Arena Pharmaceuticals, Inc. (ARNA) announced that its pulmonary arterial hypertension (PAH) candidate APD811 has received orphan drug status from the FDA. The company plans to initiate a phase II study evaluating APD811 in PAH patients later this year.

We note that the FDA grants orphan drug designation to candidates being developed to treat rare diseases/ conditions that affect less than 200,000 people in the U.S. The status makes the candidate eligible for seven years of marketing exclusivity in the U.S. following approval. This designation also makes Arena Pharma eligible for certain other development incentives (including tax credits for qualified clinical testing) for developing APD811.

PAH is a progressive disease that could result in heart failure and cut short life expectancy. Currently available drugs for PAH include United Therapeutics Corporation’s (UTHR) Remodulin. The prognosis for PAH is bleak with a survival rate of only 57% at five years from diagnosis as per data from the Registry to EValuate Early And Long-term PAH disease management (:REVEAL) study. This underscores the need for newer therapies targeting PAH.

Arena Pharma’s pipeline includes several other candidates including APD334 (autoimmune diseases, phase I multiple-ascending dose study, data expected early 2015) and temanogrel (thrombotic diseases, phase I completed). As of now, Arena Pharma’s growth is highly dependent on its sole marketed product Belviq for obesity.

Arena Pharma carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Amgen Inc. (AMGN) and Gilead Sciences Inc. (GILD). Both are Zacks Rank #1 (Strong Buy) stocks.

Read the Full Research Report on UTHR
Read the Full Research Report on GILD
Read the Full Research Report on AMGN
Read the Full Research Report on ARNA


Zacks Investment Research