Navigation Links
FDA Approval of Cimzia(R) for Crohn's Disease Represents Latest Milestone for Nektar's PEGylation Technology Platform
Date:4/23/2008

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 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(R), Roche's PEGASYS(R) for hepatitis C and Amgen's Neulasta(R) for neutropenia.

About Cimzia(R) (certolizumab pegol)

Cimzia(R) is the first and only PEGylated anti-TNFa (Tumor Necrosis Factor alpha). Cimzia(R) 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(R) in Crohn's Disease, RA and other autoimmune disease indications. For additional information, including safety information, please refer to the Cimzia(R) factsheet in the "News" section of UCB's website (http://www.ucb-group.com). Cimzia(R) 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).

About Nektar

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(R), 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(R) will depend on UCB's sales of Cimzia(R), (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.

Contacts:

Tim Warner (650) 283-4915 or twarner@nektar.com

Stephan Herrera (415) 488-7699 or sherrera@nektar.com

Jennifer Ruddock (650) 631-4954 or jruddock@nektar.com


'/>"/>
SOURCE Nektar Therapeutics
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Arkion(R) Life Sciences Receives Crisis Exemption to US EPA Section 18 Approval in Mississippi and Tennessee to Market Avitec Corn Seed Treatment
2. Mylan Announces Final FDA Approval for Felodipine Extended-Release Tablets, USP
3. Breckenridge Announces Approval of Generic Activella(R)
4. Extrel CMS Announces ATEX Approval for Process Mass Spectrometer
5. OrbusNeich Receives CE Mark Approval for Sapphire(TM) 1.25MM PTCA Dilatation Catheter
6. iCAD Receives FDA Approval for Its SecondLook Digital for Use With Fujis Digital Mammography System
7. FORSTEO(R) Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis
8. Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted Personalized Sedation System
9. Correction: Evalve Announces CE Mark Approval of the Worlds First Percutaneous Valve Repair System
10. Evalve Announces CE Mark Approval of the Worlds First Percutaneous Valve Repair System
11. Alsius Corporation Receives Regulatory Approval in China and Mexico
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... client, The Grove Investment Group (TGIG), has initiated cultivation and processing operations at ... Las Vegas and Pahrump, Nevada. , Puradigm is the manufacturer of a complete ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  American Respiratory Labs (ARL), a ... now able to perform sophisticated lung assessments in patients, homes, thanks ... Inc. Patients are no longer limited to having ... PRO ® , ARL patients like Jeanne R. of ... the comfort of her own home. ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
Breaking Medicine Technology: