By Dow Jones Business News, March 02, 2013, 11:34:00 AM EDT
By Joseph Walker
Celgene Corp. ( CELG ) said its experimental anti-inflammatory drug Apremilast relieved symptoms in about a third of
psoriasis patients during a late-stage study, a data point the firm will use to seek regulatory approval for what it
expects could be a drug with annual sales reaching $2 billion.
However, a smaller proportion of patients saw a significant improvement from Apremilast in the late-stage trial than
in a previous study, which could dampen hopes for the drug's market potential. Even before the data were announced
Saturday, some analysts had expressed skepticism about Celgene's ambitious revenue estimates for the drug, which will
compete against generic topical creams and branded drugs from AbbVie Inc. (ABBV) and Amgen Inc. (AMGN).
Celgene is counting on Apremilast to become one of three new blockbusters as it expands its portfolio beyond its core
blood-cancer therapies. If approved, the drug would become a new treatment for millions of patients with mild-to-severe
psoriasis, an autoimmune skin disease that reddens the skin and causes patches of dead cells and silvery scales to
develop on the body.
In data presented at a meeting of the American Academy of Dermatology in Miami, Celgene said 33.1% of patients in the
late-stage study had a 75% reduction in their psoriasis, compared to 5.3% of patients who received a placebo. The
earlier mid-stage trial showed improvement among 41% of patients, according to the ISI Group, though that study had far
fewer patients. Celgene said 58.7% of patients saw their psoriasis symptoms reduced by 50%, compared to 17% of placebo
The late-stage trial showed positive safety data, with about 3.6% of patients experiencing severe adverse events,
compared to 3.2% in the placebo group. There were no cases of tuberculosis or lymphoma after 16 weeks of treatment.
Celgene said the drug's safety profile could position it well against competing therapies such as Amgen's Enbrel and
AbbVie's Humira, which have labels warning of the risk of lymphoma and TB.
"Dermatologists want safety--they don't want long term monitoring of serious side effects for their patients," said
Brian Gill, Celgene's vice president of communications.
Despite their safety risks, however, existing drugs such as Enbrel and Humira are generally thought to be more
effective than Apremilast, and in 2011 each generated more than $1 billion in world-wide psoriasis sales, according to
the ISI Group.
Celgene, which said in January that the late-stage trial had achieved its primary endpoint, will seek regulatory
approval from the U.S. Food and Drug Administration in the first half of this year. The new drug application will
include data from an additional late-stage Apremilast trial, which will be released before the company files a new drug
application with the FDA.
The company also will seek U.S. approval for Apremilast in treating psoriatic arthritis in the next several weeks, Mr.
Gill said. In January, the company projected that Apremilast in both indications would generate between $1.5 and $2
billion by 2017.
Celgene shares have risen 34% so far this year as investors have bet on the strength of its late-stage product
pipeline. Shares rose 2.3% to $105.62 through Friday's close.
Earlier this month, Celgene received FDA approval for its drug Pomalyst in treating multiple myeloma. In January, the
Summit, N.J., firm said it would seek approval for Abraxane in treating pancreatic cancer in the first half of this
year. Together with Apremilast, Celgene expects the three drugs to eventually reach more than $1 billion in sales each,
helping the company to double revenue by 2017.
Write to Joseph Walker at Joseph.Walker@dowjones.com
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