Omeros Corporation (OMER) recently announced that the U.S. Food and Drug Administration (:FDA) has granted orphan drug designation to its candidate OMS721 for the prevention of complement-mediated thrombotic microangiopathies (TMAs).
OMS721’s orphan drug designation will not only accelerate its development but will also benefit Omeros in various stages of drug development, including faster approval process, seven years of market exclusivity following marketing approval and tax credits on U.S. clinical trials.
Shares of Omeros were up 18% on the news. Meanwhile, a phase I study on OMS721 is underway to assess the safety and pharmacokinetics of the candidate.
We note that Omeros announced positive data from the phase I trial on OMS721 in Nov 2013. The data showed that a subcutaneous administration of OMS721 achieved a high degree of lectin pathway inhibition. The data also showed that the drug was well tolerated and no adverse events were observed.
Omeros expects to report additional data from the phase I study in early 2014. Omeros also plans to initiate enrolment for a phase II study in the first quarter of 2014 to evaluate OMS721 for the prevention of complement-mediated TMAs.
We are encouraged by the pipeline progress at Omeros. Omeros is looking to get its candidate, Omidria (OMS302), approved in the U.S. and EU for the treatment of patients undergoing intraocular lens replacement (:ILR) surgery in 2014. Omidria is Omeros’ proprietary pharmacosurgery product.
Omeros will also initiate a phase II study on its other pipeline candidate, OMS824, for the indication of Huntington's disease. The company also expects to report phase II data on OMS824, evaluated for the treatment of schizophrenia.
Omeros currently carries a Zacks Rank #3 (Hold). Stocks that currently look attractive include Actelion (ALIOF), Vanda Pharmaceuticals Inc. (VNDA) and Affymetrix Inc. (AFFX). While Actelion and Vanda Pharma carry a Zacks Rank #1 (Strong Buy), Affymetrix is a Zacks Rank #2 (Buy) stock.