AbbVie's Humira Gets Orphan Drug Designation - Analyst Blog

AbbVie Inc. ABBV announced that its drug, Humira, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis (rare but serious inflammatory diseases of the eye).

Orphan drug designation is usually granted to novel drugs or biologics targeting rare diseases or conditions that affect less than 0.2 million patients in the U.S. Under this status, the company developing the orphan drug enjoys a seven-year period of marketing exclusivity, receives assistance on studies conducted on the drug and tax credits on costs related to such studies, can apply for annual grant funding and is exempted from paying fees under the Prescription Drug User Fee Act (PDUFA).

We note that Humira is the key growth driver at AbbVie. The product generated revenues of $2.6 billion in the first quarter of 2014, more than 57% of the company's total revenues.

Humira is already approved for several indications including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, ulcerative colitis and juvenile idiopathic arthritis among others.

AbbVie is working on expanding Humira's label further. The company is evaluating Humira for the treatment of non-infectious uveitis (phase III). Additionally, the company has initiated a pivotal phase III study that will evaluate the use of Humira for fingernail psoriasis in patients with moderate-to-severe chronic plaque psoriasis.

AbbVie carries a Zacks Rank #3 (Hold). Stocks like Allergan AGN, Gilead Sciences GILD and Alexion Pharmaceuticals ALXN are better ranked in the health care space. While Allergan and Gilead are Zacks Rank #1 (Strong Buy) stocks, Alexion holds a Zacks Rank #2 (Buy).

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