FDA delivers less than half a loaf to INCY and LLY in approving Olumiant

Today the U.S. Food & Drug Administration did finally approve Baricitinib, now known as Olumiant, for the treatment of moderately-to-severely active rheumatoid arthritis.

But the approval carries more restrictions than expected.

The FDA approved only the 2 milligram dose of the drug not the 4 milligram does that was likely to gain more market share. (Rheumatoid arthritis, which causes inflammation and destruction of joints, affects more than 23 million people worldwide.)

The approval restricts the drug of patients who have already been treated with TNF inhibitors such as Humira from AbbVie (ABBV), so that will slow adoption and restrict the market.

And Olumiant will come with a boxed warning–the strictest type of warning from the FDA–against risk of blood clotting, serious infections and malignancies including lymphoma.

The restrictions are actually more severe than recommended by the independent advisory committee two months ago.

It’s important to note that shares of Incyte (INCY) have hardly budged today–they were down 0.47% as of 2:30 p.m. New York time. I think that’s an indication that most Wall Street analysts and investors had already taken sales of Baricitinib/Olumiant out of their models for Incite and Eli Lilly (LLY).

It’s not like Wall Street is expecting the drug to deliver no sales–they just threw it out of the financial models when it became clear this wasn’t going to be a $1 billion blockbuster. J.P. Morgan, for example, is now estimating that the drug will show U.S. sales of about $400 million in 2022.

It’s also interesting to note that shares of AbbVie, the maker of Humira, which is a blockbuster to end all blockbusters, barely rippled lower today with AbbVie off 0.71% at 2:30 p.m. in New York. That’s actually kind of surprising to me, not because of the Incyte/Eli Lilly news but because Novartis (NVS) won the recommendation of a European panel for its biosimilar version of AbbVie’s Humira. A near copy of Humira would gather some of that drug’s $18 billion in annual sales. (I’d also note here that Eli Lilly has announced that Olumiant will sell for $25,000 a year, which is a 60% discount to Humira. and half the price of Xeljanz from Pfizer (PFE).) AbbVie’s primary patent on Humira expires in October in Europe but, so far, looks set to run until 2023 in the United States.

I’ll  be plugging all this news into my model for Incyte (and factor in the prospects for drug candidates in the pipeline) and will give you a new recommendation for Incyte shares and options (in my Jubak Picks and Volatility portfolios) next week.