Category Archives: Psoriasis

Celgene Corporation ( CELG ) announced a label expansion for its drug Otezla in the U.S. Otezla, already approved by the FDA for treating adults suffering from active psoriatic arthritis, can now be used in treatment-nave as well treatment experienced patients suffering from moderate-to-severe plaque psoriasis. The FDA approved the drug, an oral and selective inhibitor of phosphodiesterase 4 (PDE4), to treat those patients for whom phototherapy or systemic therapy is suitable.

Celgene said that following the FDA nod, Otezla becomes the first inhibitor in the above category to gain approval in the U.S. for the plaque psoriasis indication. Currently, psoriasis patients are mostly treated with injectable drugs like AbbVie's ( ABBV ) Humira and Amgen's ( AMGN ) Enbrel.

The FDA cleared Otezla for the new indication primarily on the basis of encouraging data from two multi-center, randomized, double-blind, placebo-controlled studies - ESTEEM 1 and ESTEEM 2. The U.S. regulatory body, however, recommended that patients taking Otezla should have their body weights monitored on a regular basis. Moreover, patients with a history of depression or suicidal behavior should inform the same to their doctors before commencing Otezla therapy.

We remind investors that Otezla gained FDA approval for the psoriatic arthritis indication in March this year (read more: Update on Celgene's Product Portfolio ). The drug contributed $5 million to Celgene's top line in the second quarter of 2014. Approval for the additional indication, which offers significant commercial potential, will boost Otezla's sales going forward. According to the National Psoriasis Foundation, the immune-mediated, non-contagious chronic inflammatory skin disorder affects 7.5 million Americans.

Celgene is seeking EU approval for Otezla in the combined psoriasis and psoriatic arthritis indication, with an opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use expected by Dec 31, 2014. The candidate is further being evaluated for treating patients suffering from Behet's disease (phase III expected to commence by year end), ulcerative colitis (phase II b expected to commence by year end) and atopic dermatitis (phase II).

Celgene carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care space include Gilead Sciences ( GILD ) and Medivation ( MDVN ). Both the stocks sport a Zacks Rank #1 (Strong Buy).

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Celgene Corp. (CELG) won U.S. approval for its drug to treat the skin disease psoriasis, a medicine that will compete with injections that now generate billions of dollars in sales each year.

The Food and Drug Administration cleared Otezla for people with moderate to severe psoriasis, Celgene said today in a statement. Psoriasis is the most common autoimmune disease in the U.S., affecting 7.5 million Americans, according to the National Psoriasis Foundation. The agency in March authorized the treatment, also known as apremilast, to combat a related condition.

Psoriasis causes raised, red, scaly patches on the skin. Its commonly treated with injections, including AbbVie Inc. (ABBV)s Humira, and Enbrel from Amgen Inc. (AMGN) and Pfizer Inc. (PFE) Otezla is expected to generate $1.03 billion in sales in 2017, according to the average of 11 analysts estimates compiled by Bloomberg.

Otezla offers an important new treatment option for patients whose symptoms are not adequately improving with their current treatments, M. Shane Chapman, section chief of dermatology at Dartmouth-Hitchcock Medical Center, said in the statement. Because the product labeling does not require routine laboratory monitoring, oral Otezla may be a welcome new option for patients and physicians looking for a different treatment experience.

Celgene, the Summit, New Jersey-based maker of the cancer drug Revlimid, rose 1 percent to $93.12 at the close in New York. The companys shares have gained 27 percent in the past 12 months.

The FDA approved Otezla this year to treat psoriatic arthritis, which causes painful, stiff and swollen joints and occurs in about 30 percent of people who suffer from psoriasis. The drug is associated with an increased risk of depression. Common side effects include diarrhea, headache and nausea.

Celgene is studying Otezla for use against other diseases as well, including rheumatoid arthritis and another form of arthritis that can lead to a new bone formation on the spine, called ankylosing spondylitis. The company said in June the drug failed to significantly help patients in a trial with ankylosing spondylitis.

To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net

To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Drew Armstrong, Andrew Pollack

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Celgene Wins U.S. Approval of New Psoriasis Pill

Hollie McEwen fell into depression after suffering from severe psoriasis The 'beautiful, vibrant' 28-year-old had first class honours degree in nursing She was found hanged after she became tormented by the skin condition Inquest heard skin condition played a 'large part' in what she decided to do Medical professionals had prescribed her drugs to help combat depression

By Corey Charlton for MailOnline

Published: 05:08 EST, 24 September 2014 | Updated: 12:06 EST, 24 September 2014

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A health visitor with a first class honours degree in nursing was found hanged after she became tormented by her severe skin condition.

Hollie McEwen, a dedicated professional, first suffered psoriasis as a 12-month-old but it eased with treatment.

However, it later reappeared due to stress and the 28-year-old became so depressed she took her own life at home.

Her father Andrew told an inquest: 'Her condition played a large part in what she decided to do.

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Nurse Hollie McEwen hanged herself after becoming tormented by chronic psoriasis

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