Glaxo/J&J File For Rheumatoid Arthritis Drug Sirukumab In EU

GlaxoSmithKline plc (NYSE:GSK) and Johnson & Johnson’s (NYSE:JNJ) Janssen Biologics announced the submission of a Marketing Authorisation Application (MAA) for sirukumab (subcutaneous formulation) for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).

The companies are seeking approval for sirukumab, in combination with methotrexate, in RA patients who have failed or are intolerant to conventional or biologic disease-modifying antirheumatic drugs (DMARDs); and as monotherapy in these patients for whom treatment with methotrexate is inappropriate.

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

Sirukumab is currently being evaluated in a phase III study for the treatment of patients with giant cell arteritis. In addition, Glaxo disclosed its plans to initiate a phase II study on sirukumab for the treatment of asthma in 2016.

The RA market holds great potential given more than 23.5 million individuals suffering from the condition across the world, including approximately 6.2 million individuals in the EU.

In a separate press release, Glaxo announced a series of agreements with Aspen pursuant to its strategy of simplifying its business model by focusing solely on core therapeutic areas.

Glaxo will divest its anesthetics – Ultiva, Nimbex, Tracrium, Mivacron and Anectine – to Aspen for £180 million plus milestones of up to £100 million. The anesthesia portfolio generated sales of £35 million in the first half of 2016.

In addition, the companies have entered into parallel agreements to terminate their collaboration in Sub-Saharan Africa and for Aspen to exercise its option to acquire Glaxo’s remaining thrombosis business in certain retained markets.

Glaxo is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are Corcept Therapeutics Incorporated (NASDAQ:CORT) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . Both stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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