Roche Holding AG (RHHBY - Analyst Report) recently announced that the company has launched the subcutaneous injection formulation of its rheumatoid arthritis (RA) drug Actemra in Japan.
The subcutaneous version of the drug was approved for treating RA patients who do not respond adequately to one or more existing therapies.
We note that Roche, through its subsidiary Chugai Pharmaceuticals Ltd., obtained a manufacturing and marketing approval for the subcutaneous formulation of Actemra in Japan in Mar 2013.
Additionally, Actemra was also listed on the National Health Insurance (NHI) reimbursement price list on May 24, 2013.
Meanwhile, the subcutaneous version of the RA drug is currently under review in the US and the EU.
We note that the intravenous version of Actemra is available in Japan since Jun 2005. Actemra is approved in Japan for additional indications.
We believe that the launch of new subcutaneous formulation of Actemra along with the existing intravenous infusion will further boost the sales potential of Actemra. We remind investors that Actemra is a leading drug of Roche with sales of CHF 842 million in 2012 (up 33% from 2011).
We note that the intravenous version of the drug is available in the EU (branded as RoActemra) since 2009 for treating adult RA patients, who did not respond adequately or were intolerant to, previous medication with one or more disease-modifying antirheumatic drugs (DMARDs) or tumor necrosis factor (TNF) inhibitors.
Subsequently, Actemra was approved by the US Food and Drug Administration (FDA) in Jan 2010 for treating adults suffering from moderately to severely active RA, who have responded inadequately to one or more TNF inhibitors.
The indication was expanded in 2012. Actemra was also approved in the US and EU in Apr 2011 and Aug 2011,respectively, for the treatment of patients (aged two and above) suffering from active systemic juvenile idiopathic arthritis (SJIA).
Moreover, in Apr 2013, the FDA approved Actemra for the treatment of polyarticular-course juvenile idiopathic arthritis (PJIA). We note that Roche is currently seeking EU approval of the drug for PJIA. The Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the PJIA indication in Apr 2013 and hence Roche expects an approval shortly.
However, competition is stiff in the RA market for Roche. Actemra primarily faces competition from UCB SA’s (UCBJF - Snapshot Report) Cimzia and AbbVie Inc.’s (ABBV - Analyst Report) Humira in the RA space.
Roche currently carries a Zack Rank #3 (Hold). Right now, Santarus, Inc. appears to be well placed with a Zacks Rank #1 (Strong Buy).