Glaxo's Promacta in Phase III for MDS - Analyst Blog

GlaxoSmithKline GSK has initiated a randomized, double-blind, placebo-controlled phase III SUPPORT study (TRC112121) on Promacta (eltrombopag) plus Vidaza (azacitidine) in intermediate-1, intermediate-2 or high risk patients suffering from myelodysplastic syndromes (MDS).

In this study, the patients will randomly receive either Promacta/Vidaza combination every 28 days for at least 6 cycles, or placebo plus Vidaza. The primary endpoint of the study is to compare the effect of Promacta/Vidaza combination with that of placebo plus Vidaza in patients who who are platelet transfusion free during the first four cycles. The company intends to enroll 350 patients in the study.

According to Glaxo, MDS gets evolved into acute myeloid leukaemia (AML) in up to 45% of the patients. Approval of Promacta for the additional indication would boost the drug's sales potential.

We note that Promacta has already been approved for the treatment of thrombocytopenia in patients suffering from chronic immune (idiopathic) thrombocytopenic purpura (cITP). The drug is also approved for the treatment of thrombocytopenia in patients with chronic hepatitis C virus (HCV) infection. Promacta is marketed in Europe and other countries under the trade name Revolade.

Meanwhile, Glaxo is evaluating Promacta in pediatric patients for the treatment of cITP. Earlier this month, the company announced positive results from the phase III PETIT2 pediatric study.

Glaxo is also looking to expand Promacta's label. The drug is under FDA review for the treatment of cytopenic patients with severe aplastic anemia, who had responded insufficiently to immunosuppressive therapy. With a Breakthrough Therapy designation in the U.S., the review process for the candidate should speed up.

Glaxo has a licensing agreement with Ligand Pharmaceuticals LGND for Promacta.

Glaxo carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP and Allergan Inc. AGN. Both stocks carry a Zacks Rank #1 (Strong Buy).

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