Ascendia Pharmaceuticals Announces Issuance of New Patent for Acute Coronary Syndrome Program

Ascendia Pharmaceuticals, a specialty pharmaceutical company engaged in nano-formulation design, development, and manufacture for poorly soluble molecules, recently announced it has been awarded a new patent. US Patent No. 9,480,680, titled 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, PhD, 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 preclinical 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 nano-emulsions, AmorSol for creating amorphous solid dispersions, and NanoSol for formulating nano-particles. For more information, visit Ascendia at www.ascendiapharma.com.

Contact

Jinjung “Jim” Huang, PhD, CEO
Ascendia Pharmaceuticals
(732)-640-0058
j.huang@ascendiapharma.com