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
'/>"/>

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

Page: 1 2 3

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:12/24/2014)... (PRWEB) December 23, 2014 ... series is designed to introduce cutting edge ... users and partners of platform upgrades. This ... benefits; empowering users in their quest to ... tools. , According to SoundConnect’s Marketing Manager, ...
(Date:12/24/2014)... Dallas, Texas (PRWEB) December 23, 2014 ... on methyl mercaptan such as its definition, ... also presents product specification, manufacturing process, and ... regions, technology and applications. The analysis also ... survey, marketing channels, industry development trend and ...
(Date:12/24/2014)... December 23, 2014 Pipette.com announces their ... Twitter followers can submit their #HolidayInTheLab pictures for a ... lab mates. , For those struggling to think of ... Pipette.com Holiday in the Lab Contest provides the ideal ... followers to send pictures of their chemistree, holiday ...
(Date:12/24/2014)... 23, 2014 PharmaBoardroom,s new ... today and available for free download , digs deep ... and growth in the sector today. One area ... has been in developing a homegrown pharmaceutical manufacturing base, even ... still remains some way off. A cursory comparison with neighboring ...
Breaking Biology Technology:SoundConnect Launches Leading Edge Business Communications Webinar Series 2SoundConnect Launches Leading Edge Business Communications Webinar Series 3Worldwide Methyl Mercaptan Market 2015-2020 Forecasts on Development & Trends Now Available at ReportsnReports.com 2Major Pipette Distributor Pipette.com Announces their Holiday in the Lab Contest 2PharmaBoardroom Releases New Algeria Pharmaceuticals Report 2PharmaBoardroom Releases New Algeria Pharmaceuticals Report 3
... 6 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: ... on endocrine therapy and oncology, today announced that its ... corporate overview at the upcoming Canaccord Adams 29th Annual ... 2:00 p.m. (eastern time) at the Intercontinental Hotel in ...
... 6 Repligen Corporation (Nasdaq: RGEN ) today reported ... 2009. Total revenue for the quarter was $5,061,000 compared to ... 2009. The prior year results were favorably impacted by a ... the U.S. sales of Orencia(R) prior to the April 2008 patent ...
... , , SEATTLE, Aug. 6 ... recent achievements and financial results for the second quarter and six ... second quarter of 2009 was a transforming quarter for the Company ... data at the American Society of Clinical Oncology Annual Meeting and ...
Cached Biology Technology:Repligen Reports First Quarter Fiscal Year 2010 Financial Results 2Repligen Reports First Quarter Fiscal Year 2010 Financial Results 3Repligen Reports First Quarter Fiscal Year 2010 Financial Results 4Repligen Reports First Quarter Fiscal Year 2010 Financial Results 5Repligen Reports First Quarter Fiscal Year 2010 Financial Results 6Repligen Reports First Quarter Fiscal Year 2010 Financial Results 7Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 2Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 3Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 4Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 5Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 6Cell Therapeutics Second Quarter Net Loss Decreases 54%; Pixantrone NDA Submitted to the FDA for Approval 7
(Date:12/10/2014)... Forest Baptist Medical Center today announced plans for a ... Funding for this $50 million capital project is part ... launched next summer. The medical education ... R.J. Reynolds Tobacco Company complex, adjacent to 525@vine in ... plans to be ready to welcome medical students in ...
(Date:12/10/2014)... Research and Markets ( http://www.researchandmarkets.com/research/xclcvw/biometrics_market ... "Biometrics Market in Japan 2014-2018" report to ... The integration of biometrics and ... and upgradation of the driver,s license is one ... Besides the aforementioned projects, biometrics is being used ...
(Date:12/5/2014)... 4, 2014 Increased emphasis on product ... new testing and inspection technologies. The convergence of ... a range of innovative test solutions. This trend ... Y, which is generally more inclined towards communication, ... development strategies of test equipment vendors will cater ...
Breaking Biology News(10 mins):Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 2Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 3Wake Forest Baptist to Build New Medical Education Facility In Wake Forest Innovation Quarter 4Biometrics Market in Japan 2014-2018: Key Vendors are DDS, Fujitsu, Hitachi and NEC 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 2Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 3Emerging Technologies Enable Smarter Monitoring of Assets, Push Industrial Testing, Inspection and Monitoring Market 4
... Researchers have used a drug to achieve normal ... to have abnormally high insulin levels. If this ... innovative medicine for children with congenital hyperinsulinism, a ... insulin levels become dangerously high. "There is ...
... that sucks water and nutrients from its plant host also ... research could lead to new ways to combat parasites that ... the UC Davis Section of Plant Biology studied dodder vines ... RNA molecules from the host could be found in the ...
... universal means of communication. For example, a sudden rush of ... or cause a heart cell to beat. A longstanding mystery ... respond to the variety of calcium fluctuations within cells. ... team of biomedical engineers at the Johns Hopkins School of Medicine ...
Cached Biology News:Treatment corrects severe insulin imbalance in animal studies 2Treatment corrects severe insulin imbalance in animal studies 3Like eavesdropping at a party 2
... (ECM) is an important step in tumor ... adhering to and spreading along the blood ... MMP collagenases, dissolve tiny holes in the ... vessels to allow cancer cells to invade.,The ...
... This CLS number is a ... easily match Cornings product number. ... please order under the old ... customer service for assistance. ID ...
Kit containing MACS equipment and reagents for immunopurification of proteins....
... quality running into billions of dollars ... increasing pressure to reduce expensive rework ... distribution of ingredients is known to ... dissolution, stability, bio-availability and hardness. However, ...
Biology Products: