January 6, 2017


An injectable formulation of the platelet aggregation inhibitor drug clopidogrel

NORTH BRUNSWICK, NJ — (BUSINESS WIRE) — January 06, 2017 — Ascendia Pharmaceuticals, a specialty pharmaceutical company engaged in nano-formulation design, development, and manufacture for poorly soluble molecules, today announced that it has been awarded a new patent. U.S. Patent No. 9,480,680, entitled “Stable Pharmaceutical Composition of Clopidogrel Free Base for Oral and Parenteral Delivery”, describes the application of Ascendia’s EmulSol nanotechnology to formulate a stable, ready-to-use, rapid-onset, injectable form of clopidogrel.

About ASD-002

Clopidogrel, a top-selling blood thinner medicine, has never been successfully developed in an injectable dosage form due to its inherent chemical instability and poor solubility.

“There is a significant unmet medical need for a parenteral clopidogrel dosage form for the treatment of Acute Coronary Syndrome under life-threatening situations,” said Jingjun “Jim” Huang, Ph.D., CEO of Ascendia. “With our nanoemulsion platform technology, Ascendia has demonstrated that a ready-to-use, stable and soluble, parenteral form of clopidogrel is both technically and commercially feasible.” When a patient presents with a suspected coronary event, a high oral dose of clopidogrel is frequently administered as the only available forms of clopidogrel are tablets – not ideal in an emergency setting. Also, when delivered orally, there is a significant delay in the time required for the medicine to become fully absorbed and effective.

ASD-002 can be administered as a single high-dose injection of clopidogrel, capable of overcoming CYP2C19 resistance in a percutaneous coronary intervention (PCI) setting (which 30% of patients experience). Thus ASD-002 will address the unmet need for rapid platelet inhibition, while reducing bleeding risk, associated with newer P2Y12 agents, and has the potential to expand the $2 billion PCI market in peripheral artery disease. ASD-002 for injection also has the potential to provide an advantage compared to the recently approved IV anti-thrombotic drug cangrelor, as ASD-002 should not have an indication exclusion for patients currently on a P2Y12 inhibitor.

About Ascendia Pharmaceuticals LLC

Ascendia is a specialty pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. We specialize in creating formulation solutions for poorly water-soluble molecules and other challenging pharmaceutical development projects.

Ascendia formulates products for injection (IV, SC or IM); transdermal, ophthalmic or nasal delivery; and both immediate-release and controlled-release products for oral administration. We have three technology platforms – EmulSol for producing nanoemulsions, AmorSol for creating amorphous solid dispersions, and NanoSol for formulating nano-particles. For more information, please visit Ascendia’s website at www.ascendiapharma.com.

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