) 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.
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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
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
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.
Anika Therapeutics Inc.
Jazz Pharmaceuticals Public Limited Company
) appear to be favorably placed with a Zacks Rank #1 (Strong