Healthcare Industry News: Inflammatory Bowel Disease
News Release - April 23, 2008
FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology PlatformCimzia(R) marks the first FDA approval of a PEGylated Fab' fragment of a humanized anti-TNF-alpha antibody
SAN FRANCISCO, April 23 (HSMN NewsFeed) -- 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 ) 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).
Nektar Therapeutics is a biopharmaceutical company that develops and enables differentiated therapeutics with its industry-leading PEGylation and pulmonary drug development technology platforms. Nektar applies its PEGylation and pulmonary technology platforms to existing medicines with the objective to enhance performance, such as improving efficacy, safety and compliance.
This press release contains forward-looking statements regarding the potential of Cimzia®, Nektar's technology platforms, research and development plans and business strategy. These forward-looking statements involve important risks and uncertainties, including but not limited to: (i) Nektar's actual manufacturing revenues and royalties from Cimzia® will depend on UCB's sales of Cimzia®, (ii) Nektar's efforts to develop product candidates based on its technology platforms is subject to numerous scientific, clinical and regulatory risks and the risk of failure is high and can unexpectedly occur at any stage, and (iii) Nektar's patent applications may fail to issue; patents that have issued may not be enforceable; or unanticipated intellectual property licenses from third parties may be required in the future. Other important risks and uncertainties are detailed in the Nektar's reports and other filings with the Securities and Exchange Commission including its most recent Annual Report on Form 10-K. Actual results could differ materially from the forward-looking statements contained in this press release. Nektar undertakes no obligation to update forward- looking statements, whether as a result of new information, future events, or otherwise.
Source: Nektar Therapeutics
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