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GlaxoSmithKline’s Benlysta Positive in Continuation Trial

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GlaxoSmithKline plc GSK announced positive results from a phase II continuation study evaluating the efficacy and safety of its marketed drug Benlysta (belimumab) in combination with standard of care for treatment of patients with systemic lupus erythematosus (SLE). The study was presented at the Annual European Congress of Rheumatology (EULAR).

The above is the longest study spanning 10 years, measuring the efficacy and safety of the SLE therapy.

Benlysta is presently approved in the U.S. for treatment of adult patients with an active SLE, who are receiving standard therapy. Additionally, Benlysta is licensed in the EU as an add-on therapy in adults with the given indication. Currently, it is also the only medicine approved for SLE.

Shares of GlaxoSmithKline have outperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has rallied 13.8% compared with the broader industry’s gain of 11.4%.



The multicentre, open-label, continuation study was conducted in a total of 298 patients of which 44% remained at year 10 or tolerated Benlysta. The study also demonstrated an overall response of 65.1% at Year 10, measured by SRI (SLE Responder Index). It compared with the baseline or standard duration of Week 52. The study also portrayed no severe SLE flare in the last 30 days of the 24-week extension period.

In Nov 2015, the company reported positive results from a phase III BLISS-SC study, evaluating Benlysta for SLE. The trial was designed to evaluate the efficacy and safety of Benlysta. It is administered subcutaneously to patients.

We remind investors that in Aug 2012, Glaxo had completed acquiring Human Genome Sciences for $14.25 per share in cash. With this acquisition, Glaxo has gained full control over Benlysta.

Per company’s press release, SLE is a potentially fatal autoimmune disease, extremely difficult to treat. Around 5 million people globally suffer from this malady. Hence, there is an immense market opportunity for the company to address the widely unmet needs of patients suffering from the disease worldwide.

GlaxoSmithKline PLC Price

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Zacks Rank & Key Picks

GlaxoSmithKline currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector are VIVUS, Inc. VVUS, Bayer AG BAYRY and Regeneron Pharmaceuticals, Inc. REGN. each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in the last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters, with an average beat of 233.69%.

Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10, over the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters, with an average beat of 0.45%.

Bayer’s earnings per share estimates increased from $8.75 to $8.86 for 2017 and from $9.41 to $9.53 for 2018, over the last 30 days. The company delivered a positive earnings surprise in three of the four trailing quarters, with an average beat of 10.25%.

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