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CELG Presents Positive Long-term Data

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Celgene Corporation (CELG) recently announced encouraging results from a phase III study (PALACE 1) on its pipeline candidate apremilast. The study evaluated apremilast for 52 weeks in patients suffering from psoriatic arthritis at 20 mg and 30 mg dosages. Results were presented at the annual meeting of the European Congress of Rheumatology held in Spain.

Results from the multi-center, double-blind, placebo-controlled, parallel-group phase III study showed that treatment with apremilast caused significant improvements in the symptoms of the disease compared to placebo from week 24 through week 52 in psoriatic arthritis patients across both dosage strengths.

Data revealed that 63% patients treated with 20 mg of apremilast (twice daily) achieved atleast 20% reduction in the disease symptoms and 55% patients treated with the 30 mg dosage (twice daily) achieved similar response. The measure is known as American College of Rheumatology (:ACR) 20. Results from the study also revealed similar improvements over time with respect to the ACR 50 and ACR 70 scores.

We note that the primary endpoint of the study was the proportion of patients showing improvement according to ACR20 compared to week 16. We remind investors that Celgene presented encouraging 16 week data from the PALACE 1 study in Nov 2012. At week 16, 31.5% and 50.8 % patients in the 20 mg and 30 mg arms achieved the criteria of 20% improvement laid down by ACR respectively.

Besides the PALACE 4 study, the PALACE program also consists of three more phase III studies (PALACE 1, PALACE 2 and PALACE 3) on apremilast in the psoriatic arthritis indication.

Earlier this year, Celgene submitted regulatory submissions for the approval of apremilast (psoriatic arthritis) in the US and Canada, based on the positive results from PALACE 1, 2 and 3 studies.

We note that apart from psoriatic arthritis, apremilast is also being developed for other indications including psoriasis. Celgene intends to seek US approval for the psoriasis indication in the latter half of the year. The company intends to seek European approval for apremilast in the psoriatic arthritis and psoriasis indications on a combined basis in the second half of the year.

Celgene was also in the news recently when its board cleared a program to buy back up to an additional $3 billion of its common stock, thus returning cash to shareholders. The move will boost Celgene’s bottom line.

We note that so far in the year Celgene has bought back approximately $1.8 billion of its common stock. The biopharmaceutical company has exhausted the previous $2.5 billion stock repurchase authorization. A share repurchase at the company would lead to lower number of outstanding shares, escalating its earnings per share ratio, even if profits remain the same.

Celgene carries a Zacks Rank # 3 (Hold). Companies such as Biogen Idec Inc. (BIIB), Anika Therapeutics Inc. (ANIK) and Jazz Pharmaceuticals Public Limited Company (JAZZ) appear to be favorably placed with a Zacks Rank #1 (Strong Buy).

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