Click here to close now.

SYS-CON MEDIA Authors: Blue Box Blog, Carmen Gonzalez, Lori MacVittie, Plutora Blog, Roger Strukhoff

News Feed Item

Advancement of Ascendia Pharmaceutical’s Nano-Emulsion Technology Platform with Its Lead Development Program ASD-002

Ascendia Pharmaceuticals, a start-up specialty pharmaceutical company in the business of providing formulation technologies and product development services for poorly soluble molecules, today announced that the company has successfully applied its nano-emulsion technology platform to a novel injectable formulation of clopidogrel - the world’s top-selling blood thinner medicine. Ascendia has advanced the program to pre-IND development stage, and has filed US and worldwide PCT patent applications on the product.

“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 nano-emulsion platform technology, Ascendia has demonstrated that a ready-to-use, stable and soluble, parenteral form of clopidogrel is both technically and commercially feasible - by addressing the solubility, physical and chemical stability, API sourcing, manufacturing, and delivery challenges of this difficult compound.” Ascendia was founded in 2012 by Dr. Huang and has its commercial operations in North Brunswick, NJ.

About ASD-002

ASD-002 is a parenteral form of clopidogrel formulated as an oil-in-water nano-emulsion suspension. Ascendia is developing ASD-002 for the treatment of Acute Coronary Syndrome - which refers to either unstable angina or when blood supply to the coronary arteries becomes suddenly fully or partially blocked (i.e., a myocardial infarction). When a patient presents with a suspected coronary event, a 300-600 mg loading dose of clopidogrel is frequently administered. However, the only commercially available dosage forms of clopidogrel are oral tablets in 300 mg and 75 mg strengths - not ideal for administration in an emergency setting. Also, when delivered orally there is a significant delay in the time required for the medicine to become effective - although clopidogrel is rapidly absorbed, the time to reach peak concentration and therapeutic effect can require several hours. Therefore, in an acute, emergency setting, a more rapidly acting, injectable clopidogrel dosage form is desirable.

The barrier to developing such a product is due to clopidogrel’s challenging solubility, physical form, and chemical stability properties. Clopidogrel is practically insoluble in water (the oral tablet composition uses the bisulfate salt form of clopidogrel which is soluble at gastric pH, but not suitable for injection). Clopidogrel free-base is a semi-solid, viscous, oily form, thus presenting difficulties in storage, dispensing and processing. Moreover, the free-base form is chemically unstable and undergoes both hydrolysis and oxidation. In addition, clopidogrel is a chiral molecule - only the S-enantiomer is biologically active, and chiral conversion to the R-enantiomer can easily occur in a liquid dosage form. ASD-002 overcomes these stability and delivery challenges by stabilizing the free-base form of clopidogrel in the nano-emulsion formulation.

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 - using our suite of nano-particle technologies, we can assess the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability. We execute rapid, comprehensive, and cost-effective programs for our clients. We have three technology platforms - EmulSol for producing nano-emulsions, AmorSol for creating amorphous solid dispersions, and NanoSol for formulating nano-crystals. Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up. For more information, please visit Ascendia’s website at www.ascendiapharma.com.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Between the compelling mockups and specs produced by your analysts and designers, and the resulting application built by your developers, there is a gulf where projects fail, costs spiral out of control, and applications fall short of requirements. In his session at DevOps Summit, Charles Kendrick, CTO and Chief Architect at Isomorphic Software, will present a new approach where business and development users collaborate – each using tools appropriate to their goals and expertise – to build mo...
Chuck Piluso will present a study of cloud adoption trends and the power and flexibility of IBM Power and Pureflex cloud solutions. Speaker Bio: Prior to Data Storage Corporation (DSC), Mr. Piluso founded North American Telecommunication Corporation, a facilities-based Competitive Local Exchange Carrier licensed by the Public Service Commission in 10 states, serving as the company's chairman and president from 1997 to 2000. Between 1990 and 1997, Mr. Piluso served as chairman & founder of ...
There are lots of challenges in IoT around secure, scalable and business friendly infrastructure for enterprises. For large corporations, IoT implementations are one of the top priorities of the decade. All industries are seeing a competitive need to sustain by investing in IoT initiatives. The value addition comes from improved customer service, innovative product and additional revenue streams. The data from these IP-connected devices can be leveraged for a variety of business applica...
To manage complex web services with lots of calls to the cloud, many businesses have invested in Application Performance Management (APM) and Network Performance Management (NPM) tools. Together APM and NPM tools are essential aids in improving a business's infrastructure required to support an effective web experience... but they are missing a critical component - Internet visibility. Internet connectivity has always played a role in customer access to web presence, but in the past few years u...
Working with Big Data is challenging, especially when decision makers depend on market insights and intelligence from your data but don't have quick access to it or find it unusable. In their session at 6th Big Data Expo, Ian Khan, Global Strategic Positioning & Brand Manager at Solgenia; Zel Bianco, President, CEO and Co-Founder of Interactive Edge of Solgenia; and Ermanno Bonifazi, CEO & Founder at Solgenia, discussed how a revolutionary cloud-based BI along with mobile analytics is already c...
The WebRTC Summit 2015 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
In this session we look at creating interactive communications via the web by adding messaging, file transfer, and group communication (group chat and audio/video conferencing) into the web experience. We will also discuss potential applications of this technology in areas including B2B, B2C, P2P, and gaming. Peter is Technical Director at Acision. He graduated from The University of Edinburgh in 2000 with a BSc (Hons) in Computer Science. After graduation Peter worked on a PSTN switch dev...
Recent technology advances in miniaturization has positioned the wearables as the pinnacle of technology convergence with the human body. We inquire if wearables are mere standard miniaturized devices extended with the connectivity and present our views on considerations like design, applications, performance, efficiency, interoperability, usage scenarios, human device interaction and consequent trade-offs enabling wearables to impart optimal value.
The Internet of Things Maturity Model (IoTMM) is a qualitative method to gauge the growth and increasing impact of IoT capabilities in an IT environment from both a business and technology perspective. In his session at @ThingsExpo, Tony Shan will first scan the IoT landscape and investigate the major challenges and barriers. The key areas of consideration are identified to get started with IoT journey. He will then pinpoint the need of a tool for effective IoT adoption and implementation, whic...
Shipping daily, injecting faults, and keeping an extremely high availability "without Ops"? Understand why NoOps does not mean no operations. Agile development methodologies require evolved operations to be successful. In his keynote at DevOps Summit, David Tesar, Microsoft Technical Evangelist on Microsoft Azure and DevOps, will discuss how Microsoft teams who have made huge progress with a DevOps transformation effectively utilize operations staff and how challenges were overcome. Regardless ...
Software is eating the world. Companies that were not previously in the technology space now find themselves competing with Google and Amazon on speed of innovation. As the innovation cycle accelerates, companies must embrace rapid and constant change to both applications and their infrastructure, and find a way to deliver speed and agility of development without sacrificing reliability or efficiency of operations. In her Day 2 Keynote DevOps Summit, Victoria Livschitz, CEO of Qubell, discussed...
Cloud computing started a technology revolution; now DevOps is driving that revolution forward. By enabling new approaches to service delivery, cloud and DevOps together are delivering even greater speed, agility, and efficiency. No wonder leading innovators are adopting DevOps and cloud together! In his session at DevOps Summit, Andi Mann, Vice President of Strategic Solutions at CA Technologies, explored the synergies in these two approaches, with practical tips, techniques, research data, wa...
SYS-CON Events announced today that AIC, a leading provider of OEM/ODM server and storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. AIC is a leading provider of both standard OTS, off-the-shelf, and OEM/ODM server and storage solutions. With expert in-house design capabilities, validation, manufacturing and production, AIC's broad selection of products are highly flexible and are conf...
SYS-CON Events announced today that Vicom Computer Services, Inc., a provider of technology and service solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. They are located at booth #427. Vicom Computer Services, Inc. is a progressive leader in the technology industry for over 30 years. Headquartered in the NY Metropolitan area. Vicom provides products and services based on today’s requirements...
SYS-CON Events announced today that Blue Box has been named “Bronze Sponsor” of SYS-CON's DevOps Summit New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Blue Box delivers Private Cloud as a Service (PCaaS) to a worldwide customer base. Built on a technology platform leveraging decades of operational expertise in cloud and distributed systems, Blue Box Cloud is a managed private cloud product available in both hosted and on-prem versions. Each Blue Box ...