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Newswise MIAMI BEACH, Fla. (March 1, 2013) Clinicians looking to enhance their ability to diagnose and treat patients with psoriasis and psoriatic arthritis have a new tool available with the introduction of the American Academy of Dermatologys (Academy) mobile app of the Academys evidence-based clinical guidelines for these skin and joint conditions.

Developed by a team of dermatologists who specialize in the management of psoriasis, the comprehensive guidelines published in the Journal of the American Academy of Dermatology (JAAD) from 2008 to 2011 assessed the available therapies for psoriasis based on an extensive review of the scientific literature. The guidelines focused on each of the four major therapeutic areas for psoriasis biologics, topical therapies, traditional systemic agents, and phototherapy and photochemotherapy and the treatment of psoriatic arthritis.

Psoriasis is a complex skin condition that requires proper evaluation, a customized treatment approach and regular monitoring, said board-certified dermatologist Daniel M. Siegel, MD, FAAD, president of the Academy. This new app is a valuable resource that will aid dermatologists and all clinicians with its easy-to-use recommendations and treatment algorithms for psoriasis and psoriatic arthritis.

The free psoriasis app is available at http://www.aad.org/PsoriasisApp and contains valuable clinical information on psoriasis and psoriatic arthritis, including: Clinical decision tree Quick reference guide for diagnoses Arthritic diagnostic checklist and scoring Clinical recommendations for all available therapies Guide to topical therapy and methotrexate treatment Phototherapy/photochemotherapy dosing guidelines CPT and HCPCS Codes, and treatment reimbursement algorithm Case studies and treatment algorithm

Psoriasis is a chronic skin condition that usually develops before age 35 and is characterized by thick, red, scaly patches that itch and bleed. Nearly 7.5 million Americans are living with this skin condition. Both genetic and environmental factors contribute to causing this disease. A joint condition, psoriatic arthritis is a chronic disease characterized by stiffness, pain, swelling and tenderness of the joints, surrounding ligaments and tendons. Nearly 85 percent of psoriatic arthritis patients develop psoriasis before psoriatic arthritis. Research suggests psoriasis patients have an increased risk of developing serious medical conditions, including cardiovascular disease, type 2 diabetes, lymphoma, obesity and metabolic syndrome. # # #

Celebrating 75 years of promoting skin, hair and nail health Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 17,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails. For more information, contact the Academy at 1-888-462-DERM (3376) or http://www.aad.org. Follow the Academy on Facebook (American Academy of Dermatology) or Twitter (@AADskin).

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American Academy of Dermatology Announces New Mobile App for Physicians to Access Comprehensive Psoriasis and ...

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 patients.

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.

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Celgene's Psoriasis Drug Eases Symptoms in One Third of Patients

(Reuters) - Celgene Corp's experimental drug apremilast proved to be more effective than a dummy pill for psoriasis patients in a late-stage study, clearing the way for the company to file for U.S. regulatory approval in the second half of 2013.

Celgene said 59 percent of patients in the 844-patient trial achieved a 50 percent improvement in symptoms at 16 weeks, using a standard score of the severity and extent of psoriasis, compared with 17 percent of placebo patients. A 75 percent improvement in symptoms was seen in 33 percent of the treatment group and 5 percent of the placebo group.

The Phase 3 trial is the first of two pivotal studies of the drug in patients with psoriasis, a disease in which itchy, painful skin plaques are thought to be caused by an inflammatory response initiated by the body's immune system.

Apremilast is a pill that inhibits an enzyme known as phosphodiesterase 4, or PDE4, and acts to damp down inflammation.

Celgene said previously it planned to file for Food and Drug Administration approval of the drug as a treatment for psoriatic arthritis in the first quarter of this year.

Side effects were consistent with those seen in earlier trials of the drug, with the most common being diarrhea and nausea.

Celgene said no cases of tuberculosis or lymphoma were observed through Week 16, and there was no increase in risk of cardiovascular events or serious opportunistic infection.

"From a physician's perspective, this can definitely be a first-line therapy because of the excellent risk/benefit profile," said Dr. Richard Langley, director of dermatology research at Dalhousie University in Halifax, and one of the study's lead investigators. "I think the patient acceptance of this drug and the physician acceptance is going to be extremely high."

He noted that most psoriasis patients are currently treated with methotrexate, which can cause serious side effects.

Newer biologic drugs used to treat psoriasis, which include Amgen Inc's Enbrel and AbbVie Inc's Humira, can make patients more susceptible to infection, Dr. Langley said.

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Celgene drug shown to be effective, safe in psoriasis trial

Celgene Corp. (CELG), the maker of the cancer drug Revlimid, said its experimental psoriasis medicine helped quell the redness and inflammation associated with the skin disorder in a study.

The drug, apremilast, helped one-third of patients achieve a 75 reduction of symptoms, based on a standard Psoriasis Area and Severity Index measurement. That compared with 5.3 percent of those on placebo with the same score, called PASI-75, Celgene said in a statement as it presents the data at the American Academy of Dermatology meeting in Miami Beach, Florida, today.

Psoriasis is an autoimmune disease that causes red, scaly patches on the skin and affects as many as 7.5 million in the U.S., according to the National Psoriasis Foundation. The market for treatments may approach $10 billion worldwide, according to Mark Schoenebaum, an analyst with ISI Group Inc. in New York. He said investors may have been looking for at least 40 percent of patients reaching the PASI-75 metric.

This would place apremilast slightly less effective than the biologic therapies (e.g., Enbrel, Humira, Stelara) but with a best-in-class safety profile, Schoenebaum wrote in a Feb. 28 research note.

The data presented today were from a study called ESTEEM 1, one of two clinical trials in the third and final phase generally required for regulatory approval. Summit, New Jersey- based Celgene said in January that both ESTEEM 1 and ESTEEM 2, which together included about 1,250 patients, had met their study goals and that it plans to seek regulatory approval for apremilast in psoriasis in the second half of this year.

Celgene also has tested the drug in psoriatic arthritis, another autoimmune condition, and has plans to apply for approval in that indication in the first half of this year. Its also running trials in ankylosing spondylitis, Behcets disease and rheumatoid arthritis. Apremilast may bring in $1.14 billion in revenue in 2017, according to the average of 12 analysts estimates compiled by Bloomberg.

Celgene today also reported that 59 percent of patients achieved a 50 percent reduction in symptoms, compared with 17 percent of those taking a placebo. The drug was generally well tolerated, with a 3.6 percent of patients on apremilast and 3.2 percent on placebo reporting severe side effects, Celgene said.

Apremilast is an oral drug that inhibits an enzyme called PDE4 thats associated with inflammation, according to Celgene. Other drugs such as Amgen Inc. (AMGN) and Pfizer Inc. (PFE)s Enbrel and AbbVie Inc. (ABBV)s Humira, which target the inflammatory protein TNF, and Johnson & Johnson (JNJ)s Stelara, which suppresses IL-12 and IL-23, are given by injection.

To contact the reporter on this story: Meg Tirrell in New York at mtirrell@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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Celgene Psoriasis Drug Helped Third of Patients in Study

DUBLIN--(BUSINESS WIRE)--

Research and Markets (http://www.researchandmarkets.com/research/24x56x/plaque_psoriasis) has announced the addition of Global Markets Direct's new report "Plaque Psoriasis (Psoriasis Vulgaris) - Pipeline Review, H2 2012" to their offering.

Global Markets Direct's, 'Plaque Psoriasis (Psoriasis Vulgaris) - Pipeline Review, H2 2012', provides an overview of the Plaque Psoriasis (Psoriasis Vulgaris) therapeutic pipeline. This report provides information on the therapeutic development for Plaque Psoriasis (Psoriasis Vulgaris), complete with latest updates, and special features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Plaque Psoriasis (Psoriasis Vulgaris).

Scope

- A snapshot of the global therapeutic scenario for Plaque Psoriasis (Psoriasis Vulgaris).

- A review of the Plaque Psoriasis (Psoriasis Vulgaris) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources.

- Coverage of products based on various stages of development ranging from discovery till registration stages.

- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.

- Coverage of the Plaque Psoriasis (Psoriasis Vulgaris) pipeline on the basis of route of administration and molecule type.

- Profiles of late-stage pipeline products featuring sections on product description, mechanism of action and research & development progress.

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Research and Markets: Plaque Psoriasis (Psoriasis Vulgaris) - Pipeline Review, H2 2012