MSB Trading - 2019, page-1151

I have done some further research and answered my own question - it is awaiting FDA approval ... Obviously just needed more coffee .... lol .... the good thing is if the FDA approve it MSB will receive further revenues from milestones and royalties




https://www.drugdevelopment-technol...ent-complex-perianal-fistulas-crohns-disease/
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DRUG (BRAND / GENERIC)

Alofisel® / darvadstrocel
COMPANY / LICENSEE

TiGenix NV / Takeda Pharmaceutical Company
THERAPY CLASS

Allogeneic stem cell therapy

Alofisel® (formerly Cx601 / darvadstrocel) is the first allogeneic stem cell therapy to be approved for the treatment of complex perianal fistulas in adult patients with Crohn’s disease.
The drug was discovered by TiGenix NV and co-developed by Takeda Pharmaceutical Company.
Alofisel received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and the Committee for Advanced Therapies (CAT) in December 2017.
The drug was granted orphan designation by the European Commission (EC) and the US Food and Drug Administration (FDA) in 2009 and 2017 respectively.
It subsequently received marketing authorisation (MA) in Europe from the EC in March 2018.
The FDA approval for Alofisel is currently under review.


MSB Announcement dated 14 December 2017

New York, USA, Melbourne, Australia and Leuven, Belgium, December 14, 2017

Mesoblast Limited (ASX: MSB; Nasdaq: MESO) and TiGenix NV (Euronext Brussels and Nasdaq: TIG) today announce that Mesoblast has granted TiGenix exclusive access to certain of its patents to support global commercialization of the adipose-derived mesenchymal stem cell product Cx601 for the local treatment of fistulae.

The agreement includes the right for TiGenix to grant sub-licenses to affiliates and third parties, including TiGenix’s current development and commercialization partner ex-United States. As consideration, Mesoblast will receive up to €20 million (approximately USD$24 million) in payments, with €5 million upfront, €5 million within 12 months, and up to €10 million in product regulatory milestones. Additionally, Mesoblast will receive single digit royalties on net sales of Cx601.