FORT COLLINS, Colo., March 24 /PRNewswire/ -- PR Pharmaceuticals, Inc. (PRP) of Fort Collins, Colorado today reported that the United States Patent and Trademark Office has issued Patent No. 6,706,289 “Methods and Compositions for Enhanced Delivery of Bioactive Molecules” assigned to PR Pharmaceuticals, Inc. The patent claims cover the use of PEGylated bioactive molecules in drug delivery compositions comprising biodegradable polymers such as poly(d,l-lactide-co-glycolide) (PLGA). PLGA is the material used in successful controlled release products on the market including Lupron Depot(R) (TAP Pharmaceutical Products, Inc.) and Risperdal Consta(R) (Janssen Pharmaceutica). The attachment of non-toxic long-chain polymers such as poly(ethylene glycol) (PEG) to drugs such as proteins may increase blood circulation lifetimes, improve efficacy and safety, and increase stability. Protein drugs such as interferon-alpha can be improved with the attachment of PEG yielding the marketed products PEG-INTRON(R) (Schering-Plough/Enzon) and PEGASYS(R) (Hoffmann-LaRoche).
According to Dr. Paul Schmidt, PRP’s Vice-President for Pharmaceutical Formulation Development, the essence of PRP’s new patent lies in an innovative method to combine PEGylated bioactive molecules with PLGA. PRP’s unique technology achieved high drug loading, preserved protein structure and activity while providing sustained release, with minimal burst of the PEGylated molecule for periods of time several fold greater than that of the PEGylated molecule alone. The new technology, described in US Patent 6,706,289, is known as ProPhase(TM). The Company expects its ProPhase(TM) technology to become an important tool in enhancing the clinical utility of proteins and improving patient compliance by reducing the frequency with which these drugs need to be administered.
The most advanced product utilizing ProPhase(TM) technology is its application in the encapsulation of PEGylated insulin in PLGA microspheres to form a novel insulin formulation called InsuLAR(TM). In animal studies, InsuLAR(TM) releases a sustained level of human recombinant insulin over a 1-week period. PRP is seeking collaboration with a major pharmaceutical company to co-develop this innovative insulin product in order to expedite market approval of this potentially significant management tool for diabetes.
PRP is a privately held, specialty biopharmaceutical company with a focus on formulation and manufacturing of injectable sustained release products. PRP has recently received two FDA approvals for sustained release products, which it manufactures in a dedicated state-of-the-art facility in Fort Collins, Colorado.
PR Pharmaceuticals, Inc.
CONTACT: Patrick Bols, President and Corporate Development Officer of PRPharmaceuticals, Inc., +1-970-484-5560, pbols@prpharm.com
