Johnson & Johnson Updates: Receives FDA Approval For New Tuberculosis Drug

Johnson & Johnson (NYSE:JNJ) has secured approval for its experimental drug, Bedaquiline or Sirturo, for multi-drug resistant TB (MDR-TB) patients. ^[1] MDR-TB is a form of TB in which patients become resistant to most effective anti-TB drugs isoniazid and rifampicin. ^[2] The approval was anticipated as the drug had received the FDA’s priority review status recently and a FDA panel unequivocally backed the drug’s efficacy last month even as some safety concerns were also raised. ^[3] The FDA’s nod makes Bedaquiline the first drug with new mechanism to be approved for TB in the last 40 years. ^[1]

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JNJ has been battling revenue losses in its pharmaceutical franchise due to patent expiries in recent years. The healthcare conglomerate lost patent protection for some of its largest selling drugs like Concerta and Levaquin in 2011, which was followed by, Invega, a mental disorder pill in 2012. The patent for Aciphex, a heartburn drug, is set to expire in mid 2013.

Bedaquiline will be a part of the company’s Anti-Infectives division, which is seeing a near-term decline in revenues due to Levaquin’s patent expiry. And a prior approval for Bedaquiline could lead the gradual recovery in the segment. The drug has received FDA approval based on results of two mid-stage clinical trials, where it showed most patients taking Bedaquiline with conventional drugs were cured significantly earlier than those taking a placebo with conventional drugs. ^[3] JNJ will conclude the phase III trials only by 2013 end. And we don’t see JNJ facing any setback there.

The drug, however, will have to wait for approvals from other countries, especially developing countries, to reach its full sales potential of $300 million. The disease is rare in the U.S. even as worldwide nearly 9 million people are infected with the disease each year and over a million of them die. ^[4] Out of these new patients, nearly 4% patients have MDR-TB and an estimated 60% of these MDR-TB patients are concentrated in BRICS (Brazil, China, India, Russia) countries. ^[2] While many MDR-TB patients in developing countries are left untreated, only 50% of patients enrolled for treatment are successfully treated with current treatments. ^[2]

This provides an opportunity for new treatments like Bedaquiline. While the FDA’s approval should mark the beginning of approvals from other countries as well, serious safety concerns could hinder the growth potential as the FDA has warned about potentially deadly heart problems from the drug. ^[1]

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1. FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant Tuberculosis, JNJ, Dec 31 2012 [↩] [↩] [↩]
2. Multidrug-resistanttuberculosis (MDR-TB) 2012 Update, WHO [↩] [↩] [↩]
3. FDA advisory panel backs efficacy of J&J TB drug, Reuters, Nov 29 2012 [↩] [↩]
4. Global tuberculosis report 2012, WHO [↩]