Arena Pharmaceuticals, Inc. (ARNA) recently announced that it has completed a phase Ib trial on its pulmonary arterial hypertension (:PAH) candidate, APD811. Based on the results from the study, the company plans to advance the candidate further and initiate a phase II trial in the first quarter of 2014.
The randomized, double-blind and placebo-controlled phase Ib trial assessed the safety, tolerability and pharmacokinetics of APD811 in multiple dose strengths.
If approved, APD811 will face stiff competition as the PAH market is currently very crowded. The market already has companies like Actelion Ltd. (ALIOF).
We remind investors that the company's sole marketed product is Belviq, which was launched in the U.S. in Jun 2013. On Jun 27, 2012, Belviq was approved by the U.S. Food and Drug Administration (:FDA) as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese or overweight people.
In the EU, Arena decided to withdraw its Marketing Authorization Application for Belviq. The Committee for Medicinal Products for Human Use, European Medicines Agency’s advisory body, believes that the results of non-clinical studies were not sufficient for the drug’s approval. The company intends to submit the application at a later date.
Currently approved product in the obesity market includes VIVUS Inc.’s (VVUS) Qsymia. Orexigen Therapeutics, Inc. (OREX) is also developing a candidate, Contrave, targeting the lucrative obesity market.
Arena Pharma currently carries a Zacks Rank #3 (Hold). However, biopharma stocks like Actelion look better positioned with a Zacks Rank #1 (Strong Buy).
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