SOURCE: TNI BioTech, Inc.

December 03, 2013 08:14 ET

TNI BioTech, Inc. Subsidiary Granted Certificate of Free Sale by Nicaraguan Minister of Health for Low Dose Naltrexone

Certificate Allows for Product to Be Exported by TNI BioTech's Nicaraguan Manufacturing Facility

WHITE PLAINS, NY--(Marketwired - Dec 3, 2013) - TNI BioTech Inc (OTCQB: TNIB) today announced that the Nicaraguan Ministry of Health has granted a certificate of free sale to the company's wholly-owned subsidiary, TNI BioTech International Ltd., for TNI BioTech's Low Dose Naltrexone product (LDN) for the treatment of patients with autoimmune diseases HIV/AIDS, Crohn's Disease, Multiple Sclerosis and certain cancers. 

TNI BioTech's LDN product is manufactured for the company by Laboratorios Ramos in Managua, Nicaragua. The issuance of the certificate of free sale allows LDN to be exported from the Managua facility to other jurisdictions where the company is approved to market and sell LDN in satisfaction of the import requirements of such jurisdictions. The free sale certificate is not a license for export, which is issued separately for a specific product in both the country of export as well as the country of import.

At this time, TNI BioTech also has received the Certificate of Free Sale and export licenses for the following countries: Republic of Nigeria, Republic of Equatorial Guinea, Republic of Malawi and the Republic of Gabon. TNI BioTech has been in discussion with a number of other emerging countries concerning the approval of LDN and hopes to receive approvals in these countries over the next year.

TNI BioTech expects to generate over $50 million in gross revenue in 2014 from the sale of LDN based solely on the company's existing distributor agreement in Nigeria with AHAR Pharma which was signed in October 2013. In Nigeria, LDN will be marketed under the name Lodonal™.

Noreen Griffin, chief executive officer of TNI BioTech, stated, "This is a great accomplishment for our company. This certificate of free sale from Nicaragua, coupled with our growing distributor base and enhanced management team, including Julian Casciano from eMax Health Systems Inc, Larry Martin and Gary Gemignani, shows TNI BioTech's commitment to international sales and the further development of our therapies." 

TNI BioTech holds a number of patents surrounding LDN. In clinical trials, LDN has demonstrated an immunomodulatory effect that can decrease the negative inflammatory response in certain autoimmune diseases and help increase the immune response in chronic diseases like cancer.

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 programs involve immunotherapy with met-enkephalin ("MENK") (sometimes referred to as opioid growth factor ("OGF")) and Low Dose Naltrexone product (LDN), 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 MENK and LDN 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.


This press release and the statements of representatives and partners of TNI Biotech, Inc. and its subsidiaries (the "Company") related thereto include 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 "plan," "project," "potential," "seek," "may," "will," "expect," "believe," "anticipate," "intend," "could," "estimate" or "continue" used in the Company's press releases and in the Company's filings with the Securities and Exchange Commission as well as 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 assumptions and significant risks and uncertainties. Readers are cautioned that certain important factors may affect the Company's actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release, and thus readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date thereof. Actual results (including, without limitation, the Company's actual sales results for 2014 and the impact of the Certificate of Free Sale described herein) may differ significantly from those set forth in the forward-looking statements. 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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© 2013 TNI Biotech, Inc. All rights reserved.

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