[Ip-health] MSF response to announcement of Otsuka’s donation programme for the TB drug delamanid

Michelle French Michelle.French at newyork.msf.org
Wed Apr 29 11:33:07 PDT 2015

MSF issued the following flash quote today, in response to a WHO 
announcement (link below) that was sent out late yesterday.

Geneva, 29 April 2015


MSF response to announcement of Otsuka’s donation programme for the TB 
drug delamanid

WHO announcement:
An initiative to extend access to a new TB drug

Background information:
The new TB drug delamanid, produced by Otsuka, has been included in WHO 
guidance for treating multidrug-resistant TB (MDR-TB) since October 2014. 
The drug has so far only been registered in the EU, Japan and South Korea. 
To date, only about one hundred patients with multidrug-resistant TB 
(MDR-TB) have had access to the drug outside clinical trials. Broader use 
of the drug has been severely hindered by a lack of public information 
available about the registration and pricing plans for this potentially 
promising drug.
Otsuka has just outlined an objective to ensure that 20% of all diagnosed 
and treated MDR-TB patients in quality programmes have access to delamanid 
by 2020 – this is a move in the right direction. MSF positively 
acknowledges the development of new products for MDR-TB, attempts to scale 
up their use, and work on a clinical trial for a pediatric formulation of 
Yesterday, the WHO Global TB Program announced that Otsuka would make 
limited quantities of the drug available through a ‘targeted access 
donation programme,’ although few details about the programme are known.
MSF continues to express concern over the use of limited-scope donation 
programmes as a primary means of providing access to new TB drugs in 
countries affected by drug-resistant TB, as they are not a long-term 
solution to facilitating scale-up of treatment. Much more must be done to 
rapidly provide access to these drugs, so that the current toxic regimen 
for drug-resistant TB can be improved, and the potential of these new 
drugs maximized.
MSF Response:  statement by Dr Manica Balasegaram, Executive Director, 
Médecins Sans Frontières Access Campaign:
“Countries affected by drug-resistant TB and patients without other 
treatment options urgently need access to new drugs like delamanid, which 
has been recommended by WHO.
New, promising TB drugs should be made available to everyone who needs 
them, and TB programs must be strengthened to ensure good stewardship of 
the drugs, improved quality of care, and better patient outcomes. Pricing 
of the new drugs must be transparent, with one affordable price available 
to all developing countries, and the drugs must be registered in all 
countries with a high burden of drug-resistant TB as soon as possible.
New TB drugs are currently added to existing regimens that cost thousands 
of dollars per treatment course; MSF believes that the total price for a 
full treatment course should be no more than $500, in order to facilitate 
rapid scale-up of treatment for drug-resistant TB.
After a 50 year wait for new TB drugs and more than 200,000 patients dying 
from MDR-TB every year, the lack of access to the new TB drugs is not 
acceptable. A recent letter from civil society urged governments, global 
health actors and drug manufacturers to move swiftly towards putting more 
people on available treatments, and recommended setting clear and 
ambitious targets for scaling up the use of treatment regimens that 
include the most promising TB drugs. Donations are not a long-term 
solution to the urgent need to significantly scale up treatment.
We urge drug manufacturers to prioritise and facilitate trials for new TB 
regimens, and for the NIH to commence the long-planned study to look at 
the safety of combining delamanid and bedaquiline as soon as possible.” 

Michelle French
Communications Officer, MSF Access Campaign
Doctors Without Borders\Médecins Sans Frontières (MSF)
Office: +1.212.763.5735 | Mobile: +1.646.552.4600
michelle.french at newyork.msf.org | Skype: michellejfrench
www.msfaccess.org | twitter.com/MSF_access | www.facebook.com/MSFaccess

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