AbbVie Inc. (ABBV) announced that Humira met the primary endpoint in a pivotal phase III study (PIONEER II) conducted in patients suffering from moderate-to-severe hidradenitis suppurativa (HS). The data was presented at the European Academy of Dermatology and Venereology Congress meeting.
The 36-week, multicenter, randomized, double-blind, two-period PIONEER II study (n= 326) revealed that Humira 40 mg demonstrated a statistically significant improvement in HS-related abscesses and inflammatory nodules at 12 weeks compared to placebo (58.9% versus 27.6%).
We remind investors that AbbVie had announced positive data from the first phase III (PIONEER I) study last month. AbbVie intends to submit regulatory applications for this indication based on data from the PIONEER I and PIONEER II studies.
We note that Humira is the flagship product of AbbVie. The product generated revenues of $5.9 billion in the first half of 2014. It contributed almost 62% to the company’s total net sales during this period.
Humira is already approved for several indications including rheumatoid arthritis, psoriatic arthritis, enthesitis-related arthritis, ankylosing spondylitis, Crohn’s disease, plaque psoriasis, ulcerative colitis and polyarticular juvenile idiopathic arthritis among others. Meanwhile, AbbVie is working on expanding Humira’s label further into indications like fingernail psoriasis in patients with moderate-to-severe chronic plaque psoriasis.
We are pleased with the encouraging results from the PIONEER II study. According to the press release issued by AbbVie, HS affects nearly 1% of the general adult population. Once approved, the new medication will provide significant benefit to patients suffering from HS considering the lack of approved treatments.
Meanwhile, we are encouraged by AbbVie’s decision to acquire Shire (SHPG). The deal, which is expected to close in the fourth quarter of 2014, will add Shire’s rare disease and neuroscience franchises among others to AbbVie’s portfolio. The upcoming acquisition is also expected to reduce AbbVie’s dependence on Humira.
AbbVie carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Ligand Pharmaceuticals Inc. (LGND) and Allergan Inc. (AGN). While Ligand Pharma holds a Zacks Rank #1 (Strong Buy), Allergan is a Zacks Rank #2 (Buy) stock.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment