Glaxo Gains Positive EU Opinion - Analyst Blog

GlaxoSmithKline (GSK) recently received good news with the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issuing a positive opinion for its oral thrombopoetin agonist, Revolade (eltrombopag). Glaxo is seeking approval for the use of Revolade as an oral treatment for thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). 

The Committee recommended that Revolade should receive marketing authorization in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, like corticosteroids and immunoglobulins therapies. The Committee also recommended the use of Revolade as a second-line treatment option for adult patients who cannot get their spleen removed due to contraindications. 

Revolade is already approved in several countries including the US (trade name: Promacta), Venezuela, Kuwait, Chile and Russia. We expect final approval in the EU shortly. Revolade enjoys orphan designation in the EU for the treatment of ITP. 

Revolade/Promacta was discovered under a research collaboration between Glaxo and Ligand Pharmaceuticals (LGND). Glaxo is also studying Promacta in hepatitis-C related thrombocytopenia and in early Nov 2007 announced the commencement of two phase III studies, ENABLE 1 and ENABLE 2, to evaluate the ability of Promacta/Revolade to sufficiently raise platelet counts in order for patients with hepatitis-C related thrombocytopenia to undergo antiviral therapy. Glaxo is also studying Revolade/Promacta for the treatment of chemotherapy induced thrombocytopenia (CIT). However, mixed phase III data presented in 2006 will delay the filing of this indication. 

We believe Promacta/Revolade offers excellent potential in both idiopathic thrombocytopenic purpura and hepatitis-C related thrombocytopenia (phase III). The drug should have £1 billion peak potential, but will compete with Amgen’s (AMGN) Nplate (approved in August 2008). 

We currently have a Neutral recommendation on Glaxo. Glaxo's diversified base and presence in different geographical areas should help support revenue growth. Meanwhile, Glaxo’s restructuring initiative should help offset the impact of increasing generic competition in the next few years and help earnings grow faster than revenues. With several of its products scheduled to go off patent in the next few years, we expect Glaxo to accelerate growth through acquisitions and further partnering arrangements.
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