Novartis Reports Positive Results On Thrombocytopenia Drug

Novartis AG (NYSE:NVS) announced encouraging results on Revolade from the EXTEND study.

The open-label extension study from four trials (TRA100773A, TRA100773B, TRA102537/RAISE and TRA108057/REPEAT) showed long-term disease control in chronic/persistent immune thrombocytopenia (ITP) patients. The research evaluated patients for up to 8 years of continuous treatment. The study found that majority of patients maintained a substantial clinical response and might not need concomitant ITP medications any further.

Patients suffering from ITP have a low number of platelets which in turn does not let the blood to clot resulting in bruising and bleeding. The study results showed that nearly 70% of patients maintain platelet counts without rescue therapy for prolonged periods, reducing the overall risk of bleeding. In addition, more than one-third of patients permanently stopped one or more concomitant ITP medications (including corticosteroids, danazol, azathioprine). The results establish long-term safety profile and demonstrates treatment benefit with Revolade.

We note that the drug is approved in the United States and Europe for the treatment of thrombocytopenia in pediatric patients 1 year or older with chronic ITP who have had an insufficient response to corticosteroids and immunoglobulins. It is marketed as Promacta in the United States.

We remind investors that the drug was acquired from GlaxoSmithKline plc. (NYSE:GSK) . Novartis has a collaboration agreement with Ligand Pharmaceuticals, Inc., (NASDAQ:LGND) for the marketing of the drug.

Novartis is currently going through a transitional stage. In March 2015, Novartis acquired certain oncology products and pipeline compounds from Glaxo. In exchange, it sold its non-influenza Vaccines business to Glaxo. In January 2015, Novartis divested its Animal Health Division to Eli Lilly and Company (NYSE:LLY) .

The company’s blockbuster drug, Diovan, is facing stiff generic competition in the United States, EU and Japan. Gleevec lost exclusivity in the United States in February 2016. The company also lost patent protection for the drug in EU in December 2016 leading to generic competition. The loss of patent protection for these top-selling drugs continue to hurt sales.

Nevertheless, Novartis has a strong oncology portfolio of drugs like Afinitor, Exjade, Jakavi, Zykadia, Tasigna, Jadenu, and Kisqali. The recent approval of Kymriah for acute lymphoblastic leukemia is a major boost for Novartis given the potential in the CAR T therapy space. Growth drivers like Cosentyx and Entresto, more than offset the impact of generic erosion, mainly due to Glivec.

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