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Johnson & Johnson set to ship TB medicine

Johnson & Johnson will shortly begin shipping supplies of the first new drug developed for tuberculosis in half a century, following US regulatory approval this week.

Paul Stoffels, joint head of Janssen, the US healthcare group’s pharmaceutical division, pledged to make the medicine available affordably to patients around the world rather than focusing on charging high prices for a drug that could help revolutionise treatment.

“We have not yet decided the pricing, but we want to make sure the drug is accessible to people,” he said. “The first objective is not to sell a very high-priced drug but to bring an essential drug to the world for world health. We will act as a responsible global player to make sure [it] becomes available to people who need it.”

The move marks an important breakthrough against one of the world’s leading killer infectious diseases, which continues to pose a threat in developed as well as developing countries with nearly 9m new cases and 1.4m deaths each year.

The drug, which is called bedaquiline and will be sold under the brand name Sirturo, has been approved for use with the US for “salvage” treatment of multi-drug resistant TB in combination with other medicines.

Clinical trials showed it could both cure and reduce the period during which patients are infectious and need to be held in isolation in hospitals.

That could help provide a financial boost for Johnson & Johnson, which was granted a rare “priority review voucher” by US regulators as an incentive for developing a tropical disease treatment. This allows it to seek accelerated approval of any other of its experimental medicines, potentially adding six months to the life of the patent.

Sirturo could offer a strong publicity fillip to the company, although it will also come under sharp scrutiny from Aids and other health advocates to ensure it is made available rapidly and cheaply in low income countries where the majority of patients with drug resistance TB live – many of whom are also infected with HIV.

Johnson & Johnson will tightly control distribution of the drug through hospital specialists, although there are dangers that unauthorised production and sale of the drug in uncontrolled circumstances in some poorer countries could trigger resistance and undermine its effectiveness.

The company has worked in partnership with the TB Alliance, a non-profit group, which is testing the efficacy and safety of using Sirturo in drug-sensitive or first-line cases of TB. There is also future scope to examine its potential in treating cases of “dormant” TB to prevent it becoming active and lethal.


Source: FT.com

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By Andrew Jack

Published: Jan. 10, 2013, 7:33 p.m.

Last updated: Jan. 10, 2013, 8:36 p.m.

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