[Ip-health] Devex: Zika vaccine could be delayed, unaffordable after US Army grants exclusive rights to pharma company

Jamie Love james.love at keionline.org
Fri Jan 27 09:44:07 PST 2017

Interesting to hear Paul Wilson's opinions.  Does he know much money Sanofi
has promised to invest?
told Statnews they expected the US government to pay for the late stage
​.  Was Sanofi lying then, or now? ​
 Sanofi certainly is not paying for the current trials
​.  The Army won't say anything about who will be paying for the future
trials, although the NIH is putting out press releases about the six year
funding agreement with Sanofi.​

he 2009 vaccine for Japanese encephalitis that used the same platform as
​ wasn't developed a big pharma company, I believe it was registered by I
ntercell AG
​, a firm few have heard of.
The notion that only a few big companies can make and distribute vaccines
is false.
​And in any case, Sanofi has already been given $43 million to work on
this, without a license.  ​

The notion that GAVI is going to protect people in developing countries
from price gouging from Sanofi would be more compelling if Sanofi was not
given exclusive rights.   Why give a company a monopoly and then have a
discussion about the price?   And, what about US residents who want to
avoid having babies with small heads and brain damage?  If GAVI going to
help them?  No.

​  Jamie​

On Fri, Jan 27, 2017 at 5:47 PM, Zack Struver <zack.struver at keionline.org>

> https://www.devex.com/news/zika-vaccine-could-be-delayed-una
> ffordable-after-us-army-grants-exclusive-rights-to-pharma-company-89519#
> Zika vaccine could be delayed, unaffordable after US Army grants exclusive
> rights to pharma company
> By Sophie Edwards | 27 January 2017
> The U.S. Army’s plan to grant exclusive rights to a promising Zika vaccine
> to a major pharmaceutical company has raised questions about whether that
> threatens its future affordability and availability to people in developing
> countries.
> The purified, inactivated Zika virus vaccine — called ZP IV — has been
> developed by the U.S. Army and is currently in its first phase of testing
> at the Walter Reed Army Institute of Research in Maryland and the National
> Institutes of Health.
> If it successfully passes clinical trials, the vaccine would have the
> potential to halt the spread of the virus, transmitted by mosquitoes and
> sexual intercourse, which has been reported in 69 countries since 2015,
> including the United States, and is linked to serious birth defects in
> children.
> The deal was posted by the Army on the public Federal Register in December
> and will give Sanofi Pasteur, the vaccine unit of French multinational
> pharmaceutical company Sanofi, exclusive access to the new vaccine
> technology, which has been developed and paid for by the U.S. government.
> In return, Sanofi will take on the role of conducting clinical trials,
> getting regulatory approval, manufacturing and distributing the vaccine.
> The humanitarian aid organization Médecins Sans Frontières has criticized
> the Army’s decision to grant Sanofi the patent license, which will give the
> company an exclusive right to make, use and sell the vaccine for 20 years,
> as well as 12 years of marketing and data exclusivity even after the patent
> has expired. MSF is saying this will give the company a monopoly on the
> drug and thus no incentive to make it affordable. Sanofi could also choose
> to stop developing the vaccine if it decides it is commercially
> unattractive.
> MSF wants the U.S. Army to consider granting an “open nonexclusive” patent
> license instead, opening up the technology to other pharmaceutical
> companies for testing and development. MSF argues this will increase
> competition and thus bring down the price and ensure the vaccine reaches
> those who need it in middle-income and developing countries.
> “Ministries of Health and people around the world will only be able to
> benefit from the U.S. government investment if the resulting vaccine is
> effective, safe, available, affordable and suitably adapted to the
> resource-limited settings where most people affected by Zika virus live,”
> MSF said in a statement.
> “The next step in the Zika vaccine development process, including its
> licensing and technology transfer strategy, needs to ensure that U.S.
> government funding and leadership in vaccine R&D results in a vaccine that
> is effective and accessible for all patients in need in the U.S. and
> globally, including the most neglected,” the group added.
> The United Nations High Level Panel on Access to Medicines, formed in 2015
> to address the lack of access to medicines in many developing countries,
> appears to agree with MSF’s recommendations. In its 2016 report, the panel
> said: “Universities and research institutions that receive public funding
> must prioritize public health objectives over financial returns in their
> patenting and licensing practices,” and listed the use of nonexclusive
> licenses, the donation of IP rights, and taking part in public sector
> patent pools as potential mechanisms by which to do this.
> Sanofi has responded by saying it’s assuming “financial and opportunity
> risks” by partnering with the government on Zika as there is no guarantee
> of a commercial market for the vaccine.
> “...we’re still assuming financial and opportunity risks because there is
> no clear path to commercialization at this time, as the epidemiology of
> this infectious disease is still a moving target,” according to Sanofi’s
> research and development project lead, Jon Heinrichs.
> The U.S. Army told Devex in an email statement: “We believe granting an
> exclusive license in this case is reasonable and necessary to most quickly
> and most safely provide this potential vaccine for public use to combat the
> growing international threat of the Zika virus.”
> Unusually, the U.S. Army has requested to extend the time period for
> comments on the announcement in the Federal Register by an additional 45
> days until mid-March, the second time the comment period has been extended,
> to allow time to compose written responses to the submissions.
> Experts have predicted the Zika market could be worth more than $1 billion
> a year, driven by U.S. and European travelers willing to pay high prices
> for such vaccines, Reuters reported in October.
> Sanofi is part of a race to develop a Zika vaccine
> The ZP IV vaccine — which is thought to be the furthest along in terms of
> development in the Zika vaccine field — is developed from the inactivated
> Zika virus. The vaccine was shown to give 100 percent protection against
> the Zika virus in mice, according to a study published in science journal
> Nature last August.
> Sanofi is not alone in working on the Zika virus vaccine. It is not even
> the only drug company to receive U.S. government funding to work on the
> issue; GlaxoSmithKline has partnered with the NIH to evaluate a new vaccine
> technology for Zika known as SAM (self-amplifying mRNA), and Japanese
> company Takeda has also entered the vaccine hunt with $312 million funding
> from BARDA.
> Another group of concerned organizations — including Knowledge Ecology
> International, a nonprofit that lobbies to increase access to medicines —
> have also written to the Army to complain about the Sanofi deal.
> KEI says Sanofi does not need to be incentivized to develop the vaccine and
> take it to the market — the standard justification for granting such
> exclusive licenses — since the candidate vaccine has already received
> “extensive government subsidies” and is extremely likely to get additional
> funds.
> “The grant of the exclusive rights in the patent is an unnecessary
> incentive to bring the invention to practical application because of the
> significant federal funding in the clinical trials and the grant of
> additional exclusivities and subsidies,” KEI said.
> In September, BARDA — the U.S. Biomedical Advanced Research and Development
> Authority, a unit within the U.S. Department of Health and Human Services —
> gave Sanofi $43.2 million “for phase II development and manufacturing” of
> the Zika vaccine, according to a Sanofi press release.
> KEI communications and research associate Zack Struver explained that if
> approved, Sanofi will also earn a priority review voucher from the U.S.
> Food and Drug Administration, which it could “sell on for millions of
> dollars,” and so already has “sufficient incentive” to develop the vaccine
> with or without the exclusive license, he said.
> Priority review vouchers are designed to speed up the review process for
> new drug products and thus incentivize drug companies to work to develop
> treatments for rare diseases or those without a robust market. Vouchers are
> transferable and have been sold to other companies for upwards of $300
> million.
> However, the statement from the U.S. Army said there was a strong case for
> granting Sanofi exclusive rights to the technology, due to competition from
> the “many” groups working on a Zika vaccine. Sanofi is taking on “risk” by
> accruing the license since there is a “long way to go in terms of time and
> money” before a Zika vaccine can be approved, they said. Furthermore, the
> army is also yet to receive the patent from the U.S. Patent and Trademark
> Office, and there is a chance it “may never issue,” adding more “risk” for
> Sanofi.
> “The federal government needs a non-federal partner with the research and
> production capabilities and the willingness to invest their own substantial
> funding to most quickly get this product to the market and available for
> public use,” the spokesperson added.
> The KEI letter to the army also asks for four conditions to be imposed on
> the licensing agreement.  These include requiring Sanofi to limit the price
> of the vaccine to “no more than the median price being charged in other
> high income countries;” limiting the length of time that Sanofi has
> exclusive rights to the technology, requiring the vaccine be made
> “available and affordable” in developing countries; and requiring Sanofi to
> be transparent about the costs of research and development.
> The U.S. Army responded by saying the license agreement has stipulations in
> place to “protect the public interest,” including the option to terminate
> if Sanofi fails to “bring the invention to practical application within a
> reasonable time,” or “make the benefits of the invention reasonably
> accessible to the public.”
> Sanofi says no “clear path to commercialization” for Zika at this time
> The pharmaceutical company says that even with the public funding from
> BARDA, taking ZP IV through the many stages of testing, approval and
> manufacturing requires Sanofi to take on “financial and opportunity risks”
> due to the fact Zika is “still a moving target” and there is “no clear path
> to commercialization at this time,” according to Heinrichs, Sanofi’s
> research and development project lead.
> “We have modeled various commercial scenarios including current endemic
> areas, spread to other geographies and the travel market, among others. The
> nature of the epidemiology and spread of the virus will impact the degree
> of profitability,” Heinrichs said.
> Sanofi may have a point, according to Paul Wilson, assistant professor of
> clinical population and family health at Columbia University’s Mailman
> School of Public Health, who says there is “genuine uncertainty”
> surrounding how big the Zika problem will be and how widely a vaccine would
> be used. This is compounded, he said, by the fact that the virus could
> ultimately become widespread but “without causing harm,” or even die out as
> people become immune.
> If this turns out to be the case, however, MSF’s and KEI’s concerns may be
> valid since Sanofi would likely lose interest in the project and fail to
> drive the vaccine all the way through development, WIlson said.
> “I’m sympathetic to MSF’s position — when you have a vaccine being
> developed with public funding and you give the rights to one firm, you have
> every right to put in place conditions to make sure vaccine will be
> available to all who need it,” he said.
> “The U.S. government has to at least justify why an exclusive license is
> necessary,” WIlson added.
> Sanofi could be the best company for the job
> The company has experience with vaccines against viruses in the same family
> as Zika, known as flaviviruses, having developed vaccines for Japanese
> encephalitis and dengue fever.
> This could explain why the U.S. Army is keen to entrust the Zika virus
> vaccine to Sanofi, which is an established player and one with a track
> record of supplying vaccines to developing countries, according to Wilson.
> “It is still more or less true that only the big multinational
> pharmaceutical companies have ever been able to successfully bring a truly
> new vaccine to market. Even when you have a vaccine candidate that’s at the
> stage of this Zika one is now, there are still many challenges involved in
> the later stages of development,” he said.
> However, the capacity of pharmaceutical firms in India, Brazil and China to
> develop vaccines is “growing rapidly” and some of these firms could
> probably bring the vaccine to market, although perhaps not as rapidly as a
> multinational, WIlson said.
> The vaccine industry has long been dominated by four major multinational
> pharmaceutical companies — GlaxoSmithKline, Merck, Sanofi-Pasteur, and
> Pfizer, which accounted for approximately 86 percent of global vaccine
> revenue in 2015. Their monopoly is attributed to entry barriers such as
> high start-up costs and long lead times; vaccines can take anywhere from 10
> to 16 years to reach the market, preventing other companies from competing.
> Phase III trials are technically difficult to conduct and many drugs and
> vaccines fail them, and developing a robust manufacturing process is “very
> technical” and is subject to “stringent regulatory requirements,” which can
> be hard to navigate, Wilson explained.
> “The U.S. Army may want a MNC partner because they believe that is the
> surest way to ensure that the vaccine gets developed quickly. There are
> only a few companies out there that have the relevant experience and have
> shown an active interest in developing country markets, which Sanofi has
> demonstrated,” he said.
> Access will not be an issue in the poorest countries if GAVI steps in
> In relation to MSF’s and KEI’s concerns about access to the vaccine, if
> approved, GAVI, the Vaccine Alliance — a partnership of major donors and
> pharmaceutical companies designed to ensure access to vaccines for children
> in developing countries — could support low-income countries in purchasing
> the vaccine, Wilson said.
> Sanofi confirmed in an email to Devex that it has worked with GAVI on
> distribution of vaccines in the past, and so working with the alliance on
> the Zika vaccine was “certainly a possibility,” but that a strategy for
> “pricing and distribution” would be developed later in the process.
> However, the real problem of access will be in middle-income countries,
> such as Brazil, which are ineligible for GAVI funding but where the vaccine
> is urgently needed.
> “Sanofi doesn’t see a market in the poorest countries and so they’re happy
> to provide vaccines at a reasonable price there through GAVI, since it
> would be seen as bad PR not to. But they are not necessarily prepared to
> make those concessions in places like Brazil and India, where the greatest
> access concerns would be,” Wilson said.
> Sanofi has bad track record when it comes to serving developing countries,
> MSF says
> MSF spoke out against Sanofi in 2015 after the company decided to stop
> manufacturing a pan-African snakebite antivenom because it was no longer
> lucrative, leaving a gap in supplies that MSF said would be likely to lead
> to unnecessary deaths.
> The NGO is worried that if given the exclusive license for the Zika
> vaccine, the pharmaceutical company will follow the same path and neglect
> countries with great need but less opportunities for profit, according to
> Judit Rius Sanjuan, MSF’s U.S. access campaign manager.
> Instead, Sanjuan wants the U.S. Army to offer Sanofi a nonexclusive
> license, which she argued would be “better public policy,” ensure the Zika
> virus has broader geographical scope, and protects the U.S. government from
> “having all its apples in one basket.”
> There are other ways to get medicines through development and into markets
> There have been successful examples of the U.S. government offering
> nonexclusive licenses for patented technologies through the United Nations
> backed Medicines Patent Pool, a global health financing mechanism set up in
> 2010 to share drug technology and research to speed up development, lower
> costs and increase access to newer HIV/AIDS, viral hepatitis C, and
> tuberculosis treatments in developing countries.
> MPP works by signing agreements with patent holders — such as the NIH and
> the U.S. Army but also nonprofits, pharmaceutical companies and individuals
> — to create a pool of relevant patents. The partners are then licensed to
> generic drug manufacturers who can then produce generic versions of the
> medicines, often utilizing more than one patented technology in the process
> of development.
> For example, in 2010, the NIH licensed a patent on Darunavir to the MPP,
> which spurred the development of a new combination drug. Furthermore, Johns
> Hopkins University announced on Jan. 25 that it is licensing its patent for
> the drug candidate sutezolid, which could be used to treat tuberculosis,
> exclusively to the MPP.
> While the MPP does not currently work on vaccines, and so licensing to the
> MPP was not an option for the U.S. Army, these examples set a “good
> precedent” for “innovative” nonexclusive licensing agreements and how
> effectively sharing research can expedite research and development,
> increase collaboration, and diversify the medicine development process,
> MSF’s Sanjuan said.
> Furthermore, there have been other notable examples of the U.S. granting
> nonexclusive licenses for the development of vaccines. For example, the
> human-bovine rotavirus vaccine technology was licensed by the NIH to eight
> organizations, one in the United States and seven in the developing
> countries, to manufacture and distribute the rotavirus vaccine.
> --
> Zack Struver, Communications and Research Associate
> Knowledge Ecology International
> zack.struver at keionline.org
> Twitter: @zstruver <https://twitter.com/zstruver>
> Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
> keionline.org
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James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670 <(202)%20332-2670>, US Mobile: +1.202.361.3040
<(202)%20361-3040>, Geneva Mobile: +41.76.413.6584
<+41%2076%20413%2065%2084>, twitter.com/jamie_love

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