Researchers at Duke University in the United States and UK based Product Development Partnership IVCC have proposed a new mechanism for stimulating public sector product development to fight malaria and neglected tropical diseases (NTDs). The Vector Expedited Review Voucher (VERV) is based on a similar proposal, called the Priority Review Voucher (PRV) that has been stimulating drug development in NTDs in the United States since it was first introduced in 2007.

“It’s about reducing inefficiency in the regulatory process, and using the gains to fix a market failure in product development to benefit society as a whole,” said David Ridley, a professor at Duke University’s Fuqua School of Business and part of the team proposing the voucher reward for approving new public health insecticides through the U.S. Environmental Protection Agency (EPA).

The team’s findings, “A Voucher System to Speed Regulatory Review Could Promote a New Generation of Insecticides to Fight Vector-Borne Diseases,” are published in the August edition of Health Affairs.

Nick Hamon, CEO of IVCC said: “Insecticides used in bednets and for treating homes have prevented millions of deaths from malaria and other diseases. But while the population of disease-carrying insects resistant to current treatments has grown, no new class of insecticides have been developed specifically for public health in the last 40 years because there is little profit opportunity to innovate in these markets.”

The Vector Expedited Review Voucher proposal would offer the company behind the new product an expedited regulatory review for a second, more profitable product intended to protect crops – as a way to encourage large agrochemical companies to invest in developing less profitable innovative products for public health use.

The VERV proposal is based on the system David Ridley, Jeffrey Moe and Henry Grabowski of Duke University proposed for the U.S. Food and Drug Administration a decade ago to encourage the development of treatments for neglected tropical diseases.

Congress made that proposal law in 2007. The FDA has issued 14 vouchers since that program began. They offer review of a drug in six months rather than the usual 10 months, which can make a huge difference to firms bringing a new product to market. Seven of the vouchers issued so far have been sold, fetching as much as $350 million.

“We brought a creative solution to drug development, and now we want to apply it to public health insecticide development,” Moe said.

Ridley and Moe partnered with Nick Hamon, CEO of the IVCC, a UK based not for profit product development partnership (PDP) that works to prevent the spread of malaria and other NTDs. IVCC is funded by the Bill & Melinda Gates Foundation, UKaid, USAID, Unitaid and The Swiss Agency for Corporation and Development (SDC).

“Medicines are an important tool in fighting these diseases, but they are not the only tool,” said Professor Moe. Whereas 65 percent of research and development funding for malaria was for drugs and vaccines, only 6 percent was for vector control, according to the paper. Similarly, the market for vector control insecticides is significantly less than $1 billion, while agricultural chemicals exceed $47 billion in annual sales. The development of a novel insecticide from discovery through to launch can cost between $100-$250m can take up to twelve years, making a return on investment in vector control almost impossible. Awarding a VERV gives an innovator company an opportunity to generate a financial return on an agricultural product as well as reducing the time to market of critically important products.

The Vector Expedited Review Voucher (VERV) proposal incorporates lessons learned through 10 years of the FDA Priority Review Voucher program, by proposing that ensuring that projects that gain a voucher are truly novel and will go where they’re needed.

“Not a week goes by in which we don’t discuss ways we can make the voucher review program better,” Ridley said.

Ridley, who also works with Duke’s Margolis Center for Health Policy, said he expects to see more of the vector review vouchers to be used by the companies that win them, because the industry is dominated by larger players that are less likely to sell to competitors.

“However, we might be surprised,” he said. “There could be companies we’ve never heard of that receive investor funding and develop products because of the potential value of a VERV. That’s one of the beauties of prizes like this – you don’t pick the winners in advance.”

Sumitomo Chemical and IVCC are proud to announce that Sumishield® 50WG has been prequalified by the World Health Organization (WHO).   With a brand-new mode of action chemistry for indoor residual spraying (IRS), Sumishield® 50WG represents a significant breakthrough, providing a new tool to allow program managers to rotate between chemistries and be better equipped to manage resistance.

IVCC supported Sumitomo Chemical by providing scientific advice, laboratory support as well as leading rigorous field trials to prove Sumishield® 50WG’s efficacy.

Dr. Nick Hamon, Chief Executive Officer at Innovative Vector Control Consortium (IVCC), said: “Mosquito resistance to current insecticides is threatening the huge gains made so far in reducing deaths from malaria, so we desperately need effective chemistry with modes of action new to public health to combat these resistant mosquitoes, and enable rotation with other products.  News that Sumishield® 50WG has recently obtained a WHO PQ listing is therefore very welcome and will prove to be a very valuable tool in the vector control toolbox.”

“IVCC and its partners on the Unitaid-funded NgenIRS project are looking forward to adding this new third generation indoor residual spray (3GIRS) to the toolbox of insecticides that can be supported through the established reduced pricing mechanism.  This will give African malaria programs a second affordable long-lasting insecticide to be used in rotation for resistance management.”

With a single mode of action chemistry based on the neonicotinoid insecticide, clothianidin, Sumishield 50WG gives malaria prevention programs greater flexibility when rotating with other chemistries. The formulation has proven efficacy under WHO supervised trials and continues to work effectively for up to nine months after spraying, even against highly resistant mosquitoes.

Due to a non-repellent formula, mosquitoes are exposed to SumiShield 50WG for longer, increasing mortality and reducing the chances of resistance developing. The odourless spray also has very low mammalian toxicity, doesn’t cause irritation through skin contact and won’t stain walls, which creates better acceptance by householders.

WHO figures show that nearly half the world’s population is at risk of malaria and despite great gains madea drop in both incidence and mortality rates in recent years, there are over 200 million new cases every year. Increased prevention and control measures have led to significant gains, but these are under threat due to insecticide resistance, which affects 75% of countries with ongoing transmission of the disease. Rotating insecticides is one of the key strategies for avoiding resistance, however nearly 87% of affected countries are failing to do this, largely due to a lack of alternative chemistries to choose from.

For further information on the WHO Prequalification of SumiShield, visit : http://www.who.int/entity/pq-vector-control/prequalified-lists/sumishield50wg/en/index.html

IVCC is pleased to announce that it has secured partnership role on a recently granted contract to Abt Associates to reduce the burden of malaria across Africa.

IVCC is part of a five-year, $472 million contract awarded to Abt Associates, under the Prevention of Mosquito-Borne Diseases through Vector Control IDIQ, by The United States Agency for International Development (USAID) through the U.S. President’s Malaria Initiative (PMI).  Through this contract, Abt Associates will support PMI and USAID to plan and implement an integrated vector control approach with the overall goal of reducing the burden of malaria in Africa.

As a partner, IVCC will be responsible for advising on the Indoor Residual Spraying (IRS) and other vector control product development pipeline and the timing and availability of products for trials and pilot launches.

IVCC will also be responsible for building and negotiating Public Private Partnerships with manufacturers of new vector control technologies and will, in partnership with Abt Associates and industrial partners, lead the planning and project management of the late stages of product development launch.  Through its relationship with Innovation to Impact (I2I), IVCC will also assist in managing products through the WHO/pre-qualification and policy recommendation review processes.

Nick Hamon, CEO of IVCC said: “Since 2000, Africa has seen major reductions in morbidity and mortality from malaria, primarily due to investments in vector control interventions.  IVCC will be able to leverage its expertise in integrating best practices and innovative solutions in the field of product development, product introduction, design of sustainable approaches to vector control and resistance management.”

“Through our partnership with Abt, this project gives IVCC increased connectivity to the market place and an additional route for testing new interventions which will further support our Access programmes.”

London: 18 April 2018 -Today, at the London Commonwealth Heads of Government Meeting, the world’s leading Crop Protection companies announce their commitment to support the research, development and supply of innovative products to save lives and help eradicate malaria by 2040.

BASF, Bayer, Mitsui Chemicals, Sumitomo Chemical Company and Syngenta have been the major driving force behind the development of innovative vector control solutions, such as bednets and indoor spraying.  Since 2000, nearly 4 in every 5 malaria cases successfully averted through intervention have been due to long-lasting insecticide treated bednets (LLINs) and indoor residual spraying (IRS), saving millions of lives.

In coming together under the ‘ZERO by 40’ banner, these companies are, with the support of the Bill & Melinda Gates Foundation and Liverpool based IVCC (the Innovative Vector Control Consortium), reaffirming their commitment to use their expert knowledge and chemical resources to supply and develop innovative vector control solutions to help reduce the malaria burden, which today is increasingly being threatened by insecticide resistance.

In 2005 these companies opened up their chemical libraries to IVCC to support the search for new chemistry to help address the danger of insecticide resistance. As a result, a strong pipeline of innovative solutions is beginning to emerge.  Recent successes include:

•   In 2016 Actellic®300CS, a next generation IRS developed by Syngenta, was introduced into the NgenIRS programme, a 4-year $65.1 million UNITAID-funded market shaping initiative, now stretching across 14
African countries.

•   This was joined in 2017 by Sumitomo Chemical’s SumiShield^® 50WG, a brand-new mode of action chemistry for indoor residual spraying, to enable improved resistance management through rotation.

•   Bayer’s next generation IRS product combining two modes of action, Fludora^® Fusion, is currently undergoing final stage trials required for WHO prequalification and is expected to join the fight in preventing disease transmission for millions of people across sub-Saharan Africa.

•   In 2017, BASF received a WHO interim recommendation for Interceptor^® G2, a new generation mosquito net developed using a repurposed insecticide (chlorfenapyr) from agriculture to help combat resistant mosquitoes.

•   Mitsui Chemicals, which has a long history in the field of vector control, is developing unique mode of action insecticides across a wide range of product applications such as sprays and bednets.

Nick Hamon, CEO of IVCC said “Our industry collaboration, supported by our funders including the Bill & Melinda Gates Foundation and the UK’s Department of International Development (DFID), is starting to bear fruit and is saving lives today. But we still have a long way to go to achieve our ambition of ending the disease burden of malaria by 2040. This new initiative will not only secure the current supply of solutions, but will pave the way for desperately needed new forms of chemistry and new vector control tools to reduce the disease burden of malaria which still affects millions of people.”

Saori Dubourg, Member of the Board of Executive Directors, BASF SE, said “Next Wednesday is World Malaria Day, but for half of our world, every day is a fight against this devastating disease. Malaria causes sickness and death, reduces productivity, fuels poverty and creates hunger, especially in impoverished, rural farming communities. ZERO by 40 will connect the smartest minds in public health and science, and I am truly optimistic that it will be a force for change. We can be the generation to end malaria.”

Dr. Jacqueline M. Applegate, Member of the Crop Science Executive Committee & President of Environmental Science of Bayer AG, said “The magnitude and global reach of the disease requires the engagement of all major stakeholders to work together if we are to achieve our bold and ambitious goal of ending the malaria burden within a generation. The declaration signed today with our industry partners confirms the willingness to mobilize our diverse know-how and resources. At Bayer, we are committed to using science and innovation to improve people’s lives and are very proud to be a signee of this declaration.”

Kazunori Tani, Executive adviser of Mitsui Chemicals Agro, Inc. said “Through our continued dedication to innovation in organic chemistry technology, Mitsui Chemicals has discovered novel insecticides that effectively control mosquitos resistant to existing chemicals. With our new technologies, we are proud to contribute to the eradication of Malaria, one of the Sustainable Development Goals (SDGs) set by the United Nations.”

Ray Nishimoto, Representative Director & Senior Managing Executive Officer and President of
Health & Crop Sciences Sector, Sumitomo Chemical added “Sumitomo Chemical was founded with the precept that to succeed in the long run, business activities must benefit society. This core value is the basis of our long-standing commitment to continuously develop innovative vector control technologies that will help end malaria for good. On the occasion of the Malaria Summit London 2018, Sumitomo Chemical is proud to join in the Vector Control Malaria Declaration, alongside other leading crop protection companies, and to confirm that we will continue to innovate and invest to bring new vector control solutions to market until malaria is ultimately eradicated.”

Erik Fyrwald, Syngenta CEO said “The WHO reported that in 2016 445,000 people died from Malaria and around 216 million people were infected so we all have a responsibility to help fight this terrible disease.
We are here today to reinforce our commitment in the fight against Malaria and we will work closely to IVCC, and Bill & Melinda Gates Foundation and the companies of our industry to eradicate it.”

Commenting on the initiative, Trevor Mundel, President of Global Health at the Bill & Melinda Gates Foundation, said “Innovative vector control is essential to the success of malaria control and elimination efforts. It’s proven key to saving millions of lives over the past 15 years. That’s why we’re pleased that the companies that have played such an essential role in delivering innovation are extending their commitments to help end malaria for good. The Bill & Melinda Gates Foundation is pleased to support IVCC and its private-sector partners in their efforts to accelerate the discovery and development of new insecticides for public health.”