Second Therapeutic Using iCeutica's SoluMatrix Fine Particle Technology™ Receives FDA Approval

PHILADELPHIA. (February 24, 2014) -- iCeutica Inc., today announced that its partner Iroko Pharmaceuticals, LLC has received FDA approval to market TIVORBEX™ (indomethacin) capsules, a non-steroidal anti-inflammatory drug (NSAID) at 20mg and 40mg doses that utilizes SoluMatrix Fine Particle Technology™. Iroko developed TIVORBEX™ (indomethacin) capsules under a collaboration and license agreement with iCeutica. This is one of several products in development by Iroko that utilize iCeutica’s SoluMatrix Fine Particle Technology™.

“Following on from the recent approval of ZORVOLEX™ (diclofenac) capsules, we are very excited by the further validation that this approval provides to our approach to creating new branded medicines with SoluMatrix™ technology. This is the second product to be approved by the FDA and is a significant milestone for iCeutica and Iroko,” said Matthew Callahan, President and CEO of iCeutica.

iCeutica creates branded medicines that provide meaningful clinical benefits to patients, physicians and payers and is developing a pipeline of products that utilize SoluMatrix Fine Particle Technology™. iCeutica commercializes those products with partners and through establishing new companies in focused therapeutic areas.

“We congratulate our partner, Iroko, on this exciting achievement and we look forward to the progression of additional products iCeutica is developing in collaboration with Iroko as they move towards regulatory approval,” he said.

About SoluMatrix™

SoluMatrix Fine Particle Technology™ is a proprietary platform that enables the creation of valuable new medicines with clinically meaningful patient benefits. SoluMatrix™ technology uses a dry milling process to make finely dispersed drug particles that are 10 – 200 times smaller than conventional drug particles. The SoluMatrix™ process has the potential to create drugs that work faster, act more effectively at lower doses, reduce side effects and allows different and more convenient delivery for patients.

About iCeutica

iCeutica creates branded medicines by combining our proprietary SoluMatrix Fine Particle Technology™ with deep scientific expertise and commercial insights. Our pipeline products provide meaningful clinical benefits for patients and have clearly defined pathways to regulatory and commercial success. We rapidly drive products to market with pharmaceutical partners and by creating new opportunities in focused therapeutic areas.

Media Contacts

Douglas MacDougall or Jennifer Conrad, MacDougall Biomedical Communications, 781.235.3060