Sunshine Biopharma''s Wholly Owned Canadian Subsidiary Completes the SOP''s Required by Health Canada to Secure Drug Establishment License
(firmenpresse) - MONTREAL, QC -- (Marketwired) -- 10/01/14 -- Sunshine Biopharma Inc. (OTCQB: SBFM), a pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer, today announced that its wholly owned Canadian subsidiary has completed the drafting of all of the Standard Operating Procedures (SOP''s) required by Health Canada for the procurement of a Drug Establishment License (DEL). The completed SOP''s comprise 18 binders and over 2,000 pages of documentation. It is necessary for Sunshine to have the DEL in place in order to become a fully integrated pharmaceutical company with proprietary (Adva-27a) and generic pharmaceutical products offering.
"In addition to the generic pharmaceutical business unit we are putting into place, we are moving full speed ahead with the development of our flagship proprietary anticancer drug, Adva-27a," said Dr. Steve N. Slilaty, CEO of Sunshine Biopharma. "Not unlike other fully integrated pharmaceutical companies, Sunshine plans to fund its proprietary drug development program through the sale of generic pharmaceuticals around the world. This is an important strategic positioning of the Company in order to become less dependent, if at all, on capital markets for the financing of our operations."
Adva-27a is Sunshine Biopharma''s lead anticancer compound, a small molecule that has recently been shown to be effective at killing Multidrug Resistant Breast Cancer cells, Small-Cell Lung Cancer cells, Uterine Sarcoma cells and Pancreatic Cancer cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Adva-27a is currently in the IND-Enabling stage of development. The original U.S. patent covering Adva-27a was issued on August 7, 2012 under U.S. patent number 8,236,935. The Company is planning a Phase I clinical trial of Adva-27a for Pancreatic Cancer in parallel to the Phase I clinical trial of Adva-27a for multidrug resistant Breast Cancer to be conducted at McGill University''s Jewish General Hospital in Montreal (Canada).
To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, future collaboration agreements, the success of the Company''s development, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.
Camille Sebaaly
CFO
Sunshine Biopharma Inc.
Direct Line: 514-814-0464
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Datum: 01.10.2014 - 06:00 Uhr
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