Replies to post #215049 on Biotech Values

[biotech jim]

Has NVS provided any update on the manufacturing issue they have with brolucizumab?

[DewDiligence]

REGN cans Nesvacumab program after phase-2 failures as an addend to Eylea in AMD/DME:

http://investor.regeneron.com/releaseDetail.cfm?ReleaseID=1049746

Regeneron Pharmaceuticals…today announced that results from two Phase 2 studies that added the angiopoietin2 (Ang2) antibody nesvacumab to EYLEA (aflibercept) Injection did not provide sufficient differentiation to warrant Phase 3 development. The RUBY study evaluated patients with diabetic macular edema (DME) and the ONYX study evaluated patients with wet age-related macular degeneration (wet AMD).

[DewDiligence]

NVS buys PRV for $130M from RARE—RTH258 likely beneficiary (IMO):

https://finance.yahoo.com/news/ultragenyx-sells-priority-review-voucher-133000076.html

See #msg-136129447 for phase-3 data on RTH258 (a/k/a brolucizumab).

[DewDiligence]

Data support 12-week dosing of RTH258 for some wet-AMD patients: #msg-140425036.

https://globenewswire.com/news-release/2018/04/30/1490310/0/en/New-Novartis-Phase-III-data-for-brolucizumab-demonstrate-reliability-of-12-week-treatment-interval.html

These are pre-specified secondary-endpoint data from phase-3 trials (the HAWK and HARRIER studies) whose successful overall results were presented in Nov 2017 (#msg-136129447).