Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button


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

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, has withdrawn its European marketing authorization application (MAA) for Sinerem™ (trade name Combidex® in the U.S.).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, the content of which is not part of this press release.

For more information, please click here

AMAG Pharmaceuticals, Inc.
Kristen Galfetti

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.

Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press


Nanoparticles simplify DNA identification and quantification November 27th, 2015

Scientists 'see' detailed make-up of deadly toxin for the first time: Exciting advance provides hope for developing novel potential method of treating pneumococcal diseases such as bacterial pneumonia, meningitis and septicaemia November 25th, 2015

Electric fields remove nanoparticles from blood with ease November 24th, 2015

Production of Nanocapsules Containing Omega-3 Powder in Iran November 24th, 2015


'Material universe' yields surprising new particle November 28th, 2015

Iranian Scientists Discover New Catalyst to Remove Pharmaceutical Compounds from Wastewater November 28th, 2015

RAMAN Spectrometry Makes Characterization of Various Nanostructures Possible November 28th, 2015

Nanoparticles Boost Impact Resistance of Special Type of Polymer November 28th, 2015

Alliances/Trade associations/Partnerships/Distributorships

New EU project designed to link diagnosis and treatment of diseases over the long term: Joint research project aims at the improvement of companion diagnostics and therapy of tumor diseases November 23rd, 2015

EuroCPS, a Horizon 2020 Project, Announces Next Round Of Support for Innovative Companies and their CPS projects November 20th, 2015

Leti and Partners in Silicon Photonics Supply-Chain Project Announce Developments on Three Mature Platforms: PLAT4M Project Focused on Speeding Industrialization of the Technology November 18th, 2015

FEI and ICON Analytical Demonstrate the Power of TEM for Materials and Life Sciences Research: FEI’s Talos scanning transmission electron microscope will be available for demos and workshops at the Indian Institute of Science from 23 November to 15 December 2015 November 17th, 2015

The latest news from around the world, FREE

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

Nanotechnology Now Featured Books


The Hunger Project

Car Brands
Buy website traffic