SOURCE: Omni Bio Pharmaceutical, Inc.

Omni Bio Pharmaceutical, Inc.

November 18, 2014 08:00 ET

Omni Bio Successfully Completes Cell Line Optimization for Novel Recombinant Biologic

Achieves Critical Manufacturing Milestone for Production of AAT-Fc

Engages Destum Partners, Inc. to Advise on Business Development Initiatives

FORT COLLINS, CO--(Marketwired - Nov 18, 2014) -  Omni Bio Pharmaceutical, Inc. (OTCBB: OMBP) ("Omni Bio"), an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory diseases, announced today its manufacturing partners, Patheon and Sigma-Aldrich Fine Chemicals (SAFC), have successfully identified several high-expression cell lines able to produce Omni Bio's novel recombinant alpha-1 antitrypsin molecule (AAT-Fc) in large enough quantities to be considered commercially viable. This is a highly significant de-risking milestone that enables Omni Bio to move toward IND-enabling toxicology studies with the first and only pharmaceutically feasible recombinant AAT candidate currently in development.

Ten candidate cell lines have been selected for further characterization based on their ability to achieve economically attractive AAT-Fc yields. The best performing cell line is expected to move into manufacturing scale-up activities in early 2015 to support further preclinical investigations and early clinical studies. 

Bruce Schneider, Ph.D., Chief Executive Officer of Omni Bio, stated, "On behalf of Omni Bio and our manufacturing partners, we are thrilled to achieve this critical milestone. This achievement sets us apart from other companies that have attempted and failed to produce a recombinant AAT molecule in a pharmaceutically appropriate form. Our Fc fusion technology not only enables scalable manufacturing of this novel product candidate, but also offers the promise of significantly improved potency, longer duration of action and patient-friendly subcutaneous dosing compared to current plasma-derived AAT products. We have now set the stage for the testing of AAT-Fc in various immune-mediated inflammatory diseases, including but not limited to Type 1 diabetes, graft-versus-host disease and chronic gout."

Having achieved this important value inflection point, Omni Bio also announced that it has engaged Destum Partners, Inc. (Destum), a biopharmaceutical and life sciences-focused advisory firm, to assist the company in securing a strategic partner for advancement of AAT-Fc. The company's goal is to license rights to develop and commercialize AAT-Fc, and certain other intellectual property, as a means of infusing Omni Bio with non-dilutive capital to fuel ongoing operating activities.

Dr. Schneider concluded, "Destum's results-oriented track record in pharmaceutical business development is impressive. With a key development hurdle for AAT-Fc now overcome, we look forward to working closely with them to identify one or more partners who can help us accelerate our efforts to bring our AAT-Fc treatment candidate to patients."

About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical, Inc. ("Omni Bio") is an emerging biopharmaceutical company focused on revolutionizing the treatment of immune-mediated inflammatory disease. The Company's technology platform, AAT-Fc, is a recombinant version of plasma-derived alpha-1 antitrypsin (p-AAT), a naturally occurring human protein that is currently commercialized as an intravenous supplementation therapy for AAT-deficient individuals. Omni Bio seeks to capitalize on emerging scientific evidence of AAT's fundamental role in mediating multiple anti-inflammatory and tissue protective pathways by developing first-in-class therapeutics to address a broad array of new clinical opportunities.

Omni Bio's recombinant AAT-Fc can offer several potential advantages over current p-AAT products, including superior potency, longer half-life, improved safety and easy-to-administer subcutaneous dosing, as well as significantly enhanced manufacturing scalability. Omni Bio intends to exploit AAT-Fc's enhanced product potential to address multiple, high-value immune-mediated inflammatory disease indications, such as Type 1 diabetes, graft versus host disease and chronic gout. The Company holds broad intellectual property covering both recombinant and plasma-derived AAT for these and other indications.

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About Patheon
Patheon® is a leading provider of contract development and commercial manufacturing (CDMO) services to the global pharmaceutical industry for a full array of solid and sterile dosage forms, including small molecule API and biologic drug substances. Patheon, a business unit of DPx Holdings B.V., recently strengthened its biologics capabilities through its recent acquisition of Gallus BioPharmaceuticals. The combined commercial manufacturing capabilities and pharmaceutical product development service group is #1 in product development services, #2 in commercial scale product manufacturing and is #1 in quality.

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Forward-Looking Statements
This press release contains forward-looking statements that reflect the Company's current expectations as of the date of this press release, and involve certain risks and uncertainties that could cause actual results to differ materially from those anticipated in these forward-looking statements. Factors that could cause future results to materially differ from forward-looking statements include the risks described in Omni Bio Pharmaceutical, Inc.'s Form 10-K for the fiscal year ended March 31, 2014 and other reports filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements. The Company's further development is highly dependent on raising capital to support its activities, future medical and research developments and market acceptance, and other risks that are outside of the Company's control.

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