BETHESDA, MD, September 4, 2013 – TNI BioTech, Inc. (OTCQB: TNIB) and Laboratorios Ramos announced today that they entered a manufacturing and supply agreement for the production of Low Dose Naltrexone (“LDN”) for commercial use. This agreement enables TNIB to focus on the development and commercialization of therapeutic treatments for cancer, HIV/AIDS and autoimmune diseases by combating these fatal diseases through the activation and modulation of the body’s immune system. Under the agreement, TNIB and Laboratorios Ramos are responsible for the technology transfer, under a manufacturing agreement, and commercial production of LDN at the Laboratorios Ramos processing facility. Laboratorios Ramos operates "under the principles of the ICH" for cGMP and currently produces commercial products for sale in Nicaragua. The financial terms of the agreement have not been disclosed.
“Laboratorios Ramos is pleased to establish this collaboration with TNIB on the commercial production of LDN,” stated a representative from Laboratorios Ramos. “We look forward to leveraging our experience with production to ensure the rapid commercial launch of this important product.”
“This manufacturing agreement with Laboratorios Ramos is an important operational milestone taking us one step closer to the commercial introduction of LDN later this year," said Noreen Griffin Chief Executive Officer of TNIB. "We believe Laboratorios Ramos is the right manufacturing partner for TNIB and the agreement allows TNI BioTech to move the product forward in the most cost effective way.” Management believes the Laboratorios Ramos facility is well suited to supply commercial quantities of LDN. The multi-purpose finished product processing facility houses production clean rooms with a broad range of formulation and packaging equipment to meet all requirements for commercial production of LDN.
About TNI BioTech, Inc.
TNI BioTech, Inc. is a biotech company working to combat chronic, life-threatening diseases through the activation and modulation of the body's immune system using our patented immunotherapy. Our products and immunotherapy technologies are designed to harness the power of the immune system to improve the treatment of cancer, infections such as HIV/AIDS, chronic inflammatory diseases, and autoimmune diseases.
Our proprietary technology, therapies and patents include the treatment of a wide range of cancers. Our most advanced clinical program involves immunotherapy with met-enkephalin (“MENK”) and/or opioid growth factor (“OGF”), which have been shown to stimulate the immune system even in patients with advanced cancer. Even though management considers any condition that results in altered-immune response a target for investigation, the company will most likely pursue additional investigations for low dose naltrexone and/or MENK as valuable candidates in the treatment of the following:?autoimmune states such as rheumatoid arthritis and multiple sclerosis;?as an adjunct in cancer patients undergoing chemotherapy, radiation treatments or surgery; and as an adjunct to antibiotics in the treatment of a variety of infectious diseases, including patients with AIDS, in combination with retroviral drug therapy.
About Laboratorios Ramos
Laboratorios Ramos is a laboratory dedicated to the design, development, and production of high quality generic medicines at affordable prices. Laboratorios Ramos works to ensure that the effectiveness and reliability of its laboratory is sufficient to provide added value to its portfolio of products and services.
Laboratorios Ramos is an organization geared toward quality and the consumer. Good Manufacturing Practices and other technical-scientific tools govern the work of the laboratory.
Laboratorios Ramos develops innovative projects aimed at expanding the range of therapeutic classes, presentations and dosage forms that provide competitive pharmaceutical solutions to meet the demand of the population and contribute to improving the health of all people. Social responsibility is important to Laboratories Ramos as it cultivates its new image and values for the company.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release includes various “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which represent the Company's expectations or beliefs concerning future events. Statements containing expressions such as “believes,” “anticipates,” “intends,” or “expects,” used in the Company's press releases and in Disclosure Statements and Reports filed with the Over The Counter Markets through the OTC Disclosure and News Service are intended to identify forward-looking statements. All forward-looking statements involve risks and uncertainties. Although the Company believes its expectations are based upon reasonable assumptions within the bounds of its knowledge of its business and operations, there can be no assurances that actual results will not differ materially from expected results. The Company cautions that these and similar statements included in this report are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. The Company undertakes no obligation to publicly release any revisions to such forward-looking statements to reflect events or circumstances after the date hereof.
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SOURCE TNI Biotech, Inc.