SOURCE: ONI BioPharma Inc.

October 14, 2008 16:30 ET

ONI BioPharma Inc. Announces Successful Antibiotic Synthesis Using DPOLT™ Technology

ALACHUA, FL--(Marketwire - October 14, 2008) - ONI BioPharma Inc. (AMEX: ONI) announced today the successful synthesis of an antibiotic using its proprietary DPOLT technology. The molecule belongs to a class of antibiotics called Lantibiotics that were first discovered over 80 years ago. Although there are now over 50 different Lantibiotics known, this is the first report of a cost-effective method for making one in sufficient quantities and with sufficient purity to enable comprehensive testing and commercial viability.

This initial antibiotic is very closely related to ONI's lead antibiotic, MU1140, which has the potential to treat a wide variety of infections, including those caused by MRSA and other drug resistant Gram positive bacteria. Domestically, hospital acquired infections have been on the rise, with an estimated two million patients contracting dangerous infections annually leading to one hundred thousand deaths. Preliminary studies also indicate that MU1140 may be the first new antibiotic in 35 years for the treatment of tuberculosis.

Dr. Jeffrey D. Hillman, ONI's Chief Scientific Officer, stated that, "This successful proof of principle of DPOLT is the result of many years of very hard, extremely imaginative work by our scientists. In addition to MU1140, this technology will allow us to synthesize all 50 of the known lantibiotics and to conveniently modify their structures in order to improve their usefulness as antibiotics for the treatment of infectious diseases. In effect, DPOLT should provide a much needed pipeline of antibiotics at a time when drug resistant bacteria are on the rise."

Stanley B. Stein, the Company's President and CEO stated today that, "The development of the DPOLT synthetic route to a novel class of antibiotics is nothing less than a seminal healthcare event, and could not have come at a more compelling time. We anticipate that synthetic MU1140, with additional synthetic Lantibiotics to follow, will potentially save hundreds of thousands, if not millions, of lives around the world."

As a first step in further development, the Company has retained Almac Sciences, a leading contract manufacturer and a division of the Almac Group, to refine and scale-up GMP production of the synthetic MU1140 analogue to achieve sufficient quantities for it to be fully tested for regulatory approval. It is estimated that the regulatory process will take three years before this drug could become available. Other synthetic Lantibiotics will follow as they are developed and tested.

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.

About Almac

The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

The company has almost 2,200 employees and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company's new $100m North American Headquarters started in July 08 and is expected to be completed 2010.

To find out more about Almac visit

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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