Oncimmune LLC CMO Producing First Batch Of Tretinoin For Acute Promyelocytic Leukemia
Published: Oct 02, 2017
BATON ROUGE, La., Sept. 29, 2017 (GLOBE NEWSWIRE) -- OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a revenue-stage biopharmaceutical company engaged in the development of a proprietary cancer vaccine technology, targeted cancer therapies and commercialization of a portfolio of products internationally, is pleased to announce that it has successfully achieved development milestones in formulation and stability with tretinoin, also known as all-trans retinoic acid (ATRA), an oral drug for the treatment of Acute Promyelocytic Leukemia (APL). OncBioMune owns the commercialization rights for tretinoin throughout Mexico, Central America and Latin America.
PROCAPS S.A.S., the Company’s contract manufacturing organization, is currently in the midst of manufacturing the first batch of tretinoin from its state-of-the-art cGMP facility in Colombia. OncBioMune has been advised that production remains on schedule for the planned product launch scheduled in 2018.
"Achieving development milestones with PROCAPS has us now making preparations for the tretinoin launch in Mexico early next year and subsequently into Central and Latin America where APL remains problematic,” commented Andrew Kucharchuk, President at OncBioMune. “To have a partner like PROCAPS with their experience and leading production facility is invaluable in meeting our high standards on time and within budget.”
There are currently no approved drugs in Mexico for the treatment of APL, an aggressive type of Acute Myeloid Leukemia in which there are too many immature blood-forming cells in the blood and bone marrow, which leads to a shortage of healthy white and red blood cells and platelets. In developed countries, APL is regarded as one of the more curable types of leukemia, with tretinoin a commonly prescribed part of the therapeutic regimen. However, little therapeutic progress has been made in developing countries to deliver a measurable benefit with respect to complete hematological remission and disease-free survival, as is highly possible with tretinoin in the treatment protocol.
Based upon these facts, OncBioMune believes it can emerge as a market leader in the treatment of APL in Mexico, Central and South America. Early financial models have the company expecting to generate approximately US$300,000 in revenue during the launch year and approximately US$750,000 in the first full year (2019) for only the Mexican Market.
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