Investorideas.com - Biotech/Pharma Stock Profile Update; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)
Recent News; BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation
Point Roberts, WA, LINCOLNSHIRE, Ill –October 27, 2010 (Investorideas.com Newswire, www.biotechindustrystocks.com) reports the following updates for showcase biotech stock BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Recent updates to the company profile include company news on its lead near term product LibiGel®, in addition to media kit highlights for investors.
The company reports recent news; “BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation.”
The company profile is available at http://www.investorideas.com/CO/BPAX/ for interested biotech investors.
Full Media Kit at: http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf
Company Overview:
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, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante’s licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), as a vaccine adjuvant, including for an H1N1 (swine flu) vaccine, and drug delivery as well as seeking opportunities for its 2A/Furin and other technologies.
Recent Company News:
BioSante Pharmaceuticals Reports Positive LibiGel® Data Monitoring Committee Recommendation
“LINCOLNSHIRE, Illinois (October 25, 2010) – BioSante Pharmaceuticals, Inc.(NASDAQ: BPAX) today announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. 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 currently no FDA approved product.”
Full News: http://www.investorideas.com/CO/BPAX/news/10252.asp
Lead Products – Multi-Billion Dollar Markets
BioSante is focused on developing innovative products for female sexual health and oncology. he current market for testosterone and estrogen products is approximately $2.5billion dollars in the U.S. alone, with estimates for female sexual dysfunction potentially adding more than $2.0 billion. In addition, the current market for hormonal contraception is approximately $3.0 billion. The market for oncology products also is a multi-billion dollar market. BioSante’s lead near term product in development is LibiGel® (testosterone gel) for the treatment of female sexual dysfunction (FSD). LibiGel’s clinical development program consists of two Phase III safety and efficacy trials, being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Each trial will enroll approximately 500 surgically menopausal women for six months of treatment in double-blind placebo-controlled trials. Also ongoing is one Phase III cardiovascular events-driven safety study, enrolling between 2,500 and 4,000 women with cardiovascular risk factors, on therapy for one year and then followed for an additional four years after New Drug Application (NDA) submission and potential FDA approval. A completed LibiGel Phase II clinical trial has shown excellent results with a significant 238% increase in the total number of satisfying sexual events. There are currently no pharmaceutical products approved for the treatment of FSD in the U.S. however over 4 million prescriptions for testosterone were written off-label by physicians in 2009. BioSante’s marketed product, ElestrinTM, is FDA approved to reduce hot flashes in menopausal women. The lower of the two approved Elestrin doses is 67% lower than the lowest dose transdermal patch available for the treatment of hot flashes. Elestrin is marketed in the U.S. by Azur Pharma. BioSante will focus primarily on LibiGel, BioSante’s testosterone gel in Phase III clinical development for the treatment of female sexual dysfunction (FSD). The Company also will seek future development opportunities for its cancer vaccines, which are non patient-specific therapies comprised of whole tumor cells that have been modified to secrete GM-CSF (granulocyte-macrophage colony-stimulating factor), an immune stimulatory cytokine, and then irradiated for safety and are administered via intradermal injections on an outpatient basis. Currently, several of BioSante’s cancer immunotherapies are in Phase II clinical trials at Johns Hopkins Cancer Center and BioSante has been granted FDA Orphan Drug designation for its pancreatic cancer, acute myeloid leukemia and chronic myeloid leukemia vaccines.
Investment Highlights
• Financial resources to implement plan
• Late stage pharmaceutical product portfolio with significant growth potential
• LibiGel in three ongoing Phase III safety and efficacy clinical studies
• Elestrin is FDA approved and marketed in the U.S.
• Proprietary cancer vaccines in Phase II clinical trials
• Proprietary CaP technology with aesthetic medicine potential
• Focused growth strategy
• Management’s proven ability to gain FDA approval, implement plans and
increase stockholder value
Financial Highlights
• At March 31, 2010, BioSante had approximately $41M in cash
• Monthly burn rate of approximately $2.5-$3.0M
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.
The Pill-PlusTM — Triple hormone
contraceptive in Phase II clinical development
combining hormone 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.
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Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com. (three thousand per month)
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.
Contact BioSante Pharmaceuticals
For Media:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Investors:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
The content from the investor Fact sheet and opinions from http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf are not the opinion of Investorideas.com or related websites.
Disclaimer: The following news is paid for by BPAX (three 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
Wednesday, October 27, 2010
Investorideas.com - Biotech Stocks Update; UV Flu Technologies (OTCBB: UVFT) Signs LOI to Acquire Leading Manufacturer of Industrial Grade Air Purification Systems
Investorideas.com - Biotech Stocks Update; UV Flu Technologies (OTCBB: UVFT) Signs LOI to Acquire Leading Manufacturer of Industrial Grade Air Purification Systems
Visit this company: www.uvflutech.com
CENTERVILLE, MA – October 27, 2010 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce that it has signed a Letter of Intent ("LOI") to acquire 100% of the ownership of a major US manufacturer of high quality air purification equipment designed for industrial applications and specializing in the medical and hospitality marketplace.
The agreement includes a patented, trademarked product line, with dozens of national distributors and representatives, an extensive customer list, inventory, and all associated manufacturing equipment. The company's sales include an installed base of several thousand units in over 1000 unique facilities nationwide.
The transaction will use commercially reasonable efforts to execute a definitive merger agreement by mid-November and the Definitive Agreement shall contain customary representation and warranties, covenants and indemnification provisions. By mutual agreement, the name of the selling company will be withheld until the close of the transaction.
"This is an excellent and timely acquisition for UV Flu," said Jack Lennon, President of UV Flu Technologies. "The company we are acquiring makes some of the finest, hi-end, air purification equipment available anywhere. Their highest volume product is patented, trade-marked, and is based on HEPA equipment which also combines UV germicidal technology designed to capture 99.97% of the particulates passing through the system. It complements and extends our existing technology and capabilities by dramatically increasing filtration protection throughout much larger spaces, particularly in areas where smoke and dust play a major role. Construction sites, casinos, smoking lounges and restaurants are significant users of the product line, including over 400 hospitals that rely on its particulate trapping abilities to clean the air of harmful pathogens. This high grade HEPA based technology is best suited to industrial/commercial environments which incorporate designated maintenance schedules and generally includes service contracts as opposed to residential or small commercial settings, where stand-alone HEPA users may neglect to change the filters in a timely manner thereby compromising the effectiveness of their systems."
"The acquisition will be operated as a subsidiary of UV Flu Technologies, and will provide a US manufacturing base to aid in the pursuit of government and DoD contract opportunities. We hope this added market segment will also lead to additional jobs and overall growth for the Company," said Mr. Lennon. "The enhanced product line will make us increasingly attractive to large US distributors, and increase our visibility within the hospital, hotel and casino marketplace. Upon the close of the transaction we will immediately introduce our distributors to the entire product line, both domestically, as well as internationally. We believe the synergies will be extraordinary and hope to dramatically increase our revenue estimates for 2011 as a result. Once our residential model is introduced to the lineup in 2011 we are highly optimistic for significant traction across the entire segment. We are excited by the prospects and look forward to offering a full line of products that really work; all with verified and laboratory proven test data for every application."
Further details regarding the Company's business, 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)
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Visit this company: www.uvflutech.com
CENTERVILLE, MA – October 27, 2010 (Investorideas.com Newswire) - UV Flu Technologies, Inc. (OTCBB: UVFT) (the "Company") is pleased to announce that it has signed a Letter of Intent ("LOI") to acquire 100% of the ownership of a major US manufacturer of high quality air purification equipment designed for industrial applications and specializing in the medical and hospitality marketplace.
The agreement includes a patented, trademarked product line, with dozens of national distributors and representatives, an extensive customer list, inventory, and all associated manufacturing equipment. The company's sales include an installed base of several thousand units in over 1000 unique facilities nationwide.
The transaction will use commercially reasonable efforts to execute a definitive merger agreement by mid-November and the Definitive Agreement shall contain customary representation and warranties, covenants and indemnification provisions. By mutual agreement, the name of the selling company will be withheld until the close of the transaction.
"This is an excellent and timely acquisition for UV Flu," said Jack Lennon, President of UV Flu Technologies. "The company we are acquiring makes some of the finest, hi-end, air purification equipment available anywhere. Their highest volume product is patented, trade-marked, and is based on HEPA equipment which also combines UV germicidal technology designed to capture 99.97% of the particulates passing through the system. It complements and extends our existing technology and capabilities by dramatically increasing filtration protection throughout much larger spaces, particularly in areas where smoke and dust play a major role. Construction sites, casinos, smoking lounges and restaurants are significant users of the product line, including over 400 hospitals that rely on its particulate trapping abilities to clean the air of harmful pathogens. This high grade HEPA based technology is best suited to industrial/commercial environments which incorporate designated maintenance schedules and generally includes service contracts as opposed to residential or small commercial settings, where stand-alone HEPA users may neglect to change the filters in a timely manner thereby compromising the effectiveness of their systems."
"The acquisition will be operated as a subsidiary of UV Flu Technologies, and will provide a US manufacturing base to aid in the pursuit of government and DoD contract opportunities. We hope this added market segment will also lead to additional jobs and overall growth for the Company," said Mr. Lennon. "The enhanced product line will make us increasingly attractive to large US distributors, and increase our visibility within the hospital, hotel and casino marketplace. Upon the close of the transaction we will immediately introduce our distributors to the entire product line, both domestically, as well as internationally. We believe the synergies will be extraordinary and hope to dramatically increase our revenue estimates for 2011 as a result. Once our residential model is introduced to the lineup in 2011 we are highly optimistic for significant traction across the entire segment. We are excited by the prospects and look forward to offering a full line of products that really work; all with verified and laboratory proven test data for every application."
Further details regarding the Company's business, 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
More Info:
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Tuesday, October 26, 2010
Investorideas.com - NASDAQ Biotech/Pharma News: BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Positive LibiGel® Data Monitoring Committee Recommendation
Investorideas.com - NASDAQ Biotech/Pharma News: BioSante Pharmaceuticals (NASDAQ: BPAX) Announces Positive LibiGel® Data Monitoring Committee Recommendation
Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications
LINCOLNSHIRE, Ill. - October 25, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. 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 currently no FDA approved product.
"We are very pleased that the DMC recommended that the study should continue without modification. This means that there are no general or specific safety issues based on their unblinded review of adverse events. The low number of CV events to date is consistent with the safety of testosterone in women," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects into the study will be complete. The current LibiGel safety study protocol allows for up to 4,000 women to be enrolled."
Another unblinded statistical analysis will be conducted by the DMC each time there is an additional adjudicated cardiovascular event. With approximately 2,300 women-years of exposure in the study, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, compared to an expected rate of CV events for this study of approximately two percent. Moreover, there have been seven breast cancers reported, a rate of approximately 0.32 percent, compared to an expected rate of approximately 0.35 percent.
Subjects have been in the study for an average of approximately 10.7 months. There are approximately 850 subjects who have been in the study for over one year and approximately 400 subjects who have been in the study for more than two years. The LibiGel Phase III safety study represents the largest data base of the safety of testosterone in women. A new drug application (NDA) can be submitted after an average of 12 months of exposure with subjects followed for five years in total, including after NDA submission and potential FDA approval. BioSante's objective is to submit the LibiGel NDA in 2011.
The statistical analyses of the CV events are based on predefined statistical methods, in accordance with BioSante's agreement with the FDA, to determine if LibiGel can be considered safe for post-menopausal women. Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
"With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD," said Stephen M. Simes, BioSante's president & CEO.
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and 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 Media:The Trout Group LLCTricia Swanson(646) 378-2953tswanson@troutgroup.com
or
For Investors:McKinney/ChicagoAlan Zachary(312) 944-6784 ext. 316azachary@mckinneychicago.com
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Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications
LINCOLNSHIRE, Ill. - October 25, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. 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 currently no FDA approved product.
"We are very pleased that the DMC recommended that the study should continue without modification. This means that there are no general or specific safety issues based on their unblinded review of adverse events. The low number of CV events to date is consistent with the safety of testosterone in women," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects into the study will be complete. The current LibiGel safety study protocol allows for up to 4,000 women to be enrolled."
Another unblinded statistical analysis will be conducted by the DMC each time there is an additional adjudicated cardiovascular event. With approximately 2,300 women-years of exposure in the study, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, compared to an expected rate of CV events for this study of approximately two percent. Moreover, there have been seven breast cancers reported, a rate of approximately 0.32 percent, compared to an expected rate of approximately 0.35 percent.
Subjects have been in the study for an average of approximately 10.7 months. There are approximately 850 subjects who have been in the study for over one year and approximately 400 subjects who have been in the study for more than two years. The LibiGel Phase III safety study represents the largest data base of the safety of testosterone in women. A new drug application (NDA) can be submitted after an average of 12 months of exposure with subjects followed for five years in total, including after NDA submission and potential FDA approval. BioSante's objective is to submit the LibiGel NDA in 2011.
The statistical analyses of the CV events are based on predefined statistical methods, in accordance with BioSante's agreement with the FDA, to determine if LibiGel can be considered safe for post-menopausal women. Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
"With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD," said Stephen M. Simes, BioSante's president & CEO.
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and 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 Media:The Trout Group LLCTricia Swanson(646) 378-2953tswanson@troutgroup.com
or
For Investors:McKinney/ChicagoAlan Zachary(312) 944-6784 ext. 316azachary@mckinneychicago.com
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Investorideas.com - Biotech Stock Profile Update; UV Flu Technologies, Inc. (OTCBB: UVFT) New Research Report and New Stock Trading/Chart Video
Investorideas.com - Biotech Stock Profile Update; UV Flu Technologies, Inc. (OTCBB: UVFT) New Research Report and New Stock Trading/Chart Video
Point Roberts, WA –October 26, 2010 (Investorideas.com Newswire, www.biotechindustrystocks.com) reports the following updates for showcase biotech stock UV Flu Technologies, Inc. (OTCBB: UVFT) Recent updates to the company profile include a new trading /stock Video by www.itsabull.net, in addition to and analyst report by Michael Williams. Michael Williams is America’s top authority on small-cap biotech stock picks.
The company profile is available at http://www.investorideas.com/CO/UVFT/ for interested biotech investors.
UVFT Profile Updates:
UV Flu Technologies Video: http://www.itsallbull.net/iabtv.php?id=424&ref=newsletter
Research Report; MWMarketMovers.com Analyst Report by Michael Williams
Full report at http://www.MWMarketMovers.com
Biotech News Update: A 12-page analyst report on UV Flu Technologies, Inc. (OTCBB: UVFT) will be carried by The Wall Street Journal as an advertising insert in the October 27th edition of the paper. The Wall Street Journal is published by Dow Jones, a world-class publisher of financial and business newspapers, newswires, indexes, magazines, and more. The report has been authored by Michael Williams Market Movers and can also be found online by visiting http://www.MWMarketMovers.com With the cold and flu season around the corner, the report highlights how UV Flu Technologies’ innovative products and technologies address indoor air quality issues (where bacteria may be present) by killing airborne bacteria and other contaminants at rates exceeding 99.2% on a first-pass basis. UVFT’s flagship product, the Viratech UV-400 air purification system, has been issued a coveted Class II medical listing from the FDA that enables UV Flu Technologies to market the product as a medical device. Details regarding how UVFT’s technology works are identified within the report. The 12-page color report will be featured in the center of home-delivered copies of tomorrow’s (Wednesday’s) Wall Street Journal. The Wall Street Journal has a total average paid circulation of more than 1.5 million, according to the last Newspaper Publisher’s Statement filed in March 2010 with the Audit Bureau of Circulations. For more information on the company featured in the report, call http://www.uvflutech.com About Michael Williams Market Movers:At Michael Williams Market Movers, we keep our finger on the pulse of change - in commerce, biotech, energy, and digital opportunities way before other investors ever hear about them. To learn more, visit http://www.mwmarketmovers.com .
About UVFT.OB: UV Flu Technologies, Inc. (OTCBB: UVFT) is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector. The Company manufactures the ViraTech UV-400, which utilizes high-intensity germicidal 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. VIRATECH UV-400 is a Class II medical device and is available
UV Flu Technologies (OTCBB: UVFT) is a showcase biotech stock on Investorideas.com (please read disclosure and disclaimers)
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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.
Disclaimer: The following news is paid for by third party on behalf of UV Flu Technologies, Inc., (three 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.
The research report is the content and opinion of Michael Williams at MWMarketMovers.com and not the opinion of Investorideas.com or related websites.
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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.
Point Roberts, WA –October 26, 2010 (Investorideas.com Newswire, www.biotechindustrystocks.com) reports the following updates for showcase biotech stock UV Flu Technologies, Inc. (OTCBB: UVFT) Recent updates to the company profile include a new trading /stock Video by www.itsabull.net, in addition to and analyst report by Michael Williams. Michael Williams is America’s top authority on small-cap biotech stock picks.
The company profile is available at http://www.investorideas.com/CO/UVFT/ for interested biotech investors.
UVFT Profile Updates:
UV Flu Technologies Video: http://www.itsallbull.net/iabtv.php?id=424&ref=newsletter
Research Report; MWMarketMovers.com Analyst Report by Michael Williams
Full report at http://www.MWMarketMovers.com
Biotech News Update: A 12-page analyst report on UV Flu Technologies, Inc. (OTCBB: UVFT) will be carried by The Wall Street Journal as an advertising insert in the October 27th edition of the paper. The Wall Street Journal is published by Dow Jones, a world-class publisher of financial and business newspapers, newswires, indexes, magazines, and more. The report has been authored by Michael Williams Market Movers and can also be found online by visiting http://www.MWMarketMovers.com With the cold and flu season around the corner, the report highlights how UV Flu Technologies’ innovative products and technologies address indoor air quality issues (where bacteria may be present) by killing airborne bacteria and other contaminants at rates exceeding 99.2% on a first-pass basis. UVFT’s flagship product, the Viratech UV-400 air purification system, has been issued a coveted Class II medical listing from the FDA that enables UV Flu Technologies to market the product as a medical device. Details regarding how UVFT’s technology works are identified within the report. The 12-page color report will be featured in the center of home-delivered copies of tomorrow’s (Wednesday’s) Wall Street Journal. The Wall Street Journal has a total average paid circulation of more than 1.5 million, according to the last Newspaper Publisher’s Statement filed in March 2010 with the Audit Bureau of Circulations. For more information on the company featured in the report, call http://www.uvflutech.com About Michael Williams Market Movers:At Michael Williams Market Movers, we keep our finger on the pulse of change - in commerce, biotech, energy, and digital opportunities way before other investors ever hear about them. To learn more, visit http://www.mwmarketmovers.com .
About UVFT.OB: UV Flu Technologies, Inc. (OTCBB: UVFT) is an innovative developer, manufacturer and distributor of bio technology products initially targeting the rapidly growing Indoor Air Quality ("IAQ") industry sector. The Company manufactures the ViraTech UV-400, which utilizes high-intensity germicidal 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. VIRATECH UV-400 is a Class II medical device and is available
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
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.
Disclaimer: The following news is paid for by third party on behalf of UV Flu Technologies, Inc., (three 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.
The research report is the content and opinion of Michael Williams at MWMarketMovers.com and not the opinion of Investorideas.com or related websites.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
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Published at www.Investorideas.com - Global research by sectors
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Investorideas.com - NASDAQ Biotech News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Presenting at Upcoming Oppenheimer Healthcare Conference and Singular Research Conference
Investorideas.com - NASDAQ Biotech News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Presenting at Upcoming Oppenheimer Healthcare Conference and Singular Research Conference
NASDAQ Biotech company will provide status update on Phase III clinical studies for the treatment of female sexual dysfunction for investor conferences
Visit this company: www.biosantepharma.com
LINCOLNSHIRE, Ill. - October 26, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports it will present at the Oppenheimer Healthcare Conference being held in New York on November 2-3, 2010, and the Singular Research Conference being held on November 4, 2010 in Los Angeles.
Stephen M. Simes, BioSante's president & chief executive officer, will speak on Wednesday, November 3, 2010 at 10:50 am ET at the Oppenheimer Healthcare Conference. Phillip B. Donenberg, BioSante's senior vice president of finance and CFO will present on Thursday, November 4, 2010 at 1:20 pm PT at the Singular Research Conference.
Messrs Simes and Donenberg will provide a status update on BioSante's lead program, LibiGel® (testosterone gel), in Phase III clinical studies for the treatment of female sexual dysfunction, as well as a general overview of BioSante. A live audio webcast of Mr. Simes' remarks may be accessed at http://www.veracast.com/webcasts/opco/healthcare2010/86205557.cfm and a replay will be available at the same link.
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, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
BioSante Pharmaceuticals
For Media:The Trout Group LLCTricia Swanson(646) 378-2953tswanson@troutgroup.com
Or
For Investors:McKinney/ChicagoAlan Zachary(312) 944-6784 ext. 316azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com - http://www.investorideas.com/CO/BPAX/
Request News and Info on BPAX - http://www.investorideas.com/Resources/Newsletter.asp
Visit this company: www.biosantepharma.com
Disclosure, Disclaimer: BPAX is a paid advertising client on Investorideas.com.
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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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.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.aspInvestorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
NASDAQ Biotech company will provide status update on Phase III clinical studies for the treatment of female sexual dysfunction for investor conferences
Visit this company: www.biosantepharma.com
LINCOLNSHIRE, Ill. - October 26, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) reports it will present at the Oppenheimer Healthcare Conference being held in New York on November 2-3, 2010, and the Singular Research Conference being held on November 4, 2010 in Los Angeles.
Stephen M. Simes, BioSante's president & chief executive officer, will speak on Wednesday, November 3, 2010 at 10:50 am ET at the Oppenheimer Healthcare Conference. Phillip B. Donenberg, BioSante's senior vice president of finance and CFO will present on Thursday, November 4, 2010 at 1:20 pm PT at the Singular Research Conference.
Messrs Simes and Donenberg will provide a status update on BioSante's lead program, LibiGel® (testosterone gel), in Phase III clinical studies for the treatment of female sexual dysfunction, as well as a general overview of BioSante. A live audio webcast of Mr. Simes' remarks may be accessed at http://www.veracast.com/webcasts/opco/healthcare2010/86205557.cfm and a replay will be available at the same link.
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, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and other technologies. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
BioSante Pharmaceuticals
For Media:The Trout Group LLCTricia Swanson(646) 378-2953tswanson@troutgroup.com
Or
For Investors:McKinney/ChicagoAlan Zachary(312) 944-6784 ext. 316azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com - http://www.investorideas.com/CO/BPAX/
Request News and Info on BPAX - http://www.investorideas.com/Resources/Newsletter.asp
Visit this company: www.biosantepharma.com
Disclosure, Disclaimer: BPAX is a paid advertising client on Investorideas.com.
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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Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.aspInvestorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Investorideas.com - Biotech Stocks Update; UV Flu Technologies (OTCBB: UVFT) Featured in MWMarketMovers.com Analyst Report; Carried in Wednesday's Wall Street Journal
Investorideas.com - Biotech Stocks Update; UV Flu Technologies (OTCBB: UVFT) Featured in MWMarketMovers.com Analyst Report; Carried in Wednesday's Wall Street Journal
Analyst Report by Michael Williams; Published in Wall Street Journal, October 27, 2010
Visit this company: www.uvflutech.com
New York, NY – October 26, 2010 (Investorideas.com Newswire) - Biotech News Update: A 12-page analyst report on UV Flu Technologies, Inc. (OTCBB: UVFT) will be carried by The Wall Street Journal as an advertising insert in the October 27th edition of the paper. The Wall Street Journal is published by Dow Jones, a world-class publisher of financial and business newspapers, newswires, indexes, magazines, and more. The report has been authored by Michael Williams Market Movers and can also be found online by visiting www.MWMarketMovers.com
With the cold and flu season around the corner, the report highlights how UV Flu Technologies' innovative products and technologies address indoor air quality issues (where bacteria may be present) by killing airborne bacteria and other contaminants at rates exceeding 99.2% on a first-pass basis. UVFT's flagship product, the Viratech UV-400 air purification system, has been issued a coveted Class II medical listing from the FDA that enables UV Flu Technologies to market the product as a medical device. Details regarding how UVFT's technology works are identified within the report.
The 12-page color report will be featured in the center of home-delivered copies of tomorrow's (Wednesday's) Wall Street Journal. The Wall Street Journal has a total average paid circulation of more than 1.5 million, according to the last Newspaper Publisher's Statement filed in March 2010 with the Audit Bureau of Circulations.
For more information on the company featured in the report, call the registered UV Flu Technologies' investor relations office at 1-888-355-8838 or visit www.UVFluTech.com
About Michael Williams Market Movers:
At Michael Williams Market Movers, we keep our finger on the pulse of change - in commerce, biotech, energy, and digital opportunities way before other investors ever hear about them. To learn more, visit www.MWMarketMovers.com. MWMarketMovers.com is owned by MS Corporate Communications, Inc. Information and opinions found on MWMarketMovers.com or published by MWMarketMovers.com (MS Corporate Communications, Inc.), including web, email, print and video, are for informational and advertising purposes only. No statement or expression of opinion, nor any other matter herein, directly or indirectly, is an offer or the solicitation of any offer to buy or sell securities mentioned, nor any other securities. MWMarketMovers.com (MS Corporate Communications, Inc.) and Michael Williams are not registered investment advisors. MWMarketMovers.com (MS Corporate Communications, Inc.) does not guarantee the accuracy or completeness of information, nor does MWMarketMovers.com (MS Corporate Communications, Inc.) assume any liability for any loss that may result from reliance by any person upon any such information or recommendations. Such information & recommendations are for general or advertising information only. Information contained in this report contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the expected continual growth of the market for the specific company's products, the company's ability to fund its capital requirement in the near term and in the long term; pricing pressures; etc. This advertisement is a solicitation for subscriptions. UV Flu Technologies Inc. (hereafter “UV”), the company featured in this report, appears as paid advertising, paid by Cosworth Communications Limited (a non-affiliated third-party). UV has neither approved nor paid for this specific advertisement. Michael Williams Market Movers received a Fourteen Thousand dollar editorial fee from Cosworth Communications Limited, to cover editorial costs associated with the development of this advertising report. Michael Williams Market Movers stands to make a profit from the editorial services charged. Michael Williams Market Movers expects to generate new subscriber revenue, the amount of which is unknown at this time, to its online newsletter through the distribution of this advertisement.
Contact: Michael Williams, Michael Williams Market Movers, (212) 671-1148, info@mwmarketmovers.com
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
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Request info:
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Research more biotech stocks at the Biotech stocks Directory:
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Analyst Report by Michael Williams; Published in Wall Street Journal, October 27, 2010
Visit this company: www.uvflutech.com
New York, NY – October 26, 2010 (Investorideas.com Newswire) - Biotech News Update: A 12-page analyst report on UV Flu Technologies, Inc. (OTCBB: UVFT) will be carried by The Wall Street Journal as an advertising insert in the October 27th edition of the paper. The Wall Street Journal is published by Dow Jones, a world-class publisher of financial and business newspapers, newswires, indexes, magazines, and more. The report has been authored by Michael Williams Market Movers and can also be found online by visiting www.MWMarketMovers.com
With the cold and flu season around the corner, the report highlights how UV Flu Technologies' innovative products and technologies address indoor air quality issues (where bacteria may be present) by killing airborne bacteria and other contaminants at rates exceeding 99.2% on a first-pass basis. UVFT's flagship product, the Viratech UV-400 air purification system, has been issued a coveted Class II medical listing from the FDA that enables UV Flu Technologies to market the product as a medical device. Details regarding how UVFT's technology works are identified within the report.
The 12-page color report will be featured in the center of home-delivered copies of tomorrow's (Wednesday's) Wall Street Journal. The Wall Street Journal has a total average paid circulation of more than 1.5 million, according to the last Newspaper Publisher's Statement filed in March 2010 with the Audit Bureau of Circulations.
For more information on the company featured in the report, call the registered UV Flu Technologies' investor relations office at 1-888-355-8838 or visit www.UVFluTech.com
About Michael Williams Market Movers:
At Michael Williams Market Movers, we keep our finger on the pulse of change - in commerce, biotech, energy, and digital opportunities way before other investors ever hear about them. To learn more, visit www.MWMarketMovers.com. MWMarketMovers.com is owned by MS Corporate Communications, Inc. Information and opinions found on MWMarketMovers.com or published by MWMarketMovers.com (MS Corporate Communications, Inc.), including web, email, print and video, are for informational and advertising purposes only. No statement or expression of opinion, nor any other matter herein, directly or indirectly, is an offer or the solicitation of any offer to buy or sell securities mentioned, nor any other securities. MWMarketMovers.com (MS Corporate Communications, Inc.) and Michael Williams are not registered investment advisors. MWMarketMovers.com (MS Corporate Communications, Inc.) does not guarantee the accuracy or completeness of information, nor does MWMarketMovers.com (MS Corporate Communications, Inc.) assume any liability for any loss that may result from reliance by any person upon any such information or recommendations. Such information & recommendations are for general or advertising information only. Information contained in this report contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including statements regarding the expected continual growth of the market for the specific company's products, the company's ability to fund its capital requirement in the near term and in the long term; pricing pressures; etc. This advertisement is a solicitation for subscriptions. UV Flu Technologies Inc. (hereafter “UV”), the company featured in this report, appears as paid advertising, paid by Cosworth Communications Limited (a non-affiliated third-party). UV has neither approved nor paid for this specific advertisement. Michael Williams Market Movers received a Fourteen Thousand dollar editorial fee from Cosworth Communications Limited, to cover editorial costs associated with the development of this advertising report. Michael Williams Market Movers stands to make a profit from the editorial services charged. Michael Williams Market Movers expects to generate new subscriber revenue, the amount of which is unknown at this time, to its online newsletter through the distribution of this advertisement.
Contact: Michael Williams, Michael Williams Market Movers, (212) 671-1148, info@mwmarketmovers.com
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About our Biotech investor portal:
www.BiotechIndustryStocks.com is a global meeting place for investors and industry following the biotech and pharma sector, within Investorideas.com. Global visitors use the site daily to research the latest news, articles, audio, research reports and our stock directories.
Disclaimer: The following news is paid for by third party on behalf of UV Flu Technologies, Inc., (three 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.
The research report is the content and opinion of Michael Williams at MWMarketMovers.com and not the opinion of Investorideas.com or related websites.
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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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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.
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.
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Monday, October 25, 2010
Investorideas.com - Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Reports Positive LibiGel® Data Monitoring Committee Recommendation
Investorideas.com - Biotech/Pharma Stock News; BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) Reports Positive LibiGel® Data Monitoring Committee Recommendation
Visit this company: www.biosantepharma.com
LINCOLNSHIRE, Ill. - October 25, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. 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 currently no FDA approved product.
"We are very pleased that the DMC recommended that the study should continue without modification. This means that there are no general or specific safety issues based on their unblinded review of adverse events. The low number of CV events to date is consistent with the safety of testosterone in women," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects into the study will be complete. The current LibiGel safety study protocol allows for up to 4,000 women to be enrolled."
Another unblinded statistical analysis will be conducted by the DMC each time there is an additional adjudicated cardiovascular event. With approximately 2,300 women-years of exposure in the study, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, compared to an expected rate of CV events for this study of approximately two percent. Moreover, there have been seven breast cancers reported, a rate of approximately 0.32 percent, compared to an expected rate of approximately 0.35 percent.
Subjects have been in the study for an average of approximately 10.7 months. There are approximately 850 subjects who have been in the study for over one year and approximately 400 subjects who have been in the study for more than two years. The LibiGel Phase III safety study represents the largest data base of the safety of testosterone in women. A new drug application (NDA) can be submitted after an average of 12 months of exposure with subjects followed for five years in total, including after NDA submission and potential FDA approval. BioSante's objective is to submit the LibiGel NDA in 2011.
The statistical analyses of the CV events are based on predefined statistical methods, in accordance with BioSante's agreement with the FDA, to determine if LibiGel can be considered safe for post-menopausal women. Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
"With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD," said Stephen M. Simes, BioSante's president & CEO.
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and 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 Media:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Investors:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
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Visit this company: www.biosantepharma.com
LINCOLNSHIRE, Ill. - October 25, 2010 (Investorideas.com newswire) BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that the Phase III LibiGel (testosterone gel) cardiovascular and breast cancer safety study will continue without modifications and will continue to enroll new subjects as a result of the fourth unblinded review of adverse events and the first unblinded statistical analysis for sample-size determination by its independent Data Monitoring Committee (DMC). The review and statistical analysis were based on 2,500 subjects who have been enrolled in the study. 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 currently no FDA approved product.
"We are very pleased that the DMC recommended that the study should continue without modification. This means that there are no general or specific safety issues based on their unblinded review of adverse events. The low number of CV events to date is consistent with the safety of testosterone in women," stated Michael Snabes, M.D., Ph.D., the senior vice president of medical affairs for BioSante. "Once the DMC determines that there are enough subjects enrolled for statistical significance, enrollment of new subjects into the study will be complete. The current LibiGel safety study protocol allows for up to 4,000 women to be enrolled."
Another unblinded statistical analysis will be conducted by the DMC each time there is an additional adjudicated cardiovascular event. With approximately 2,300 women-years of exposure in the study, there have been only 14 adjudicated cardiovascular (CV) events, a rate of approximately 0.65 percent, compared to an expected rate of CV events for this study of approximately two percent. Moreover, there have been seven breast cancers reported, a rate of approximately 0.32 percent, compared to an expected rate of approximately 0.35 percent.
Subjects have been in the study for an average of approximately 10.7 months. There are approximately 850 subjects who have been in the study for over one year and approximately 400 subjects who have been in the study for more than two years. The LibiGel Phase III safety study represents the largest data base of the safety of testosterone in women. A new drug application (NDA) can be submitted after an average of 12 months of exposure with subjects followed for five years in total, including after NDA submission and potential FDA approval. BioSante's objective is to submit the LibiGel NDA in 2011.
The statistical analyses of the CV events are based on predefined statistical methods, in accordance with BioSante's agreement with the FDA, to determine if LibiGel can be considered safe for post-menopausal women. Upon completion of the statistical analyses of the safety study and efficacy trials, BioSante intends to submit an NDA to the FDA, requesting approval to market LibiGel for the treatment of HSDD in menopausal women.
"With this most recent favorable DMC recommendation, we continue to believe that LibiGel will be the first product approved by the FDA to treat HSDD in menopausal women, also referred to as FSD," said Stephen M. Simes, BioSante's president & CEO.
About the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study
The Phase III LibiGel safety study is a randomized, double-blind, placebo-controlled, multi-center, cardiovascular (CV) events and breast cancer study that will enroll between 2,500 and 4,000 women. The study will continue for a total of five years, however, BioSante can use the safety study data as part of an NDA submission after an average of 12 months of exposure to LibiGel or placebo.
The LibiGel safety study is tracking a predefined list of CV events, in agreement with the FDA, including CV death, myocardial infarction and stroke in women 50 years of age or older and suffering from at least two CV risk factors including hypertension and diabetes. The objective of the safety study is to show the relative safety of testosterone compared to placebo in the number of CV events. The incidence of breast cancer also is being tracked over the course of the study.
About LibiGel®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD). The on-going Phase III efficacy trials are double-blind, placebo-controlled trials that will enroll up to approximately 500 surgically menopausal women each for a six-month clinical trial. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is absorbed quickly through the skin after applying a once-daily pea-sized topical application on the upper arm that delivers testosterone to the bloodstream evenly over time.
In a Phase II trial, LibiGel significantly increased the number of satisfying sexual events in surgically menopausal women suffering from FSD by 238 percent versus baseline (p < 0.0001); this increase also was significant versus placebo (p < 0.05). In this study, the effective dose of LibiGel produced testosterone blood levels within the normal range for pre-menopausal women and had a safety profile similar to that observed in the placebo group. In addition, no serious adverse events and no discontinuations due to adverse events occurred in any subject receiving LibiGel. The Phase II clinical trial was a double-blind, placebo-controlled trial, conducted in the United States, in surgically menopausal women distressed by their low sexual desire and activity.
About BioSante Pharmaceuticals, Inc.
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment, and Elestrin™ (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, which is marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines (GVAX), three 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 developing its calcium phosphate technology (CaP) for aesthetic medicine (BioLook™), among other uses, as well as seeking opportunities for its 2A/Furin and 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 Media:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Investors:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
Visit the BPAX showcase profile at Investorideas.com
Request News and Info on BPAX
Disclosure, Disclaimer/ BPAX is a paid advertising client on Investorideas.com.
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.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
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 DirectoryBiotech Companies - become a biotech showcase stock on www.investorideas.com and www.biotechindustrystocks.com for as little as $1000 month !
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