Sunshine Biopharma Narrows Kilogram Manufacturing Options for Adva-27a Breast Cancer Drug Candidate to Three Suppliers
01 May 2013 - 1:00PM
Marketwired
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: Camille Sebaaly CFO
Sunshine Biopharma Inc. Direct Line: 514-814-0464
camille.sebaaly@sunshinebiopharma.com www.sunshinebiopharma.com