SCOTTSDALE, AZ--(Marketwire - September 22, 2009) - ImmuneRegen BioSciences®, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), today announced an agreement with Bachem, Inc., enabling Bachem to be the primary manufacturer of ImmuneRegen’s Homspera® drug substance. Homspera is a peptide analog of the endogenous neurokinin Substance P, and is actively being developed by ImmuneRegen for a number of therapeutic indications including cancer, infectious diseases, pulmonary diseases such as Idiopathic Pulmonary Fibrosis, and wound healing.
Under the agreement Bachem will produce the active pharmaceutical ingredient Homspera under current Good Manufacturing Practices (cGMP) in quantities necessary to support formulation, pre-clinical studies and to perform a number of Phase I studies in humans under an FDA-cleared Investigation New Drug Application (IND). Only drugs produced under cGMP may be administered to humans.
“The opportunity to partner with Bachem for our manufacturing needs is priceless for ImmuneRegen,” said Michael Wilhelm, CEO of ImmuneRegen. “Bachem has produced a broad range of peptides under cGMP for use in preclinical and clinical studies. Having a relationship with a manufacturer as well-known and well-respected as Bachem eliminates a number of manufacturing-related hurdles, and provides ImmuneRegen with a partner who understands what the U.S. FDA is looking for from peptide manufacturers. We feel this relationship will thus facilitate ImmuneRegen’s FDA interactions regarding Homspera.”
About Bachem, Inc.
Bachem is an independent, technology-based, public biochemicals company providing full service to the pharma and biotech industry. Bachem is specialized in the process development and the manufacturing of peptides and complex organic molecules as active pharmaceutical ingredients (APIs), as well as innovative biochemicals for research purposes. With headquarters in Bubendorf, Switzerland, and affiliates in Europe and the US, Bachem works on a global scale and holds a leading position in the field of peptides. For more information please visit www.bachem.com
About ImmuneRegen BioSciences, Inc.
ImmuneRegen BioSciences, Inc., a wholly owned subsidiary of IR BioSciences Holdings, Inc. (OTCBB: IRBS), is a development-stage biotechnology company focused on the research, development and licensing of Homspera® and its derivatives. Homspera is an adult stem cell active compound that in study results has been shown to regenerate and strengthen the immune system and enhance wound healing. Viprovex®, a derivative of Homspera, is being developed for potential use against infectious diseases as a stand-alone or combination therapy and as a vaccine adjuvant. To advance its mission, the Scottsdale, Arizona based company has forged numerous study partnerships with industry and academic leaders, including Celgene Cellular Therapeutics, HemoGenix, Lovelace Respiratory Research Institute and Virion Systems. For more information, please visit www.immuneregen.com.
Statements about ImmuneRegen’s future expectations, including statements about the potential use and scientific results for ImmuneRegen’s drug candidates, science and technology, and all other statements in this press release other than historical facts, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and as that term is defined in the Private Securities Litigation Reform Act of 1995. ImmuneRegen intends that such forward-looking statements be subject to the safe harbors created thereby. These future events may not occur as and when expected, if at all, and, together with ImmuneRegen’s business, are subject to various risks and uncertainties. ImmuneRegen’s actual results could differ materially from expected results as a result of a number of factors, including the uncertainties inherent in research and development collaborations, pre-clinical and clinical trials and product development programs (including, but not limited to the fact that future results or research and development efforts may prove less encouraging than current results or cause side effects not observed in current pre-clinical trials), the evaluation of potential opportunities, the level of corporate expenditures and monies available for further studies, capital market conditions, and others set forth in ImmuneRegen’s periodic report on Form 10-KSB for the year ended December 31, 2008 as filed with the Securities and Exchange Commission. There are no guarantees that any of ImmuneRegen’s proposed products will prove to be commercially successful. ImmuneRegen undertakes no duty to update forward-looking statements.
Contact:
John Fermanis
ImmuneRegen BioSciences Inc.
Phone: 480-922-3926
E-mail: Email Contact
Michael K. Wilhelm
Email: Email Contact