Celgene Drug Meets Study Goal

Celgene Corp. (CELG) recently disclosed that its drug candidate, apremilast, for treating patients with moderate-to-severe plaque-type psoriasis, met key goals in a mid-stage study (n=352). The multi-center study, in which apremilast reduced the severity of moderate-to-severe psoriasis, saw patients receiving 10 mg, 20mg or 30mg of apremilast twice daily, or placebo.
 
The data revealed that 41 % patients treated with 30 milligrams of apremilast, twice daily, underwent a 75 % reduction in symptoms. The symptoms were measured by a score known as the Psoriasis Area and Severity Index (PASI-75) after 16 weeks. However, only 6 % of patients who received a placebo reached that score. Furthermore, 29% of patients in the 20mg arm of apremilast and 11% of patients in the 10mg arm achieved a PASI-75 respectively. Celgene intends to commence late-stage studies of apremilast in inflammatory conditions in 2010.
 
Psoriasis represents a chronic inflammatory skin condition whose symptoms include redness and irritation. The most common type of psoriasis is plaque psoriasis which affects about 80 % of patients having psoriasis. The disease is characterized by patches of raised, reddish skin covered by silvery-white scales. These patches (plaques) are formed mostly on the elbows, knees, lower back, and scalp. Psoriasis affects males and females almost equally.
 
It was observed that 48 % patients treated with apremilast developed an infection as opposed to 33 % in the placebo group. Side effects-related discontinuation of treatment came in at 14 % for the apremilast group as against 6 % in the placebo group. However, most of the treatment emergent adverse events which included headache, nausea, upper respiratory tract infection and diarrhea were mild to moderate in nature. No serious apremilast related adverse events were reported in the mid-stage study.
 
Apremilast, on hitting the market would have to have to face stiff competition from other drugs. Amgen’s (AMGN) Enbrel dominates the psoriasis market. Enbrel, which inhibits a protein known as tumor necrosis factor (TNF), is administered via injection while apremilast is an oral drug. Furthermore, Abbott’s (ABT) Humira is rapidly becoming the anti-tumor necrosis factor (TNF) drug of choice, gaining sizable market share from Enbrel and Johnson & Johnson’s (JNJ) Remicade. Currently approved for several indications, we believe Humira, whose sales increased 48% to $4.5 billion in 2008, has blockbuster potential in the psoriasis indication alone given its first-in-class efficacy and convenient self-administration. Johnson & Johnson recently launched Stelara for treating adult patients suffering from moderate to severe plaque psoriasis.
 
Currently we are Neutral on Celgene.

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