Sequella Receives International Support for Phase 2 Clinical Trials of SQ109, its Lead Antitubercular Drug Candidate

For Immediate Release October 18th, 2010 Sequella Receives International Support for Phase 2 Clinical Trials of SQ109, its Lead Antitubercular Drug Candidate Rockville, MD -- Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa. The Phase 2 studies, which will support international regulatory submissions, will be performed by the Pan African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA). The studies will be funded by a €12 million grant by the European and Developing Countries Clinical Trials Partnership (EDCTP) and a €3 million commitment by Sequella for in-kind and corporate funding. The multi-year clinical program will be directed by Professor Michael Hoelscher, Department of Infectious Diseases and Tropical Medicine, University Hospital of LMU, in conjunction with Sequella. “TB is a global health problem that will only be solved by international cooperation and focus on improvement in patient care,” said Dr. Carol A. Nacy, CEO of Sequella. “We are excited by the opportunity to work with EDCTP, the LMU, and the very talented group of TB experts in PanACEA to further the clinical development of SQ109.” PanACEA members include TB experts from six European research institutions, twelve sub-Saharan Africa clinical trial sites, and two pharmaceutical companies. The SQ109 Phase 2 trials will be conducted in clinical sites located in South Africa, Tanzania, Gabon, and Zambia. “The EDCTP is pleased to have an important role in supporting the development of SQ109, a promising new antibiotic to treat tuberculosis,” said Charles S. Mgone, Executive Director, EDCTP. “This is part of the ongoing series of cooperative clinical trials conducted by PanACEA, the EDCTP funded network that aims at simplifying and shortening tuberculosis treatment. We look forward to the results of the clinical studies.” “LMU and PanACEA are enthusiastic to have SQ109 in our drug evaluation portfolio as the preclinical data look very promising.” said Michael Hoelscher, PanACEA Chief Investigator. ”We are therefore looking forward to start the first SQ109 study in Cape Town before the end of this year.” ### About SQ109 SQ109, identified as the lead drug candidate from among 63,000 compounds synthesized in a combinatorial chemistry program, is currently under US IND. SQ109 completed two phase 1 studies in the U.S. in December 2009. With a mechanism of action distinct from all other antibiotics used in TB therapy, SQ109 has excellent activity against both drug susceptible and drug resistant TB bacteria, including XDR-TB strains. SQ109 also enhances the activity of the anti-tubercular drugs Isoniazid and Rifampin and shortens by >30% the time required to cure mice of experimental TB. SQ109 could replace one or more of the current first-line antitubercular drugs, simplify therapy, and shorten the TB treatment regimen. About Tuberculosis (TB) TB is a contagious infectious disease caused by the bacterium Mycobacterium tuberculosis. TB bacteria can be inhaled into lungs and are able to avoid destruction by certain white blood cells. Without containment by immune cells, the bacteria can spread throughout the body, multiply, survive and remain dormant for years. TB is the leading single-agent cause of global deaths resulting from infectious diseases. About Sequella, Inc. Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases. The company leverages its global influence, R&D platforms, and disease expertise to proactively address emerging health threats. Through focused execution, clear commercialization pathways, and strategic partnerships, Sequella intends to commercialize a broad product portfolio designed to treat global health threa ts with significant market opportunity. For more information, please visit www.sequella.com. Forward-Looking Statement This press release contains forward-looking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law. MEDIA CONTACT: Alan Klein, Executive Vice President, Corporate Development, Sequella, Inc., 301-762-7776 or [email protected]

The release as fetched from its publisher. sequella.com ↗