Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nyse  >  Johnson & Johnson    JNJ

JOHNSON & JOHNSON (JNJ)
Mes dernières consult.
Most popular
  Report  
Delayed Quote. Delayed  - 02/23 10:00:14 pm
132.02 USD   +1.62%
08:24aJOHNSON & JOHNS : and Talcum
AQ
02/23JNJ The Law Offices of Vincent Wong Notifies Investors of a Class..
BU
02/22JOHNSON & JOHNS : Sharing is caring
AQ
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets

Johnson & Johnson : FDA Approves J&J's Drug for Tough-to-Treat Tuberculosis

share with twitter share with LinkedIn share with facebook
share via e-mail
0
12/31/2012 | 08:19pm CET

--FDA approves J&J's Sirturo but requires prominent warning label

--Drug is unlikely to be a big moneymaker but may accrue goodwill to J&J

--Fewer than 100 Americans suffer from the disease, multidrug resistant TB

(Adds details on safety risks in paragraph eight, and comments from consumer group Public Citizen and FDA official in paragraphs 13-16.)

 
   By Joseph Walker and Nathalie Tadena 
 

The U.S. Food and Drug Administration approved Johnson & Johnson's (JNJ) drug to treat a form of resistant tuberculosis that is uncommon in the U.S. but growing globally.

The drug, Sirturo, will treat patients with multidrug resistant tuberculosis, or MDR-TB, a possibly fatal disease that affects as many as 630,000 people world-wide who can't be cured with existing therapies alone. Tuberculosis is a bacterial infection that mostly involves the lungs.

Sirturo, also known as bedaquiline, is not expected to be a large moneymaker for Johnson & Johnson (JNJ), one of the world's largest health-care conglomerate, because the disease is prevalent in poorer countries unable to afford high prices for the treatment. Providing the drug, though, could help the company create goodwill among regulators, governments and patients around the world.

"The commercial opportunity is very limited," said Pamela Van Houten, a J&J spokesperson. "This is part of our commitment to advance innovative medicines that help address serious public health issues."

The company said it expects to begin selling Sirturo in the second quarter of 2013, and won't announce its sales price until then. Fewer than 100 Americans have MDR-TB, according to J&J, but FDA approval is likely to strengthen the chances for approval in regions where the disease is more prevalent, including India, China and Eastern Europe.

However, the drug's potential side effects, including an increased risk of death, has raised concerns among members of the FDA. The agency will require that a prominent warning label be placed on the drug, informing consumers that patients taking Sirturo in clinical trials saw increased rates of fatalities.

"Because the drug also carries some significant risks, doctors should make sure they use it appropriately and only in patients who don't have other treatment options," said Edward Cox, an FDA official.

About 11.4% of patients taking Sirturo died in during clinical trials, compared to 2.5% taking placebos.

The FDA granted Sirturo accelerated approval, which is a type of temporary approval for diseases that don't have viable treatment options, based on less clinical data than required for traditional drug approvals.

The accelerated approval was based on data from a pair of Phase 2 studies--one of which showed 77.6% of patients in the treatment group reaching treatment success after 24 weeks compared with 57.6% of those in the placebo group.

It is still unclear, though, whether Sirturo caused the increase death rate, said Mel Spigelman, chief executive of the Global Alliance for TB Drug Development, which is partnering with J&J to develop Sirturo in more common strains of tuberculosis.

"It looked more likely that this was just a bad coincidence," Dr. Spigelman said. "But you have to be careful, and the monitoring will have to be rigorous."

Last month, an FDA panel supported a type of early approval for J&J's experimental drug; however, panel members were divided on whether Sirturo played a role in deaths seen in clinical studies.

"A greater number of deaths in the bedaquiline arm is concerning," FDA Deputy Director of Anti-Infective Products, said in a presentation to the panel. "The role of bedaquiline in deaths where hepatoxocity and cardiac failure are contributory could not be ruled out."

The consumer group Public Citizen, which had been strongly opposed to approval, said Monday that it was disappointed in the FDA's decision.

"There were five times more deaths in the drug group than in the placebo group," said Sidney Wolfe, director of health research at Public Citizen. "I don't see how [the FDA] can be so dismissive about it."

Tuberculosis usually is treated with a combination of four drugs for at least six months, according to the National Heart, Lung and Blood Institute. Some forms of tuberculosis, however, can't be treated with currently available drugs, which the FDA has said "threatens to erode the progress made in the world-wide control of tuberculosis."

Sirturo is designed to work in a new way to treat tuberculosis and would be used with other drugs.

Shares of J&J rose 27 cents to $69.75.

Write to Joseph Walker at [email protected]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article
ChangeLast1st jan.
JOHNSON & JOHNSON 1.62% 132.02 Delayed Quote.-7.02%
share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on JOHNSON & JOHNSON
08:24aJOHNSON & JOHNSON : and Talcum
AQ
02/23JNJ The Law Offices of Vincent Wong Notifies Investors of a Class Action Invo..
BU
02/23JOHNSON & JOHNSON : New TREMFYA® guselkumab Data Demonstrates Long-Term Skin Cle..
AQ
02/23JOHNSON & JOHNSON : Pawar Law Group Announces That a Class Action Lawsuit Has Be..
AC
02/23JOHNSON & JOHNSON : AMBER, Johnson & Johnson to establish 3D bioprinting lab
AQ
02/22JOHNSON & JOHNSON : Ireland to get its own dedicated 3D bioprinting lab to grow ..
AQ
02/22JOHNSON & JOHNSON : Medical Devices Companies Acquire Orthotaxy to Develop Next-..
AQ
02/22JOHNSON & JOHNSON : to Participate in Cowen 38th Annual Healthcare Conference
AQ
02/22JOHNSON & JOHNSON : Sharing is caring
AQ
02/21JOHNSON & JOHNSON : MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATION..
AQ
More news
News from SeekingAlpha
02/24RETIREMENT STRATEGY : What The Heck Are You Waiting For? 
02/22GE : Keeping Management 'Honest' On 2018 Guidance - Share Price Could Go To $10 
02/22Upcoming Dividends; 89 Companies, 32 Increases, 14 Double-Digit Increases 
02/22Volatility And Your Retirement Plan 
02/21Tracking Tweedy Browne Portfolio - Q4 2017 Update 
Financials ($)
Sales 2018 81 103 M
EBIT 2018 24 826 M
Net income 2018 19 539 M
Debt 2018 11 371 M
Yield 2018 2,79%
P/E ratio 2018 18,02
P/E ratio 2019 16,84
EV / Sales 2018 4,44x
EV / Sales 2019 4,08x
Capitalization 349 B
Chart JOHNSON & JOHNSON
Duration : Period :
Johnson & Johnson Technical Analysis Chart | JNJ | US4781601046 | 4-Traders
Technical analysis trends JOHNSON & JOHNSON
Short TermMid-TermLong Term
TrendsBearishBearishNeutral
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 22
Average target price 151 $
Spread / Average Target 16%
EPS Revisions
Managers
NameTitle
Alex Gorsky Chairman & Chief Executive Officer
Dominic J. Caruso Chief Financial Officer & Vice President
Paulus Stoffels Chief Scientific Officer & Executive VP
Charles O. Prince Independent Director
William David Perez Independent Director
Sector and Competitors
1st jan.Capitalization (M$)
JOHNSON & JOHNSON-7.02%349 006
NOVARTIS-2.94%222 939
PFIZER-1.33%213 155
ROCHE HOLDING LTD.-9.41%207 036
MERCK AND COMPANY-3.02%148 618
AMGEN4.92%132 428