FAST Act to Modernize Approval Process -- Cardium and BioSante Poised to Benefit

2012-03-19 08:20 ET - News Release

NEW YORK, NY -- (MARKET WIRE) -- 03/19/12

Biotechnology stocks continue to be some of the strongest performers in the markets as favorable legislation out of Washington boosts the sector's reach. The iShares NASDAQ Biotechnology Index (IBB) is currently up more than 16 percent year to date, reflecting an uptick in investor sentiment. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Cardium Therapeutics Inc. (NYSE Amex: CXM) & BioSante Pharmaceuticals Inc. (NASDAQ: BPAX). Access to the full company reports can be found at:

www.paragonreport.com/CXM

www.paragonreport.com/BPAX

Earlier this month the Biotechnology Industry Organization applauded the Faster Access to Specialized Treatments (FAST) Act. According to BIO the legislation will modernize the Accelerated Approval pathway to expedite the development of modern, targeted, and personalized therapies for patients suffering from serious and life-threatening diseases.

BIO President and CEO Jim Greenwood says the FAST act will speed access to innovative new therapies and cures to patients living with debilitating and life-threatening diseases such as Parkinson's, Alzheimer's, diabetes and numerous rare diseases for which there is currently no treatment or cure.

The Paragon Report provides investors with an excellent first step in their due diligence by providing daily trading ideas, and consolidating the public information available on them. For more investment research on the biotechnology industry register with us free at www.paragonreport.com and get exclusive access to our numerous stock reports and industry newsletters.

Cardium Therapeutics is focused on the acquisition and strategic development of new and innovative bio-medical product opportunities and businesses with the potential to address significant unmet medical needs that have definable pathways to commercialization, partnering and other economic monetizations. Earlier this month the company reported that it is making its MedPodium Nutra-Apps products available across the United States by working with Nutritional Products International (NPI) and InHealth Media.

BioSante is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). Earlier this month the company reported that its net loss was $51.6 million or $0.52 per share for the year ended December 31, 2011, compared to a net loss of $46.2 million or $0.70 per share for 2010.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at http://www.paragonreport.com/disclaimer  

hier noch ,
bis sich die bude ausgekotzt hat...

eine zulassung fda und dann sowas  

schau dir mal DSCO an... da genau das gleiche! Bin froh, dass ich da noch mit Gewinn raus war!

 

BioSante Pharmaceuticals Announces Positive Pill-Plus™ Data Presentation

2012-03-20 07:55 ET - News Release

Improvements reported in sexual desire, arousal, responsiveness and activity


LINCOLNSHIRE, Ill. -- (Business Wire)

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that data from studies of the Pill-Plus “triple component” oral contraceptive were presented on March 10, 2012 by Pantarhei Bioscience at the World Congress of Gynecological Endocrinology in Florence, Italy. The title of the Pantarhei presentation was, “Clinical effects of normalizing testosterone levels during oral contraception.” The United States patents for oral use of the Pill-Plus are licensed by BioSante to Pantarhei Bioscience, a Netherlands-based pharmaceutical company, for development and marketing in the United States. BioSante retains rights to the Pill-Plus for transdermal development and marketing.

To date, six prospective, randomized controlled (placebo or active) Phase II clinical studies of the Pill-Plus have been completed in 355 subjects. In these studies, use of the Pill-Plus has been shown to increase frequency of sexual activity, arousal, responsiveness to partner, genital sensations and vaginal lubrication. In addition, improvements were seen in quality of life scores. No significant androgenic effects were noted.

“We are pleased with the results to date in the clinical work being carried out by Pantarhei Bioscience,” said Stephen M. Simes, BioSante’s president & CEO. Herjan J.T. Coelingh Bennink, Pantarhei’s president and CEO added, “With these positive clinical results in hand, Pantarhei’s current objective is to seek a development partner to move the Pill-Plus concept into Phase III clinical development.”

BioSante will receive royalty payments on sales of the Pill-Plus in the U.S., if and when introduced. If the product is sublicensed by Pantarhei to another company BioSante will receive a percentage of any and all payments received by Pantarhei for the sublicense from a third party. BioSante has retained all rights under the BioSante-licensed patents to the transdermal delivery of triple component contraceptives.

The Pill-Plus concept, also known as Androgen Restored Contraception (ARC), is to create an oral contraceptive that protects against androgen loss which occurs with current oral contraceptives, potentially causing reduced arousal, orgasms, pleasure and less frequent satisfying sexual activity in oral contraceptive users. The restoration of testosterone levels is achieved by adding the natural human adrenal steroid DHEA to current estrogen/progestogen combination oral contraceptives. DHEA restores testosterone levels by metabolic conversion to testosterone.

About Pantarhei Bioscience B.V.

Pantarhei Bioscience B.V. is a bioscience company located in Zeist, the Netherlands. Its management has an extensive track record in the pharmaceutical industry. Pantarhei develops patent protected new medical uses of existing compounds (hormones, biologicals and approved drugs) in Women’s Health and Endocrine Cancer. Pantarhei operates by outsourcing all activities with the objective to obtain patent protection of concepts and demonstrate proof of concept (phase II) in the human. For development and commercialization into the final phase III, Pantarhei will generally seek partnerships with pharmaceutical companies. Additional information is available online at: www.pantarheibio.com.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante´s licensee. Additional information is available online at: www.biosantepharma.com.

Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s and Pantarhei’s plans, objectives, expectations and intentions with respect to its products and other statements identified by words such as "anticipates," "will," "continue," "could," "believe," "intends," "expects," "plans," “hopes,” "may," "potential," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante´s actual results to be materially different than those expressed in or implied by BioSante´s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante´s actual results are described in BioSante´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com  

Was ist mit News..? Kein Beitrag mehr wert hier..?!

 

 

 

@st
die meisten leute , die sich als wohl erzogen
fuehlen,
haben nicht mal ne genaue satzstellung
um sich gegen irgendwas
im staat ...oder sonstwo ..firma
durchzusetzen..  

oder wie....?

da oben um 2 dollar ist noch ein offnes gap...

vllt machen sich da mal einige dran ..das zu schliessen  

reinziehen ...
im jahreschart   faellt die kruecke seit mitte februar
und der macd   waechst immer noch in den ueberkauften
bereich

die muessen noch mit den schiebeperlen
http://www.rechnen-ohne-strom.de/rechner-galerie/zahlenschieber/
rechnen...hahahaaaaaaa  

BioSante Pharmaceuticals, Inc. to Present at BioCentury Future Leaders in the Biotech Industry Conference

2012-04-17 07:55 ET - News Release


LINCOLNSHIRE, Ill. -- (Business Wire)

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that Stephen M. Simes, BioSante’s president & CEO will present a corporate update at the BioCentury Future Leaders in the Biotech Industry Conference in New York on April 20, 2012 at 11:00 am EDT.

A live audio webcast of remarks by Mr. Simes may be accessed at http://www.media-server.com/m/p/96c3m5dm. The webcast will be archived for 90 days.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, for which a New Drug Application (NDA) was approved by the FDA on February 14, 2012, which is licensed to Teva Pharmaceuticals USA, Inc., and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Jazz Pharmaceuticals, BioSante´s licensee. Additional information is available online at: www.biosantepharma.com.

Contacts:

For Investors:
The Trout Group LLC
Tricia Swanson, (646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary, 312-506-5220
azachary@harrisdmckinney.com

Source: BioSante Pharmaceuticals, Inc.  

 

Pharmaceutical Companies Look To Biotech Industry To Combat Losses From Expiring Patents
April 23, 2012

The Paragon Report Provides Stock Research on Biosante Pharmaceuticals Inc. and Exelixis, Inc.

New York, NY (Marketwire) - Mergers and Acquisitions have been a hot topic in in the Biotechnology Industry recently. Pharmaceutical giants face an unprecedented number of patent expirations for its pharmaceutical products between 2009 and 2013. It is apparent that pharmaceutical companies have begun to make strategic decisions to combat the anticipated losses. The Paragon Report examines investing opportunities in the Biotechnology Industry and provides equity research on Biosante Pharmaceuticals Inc. (NASDAQ: BPAX) and Exelixis, Inc. (NASDAQ: EXEL).  

In September, Sangamo presented data at a scientific conference showing that its gene therapy helped six patients fight off HIV without use of other drugs. The most common side effect for patients was a persistent smell of garlic, the study found.

Today’s study was funded by the National Institutes of Health in Bethesda, Maryland, the University of Pennsylvania Center for AIDS Research, and the Infectious Diseases Clinical Research Program, a U.S. Department of Defense project. Some of the study patients were recruited by Cell Genesys, now a unit of BioSante Pharmaceuticals Inc. (BPAX) (BPAX)


http://www.businessweek.com/news/2012-05-02/...-that-may-widen-use#p2  

BioSante Pharmaceuticals Reports First Quarter Financial Results

2012-05-08 16:05 ET - News Release


LINCOLNSHIRE, Ill. -- (Business Wire)

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today reported on its financial results for the first quarter of 2012 and cash balance as of March 31, 2012.

BioSante’s cash balance as of March 31, 2012 was approximately $49.5 million, compared to a cash balance of approximately $57.3 million on December 31, 2011.

BioSante incurred a net loss of approximately $10.3 million or $(0.09) per share for the quarter ended March 31, 2012, compared to a net loss of $17.3 million or $(0.20) per share for the same period in 2011. The decrease in the net loss was due primarily to lower expenses associated with the clinical development of LibiGel® (testosterone gel).

BioSante’s corporate strategy always has included product development of high value medically-needed pharmaceutical products. In light of the top-line results from the two pivotal LibiGel Phase III efficacy trials, which indicated that LibiGel did not meet its co-primary or secondary endpoints, management continues to assess LibiGel’s path forward and potential alternative strategies to utilize the continuing LibiGel Phase III cardiovascular events and breast cancer safety study. Management also has expanded efforts to explore new product development projects through in-licensing and mergers and acquisitions as well as to develop further the GVAX cancer vaccine portfolio.

The current projected cash burn rate for 2012 is approximately $2.5 million per month, including expenditures related to the ongoing LibiGel safety study. If a decision is made to halt the LibiGel safety study, the monthly cash burn rate will decline to approximately $1.5 million per month, pending other product development and corporate activities.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante´s products include LibiGel® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development. BioSante also is developing a portfolio of cancer vaccines, with 17 Phase I and Phase II clinical trials currently on-going. Four of these vaccines have been granted Orphan Drug designation by the U.S. Food and Drug Administration (FDA). BioSante´s other products include a testosterone gel for male hypogonadism, which is licensed to Teva Pharmaceuticals USA, Inc., and for which a New Drug Application (NDA) was approved by the FDA in February 2012, and the Pill-Plus™, an oral contraceptive in Phase II clinical development by Pantarhei Bioscience B.V. BioSante´s first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, is marketed in the U.S. by Jazz Pharmaceuticals, BioSante´s licensee. Additional information is available online at: www.biosantepharma.com.

Forward-Looking Statements

To the extent any statements made in this news release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about BioSante’s future monthly burn rate and other statements identified by words such as "anticipates," "will," "continue," "could," "believes," "intends," "expects," “projects,” "may," "potential," other words of similar meaning, derivations of such words and the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante´s actual results to be materially different than those expressed in or implied by BioSante´s forward-looking statements. For BioSante, particular uncertainties and risks include, among others, uncertainties regarding clinical testing, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing and other success of BioSante´s licensees or sublicensees and BioSante´s future revenues, if any, from its licensees and sublicensees; uncertainties relating to the future and costs of BioSante´s product development programs and BioSante´s need for and ability to obtain additional financing if needed. More detailed information on these and additional factors that could affect BioSante´s actual results are described in BioSante´s filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K. All forward-looking statements in this news release speak only as of the date of this news release and are based on BioSante´s current beliefs and expectations. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
Harris D. McKinney, Inc.
Alan Zachary
312-506-5220
azachary@harrisdmckinney.com

Source: BioSante Pharmaceuticals, Inc.  

keine Umsätze (Revenues)

durchschnittliches Cash-burn von 13 Mio. $ pro Quartal

Mittelbeschaffung nur durch Ausgabe neue Aktien möglich  

und schonwieder knapp 20% rückgang in nichtmal einer woche

http://www.mysmartrend.com/news-briefs/...ante-pharmaceuticals-bpax-0  

short squezze ?  

keryx steigt heute auch wieder - dort sehe ich noch bessere chance auf long - aber momentan biotech wohl eher die zockeraktien!

 

Bist du noch investiert bei KERX? Ich dachte, du bist bei 2,00$ raus... weil es so ruhig geworden ist ;)

 

mein SL hat es gezogen mit 20 Prozent Gewinn. Geld erstmal parken und Monat Mai abwarten!

 

 

Übertreib nicht, aber es sieht nicht schlecht aus.  

liegt doch was in der luft? über 9,25 mio stk gehandelt

bei steigendem kurs

servu$