Mumbai-based drugmaker Wockhardt has received the final approval from the country’s drug regulatory authority to market its novel antibiotic, Nafithromycin, in India. The country’s first indigenous Macrolide antibiotic, branded as Miqnaf, is touted to be “10 times” more effective than the existing treatments such as the popular azithromycin and the drug will hit the market in the next few months.
Dr Habil Khorakiwala, chairman, Wockhardt, told News18 exclusively that the company received the final approvals from the drug controller general of India (DCGI) for the marketing of the drug in India on Wednesday, January 1.
On being asked about the pricing of the medicine, Khorakiwala said it was still under discussion; however, it is not going to be in the same range as the existing antibiotics. “Nafithromycin is a complex and a whole new molecule… Its manufacturing cost is several times more than the existing options and hence, it will be priced differently.”
Wockhardt is basking in the spotlight globally for the development of two groundbreaking molecules – Nafithromycin and Zaynich.
While Nafithromycin (Miqnaf) is used in the treatment of community-acquired bacterial pneumonia (CABP) where current antibiotics have become resistant, Zaynich is effective against all major superbugs that have become resistant to almost all antibiotics used today. These two drugs are labelled as potential breakthroughs in antibiotic research, making it more special for India.
“We have invested around $500 million (Rs 4,250 crore) in the drug discovery programme, including the development of Zaynich and Miqnaf, over the years. While Miqnaf has taken an investment of around Rs 500 crore, much more has been invested in Zaynich.”
Also, Nafithromycin has received support from the Biotechnology Industry Research Assistance Council (BIRAC) under the Department of Biotechnology (DBT), using government funding of Rs 8 crore.
WOCKHARDT’S DRUG DISCOVERY JOURNEY
The journey of developing novel antibiotics started more than two decades ago, said Khorakiwala, who founded Wockhardt in 1967.
Wockhardt claims to be the only company in the world which has got the QIDP Status (Qualified Infectious Disease Product) from American drug regulator US FDA for six of its anti-bacterial discovery programmes. The company is known for its comprehensive drug discovery team and clinical organisation.
“Our antibiotic research programme started around 25 years ago,” he said, detailing how he created an organisation with 15 different disciplines focused on research and development.
“There are two primary reasons we focussed on antibiotic research,” he said, adding, “First is the large usage of antibiotics in India with a 10 to 12 per cent market size. Another is that we saw big pharma and multinationals exiting this field. We believe that new antibiotics will be required due to the emerging threat of antimicrobial resistance. More than 50 lakh people die every year due to the resistance.”
To bolster its internal drug discovery mechanism, the company has collaborated with almost 30 international organisations to discuss and present the ongoing work for suggestions and better ideation. “American and European universities, international laboratories or panels of experts – we have become part of several networks of experts. We also established an advisory board of key opinion leaders in various fields and conducted half a dozen meetings lasting about three days where our scientists share their work and get the perspectives or opinions of the experts,” he said.
Khorakiwala explained why it was important to ensure that the product is innovative enough to reap commercial benefits. “You have to keep track of all other new drugs that are being developed worldwide and where your drug stands. Unless it is a very innovative drug, you can’t get a patent and this is essential for investment or to get commercial value… Hence, you first need to be sure that what you are doing is innovative.”
MIQNAF & ZAYNICH ARE SET FOR INDIA LAUNCH IN 2025
For Nafithromycin (Miqnaf), the drug has completed phase-3 clinical trials last April, following earlier phase-1 and phase-2 trials conducted in the US and Europe.
This drug will be used in the treatment of community-acquired bacterial pneumonia (CABP) where the mortality is generally due to resistance against the prevailing antibiotics. The government data shows that India faces 1.8 crore pneumonia cases annually, highlighting a major unmet medical need.
The drug is ready to be rolled out in India in the next few months. “The drug will be available on the prescription of registered medical practitioners in pharmacy outlets across India.” Wockhardt expects that the domestic market for Nafithromycin may reach around Rs 400-500 crore in the next five years.
The second drug, Zaynich, works against gram-negative infections, which are prevalent only in hospital settings. The drug is not used in community settings or hospital wards. It is used where existing drugs become non-usable, mostly for critically ill patients in intensive care units (ICUs).
The company has given Zaynich to 45 patients on a compassionate basis so far and the company claims that all 45 lives were saved. “Two were American nationals and the rest were Indians and each of the patients was cured,” Khorakiwala said. “The drug has shown to work efficiently in treating highly immunocompromised people such as those suffering from cancer or organ transplant patients.”
Globally, Zaynich is undergoing phase-III clinical trials in countries, including the US, China, Europe and India. Wockhardt expects no major global competition for this drug for more than a decade as no similar drugs are currently in development.
“We are expecting the results from the clinical trials in the next six weeks, and we expect to apply for its India launch by the middle of 2025.”
HOW CAN INDIA IMPROVE ITS RATE OF DRUG DISCOVERY?
“By accelerating the regulatory approval procedures,” said Khorakiwala. He compared India to global regulators on several parameters which showed India’s was a time-consuming market.
“The regulatory mechanism is not fully appreciative of the complexities of research, and they take an enormous time at every stage of clearance. If I have to conduct phase-I clinical trials in some Western countries, the hospital’s ethics committees give the clearances, whereas in some others the approval for starting the trial comes within 30 days. Here in India, the approvals could take anywhere between three to six months, and we must understand that in research programmes, time is very crucial. India needs to create a framework similar to the US FDA where it has created a fast-track approval process.”
The US FDA, he explained, evaluates the drug scientifically and then helps create a pathway for quicker trial because of the urgency of the drug and unmet needs. In place of the standard approval time of 12 to 15 months, they take only six months. “This is how regulatory handholding can encourage research.”
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