[Ip-health] NPR story on Sanofi/Zika exclusive license to Zika vaccine patent

Jamie Love james.love at keionline.org
Tue May 30 06:56:26 PDT 2017


Sanofi make its clear, they aren't putting money into the vaccine, but they
have agreed to accept $173 million to spend time working it, and we should
see that as an investment on their part:

-----------
"So while it's true that those costs are being paid for by the U.S.
government, we do have substantial investments in this vaccine," says Dr.
Jon Heinrichs, an associated vice president at Sanofi Pasteur in
Pennsylvania, where he leads vaccine development.   "And really what it
costs us are the opportunity costs where those individuals could be working
on projects that have a more certain commercial return," he says. "And
while they're working on Zika, they can't be working on those projects."
-------------

Jamie


http://www.npr.org/sections/health-shots/2017/05/30/529887446/states-fear-price-of-new-zika-vaccine-will-be-more-than-they-can-pay

States Fear Price Of New Zika Vaccine Will Be More Than They Can Pay
May 30, 20177:36 AM ET
Heard on Morning Edition
Alison Kodjak

The U.S. Army is planning to grant an exclusive license to the French
pharmaceutical company Sanofi Pasteur, Inc. to manufacture and sell a Zika
vaccine the Army developed last year.

And that has Rebekah Gee, Louisiana's secretary of health, worried about
paying for it.

"God forbid we have a Zika outbreak. We're in the middle of a fiscal
crisis, we're already cutting services to people and we're already
potentially cutting our funding to fight the Zika virus," Gee says.

If the Army goes through with its plan, she says, Sanofi could set a price
for the vaccine at a level that Louisianans just won't be able to afford.

Gee is among a growing number of public officials and activists who are
demanding that Sanofi agree to show restraint when it sets the price for
the vaccine, which was developed by the Army.

She wants the company to promise in writing that it won't charge U.S.
buyers any more than it charges in other wealthy countries – like its home,
France.

"If the American public funds the life-saving intervention, we need price
protections for states that have to foot the bill," Gee says.

Last week, several groups including Doctors without Borders and Knowledge
Ecology International appealed to the Army to delay granting Sanofi the
exclusive license until the company agrees to reasonable price terms.

Zika is a virus that is transmitted by the Aedes aegypti mosquito. It can
cause severe defects to babies born to infected mothers.

Because of its hot, wet climate, Louisiana is a prime target for the Zika
virus in this country, Gee says. If there were a local outbreak, the state
would want to ensure that every person of childbearing age got vaccinated.
And today, there are about 540,000 people of reproductive age on
Louisiana's Medicaid rolls, which means the state and federal governments
would cover the costs to vaccinate them.

There's no vaccine against Zika available yet. So there is no way to
determine where Sanofi, or any other company may set the price. But if it
were too high?

"We'd then be in a situation where we'd have to decide between funding for
K-12 education and the Zika vaccine," Gee says. "And that just shouldn't
happen when the U.S. government and the taxpayers of this nation paid to
develop this drug."

It's actually not unusual for the government to give private companies an
exclusive license to government research and inventions to develop
medications. In most cases, however, the government has paid for only part
of the development.

In the case of the Zika vaccine, the government's contribution is much
larger.

"The inventors of the vaccine are all federal employees — they're all
employees of the army," says Jamie Love, director of Knowledge Ecology
International, a non-profit public interest group.

Knowledge Ecology and other groups filed a formal appeal earlier this
month. They want the Army to require Sanofi to give U.S. buyers a fair
price — charging the same price here as it charges in other wealthy
countries — like its home country France. Louisiana Gov. John Bel Edwards
also asked the Army for such a guarantee.

The groups have been pressing the Army for months over the proposed
license. The Army wrote in an April 21 letter that it has to give the
company exclusivity because of the "high risk and high costs involved in
advanced vaccine development."

Those costs aren't clear however, at least when it comes to Sanofi.

"It's not obvious what they've done," Love says of Sanofi. "They didn't
invent the vaccine, they didn't do the Phase 1 [clinical trial]. They're
not paying for the Phase II or III trials."

The Army right now is conducting the Phase I trial, intended to determine
whether the vaccine is safe.

If that goes well, the Department of Health and Human Services will give
Sanofi $43 million for a Phase II trial, which determines whether the
vaccine actually works and whether it has side effects.

And HHS is offering up another $130 million for the Phase III trial if the
second stage is successful.

Sanofi says it has devoted 60 scientists to the project full time and is
using "proprietary technical manufacturing expertise," as well as the
clinical trial network it has developed over the years in testing other
vaccines to help with the studies.

"So while it's true that those costs are being paid for by the U.S.
government, we do have substantial investments in this vaccine," says Dr.
Jon Heinrichs, an associated vice president at Sanofi Pasteur in
Pennsylvania, where he leads vaccine development.

"And really what it costs us are the opportunity costs where those
individuals could be working on projects that have a more certain
commercial return," he says. "And while they're working on Zika, they can't
be working on those projects."

It's still not certain the vaccine developed by the Army will work, or that
there will be a market for it in the end, he says. There are many other
efforts to develop Zika vaccines, some of which have government funding,
and it's not clear which will be most effective. Plus viruses can mutate,
so a vaccine that is effective this year may not be in the future.

And Elias Zerhouni, a former director of the National Institutes of Health
and president of global research and development at Sanofi said in a letter
to the New York Times that the company will pay royalties to the Army for
the license, so the government can recoup its investment.

Sen. Bernie Sanders, I-Vermont, isn't impressed with Sanofi's arguments. He
has been urging the Army to withhold the license from Sanofi until the
company agrees to charge U.S. customers a fair price.

"It seems to me that if we are providing substantial amounts of money to a
company to distribute and develop this drug that the American people should
be guaranteed that they're going to be able to afford the price of the
vaccine," Sanders tells Shots. "And currently that is not the case."

Sanders says the Army has asked Sanofi for a guarantee that it will charge
U.S. customers, including state and federal public health and Medicaid
programs, no more than it charges other wealthy countries for the vaccine.
And the company, Sanders says, refused.

"Well, you know, we have not refused," Heinrichs says. "And we intend to
make this vaccine available at a reasonable price. And I think our record
stands, and that we have made many of our vaccines available to those who
need them at affordable prices."

The Army did not respond to multiple calls to its Medical Research and
Material Command at Ft. Detrick, Md., where the Zika work is happening.

Sanders and KEI point out that Sanofi has charged more in the U.S. for many
medications, including the multiple sclerosis drug Aubagio, which costs
Medicare more than $5,000, but in France it's priced at about $745.

"Sanofi wants to do business the old-fashioned way, and that is take
taxpayers money and then charge any price that they want," Sanders says.
"Our job now is to make it clear that what Sanofi wants it not acceptable."

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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