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:6/1/2015)... June 1, 2015 GenomeDx Biosciences ... analysis platform, successfully classified various subtypes of ... of certain biomarkers, including one type associated ... unique genomic signature has potential as a ... chemotherapy in patients with muscle-invasive bladder cancers ...
(Date:6/1/2015)... - BIOREM Inc. (TSX-V: BRM) ("Biorem" or "the Company") today announced results ... 2015 first quarter financial statements and MD&A have been filed on ... March 31,(in CDN$,000 except per share data) , 2015 ... Gross profit , 1,531 , 329 Ebitda* , ... 528 , (531) Basic earnings (loss) per share ...
(Date:6/1/2015)... June 1, 2015 Research ... addition of the "Global PDT Machine Industry ...        (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ... is a professional and in-depth study on the ... report provides a basic overview of the industry ...
(Date:6/1/2015)... Morton Grove, IL (PRWEB) June 01, 2015 ... leader in developing and manufacturing of chiral stationary ... Expanding the options for its current and presenting ... Separation Service to its portfolio. This valuable addition ... a fast and effective advantage that can tackle ...
Breaking Biology Technology:GenomeDx's Decipher Platform Validates Genomic Signature that may Predict Resistance to Chemotherapy in Bladder Cancer Patients in Study Presented at ASCO 2015 Annual Meeting 2GenomeDx's Decipher Platform Validates Genomic Signature that may Predict Resistance to Chemotherapy in Bladder Cancer Patients in Study Presented at ASCO 2015 Annual Meeting 3GenomeDx's Decipher Platform Validates Genomic Signature that may Predict Resistance to Chemotherapy in Bladder Cancer Patients in Study Presented at ASCO 2015 Annual Meeting 4Biorem Reports Increased Revenues and Earnings for First Quarter 2Biorem Reports Increased Revenues and Earnings for First Quarter 3Global PDT Machine Industry Report 2014 2Regis Technologies Offers Chiral Chromatography Service 2Regis Technologies Offers Chiral Chromatography Service 3
... Wis. - Expect the face of small business to ... class diversifies to an even greater degree, according to a ... of small business sponsored by Intuit , the California-based ... authored by the Institute for the Future , paints ...
... Dr. William Yasnoff agreed that $30 million is ... the adoption of electronic health records, but not too small ... idea. , ,Yasnoff, founder of the eHealth Trust Initiative, continues ... or bank, for all electronic health records. He views a ...
... information officers try to measure their value in financial terms, and ... Sauk Sauk, vice president and CIO of University of ... on investment; he has in mind a more practical form of ... accepted in August of 2006, Sauk told UWHC executives that he ...
Cached Biology Technology:Small-business trends: Intuit sees more mom-preneurs 2Small-business trends: Intuit sees more mom-preneurs 3Small-business trends: Intuit sees more mom-preneurs 4Yasnoff: Wisconsin should invest in health record bank 2Yasnoff: Wisconsin should invest in health record bank 3CIO Leadership Series: Mike Sauk, UW Hospital and Clinics 2CIO Leadership Series: Mike Sauk, UW Hospital and Clinics 3CIO Leadership Series: Mike Sauk, UW Hospital and Clinics 4CIO Leadership Series: Mike Sauk, UW Hospital and Clinics 5
(Date:4/20/2015)... The announcement comes as demand ... Management (GRM), Ireland,s foremost records management ... built up an impressive track record of clients within the ... the records management sector in Dubai . ... staffbase and employ a further eight staff members at its ...
(Date:4/14/2015)... 2015  HYPR Corp. today announced it has ... Alliance tm , an industry consortium transforming online ... share technology and collaborate to deliver open specifications ... secure and private, and easier to use. ... protects sensitive user information and eliminates the dependency ...
(Date:4/13/2015)... , April 13, 2015 ... Research, "Global Biometrics Market Forecast & Opportunities, 2020", the ... CAGR of around 14% till 2020. The biometrics ... large scale implementation and review of biometric management ... of new products with greater efficiency, are resulting ...
Breaking Biology News(10 mins):Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 2Glenbeigh Records Management Wins Contract With Dubai Islamic Bank 3HYPR Corp. Joins the FIDO Alliance 2HYPR Corp. Joins the FIDO Alliance 3Global Biometrics Market to Cross US$ 21 Billion by 2020: TechSci Research 2
... For smokers with asthma, quitting smoking can improve lung function ... two months. , The findings appear in the second ... and Critical Care Medicine, published by the American Thoracic Society. ... Medicine and Immunology at the University of Glasgow, and seven ...
... more than 120,000 children under age 6 in Massachusetts ... young children--especially infants--are now more likely to be overweight. ... Care and Prevention of Harvard Medical School and Harvard ... of Obesity. , "The obesity epidemic has spared no ...
... to feed exclusively on blood, including human blood, recognize their ... published today in the open access journal BMC Biology, vampire ... breathing sounds much better than human participants could. Vampire bats ... authors of the study propose that the bats use breathing ...
Cached Biology News:Quitting smoking improves lung function considerably 2Today's babies are fatter babies 2
Rabbit polyclonal to hCG ( Abpromise for all tested applications). entrezGeneID: 1081 SwissProtID: P01215...
Glutathione Agarose Beads 10 ml...
...
Human Regulatory T cell Staining Kit #2 (w/ APC Foxp3 PCH101, FITC CD4, PE CD25)...
Biology Products: