SOURCE: ONI BioPharma Inc.

October 16, 2008 10:55 ET

ONI BioPharma Inc. Announces Latin American Affiliate

ALACHUA, FL--(Marketwire - October 16, 2008) - ONI BioPharma Inc. (AMEX: ONI) announced today that it has agreed to terms with its partners for the creation of a corporate affiliate to serve the rapidly emerging Latin American market. This new company is to be based in Mexico City and will pursue scientific discovery and clinical trials, and sell and distribute products in Mexico, Central America, the Caribbean, and South America. This vast region has a population of approximately 1 billion, which will benefit from both existing ONI products and new products to be developed in conjunction with scientists seeking solutions to a vast array of biotechnological issues.

Bringing ONI's products and technologies to this tremendous market is a major step in the Company's goal of creating a global enterprise where its currently commercialized products, such as the Evora™ oral health care line and PIVIAT™ and PCMAT™ enhanced diagnostic platforms, will be available to Latin America. The Company expects revenues from its Latin American expansion early in the next calendar year. These revenues will augment the Company's expected revenues in the United States.

In addition, the Company plans to complete clinical testing and seek registration in selected countries for its long-awaited SMART™ dental therapy line, which will decrease the risk of tooth decay for a lifetime with a single dose. Furthermore, the Company intends to clinically test and seek registration, where appropriate, for its other products, including groundbreaking antibiotics created synthetically using its DPOLT™ technology.

Finally, the Company intends to apply, in cooperation with academic and industrial partners, its extraordinary platform technologies, PIVIAT™ and PCMAT™, to meet challenges in human healthcare, diagnostics, agricultural diseases, and animal diseases that plague Latin America, as well as other fast-emerging countries around the world. ONI already has the necessary technology to achieve these goals. In time, ONI intends to seek a presence in the European markets from its U.S. headquarters or through its Latin American subsidiary, depending on regulatory timing and other factors.

Stanley B. Stein, the President and Chief Executive of ONI, stated that, "For too long the enormous health challenges of Latin America and the Caribbean have been overlooked and avoided by pharma companies. The reality is that Mexico and neighboring countries have first rate science that will be amplified by ONI's biotechnological expertise. The result will be an explosion of biotechnological solutions to the litany of diseases that confront the region. I believe ONI will thrive in this region."

ONI's partner in this expansion is Dr. Raúl Medina-Mora, a "thought leader" in the global scientific, academic, and technology communities. Dr. Medina-Mora comes from a family that has devoted itself to public service in Mexico. Dr. Medina-Mora is joined by his long time business partner, Mr. Alejandro Martinez, a leader in the information technology field. ONI expects its Latin American affiliate will be a leader in biotechnology. Its founders hope that its success will augment efforts already underway to position Mexico as a center for excellence in biotechnology.

The transaction is conditioned on ratification by ONI's Board of Directors. ONI is being advised by Shumaker, Loop & Kendrick, LLP and Baker & McKenzie.

About ONI BioPharma Inc.

ONI BioPharma Inc. is a biopharmaceutical company with a pipeline of unique proprietary technologies, some of which are being commercialized. The Company also has a number of products in discovery, preclinical and clinical development, with a concentration in the main therapeutic area of infectious diseases, diagnostics, and oral health. The Company has developed platform technologies with respect to its products, thereby creating a pipeline of future products, which the Company expects to develop.

Safe Harbor Statement: Under the Private Securities Litigation Reform Act of 1995: This release includes forward-looking statements that reflect ONI BioPharma's current views with respect to future events and financial performance. These forward-looking statements are based on management's beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to those set forth in our most recently filed annual report on Form 10-KSB and quarterly report on Form 10-Q, and other factors detailed from time to time in filings with the Securities and Exchange Commission. We expressly disclaim any responsibility to update forward-looking statements.

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