France’s High Council for Biotechnology also publishes Supportive Position

OXFORD, England, July 12, 2017 /PRNewswire-HISPANIC PR WIRE/ –The National Institute of Public Health and the Environment (RIVM) in the Netherlands today published its “Technical evaluation of a potential release of OX513A Aedes aegypti mosquitoes on the island of Saba“, which positively concludes a vector control program using Oxitec’s Friendly™ Aedes aegypti mosquitoes would pose negligible risks to human health and the environment.

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RIVM’s GMO office undertook its biosafety evaluation of Oxitec’s Friendly™ self-limiting mosquito technology following the guidance for risk assessment of genetically modified animals by the European Food Safety Authority (EFSA) and the European risk assessment framework, which is considered one of the most robust and thorough biosafety frameworks globally.  Additionally this independent review reflected guidance from the World Health Organization (WHO) for testing of genetically modified mosquitoes as well as the Cartagena Protocol on the Biosafety to the Convention on Biological Diversity.

“We welcome the favorable outcome of the RIVM’s extensive review indicating a positive safety profile of our bio-based mosquito technology,” said Mark Carnegie-Brown Chief Executive Officer at Oxitec. “When combined with our excellent efficacy data, this result points to the significant potential of the Oxitec platform to safely address the growing global challenge from dangerous Aedes aegypti mosquitoes. We are committed to working with regulators worldwide to bring this important technology to market.”

This result reinforces the affirmative biosafety profile of Oxitec’s self-limiting technology for deployment in vector control programs, and also supports the conclusions of environmental assessments conducted elsewhere including from Brazil’s National Technical Commission of Biosafety (CTNBio) and the U.S. Food and Drug Administration (FDA) whose review team consisted of experts from the Center for Veterinary Medicine, the Centers for Disease Control and Prevention, and the Environmental Protection Agency.

Additionally, France’s High Council for Biotechnology (HCB) last month published its supportive position on the use of genetically modified mosquitoes for vector control, following the emergence of mosquito-borne diseases in French overseas territories and perceived threats to metropolitan France. Oxitec has been working closely with the HCB to help inform their evaluation and welcomes HCB’s opinion on self-limiting Aedes aegypti. The HCB opinion will help to shape the policy landscape in France towards the deployment of new tools for vector control, and is a positive step towards advancing Oxitec vector control projects in the French Caribbean.

How Friendly™ Aedes works

Oxitec has been working in Aedes aegypti control for over a decade and pioneered the use of a biological method to suppress wild populations of this dangerous mosquito species through the release of Friendly™ Aedes males, which do not bite and do not transmit diseases. When released, these males search for wild females to mate, and their offspring inherit a self-limiting gene that causes them to die before reaching functional adulthood.  Friendly™ Aedes’ offspring also inherit a fluorescent marker that allows tracking and monitoring at a level never before achieved, making the assessment of effectiveness more accurate throughout the whole Friendly™ Aedes deployment program. Unlike other approaches, Friendly™ Aedes mosquitoes die along with their offspring, and therefore do not persist in the environment or leave any ecological footprint.

About Oxitec

Oxitec is a pioneer in using genetic engineering to control insect pests that spread disease and damage crops, and was founded in 2002 as a spinout from Oxford University (UK). Oxitec is a subsidiary of Intrexon Corporation (NYSE: XON), which engineers biology to help solve some of the world’s biggest problems.  Follow us on Twitter at @Oxitec.

OXFORD, England, Oct. 26, 2016 /PRNewswire-HISPANIC PR WIRE/ –Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, today announced its wholly owned subsidiary Oxitec has opened its new Friendly™ Aedes mosquito production facility in Piracicaba, Brazil.  The new 5,000 m² facility has the capacity to produce 60 million Friendly™ Aedes per week which can help protect up to 3 million people by significantly reducing local populations of the dangerous Aedes aegypti mosquito.

Lieutenant General (Ret.) Thomas P. Bostick, Ph.D., P.E., Senior Vice President and Head of Intrexon’s Environment Sector stated, “The scalability of our biological solution has taken a meaningful step forward with the inauguration of this new world-class facility in Brazil.  With the rising global incidence of harmful viral infections including Zika, dengue, chikungunya, yellow fever, and now Mayaro, driven primarily by the bite of the dangerous Aedes aegypti, it is essential we make Oxitec’s proven, unparalleled Friendly™ Aedes vector control solution more available to the many countries this disease-spreading mosquito has invaded.  We continue to engage and work with numerous government agencies and non-governmental organizations to achieve this mission.”

Oxitec’s pioneering biological method involves the release of engineered, non-biting male mosquitoes that mate with wild females.  The resulting offspring inherit a self-limiting gene preventing them from reaching adulthood and the males themselves die within days providing an eco-friendly solution that solely targets Aedes aegypti and does not persist in the environment.  Oxitec will utilize a portion of the new facility’s significant production capability to support its ongoing deployment program in Piracicaba’s downtown area and CECAP/Eldorado district to suppress Aedes aegypti.

In conjunction with independent collaborators, Oxitec has conducted five open field trials of its self-limiting mosquitoes in Brazil, Panama and the Cayman Islands.  Each trial led to a greater than 90% reduction of the wild Aedes aegypti population, achieving these unparalleled suppression results within six months on average.  More recently, Piracicaba’s Epidemiologic Surveillance service released data showing the incidence of dengue had decreased by 91% to just 12 cases in the CECAP/Eldorado district where Friendly™ Aedes mosquitoes were released, compared to a 52% reduction in the rest of the city during the same 12-month period.

Notably the public support for the Friendly™ Aedes project has been strong. A survey conducted by the CW7 Market Research Institute in mid-2016 showed that 98% of Piracicaba’s citizens support the use of innovative tools to fight dengue, Zika and chikungunya, and 88% support the use of Friendly™ Aedes.

“This Friendly™ Aedes facility increases our current production capacity 30-fold in Brazil”, says Glen Slade, Oxitec’s VP and Director of Oxitec do Brasil. “This reaffirms our ability to produce Friendly™ Aedes at scale, and we are ready to expand our production even further to help protect the people of Brazil and beyond.”

About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is Powering the Bioindustrial Revolution with Better DNA^™ to create biologically-based products that improve the quality of life and the health of the planet.  The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells.  We call our synthetic biology approach Better DNA^®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon.

Trademarks
Intrexon, Powering the Bioindustrial Revolution with Better DNA, and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements.  These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business.  Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

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“We are delighted Piracicaba is encouraged by our strong results and expanding the program. Our new facility will support the roll out of our groundbreaking vector-control across the heart of the city and beyond,” said Oxitec CEO Hadyn Parry. “As the principal source for the fastest growing vector-borne infection in the world in Dengue Fever, as well as the increasingly challenging Zika virus, controlling the Aedes aegypti population provides the best defense against these serious diseases for which there are no cures.”

Following approval by Brazil’s National Biosafety Committee (CTNBio) for releases throughout the country, Piracicaba’s CECAP/Eldorado district became the world’s first municipality to partner directly with Oxitec and in April 2015 started releasing its self-limiting mosquitoes whose offspring do not survive. By the end of the calendar year, results had already indicated a reduction in wild mosquito larvae by 82%. Oxitec’s efficacy trials across Brazil, Panama and the Cayman Islands all resulted in a greater than 90% suppression of the wild Ae. aegypti mosquito population – an unprecedented level of control.

Based on the positive results achieved to date, the ‘Friendly Aedes aegypti Project’ in CECAP/Eldorado district covering 5,000 people has been extended for another year. Additionally Oxitec and Piracicaba have signed a letter of intent to expand the project to an area of 35,000-60,000 residents. This geographic region includes the city’s center and was chosen due to the large flow of people commuting between it and surrounding neighborhoods which may contribute to the spread of infestations and infections.

According to Mayor Gabriel Ferrato, “The city of Piracicaba has always sought innovative solutions to serious problems. In the case of Aedes aegypti, we looked for the tool that seemed most appropriate to help in the tough battle against this mosquito that transmits dengue, Zika and chikungunya. Based on the results presented today, we decided to extend the project in CECAP/Eldorado district for another year and also signed a record of intent to expand the project to the central area of Piracicaba. This will bring to the city a new Oxitec factory to meet demand for years to come and help protect the public’s health with this clean and innovative technology.”

Like many invasive insect species, Ae. aegypti’s territory is expanding as are the diseases it spreads, including dengue, chikungunya and Zika virus, which collectively impact over 100 countries and approximately 400 million people globally each year. Today Brazil has the highest reported incidence of dengue in the Western Hemisphere, and with both chikungunya and Zika virus having entered the country in 2014 and 2015 respectively, the Ae. aegypti mosquito has become an increasing health risk. As a result, Brazil’s Ministry of Health spent over 1.2 billion reals last year and allocated an additional 500 million reals for states and municipalities in January 2016 to combat the mosquito.

As per the recent New England Journal of Medicine publication titled “Zika Virus in the Americas — Yet Another Arbovirus Threat”, Brazil is not alone. Authors Anthony S. Fauci, M.D., and David M. Morens, M.D., from the National Institute of Allergy and Infectious Diseases noted, “The explosive pandemic of Zika virus infection occurring throughout South America, Central America, and the Caribbean and potentially threatening the United States is the most recent of four unexpected arrivals of important arthropod-borne viral diseases in the Western Hemisphere over the past 20 years.”

Samuel Broder, M.D., SVP and Head of Intrexon’s Health Sector commented, “As a vector that transmits a number of serious diseases, the Aedes aegypti mosquito poses a major threat to public health and the economic welfare of nations. Brazil has been hard hit by dengue and the situation there has been aggravated by the recent introduction of Zika virus infections leading to a startling increase in the number of children being born with microcephaly.” Dr. Broder continued, “Through the responsible engineering of biology, we demonstrate a new paradigm of species-specific vector control resulting in dramatic reductions of dangerous mosquitoes, without persistence or harm to the ecosystem, representing a major scientific, environmental and clinical advance.”

Diseases spread by the Aedes aegypti mosquito:

• Dengue Fever infects up to 400 million people every year with an estimated 40% of the world’s population perpetually at risk.
• Zika Virus is rapidly spreading into new countries. In 2015 it emerged in Brazil where it has been linked to a sudden increase in birth defects (microcephaly). The number of children born with microcephaly in Brazil has now risen to more than 3500.
• Chikungunya swept into Central America and the Caribbean in 2013 with an epidemic spiking to over a million cases within only a year.
• Yellow Fever remains a major health threat. There are an estimated 200,000 cases of yellow fever, causing 30,000 deaths, worldwide each year, with 90% occurring in Africa.

About Oxitec
Oxitec is the only GM insect company in the world and a pioneer in using genetic engineering to control insect pests that spread disease and damage crops. Oxitec was founded in 2002 as a spinout from Oxford University (UK), and is now a subsidiary of Intrexon Corporation (NYSE: XON), which engineers biology to help solve some of the world’s biggest problems. Oxitec’s self-limiting insect control targets only the one species of pest in a way that is non-toxic and pesticide-free, providing vector control that is both effective and environmentally friendly. Follow us on Twitter at @Oxitec.

About Intrexon Corporation
Intrexon Corporation (NYSE: XON) is Powering the Bioindustrial Revolution with Better DNA^™ to create biologically-based products that improve the quality of life and the health of the planet. The Company’s integrated technology suite provides its partners across diverse markets with industrial-scale design and development of complex biological systems delivering unprecedented control, quality, function, and performance of living cells. We call our synthetic biology approach Better DNA^®, and we invite you to discover more at www.dna.com or follow us on Twitter at @Intrexon.

Trademarks
Intrexon, Powering the Bioindustrial Revolution with Better DNA, and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

For more information contact:
Corporate Contact:
Marie Rossi, Ph.D.
Senior Manager, Technical Communications
Tel: +1 (301) 556-9850
publicrelations@intrexon.com

Investor Contact:
Christopher Basta
Vice President, Investor Relations
Tel: +1 (561) 410-7052
investors@intrexon.com

Oxitec Contact:
Chris Creese, Ph.D.
Communications Manager
Tel: +44 (0) 7972 103372
info@oxitec.com

Media Contact:
Elana Ferrari
Edelman US
Tel: +1 (312) 233-1336
Email: Elana.Ferrari@edelman.com