Nanotechnology Now

Our NanoNews Digest Sponsors

Heifer International

Wikipedia Affiliate Button

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AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that its European partner, Guerbet S.A. of France, has withdrawn its European marketing authorization application (MAA) for Sinerem™ (trade name Combidex® in the U.S.).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

Synthetic protein packages its own genetic material and evolves computationally designed protein assemblies are advancing research in synthetic life and in targeted drug delivery December 15th, 2017

Perking up and crimping the 'bristles' of polyelectrolyte brushes December 13th, 2017

Leti to Demo Wristband with Embedded Sensors to Diagnose Sleep Apnea: APNEAband, Which Will Be Demonstrated at CES 2018, Also Monitors Mountain Sickness, Dehydration, Dialysis Treatment Response and Epileptic Seizures December 12th, 2017

Untangling DNA: Researchers filter the entropy out of nanopore measurements December 8th, 2017

Announcements

Quantum memory with record-breaking capacity based on laser-cooled atoms December 15th, 2017

Record high photoconductivity for new metal-organic framework material December 15th, 2017

Error-free into the quantum computer age December 15th, 2017

Leti Will Demonstrate First 3D Anti-Crash Solution for Embedding in Drones: Fitted on a Mass-Market Microcontroller, 360Fusion Software Technology Detects any Dynamic Obstacle and Helps Guide Drones Away from Collisions December 15th, 2017

Alliances/Trade associations/Partnerships/Distributorships

A new product to help combat mouldy walls, thanks to technology developed at the ICN2 December 14th, 2017

JPK Instruments announce partnership with Swiss company, Cytosurge AG. The partnership makes Cytosurge’s FluidFM® technology available on the JPK NanoWizard® AFM platform December 8th, 2017

Nano Global, Arm Collaborate on Artificial Intelligence Chip to Drive Health Revolution by Capturing and Analyzing Molecular Data in Real Time November 21st, 2017

EC Project Aims at Creating and Commercializing Cyber-Physical-System Solutions November 14th, 2017

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