BioSante Pharmaceuticals Announces Receipt of NIH Grant for Inhaled Interferon

BioSante Pharmaceuticals Announces Receipt of NIH Grant for Inhaled Interferon

LINCOLNSHIRE, Ill.--(BUSINESS WIRE)--BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today that the company has been awarded a $150,000 Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support the company's development of formulations for the pulmonary delivery of interferon alpha (IFN-α) using its proprietary calcium phosphate nanoparticulate (CaP) technology.

The new grant will be used to fund product development for IFN-α formulated with CaP particles for administration via inhalation. The desired outcome is safe and effective treatment of hepatitis B and C. An inhaled product may allow for convenient self treatment which would be an improvement over the current injectable IFN-α. Dr. Tulin Morcol, director of preclinical development for BioSante, will serve as the principle investigator.

Dr. Morcol said, "Our advanced CaP technology for inhaled drugs (BioAirTM) not only allows noninvasive delivery of large molecule drugs, but also may substantially reduce the size and frequency of dosing required." Dr. Morcol noted that this innovative technology also is being developed for topical/transdermal delivery of large proteins.

"We are honored to receive this grant from the NIH," said Stephen M. Simes, president and chief executive officer of BioSante. "This represents further validation of the potential use our CaP technology for alternative delivery of current drug formulations.

Initiated by the NIH in 1982, the SBIR grants program is designed to encourage research and development of innovative technology by small businesses with the potential for commercialization. Phase I grants of up to $150,000 are awarded for research establishing technical merit and feasibility of the project. Successful programs are eligible to apply for Phase II grants of up to $2,000,000 to continue the research. Each division of the NIH awards its own grants to qualified companies; BioSante's grant is from the National Institute of Allergy and Infectious Diseases (NIAID).

"The reduced bioavailability observed with previous delivery systems for inhaled drugs (such as ExuberaTM Insulin) has been a major concern, and have been called insurmountable," said Dr. Morcol. "However, results of this study may support the potential use of CaP particles to increase the safety and effectiveness of drug delivery through the lung."

About Bio-AirTM and Bio-VantTM

BioSante's proprietary calcium phosphate nanoparticles (CaP) are vehicles for delivering drugs and vaccines more efficiently, and enhancing their therapeutic effects. BioSante is developing Bio-Air using CaP to improve the delivery and therapeutic effects of proteins, including insulin and IFN-α. Bio-Vant is being developed using CaP as an adjuvant to improve the safety and efficacy of vaccines. The CaP technology consists of microscopic particles of a natural compound similar to that found in teeth and bones. The patented formulation is nontoxic and biodegradable, offering a multitude of potential medical applications.

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 ElestrinTM (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-GelTM, a testosterone gel for male hypogonadism, and an oral contraceptive in Phase II/III 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. The company also is developing its calcium phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic medicine (BioLookTM). Additional information is available online

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding BioSante contained in this news release that are not historical in nature, particularly those that utilize terminology such as "will," "potential", "could," "can," "intends," "continue," "plans," "expects" or comparable terminology, are forward-looking statements. Forward-looking statements are based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to BioSante that could cause actual results to differ materially from those expressed in such forward-looking statements include the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance, the success of clinical testing, and other factors identified and discussed from time to time in BioSante's filings with the Securities and Exchange Commission, including those factors discussed in BioSante's most recent annual report on Form 10-K and subsequent quarterly report on Form 10-Q, which discussions also are incorporated herein by reference. All forward-looking statements 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.