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News Room / Sunshine Biopharma Files an Application with Health Canada for a Drug Establishment License

Sunshine Biopharma Files an Application with Health Canada for a Drug Establishment License

MONTREAL, QC / ACCESSWIRE / June 19, 2017 / Sunshine Biopharma Inc. (OTC PINK: SBFM), a fully integrated pharmaceutical company offering generic and proprietary drugs for the treatment of cancer and other acute and chronic indications, is pleased to announce that it has filed an application for a Drug Establishment License ("DEL") with Health Canada, the Canadian equivalent of the FDA in the United States. Obtaining a DEL is the first step in the certification process of a company to be able to handle drugs, including manufacturing, storage, tracking and distribution. Following the procurement of a DEL, the Company will apply for Drug Identification Numbers ("DIN's") for its pharmaceutical products which are currently comprised of the following:

  • Anastrozole (brand name Arimidex® by AstraZenica) for treatment of Breast Cancer
  • Letrozole (brand name Femara® by Novartis) for treatment of Breast Cancer
  • Bicalutamide (brand name Casodex® by AstraZenica) for treatment of Prostate Cancer
  • Finasteride (brand name Propecia® by Merck) for treatment of BPH (Benign Prostatic Hyperplasia)

Worldwide sales of the brand name version of these products as reported by the respective owner of the registered trademark are approximately as follows:

  • Arimidex® $232M in 2016
  • Femara® $380M in 2014
  • Casodex® $247M in 2016
  • Propecia® $183M in 2015

In addition to these four (4) antitumor products, Sunshine Biopharma is currently evaluating a number of other Generic Pharmaceuticals in the area of Hypertension, Diabetes, Cholesterol management and Antimicrobials for in-licensing.

Revenues from sales of Generic Products are intended to be used to finance the Company's proprietary drug development program including Adva-27a, the Company's flagship anticancer compound. A Topoisomerase II inhibitor, Adva-27a is a small molecule that has recently been shown to be effective at destroying Multidrug Resistant Breast Cancer cells, Pancreatic Cancer cells, Small-Cell Lung Cancer cells and Uterine Sarcoma cells (Published in ANTICANCER RESEARCH, Volume 32, Pages 4423-4432, October 2012). Sunshine Biopharma is direct owner of all issued and pending worldwide patents pertaining to Adva-27a including U.S. Patent Number 8,236,935.

Safe Harbor Forward-Looking Statements

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.

For Additional Information:

Sunshine Biopharma Inc.
Camille Sebaaly, CFO
Direct Line: 514-814-0464
[email protected]

SOURCE: Sunshine Biopharma Inc.