Latest news with #Zaynich
Hans India
5 days ago
- Business
- Hans India
Wockhardt eyes $7 bn mkt opp for antibiotic Zaynich
New Delhi: Drugmaker Wockhardt said its novel antibiotic Zaynich has an addressable market opportunity of $7 billion in the US and Europe. The company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May 2025. Filing to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory filing. The company plans for regulatory approval for the product in Europe and emerging markets in the second half of the current financial year, it added. Wockhardt said it has also filed for approval of Zaynich with the Drug Controller General of India (DCGI) and expects to launch the product in the domestic market in the second half of the current fiscal. The antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, the Mumbai-based drug maker said.
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Business Standard
5 days ago
- Business
- Business Standard
Wockhardt eyes $9 bn market opportunity for novel antibiotic Zaynich
Mumbai-based pharmaceutical major Wockhardt, which is set to launch a new class of antibiotic, Zaynich, in India this year, estimates a total addressable market opportunity of $9 billion. This includes a $7-billion market in the US and Europe, and a ₹17,000-crore opportunity in India. The company's stock rose 2.4 per cent on the BSE on Thursday following an investor presentation outlining its growth plans for the next three to five years. Zaynich (or WCK 5222) is a key research candidate in Wockhardt's pipeline. It has completed global Phase 3 clinical trials, demonstrating a 20 per cent higher (statistically superior) composite cure rate compared to Meropenem, the current gold standard in antibiotics. Wockhardt claims Zaynich is the first new class of antibiotic in over 30 years to treat gram-negative infections. The drug has already saved 51 lives under compassionate use, including three in the US, where patients had failed all existing therapies. Zaynich is indicated for complicated urinary tract infections (UTIs), hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infections, and complicated intra-abdominal infections. The company expects approval from the Drugs Controller General of India (DCGI) shortly and plans to launch the drug in the second half of this financial year. Wockhardt has completed a pre-NDA (New Drug Application) meeting with the US Food and Drug Administration (USFDA) in May and plans to file in Q2FY26, targeting a potential launch in FY27. Regulatory filings in the EU and emerging markets are scheduled for the second half of FY26. Wockhardt estimates that around 1.1 million patients in India may benefit from Zaynich, while 371,000 carbapenem-resistant cases in the US and Europe are potential candidates. Overall, there are 4.3 million hospitalised cases involving key gram-negative pathogens in the US and EU. The firm sees a combined addressable patient pool of 2 million across India, the US, Europe, and China. Apart from Zaynich, Wockhardt is also betting on other antibiotics in its portfolio, such as Miqnaf (Nafithromycin), and its biotechnology portfolio, including insulin products. Miqnaf, already launched in India, treats community-acquired bacterial pneumonia (CABP) and upper respiratory tract infections. It has received Qualified Infectious Disease Product (QIDP) status from the USFDA, signifying unmet medical need, and Breakthrough Medicinal Product (BMP) designation in Saudi Arabia. Miqnaf targets a ₹10,800-crore market in India, with over 96 million potential prescriptions. In the biosimilars segment, Wockhardt is focusing on diabetes care and sees significant opportunity arising as Danish major Novo Nordisk phases out human insulin cartridges. This creates a ₹450-crore opportunity in India and a $157-million market across emerging economies. With only three major players in India, including itself, Wockhardt expects to benefit substantially. The company is doubling its diabetes biosimilars capacity over the next three years to meet growing demand, targeting business growth of 20–25 per cent.
Time of India
5 days ago
- Business
- Time of India
Wockhardt eyes USD 7 billion market opportunity for antibiotic Zaynich in US, Europe
Wockhardt's new antibiotic, Zaynich, targeting gram-negative infections, anticipates a significant USD 7 billion market in the US and Europe. Following a successful pre-NDA meeting with the USFDA, the company plans to file for approval this quarter, aiming for a launch in FY27. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Drugmaker Wockhardt on Friday said its novel antibiotic Zaynich has an addressable market opportunity of USD 7 billion in the US and company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory company plans for regulatory approval for the product in Europe and emerging markets in the second half of the current financial year, it said it has also filed for approval of Zaynich with the Drug Controller General of India (DCGI) and expects to launch the product in the domestic market in the second half of the current antibiotic, to be used against gram-negative infections, is expected to help 11 lakh cases in India alone, the Mumbai-based drug maker May, the drug firm reported a narrowing of consolidated net loss at Rs 45 crore in the fourth quarter ended March 31, company had reported a net loss of Rs 177 crore in the January-March quarter of from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago FY25, the company said its net loss stood at Rs 57 crore against Rs 472 crore in the year-ago increased to Rs 3,012 crore from Rs 2,798 crore in the 2023-24 of Wockhardt Ltd on Thursday ended 2.42 per cent higher at Rs 1,528.60 apiece on the BSE.
News18
30-04-2025
- Business
- News18
‘Never Exported To Pakistan': Wockhardt's Khorakiwala Downplays Impact Of Trade Freeze Between Neighbours
Talking about the impact of Donald Trump's tariff terror on Indian pharma companies, Khorakiwala believes that Indian companies need to form new strategies and look for new markets The ongoing freeze in India-Pakistan trade ties is expected to have minimal impact on the Indian pharmaceutical sector as most companies, including most of the country's largest drug-makers, have never exported to Pakistan, Habil Khorakiwala, chairman of Wockhardt, told News18. 'We, in our 50-year history, have never exported drugs to Pakistan, and most Indian companies don't export there as the size of the market is unattractive, and a host of restrictions make the business restrictive," Khorakiwala, founder chairman of the Mumbai-headquartered firm told News18 in an exclusive interview. He was responding to a question on the growing strain on bilateral trade relations between India and Pakistan triggered by the terror attack in Kashmir's Pahalgam. 'Hence, trade snapping may not mean anything to us in pharma." Talking about the impact of US President Donald Trump's tariff terror on Indian pharma companies, Khorakiwala believes that Indian companies need to form new strategies and look for new markets. However, he said, 'Overall, any tariffs on pharmaceutical products would prove counter-productive for American consumers and healthcare providers." Headquartered in Mumbai, Wockhardt Limited is globally making headlines with its novel antibiotic, Zaynich, which has shown extraordinary efficacy against multidrug-resistant gram-negative infections. While on one end, the company is planning to apply for US FDA approval for Zaynich in the next two to three months, on the other end, it has decided to exit the US generic business and focus only on specialty drugs. The company has steered its focus towards 'emerging markets' with its segment of biologics and insulin products in the 'anti-diabetic' or 'anti-obesity, weight loss' product category. BSE-listed Wockhardt Group operates in several fields, including pharmaceuticals, biotechnology, active pharmaceutical ingredients (APIs), and super-specialty hospitals. 'We offer a range of products, including generic drugs, bulk drugs, along with our biologics drug portfolio," he said, adding: 'We have a different plan to diversify. While we have decided to exit the generic business in the US market, we will focus on the emerging markets, leading with our biologics drug portfolio." The company plans to focus on its biologics portfolio, especially consisting of anti-diabetic medicines. 'We will remain in the anti-diabetic space in biologics and focus on it," he said, sharing examples of top pharma companies such as Eli Lilly and Novo Nordisk withdrawing insulin brands Basaglar and Human Mixtard from the Indian market, hence creating opportunities for other players. 'Diabetic products are in focus, along with anti-obesity or weight loss drugs. We will introduce new products, but we have decided to remain in the emerging markets. There is a huge market opportunity, and competition is also limited." The company is known as the first mover in biotechnology in India, and it claims to be the first Asian company and the third in the world to synthesise, manufacture and successfully market recombinant insulin. Effect Of Trump Tariff Responding to the possibility of impact on the Indian pharma due to imposition of tariffs led by Trump, the Wockhardt chairman said, 'There is so much uncertainty and things are changing every day. However, in our industry, it's not easy to switch supplies." He highlighted that India supplies 40 per cent of total prescription drugs to the US and hence, India is not a marginal player. 'We are a very, very significant player, maybe the largest one supplying to the US." Khorakiwala estimates that the majority of the price surge will be borne by the consumer or healthcare providers. 'Partly by the government and partly by the private sector… 90 per cent of the prices of medicines are borne by insurance companies. The entire approach could end up being ineffective for the US." He highlighted that the technical procedures for switching medications are not easy as the USFDA approval process takes several years, maybe up to two to three years. 'Unlike other areas, here you cannot substitute one drug for another. Also, drug shortages have been a major issue in the US, and this move may also lead to some kind of drug shortages." What should Indian companies do now? Industry veteran Khorakiwala, who founded Wockhardt in 1967, advises Indian drug-makers to focus on other markets beyond the US. 'The US is a big advantage for Indian companies as it is a very important market both in terms of size and price points. However, because of this advantage, I think Indian companies are not focused enough on the other possible markets and geographical expansion." Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : bse donald trump Pahalgam attack pakistan US FDA Wockhardt Location : New Delhi, India, India First Published: April 30, 2025, 08:49 IST
