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Thursday, April 21, 2011

Biotech/Pharma Investor Spotlight; Profile for BioSante Pharmaceuticals (NASDAQ: BPAX) and its Lead Products, LibiGel® and Bio-T-Gel™

Point Roberts, WA - April 21, 2011 (Investorideas.com Newswire) Investorideas.com, a leader in sector stock research including biotech and pharma stocks, profiles BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) and its lead products, LibiGel® (testosterone gel) and Bio-T-Gel.
Hi-lights are featured within the research report, updated product brochure, recent news and a recent Q&A interview.
Recent Equity Research:
"Our $5 price target is derived by applying a 5x multiple to our base case projection for LibiGel sales of $422MM in 2016, discounted by 30% per year." JMP Securities
Read the full report:
http://www.investorideas.com/CO/BPAX/news/Initiating-Coverage-031611.pdf
Recent News for LibiGel Product:
Biotech/Pharma Stock News; BioSante Pharmaceuticals (NASDAQ: BPAX) Completes Enrollment in Both Pivotal LibiGel® Phase III Efficacy Trials
LINCOLNSHIRE , Ill. - March 30, 2011 (Investorideas.com newswire) - BioSante Pharmaceuticals, Inc. (NASDAQ:BPAX) today announced that enrollment of subjects in the second of two pivotal Phase III LibiGel (testosterone gel) safety and efficacy trials has been completed. Enrollment in the first LibiGel efficacy trial was completed in February. The efficacy trials are being conducted under an FDA-approved special protocol assessment (SPA) agreement. LibiGel is in development for the treatment of female sexual dysfunction (FSD), specifically, hypoactive sexual desire disorder (HSDD) in menopausal women, for which there is no FDA-approved product.
"This is an important achievement for BioSante and a key step toward completing the LibiGel Phase III clinical development program," said Joanne Zborowski, BioSante's vice president of clinical development. "There are more than 1,000 subjects in the efficacy trials and we anticipate announcing top-line efficacy data this fall. In addition, we have over 3,000 subjects enrolled in our LibiGel Phase III safety study," she added.
Read Full News at: http://www.investorideas.com/CO/BPAX/news/2011/03301.asp
Highlights from the LibiGel Brochure:
Read the Full Brochure at: http://www.biosantepharma.com/libigel/LibiGel-Brochure.pdf
Recent News for Bio-T-Gel: Bio-T-Gel NDA pending with PDUFA date of November 14, 2011. NDA filed by Teva
On April 13, 2011, BioSante announced that a New Drug Application (NDA) has been accepted for filing by the U.S. Food and Drug Administration (FDA) following submission in January 2011 by a subsidiary of Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA). The FDA has assigned a PDUFA date of November 14, 2011. The PDUFA date is the target date for the FDA to complete its review of the NDA.
Bio-T-Gel is a testosterone gel for the treatment of male hypogonadism or low testosterone levels. Bio-T-Gel was developed initially by BioSante, and then it was licensed to Teva for late stage clinical development. Teva is responsible for all Bio-T-Gel regulatory and marketing activities. BioSante will receive certain milestone payments and royalties upon commercialization. The current U.S. market for male testosterone products is over $1.2 billion .
LibiGel R & D Event
On April 7, 2011, BioSante hosted a review of female sexual dysfunction (FSD) and the safety of testosterone in women by independent experts, as well as an update of the LibiGel (testosterone gel) development program, for institutional investors and analysts in New York City. The full presentations and slides presented at the LibiGel R & D Event are available on BioSante’s website at www.biosantepharma.com
Interview
Full interview with Mr. Simes can be read here: http://www.investorideas.com/CO/BPAX/news/2011/03281.asp
About BioSante Pharmaceuticals, Inc.
BioSante (NASDAQ: BPAX) is a specialty pharmaceutical company focused on developing products for female sexual health and oncology. BioSante’s lead products include LibiGel ® (transdermal testosterone gel) for the treatment of female sexual dysfunction (FSD) which is in Phase III clinical development under a U.S. Food and Drug Administration (FDA) Special Protocol Assessment. BioSante’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 products are Bio-T-Gel™, a testosterone gel for male hypogonadism, for which an NDA is pending with a PDUFA date of November 14, 2011, licensed to Teva Pharmaceuticals, and an oral contraceptive in Phase II clinical development using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.
This news release may contain forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include statements about BioSante’s plans, objectives, expectations and intentions with respect to future operations and products, future market acceptance, size and potential of LibiGel and other statements identified by words such as "will,” "potential,” "could,” "would,” "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 presentation speak only as of the date of this presentation. BioSante undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact BioSante:
For Investors:
The Trout Group LLC
> Tricia Swanson
(646) 378-2953
tswanson@troutgroup.com
or
For Media:
McKinney/Chicago
Alan Zachary
(312) 944-6784 ext. 316
azachary@mckinneychicago.com
The full BPAX company profile is available at Investorideas.com
http://www.investorideas.com/CO/BPAX/
Research more biotech stocks at the Biotech stocks Directory: http://www.investorideas.com/BIS/Stock_List.asp
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