We are passing through some difficult times. Families communitiesneighbourhoods and economies have all been impacted by this unprecedented healthcarecrisis of COVID-19. The pandemic has shaken up the very core of our existence and remindedus of how precious good health is and how we must do everything we can to safeguard it. Inthis 25th year of our existence as an organisation it has only reinforced ourresolve to continue working towards the mission of creating healthier communities throughinnovation making therapies accessible and bridging unmet healthcare needs.
The deep expertise and capabilities that we have developed through theyear have enabled us to support the nation and the world in the fight against COVID-19.Our Company has been at the forefront contributing with therapeutics vaccines anddiagnostics.
Our vaccine research team swung into action in February 2020 workingon a vaccine in which the plasmid DNA would be introduced into the host cells. Once thisis done it would be translated into the viral protein and elicit a strong immune responsemediated by the cellular and humoral arms of the human immune system which play a vitalrole in protection from disease as well as viral clearance. After a crucial pre-clinicalstage where the vaccine ZyCoV-D was found to be safe immunogenic and well tolerated wehave received the permission from the Drug Controller General of India (DCGI) and CentralDrugs Standard Control Organisation (CDSCO) to initiate the Adaptive Phase I/II humanclinical trials. We are extremely thankful for the support extended by National BiopharmaMission (BIRAC) Department of Biotechnology Government of India and
regulatory agencies ICMR and DCGI in this journey. With the humandosing underway we hope that our quest to provide a safe and efficacious vaccine toprevent COVID-19 is a fruitful one.
Even as the country wide lockdown was first announced pharmaceuticalmanufacturing was placed under essential services as it was necessary for uninterruptedsupplies of medicines. In these early days when the world at large was in search of acure a team of French researchers produced clinical evidence of hydroxychloroquine (HCQ)proving to be successful in the treatment of COVID-19 and some European and South Koreanhospitals included HCQ as a part of the treatment protocol for the treatment of COVID-19.As one of the largest producers of HCQ in the world we knew that we had to support thecall for this therapy. Our teams swung into action and took the call of ramping up theproduction from 3 metric tonnes to 20 metric tonnes and subsequently scalable to 30 metrictonnes. We ensured supplies to the Government in India and also to the other countries asmandated. With our robust manufacturing infrastructure agile working capabilities and adedicated workforce we were ready to face the challenges and devote all our resources tonavigate through these difficult circumstances.
Tracking every possibility of a cure our team found interestingresearch data in the two non-peer reviewed research articles at bioRxiv and medRxiv theCOVID-19 pre-print servers hosted by Cold Spring Harbor Laboratory. The first one by theUniversity of Texas Medical Branch Galveston showed an evidence of a direct anti-viraleffect of Interferon alpha against novel Coronavirus in vitro. The study demonstratedaround 10000 fold reduction in virus titre in cells that were pre-treated with Interferonalpha 48 hours earlier. The second by a group of universities in China Australia andCanada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed thatthose who received Interferon alpha-2b showed a significant reduction in the duration ofvirus shedding period and even in levels of the inflammatory cytokine IL-6. This suggeststhat if a long-acting molecule like Pegylated Interferon alpha is given early on in theinfection the patient suffering from COVID-19 will have a significant benefit as theviral load is reduced lesser IL-6 is produced and virus eliminating specific immuneresponse is generated. Following up on this we approached the USFDA to open anInvestigational New Drug (IND) filing for Pegylated Interferon alpha-2b and explorepossibility for Compassionate Use Programme and also approached the Department ofBiotechnology Government of India to investigate the role of Pegylated Interferonalpha-2b for COVID-19. Even as the clinical trials get underway in India we have receivedpermissions from COFEPRIS to conduct clinical trials in Mexico. Pegylated Interferon alpha2b is already being manufactured by our Company and we have the capabilities tomanufacture this in a large scale. While grappling to cope with a pandemic testing andsurveillance
are most critical tools. Our Company collaborated with ICMR-NIV Puneto manufacture Covid Kavach Elisa test kits which are the first indigenously manufacturedkits for COVID-19. The test was found to have high sensitivity and specificity and alsohave the advantage of testing 90 samples together in a single run of 2.5 hours. In all30000 test kits were manufactured and supplied to ICMR free of cost.
As we study the disease patterns and more findings come to the forenewer pathways are being explored. To study the Novel mechanism of targetinghypoxia' through HIF-PH inhibitor in COVID-19 for the very first time weapproached COFEPRIS to conduct clinical trials in Mexico. These trials are now underwayand we are conducting a Phase 2b Multicenter Open-label Randomized Comparator -Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for theManagement of COVID-19 patients. Desidustat is currently undergoing Phase III clinicaldevelopment is a novel oral HIF-PH inhibitor for treating Anemia.
A well experienced team to closely assess scenarios and activelymonitor situation on the ground across geographies and our ability to rally around in acrisis and look for solutions helped us make positive contributions in this fight. We havebeen putting all our might to fight the healthcare crisis and will continue to doeverything we can to fight this pandemic.
We are grateful to all the stakeholders - our customers partnerssuppliers vendors who supported us in this fight. Our team of 25000 Zydans who haveworked tirelessly through these months to resolve concerns and ensured that we are able todeliver medicines in India and across the world. I am especially proud of these championsat work who showed steely resolve and courage and defied the odds to continue theircritical work in these times. Their dedication to serve deserves our heartfelt thanks.
I also want to thank all the medical professionals and the medicalfraternity at large for their selfless work in caring for those infected with the virus.Your care has given a new lease of life to many who survived the health scare.
In this financial year that has been dripped with the scare of thepandemic there has also been a silver lining. The search for the elusive cure for NonAlcoholic Steato Hepatitis or NASH an unmet healthcare need globally ended withSaroglitazar becoming the first drug in the world to be approved for this indication. TheDrug Controller General of India granted approval for the drug to be used for thetreatment of NASH ranks as one of the major causes of cirrhosis behind hepatitis C andalcoholic liver disease and is a leading cause of liver transplant.
Bringing more innovation to life and commitment to create healthiercommunities with patient-centric approaches will be our overarching purpose as we movebeyond our silver years to a new decade.
|Pankaj R. Patel |
|July 17 2020 |