Investorideas.com newswire, breaking biotechnology and pharma news

Tuesday, November 15, 2011

Biotech News Alert; Investor Update for BioSante Pharmaceuticals (NasdaqGM: BPAX); Jefferies Initiating at Buy: Positive Ahead of Phase III LibiGel Data

Point Roberts, WA - November 15, 2011 - Investorideas.com, an investor research portal specializing in sector research including biotech and pharma stocks, issues an investor update for BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX). Jefferies & Company, Inc. has initiated a buy rating on the stock with a price target of $5.00, driven by Phase III LibiGel testosterone gel.
Jefferies thinks investors should own BioSante Pharmaceuticals, Inc. (NasdaqGM: BPAX) in front of LibiGel P3 data in early December.
According to Jefferies & Company, Inc. "Our $5 PT is based on an SOTP valuation, driven primarily by a LibiGel DCF (out to 2026, discounted 15%). We assume a LibiGel partnership w/ traditional 15-25% royalties, but have milestones as upside to our model. Risks include: negative LibiGel P3 efficacy (Dec.) & safety (3Q12) results; LibiGel regulatory delay/rejection; and an inability to partner LibiGel."
About LibiGel ®
LibiGel is a testosterone gel in Phase III clinical development for the treatment of women who suffer from female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD). The completed Phase III efficacy trials are double-blind, placebo-controlled trials that enrolled over 500 surgically menopausal women each for six-months of therapy. The completed efficacy trials were conducted under an FDA-agreed 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. (NASDAQ:BPAX)
BioSante is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante's lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD), specifically hypoactive sexual desire disorder (HSDD), which is in Phase III clinical development according to a U.S. Food and Drug Administration (FDA) Special Protocol Assessment (SPA). BioSante's first FDA-approved product is Elestrin™ (estradiol gel) indicated for the treatment of hot flashes associated with menopause, marketed in the U.S. by Azur Pharma, BioSante's licensee. BioSante also is developing a portfolio of cancer vaccines, four of which have been granted Orphan Drug designation, and are currently in several Phase II clinical trials. Other BioSante products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development. Additional information is available online at: www.biosantepharma.com.
For more information, please contact:
For Investors:
The Trout Group LLC
Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
For Media:
Harris D. McKinney
Alan Zachary
312-506-5220
azachary@harrisdmckinney.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,� �continue,� �could,� �believe,� �intends,� �continue,� �expects,� �anticipates,� �estimates,� �may,� other words of similar meaning, derivations of such words or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause BioSante's actual results to be materially different than those expressed in or implied by BioSante's forward-looking statements. For BioSante, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of BioSante's licensees or sublicensees; the success of clinical testing; and BioSante's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect BioSante's actual results are described in BioSante's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
About InvestorIdeas.com:
InvestorIdeas.com is a leader in investor stock research by sectors. Sectors we cover include; water stocks, gold and mining stocks, China stocks, oil and gas stocks, renewable energy stocks, coal stocks, tech stocks, biotech stocks, defense stocks, nanotech, agriculture and gaming.
Follow Investorideas.com on Twitter http://twitter.com/#!/Investorideas
Follow Investorideas.com on Facebook http://www.facebook.com/Investorideas
Disclaimer/ Disclosure : The Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising. BioSante is a paid advertising biotech stock on Investorideas.com (six thousand five hundred for three months)
Source - Investorideas.com 800-665-0411
BioSante Pharmaceuticals, Inc: (NASDAQ: BPAX) is a featured showcase biotech/pharma stock on Investorideas.com
Request news, updates and trading alerts on BPAX and other showcase stocks http://www.investorideas.com/Resources/Newsletter.asp
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
About InvestorIdeas.com:
InvestorIdeas.com is a leading global investor and industry research resource portal specialized in sector investing, covering leading industry sectors including biotech and pharma stocks.
Disclaimer: The following news/content is paid for as part of the BPAX showcase program (two thousand per month) Investorideas.com is a third party publisher of news and research Our sites do not make recommendations, but offer information portals to research news, articles, stock lists and recent research. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. This site is currently compensated by featured companies, news submissions and online advertising.
Investorideas.com Disclaimer: http://www.investorideas.com/About/Disclaimer.asp
Investorideas.com Disclosure: http://www.investorideas.com/About/News/Clientspecifics.asp
Source: Investorideas.com, BioSante, Investorideas.com
800 665 0411 cvanzant@investorideas.com

No comments:

Post a Comment