LONDON (ShareCast) - (ShareCast News) - Syncona noted on Friday that Blue Earth Diagnostics - which it funds - received a positive opinion recommending that Axumin be granted marketing authorisation in the European Union from the Committee for Medicinal Products for Human Use of the European Medicines Agency.
The FTSE 250 firm holds a 90% interest in the share capital of Blue Earth.

It said the recommendation was for Axumin (fluciclovine 18F) use in Positron Emission Tomography imaging, to detect the recurrence of prostate cancer in adult men who had a suspected recurrence based on elevated blood prostate specific antigen levels, after primary curative treatment.

That was an area of "significant" unmet need, according to Syncona's board.

A CHMP positive opinion was a "key step" in achieving approval to sell Axumin in the European Union, it added.

The opinion on Axumin would now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

A final decision was expected in the coming months and would be applicable to all European Union member states as well as in Iceland, Liechtenstein and Norway.

Axumin was already approved by the Food and Drug Administration in the United States in May 2016, and sales commenced in August.

Since then the business reportedly continued to make good strategic and commercial progress in the region.

The positive opinion of the CHMP, coupled with good progress in the US, had resulted in Syncona's investment in Blue Earth being written up to £109.01m - a £25.5m or 3.9p per share uplift to the last published valuation of £83.5m.

"In the three years since formation Blue Earth has successfully delivered to the US market a product with the potential to transform how patients with recurrent prostate cancer are treated," said Syncona Investment Management partner and Blue Earth director Iraj Ali.

"It is now a significant step closer to doing the same in Europe, which is testament to the efficacy of the product, hard work of the team and the strength of Syncona's long term partnership model."

Blue Earth chief executive, Jonathan Allis, called the CHMP's positive recommendation for Axumin a "major advance" for Blue Earth.

"We now look forward to working with our commercial manufacturing and distribution associates to be ready to make Axumin widely available to doctors and their patients across Europe."

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