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Glaxo/J&J File BLA for Rheumatoid Arthritis Drug in the U.S.


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GlaxoSmithKline plc (GSK - Analyst Report) and Johnson & Johnson’s (JNJ - Analyst Report) Janssen Biotech, Inc. announced the submission of a Biologics License Application (BLA) for sirukumab for the treatment of adults with moderate-to-severely active rheumatoid arthritis (RA).

The companies are seeking approval for a subcutaneous formulation of sirukumab in two presentations – single-dose prefilled syringe and single-dose auto-injector – for the treatment of RA in patients who have failed or are intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).

Note that sirukumab is being developed under a licensing and co-development agreement with Janssen. The agreement gives both companies the option to evaluate the candidate for additional indications beyond RA.

We remind investors that earlier this month, the companies had filled a Marketing Authorisation Application (MAA) for sirukumab in the EU.

Meanwhile, sirukumab is being evaluated in a phase III study for the treatment of patients with giant cell arteritis. Glaxo has also disclosed its plans to initiate a phase II study on the candidate for the treatment of asthma this year.

RA, a chronic, systemic inflammatory condition, is estimated to affect more than 23.5 million individuals across the world. Drugs currently approved to treat RA include Xeljanz, Humira, Enbrel and Orencia among others.

In a separate press release, Glaxo announced that it has filed regulatory application for a subcutaneous formulation of Benlysta in both the U.S. and the EU.

In the U.S., a BLA was filed for the treatment of adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) who are receiving standard therapy. On the other hand, an extension MAA was filed for Benlysta in the EU as add-on therapy in adult patients with active autoantibody-positive SLE with a high degree of disease activity despite standard therapy.

Glaxo is seeking an approval of Benlysta as a subcutaneous formulation in two presentations – single-dose prefilled syringe and single-dose auto-injector. The company has stated that it will file regulatory applications in other countries in 2016 and 2017.

Benlysta is currently approved as an intravenous formulation for use as a one-hour infusion every four weeks. In the first six months of 2016, the drug generated sales of £143 million, up 24% year over year.

Both Glaxo and Johnson & Johnson carry a Zacks Rank #3 (Hold).

Stocks to Consider

A couple of better-ranked stocks in the health care sector include Corcept Therapeutics Incorporated (CORT - Analyst Report) and Anika Therapeutics, Inc. (ANIK - Snapshot Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Corcept Therapeutics witnessed an increase of 25% and 12.5% in its earnings estimates for 2016 and 2017, respectively, in the last 60 days. The company has posted a positive earnings surprise in three out of the last four quarters, bringing the average beat to 100%. The company’s share price has surged 39.3% year to date.

Anika Therapeutics’ earnings estimates for 2016 and 2017 were up a respective 12.6% and 14% over the last 60 days. The company’s earnings have beaten estimates in each of the last four quarters with an average beat of 42.19%. The company’s share price has jumped 23.2% year to date.

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