Roche gets hit with another big R&D setback as a prospective AMD blockbuster flops in PhIII

At one point Genentech’s eye drug lampalizumab was a comfort to Roche CEO Severin Schwan as he contemplated the loss of patent protection on the Swiss pharma giant’s three big franchise drugs. Today, as generic competition gets serious, it’s another cautionary tale about the high-risk world of drug development.

Roche said on Friday that lampalizumab flopped in its first of two late-stage studies, likely delivering a killer blow to a drug that once figured as a potential megablockbuster that Deutsche Bank analysts estimated could bring in $6 billion a year.

Roche shares $RHHBY dropped 2%.

Sandra Horning

Lampalizumab did not reduce mean change in geographic atrophy lesion area compared to placebo at one year (48 weeks). Given the lack of efficacy, says Roche, “further dosing in patients will be interrupted until the results from the second Phase III study are evaluated.”

It won’t be long before Roche decides what to do next.

“While this result is disappointing,” says Roche CMO Sandra Horning, “we will continue to evaluate results from Spectri to get a clearer understanding of the data as we await the results of our second Phase III study, Chroma, anticipated in November.

Just days ago a small Kentucky biotech called Apellis says it was able to make a mark in exactly the same field. The biotech has been focused on what it believes is a better way of shutting down several disease pathways using a complement C3 inhibitor. In the AMD study, which recruited 246 AMD patents with geographic atrophy at 40 clinical sites, Apellis’ drug APL-2 — delivered monthly — produced a 29% average reduction in the rate of geographic atrophy lesion growth over 12 months.

The pharma giant is getting hit at a particularly bad time. Shire is saying damning things about its rival hemophilia drug ACE910, while Roche sold off a floundering asthma drug, lebrikizumab, and failed to convince anyone that its combination of Perjeta and Herceptin would win over payers. A key Phase III failure for its checkpoint Tecentriq last spring cast a pall over all of 2017.

Drug development is a tough business, as we are reminded every day. And this week marks another key late-stage setback for one of the biggest players in R&D.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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