bullish
Good manufacturing status allows sales to start
SUMMARY
With Italian GMP approval of the Spherotide one-month formulation, Xbrane can ship a SEK7m order to Iran. A Chinese deal worth SEK17m upfront, $8m total, may be signed in H117. European partnering and launches are possible from 2019 after clinical trials. Xbrane (or a partner) may sell Xlucane, its low-cost biosimilar of Lucentis (2015 sales $3.6bn), in the US after 2021 and from 2022 in Europe. A study has been done on pilot scale batches showing high biosimilarity, giving a solid basis for scale up.
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Edison Investment Research
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- Good manufacturing status allows sales to start02 Mar 2017
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