Posts Tagged ‘Health news’

Oxitec’s Friendly™ Aedes Mosquito Receives Positive Evaluation for European Standard in relation to Human Health and the Environment

FacebookTwitterGoogle+Share

RIVM concludes negligible risk of Oxitec’s Friendly™ Aedes mosquitoes

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.

(Logo: http://photos.prnewswire.com/prnh/20150630/227348 )

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.

Click Here for More Information »

Partial Settlement of a Class Action Lawsuit for Purchasers of Solodyn and/or Its Generic Equivalent is Announced

NEW YORK, April 28, 2017 /PRNewswire-HISPANIC PR WIRE/ –

If You Purchased Solodyn and/or Its Generic Equivalent Partial Settlements of a Class Action Lawsuit May Affect Your Rights

Partial settlements have been reached in a class action lawsuit involving the antibiotic drug Solodyn. The lawsuit claims that Medicis Pharmaceutical Corp., Valeant Pharmaceuticals International, Inc., Impax Laboratories, Inc., Lupin Limited, Lupin Pharmaceuticals Inc., and Sandoz Inc. (the “Defendants”) violated state competition (i.e. antitrust and consumer protection) and unjust enrichment laws by agreeing not to compete with each other and keeping lower-cost generic versions of Solodyn off the market. The Defendants deny this. No one is claiming that Solodyn is unsafe or ineffective.

WHAT DO THE SETTLEMENTS PROVIDE?

To settle the lawsuit, Lupin Pharmaceuticals Inc. and Lupin Limited (”Lupin Defendants”) and Sandoz Inc. (”Sandoz”) have each agreed: (a) that they would be willing to provide certain witnesses that Plaintiffs could call and a declaration that the Plaintiffs could use during the Solodyn case involving the overall End-Payor Class, other Plaintiffs, and the Non-Settling Defendants; and (b) to deposit $625,000 and $1.75 million, respectively, into Settlement Funds. If the Settlements are approved by the Court and become final, the Settlement Funds, inclusive of interest, will be used to: (1) pay for costs and expenses incurred or to be incurred by Counsel in continuing the lawsuit against Medicis Pharmaceutical Corp., Valeant Pharmaceuticals International, Inc., and Impax Laboratories, Inc. (the “Non-Settling Defendants”); (2) cover taxable costs and taxes payable on the Settlement Funds; (3) pay for notice and other expenses; and (4) pay for service awards not to exceed $10,000 to the class representatives in recognition of their efforts to date on behalf of the Classes. Any remainder in the Settlement Funds, after the payment of the above expenses, shall be distributed to the End-Payor Class for the Lupin Settlement and the End-Payor Class for the Sandoz Settlement in a manner approved by the Court at the conclusion of the litigation. The Settlement Agreements, available at the website www.SolodynCase.com contain more details. These Settlements involve only the Lupin Defendants and Sandoz. The case will continue against the Non-Settling Defendants.

WHO IS INCLUDED IN THE CLASSES?

Generally, you are included in the Classes if you purchased, paid and/or provided reimbursement for some or all of a Solodyn and/or its generic equivalent prescription in the United States and its territories, including Puerto Rico, in tablet form, from July 23, 2009, onward. Certain third-party payors are also members of the Classes.

You are NOT a member of the Classes if: you paid a “flat co-payment” for all of your prescription drug purchases regardless of whether they are brand or generic; you are one of the Defendants or an officer, director, manager, employee, subsidiary, or affiliate of any Defendant(s); you purchased only directly from Defendants or for resale purposes; you purchased or received Solodyn or its generic equivalent only through a Medicaid program; you are the judge in this lawsuit or a member of the judge’s immediate family; and/or you previously excluded yourself from the overall End-Payor Class.

YOUR RIGHTS AND OPTIONS

If you are a Class Member, you have the right to exclude yourself (to opt-out) from one or both of the Settlements no later than June 12, 2017. You may also comment on or object to one or both of the proposed Settlements. To do so, you must act by June 12, 2017. Details on how to request exclusion, comment, or object are at www.SolodynCase.com.

The Court will hold a hearing tentatively set for 3:00 p.m. on November 27, 2017, to consider whether the Settlements and all of their terms are fair, reasonable, and adequate. Please check the website for updates.

FOR MORE INFORMATION
Visit www.SolodynCase.com
Call 1-800-332-7414

Click Here for More Information »

Expansion of Oxitec’s Vector Control Solution in Brazil Attacking Source of Zika Virus and Dengue Fever after Positive Program Results

OXFORD, England and GERMANTOWN, Maryland, Jan. 19, 2016 /PRNewswire-HISPANIC PR WIRE/ — Intrexon Corporation (NYSE: XON), a leader in synthetic biology, today announced its subsidiary Oxitec and Piracicaba City Hall have expanded the ‘Friendly Aedes aegypti Project’ in Piracicaba, Brazil following strong results for controlling the Ae. aegypti mosquito population, the primary vector for dengue, chikungunya and Zika virus outbreaks around the world. In preparation of this growing program and to meet increasing demand for its proprietary vector control solution, Oxitec is initiating a new mosquito production facility in Piracicaba that will have capacity to protect over 300,000 people.

Logo – http://photos.prnewswire.com/prnh/20130919/NY83283LOGO
Logo – http://photos.prnewswire.com/prnh/20160118/323303LOGO

“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

Click Here for More Information »

Cutting edge therapy for Psoriasis patients now available in the Caribbean

- Clinical trials with over 3,000 treated patients demonstrate its efficacy.

- Studies demonstrated that at least two thirds of the patients obtained 75% improvement of Psoriasis Activity Severity Index.

- This treatment significantly improves the quality of life of patients with moderate to severe plaque psoriasis.

PANAMA CITY, Dec. 2, 2015 /PRNewswire-HISPANIC PR WIRE/ – Psoriasis is a chronic skin disease that affects around 140 million people worldwide.  It’s more frequent between the ages of 15 and 25, but may develop at any age and highly impacts the quality of life.

Several types of psoriasis exist, which range from mild to severe and disabling. Plaque psoriasis is the most common form and is known for producing inflammation and scaly patches of thickened skin called “plaques”. It is caused due to a problem in the immunologic system, where white blood cells that normally become activated to fight infections, are in this case activated against the healthy skin cells.  The cause of the disease is unknown. The immunologic system is activated and produces inflammatory mediators which are responsible for the skin lesions.

During this process, white blood cells release chemical products called “cytokines”, which produce inflammation, reddening of the skin and make the cutaneous cells move from deeper skin layer to surface at a higher speed than normal, (almost 5 times). These cells accumulate and generate the scaly patches. Psoriatic lesions show the aspect of scales, sometimes with a white silver color, while the skin below is red and if scratched it can bleed. Two specific cytokines are increased in the pathogenesis of psoriasis and produce the inflammatory process of the disease (Interleukin 12 and Interleukin 23).

Ustekinumab is a monoclonal antibody that represents the first of a new class of psoriasis therapies that specifically and selectively targets IL-12/IL-23.

Ustekinumab is now available in the Caribbean, specifically in Aruba, Bahamas, Bermuda, Cayman Islands, Curacao and Jamaica.[i] Ustekinumab is commercialized under the brand Stelara™.

This therapeutic alternative is the latest generation of psoriasis treatment. With over 3,000 treated patients (in clinical trials) up to 5 years of treatment. The data obtained proves that the treatment is well tolerated and safe.

Clinical trials demonstrated that at least two thirds of the patients obtained a 75% improvement of the psoriasis, in accordance with the Psoriasis Activity Severity Index (PASI 75), after only two doses of Ustekinumab. This innovative treatment has a very convenient dosage regimen when compared with other biological therapies for psoriasis. After 5 years, approximately 80% of the patients treated with Ustekinumab maintain response.

Until recent years, psoriasis was considered a disease limited to the skin. Recent evidence, from important population studies in psoriatic patients, has demonstrated an increase in mortality and a decrease in life expectancy between 3 to 4 years in patients with psoriasis.

On the other hand, the impact of psoriasis notably influences the quality of life, and this is reflected in the increase of different social and psychoactive pathologies, and in the acquisition of unhealthy habits like tobacco and alcohol, favored by low self-esteem, anxiety, depression and the isolation which patients feel subjected to.[ii]

“Ustekinumab significantly improves the quality of life of patients with moderate to severe psoriasis, as well as their physical and mental functions. After 12 weeks of treatment, patients treated with Ustekinumab present a significant improvement in their mental well-being and their physical condition”, affirmed Dr. Eduardo Franco; Janssen’s Medical Director for Central America and the Caribbean.

The itching and pain, the plaques in their hands and feet may hinder the performance of certain tasks or participation in some activities. Overtime, about 40% of psoriatic patients develop arthritis. “The most severe cases of psoriasis may even generate immobility of the patient. Some patients compare the reduction of their physical activities to the ones generated by other diseases as cancer or heart diseases”, pointed out Dr. Jose Antonio Herrera, Immunology Medical Manager for Janssen.

About Janssen

Janssen is a Company dedicated to the research of providing innovative products that help protect and improve the life of people, and face and solve the most important and unresolved medical needs of our times, in the areas of oncology, immunology, neurosciences and infectious, cardiovascular and metabolic diseases.

Across the different companies of the Johnson & Johnson group, our people are united in the passionate pursuit of solutions through science, in benefit of the patients.

Present in over 50 countries, we share the commitment of the founders of the Company, of innovating in ideas, products and services for the patients of the whole world.

[i] Ustekinumab was approved by the following Health Authorities:
Aruba: Drug Registration Board,
Curacao; Drug Registration Board
Jamaica: Ministry of Health.
Cayman Islands, Bahamas and Bermuda are not regulated countries.

[ii] 2009 Latin American Psoriasis Consensus, treatment guides, Latin American Psoriasis Society

Fact Sheet Psoriasis

  1. Psoriasis is a chronic disease that affects over 140 million people worldwide.
  2. It presents itself more frequently between the ages of 15 and 25, but may develop at any age and highly impacts the quality of life.
  3. The main cause for this disease is unknown. The immunologic system is activated and produces inflammatory mediators which stimulated white cells and infiltrate the skin layers. The deep layer cells move to the outer layer of the skin at least 5 time faster than usual, and this produces the characteristic plaque of the psoriasis.
  4. There are several clinical forms of the disease, plaque psoriasis being the most common form. It is known for producing inflammation and scaly patches of thickened skin called “plaques”.
  5. Moderate to severe plaque psoriasis, notably influences the quality of life.  Severe cases of psoriasis may even generate immobility of the patient.
  6. Some patients compare the reduction of their physical activities to the ones generated by other diseases such as cancer or heart disease.
  7. Ustekinumab is now available in the Caribbean, specifically in Aruba, Bahamas, Bermuda, Caiman Islands, Curacao and Jamaica.[i]  Ustekinumab is commercialized under the brand Stelara™.
  8. Clinical trials with over 3,000 patients treated with Ustekinumab have demonstrated its efficacy. At least two thirds of the patients obtained a 75% improvement of the Psoriasis Activity Severity Index.
  9. After 5 years, approximately 80% of the patients treated with Ustekinumab maintain response.

[i] Ustekinumab was approved by the following Health Authorities:
Aruba: Drug Registration Board,
Curacao; Drug Registration Board
Jamaica: Ministry of Health.
Cayman Islands, Bahamas and Bermuda are not regulated countries.

CONTACT:  Janssen, JoanTownsend, (507) 64306252 or (507) 3989740, tojoa

Click Here for More Information »