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Tigenix draws closer to European nod

Tigenix draws closer to European nod


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December 18, 2017

With Friday’s positive opinion from European regulators Tigenix  is on track for an early 2018 EU approval for  Cx601 , its cell therapy  for complex anal fistulas in Crohn’s disease.

While the company is trumpeting Cx601  as potentially the first allogeneic  stem cell therapy  to be approved in Europe, it will be hoping that a change of therapy focus, orphan drug status and more importantly growing comfort in the reimbursement of cell-based therapies will prevent  Cx601  going the way of its last cell-based product,  Chondrocelect .

The 15% jump in Tigenix  shares on Friday appears to indicate that investors believe that  Cx601  will live up to its promise as one of the few new treatments for Crohn’s-related anal fistulas in years.

Onwards and westwards

If the group does clear the final European regulatory hurdle it will help set up expectations for the more important US market, where Tigenix  holds full rights. In Europe  Cx601  is licensed to  Takeda

On a conference call on Monday Eduardo Bravo, Tigenix  chief executive, said a 320-patient phase III trial for US registration was now  enrolling . He added that the group was hoping to file either at the end of 2018 or early in 2019 using the European data, while simultaneously conducting the pivotal US trial.

Getting this far in Europe, however, has not been without issues. Last year, the EMA raised a number of serious questions about the project, including about stability of the master stock and deficiencies in the primary endpoint. Friday’s thumbs-up from the regulator appears to indicate that Tigenix  has satisfactorily answered these questions.

The group has also sorted out some of the patent concerns surrounding Cx601 . Earlier this month it agreed a €20m ($23m) settlement with Mesoblast  under which  Tigenix  gained exclusive global rights to some of  Mesoblast ’s patents, allowing Tigenix  to use expanded adipose-derived mesenchymal cells  in Cx601 .

Though the deal is largely positive it highlights the increasing murky IP rights associated with innovative cell therapies as more products come closer to the market.

Making it rain

Even when cell therapies do make it to approval the path is often not smooth sailing, as Tigenix  is well aware.

ChondrocelectTigenix ’s product for knee cartilage repair, was divested to another company five years after its 2009 European launch, owing to low sales. But the divestment was not enough to turn fortunes around, and in 2016 Tigenix  ended the deal and withdrew EU marketing authorisation, citing the difficulties in gaining reimbursement in key countries.

Orphan drug designation for Cx601  in Europe and the US for should, hopefully, give  Tigenix  and  Takeda  some leeway in pricing the product in its niche indication.  Takeda ’s marketing muscle could also give a better outcome in Europe this time around.

With a €15m EU approval payout on the cards and estimated royalties of 18% from TakedaTigenix  will also be banking on  Takeda ’s success (Tigenix the latest to find stem cell appetite in Japan, July 5, 2016).

But, as ever with Tigenix , the big test of success will come with US approval.