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Symbol: NASDAQ: BPAX

Sector: Biotech / Pharma

Website: biosantepharma.com


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Company Research

Analyst Coverage for BioSante

JMP Securities Clear Timelines Set for LibiGel; Initiating Coverage with Market Outperform Rating - March 16, 2011
Leerink Swann
Oppenheimer & Co.
Rodman & Renshaw
Roth Capital Partners
Singular Research

 

Company Overview

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 (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 using BioSante patented technology. Additional information is available online at: www.biosantepharma.com.

 

Management

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

Stephen M. Simes
President & Chief Executive Officer
BioSante Pharmaceuticals, Inc.

Stephen M. Simes has served as Vice Chairman, President, Chief Executive Officer and a director of BioSante Pharmaceuticals, Inc., since 1998.

From 1994 to 1997, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., (currently a wholly owned subsidiary of Abbott Laboratories) a company with a product focus on infectious diseases, AIDS, endocrinology and oncology. From 1989 to 1993, Mr. Simes was Chairman, President and Chief Executive Officer of Gynex Pharmaceuticals, Inc., a company which concentrated on the AIDS, endocrinology, urology and growth disorders markets. In 1993, Gynex was acquired by Savient Pharmaceuticals Inc. (formerly Bio-Technology General Corp.), and from 1993 to 1994, Mr. Simes served as Senior Vice President and director of Savient Pharmaceuticals Inc. Mr. Simes's career in the pharmaceutical industry started in 1974 with G.D. Searle & Co. (now a part of Pfizer Inc.). Mr. Simes also serves as BioSante’s designee on the board of directors of Ceregene, Inc., a privately held biotechnology company focused on the treatment of major neurodegenerative disorders.

 

Lead Products - Multi-Billion Dollar Markets

BioSante is focused on developing innovative products for female sexual health and oncology. The current market for testosterone and estrogen products is approximately $2.5 billion dollars in the U.S. alone, with estimates for female sexual dysfunction (FSD) 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 is over $20 billion.

BioSante's lead near term product in development is LibiGel® (testosterone gel) for the treatment of FSD. 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.

BioSante's marketed product, Elestrin™, 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.

Bio-T-Gel™ for the treatment of male hypogonadism, or low testosterone levels, has an NDA pending with a PDUFA date of November 14, 2011; to be marketed by Teva Pharmaceuticals. The current testosterone gel market in the U.S. for male hypogonadism is over $1.1 billion.

BioSante is focused primarily on LibiGel, however, the Company also is seeking 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 and melanoma vaccines.

 

Management Team

Stephen M. Simes
President & Chief Executive Officer
BioSante Pharmaceuticals, Inc.

Stephen M. Simes has served as Vice Chairman, President, Chief Executive Officer and a director of BioSante Pharmaceuticals, Inc., since 1998.

From 1994 to 1997, Mr. Simes was President, Chief Executive Officer and a Director of Unimed Pharmaceuticals, Inc., (currently a wholly owned subsidiary of Abbott Laboratories) a company with a product focus on infectious diseases, AIDS, endocrinology and oncology. From 1989 to 1993, Mr. Simes was Chairman, President and Chief Executive Officer of Gynex Pharmaceuticals, Inc., a company which concentrated on the AIDS, endocrinology, urology and growth disorders markets. In 1993, Gynex was acquired by Savient Pharmaceuticals Inc. (formerly Bio-Technology General Corp.), and from 1993 to 1994, Mr. Simes served as Senior Vice President and director of Savient Pharmaceuticals Inc. Mr. Simes's career in the pharmaceutical industry started in 1974 with G.D. Searle & Co. (now a part of Pfizer Inc.). Mr. Simes also serves as BioSante’s designee on the board of directors of Ceregene, Inc., a privately held biotechnology company focused on the treatment of major neurodegenerative disorders.

Phillip B. Donenberg, CPA (Senior Vice President of Finance, Chief Financial Officer and Secretary)

Mr. Donenberg served as our Chief Financial Officer, Treasurer and Secretary from 1998 to 2010.

Before joining our company, Mr. Donenberg was Controller of Unimed Pharmaceuticals, Inc. (currently a wholly owned subsidiary of Abbott Laboratories) from 1995 to 1998. Prior to Unimed Pharmaceuticals, Inc., Mr. Donenberg held similar positions with other pharmaceutical companies, including Gynex Pharmaceuticals, Inc. (currently Savient Pharmaceuticals, Inc.), Applied NeuroSolutions, Inc. (formerly Molecular Geriatrics Corporation) and Xtramedics, Inc

William D. Milling, CPA (Vice President, Operations)

Mr. Milling served as our Controller and Senior Director of Operations from 2004 to 2010.

Before joining our company, Mr. Milling was the Controller of Dor BioPharma from 2002 to 2004. From 1994 to 2002, Mr. Milling was with CCH, Inc. where he held various financial and systems positions of increasing responsibility.

Michael C. Snabes, M.D., Ph.D. (Senior Vice President Medical Affairs)

Dr. Snabes served as our Vice President of Clinical Development from 2008 to 2010. Prior to this, Dr. Snabes served as a medical consultant to BioSante on clinical and regulatory matters since 2005. Dr. Snabes is a board certified reproductive endocrinologist, as well as holding a Ph.D. in physiology and reproductive endocrinology.

Before joining our company, Dr. Snabes was an Associate Professor in the Section of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology at The University of Chicago Pritzker School of Medicine. From 2003 to 2004, Dr. Snabes served as Medical Advisor in Clinical Research and Development in Inflammation, Arthritis, and Pain at Pfizer, Inc. and from 1999-2003 in the same position at Pharmacia, Inc. where he worked on the successful development of the COX-2 inhibitors, Celebrex and Bextra. From 1997 to 1999, Dr. Snabes served as Associate Director in Clinical Research in Women's Health at Searle/Monsanto. Dr. Snabes is an elected Fellow of the American College of Obstetrics and Gynecology, the American College of Surgeons and the American College of Endocrinology. Dr. Snabes is the author of more than 135 publications and abstracts.

Joanne Zborowski (Vice President, Clinical Development)

Ms. Zborowski has served as our Vice President of Clinical Development since 2010. Prior to this Ms. Zborowski served as Director of Clinical Development since 2007 and has been with BioSante since 2002.

Before joining our company, Ms. Zborowski began her pharmaceutical industry career with Abbott Laboratories. From 1990 to 1998, she held positions in Medical Affairs and the Pharmaceutical Products Division where she worked on neuroscience, oncology and cardiovascular indications. Ms. Zborowski held similar consulting positions from 1999-2002

Jeffrey W. Winkelman, Ph.D., J.D. (Vice President, Oncology Programs)

Dr. Winkelman has served as our Vice President, Oncology Programs since 2010, and as a consultant to the Company since 2009.

Before joining our Company, Dr. Winkelman was President, IP Solutions, an independent biotechnology consulting firm. From 2004 until 2008, Dr. Winkelman was the Vice President, Intellectual Property at Cell Genesys, Inc. From 1994 until 2004, Dr. Winkelman held a number of other similar positions with other biotechnology companies, including Sibia Neurosciences, Inc., Advanced Tissue Sciences, Inc. and Elitra Pharmaceuticals. Dr. Winkelman was also an associate at the IP law firm of Brown, Martin, Haller & McClain.

 

Key Products

LibiGel® - In development under an SPA for treatment of female sexual dysfunction. Three Phase III safety and efficacy clinical studies are ongoing.

Elestrin™ - FDA approved transdermal gel for treatment of hot flashes; currently marketed in the U.S. by Azur Pharma.

Bio-T-Gel™ - NDA filed by Teva; PDUFA date of November 14, 2011

The Pill-Plus™ - Triple component 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.

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX)

 

Financial Highlights

  • At March 31, 2011, BioSante had approximately $51M in cash
  • Monthly burn rate of $4.0M

 

Investment Highlights

  • Financial resources to continue corporate strategy
  • 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.
  • Bio-T-Gel™ has an NDA pending with a PDUFA date of November 14, 2011
  • Proprietary cancer vaccines in Phase II clinical trials
  • Focused growth strategy
  • Management's proven ability to gain FDA approval, implement plans and increase stockholder value

 

Trading Data

NASDAQ: BPAX

Recent Price (7/15/11): $3.64

Market Cap: $342M

Average Daily Volume: 2.6M

Common Shares Outstanding: 93.6M

52-Week Range: $1.29-$4.02

Fiscal Year Ends: December 31

 

PR & IR contacts:

For Media:

McKinney/Chicago
Alan Zachary
(312) 506-5220; azachary@mckinneychicago.com

For Investors:

The Trout Group LLC
Tricia Swanson
(646) 378-2953; tswanson@troutgroup.com

Legal Counsel

Oppenheimer Wolff & Donnelly LLP
Minneapolis, MN

Auditors

Deloitte & Touche LLP
Chicago, IL

 

News for BioSante Pharmaceuticals, Inc.:

 

Media Links:

Top Stock Alerts for Day Traders: KeyCorp, Sirius, ON Semiconductor, and BioSante - February 8, 2012

Perception, Opportunity in Volatility - Research & Analysis on Dendreon Corporation and BioSante Pharmaceuticals, Inc. - February 7, 2012

BioSante Pharma Readying Release of 'Female Viagra' Study Results - December 14, 2011

The Next Big Things In Biotech: Biosante, The street.com

3 Small-Cap Stocks on Insiders' Radar - November 18, 2011

Trades give BioSante healthy outlook - September 12, 2011

7 Cheap Biotechs That Could Double Or Triple By Next Year - Seeking Alpha - Sept 12 2011

thepharmaletter.com – June 8, 2011 - US FDA lifts clinical hold on BioSante GVAX prostate cancer vaccine
BioSante Pharmaceuticals (Nasdaq: BPAX) says that the US Food and Drug Administration’s clinical hold on the GVAX Prostate Cancer Vaccine (GVAX Prostate) for the treatment of prostate cancer has been lifted by the agency. Manufacturing of new GVAX Prostate is complete, and planning for a Phase II clinical trial at the Johns Hopkins Kimmel Cancer Center is underway, the company notes.

March 11 2011, CeoCfoInterviews.com Interview with Mr. Stephen Simes of Biosante (NASDAQ: BPAX): "With An Eye on Women's Sexual Health, BioSante Pharmaceuticals, Inc. is Developing their LibiGel® for the Treatment of Female Sexual Dysfunction for which there is No Approved Product in the United States" - March 11, 2011

Biosante Pharma Up After FDA Announces Review of Testosterone Gel - April 13, 2011
http://seekingalpha.com/article/263360-biosante-pharma-up-after-fda-announces-review-of-testosterone-gel?source=yahoo

Drug stocks inch higher in afternoon trading - April 13, 2011
http://www.marketwatch.com/story/analyst-ratings-boost-drug-stocks-2011-04-13?siteid=yhoof

FDA to review Teva testosterone gel
http://finance.yahoo.com/news/FDA-to-review-Teva-apf-135579406.html?x=0&.v=1

BioSante says FDA accepts filing for male testosterone gel - April 13, 2011
http://www.reuters.com/article/2011/04/13/us-biosante-idUSTRE73C2RV20110413? feedType=RSS&feedName=globalMarketsNews&rpc=43

InPlay - April 13, 2011
http://finance.yahoo.com/marketupdate/inplay#bpax

Speculative Biotech Firms Remain Popular Takeover Targets - March 17, 2011
http://finance.yahoo.com/news/Speculative-Biotech-Firms-iw-2766337194.html?x=0&.v=1

BioSante says direct offering could net $23.8M - March 4, 2011
http://finance.yahoo.com/news/BioSante-says-direct-offering-apf-2617744049.html?x=0&.v=1

BioSante, Vivus in drug-sector spotlight - March 4, 2011
http://www.marketwatch.com/story/biosante-vivus-in-drug-sector-spotlight-2011-03-04?siteid=yhoof

BioSante drug meets study goals, shares rise - March 3, 2011
http://finance.yahoo.com/news/BioSante-drug-meets-study-apf-2474429190.html?x=0&.v=1

Top 24 Small Cap Stocks Being Chased by Smart Money - February 16, 2011
http://seekingalpha.com/article/253142-top-24-small-cap-stocks-being-chased-by-smart-money?source=yahoo

BioSante, Cardinal, JPMorgan, Power-One: U.S. Equity Preview - February 14, 2011
http://www.bloomberg.com/news/2011-02-11/biogen-procter-gamble-tootsie-roll-u-s-equity-preview.html?cmpid=yhoo

BioSante says tests for female sex drug positive - February 14, 2011
http://finance.yahoo.com/news/BioSante-says-tests-for-apf-1363512093.html?x=0&.v=1

Ahead of the Bell: BioSante Pharma shares rise - February 14, 2011
http://finance.yahoo.com/news/Ahead-of-the-Bell-BioSante-apf-2676662000.html?x=0&.v=1

5 Stocks Approaching Greatness - February 8, 2011
http://www.fool.com/investing/general/2011/02/07/5-stocks-approaching-greatness.aspx

TRADERS GOBBLING UP SHARES OF BIOSANTE PHARMACEUTICALS, SHARES UP 3.5% (BPAX) - February 4, 2011
http://www.zacks.com/research/get_news.php?id=035l9643

Wall Street's Best Hidden Stocks - February 1, 2011
http://www.fool.com/investing/general/2011/02/01/wall-streets-best-hidden-stocks.aspx

UPDATE 1-BioSante gets orphan status for skin cancer vaccine - January 25, 2011
http://www.reuters.com/article/idUSSGE70O0CG20110125?feedType=RSS&feedName=rbssHealthcareNews&rpc=43

Exciting Opportunities Emerge in Biotech Sector - January 10, 2011
http://finance.yahoo.com/news/Exciting-Opportunities-Emerge-iw-3174394165.html?x=0&.v=1

US HOT STOCKS: GM, Santarus, BioSante Pharmaceuticals - December 28, 2010
http://online.wsj.com/article/BT-CO-20101228-703506.html

BioSante Attracts Institutional Investors Ahead of Key FDA Catalysts in 2011 - December 28, 2010
http://seekingalpha.com/article/243819-biosante-attracts-institutional-investors-ahead-of-key-fda-catalysts-in-2011?source=yahoo

BioSante, Education Management, Tesla, TPC: U.S. Equity Movers - December 27, 2010
http://www.businessweek.com/news/2010-12-27/biosante-education-management-tesla-tpc-u-s-equity-movers.html

Biosante Drops on Securities Sale - December 27, 2010
http://www.thestreet.com/_yahoo/story/10956098/1/biosante-drops-on-securities-sale.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

Is BioSante Pharmaceuticals Next in Line to Receive Institutional Praise? - December 27, 2010
http://seekingalpha.com/article/243652-is-biosante-pharmaceuticals-next-in-line-to-receive-institutional-praise?source=yahoo

Biotech Stock Mailbag: Amarin - December 3, 2010
http://www.thestreet.com/_yahoo/story/10937085/1/biotech-stock-mailbag-amarin.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA

BPAX Featured in Seeking Alpha Article ;Amgen, Celgene and Novartis in the Fight Against Pancreatic Cancer
by: Michael Becker October 26, 2010
about: AAPL / ALPMY.PK / AMGN / BAYRY.PK / BPAX / CELG / CLDX / GNVC / IMMU / INFI / LLY / NVS / ONCY / PCYC / PFE / REGN / RHHBY.PK / SCLN / SGEN / SNY / SUPG / THLD
http://seekingalpha.com/article/232174-amgen-celgene-and-novartis-in-the-fight-against-pancreatic-cancer?source=yahoo

http://www.biosantepharma.com/downloads/BioSante-Fact-Sheet.pdf

http://www.biosantepharma.com/LibiGel.php

http://www.biosantepharma.com/NASDAQ.php

Websites

www.biosantepharma.com
www.thebloomstudy.com

Research Reports

Oppenheimer & Co.
Rodman & Renshaw
Roth Capital Partners

 

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