Just 5 months after trying to convince investors that they were on to a large pipeline of blockbusters heading to the market, J&J has already decided that two of them are essentially worthless, or just too dangerous to use.
The writing was already on the wall months ago for sirukumab, once a top prospect for rheumatoid arthritis until its partners at GlaxoSmithKline suddenly walked out. Earlier this year, though, a panel of outside experts voted down the marketing application, fretting over an unexplained imbalance in deaths in the study. The inevitable formal rejection followed.
The other drug to get the ax today is completely unexpected. It’s talacotuzumab (JNJ-56022473/CSL362) for acute myeloid leukemia. This Phase III drug, originally from CSL, uses Xencor’s antibody tech.
What went wrong? A spokesperson for J&J says the drug failed to live up to expectations in Phase III:
That decision was based on a recommendation by the Independent Data Monitoring Committee as the Phase III results did not demonstrate a positive benefit/risk ratio.
J&J also offered a statement on sirukumab, noting that it’s disappointed by the need to kill it now.
We maintain our belief in the efficacy and safety of sirukumab, an anti-IL-6 monoclonal antibody. However, the need for additional clinical data would result in significant delays to patient access in parts of the world. Given this, as well as the availability of other treatments targeting the IL-6 pathway, Janssen has made a strategic decision to prioritize other assets in our portfolio.
This is not the kind of news that J&J wants or needs right now. The pharma conglomerate has been struggling on the revenue side, leaving some prominent analysts wondering if it can continue to grow pharma sales.
In May, Joaquin Duato, J&J’s worldwide chairman for pharmaceuticals, committed to seeing J&J’s branded drug market maintain a clip of 5% annual growth through 2020, despite some stiff “headwinds” on prices — “where price growth is flattening” — with three approvals slated for 2017 and four more which the pharma giant expects to usher into the market in 2018.
These new drugs were part of one leg of the company’s three-leg strategy for growing revenue, with a promise that it can improve significantly on existing drugs — like Stelara, Invokana and Xarelto — while beefing up on a new core focus on pulmonary arterial hypertension through the Actelion buyout.
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