Amgen Reveals Topline Results from Otezla Phase 3 DISCREET Study

Amgen (AMGN) has revealed positive topline results from the Phase 3 DISCREET trial. The study was designed to evaluate the efficacy of Otezla (apremilast), an oral small-molecule inhibitor of phosphodiesterase 4 in adults suffering from moderate to severe genital psoriasis and moderate to severe plaque psoriasis.

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As per the topline analysis update, the company’s Phase 3 DISCREET study demonstrated that oral Otezla 30 mg twice daily achieved significant improvement, compared with the placebo, in the primary endpoint of the modified static Physician’s Global Assessment of Genitalia (sPGA-G) response at week 16.

Additionally, the study met all secondary endpoints and reflected significant improvements at week 16 with Otezla. The ongoing study is planned to be completed in the first half of 2022.

Update on Approvals

In the U.S., Otezla has been approved for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis, and adult patients with oral ulcers related to Behcet’s disease. (See Amgen stock charts on TipRanks)

Official Comments

EVP of Research and Development at Amgen, David M. Reese, said, “Genital psoriasis is associated with a high level of stigmatization and burden of disease and can be experienced in up to 63% of psoriasis patients over the course of their disease. Despite the use of topical therapies for the treatment of genital psoriasis, many patients still have challenges managing their disease, prompting experts to recommend the use of systemic therapies.”

“The results from the DISCREET trial further add to the growing body of evidence on the safety and effectiveness of Otezla in moderate to severe plaque psoriasis, including manifestations with high unmet medical needs, such as genital psoriasis,” Reese added.

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Wall Street’s Take

Recently, Mizuho Securities analyst Salim Syed reiterated a Hold rating on the stock and decreased the price target to $194 (3.4% downside potential) from $222.

Syed said, “As we approach 2022, we believe there are several headwinds which are not being fully incorporated into consensus, and therefore we sit around $1 billion lower vs 2022 consensus revenues of $27.0 billion.”

Overall, the stock has a Hold consensus rating based on 3 Buys, 9 Holds, and 1 Sell. The average Amgen price target of $227.42 implies 13.26% upside potential to current levels. Shares have decreased 11.4% over the past year.

Smart Score

According to TipRanks’ Smart Score system, Amgen gets a 7 out of 10, which indicates that the stock is likely to perform in line with market averages.