Navigation Links
Inspiration Biopharmaceuticals Announces Acceptance of European Marketing Authorization Application for IB1001 for the Treatment of Hemophilia B
Date:10/2/2011

LAGUNA NIGUEL, Calif., Oct. 3, 2011 /PRNewswire/ -- Inspiration Biopharmaceuticals, Inc. (Inspiration) today announced that the European Medicines Agency (EMA) has validated and accepted the filing of the Marketing Authorization Application (MAA) for Inspiration's IB1001, a recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B.  In doing so, the EMA has verified that it will begin its regulatory review process of the MAA.

The application includes safety and efficacy data from Inspiration's clinical program for IB1001, which was conducted in the U.S., Europe, Israel and India.

Based on Inspiration's partnership agreement with the Ipsen Group (Euronext: IPN; ADR: IPSEY), which was signed in January 2010, by receiving the IB1001 MAA submission acceptance for review from the EMA, Inspiration will receive a $35 million milestone payment from Ipsen.  In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen's fully diluted equity ownership position in Inspiration to approximately 38%.

In late August, Ipsen and Inspiration extended their partnership to create a hemophilia business unit structure that will act as the exclusive sales organization for all hemophilia products commercialized under the Inspiration brand in Europe.

"The MAA submission for our lead program, IB1001, is Inspiration's first product approval regulatory filing, and a key step in the Company's transformation toward becoming a commercial-stage company," stated John Taylor, Co-Founder and Chairman of Inspiration.  "We believe the hemophilia community would like to see greater product choice. Currently, individuals with hemophilia B only have one marketed recombinant FIX treatment option.  Our IB1001 program is designed to increase product supply, provide patient choice, and help achieve our mission to broaden access to care worldwide."

About IB1001IB1001, Inspiration's lead product candidate, is an intravenous recombinant FIX product being developed for the treatment and prevention of bleeding in individuals with hemophilia B.  IB1001 has completed the pivotal Phase 3 clinical testing for the European regulatory submission, while clinical testing for the U.S. regulatory submission is ongoing.  To date, IB1001 has been well-tolerated by patients and pharmacokinetic results have demonstrated non-inferiority to the one approved recombinant FIX product currently available for the treatment of hemophilia B.

About Inspiration BiopharmaceuticalsInspiration Biopharmaceuticals is dedicated exclusively to developing treatments for hemophilia, with a primary mission to broaden access to care, including prophylactic therapy, and to improve the treatment of individuals with inhibitor complications.  Inspiration has a broad portfolio of recombinant hemophilia products, which includes two products in late-stage clinical development and two pre-clinical programs.

Inspiration's lead product candidates are IB1001, an intravenous recombinant factor IX (FIX) product for the treatment and prevention of bleeding in individuals with hemophilia B, and OBI-1, an intravenous recombinant porcine factor VIII (FVIII) product for the treatment of individuals with congenital hemophilia A who have developed inhibitors against human FVIII and for individuals with acquired hemophilia.  Both products are in advanced clinical development.  Earlier-stage preclinical programs at Inspiration are focused on human recombinant factor VIIa (FVIIa), for individuals with either hemophilia A or hemophilia B who have developed inhibitors, and for individuals with factor VII deficiency; and human recombinant FVIII, to treat individuals with hemophilia A.

Inspiration has extensive expertise and experience in hemophilia product development, biologics manufacturing, regulatory approval and global commercialization. The Company's senior leadership was directly responsible for the development and commercialization of the majority of hemophilia products currently on the market.  

In addition, in January 2010, Inspiration entered into a strategic partnership with the Ipsen Group, leveraging the combined expertise and resources of the two companies, to develop a broad portfolio of hemophilia products.  As announced in late August 2011, through an extension of the Company's existing partnership with Ipsen, Inspiration will be commercializing its hemophilia product portfolio in Europe, utilizing a hemophilia business unit structure being established within Ipsen's existing European commercial organization. For further information on Inspiration, please visit http://www.inspirationbio.com. Contacts:Media

CompanyJustin Jackson

Mary BaumanMaroussia Czarny

Vice President, Global Commercial StrategyBurns McClellan

Email: mbauman@inspirationbio.comTel: +1-212-213-0006Email: jjackson@burnsmc.commczarny@burnsmc.com
'/>"/>

SOURCE Inspiration Biopharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Inspiration Biopharmaceuticals Presents Safety Data on IB1001, a Novel Recombinant Factor IX for the Treatment of Hemophilia at the International Society on Thrombosis and Haemostasis (ISTH) Annual Meeting
2. Using magnetic toys as inspiration, researchers tease out structures of self-assembled clusters
3. Keryx Biopharmaceuticals, Inc. to Hold Conference Call on Second Quarter 2008 Financial Results on Monday, August 11, at 8:30 A.M. EDT
4. XTL Biopharmaceuticals Receives Notice of Non-Compliance with Nasdaq Marketplace Rule Due to Changes in Board Composition
5. Bayer Broadens Its Manufacturing Basis for Biopharmaceuticals in Tobacco Plants
6. Nomad Bioscience: New Plant Biotechnology Company Founded to Focus on Biomaterials and Biopharmaceuticals
7. Morria Biopharmaceuticals Plc Announces Results From its Pre-Clinical Screening of Novel Anti-Inflammatory Compounds
8. Keryx Biopharmaceuticals Notified that Nasdaq Has Extended Minimum Bid Price Rule Compliance Period
9. Morria Biopharmaceuticals Plc to Present at the Rodman & Renshaw 10th Annual Healthcare Conference
10. Morria Biopharmaceuticals Plc Announces Positive Clinical Results for MRX-4 in its Phase II Clinical Study in Allergic Rhinitis Patients
11. Nventa Biopharmaceuticals Announces Third Quarter 2008 Financial Results and Recent Corporate Highlights
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... May 24, 2016 , ... Last week, Callan Capital, ... executives and entrepreneurs, held The Future of San Diego Life Science event at the ... life science community attended the event with speakers Dr. Rich Heyman, former CEO of ...
(Date:5/23/2016)... Texas (PRWEB) , ... May 23, 2016 , ... The need for blood donations in ... this week by the South Texas Blood & Tissue Center, blood donations are on the ... 30 years, and they are down 21 percent in South Texas in the last four ...
(Date:5/23/2016)... WARSAW, Ind. , May 23, 2016 Zimmer ... in musculoskeletal healthcare, today announced that its Board of Directors ... stockholders for the second quarter of 2016. ... on or about July 29, 2016 to stockholders of record ... Future declarations of dividends are subject to approval of the ...
(Date:5/23/2016)... LONDON , May 23, 2016 - ... by 40% - Frontage Implement a Single Platform to ... Compliance and Traceability Within the Bioanalytical lab Frontage Laboratories, ... the United States and China , ... its laboratory facilities. In addition to serving as the global electronic ...
Breaking Biology Technology:
(Date:5/24/2016)... Ampronix facilitates superior patient care by providing unparalleled technology to leaders of the medical ... premium product recently added to the range of products distributed by Ampronix. ... ... ... Ampronix News ...
(Date:5/20/2016)... 2016  VoiceIt is excited to announce its ... By working together, VoiceIt and VoicePass will ... VoicePass take slightly different approaches to voice biometrics, ... and usability. ... partnership. "This marketing and technology partnership ...
(Date:5/16/2016)... 2016   EyeLock LLC , a market leader ... of an IoT Center of Excellence in ... development of embedded iris biometric applications. EyeLock,s ... and security with unmatched biometric accuracy, making it the ... DNA. EyeLock,s platform uses video technology to deliver a ...
Breaking Biology News(10 mins):