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BioSante Pharmaceuticals Monetizes a Portion of U.S. Elestrin™ Royalties

Up to $3.2 million to be received plus potential for $140 million in sales-based milestones

LINCOLNSHIRE, Illinois (December 8, 2009) – BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) today announced that it has monetized a portion of its Elestrin (estradiol gel) royalty stream for $1.0 million, through a royalty buydown, with the possibility of receiving an additional $2.2 million in further buy downs within 75 days. The royalty stream was sold to Azur Pharma, BioSante’s Elestrin licensee in the U.S. In addition, BioSante has maintained the right to receive up to $140 million in sales–based milestone payments, if Elestrin reaches certain predefined sales per calendar year. This transaction affects Elestrin royalties in the U.S. only.

“We are pleased to close this transaction with Azur. Although we believe Azur is doing an excellent job in marketing Elestrin to estrogen prescribing doctors in the U.S. and sales of Elestrin have been growing each month, we wanted to bring value to our stockholders faster than growth of Elestrin would allow,” said Stephen M. Simes, president & CEO of BioSante. “We will use the additional non–dilutive cash from this transaction together with the cash we raised in our August registered direct financing and the October acquisition of Cell Genesys to complete LibiGel® (testosterone gel) Phase III clinical study enrollment in the first half of 2010. Our objective is to submit a LibiGel new drug application (NDA) to the FDA in the first half of 2011, for a potential approval by the end of 2011.”

On signing of the monetization transaction with Azur, BioSante received a payment of $1.0 million in exchange for an initial “buydown” of Elestrin royalties. The next payment of $1.05 million, payable at Azur’s option within 35 days, will buydown royalties further, and the last payment of $1.15 million, payable at Azur’s option within 75 days, will buy out BioSante’s share of the royalties Azur still will be responsible for all royalty payments due Antares Pharma, BioSante’s licensor for estradiol gel. BioSante will pay to Antares 12.5% of the second and third payments only.

About BioSante Pharmaceuticals, Inc.

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism. BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III clinical development by BioSante under a U.S. Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the treatment of female sexual dysfunction (FSD), and Elestrin™ (estradiol gel) developed through FDA approval by BioSante, indicated for the treatment of moderate–to–severe vasomotor symptoms associated with menopause, currently marketed in the U.S.

Also in development are Bio–T–Gel™, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II clinical development using BioSante patented technology. The current market in the U.S. for estrogen and testosterone products is approximately $2.5 billion and for oral contraceptives approximately $3 billion. Under BioSante’s license agreement with Antares Pharma, BioSante is required to pay Antares a portion of the royalties, license and milestone payments received for products covered by that agreement. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLook™). Additional information is available online at:


For more information please contact:

For Media:
Harris D. McKinney, Inc.
Alan Zachary
(312) 506-5220

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