FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technolog...( Cimzia(R) marks the first FDA appro...),Health

Cimzia(R) marks the first FDA approval of a PEGylated Fab' fragment of a

humanized anti-TNF-alpha antibody

SAN FRANCISCO, April 23 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) approved UCB's Cimzia(R) (certolizumab pegol) for reducing the signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate to severe active disease who have an inadequate response to conventional therapy.

Cimzia(R) is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody approved by the FDA. Cimzia(R) is the ninth marketed product enabled by Nektar's (Nasdaq: NKTR) industry leading PEGylation technology platform. Every PEGylated product approved over the last decade was enabled using Nektar's PEGylation and polymer chemistry.

"The FDA approval of Cimzia(R) is great news for both UCB and patients suffering from the debilitating effects of Crohn's disease," said Howard W. Robin, President and CEO of Nektar. "Cimzia represents another example of the value of Nektar's PEGylation technology and its potential to create important new therapeutics."

Under the terms of the agreement between Nektar and UCB, Nektar will receive manufacturing revenues and royalties on global sales of Cimzia(R) for all indications.

Nektar PEGylation Platform

Nektar PEGylation technology can enhance the properties of therapeutic agents by increasing drug circulation time in the bloodstream, decreasing immunogenicity and dosing frequency, increasing bioavailability and improving drug solubility and stability. It can also be used to modify pharmaceutical agents to preferentially target certain systems within the body. It is a technique in wh
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