MY DEAR SHAREOWNERS
The term ‘Discovery' encapsulates the essence of
Wockhardt's Research & Development (R&D) achievements and their impact on
society. Like Baruch S. Blumberg, Nobel Laureate in Physiology and Medicine for his
discovery of the Hepatitis B virus, said, "Discovery consists of seeing what
everybody has seen and thinking what nobody has thought." ‘Life Wins'
signifies the ultimate outcome of these discoveries. Every achievement in R&D brings
with it the promise of alleviating suffering, extending lifespans, and bringing hope to
millions of people worldwide. And I must tell you, we are now on the cusp of one of the
most exciting and promising phases of Wockhardt's journey.
THE PAINSTAKING PROCESS OF DISCOVERY
Let me begin by elaborating on the incredibly long and arduous process
that is involved in new drug discovery. It is a complex and multifaceted process that
involves various stages, from initial research to clinical trials and regulatory approval.
Like American biochemist and Nobel Laureate in Chemistry, Paul L. Modrich says, "The
process of drug discovery is a testament to human ingenuity, patience, and
perseverance."
The interdisciplinary expertise and knowledge resources required
include a wide range of scientific disciplines, such as medicinal chemistry, microbiology,
pharmacology, pharmacokinetics, animal toxicology, regulatory affairs, etc., to launch a
new drug from concept to market.
The entire process begins with, sequentially, Basic Research and Target
Identification, Drug Design and Development, Preclinical Studies, Investigational New Drug
(IND) Application, Clinical Trials, Regulatory Review, Post-Marketing Surveillance, and
Manufacturing and Distribution.
I must point out here that regulatory review is one of the most
critical and complex steps involved, especially when it comes to novel antimicrobial
drugs. They need huge amounts of validated data to establish their safety and efficacy as
well as ensure that the New Chemical Entities (NCEs) under development are effective
against existing and resistant bacterial infections.
While it takes a lot of investment, time, effort, and people at our
end, we also have to collaborate, coordinate, and consult with a host of experts,
professionals, companies, organisations and government departments globally before we can
go to market with a new drug. They include Regulatory Agencies, Clinical Research
Organisations (CROs), Academic and Research Institutions, International Health
Organisations, Government Health Departments, Healthcare Providers and Hospitals, etc. At
Wockhardt, we have networked and collaborated with more than 15 such organisations in our
journey of new antibiotic drug discovery.
THE JOURNEY OF WOCKHARDT'S DISCOVERY PROGRAMME
As you well know, our R&D focus on discovering novel antibiotics
began over 25 years ago when we recognised that new research in antibiotics was rapidly
declining. Understanding the danger, and recognising the opportunity, we have consistently
invested in people, processes, and technology to research our quest for novel antibiotics
to face the clear and present danger, globally, of Antimicrobial Resistance (AMR).
Interestingly enough, Scottish physician and microbiologist, Sir
Alexander Fleming, discoverer of Penicillin, the world's first antibiotic, was quoted
thus, "The time may come when penicillin can be bought by anyone in the shops. Then
there is the danger that the ignorant man may easily underdose himself and by exposing his
microbes to non-lethal quantities of the drug, make them resistant." Decades later in
2016, renowned British economist Jim O'Neill, former chairman of Goldman Sachs Asset
Management and erstwhile Conservative government minister, chaired a report,
‘The Review on Antimicrobial Resistance' that cited an
average of 700,000 deaths attributable to AMR every year and estimated that by 2050, 10
million lives every year would be at risk due to the rise of drug-resistant infections.
Within this context, our conviction to research new antibiotics, the
consistent R&D spends, and the spectacular achievements since, have vindicated and
validated our dedication and focus. Today, we have six New Chemical Entities (NCEs) with
Qualified Infectious Disease Product (QIDP) status from US FDA. You may be surprised to
know that some of the NCEs that we are developing are being discovered after nearly 30 to
40 years in their respective classes and categories. Our first multi-spectrum anti-MRSA
antibiotics launched in India, EMROK and EMROK O, have been well-received and has found
traction in the medical fraternity helping successfully treat numerous patients.
We have completed Phase 3 clinical trial for WCK 4873-Nafithromycin,
filed for trademark in India as MIQNAF, and are awaiting approval from the Drug Controller
General of India (DCGI). We expect to launch and market it in the current financial year.
I am absolutely delighted to share with you the promising developments
of our super drug WCK 5222, filed for trademark in India as ZAYNICH. Designed to address
all the major Super Bugs including Pseudomonas, Klebsiella, E. coli and Acinetobacter,
ZAYNICH is undergoing Global Phase 3 clinical trials which will be concluded during the
financial year 2024-25. I find it very gratifying to inform you that while still under
development, ZAYNICH, with due permission from the DCGI, was administered on compassionate
grounds to 30 patients including 2 paediatric patients who failed to respond to any and
all other antibiotics available globally. I am happy to report that it was a 100% clinical
and microbiological success, saving the lives of all the recipients. Three of these cases
were published in international journals across the USA (Antimicrobial Agents and
Chemotherapy, American Society for Microbiology); the UK (Annals of Clinical Microbiology
and Antimicrobials, Biomed Central); and the EU (European Journal of Clinical Microbiology
& Infectious Diseases). Additionally, one of the cases was also presented in the
prestigious Annual Conference of Clinical Infectious Disease Society, Chennai, India
(CIDSCON). Further, patents for ZAYNICH have been secured in key global markets with
strong IP protection, and a meropenem-resistant clinical study is set for first patient
recruitment for an early launch in India. We expect global approval for ZAYNICH by the end
of 2025 or in early 2026. Of course, we also continue to bolster our R&D efforts in
Biologicals where we enjoy a competitive edge, especially our strong and pathbreaking
presence in the diabetes segment. Our robust and focused pipeline of recombinant
therapeutic proteins for insulin-resistant and higher BMI diabetic needs include
recombinant Human Insulin, Insulin Glargine, and other Biosimilars like recombinant
Insulin analogues (Insulin Aspart, Insulin Lispro), GLP-1 agonists, etc.
Today, our R&D investments have yielded rich returns strengthening
Wockhardt's Intellectual Property (IP) base. In FY 2023-24 we filed 24 patents and
were granted 30 patents, taking our cumulative patents filed to 3,263 and patents won to
840.
FUNDING WOCKHARDT'S DISCOVERY PROGRAMME
We have consistently dedicated resources towards our R&D efforts
with industry-leading investments as a percentage of total revenues on a year-on-year
basis. You may be interested to know that, since inception, we have invested approximately
USD 500 million on our new drug discovery programme. Further, I am happy to report the
successful raising of funds through the Qualified Institutional Placement route. Marquee
investors like institutional giants, ICICI Prudential, Tata India Opportunities Fund,
HDFC, and many other investors have participated in our offering. While a part of these
funds will be used to pare our domestic debt, a significant part will be utilised to
further develop our wonder drug ZAYNICH (WCK 5222) for global approval and launch. This
underlines the fact that the investor community has recognised our R&D efforts, and
their positive sentiment is reflected in our share performance on the bourse.
I will conclude with a quote from Jonas Salk, developer of the Polio
Vaccine, who said, "The reward for work well done is the opportunity to do
more." Our every success only serves to encourage us to seek and explore further. We
are dedicated, committed, and focussed to do much, much, more.
Dr. Habil Khorakiwala
Founder Chairman