Ligand Pharmaceuticals Incorporated (LGND) announced the submission of a Marketing Authorisation Application to the European Medicines Agency by its partner GlaxoSmithKline (GSK) for Revolade (U.S. trade name: Promacta). Ligand Pharma and Glaxo are looking to get Revolade approved for the treatment of severe aplastic anemia (SAA) in adult patients, who are unresponsive to immunosuppressive therapy (IST).
The regulatory application was submitted on the basis of data from a pivotal open-label phase II study (ELT112523) and two supporting phase II studies (ELT116826 and ELT116643) evaluating Revolade in patients with SAA.
We remind investors that Promacta was approved in the U.S. in August this year for once-daily use in SAA patients who did not show adequate response to IST.
We note that Promacta is already approved for the treatment of thrombocytopenia (low blood platelet count) in patients suffering from chronic immune (idiopathic) thrombocytopenic purpura. Promacta is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C in order to allow them to initiate and maintain interferon-based therapy.
According to the press release issued by Ligand Pharma, nearly 40% of patients who are unresponsive to initial IST die from infection or bleeding within five years of their diagnosis. Once approved, the new treatment will provide significant benefit to patients suffering from SAA considering the lack of approved treatments in the EU.
We note that Ligand Pharma receives royalties on the sales of the drug, under a licensing agreement with Glaxo. Promacta royalties are one of the key contributors to Ligand’s top line. Upon EU approval, the drug should bring in sales and subsequently royalties to Ligand Pharma.
Ligand Pharma currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Illumina Inc. (ILMN) and Celgene Corporation (CELG). While Illumina is a Zacks Rank #1 (Strong Buy) stock, Celgene carries a Zacks Rank #2 (Buy).
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