Focuses on Psoriasis

The U.S. Federal Trade Commission has sought additional information from Bristol Myers Squibb Co and Celgene Corp and is focusing on the companies’ psoriasis treatments as part of its review of their planned merger, Bristol-Myers said on Tuesday. The parties understand that the FTC’s review is focused on marketed and pipeline products for the treatment of psoriasis.
Psoriasis is a debilitating skin disorder that affects 2% of the Caucasian population. In those with moderate-to-severe disease, treatment is challenging; with many cases ultimately proving refractory to traditional systemic therapies, such as methotrexate. For this group of patients, biologic therapies have emerged as novel; targeted approaches for management.

Overall psoriasis severity

Psoriasis Area & Severity Index, is a measure of overall psoriasis severity; also coverage of body surface area and erythema, sclerosis, and scaling. Although used rarely in clinical practice; so PASI is a key metric used in clinical trials for psoriasis drugs. Companies typically show the proportion of patients reaching a pre-specified PASI reduction score in clinical trials, which is typically PASI75.

One of these, the anti-TNF-α inhibitor adalimumab, is the focus of this article; so with emphasis on its pharmacology, clinical efficacy and safety profile. Psoriasis is an immune-mediated, chronic, inflammatory skin disease that causes significant physical and psychosocial suffering. A study conducted in 1999 revealed that the psychosocial morbidity of psoriasis and impairment of quality of life; which is the same or worse than that in individuals suffering from arthritis, diabetes or cancer.

Bristol-Myers said in a filing. Celgene’s psoriasis drug Otezla brought $448 million in sales in the quarter ended Dec. 31. Bristol-Myers is also developing a treatment for the condition and in September reported positive results from a mid-stage trial of its plaque psoriasis drug.

Multiple myeloma drug

Given the diverse range of assets from across biopharma that are either already on the market, or in development to treat psoriasis, they would be surprised if the overlap between Bristol and Celgene’s portfolios is too much for the FTC to get comfortable with, Credit Suisse analyst Vamil Divan said in a note.
However, the FTC review is not the only challenge the companies face. Some Bristol-Myers investors are against the planned $74 billion takeover of Celgene, as they see potential risk associated with Celgene’s pipeline, and expect a drop in sales of its flagship multiple myeloma drug, Revlimid, when it loses U.S. exclusivity in 2022.
However, the cancer drugmaker maintains that the Celgene acquisition would provide “significant advantages” with fewer risks compared to options like pursuing a series of small transactions. Bristol-Myers said both companies expect to close the merger in the third quarter of 2019.