Sunshine Biopharma, Inc. Narrows Kilogram Manufacturing Options for Adva-27a Breast Cancer Drug Candidate to Three Suppliers
Published: May 01, 2013
MONTREAL--(Marketwired - May 01, 2013) - 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, is pleased to report that following negotiations with several Contract Manufacturing Organizations ("CMOs") for the GMP (Good Manufacturing Practice) manufacturing of one kilogram of Adva-27a breast cancer drug candidate, the Company has narrowed the field of contenders to three CMOs. While there are timeframe variations among these three manufacturers, largely related to the availability of their large scale chemical reactors at the time we place our order, overall it will take approximately 10 to 14 weeks for a one kilogram GMP synthesis of Adva-27a to be delivered to us.
The Company anticipates that one kilogram of Adva-27a will be sufficient to complete the upcoming IND-Enabling animal toxicity studies and Phase I clinical trials. These are required to be performed using the same GMP manufactured material. Following completion of the animal toxicity studies, the Company expects to file an Investigational New Drug (IND) application with the FDA (U.S. Food and Drug Administration) and wait for authorization to proceed with the planned Phase I clinical trial scheduled to be hosted at McGill University's Jewish General Hospital in Montreal, Canada. The Company intends to make any leftover material available for "compassionate-use" programs that allow seriously-ill cancer patients gain access to the drug candidate.
"We are excited to be at the stage of conducting GMP manufacturing of our drug," said Dr. Steve N. Slilaty, President and Chief Executive Officer of Sunshine Biopharma. "The filing of our process patent to protect Adva-27a manufacturing in January this year allowed us to quickly move forward and securely share information with CMO's to supply us with kilogram quantities of Adva-27a to complete the data for the IND application and conduct Phase I clinical trials.
About Breast Cancer
The National Cancer Institute ("NCI") estimates that 232,340 women and 2,240 men in the United States will be diagnosed with breast cancer in 2013. According to the NCI website, approximately 40,000 deaths in 2013 will be attributed to breast cancer, making it the second leading cause of cancer related deaths in women in the United States. Globally, 1.38 million new cases of breast cancer were diagnosed in 2008 and 458,000 deaths resulted from the disease, according to the World Health Organization. One of the most commonly used drugs to treat breast cancer today is Herceptin® (trastuzumab), a therapeutic of Roche Holding AG designed to treat patients with HER-2 (Human Epidermal Growth Factor Receptor 2) positive form of the disease. This condition is present in approximately 20 percent of breast cancer patients. Sales of Herceptin® in 2012 were approximately $6 billion worldwide.
About Sunshine Biopharma Inc.
Sunshine Biopharma is a development stage pharmaceutical company focused on the research, development and commercialization of drugs for the treatment of various forms of cancer. Sunshine Biopharma's parent company, Advanomics Corporation, recently announced that it has filed a new patent application covering various composition matters and manufacturing processes of Adva-27a.
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 Contact:
Sunshine Biopharma Inc.
Direct Line: 514-814-0464
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