Hettie schreef op 10 februari 2017 20:46:
Industry Trend Analysis - Takeda Investment Highlights Growing Confidence In TiGenix - MAR 2017
Western Europe February 2017 / Belgium / Industry
BMI View: Takeda's equity investment in TiGenix, coinciding with a recent US IPO, highlights a growing confidence in TiGenix and its lead product, Cx601, for treating complex perianal fistulas in Crohn's disease. Although Cx601 has yet to be commercialised, and TiGenix has yet to make a profit, development of the drug is progressing smoothly. Should Cx601
be approved and launched in the US and the EU, it will be poised to become a blockbuster drug filling an underserved niche.
Takeda has exercised the option granted under a licensing agreement between it and TiGenix to make a EUR10mn (USD10.4mn) equity investment in TiGenix. Takeda Pharmaceuticals International will be subscribing some 11.7mn new ordinary shares at an issue price of EUR0.858 (USD0.895) per new share. The issue price is equal to the average closing price of TiGenix' share on Euronext Brussels over the 30 day period preceding the date on which the issuance of the New Shares commenced and represents a 23% premium over that day's closing price on Euronext Brussels. The issuance of the new shares is anticipated to commence by the end of the first week in January 2017.
On July 4 2016, Takeda and TiGenix entered into an exclusive ex-US licence, development and commercialisation agreement for Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease (CD). The licensing agreement also provided for Takeda to make an equity investment of EUR10mn in the share capital of TiGenix within the 12 months following the date of the licensing agreement. TiGenix commented that the additional funds from Takeda will allow it to remain fully focused on progressing with the MAA for Cx601 in the EU, the launch of its Phase III trial to register Cx601 in the US and advancing with other clinical assets in its pipeline.
Cx601 is a suspension of allogeneic expanded adipose-derived stem cells injected intralesionally. It is being developed for the treatment of complex perianal fistulas in CD patients. In 2009, the EC granted Cx601 orphan designation for the treatment of anal fistulas, recognising the debilitating nature of the disease and the lack of treatment options; this will give the product ten years' market exclusivity from the date of marketing authorisation.