Keywords: ThromboGenics, Ocriplasmin, BLA, USA, FDA, Ipsen, Inspiration Biopharma, IB 1011, VMA, Hemophilia
Article | 17 April 2012
Belgian biopharma company ThromboGenics NV (Euronext Brussels: THR) said this morning that it has resubmitted a Biologics License Application with the US Food and Drug Administration for ocriplasmin intravitreal injection, 2.5mg/mL, for the treatment of symptomatic vitreomacular adhesion (VMA) including macular hole.
In February 2012, the FDA indicated that it intended to assign a Priority Review designation to the original BLA submission for the same indication filed in December 2011, after which ThromboGenics outlined plans for the drug’s launch (The Pharma Letter March 12). Today’s re-submission will allow the company to meet the FDA’s Priority Review timelines and to manage the phasing of its resources to support both its European and US ocriplasmin filings. The European Medicines Agency is currently reviewing the Marketing Authorization Application for ocriplasmin for the same indication.
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A recent report from EvaluatePharma noted that ocriplasmin is potentially the first non-surgical treatment for vitreomacular adhesion, and forecast sales to reach $409 million by 2016 (The Pharma Letter January 20).
Patrik De Haes, ThromboGenics’ chief executive, said: “The resubmission of the BLA filing is a significant step in our strategy to commercialize ocriplasmin in the USA, if approved. Gaining Priority Review designation for ocriplasmin, as anticipated, would further validate the potential of this novel pharmacological drug in treating symptomatic VMA including macular hole. Following our recent commercialization agreement with Alcon for the non-US rights to ocriplasmin and our successful fundraising, we are well positioned to invest in building a first-class commercial organization in the USA and to realize the full global potential of ocriplasmin.”
Ipsen’s partner announces US filing of BLA for IB1001 for hemophilia
Also this morning, French drugmaker Ipsen (Euronext: IPN) revealed that its partner, privately-held USA-based Inspiration Biopharmaceuticals, has submitted a BLA with the FDA for the approval of IB1001, an intravenous recombinant factor IX (rFIX) for the treatment and prevention of bleeding in individuals with hemophilia B.
The IB1001 BLA filing includes a comprehensive set of pharmacokinetics, safety and efficacy data from a Phase III clinical trial in patients affected by hemophilia B. A surgery sub-study was also included.
In January 2010, Inspiration and Ipsen entered into a broad strategic partnership to develop and commercialize a unique portfolio of hemophilia products, which included Inspiration in-licensing OBI-1 from Ipsen, as well as Ipsen providing Inspiration with milestone-based funding to support the development of Inspiration’s two lead development programs. The plan was to create a hemophilia franchise worth a potential $1 billion by 2020 and could lead to Ipsen’s eventual acquisition of the US firm (TPL January 21, 2010).
Based on the terms of this partnership, Inspiration will now receive a $35 million milestone payment from Ipsen associated to the filing of the IB1001 BLA. In return, Inspiration will issue a convertible note to Ipsen, bringing Ipsen’s fully diluted equity ownership position in Inspiration to around 43.5%.
Regulatory review is now pending in both the USA and Europe. Inspiration’s MAA for IB1001 was accepted by the European Medicines Agency in September 2011. Inspiration is currently finalizing plans for additional regulatory filings and preparing for the commercial launch of IB1001.