Belrose Pharma Acquires Enzon’s Advanced Drug Formulation Technology and Clinical Assets as Foundation for Driving Development of More Effective Injectable and Sustained Release Therapies
New Specialty Pharmaceutical Company to Use Chemical Polyethylene Glycol Attachment Technique to Create Safer, Longer-Lasting, More Effective Drug Therapies
Princeton, NJ, June 19, 2013 – In its first major deal, Belrose Pharma, a new specialty pharmaceutical company dedicated to advancing development of the next generation of innovative injectable and sustained release drug therapies in patient disease populations with high unmet medical needs, today announced the acquisition of Enzon Pharmaceutical’s PEGylation Linker Technology (Customized Linker Technology®) platform and associated product pipeline. Acquisition of this technology will enable Belrose Pharma to accelerate creation of improved biologic and small molecule therapies with better treatment outcomes for patients with life-threatening diseases such as breast cancer and pediatric neuroblastoma, and orphan drug diseases such as hereditary angioedema (HAE).
Through this transaction, Belrose Pharma has added to its portfolio both “traditional” permanent PEGylation and the lesser-known releasable PEGylation technologies, as well as compounds based on both technologies. Polyethylene glycol (PEG), when permanently linked to certain compounds, has a long track record of enabling high-value commercial products through sometimes dramatic improvements in in vivo circulation, toxicity, and efficacy. The lesser-known releasable PEGylation technique provides a different set of clinical benefits – including several targeted release options without a corresponding reduction in potency, improved drug loading, pharmacokinetics, and efficacy, and a simplified and potentially shorter clinical path to market.
“This acquisition of Enzon’s permanent and releasable Customized Linker Technology® significantly strengthens our platform for accelerating the development of more patient-friendly and effective therapies in a range of specialty disease categories,” said Belrose Pharma founder and CEO, Eric Gilbert. “We look forward to being a positive force for bringing new therapies and improved formulations of existing therapies to the global healthcare marketplace and to critically ill patient populations.”
Belrose will leverage the value of the assets purchased from Enzon within Belrose’s two key business areas: (a) advancing development of internal clinical and pre-clinical compounds, and (b) product development for third party customers seeking to improve both early clinical and mid-lifecycle products using Customized Linker Technology®, where alternative technologies such as nanoparticles and lipid formulations are less suitable.
Belrose will continue development of two programs acquired from Enzon. The first program is PEG-SN38 (formerly EZN-2208), a Phase III-ready PEGylated conjugate of SN38 with improved properties including parenteral delivery, increased solubility, higher exposure, more profound deoxyribonucleic acid (DNA) damage, inhibition of angiogenesis, and longer half-life compared with native SN38. PEG-SN38 produced positive responses in clinical trials for metastatic breast cancer and pediatric neuroblastoma. The second program is PEG-C1 Esterase Inhibitor (formerly EZN-3008), a preclinical PEGylated form of plasma-derived C1-Esterase Inhibitor (C1-INH) offering the significant improvement of weekly or bi-weekly subcutaneous or intravenous injections to HAE patients currently limited to twice-weekly infusions for prophylactic use.
Subsequent to the completion of this acquisition, several members of the core technical team that was formerly involved in Enzon’s extensive research, development, and commercialization of the permanent and releasable Customized Linker Technology® have joined Belrose Pharma.
About PEGylation Technology
PEGylation technology has successfully enabled regulatory approval and launch of a series of breakthrough pharmaceutical products since Enzon first pioneered the technique in the 1980s. Since FDA approval of the first PEGylated product, Adagen® (PEG-bovine adenosine deaminase) in 1990, cumulative worldwide revenue of all PEGylated pharmaceutical products has exceeded $20 billion. PEGylation has been validated for compounds including enzymes, peptides, small molecules and antibody fragments, with the chemical attachment of polyethylene glycol (PEG) used to improve those compounds’ half lives and toxicity profiles, among other patient benefits achieved by maximizing the inherent biological activity of the native molecules.
About Belrose Pharma Inc.
Belrose Pharma Inc. (Princeton, NJ) is a specialty pharmaceutical company that operates two related businesses: (a) advancing development of internal clinical and pre-clinical compounds, and (b) product development for third party customers seeking to improve both early clinical and mid-lifecycle products using a range of technologies including Customized Linker Technology®. Belrose combines a new senior commercial management team with a core technical team previously involved in development and commercialization efforts using customized PEGylation linker technologies. Further information about Belrose can be found on the Company’s website at www.belrosepharma.com.
Note to Media and Investors
Belrose Pharma has been formed by new investors to develop pharmaceutical products with technologies and clinical programs acquired from Enzon Pharmaceuticals and others. The Belrose Pharma investors have no substantive relationship to any major equity or debt holder in Enzon Pharmaceuticals. Enzon Pharmaceuticals also does not have any equity ownership in Belrose Pharma.
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