Celgene Corporation (NASDAQ:CELG) announced that OTEZLA (apremilast), Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4), has been granted full marketing authorization by Japan’s Ministry of Health, Labor and Welfare (MHLW) for the treatment of adult patients with plaque psoriasis with an inadequate response to topical therapies, as well as adult patients with psoriatic arthritis.
“The approval of the first oral treatment in 25 years for psoriasis is good news. OTEZLA has a novel mechanism of action, is well tolerated and does not require monitoring before administration. We are pleased that OTEZLA presents a new treatment option for patients,” said Mamitaro Ohtsuki, M.D., Ph.D., Professor and Chairman, Department of Dermatology, Jichi Medical University.
OTEZLA is the first in a new class of medicines approved for the treatment of both psoriasis and psoriatic arthritis, two diseases involving dysregulated immune system activity. Plaque psoriasis is a systemic inflammatory condition characterized by raised scaly lesions on the skin. It affects an estimated 430,000 people in Japan and about 125 million people worldwide.
The approval was based on efficacy and safety results from an international phase 2b study (PSOR-005), international phase 3 studies, ESTEEM-1 and 2, and a Japanese phase 2b study (PSOR-011) conducted in adult patients with moderate to severe plaque psoriasis, and international phase 3 studies, PALACE-1,2 and 3, conducted in adult patients with psoriatic arthritis. In clinical studies, the most common side effects of OTEZLA were diarrhea, nausea, upper respiratory tract infection, tension headache, and headache.
“The approval of OTEZLA in Japan is another important milestone for Celgene in its mission to deliver innovative medicines in an effort to address the unmet needs of people worldwide living with chronic inflammatory diseases,” said Scott Smith, President, Celgene Inflammation & Immunology. “We believe that OTEZLA’s novel mechanism of action and oral administration will be a welcome new option for patients with plaque psoriasis and psoriatic arthritis in Japan.”
OTEZLA is approved in 37 countries, including the United States and Europe, as of December 2016. (Original Source)
Shares of Celgene Corporation are currently falling 0.19% to $115.51, or down $0.22 in pre-market trading Tuesday. CELG has a 1-year high of $127 and a 1-year low of $93.05. The stock’s 50-day moving average is $115.66 and its 200-day moving average is $108.10.
On the ratings front, Celgene Corporation has been the subject of a number of recent research reports. In a report issued on December 16, Jefferies Co. analyst Brian Abrahams reiterated a Buy rating on CELG. Separately, on December 9, Cantor Fitzgerald’s Mara Goldstein reiterated a Buy rating on the stock and has a price target of $159.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Brian Abrahams and Mara Goldstein have a yearly average loss of -1.9% and a return of 0.2% respectively. Abrahams has a success rate of 42% and is ranked #3655 out of 4288 analysts, while Goldstein has a success rate of 42% and is ranked #2340.
Sentiment on the street is mostly bullish on CELG stock. Out of 14 analysts who cover the stock, 12 suggest a Buy rating and 2 recommend to Hold the stock. The 12-month average price target assigned to the stock is $139.25, which represents a potential upside of 20% from where the stock is currently trading.
Celgene Corp. is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Its targeting areas include intracellular signaling pathways, protein homeostasis and epigenetics in cancer and immune cells, immunomodulation in cancer and autoimmune diseases and therapeutic application of cell therapies. The company’s products include Revlimid, Vidaza, Thalomid, Pomalyst/Imnovid, Abraxane, and Istodax.