Will Gilead enter the autoimmune diseases market?

Kim Yun-mi  Published 2019.07.22  17:34  Updated 2019.07.22 17:34


Gilead Sciences is highly likely to buy Otezla (apremilast), a new oral PDE4 inhibitor which BMS had secured by acquiring Celgene and later decided to sell, analysts say.

U.S. medical journal FiercePharma reported last Friday that buying Otezla would be “a bolt-on strategy to accelerate Gilead’s entrance into the [inflammation and immunology] space” and that “folding in the product’s commercial infrastructure would be a logical move” as the company’s filgotinib is looking ahead to an FDA filing, citing analysts.

Filgotinib is an oral JAK inhibitor Gilead Sciences is developing for rheumatoid arthritis treatment in competition with Pfizer’s Xeljanz. Gilead finished the first phase 3 clinical trial FINCH 2 in success last year and is planning for an FDA filing by the end of this year.

Analysts find that it is logical for Gilead to buy Otezla because not only does Gilead have enough financial resources but the company needs to build a sales and marketing infrastructure for autoimmune diseases, including rheumatic arthritis, psoriatic arthritis, and lupus before filgotinib is approved.

FiercePharma noted that the sales of Otezla are figured to “peak at around $2.5 billion, up from $1.6 billion in 2018.” The journal reported that analysts calculate the drug’s operating margins to be around 62 percent to 67 percent, which can “translate into a value of about $8 billion,” enabling Gilead to “afford the buy as long as competitive bidding doesn’t boost the price above $9.6 billion.”

The medical journal also mentioned the 10-year partnership Gilead recently signed with Galapagos, the original developer of filgotinib, to explain that the company “needs a new direction as its hepatitis C drugs continue to decline, its much-hyped CAR-T drug Yescarta (axicabtagene ciloleucel) scrambles for traction, and its next-gen liver drug fails to deliver.”

The company recently made an upfront payment of $5.1 billion to Galapagos and won the right to monopolize all of the pipelines for the next 10 years.

Gilead received option rights and monopolizing licenses to six trial-stage assets and 20 clinical programs through this collaboration, including GLPG 1690, an autotaxin inhibitor for idiopathic pulmonary fibrosis, and GLPG 1972, an osteoarthritis treatment.

Celgene’s Otezla was approved by the U.S. FDA last Friday with additional indications on oral ulcers associated with Behçet’s disease. The drug, which is an oral PDE4 inhibitor, was approved for the treatment of patients with moderate to severe plaque psoriasis, and also adult patients with active psoriatic arthritis in the U.S.

It was the first drug to be approved by the U.S. FDA as a treatment for oral ulcer associated with Behçet’s disease.

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