Gallus Enters Cell Line Optimization and Manufacturing Agreement with Omni Bio Pharmaceutical
(St. Louis, MO, April 29, 2014) – Gallus BioPharmaceuticals, LLC (Gallus), a premier pure-play biologics contract development and manufacturing organization (CMO), and Omni Bio Pharmaceutical, Inc. (Omni Bio) (OMBP.ob), a biopharmaceutical company focused on the commercialization of alternative uses of alpha-1 antitrypsin (AAT) for the treatment of a variety of indications and the development of next-generation recombinant forms of AAT, jointly announced finalization of a multi-stage manufacturing services agreement.
The agreement includes cell line optimization, analytical development and manufacturing scale-up activities for Omni Bio’s leading AAT Fc fusion protein with the goal of providing cGMP product to support animal toxicology studies and early clinical trials of the molecule. Under the agreement, Omni Bio has selected the commercially available CHOZN® GS Cell line commercially available from Sigma-Aldrich’s custom manufacturing and services business unit SAFC® Commercial, as the expression system. In addition, SAFC® will perform the cell line development and safety testing services, in conjunction with Gallus’ overall management of the process development and manufacturing services program for Omni Bio.
“Gallus is delighted to partner with Omni Bio in the cell line optimization, process development and clinical supply of their AAT Fc protein” said Mark R. Bamforth, Gallus’ President & CEO. “We are confident that our deep process development expertise and direct experience with Fc fusion molecules will result in high quality material effectively delivered to meet Omni Bio’s goals.”
“We are also quite pleased to be entering into this relationship with Gallus, a very experienced CMO with an excellent track record of manufacturing both early-stage and commercial-stage biopharmaceutical products” commented Dr. Bruce Schneider, CEO, Omni Bio. “We look forward to working with the Gallus technical team to advance our recombinant AAT molecule into the clinic as efficiently and effectively as possible.”
About Alpha-1 Antitrypsin (AAT)
AAT is the most abundant circulating serine protease inhibitor in the body and an acute phase reactant. Systemic deficiency in AAT due to genetic mutations can result in debilitating liver failure and chronic lung disease such as emphysema. Lifelong treatment with plasma-derived AAT, intravenously administered, is indicated for such patients. Recent evidence suggests that AAT plays an important role in modulating immunity, inflammation and apoptosis. AAT protects various cell types from cell death, inhibits caspases-1 and -3 activity and has been shown to be effective in a wide variety of animal models of human disease, including diabetes, graft versus host disease (rejection reactions following bone marrow or other transplantation procedures), refractory gout, myocardial infarction and inflammatory bowel disease.
About Omni Bio Pharmaceutical, Inc.
Omni Bio Pharmaceutical (www.omnibiopharma.com) is a biopharmaceutical company that is focused on alternative uses for AAT and on developing new recombinant forms that can be applied to the treatment of a broad range of indications as noted above. The Company holds licenses to patents and patent applications licensed from the University of Colorado and a privately held company. Since its formation, Omni Bio has supported research using animal models and human clinical studies that demonstrate that AAT is a promising agent for ameliorating these conditions. The Company is now focused on the development of a recombinant AAT Fc fusion molecule as a new biological entity.
About Gallus BioPharmaceuticals
Gallus BioPharmaceuticals is a leading contract manufacturing company offering exceptional contract services to its clients. Gallus’ world-class facility in St. Louis is distinguished by nearly three decades of biologics development and over a decade of commercial cGMP manufacturing, including the ongoing manufacturing of Stelara® and Remicade® for Janssen Pharmaceuticals. Gallus’ facility in Princeton, New Jersey, has three decades of experience in process development and clinical manufacturing of bulk and aseptic-filling of mAbs, as well as large and complex proteins such as Fc-fusion proteins, IgMs and collagens, plus over 20 years of experience of commercial manufacture including the supply of ProstaScint®. Both sites maintain exemplary quality and regulatory records.
Some of the statements made in this press release are forward-looking statements that reflect Omni Bio management’s current views and expectations with respect to future events. These forward-looking statements are not a guarantee of future events and are subject to a number of risks and uncertainties, many of which are outside our control, which could cause actual events to differ materially from those expressed or implied by the statements. These risks and uncertainties are based on a number of factors, including but not limited to the business risks disclosed in our SEC filings, especially the section entitled “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended March 31, 2012. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.