Mountain View Pharmaceuticals, Inc. ("MVP") announced its receipt of European Patent No. 1 667 708 B1, titled "Polyethylene Glycol Conjugates of Interferon-beta-1b with Enhanced in vitro Biological Potency." The conjugates covered by this patent could enable less frequent and better tolerated dosing of one of the most widely used treatments worldwide for relapsing-remitting multiple sclerosis, interferon-beta-1b.
MVP also announced the publication of an invited scientific report, titled "Next-Generation PEGylation Enables Reduced Immunoreactivity of PEG-Protein Conjugates," in the June 2012 issue of Drug Development & Delivery.
"In contrast with other patents and publications relating to PEG conjugates of interferon-beta, MVP's new European patent claims polymer conjugates of interferon-beta-1b that have increased in vitro potency, measured with human cancer cells in culture, and methods of synthesis of these novel conjugates," stated Dr. Mark G. P. Saifer, MVP's Vice President and Scientific Director. "If our preclinical results are predictive of the performance of the PEG conjugates in humans, conversion of interferon-beta-1b to a long-acting form with higher potency could enhance the utility of this drug in the treatment of multiple sclerosis, viral infections and other conditions."
Patents disclosing and claiming PEG conjugates of interferon-beta-1b have been granted to MVP previously in 13 countries outside of Europe. The new European patent, with 46 claims including claims to methoxyPEG ("mPEG") and hydroxyPEG conjugates of non-glycosylated interferon-beta, will be a key component of the company's partnering and licensing activities.
MVP's new publication provides additional evidence for the immunologic advantages of protein conjugates synthesized with the company's improved PEGylation reagents (PharmaPEG® conjugates). PharmaPEG® is MVP's registered trademark for the most advanced generation of poly(ethylene glycol) ("PEG"). PharmaPEG® forms significantly less antigenic and less immunogenic conjugates than mPEG, which is used in all currently marketed PEGylated drugs. For a wide variety of proteins, the reductions in immune responses to PharmaPEG conjugates, compared with mPEG conjugates of the same proteins, have ranged from 2-fold to >1,000-fold, as reported in Drug Development & Delivery, as well as in a recent publication in Bioconjugate Chemistry. The decreased immunoreactivity results from replacement of the methoxy group of mPEG by a hydroxy group at the end of the polymer that is not attached to the protein.
"MVP's technology related to long-acting forms of drugs based on therapeutic enzymes or cytokines is the product of more than a decade of research and represents a major advance directed toward the multi-billion-dollar market for PEGylated proteins," said Dr. Merry R. Sherman, Chief Executive Officer and President of MVP. "Our recent publications illustrating the advantages of PharmaPEG-protein conjugates, compared with conventional mPEG-protein conjugates, are expected to reach a wide audience of pharmaceutical professionals, including those attending the Biotechnology International Organization Conference ("BIO 2012") in Boston." Dr. Sherman will make a presentation on MVP's "Next-Generation PEGylation Technology" at BIO 2012 in the BioProcess Theater in Booth 0387 of the Exhibition Hall, at 2 pm on Tuesday, June 19th.