Nektar Therapeutics (NKTR)

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FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform
Wednesday April 23, 8:00 am ET
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® (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® is the first and only PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody approved by the FDA. Cimzia® is the ninth marketed product enabled by Nektar's (Nasdaq: NKTR - News) 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® 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® 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 which non-toxic polyethylene glycol (PEG) polymers are attached to therapeutic agents, and it is applicable to most major drug classes, including proteins, peptides, antibody fragments, small molecules, and other drugs.

Nektar PEGylation technology is used in nine approved partnered products in the U.S. or Europe today, including UCB's Cimzia®, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.

About Cimzia® (certolizumab pegol)

Cimzia® is the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF- alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. UCB is developing Cimzia® in Crohn's Disease, RA and other autoimmune disease indications. For additional information, including safety information, please refer to the Cimzia® factsheet in the "News" section of UCB's website (http://www.ucb-group.com). Cimzia® is a registered trademark of UCB.

About Crohn's Disease

Crohn's disease is a chronic, progressive, destructive disorder that causes inflammation of the gastrointestinal (GI) tract, most commonly at the end of the small intestine (the ileum) and beginning of the large intestine (the colon). If not effectively treated, it results in the need for surgery. Crohn's disease has been estimated to affect as many as half a million Americans. People with Crohn's can experience an ongoing cycle of flare-up and remission throughout their lives. Together with ulcerative colitis, Crohn's disease is an inflammatory bowel disease (IBD).