LINCOLNSHIRE, Ill. - March 17, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced financial results for the year ended December 31, 2010 and clinical development and business highlights.
Financial Results for 2010
As of December 31, 2010, BioSante's cash balance was approximately $38.2 million as compared to $29.9 million at December 31, 2009. Subsequently, on March 9, 2011, the company completed a registered direct offering, resulting in net proceeds of approximately $23.8 million. Consequently, on March 10, 2011, BioSante's cash balance was approximately $54 million. "We are very pleased with our progress over the last year as well as our current cash balance," said Stephen M. Simes, BioSante's president and CEO. "Through careful cash management and our financing strategy, we believe we now have removed any near-term financial risk from BioSante, and our current cash balance is sufficient to finance our operations and LibiGel clinical development well into 2012, without need for additional funds."
BioSante's net loss was $46.2 million or $0.70 per share for the year ended December 31, 2010, compared to a net loss of $47.5 million or $1.40 per share for 2009. This decrease in net loss was due primarily to transaction and non-cash technology related expenses in 2009, associated with the company's merger with Cell Genesys, Inc., offset by increased LibiGel® clinical development expenses in 2010.
LibiGel® Clinical Highlights
The increased LibiGel clinical development expenses during 2010 was the result of steady progress in BioSante's LibiGel Phase III clinical program. 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. In February 2011, the company announced completion of enrollment in the first of two LibiGel Phase III efficacy trials, and expects enrollment in the second efficacy trial to be completed in the near future. BioSante continues to expect data from the two efficacy trials in Fall 2011.
BioSante also is conducting a Phase III safety study of LibiGel which has enrolled almost 3,000 women resulting in 3,200 women-years of safety data. A maximum of 4,000 patients will be enrolled in the study and be followed for a total of five years. However, BioSante can use the safety study data as part of a New Drug Application (NDA) submission after an average of 12 months of exposure to LibiGel or placebo. The study's independent data monitoring committee (DMC) has met five times and voted unanimously each time that the study should continue as per FDA-agreed protocol, without modification.
Pipeline Updates
In addition to the LibiGel clinical program, BioSante has a number of pipeline candidates in development, including a broad portfolio of cancer vaccines. Clinical trials of BioSante's Cancer Vaccines are being conducted to treat leukemia, pancreatic cancer and breast cancer, among other cancer types. These studies are being conducted in cooperation with The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, and are sponsored or funded at little or no cost to BioSante. Through March 2011, four of these cancer vaccines, the Pancreas Cancer Vaccine, Chronic Myeloid Leukemia Cancer Vaccine, Melanoma Cancer Vaccine, and Acute Myeloid Leukemia Cancer Vaccine, have received FDA Orphan Drug designations.
BioSante's pipeline also includes Bio-T-Gel™, a testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals for development and marketing. BioSante also has a licensing agreement with Pantarhei Bioscience for the development of the Pill-Plus triple component oral contraceptive which uses patented technology from BioSante. Pantarhei is engaged in several Phase II/III clinical studies with this product.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Thursday, March 17, 2011
Biotech Stock News Alert; Aethlon Medical, Inc. (OTCBB:AEMD) Updates Shareholders
San Diego, CA, March 17, 2011 � Investorideas.com newswire; Biotech and biodefense stock news; Aethlon Medical Shareholder Letter Aethlon Medical, Inc., (OTCBB:AEMD) disclosed that its Chairman and CEO, James A. Joyce has issued the following letter to shareholders.
Website: aethlonmedical.com
To our Shareholders:
As we advance our Hepatitis-C (HCV) treatment studies in India, we have also been active in our efforts to benefit from new government policies aimed at protecting U.S. civilian and military populations from bioterror and pandemic threats. This policy shift redefines the primary strategic objective of related government agencies to be the identification and support of innovative broad-spectrum countermeasures, technologies, and platforms. This is a considerable shift from the government�s previous focus of attempting to align a single drug or vaccine countermeasure with each pathogen threat. We remain convinced that our Hemopurifier� is the most advanced broad-spectrum countermeasure, technology, or platform.
Earlier this year, we were honored to be invited by The Department of Health and Humans Services (HHS) to present our Hemopurifier� as a broad-spectrum platform technology to multi-agency health officials on January 12th at the Washington Convention Center. Since this presentation, our bioterror and pandemic threat initiative has led to follow-on meetings and presentations, including a formal presentation to the Biomedical Advanced Research and Development Authority (BARDA) on February 15th. While the pursuit of government grants and contracts is not our primary focus, it is difficult to ignore a growing pipeline of new and evolving opportunities to advance our science with non-dilutive capital resources.
On February 8th, we were pleased to learn that the Defense Advanced Research Projects Agency (DARPA) released a broad agency announcement (BAA) entitled: �Dialysis Like Therapeutics� (DLT). The goal of the DLT program is to develop a portable device that removes �dirty� blood from the body, separates harmful agents, and returns �clean� blood to the body in a manner similar to dialysis treatment of kidney failure. While the device could have an impact across multiple areas of medicine, the target application for this device is sepsis. The envisioned device will be capable of removing at least 90% of unknown pathogens, toxins, and activated cells from a patient in one day. As stated in the BAA, targets for removal include viral pathogens referenced to include Hepatitis-C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza Bio-agents, Smallpox, and viral hemorrhagic fevers. As we have proven capabilities within the scope of this BAA, we plan to respond with a full proposal by April 1st.
If you are not familiar with DARPA, their mission is to maintain the technological superiority of the U.S. military and prevent technological surprise from harming our national security by sponsoring revolutionary, high-payoff research bridging the gap between fundamental discoveries and their military use. Innovation sponsored by DARPA has resulted in groundbreaking discoveries and life changing advances such as the internet. DARPA envisions that the device developed under this BAA would save the lives of thousands of military patients each year.
If selected to participate in the DLT program, we would anticipate a multifaceted role that would involve teaming with other industry partners to advance our core Hemopurifier� as an innovative dialysis-like multi-use platform technology able to selectively target deleterious pathogens and toxins from the entire circulatory system. We would also seek expand the capabilities of our technology platform as the basis for a device targeting to reduce the presence of circulating factors that are precursors to sepsis. Our goal would be to reduce the occurrence of sepsis as post-sepsis treatment strategies to inhibit the inflammation process including the modulation of inflammatory cytokines have yet to be proven clinically beneficial. It is also possible that we could participate in the advancement of portable blood pump technology required under the BAA that would be deployed to treat wounded warfighters with extracorporeal device technologies including current and future iterations of our Hemopurifier� technology. Regardless of outcome, it is truly gratifying to witness therapeutic filtration being the focal point of a government contract opportunity. This is especially true when it comes from an agency as scientifically adept as DARPA. Once we complete our submission to DARPA, I will be back in touch with an update on other activities.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company�s ability to raise capital when needed, including obtaining government grants, the Company�s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company�s ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Disclaimer /Disclosure
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Visit the profile at Investorideas.com: http://www.investorideas.com/co/aemd/
Website: aethlonmedical.com
To our Shareholders:
As we advance our Hepatitis-C (HCV) treatment studies in India, we have also been active in our efforts to benefit from new government policies aimed at protecting U.S. civilian and military populations from bioterror and pandemic threats. This policy shift redefines the primary strategic objective of related government agencies to be the identification and support of innovative broad-spectrum countermeasures, technologies, and platforms. This is a considerable shift from the government�s previous focus of attempting to align a single drug or vaccine countermeasure with each pathogen threat. We remain convinced that our Hemopurifier� is the most advanced broad-spectrum countermeasure, technology, or platform.
Earlier this year, we were honored to be invited by The Department of Health and Humans Services (HHS) to present our Hemopurifier� as a broad-spectrum platform technology to multi-agency health officials on January 12th at the Washington Convention Center. Since this presentation, our bioterror and pandemic threat initiative has led to follow-on meetings and presentations, including a formal presentation to the Biomedical Advanced Research and Development Authority (BARDA) on February 15th. While the pursuit of government grants and contracts is not our primary focus, it is difficult to ignore a growing pipeline of new and evolving opportunities to advance our science with non-dilutive capital resources.
On February 8th, we were pleased to learn that the Defense Advanced Research Projects Agency (DARPA) released a broad agency announcement (BAA) entitled: �Dialysis Like Therapeutics� (DLT). The goal of the DLT program is to develop a portable device that removes �dirty� blood from the body, separates harmful agents, and returns �clean� blood to the body in a manner similar to dialysis treatment of kidney failure. While the device could have an impact across multiple areas of medicine, the target application for this device is sepsis. The envisioned device will be capable of removing at least 90% of unknown pathogens, toxins, and activated cells from a patient in one day. As stated in the BAA, targets for removal include viral pathogens referenced to include Hepatitis-C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza Bio-agents, Smallpox, and viral hemorrhagic fevers. As we have proven capabilities within the scope of this BAA, we plan to respond with a full proposal by April 1st.
If you are not familiar with DARPA, their mission is to maintain the technological superiority of the U.S. military and prevent technological surprise from harming our national security by sponsoring revolutionary, high-payoff research bridging the gap between fundamental discoveries and their military use. Innovation sponsored by DARPA has resulted in groundbreaking discoveries and life changing advances such as the internet. DARPA envisions that the device developed under this BAA would save the lives of thousands of military patients each year.
If selected to participate in the DLT program, we would anticipate a multifaceted role that would involve teaming with other industry partners to advance our core Hemopurifier� as an innovative dialysis-like multi-use platform technology able to selectively target deleterious pathogens and toxins from the entire circulatory system. We would also seek expand the capabilities of our technology platform as the basis for a device targeting to reduce the presence of circulating factors that are precursors to sepsis. Our goal would be to reduce the occurrence of sepsis as post-sepsis treatment strategies to inhibit the inflammation process including the modulation of inflammatory cytokines have yet to be proven clinically beneficial. It is also possible that we could participate in the advancement of portable blood pump technology required under the BAA that would be deployed to treat wounded warfighters with extracorporeal device technologies including current and future iterations of our Hemopurifier� technology. Regardless of outcome, it is truly gratifying to witness therapeutic filtration being the focal point of a government contract opportunity. This is especially true when it comes from an agency as scientifically adept as DARPA. Once we complete our submission to DARPA, I will be back in touch with an update on other activities.
On behalf of our dedicated team at Aethlon Medical, I thank you for your continued support.
Very truly yours,
James A. Joyce
Chairman, CEO
Certain of the statements herein may be forward-looking and involve risks and uncertainties. Such forward-looking statements involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aethlon Medical, Inc. to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such potential risks and uncertainties include, without limitation, the capability of the Hemopurifier� to reduce viral loads and other disease conditions or to identify or treat disease conditions such as cancer, including the ability to capture exosomes and the impact that potential ability may have on disease conditions, the Company�s ability to raise capital when needed, including obtaining government grants, the Company�s ability to complete the development of its planned products, the ability of the Company to obtain FDA and other regulatory approvals permitting the sale of its products, the ability to achieve commercialization in India as a result of the proposed treatment program at Medanta, The Medicity Institute, whether successful or not, the ability of the Hemopurifier� to improve the efficacy of SOC therapy against HCV, the Company�s ability to manufacture its products either internally or through outside companies and to create future generations of the Hemopurifier�, the impact of government regulations, patent protection on the Company�s proprietary technology, product liability exposure, uncertainty of market acceptance, competition, technological change, and other risk factors. In such instances, actual results could differ materially as a result of a variety of factors, including the risks associated with the effect of changing economic conditions and other risk factors detailed in the Company�s Securities and Exchange Commission filings.
Disclaimer /Disclosure
AETHLON MEDICAL INC (OTC BB: AEMD) is a Showcase biotech, biodefense and defense stock on Investorideas.com ($one thousand five hundred per month, $five thousand per month in 144 stock)
Effective March 15, 2011
Visit the profile at Investorideas.com: http://www.investorideas.com/co/aemd/
Wednesday, March 16, 2011
Biotech/Pharma Stocks News; UV Flu Technologies (OTCBB: UVFT) Initiates Hotel and Casino Clean Air Rental Program
CENTERVILLE, MA � March 16, 2011 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce it has commenced marketing a clean-air rental program specifically designed for the Hospitality Industry.
The program has been branded as UV Flu "Purity+" Clean Air System, and delivers an aggressively cost effective alternative for hotels and casinos to offer smoke, odor and contaminant-free rooms for their guests. UV Flu Representatives deodorize and monitor contaminants after placing a ViraTech UV-400 in the optimal location within those rooms operating in this innovative new program.
The UV-400 units are designed to kill any bacteria, allergens, and other contaminants, while also reducing any smoke and pet odors with increasing efficacy as room air is passed through the unit multiple times per hour. Company representatives are scheduled at pre-calculated intervals to monitor the room to ensure the UV-400 is performing optimally.
"The UV Flu 'Purity+' Clean Air System offers a significant opportunity for hotel management to increase their REVPAR (revenues per room), improve the level of guest satisfaction, and to decrease the number of room nights lost due to smoke odors in non-smoking rooms," said John Lennon, President of UV Flu. "Our research has shown that in some properties, as many as 1 out of 10 rooms identified as non-smoking exhibited residual smoke odors. The UV-400 can actually process smoke odors as they're being generated, while also killing all other organic contaminants."
Mr. Lennon continues, "Experienced hoteliers know that guests who enjoy fresh-smelling rooms feel healthier and sleep more soundly and report that a pleasurable experience is the key to return visits. Most seasoned travelers are perfectly willing to spend extra for this guaranteed level of service delivery."
"Our ability to provide hotel operators the option to buy, lease, and now rent our UV-400 along with a service program, gives property management the flexibility to find a solution that fits their specific needs. In our first week since we introduced the program we have been asked to provide proposals to properties with a combined room count approaching 20,000 rooms and we believe this momentum is sure to increase in the coming weeks," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
The program has been branded as UV Flu "Purity+" Clean Air System, and delivers an aggressively cost effective alternative for hotels and casinos to offer smoke, odor and contaminant-free rooms for their guests. UV Flu Representatives deodorize and monitor contaminants after placing a ViraTech UV-400 in the optimal location within those rooms operating in this innovative new program.
The UV-400 units are designed to kill any bacteria, allergens, and other contaminants, while also reducing any smoke and pet odors with increasing efficacy as room air is passed through the unit multiple times per hour. Company representatives are scheduled at pre-calculated intervals to monitor the room to ensure the UV-400 is performing optimally.
"The UV Flu 'Purity+' Clean Air System offers a significant opportunity for hotel management to increase their REVPAR (revenues per room), improve the level of guest satisfaction, and to decrease the number of room nights lost due to smoke odors in non-smoking rooms," said John Lennon, President of UV Flu. "Our research has shown that in some properties, as many as 1 out of 10 rooms identified as non-smoking exhibited residual smoke odors. The UV-400 can actually process smoke odors as they're being generated, while also killing all other organic contaminants."
Mr. Lennon continues, "Experienced hoteliers know that guests who enjoy fresh-smelling rooms feel healthier and sleep more soundly and report that a pleasurable experience is the key to return visits. Most seasoned travelers are perfectly willing to spend extra for this guaranteed level of service delivery."
"Our ability to provide hotel operators the option to buy, lease, and now rent our UV-400 along with a service program, gives property management the flexibility to find a solution that fits their specific needs. In our first week since we introduced the program we have been asked to provide proposals to properties with a combined room count approaching 20,000 rooms and we believe this momentum is sure to increase in the coming weeks," said Mr. Lennon.
Further details regarding the Company's business, acquisitions, financial reports and agreements are filed as part of the Company's continuous public disclosure as a reporting issuer under the Securities Exchange Act of 1934 filed with the Securities and Exchange Commission's ("SEC") EDGAR database. For more information, visit: www.uvflutech.com.
About UV Flu Technologies, Inc. (OTC.BB:UVFT)
UV Flu Technologies is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector (over $7.7 billion in 2008). The Company manufactures the ViraTech UV-400, which utilizes high-intensity ultraviolet radiation (UV-C) inside a killing chamber that goes beyond filtration to destroy harmful airborne bacteria, at rates exceeding 99.2% on a first-pass basis, while also reducing the concentrations of odors, and VOC's (volatile organic compounds, such as acetone, benzene, formaldehyde, etc.) The FDA has issued a coveted Class II medical listing that enables UV Flu Technologies to market the product as a medical device. For more information, visit: www.uvflutech.com. For sales: www.puravair.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that term is defined in Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press release which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects and development stage companies. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K for the most recent fiscal year, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission.
ON BEHALF OF THE BOARD
UV Flu Technologies, Inc.
John J. Lennon, President & CEO
Contact:
Investor Information:
Geaux IR Services, Inc.
Toll-Free: 1-888-355-8838
investors@uvflutech.com
SOURCE: UV Flu Technologies, Inc.
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
Visit the showcase page on Investorideas.com
http://www.investorideas.com/CO/UVFT/
Request info:
http://www.investorideas.com/Resources/Newsletter.asp
Friday, March 11, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Closes $25.1 Million Registered Direct Offering
LINCOLNSHIRE, Ill. - March 9, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced the closing of a previously announced sale of $25.1 million of securities in a registered direct offering. BioSante received net proceeds of approximately $23.8 million after deducting placement agent fees and other offering expenses. BioSante sold an aggregate of approximately 12.2 million shares of its common stock and warrants to purchase up to approximately 4.0 million additional shares of its common stock. Each unit, consisting of one share of common stock and a three-year warrant to purchase 0.33 of a share of common stock, was sold for a purchase price of $2.0613, a premium to the closing price on the day before pricing.
The warrants to purchase additional shares are exercisable immediately at an exercise price of $2.25 per share and will expire on March 8, 2014. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the U.S. Food and Drug Administration for this common and unmet medical need.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM - News), acted as the exclusive placement agent for the transaction. Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
All of the securities were offered and sold pursuant to an effective shelf registration statement filed by BioSante with the Securities and Exchange Commission. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
The warrants to purchase additional shares are exercisable immediately at an exercise price of $2.25 per share and will expire on March 8, 2014. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the U.S. Food and Drug Administration for this common and unmet medical need.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM - News), acted as the exclusive placement agent for the transaction. Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
All of the securities were offered and sold pursuant to an effective shelf registration statement filed by BioSante with the Securities and Exchange Commission. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Tuesday, March 8, 2011
Biotech Stocks; Aethlon Medical (OTCBB: AEMD) Receives FDA Approval to Export its Hemopurifier to India
Biotech Stocks; Aethlon Medical (OTCBB: AEMD) Receives FDA Approval to Export its Hemopurifier to India
Visit this company: http://www.aethlonmedical.com/
SAN DIEGO - March 8, 2011 (Investorideas.com Newswire) - Aethlon Medical, Inc. (OTC Bulletin Board:AEMD.ob), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Aethlon's request to export its Hemopurifier® medical device to India.
The FDA's approval was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the Act). Section 801 (e) of the Act covers class III medical devices, such as the Hemopurifier®, that have not yet received an approved Premarket Approval in the US by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA's Good Manufacturing Practices.
"The granting of our export license by FDA represents a critical step in our strategy to initiate future commercialization of our Hemopurifier® in India," stated Jim Joyce, Aethlon Chairman and CEO.
Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
More Info:
Published at www.Investorideas.com - Global research by sectors
If you have any questions regarding information in this press release please contact the company listed in the press release.
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More Investorideas Biotech Stocks info wwww.BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks, Biotech, Pharma and Industry News and Biotech Investor Research Tools including a Biotech Stocks Directory Biotech Companies - become a biotech showcase stock on www.investorideas.com and http://www.biotechindustrystocks.com/
for as little as $1000 month !
Visit this company: http://www.aethlonmedical.com/
SAN DIEGO - March 8, 2011 (Investorideas.com Newswire) - Aethlon Medical, Inc. (OTC Bulletin Board:AEMD.ob), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Aethlon's request to export its Hemopurifier® medical device to India.
The FDA's approval was granted under Section 801 (e) of the Federal Food, Drug, and Cosmetic Act, as amended (the Act). Section 801 (e) of the Act covers class III medical devices, such as the Hemopurifier®, that have not yet received an approved Premarket Approval in the US by the FDA. Section 801 (e) applies to medical devices that are acceptable to the importing country and that are manufactured under the FDA's Good Manufacturing Practices.
"The granting of our export license by FDA represents a critical step in our strategy to initiate future commercialization of our Hemopurifier® in India," stated Jim Joyce, Aethlon Chairman and CEO.
Aethlon is currently conducting a clinical study entitled: "Use of the Aethlon Hemopurifier® in Treating Chronic HCV Infection in Combination with Standard of Care (SOC) Drug Therapy" at the Medicity Institute (Medicity) near Delhi, India. The Medicity is a $360 million multi-specialty medical institute recently established on a 43-acre campus to be a premier center of medical tourism in India. A clinical goal of the Aethlon-Medicity study will be to demonstrate that the Hemopurifier® is able to accelerate the benefit of HCV standard of care (SOC) drug regimens. Therapeutic filtration at the outset of SOC improves early virus reduction kinetics to levels associated with that of patients most likely to achieve a sustained viral response, which is the goal of HCV therapy. Additionally, lower quantities of HCV in circulation at the outset of SOC correlate with increased cure rates. Upon demonstration of treatment efficacy, Aethlon plans to commence commercialization of its Hemopurifier® in India.
About Aethlon Medical
At Aethlon Medical, we create revolutionary devices to address infectious disease and cancer. Our devices are designed to be novel platform solutions that fill therapeutic voids or aid in disease diagnosis and monitoring.
Our Hemopurifier® is the first medical device to selectively target the removal of infectious viruses and immunosuppressive proteins from the entire circulatory system. We recently discovered that our Hemopurifier® captures tumor-secreted exosomes that suppress the immune system of those afflicted with cancer. Prior to this discovery, a therapeutic strategy to directly inhibit or reverse the immunosuppressive destruction caused by exosomes did not exist in cancer care. By eliminating this mechanism, we believe our Hemopurifier® can fill an unmet clinical need and provide the benefit of an immune-based therapy without adding drug toxicity or interaction risks to established and emerging treatment strategies.
Human studies have documented the ability of our Hemopurifier® to safely reduce viral load in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients without the administration of antiviral drugs. However, our initial clinical and commercialization focus is to establish our Hemopurifier® as an adjunct therapy to enhance the benefit of both infectious disease and cancer treatment regimens. In this regard, we plan to commercialize our Hemopurifier® in India as we advance our clinical strategies in the United States and the European Union. In vitro studies conducted by government and non-government research institutes have also verified that our Hemopurifier® has broad-spectrum capabilities against bioterror and emerging pandemic threats. These studies have confirmed the capture of Dengue Hemorrhagic Virus, Ebola Hemorrhagic Virus, Lassa Hemorrhagic Virus, West Nile Virus, H5N1 Avian Influenza Virus, 2009 H1N1 Influenza Virus, the reconstructed Spanish Flu of 1918 Virus, and Monkeypox Virus, which serves as a model for human Smallpox infection.
As a therapeutic device, the Hemopurifier® provides us with a pipeline into four significant market opportunities:
Cancer: A treatment candidate to improve patient responsiveness to established cancer therapies by removing immunosuppressive exosomes from circulation.
Hepatitis-C Virus (HCV): As an adjunct therapy to accelerate viral load reduction at the outset of standard of care drug regimens.
Human Immunodeficiency Virus (HIV): Provides a potential therapeutic option for HIV-infected individuals to manage disease progression once they become resistant to antiviral drug regimens.
Bioterror and Pandemic Threats: Represents the most advanced broad-spectrum strategy to address untreatable bioterror and emerging pandemic threats.
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
John P. Salvador
Director, Communications & Investor Relations
858.459.7800 x307
jps@aethlonmedical.com
More Info:
Published at www.Investorideas.com - Global research by sectors
If you have any questions regarding information in this press release please contact the company listed in the press release.
Connect with Investorideas.com
Publish Your News - Send a release
Disclaimer: The following news is paid for and /or published as information only for our readers. 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.
More Investorideas Biotech Stocks info wwww.BiotechIndustryStocks.com - A Leading Global Investor Website for Biotech Industry Stocks, Biotech, Pharma and Industry News and Biotech Investor Research Tools including a Biotech Stocks Directory Biotech Companies - become a biotech showcase stock on www.investorideas.com and http://www.biotechindustrystocks.com/
for as little as $1000 month !
Monday, March 7, 2011
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) to Raise $25.1 Million in Registered Direct Offering
LINCOLNSHIRE, Ill. - March 4, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has received commitments from several institutional investors to purchase $25.1 million of securities in a registered direct offering. BioSante expects to receive net proceeds of approximately $23.8 million after deducting placement agent fees and other offering expenses. BioSante has entered into securities purchase agreements with these investors pursuant to which BioSante has agreed to sell an aggregate of approximately 12.2 million shares of its common stock and warrants to purchase up to approximately 4.0 million additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.33 of a share of common stock, will be sold for a purchase price of $2.0613, a premium to the closing price on the day before pricing.
"We are pleased to have this commitment from these new and existing institutional investors," said Stephen M. Simes, BioSante's president and chief executive officer. "This additional funding provides us with added financial power to continue to fund our ongoing LibiGel� Phase III clinical study program. We recently announced completion of enrollment in the first of the two LibiGel Phase III efficacy trials and expect to announce completion of enrollment in the second in the near future. LibiGel remains the lead pharmaceutical product in the U.S. in active development for the treatment of hypoactive sexual desire disorder (HSDD) in menopausal women, and we continue to believe that LibiGel has the potential to be the first product approved by the FDA for this common and unmet medical need."
The warrants to purchase additional shares will be exercisable at an exercise price of $2.25 per share beginning immediately and will expire three years from their date of issuance. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. The offering is expected to be consummated by March 8, 2011, subject to customary closing conditions.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM), acted as the exclusive placement agent for the transaction. Oppenheimer & Co. Inc., Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
Shelf registration statements relating to the shares of common stock and warrants issued in the offering (and the shares of common stock issuable upon exercise of the warrants) have been filed with the Securities and Exchange Commission (the "SEC") and declared effective. A prospectus supplement relating to the offering will be filed by BioSante with the SEC. Copies of the prospectus supplement and accompanying prospectuses may be obtained directly from BioSante by contacting BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, Illinois 60069. Copies of the final prospectus supplement and accompanying prospectuses relating to the offering also may be obtained from Rodman & Renshaw, LLC, 1251 Avenue of the Americas 20th Floor, New York, NY 10020 or by calling (212) 356-0549. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
The warrants to purchase additional shares will be exercisable at an exercise price of $2.25 per share beginning immediately and will expire three years from their date of issuance. All of the securities were offered pursuant to an effective shelf registration statement. Proceeds from the transaction will be used for general corporate purposes, including continuing to fund BioSante's LibiGel Phase III clinical study program. The offering is expected to be consummated by March 8, 2011, subject to customary closing conditions.
Rodman & Renshaw, LLC, a subsidiary of Rodman & Renshaw Capital Group, Inc., (NASDAQ:RODM), acted as the exclusive placement agent for the transaction. Oppenheimer & Co. Inc., Roth Capital Partners, LLC, JMP Securities LLC and Trout Capital, LLC acted as financial advisors.
Shelf registration statements relating to the shares of common stock and warrants issued in the offering (and the shares of common stock issuable upon exercise of the warrants) have been filed with the Securities and Exchange Commission (the "SEC") and declared effective. A prospectus supplement relating to the offering will be filed by BioSante with the SEC. Copies of the prospectus supplement and accompanying prospectuses may be obtained directly from BioSante by contacting BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, Illinois 60069. Copies of the final prospectus supplement and accompanying prospectuses relating to the offering also may be obtained from Rodman & Renshaw, LLC, 1251 Avenue of the Americas 20th Floor, New York, NY 10020 or by calling (212) 356-0549. This announcement is neither an offer to sell nor a solicitation of an offer to buy any shares of common stock or warrants of BioSante. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other products in development are Bio-T-Gel™, a testosterone gel for male hypogonadism licensed to Teva Pharmaceuticals and an oral contraceptive in Phase II clinical development using BioSante patented technology. The company also is seeking opportunities for its other technologies. Additional information is available online at: www.biosantepharma.com.
Forward-Looking Statements
To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante's plans, objectives, expectations and intentions with respect to future operations and products, the timing of anticipated regulatory submissions and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
BioSante Pharmaceuticals
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
Friday, March 4, 2011
Biotech/Pharma Stock Trading Alert; BioSante Pharmaceuticals Inc (NASDAQ:BPAX) up over 10% on News
Point Roberts, WA. - March 3, 2011 (Investorideas.com Energy stocks Newswire) - www.InvestorIdeas.com, a leader in sector stock research including biotech stocks, releases a technical stock trading alert for BioSante Pharmaceuticals Inc (NASDAQ:BPAX). The stock is currently trading at $2.27, up 0.23 (11.82%), trading as high as $2.52 in morning trading.
The stock traded up on news headline "BioSante's (NASDAQ: BPAX) Pancreas Cancer Vaccine Shows Survival Increase in Newly Published Study."
BPAX Stock Chart
Today's News:
Biotech/Pharma Stock News; BioSante's (NASDAQ: BPAX) Pancreas Cancer Vaccine Shows Survival Increase in Newly Published Study
"LINCOLNSHIRE, Ill. - March 3, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase II clinical study that show BioSante's Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year.
In the study, titled, "A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation," published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. The median disease-free survival of patients was 17.3 months (95% CI, 14.6–22.8) with median survival of 24.8 months (95% CI, 21.2–31.6). The administration of immunotherapy was well tolerated. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that "an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer."
The 60 patient Phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante's Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. BioSante already has received Orphan Drug designation from the U.S. Food & Drug Administration for the Pancreas Cancer Vaccine.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/03031.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 (one 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.
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Source: Investorideas.com, BioSante, Investorideas.com
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Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
The stock traded up on news headline "BioSante's (NASDAQ: BPAX) Pancreas Cancer Vaccine Shows Survival Increase in Newly Published Study."
BPAX Stock Chart
Today's News:Biotech/Pharma Stock News; BioSante's (NASDAQ: BPAX) Pancreas Cancer Vaccine Shows Survival Increase in Newly Published Study
"LINCOLNSHIRE, Ill. - March 3, 2011 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced publication of results from a Phase II clinical study that show BioSante's Pancreas Cancer Vaccine increased the median survival of resected pancreatic cancer patients from 15 to 20 months, as reported in published data, to 24.8 months, an increase of more than 25 percent. In addition, the vaccine demonstrated a 35 percent increase in one year survival, from 63 percent to 85 percent. A new multicenter clinical study is planned to begin this year.
In the study, titled, "A Lethally Irradiated Allogeneic GM-CSF-Secreting Tumor Vaccine for Pancreatic Adenocarcinoma: A Phase II Trial of Safety, Efficacy, and Immune Activation," published in the February 2011 issue of Annals of Surgery, the primary endpoint was disease free survival and secondary endpoints were overall survival and toxicity, and the induction of mesothelin specific T cell responses. The median disease-free survival of patients was 17.3 months (95% CI, 14.6–22.8) with median survival of 24.8 months (95% CI, 21.2–31.6). The administration of immunotherapy was well tolerated. In addition, the postimmunotherapy induction of mesothelin-specific T cells in patients correlates with disease-free survival. The investigators concluded that "an immunotherapy approach integrated with chemoradiation is safe and effective for resected pancreas cancer."
The 60 patient Phase II study was conducted by researchers at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland. The research was funded by the National Institutes of Health and other foundations. BioSante's Pancreas Cancer Vaccine is made from allogeneic pancreatic cancer cells genetically altered to produce an immune system stimulator called GM-CSF, and irradiated to prevent cell growth. BioSante already has received Orphan Drug designation from the U.S. Food & Drug Administration for the Pancreas Cancer Vaccine.”
Full News at: http://www.investorideas.com/CO/BPAX/news/2011/03031.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.
Sign up for the free investor news letter and get stock alerts in leading sectors! 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 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.
About our Biotech investor portal : www.biotechindustrystocks.com
BiotechIndustryStocks.com is a global meeting place for investors and industry following the sector, within Investorideas.com. Global visitors use the site daily to research the latest news, articles, audio, research reports and our stock directories.
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 (one 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 to become a biotech showcase stock or research biotech stocks
800 665 0411 cvanzant@investorideas.com
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com (1000 per month).
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