[Ip-health] FT on J&J's new TB drug

Jamie Love james.love at keionline.org
Wed Jan 2 13:31:47 PST 2013

Below is a link to an FT story by Andrew Jack, regarding a
J&J announcement that they would make a new drug for TB "affordable"
globally.  There are no details on the prices.  Also, the FT notes that
Sirturo, the new TB drug, was granted an FDA "priority review voucher."


January 2, 2013

Johnson & Johnson set to ship TB medicine
By Andrew Jack in London


Highlights from the FT article:

* 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.

*  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.

*  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.

*  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.

James Love.  Knowledge Ecology International
http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.

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