Press Releases

NextSource Biotechnology Announces FDA Short Supply release of the formally known Bristol Myers Squibb (CeeNu^®) Brand Oncology product now currently marketed under the NextSource Biotechnology Lomustine (CCNU) label Exclusively in the United States

MIAMI, Jan. 24, 2014 /PRNewswire/ -- NextSource BioTechnology, LLC, (NSB), an emerging Specialty Pharmaceutical Manufacturing and Marketing Company focused on Consolidating, Re-Branding and Launching "Matured & Orphan Drugs," has announced its most recent product Lomustine (CCNU), formerly known as CeeNu^® by Bristol-Myers Squibb (BMS), which has officially been removed from the U.S. Food & Drug Administration (FDA) Drug Shortage List. As a result of this new status, Lomustine (CCNU) is now readily available through NextSource's Nationwide Authorized Distribution supply chain. Please visit us at: NextSource Bio

Due to the successful product re-launch and market availability of Lomustine (CCNU), there is no longer a need for continued use of the unregulated compound equivalent product. Pharmacies currently compounding this product are doing so against the FDA Code of Federal Regulations.

Lomustine (CCNU) will continue to be distributed under the current name, while the pending FDA "Brand" name is under review for approval. Lomustine (CCNU) is the first of many "Matured Drugs" to be launched under the NextSource Biotechnology portfolio.

"Our launch of LOMUSTINE," said Robert DiCrisci, President, CEO of NextSource Biotechnology, "is an example of the NextSource commitment to work proactively with the FDA in an effort to prevent the discontinuation of existing and future drugs that are vital in the application of a well balanced treatment plan of traditional proven therapies and New therapy options that healthcare providers and patients in the hospital settings require under the new healthcare guidelines."

About Lomustine (CCNU) - INDICATIONS AND USES

Lomustine (CCNU) is an oral chemotherapy medication that is used to treat Primary and Metastatic Brain Cancer. Lomustine belongs to a class of drugs known as nitrosourea anti-tumor alkylating agent. Unlike the more common nitrogen mustard alkylating agents, Lomustine (CCNU) crosses the blood-brain barrier quite effectively due to its high lipid solubility and the relative lack of ionization at physiological pH and is used in the treatment of both primary and metastatic brain tumors in patients. It works by bonding with DNA of rapidly dividing cells causing breakage of the DNA strands and eventually, the death of the cancer cell.

Lomustine (CCNU) has been shown to be useful as a single agent in addition to other treatment modalities, or in an established combination therapy with other approved chemotherapeutic agents in the following:

Brain tumors — primary and metastatic, in patients who have already received appropriate surgical and/or radio-therapeutic procedures.

Hodgkin’s Disease — therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.