas.com, a global investor research portal for independent investors features an investor FAQ and Fact Sheet for specialty pharmaceutical company, BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX).
BioSante’s (NASDAQ: BPAX) stock has built a significant retail investor following as well as over 40% institutional ownership and has had extensive media coverage as its key product, LibiGel®, gets closer to market as the first FDA-approved drug for female sexual dysfunction. The following FAQs and Facts can serve as an important stage of due diligence for investors and media following the company’s progress.
BioSante FAQs (Frequently asked Questions)
1) In the correct market environment cash is king. How long will your cash last?
A: BioSante is well funded and has the financial resources to continue our corporate strategy well into 2013, with a current burn rate averaging $4 Million per month which will decrease to approximately $3 million per month in 2012. As of August 2, 2011 we had about $79 million in cash.
2) What is the timeline for LibiGel clinical development?
A: LibiGel is in three pivotal Phase III clinical studies at this time. The first two trials are set to be completed in September 2011 with top-line efficacy data reported in the fourth quarter 2011. Top-line data from the third study, a safety study, will be reported in the third quarter 2012. A new drug application (NDA) is targeted to be submitted in 2012 and a potential FDA approval could come in mid-2013.
3) Other companies have tried to develop products for the treatment of female sexual dysfunction. Why is BioSante the only company active in Phase III clinical development for this indication today?
A: As stated before we believe the market for female sexual dysfunction is significant and we would welcome other companies to develop product for this market. Having said that, today LibiGel is the only product in Phase III clinical development in the world. Previous companies have failed in their development either because their efficacy data were not adequate or they did not prove the safety of their products to FDA’s satisfaction. We believe the LibiGel Phase III clinical program will show both the efficacy and the safety of LibiGel in the treatment of female sexual dysfunction, specifically hypoactive sexual desire disorder, a significant unmet medical need among women.
4) How big is the market for FSD?
A: The current market for testosterone and estrogen products is over $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction (FSD) potentially adding more than $2.0 billion. Unfortunately a full 13 years after Viagra was approved for men’s sexual health there still is no FDA-approved product for the treatment of women’s sexual health.
5) How will LibiGel be marketed?
A: According to IMS and primary research, in 2010, over four million “off label” testosterone prescriptions were written for women in the U.S. According to survey data, clinicians indicated that they would prefer to prescribe an FDA approved product that has been clinically tested and proven to be safe and effective for the treatment of HSDD, and they would switch over 90% of their patients using testosterone to LibiGel®. In addition, the physicians indicated the number of women using testosterone for HSDD would more than double given an FDA approved product. Our objective is to license LibiGel to a larger company to market it once approved.
6) Does BioSante have a pipeline beyond LibiGel?
A: Yes, BioSante has a long list of products in clinical development as well as pending FDA approval. Clearly, LibiGel represents our biggest and best near-term opportunity. In addition, our male testosterone product, Bio-T-Gel™ has an NDA pending and has been licensed to Teva for marketing in the U.S. In addition we have a portfolio of cancer vaccine currently in 15 Phase I and Phase II studies. Importantly, these studies are funded by others and therefore BioSante has no cost, but significant potential upside. Investors should visit our website, www.biosantepharma.com, to review our full product portfolio as well as review our public filings for the most information about our company.
BioSante Facts
What investors need to know about BioSante
Investment Highlights
• Financial resources to continue corporate strategy well into 2013
• 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.
• Bio-T-Gel™ has NDA pending
• 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
Financial Highlights
• At August 2, 2011, BioSante had approximately $79M in cash
• Monthly burn rate of approximately $4.0M
Key Products
LibiGel® — In development under an SPA for treatment of female sexual dysfunction. Three Phase III safety and efficacy clinical studies are ongoing.
ElestrinTM — FDA approved transdermal gel for treatment of hot flashes; currently
marketed in the U.S. by Azur Pharma.
Bio-T-GelTM — An NDA has been filed byTeva USA for the treatment of hypogonadism
in men.
The Pill-PlusTM — Triple component contraceptive in Phase II clinical development
combining oral contraceptive and androgen. Licensed to and being developed
by Pantarhei Bioscience for oral uses.
Cancer Vaccines — A portfolio of cancer vaccines in Phase II clinical trials for various
cancer types, conducted at Johns Hopkins Cancer Center.
Read the August 2011 Fact Sheet in Full
http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf
About BioSante Pharmaceuticals, Inc.
http://www.biosantepharma.com/
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante’s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220;
azachary@mckinneychicago.com
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Wednesday, August 24, 2011
Monday, August 15, 2011
Friday's Biotech/Pharma Stocks Trading; (OTCBB: AEMD), (BMY), (DNDN), (GSK)
Friday's Biotech/Pharma Stocks Trading; (OTCBB: AEMD), (BMY), (DNDN), (GSK)
Point Roberts, WA - August 15, 2011 - Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks reports on trading and recent news for companies providing novel approaches to cancer therapy . In a roller coaster market of trading last week, several of the biotech/pharma stocks closed on the upside on Friday.
Analyst Jeffrey Holford of A Jefferies & Co told clients on Friday, "We believe that the sector (pharmaceuticals stocks ) will soon likely act as a safe haven once investors reposition portfolios for slower growth and increased uncertainty over government and corporate balance sheets. "
Aethlon Medical (OTCBB: AEMD) traded in a range of $0.0750 - 0.0780 on Friday .
The Company released a new investor slide show/ media player entitled A Novel Therapeutic Strategy to Address Cancer. According to the presentation , “The Aethlon Hemopurifier® is the first therapeutic candidate to eliminate cancer exosomes from circulation ,providing a therapeutic filtration mechanism to remove cancer exosomes from the circulatory system, It allows selective exosome capture via unique high-mannose signatures resident on exosome surfaces
and provides access to the entire circulatory system. Exosomes can be accessed from entire circulatory system, which can pass through the Hemopurifier® in as little as 15 minutes
The Hemopurifier® therapy has the advantage of beingdelivered through the global infrastructure of dialysismachines that are already located in hospitals in clinics.
Bristol-Myers Squibb Company (NYSE: BMY) closed at $27.97, up 0.17 (0.61%) in Friday's trading . According to the company's Second Quarter report July 28 th , there are several key developments in its oncology divisions. In June, the Company entered into a clinical collaboration agreement with Roche to conduct a Phase I/II study to evaluate the safety and efficacy of the combination of YERVOY and vemurafenib in treating patients with metastatic melanoma.
In July, the Company announced a global agreement with Innate Pharma S.A., a biotech company in France, for the development and commercialization of IPH 2102, a novel immuno-oncology biologic in Phase I development.
Dendreon Corporation (NasdaqGS: DNDN) closed Friday at $10.44, up 0.07 (0.68%) on over 8 million shares. The Company reported Second Quarter results August 3 rd and noted, "Our accomplishments this year are foundational as we introduce an entirely new treatment paradigm for patients with advanced prostate cancer," continued Dr. Gold. "These position us well to realize the significant market potential of PROVENGE, and we have identified a solid and clear path to ensuring that the many men who can benefit from it have access to our life-extending drug."
GlaxoSmithKline (NYSE: GSK) ended trading on Friday at $41.30, up 0.49 (1.20%).
Biotech/Pharma Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
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OTCBB:AEMD slide show / media - A Novel Therapeutic Strategy to Address Cancer
http://www.slideshare.net/Aethlon/a-novel-therapeutic-strategy-to-address-cancer
A Novel Therapeutic Strategy to Address Cancer - Presentation Transcript
1.A Novel Therapeutic Strategy to Address Cancer September 2011
2.Cancer is the leading cause of deathworldwide and accounted for 7.6 million deaths in 2008 alone
3.There were 12.7 million new cases of Cancer in 2008
4.Cancer deaths in the United States are expected to exceed 570,000 in 2011
5.In 2011, new cases of Cancer are expected to exceed 1,500,000 in the U.S.
6.Innovative strategies are needed to address Cancer progression mechanisms that are beyond the reach of current drug therapies
7.A therapeutic strategy that could inhibit the proliferation of immunosuppressive exosomes released by solid tumors, lymphomas and leukemias would fill a significant unmet medical need in cancer care
8.What are Exosomes?• Cancer cells, both in vivo and in vitro, have been demonstrated to release membranous structures, defined as exosomes
9.Researchers have recently unveiled several roles that exosomes play in accelerating cancer progression
10.The resulting research publications are reporting that................
11.Exosomes cause apoptosis or programmed cell death of immune cells
12.Exosomes disrupt signaling of anti-cancer T cells
13.Exosomes contribute to tumor angiogenesis
14.Exosomes enhance the spread of tumor metastasis
15.The quantity of exosomes in circulation is indirect correlation with cancer progression
16.What if exosomes could be eliminated from circulation?
17.The Aethlon Hemopurifier® The first therapeutic candidate to eliminate cancer exosomes from circulation
18.The Aethlon Hemopurifier®• Provides a therapeutic filtration mechanism to remove cancer exosomes from the circulatory system• Allows selective exosome capture via unique high-mannose signatures resident on exosome surfaces
19.Providing access to the entire circulatory system• Exosomes can be accessed from entire circulatory system, which can pass through the Hemopurifier® in as little as 15 minutes
20.Hemopurifier® therapy has the advantage of beingdelivered through the global infrastructure of dialysismachines that are already located in hospitals in clinics
21.Our goal is to improve patient responsiveness to traditional chemotherapies and emerging classes of immune based therapies
22.To improve patient responsiveness without additional drug toxicity or interaction risks
23.In vitro binding of exosomes underlying the following cancers has been demonstrated• Breast• Ovarian• Colorectal• Lymphoma• Melanoma
24.Human Hemopurifier® treatment experience already exists
25.The Hemopurifier® has previously demonstrated the ability to reduce viral load in HIV and hepatitis C (HCV) infected individuals without the administration of antiviral drugs
26.A clinical study to evaluate the ability of the Hemopurifier® to improve HCV drug therapy benefit is currently being conducted
27.The clinical application of the Hemopurifier® in Cancer?
28.We are currently collaborating with candidate investigators to develop a clinical protocol to demonstrate the ability of our Hemopurifier® to eliminate circulating cancer exosomes
29.We invite you to follow our efforts to improve cancer care AethlonMedical.com
30.Our mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions Thank You
31.ContactJim Joyce
Chairman, CEO8910 University Center Lane
San Diego , California92122jj@aethlonmedical.com
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and Aethlon Medical intends that such forward-looking statements be subject to the safe harbor created thereby. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including the company's ability to successfully obtain FDA and other regulatory approvals for the sale of its products, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, and the company's ability to raise capital when needed. Some information in this presentation, or on which this presentation is based, has been obtained from sources that Aethlon Medical, Inc., believes to be reliable and accurate. However, it has not been independently verified and no representation or warranty, express or implied, is made as to the accuracy or completeness of any information obtained from third parties. Such risks and uncertainties, including those discussed above, are more fully described in the Securities and Exchange Commission (SEC) reports filed by Aethlon Medical, Inc., including its most recent annual report on Form 10-K. This presentation speaks only as of its date, and the company disclaims any duty to update the information herein. Further information is avail able by contacting the company or at the company's website at www.aethlonmedical.com.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
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OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
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Source - Investorideas.com
Point Roberts, WA - August 15, 2011 - Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks reports on trading and recent news for companies providing novel approaches to cancer therapy . In a roller coaster market of trading last week, several of the biotech/pharma stocks closed on the upside on Friday.
Analyst Jeffrey Holford of A Jefferies & Co told clients on Friday, "We believe that the sector (pharmaceuticals stocks ) will soon likely act as a safe haven once investors reposition portfolios for slower growth and increased uncertainty over government and corporate balance sheets. "
Aethlon Medical (OTCBB: AEMD) traded in a range of $0.0750 - 0.0780 on Friday .
The Company released a new investor slide show/ media player entitled A Novel Therapeutic Strategy to Address Cancer. According to the presentation , “The Aethlon Hemopurifier® is the first therapeutic candidate to eliminate cancer exosomes from circulation ,providing a therapeutic filtration mechanism to remove cancer exosomes from the circulatory system, It allows selective exosome capture via unique high-mannose signatures resident on exosome surfaces
and provides access to the entire circulatory system. Exosomes can be accessed from entire circulatory system, which can pass through the Hemopurifier® in as little as 15 minutes
The Hemopurifier® therapy has the advantage of beingdelivered through the global infrastructure of dialysismachines that are already located in hospitals in clinics.
Bristol-Myers Squibb Company (NYSE: BMY) closed at $27.97, up 0.17 (0.61%) in Friday's trading . According to the company's Second Quarter report July 28 th , there are several key developments in its oncology divisions. In June, the Company entered into a clinical collaboration agreement with Roche to conduct a Phase I/II study to evaluate the safety and efficacy of the combination of YERVOY and vemurafenib in treating patients with metastatic melanoma.
In July, the Company announced a global agreement with Innate Pharma S.A., a biotech company in France, for the development and commercialization of IPH 2102, a novel immuno-oncology biologic in Phase I development.
Dendreon Corporation (NasdaqGS: DNDN) closed Friday at $10.44, up 0.07 (0.68%) on over 8 million shares. The Company reported Second Quarter results August 3 rd and noted, "Our accomplishments this year are foundational as we introduce an entirely new treatment paradigm for patients with advanced prostate cancer," continued Dr. Gold. "These position us well to realize the significant market potential of PROVENGE, and we have identified a solid and clear path to ensuring that the many men who can benefit from it have access to our life-extending drug."
GlaxoSmithKline (NYSE: GSK) ended trading on Friday at $41.30, up 0.49 (1.20%).
Biotech/Pharma Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/AEMD
Get added to the company's news alerts:
http://www.investorideas.com/Resources/Newsletter.asp
OTCBB:AEMD slide show / media - A Novel Therapeutic Strategy to Address Cancer
http://www.slideshare.net/Aethlon/a-novel-therapeutic-strategy-to-address-cancer
A Novel Therapeutic Strategy to Address Cancer - Presentation Transcript
1.A Novel Therapeutic Strategy to Address Cancer September 2011
2.Cancer is the leading cause of deathworldwide and accounted for 7.6 million deaths in 2008 alone
3.There were 12.7 million new cases of Cancer in 2008
4.Cancer deaths in the United States are expected to exceed 570,000 in 2011
5.In 2011, new cases of Cancer are expected to exceed 1,500,000 in the U.S.
6.Innovative strategies are needed to address Cancer progression mechanisms that are beyond the reach of current drug therapies
7.A therapeutic strategy that could inhibit the proliferation of immunosuppressive exosomes released by solid tumors, lymphomas and leukemias would fill a significant unmet medical need in cancer care
8.What are Exosomes?• Cancer cells, both in vivo and in vitro, have been demonstrated to release membranous structures, defined as exosomes
9.Researchers have recently unveiled several roles that exosomes play in accelerating cancer progression
10.The resulting research publications are reporting that................
11.Exosomes cause apoptosis or programmed cell death of immune cells
12.Exosomes disrupt signaling of anti-cancer T cells
13.Exosomes contribute to tumor angiogenesis
14.Exosomes enhance the spread of tumor metastasis
15.The quantity of exosomes in circulation is indirect correlation with cancer progression
16.What if exosomes could be eliminated from circulation?
17.The Aethlon Hemopurifier® The first therapeutic candidate to eliminate cancer exosomes from circulation
18.The Aethlon Hemopurifier®• Provides a therapeutic filtration mechanism to remove cancer exosomes from the circulatory system• Allows selective exosome capture via unique high-mannose signatures resident on exosome surfaces
19.Providing access to the entire circulatory system• Exosomes can be accessed from entire circulatory system, which can pass through the Hemopurifier® in as little as 15 minutes
20.Hemopurifier® therapy has the advantage of beingdelivered through the global infrastructure of dialysismachines that are already located in hospitals in clinics
21.Our goal is to improve patient responsiveness to traditional chemotherapies and emerging classes of immune based therapies
22.To improve patient responsiveness without additional drug toxicity or interaction risks
23.In vitro binding of exosomes underlying the following cancers has been demonstrated• Breast• Ovarian• Colorectal• Lymphoma• Melanoma
24.Human Hemopurifier® treatment experience already exists
25.The Hemopurifier® has previously demonstrated the ability to reduce viral load in HIV and hepatitis C (HCV) infected individuals without the administration of antiviral drugs
26.A clinical study to evaluate the ability of the Hemopurifier® to improve HCV drug therapy benefit is currently being conducted
27.The clinical application of the Hemopurifier® in Cancer?
28.We are currently collaborating with candidate investigators to develop a clinical protocol to demonstrate the ability of our Hemopurifier® to eliminate circulating cancer exosomes
29.We invite you to follow our efforts to improve cancer care AethlonMedical.com
30.Our mission is to create innovative devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions Thank You
31.ContactJim Joyce
Chairman, CEO8910 University Center Lane
San Diego , California92122jj@aethlonmedical.com
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and Aethlon Medical intends that such forward-looking statements be subject to the safe harbor created thereby. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including the company's ability to successfully obtain FDA and other regulatory approvals for the sale of its products, the capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, and the company's ability to raise capital when needed. Some information in this presentation, or on which this presentation is based, has been obtained from sources that Aethlon Medical, Inc., believes to be reliable and accurate. However, it has not been independently verified and no representation or warranty, express or implied, is made as to the accuracy or completeness of any information obtained from third parties. Such risks and uncertainties, including those discussed above, are more fully described in the Securities and Exchange Commission (SEC) reports filed by Aethlon Medical, Inc., including its most recent annual report on Form 10-K. This presentation speaks only as of its date, and the company disclaims any duty to update the information herein. Further information is avail able by contacting the company or at the company's website at www.aethlonmedical.com.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sector. Sectors we cover include; cleantech and renewable energy stocks, biotech stocks, mining and gold stocks, energy stocks, water, tech, defense stocks, nanotech, agriculture and gaming.
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, 200,000 144 shares )
OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Wednesday, August 10, 2011
Biotech/Pharma Stocks Trading News: AEMD, ANX, OXGN, CHTP, EXEL
Navigating the Biotech Sector in a Volatile Market
Point Roberts, WA- Aug 10, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for biotech and pharma stocks trading August 9th. Yesterday’s trading session saw gains for investors in a very volatile global market. As investors navigate this market, there are still profits to be made in all sectors.
Aethlon Medical (OTCBB: AEMD), a pioneer in developing therapeutic filtration devices, traded relatively flat yesterday and is seeing gains in morning trading today, August 10th. The stock is trading at $0.0839, up 0.0049 (6.20%) .
The company recently introduced the Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies. The Aethlon ADAPT™ system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT™ system being the impetus for industry collaborations that offer new channels of early revenue generation.
In yesterday’s session, OXiGENE, Inc. (NASDAQ:OXGN) gained 0.44 (39.64%) to $1.55 as the stock has slumped about 60% in the past one week. The stock made its new 52-week low of $1.08 on Monday. The stock is down 68% so far this year.
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) shares also climbed 0.45 (21.53%) to $2.54 after it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Exelbine™ (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.
Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) climbed 0.72 (20.22%) to $4.28 after it has successfully reached its target enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.
Exelixis, Inc. (NASDAQ:EXEL) added 1.07 (17.95%) to $7.03. Last week, the company reported a loss of 16 cents a share on revenue of $32.2 million, better than analysts’ estimates of a loss of 17 cents a share on revenue of $37.47 million.
The company sees FY2011 revenue of $220-$250 million, versus prior guidance of $145-$160 million and the consensus of $166.3 million.
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
Visit the AEMD showcase page on Investorideas.com
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At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Point Roberts, WA- Aug 10, 2011- Investorideas.com , an investor research portal specializing in sector research including biotech and pharma stocks, issues a trading alert for biotech and pharma stocks trading August 9th. Yesterday’s trading session saw gains for investors in a very volatile global market. As investors navigate this market, there are still profits to be made in all sectors.
Aethlon Medical (OTCBB: AEMD), a pioneer in developing therapeutic filtration devices, traded relatively flat yesterday and is seeing gains in morning trading today, August 10th. The stock is trading at $0.0839, up 0.0049 (6.20%) .
The company recently introduced the Aethlon ADAPT™ (Adaptive Dialysis-Like Affinity Platform Technology) system, as an innovative medical device platform that provides a basis to create new therapeutic devices through the convergence of affinity drug agents and plasma membrane technologies. The Aethlon ADAPT™ system provides a previously unrecognized commercialization pathway to antibody and other affinity drug developers, who should also appreciate a less onerous medical device regulatory pathway. We are already seeing evidence of our ADAPT™ system being the impetus for industry collaborations that offer new channels of early revenue generation.
In yesterday’s session, OXiGENE, Inc. (NASDAQ:OXGN) gained 0.44 (39.64%) to $1.55 as the stock has slumped about 60% in the past one week. The stock made its new 52-week low of $1.08 on Monday. The stock is down 68% so far this year.
ADVENTRX Pharmaceuticals, Inc. (AMEX:ANX) shares also climbed 0.45 (21.53%) to $2.54 after it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company's New Drug Application (NDA) for Exelbine™ (vinorelbine injectable emulsion) for the treatment of non-small cell lung cancer.
Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) climbed 0.72 (20.22%) to $4.28 after it has successfully reached its target enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.
Exelixis, Inc. (NASDAQ:EXEL) added 1.07 (17.95%) to $7.03. Last week, the company reported a loss of 16 cents a share on revenue of $32.2 million, better than analysts’ estimates of a loss of 17 cents a share on revenue of $37.47 million.
The company sees FY2011 revenue of $220-$250 million, versus prior guidance of $145-$160 million and the consensus of $166.3 million.
Biotech Medical Company Snapshot for Aethlon Medical (OTCBB: AEMD)
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At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
1.Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
2.Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
3.Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
4.Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
The Hemopurifier® is an expansive multi-patented platform technology whose mechanism of action can be leveraged to provide therapeutic, diagnostic, and biomarker discovery solutions. As a therapeutic, the Hemopurifier® is a single-use disposable cartridge designed for implementation within the established infrastructure of dialysis machines and other blood circulatory pumps already located in hospitals and clinics worldwide.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 minutes.
Our wholly owned subsidiary, Exosome Sciences, Inc. (ESI) is focused on the development of exosome-targeted products and services that improve cancer diagnosis, provide post-treatment cancer surveillance, and aid in the discovery of biomarkers that allow doctors to optimize patient therapy. Additional information regarding Aethlon Medical and Exosome Sciences can be accessed online at www.aethlonmedical.com.
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the company's ability to commercialize its Hemopurifier® in India, capability of the Hemopurifier® to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer or Hepatitis-C, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company's ability to raise capital when needed, the Company's ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the Company's ability to manufacture its products either internally or through outside companies and provide its services, the impact of government regulations, patent protection on the Company's proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company's Securities and Exchange Commission filings.
Contacts:
James A. Joyce
Chairman, CEO
858.459.7800 x301
jj@aethlonmedical.com
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, including biotech stocks
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. AETHLON MEDICAL INC(OTC BB: AEMD ) Showcase biotech, biodefense and defense stock on Investorideas.com ( $one thousand five hundred per month, $five thousand per month in 144 stock)Effective March 15, 2011
BC Residents and Investor Disclaimer : Effective September 15 2008 - all BC investors should review all OTC and Pink sheet listed companies for adherence in new disclosure filings and filing appropriate documents with Sedar. Read for more info: http://www.bcsc.bc.ca/release.aspx?id=6894
800-665-0411 - cvanzant@investorideas.com
Source - Investorideas.com
Tuesday, August 9, 2011
Biotech and Pharma Investor Alert; BioSante (NASDAQ: BPAX) Rebounds, Trading up over 14%
Point Roberts, WA, LINCOLNSHIRE, Ill –August 9, 2011,– Investorideas.com, a leader in sector stock research for independent investors , issues a trading alert for specialty biotech/pharma stock, BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) for August 9th. The stock has bounced back as high as $2.37 in today’s trading. BioSante (NASDAQ: BPAX) fell yesterday with the general market fear, following the US downgrade.
News Excerpt: Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX), Discusses the Future of LibiGel® Following Closing of $48 Million Offering
“ BioSante plans to use the net proceeds from the offering for general corporate purposes, including funding the ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, following the closing of the $48 Million offering, you report use of proceeds will include ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD). How far will this take you into the study and what does this mean for investor confidence in taking this product to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The proceeds of the $48 million underwritten financing together with the cash we had before the transaction results in almost $80 million in cash. This cash balance is sufficient to fund the LibiGel program and BioSante through our anticipated LibiGel new drug application (NDA) submission by the end of 2012, and in fact all the way through a potential FDA approval which could come in mid-2013. This long runway was one of the key reasons for executing the transaction at this time. Another reason for executing the transaction at this time was so that in the fourth quarter of this year when we announce LibiGel efficacy data investors can concentrate on the quality of the data versus being concerned that we would need to raise money.”
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
News Excerpt: Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX), Discusses the Future of LibiGel® Following Closing of $48 Million Offering
“ BioSante plans to use the net proceeds from the offering for general corporate purposes, including funding the ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, following the closing of the $48 Million offering, you report use of proceeds will include ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD). How far will this take you into the study and what does this mean for investor confidence in taking this product to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The proceeds of the $48 million underwritten financing together with the cash we had before the transaction results in almost $80 million in cash. This cash balance is sufficient to fund the LibiGel program and BioSante through our anticipated LibiGel new drug application (NDA) submission by the end of 2012, and in fact all the way through a potential FDA approval which could come in mid-2013. This long runway was one of the key reasons for executing the transaction at this time. Another reason for executing the transaction at this time was so that in the fourth quarter of this year when we announce LibiGel efficacy data investors can concentrate on the quality of the data versus being concerned that we would need to raise money.”
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante’s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “continue,” “could,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante’s actual results to be materially different than those expressed in or implied by BioSante’s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante’s licensees or sublicensees; the success of clinical testing; and BioSante’s need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante’s actual results are described in BioSante’s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For info about BioSante Pharmaceuticals, Inc
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
(312) 506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks. Investorideas.com is known for its comprehensive stock directories in each sector and sector specific newswires.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
Contact Investorideas.com
800 665 0411 cvanzant@investorideas.com
Monday, August 8, 2011
Mr. Stephen M. Simes, President and CEO of BioSante Pharmaceuticals (NASDAQ: BPAX), Discusses the Future of LibiGel® Following Closing of $48 Million Offering
Point Roberts, WA, LINCOLNSHIRE, Ill - August 8, 2011 - (Investorideas.com newswire.com) Investorideas.com, an investor research portal covering leading sectors including biotech and pharma stocks, features an exclusive Q&A interview with Mr. Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals (NASDAQ:BPAX), following the announcement of the closing of a $48.0 Million public offering.
BioSante plans to use the net proceeds from the offering for general corporate purposes, including funding the ongoing Phase III clinical study program for LibiGel� for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, following the closing of the $48 Million offering, you report use of proceeds will include ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD). How far will this take you into the study and what does this mean for investor confidence in taking this product to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The proceeds of the $48 million underwritten financing together with the cash we had before the transaction results in almost $80 million in cash. This cash balance is sufficient to fund the LibiGel program and BioSante through our anticipated LibiGel new drug application (NDA) submission by the end of 2012, and in fact all the way through a potential FDA approval which could come in mid-2013. This long runway was one of the key reasons for executing the transaction at this time. Another reason for executing the transaction at this time was so that in the fourth quarter of this year when we announce LibiGel efficacy data investors can concentrate on the quality of the data versus being concerned that we would need to raise money.
Q: Investorideas.com
Mr. Simes can you tell investors what it means to BioSante to have some of the top names in Healthcare Banking, such as Jefferies backing the financing for your company to pave your way for the treatment of female sexual dysfunction?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We are happy to have had Jefferies as the lead banker on this important and well executed BioSante financing. This is our first underwritten transaction, our first financing without issuing warrants and the largest single financing we have ever executed. The institutional investors in this transaction include new and existing stockholders of BioSante, most of which concentrate in biotech/pharma investing. All of these factors are important indicators of investor confidence in BioSante.
Q: Investorideas.com
Mr. Simes besides funding the ongoing Phase III clinical study program for LibiGel how else will BioSante use their funding proceeds?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The vast majority of BioSante spending over the last few years has been and will continue to be funding the LibiGel Phase III clinical development program. This has been a long-term commitment of BioSante, and we believe represents a major upside for our stockholders and the women of the United States. A full 13 years after Viagra was approved for men in the United States there still is no pharmaceutical product approved by the FDA for women's sexual health. LibiGel is the only product in the world in Phase III clinical development for the treatment of hypoactive sexual desire disorder, a significant unmet medical need.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “could,” “should,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, subsequent quarterly report on Form 10-Q and final prospectus supplement dated July 28, 2011. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
BioSante plans to use the net proceeds from the offering for general corporate purposes, including funding the ongoing Phase III clinical study program for LibiGel� for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
BioSante Pharmaceuticals Interview
Q: Investorideas.com
Mr. Simes, following the closing of the $48 Million offering, you report use of proceeds will include ongoing Phase III clinical study program for LibiGel® for the treatment of female sexual dysfunction (FSD). How far will this take you into the study and what does this mean for investor confidence in taking this product to market?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The proceeds of the $48 million underwritten financing together with the cash we had before the transaction results in almost $80 million in cash. This cash balance is sufficient to fund the LibiGel program and BioSante through our anticipated LibiGel new drug application (NDA) submission by the end of 2012, and in fact all the way through a potential FDA approval which could come in mid-2013. This long runway was one of the key reasons for executing the transaction at this time. Another reason for executing the transaction at this time was so that in the fourth quarter of this year when we announce LibiGel efficacy data investors can concentrate on the quality of the data versus being concerned that we would need to raise money.
Q: Investorideas.com
Mr. Simes can you tell investors what it means to BioSante to have some of the top names in Healthcare Banking, such as Jefferies backing the financing for your company to pave your way for the treatment of female sexual dysfunction?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
We are happy to have had Jefferies as the lead banker on this important and well executed BioSante financing. This is our first underwritten transaction, our first financing without issuing warrants and the largest single financing we have ever executed. The institutional investors in this transaction include new and existing stockholders of BioSante, most of which concentrate in biotech/pharma investing. All of these factors are important indicators of investor confidence in BioSante.
Q: Investorideas.com
Mr. Simes besides funding the ongoing Phase III clinical study program for LibiGel how else will BioSante use their funding proceeds?
A: Stephen M. Simes, President and Chief Executive Officer of BioSante Pharmaceuticals
The vast majority of BioSante spending over the last few years has been and will continue to be funding the LibiGel Phase III clinical development program. This has been a long-term commitment of BioSante, and we believe represents a major upside for our stockholders and the women of the United States. A full 13 years after Viagra was approved for men in the United States there still is no pharmaceutical product approved by the FDA for women's sexual health. LibiGel is the only product in the world in Phase III clinical development for the treatment of hypoactive sexual desire disorder, a significant unmet medical need.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as “will,” “could,” “should,” “believe,” “intends,” “continue,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K, subsequent quarterly report on Form 10-Q and final prospectus supplement dated July 28, 2011. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
McKinney/Chicago
Alan Zachary
312-506-5220
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com :
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
Wednesday, August 3, 2011
Biotech and Pharma News; BioSante Pharmaceuticals (NASDAQ: BPAX) Closes $48.0 Million Public Offering of Common Stock
LINCOLNSHIRE, Ill. - August 3, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced the closing of its underwritten public offering of 16.0 million shares of common stock at a public offering price of $3.00 per share, for total gross proceeds of $48.0 million before underwriting discounts and commissions. The offering resulted in net proceeds to BioSante of approximately $45.0 million. All of the shares in the offering were sold by BioSante. BioSante has granted the underwriters a 30-day option to purchase up to an aggregate of 2.4 million additional shares of common stock at the same price to cover over-allotments, if any.
BioSante anticipates using the net proceeds from the offering for general corporate purposes, including, without limitation, funding the ongoing Phase III clinical study program for LibiGel� for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
Jefferies & Company, Inc. acted as the sole book-running manager for the offering. Rodman & Renshaw, LLC, JMP Securities LLC, and Roth Capital Partners, LLC acted as co-managers for the offering.
A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (SEC) and is effective. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC�s website at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from the offices of Jefferies & Company, Inc., Equity Syndicate Prospectus Department, at 520 Madison Avenue, 12th Floor, New York, NY 10022, at 877-547-6340 and at Prospectus_Department@Jefferies.com.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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 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 the completion and timing of the public offering and the amount of net proceeds to be received. Such statements are identified by words such as �expect,� �intend,� "will," �may,� "continue," "could," "believe," �anticipate," and other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, risks and uncertainties related to market and other conditions and the satisfaction of customary closing conditions related to the public offering. There can be no assurance that BioSante will be able to complete the public offering on the anticipated terms, or at all. Additional risks and uncertainties related to the public offering, BioSante and its business are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q and in the preliminary prospectus supplement related to the proposed offering filed with the SEC and in the final prospectus supplement related to the offering to be filed with the SEC on or about the date hereof. All forward-looking statements in this release speak only as of the date of this release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
BioSante anticipates using the net proceeds from the offering for general corporate purposes, including, without limitation, funding the ongoing Phase III clinical study program for LibiGel� for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA).
Jefferies & Company, Inc. acted as the sole book-running manager for the offering. Rodman & Renshaw, LLC, JMP Securities LLC, and Roth Capital Partners, LLC acted as co-managers for the offering.
A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (SEC) and is effective. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC and will be available on the SEC�s website at www.sec.gov. When available, copies of the final prospectus supplement may also be obtained from the offices of Jefferies & Company, Inc., Equity Syndicate Prospectus Department, at 520 Madison Avenue, 12th Floor, New York, NY 10022, at 877-547-6340 and at Prospectus_Department@Jefferies.com.
This news release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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 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 the completion and timing of the public offering and the amount of net proceeds to be received. Such statements are identified by words such as �expect,� �intend,� "will," �may,� "continue," "could," "believe," �anticipate," and other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, risks and uncertainties related to market and other conditions and the satisfaction of customary closing conditions related to the public offering. There can be no assurance that BioSante will be able to complete the public offering on the anticipated terms, or at all. Additional risks and uncertainties related to the public offering, BioSante and its business are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q and in the preliminary prospectus supplement related to the proposed offering filed with the SEC and in the final prospectus supplement related to the offering to be filed with the SEC on or about the date hereof. All forward-looking statements in this release speak only as of the date of this release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com
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