SOURCE: TNI BioTech, Inc.

September 11, 2012 07:53 ET

TNI BioTech, Inc. Signs Memorandum of Agreement to Open Pharmaceutical Plant for the Production of IRT-103 (LDN)

NEW YORK, NY--(Marketwire - Sep 11, 2012) - TNI BioTech, Inc., (PINKSHEETS: TNIB), a public company operating in the biotech sector, announced today the signing of a Memorandum of Agreement between the company and MOV-FAS S.A. to open a pharmaceutical plant in Managua, Nicaragua.

TNIB acquired a number of patents from Dr. Bernard Bihari involving Low-Dose Naltrexone (LDN) for the treatment of HIV/AIDS, cancer and other diseases. These patents and the clinical trials include over 20 years of data showing Low Dose Naltraxone (LDN) as a effective immune system modulator, without significant toxic side effects, non-addicting and can be administered by a single capsule once daily at bedtime. In anticipation of meeting the company's obligations under existing contracts, as well as those under negotiation, TNI BioTech reached an agreement with MOV-FAS S.A. to finance and construct a pharmaceutical plant for the production of IRT-103.

The TNI BioTech, Inc. plant will occupy approximately 20,000m² of area in Managua, Nicaragua; an economic free zone designed to promote industrial growth and development in the Managua area. The company has a lease on the premises with ample room for future expansion. Plant construction began in September of 2012 and is being built pursuant to international pharmaceutical GMP (Good Manufacturing Practice) standards. The TNI BioTech, Inc. facility will be fully operational at the end of October 2012.

The TNI Biotech, Inc. facility will manufacture LDN under the trade name of IRT-103 which will be for sale in Africa and nearby export markets. The plant has the capacity to manufacture approximately One Billion Four Hundred Thousand (1,400,000,000) capsules year.

Joint Venture Partners

TNIB has formed a partially owned subsidiary for this joint venture. The partners in the TNI BioTech joint venture are TNI BioTech, Inc. (which owns 55%); MOV-FAS S.A., the development company (which owns 35%); Pharmaceutical Care Consultant of South Florida, d/b/a Skips Pharmacy (which owns 5%); and GB Pharma Holdings LLC, a subsidiary of GB Oncology & Imaging Group LLC (which owns 5%). TNI BioTech, Inc., as the senior partner in the enterprise, is expected to provide most of the technology; Pharmaceutical Care Consulting will provide quality control and management; GB Oncology & Imagining Group, LLC has provided the initial contracts for the sale of IRT-103; and MOV-FAS will provide the initial capital, the land and building, but more importantly, local relations to handle all permitting and approval for the venture.

Frank Owens, the managing member of MOV-FAS S.A., and a successful entrepreneur with over 30 years experience in building and operating businesses in Central and South America, stated, "We are on target to open the new pharmaceutical facility October 15, 2012. The facility will be expanded from production for One Hundred Thousand (100,000) capsules a day to Four Million (4,000,000) capsules per day as demand for the product increases. MOV FAS entered this venture because it believes the project will be a financial success, and simultaneously allow us to provide low cost effective treatments for HIV/AIDS and autoimmune diseases to millions of people in developing nations."

Christopher Pearce, CFO of TNI BioTech, Inc., said, "TNI BioTech looks forward to working with noted, successful and innovative businessmen such as Mr. Frank Owens and Robert E. Friedrich. Their extensive experience in the field of business development and manufacturing provides the company with a partner ensuring TNIB can meet its IRT-103 delivery contracts beginning the last quarter of 2012." 

Noreen Griffin, TNI BioTech, Inc. CEO, stated, "The opening of this facility is very important for TNIB, as it is a significant step in the company's development of its licensed, patented, low cost effective treatment for a number of autoimmune diseases and will provide revenue for the company." 

About TNI BioTech, Inc.

TNI BioTech, Inc., is a biotech company combating fatal diseases through the activation and mobilization 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 will be used to treat a wide range of cancers. Our most advanced clinical programs involve immunotherapy that works by isolating a patient's lymphocytes and then incubating them together with Methionine Enkephalin (MENK) in an enriching external incubation system. After incubation the patient's lymphocytes are re-infused back into the patient where they combat and destroy tumor cells.

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 MENK as a valuable candidate in the treatment of the following:

  • Autoimmune states such as rheumatoid arthritis and multiple sclerosis;
  • As an adjunct to antibiotics in the treatment of infectious diseases;
  • In cancer patients undergoing chemotherapy, radiation treatments or surgery;
  • Patients with AIDS, in combination with retroviral drug therapy; and
  • In wound healing or herpes viral infections.

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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