[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?
​Sanofi​
told Statnews they expected the US government to pay for the late stage
trials
​.  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.​


​T​
he 2009 vaccine for Japanese encephalitis that used the same platform as
ZPIV
​ 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>
wrote:

> 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
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