[Ip-health] Pharmalot: J&J Makes HIV Drug Available To Poor Countries

Joanna Keenan-Siciliano joanna.l.keenan at gmail.com
Thu Nov 29 08:37:23 PST 2012


 J&J Makes HIV Drug Available To Poor
Countries<http://www.pharmalot.com/2012/11/jj-makes-hiv-drug-available-to-poor-countries/>

By Ed Silverman // November 29th,
2012<http://www.pharmalot.com/2012/11/29/>// 9:14 am
http://www.pharmalot.com/2012/11/jj-makes-hiv-drug-available-to-poor-countries/

A year ago, Johnson & Johnson was harshly criticized for declining to join
Medicines Patent Pool, which is an initiative designed to streamline patent
licensing for producing generics of patented HIV meds and offering lower
prices in poor countries. Now, the health care giant is going its own way
and agreed not to enforce patent rights for its Prezista HIV drug, which
will be licensed to generic drugmakers for distribution in 64 poor
countries.

“The goal is to provide access without benefit to us and we have the
intention to do the same with the other (HIV) drugs,” Paul Stoffels, the
J&J scientific officer who chairs the worldwide pharmaceutical business,
tells us. “There are no obligations to us as long as they (the licensed
generic drugmakers) provided they make medically acceptable versions.”

This is actually the second time in nearly two years that J&J (JNJ) has
attempted to make an HIV medicine accessible to poor nations. In early
2011, the health care giant struck a licensing deal with several generic
drugmakers to manufacture, market and distribute its Edurant HIV drug in
India, sub-Saharan Africa and Least Developed Countries. But the terms
prompted AIDS and patient advocacy groups to accuse J&J of undermining the
Patent Pool (back
story<http://www.pharmalot.com/2011/04/johnson-johnson-turns-its-back-on-aids-patients/>
).

But Stoffels says that striking deals independently makes the J&J team more
comfortable. “We’re medically and scientifically responsible to make sure
that the drug is used properly, and when it will do good and not do good.
In this way, we think we need to have continued control over how to use the
drug,” he says. “…And with Prezista, we’re more comfortable that we can
release it now.”

The decision was made, he explains, after Prezista was recently added to
lists of HIV drugs products needed in the developing world, which means
that “Prezista will be in pretty high need for second and third-line use.”
The drug is currently indicated for highly treatment-experienced HIV
patients in sub-Saharan Africa and has been recommended by the World Health
Organization, as well included in HIV treatment guidelines in that region.

However, he maintains that J&J intends to construct the same arrangement
for Edurant and Intelence. First, though, he wants to be certain that any
generic drugmaker has the capability to manufacture Intelence, which he
says requires “complicated production methods,” because if the drug is not
correctly formulated, there would be limited absorption and create
resistance among HIV patients.

As for Edurant, he says the drug “needs to be used in right combination and
the WHO is going to provide guidelines going forward on how to use that,
and we’re working with generic companies to make sure that the right
combinations will be available. Just releasing the IP will probably result
in too much incorrect use and hassles and medical issues, because too many
people will become resistant.”

In the past, Medicins Sans Frontiere, or Doctors Without Borders, and
Knowledge Ecology International, have been among the most vocal critics of
the J&J refusal to join the Patent Pool. We have asked both organizations
for comment and will update you accordingly.

[*UPDATE*: - Judit Rius-Sanjuan, US Manager for the MSF Access Campaign,
sends us this: "This announcement by J&J is not as significant as it
appears. In most countries included in J&J’s announcement, the real barrier
to accessing
(Prezista) is not patents, but the fact that the medicine is not
registered. Also, J&J’s announcement does not cover the countries where the
company does have patents, where HIV programmes have been running the
longest and
where the need for newer treatment options is, therefore, the most
pressing. Brazil, for example, is paying $6,037 per person per year for
(Prezista) alone.

"J&J is in fact actively fighting the decision by India, where most of the
world’s affordable generic HIV medicines are produced, to not grant patents
on (Prezista) and it is also actively seeking patents on combinations of
(Prezista) with other medicines. A more helpful move by J&J would be to
pursue wider registration of this
drug in developing countries, or to put their patents on darunavir into the
Medicines Patent Pool, which aims to facilitate access to affordable HIV
medicines in developing countries.”]



Note - MSF's full quote in response is here:

*Médecins Sans Frontières (MSF) response to Johnson & Johnson announcement
on access to HIV medicine darunavir*

“Darunavir is especially important for people who have been on HIV
treatment for a while and need to be switched to different medicines
because their treatment is no longer working. MSF is using darunavir in
several of its projects, but the drug is incredibly expensive.

This announcement by J&J is not as significant as it appears. In most
countries included in J&J’s announcement, the real barrier to accessing
darunavir is not patents, but the fact that the medicine is not registered.
Also, J&J’s announcement does not cover the countries where the company
does have patents, where HIV programmes have been running the longest and
where the need for newer treatment options is therefore the most pressing.
Brazil, for example, is paying $6,037 per person per year for darunavir
alone.

J&J is in fact actively fighting the decision by India, where most of the
world’s affordable generic HIV medicines are produced, to not grant patents
on darunavir and it is also actively seeking patents on combinations of
darunavir with other medicines.

A more helpful move by J&J would be to pursue wider registration of this
drug in developing countries, or to put their patents on darunavir into the
Medicines Patent Pool, which aims to facilitate access to affordable HIV
medicines in developing countries.”

*- Judit Rius-Sanjuan, US Manager, MSF Access Campaign
*


**


**

*Joanna Keenan
Press Officer
Médecins Sans Frontières - Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: twitter.com/joanna_keenan

msfaccess.org
twitter.com/MSF_access
facebook.com/MSFaccess
*

*   *



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