AbbVie's ABT-414 Receives Orphan Drug Status in U.S. and EU - Analyst Blog


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AbbVie 's ( ABBV ) oncology candidate ABT-414 received orphan drug status in the U.S. and the EU for the treatment of glioblastoma multiforme. AbbVie is developing ABT-414 with certain components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics ( SGEN ).

Orphan drug status is granted to treatments being developed for rare diseases (affecting less than 200,000 people in the U.S. and up to 5 out of 10,000 people in the EU).

Glioblastoma multiforme is the most common and aggressive type of malignant primary brain tumor. According to the press release issued by AbbVie, 2−3 out of 100,000 people in the U.S. and Europe are diagnosed with glioblastoma multiforme each year, with a five-year survival rate of only 4% (approximately). After nearly 15 months of diagnosis, patients are found to succumb to their disease.

Currently, ABT-414 is in a phase II program for the treatment of glioblastoma multiforme.

Considering the limited treatment options for glioblastoma multiforme, there is urgent need for new treatments in this field. If successfully developed and commercialized, ABT-414 will boost the company's portfolio.

Meanwhile, Tocagen Inc.'s Toca 511 in combination with Toca FC is also under development for the treatment of glioblastoma multiforme.

We remind investors that AbbVie is working on strengthening its portfolio. In Jul 2014, the company announced its plans to acquire Shire plc ( SHPG ).  This deal makes AbbVie the latest to join a string of U.S. health care companies that have been looking towards overseas acquisitions to lower their tax rates.

AbbVie will not just lower its taxes through this acquisition; it will also boost its product portfolio significantly. This acquisition is very important for the company, which was mainly dependent on a single drug, Humira, for growth.

AbbVie carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Actelion ( ALIOF ), carrying a Zacks Rank #1 (Strong Buy). Seattle Genetics carries a Zacks Rank #2 (Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

This article appears in: Investing , Business , Stocks
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