Zika – An International Public Health Emergency Poses Blue Ocean Opportunity to Global Pharmaceutical and Diagnostic Testing Companies

A Global Health Emergency

The World Health Organization declared the Zika virus outbreak to be an international public health emergency in January 2016. While one hand this outbreak presents an absolute blue ocean opportunity for drug makers globally, on the humanitarian side of things – the outbreak is expected to affect the most vulnerable section of the society – pregnant mothers and newborn babies. This huge dilemma of opportunity versus outbreak calls for an in-depth understanding of causes and effects of the disease along with regional disease incidence and epidemiology.

Medium of Transmission and Effects

As per the US Centers for Disease Control and Prevention (CDC), Zika virus belongs to the Flaviviridae family. Zika virus disease (Zika) is transmitted to humans from the bite of an infected mosquito from the Aedes genus. This mosquito is also associated with transmission of other related diseases such as dengue, chikungunya and yellow fever. In most cases, symptoms of the disease are mild and usually last up to 7 days. Patients suffering from Zika exhibit symptoms such as fever, rash, joint pain and conjunctivitis (red eyes), all of which are similar to those of the aforementioned diseases. Pregnant women and newborn babies are most susceptible to the disease. This can cause microcephaly among newborn babies, wherein they are born with very small heads and underdeveloped brain. However, tests to establish the link between the virus and microephaly have proved to be inconclusive. Among adults, the virus can lead to an autoimmune disease called Guillain-Barre syndrome (GBS) that can progress to profound paralysis and cardiovascular complications, among others.

Current Treatment Landscape

The first alert regarding the disease was issued by Pan American Health Organization (PAHO) in May 2015, when the first confirmed case was established in Brazil. While there are no prophylaxis, treatment or vaccines to protect against Zika virus infections (ZIKV) currently available in the market, on February 3, 2016, India-based Bharat Biotech Pvt. Ltd. announced the development of ZIKAVAC—the first vaccines candidate for Zika virus. Of the two candidates, one is an inactivated vaccine at the pre-clinical testing stage. The World Health Organization (WHO) recommends preventive measures such as removal of potential breeding sites for mosquitoes, use of  insect repellent, wearing light-coloured clothes covering most of the body, to name a few.  Another preventive method is restricting travel to affected places. In this regard, the US CDC has urged pregnant women to restrict travelling to over two dozen countries, mainly in the Caribbean and Latin America.

Diagnosis

Diagnosis of the disease is mainly carried out through virus isolation and polymerase chain reaction (PCR) from blood samples. Serology is not preferred for diagnosis, as the Zika virus can cross-react with similar arbovirus such as West Nile, yellow fever and dengue.

Estimated Disease Epidemiology

Over the last nine months, Zika virus cases have been reported from 30 countries. In January 2016, two new countries, El Salvador and Venezuela, have reported an alarming increase in disease incidence levels above the baseline for Guillain-Barre Syndrome (GBS), concomitant with the development of Zika outbreaks in these countries. Brazil has reported over 4,000 cases of microcephaly that are linked to the Zika virus.

The first reported outbreak of Zika virus disease was in 2007 in Yap Main Islands, part of the Federated States of Micronesia. More recently, major outbreaks were reported in 2013 and 2015 in French Polynesia and Brazil, respectively. Apart from mosquito bites, other methods of transmission are vertical, perinatal and sexual. Although method of testing the Zika viral infection is still experimental, the clear clinical and laboratorial differential diagnosis between acute ZIKV, CHIKV and DENV infection is expected to contribute to better patients’ prognosis and help in driving stringent surveillance actions

Industry Efforts to Curb Zika Virus Infections

WHO’s recent declaration of the Zika outbreak as an international public health emergency is expected to drive funding for better research and development for effective treatment methods from various public and non-profit organizations. A surge in public-private partnerships for harnessing incremental innovation is surely on the horizon for development of better drugs for the virus.

Companies that have expressed intent for conducting R&D on vaccines for curbing Zika virus include Sanofi Pasteur, GlaxoSmithKline, NewLink Genetics Corp., and GeneOne Life Science Inc. from South Korea in association with US-based Inovio Pharmaceuticals. Several universities have also taken initiative to launch research studies on understanding transmission pattern of the virus, viral genome sequencing and outlining easier methods of devising a potential vaccine for the same.

As a first step in devising a vaccine for the virus, Sanofi Pasteur has declared it will capitalize on its research activities to devised vaccine for dengue fever — the world’s first ever vaccine for mosquito-borne illness. This is due to the fact that Zika and dengue viruses belong to the same Flaviviridaefamily. The company also noted there could be some chances of deriving cross-immunity from the dengue vaccine devised by them. A different community of researchers from Washington University at St. Louis has, however, cautioned that the similarity between Zika and dengue viruses could add complexity to vaccine development. WHO and United Nations public-health agency, are acting on formation of required recommendations of an emergency committee to facilitate effective surveillance, research and efforts to control the virus’s spread. 

A Blue Ocean of Opportunities for Pharmaceutical and Diagnostic Testing Companies

In 2015, the US National Institute of Health received funding worth US$ 97 Mn for research on flaviviruses, although none of it is still marked for Zika. The institute is in the process of evaluating two pathways for developing an experimental vaccine for the virus, one of which could enter phase I trials in 2016. With very limited R&D activities and vaccines for the disease in the pipeline, the current scenario provides lucrative first mover advantage to various major players such as Inovio Pharmaceuticals and GeneOne LifeScience. The emergence of Zika as a global pandemic offers both a ginormous challenge and stupendous opportunity for the global healthcare industry, with a panacea on the horizon.