Nanotechnology Now







Heifer International

Wikipedia Affiliate Button


DHgate

Home > Press > AMAG Pharmaceuticals, Inc. Announces Update on Sinerem™ in Europe

Abstract:
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, has withdrawn its European marketing authorization application (MAA) for Sinerem™ (trade name Combidex® in the U.S.). Guerbet submitted an MAA to the European Medicines Agency (EMEA) in November 2006 seeking marketing approval for Sinerem™ for the detection and characterization of metastatic lymph nodes in patients with pelvic cancer. According to Guerbet, the Committee for Medicinal Products for Human Use (CHMP) indicated that the Phase III data submitted by Guerbet does not provide sufficient statistical demonstration of the efficacy of Sinerem™. Guerbet stated that it plans to evaluate all possible options that would satisfy the EMEA's requirements for the proposed indication.

AMAG Pharmaceuticals, Inc. Announces Update on Sinerem™ in Europe

Cambridge, MA | Posted on December 13th, 2007

Sinerem™/Combidex is AMAG Pharmaceutical's investigational functional molecular imaging agent consisting of superparamagnetic iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) as an aid in the differentiation of cancerous from normal lymph nodes. AMAG Pharmaceuticals, Inc. has granted Guerbet an exclusive right to manufacture and sell Sinerem™ in certain countries in Europe and other parts of the world.

About Combidex®

In March 2005, AMAG Pharmaceuticals, Inc. received an approvable letter from the U.S. Food and Drug Administration (FDA) with respect to Combidex subject to certain conditions. The company is working to determine whether additional data from a Phase III study sponsored by Guerbet in Europe in patients with pelvic cancers, including prostate, bladder, cervical and uterine cancer, together with other additional analyses and new information to be provided to the FDA will address the concerns raised in the March 2005 approvable letter. Based on a preliminary review of the data from the Guerbet trial, it remains highly uncertain whether the data from that trial will be sufficient to address the concerns raised by the FDA, and until the evaluation is complete and until the company meets with the FDA to discuss its intended response to the March 2005 approvable letter, the company cannot predict with certainty the timing or likelihood of its ability to satisfy the conditions specified by the FDA for approval of Combidex.

####

About AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.

Ferumoxytol, the company’s key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease patients. The company has completed four Phase III clinical trials with fermuoxytol and has presented data on all four trials.

The company has two commercial products, Feridex I.V.® and GastroMARK®, both of which are imaging agents that are approved and marketed in the United States, Europe and other countries.

For more information about AMAG Pharmaceuticals, please visit our website at http://www.amagpharma.com, the content of which is not part of this press release.

For more information, please click here

Contacts:
AMAG Pharmaceuticals, Inc.
Kristen Galfetti
617-498-3362

Copyright © Business Wire 2007

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

Nanomedicine

A better way to build DNA scaffolds: McGill researchers devise new technique to produce long, custom-designed DNA strands May 6th, 2015

Thermometer-like device could help diagnose heart attacks May 6th, 2015

Improving Clinical Care and Patient Quality of Life in Advanced Liver Disease, d-LIVER Workshop, Milan, 27 May 2015 May 6th, 2015

Arrowhead Completes Dosing Healthy Volunteers and Initiates Transition to Patients in Phase 1 Study of ARC-AAT May 5th, 2015

Announcements

The next step in DNA computing: GPS mapping? May 6th, 2015

Improving Clinical Care and Patient Quality of Life in Advanced Liver Disease, d-LIVER Workshop, Milan, 27 May 2015 May 6th, 2015

Grafoid Acquires MuAnalysis Inc; Expands Its Advanced Materials Testing Capabilities May 6th, 2015

Winner Announced for NNI’s First ‘EnvisioNano’ Nanotechnology Image Contest May 6th, 2015

Alliances/Partnerships/Distributorships

Silicon Storage Technology and GLOBALFOUNDRIES Announce Qualification of Automotive Grade 55nm Embedded Flash Memory Technology May 5th, 2015

How can you see an atom? (video) April 10th, 2015

FibeRio and VF Corporation Form Strategic Partnership to Lead the Apparel and Footwear Markets in Nanofiber Technology April 8th, 2015

UK National Graphene Institute Selects Bruker as Official Partner: World-Leading Graphene Research Facility Purchases Multiple Bruker AFMs April 7th, 2015

NanoNews-Digest
The latest news from around the world, FREE




  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoTech-Transfer
University Technology Transfer & Patents
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More










ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project