Hurdle for Abbott's Psoriasis Drug - Analyst Blog

In a filing with the US Securities and Exchange Commission (SEC), Abbott Laboratories (ABT) recently announced the withdrawal of its marketing applications for its psoriasis candidate, briakinumab (ABT-874). The company said that it has withdrawn its US biologics license application (BLA) as well as European marketing authorization application (MAA) based on feedback from regulatory authorities.

According to the company, the regulatory authorities may require further analysis and maybe additional studies before granting approval to the psoriasis candidate. Abbott Labs intends to evaluate the forward regulatory path which may include the resubmission of the applications at a later date.

In October 2010, Abbott Labs had presented data on briakinumab from four pivotal phase III studies at the European Association of Dermatology and Venereology scientific sessions. Results showed that a higher number of patients being treated with briakinumab achieved skin clearance rates of at least 75% compared to patients being treated with Amgen/Pfizer's (AMGN/PFE) Enbrel, methotrexate or placebo. The studies were conducted in patients with moderate to severe chronic plaque psoriasis. However, the candidate has been associated with cardiovascular concerns.

Abbott Labs had submitted the regulatory applications for briakinumab in 2010. The company already has a successful psoriasis drug in its portfolio in the form of Humira, which is approved for several indications including psoriasis. Humira sales came in at $5.5 billion in 2009.

Neutral on Abbott Labs

We currently have a Neutral recommendation on Abbott Labs. Despite lingering challenges like the impact of the US healthcare reform, product recalls, foreign exchange headwinds and EU pricing austerity, we believe Abbott Labs' strong business segments, contributions from recent acquisitions and late-stage pipeline should help the company deliver strong earnings growth.

 
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