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Last Updated: November 28, 2021

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Patent: 8,435,540

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Summary for Patent: 8,435,540
Title:Dimeric alpha interferon PEGylated site-specifically shows enhanced and prolonged efficacy in VIVO
Abstract: The present invention concerns methods and compositions for PEGylated complexes of defined stoichiometry and structure. Preferably, the PEGylated complex is formed using dock-and-lock technology, by attaching a therapeutic agent to a DDD sequence and a PEG moiety to an AD sequence, allowing the DDD sequence to bind to the AD sequence in a 2:1 stoichiometry, to form PEGylated complexes with two therapeutic agents and one PEG moiety. Alternatively, the therapeutic agent may be attached to the AD sequence and the PEG to the DDD sequence to form PEGylated complexes with two PEG moieties and one therapeutic agent. In more preferred embodiments, the therapeutic agent may comprise any peptide or protein of physiologic or therapeutic activity, preferably a cytokine, more preferably interferon-.alpha.2b. The PEGylated complexes exhibit a significantly slower rate of clearance when injected into a subject and are of use for treatment of a wide variety of diseases.
Inventor(s): Chang; Chien-Hsing (Downingtown, PA), Goldenberg; David M. (Mendham, NJ), McBride; William J. (Boonton, NJ), Rossi; Edmund A. (Woodland Park, NJ)
Assignee: IBC Pharmaceuticals, Inc. (Morris Plains, NJ)
Application Number:13/412,816
Patent Claims:see list of patent claims

Details for Patent 8,435,540

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Sharp & Dohme Corp. PEGINTRON peginterferon alfa-2b Injection 103949 2001-01-19 ⤷  Free Forever Trial 2025-04-06
Merck Sharp & Dohme Corp. SYLATRON peginterferon alfa-2b For Injection 103949 2011-03-29 ⤷  Free Forever Trial 2025-04-06
Hoffmann-la Roche Inc. PEGASYS peginterferon alfa-2a Injection 103964 2002-10-16 ⤷  Free Forever Trial 2025-04-06
Hoffmann-la Roche Inc. PEGASYS peginterferon alfa-2a Injection 103964 2004-01-07 ⤷  Free Forever Trial 2025-04-06
Hoffmann-la Roche Inc. PEGASYS peginterferon alfa-2a Injection 103964 2011-09-29 ⤷  Free Forever Trial 2025-04-06
Hoffmann-la Roche Inc. PEGASYS COPEGUS COMBINATION PACK peginterferon alfa-2a and ribavirin 125083 2004-06-04 ⤷  Free Forever Trial 2025-04-06
Schering Corporation A Subsidiary Of Merck & Co., Inc. PEGINTRON/ REBETOL COMBO PACK peginterferon alfa-2b and ribavirin 125196 2008-06-13 ⤷  Free Forever Trial 2025-04-06
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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