Latest news with #Wockhardt
Hans India
20 hours 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
a day 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
a day 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.
Business Standard
29-05-2025
- Business
- Business Standard
Wockhardt reports consolidated net loss of Rs 25.00 crore in the March 2025 quarter
Sales rise 6.14% to Rs 743.00 crore Net Loss of Wockhardt reported to Rs 25.00 crore in the quarter ended March 2025 as against net loss of Rs 169.00 crore during the previous quarter ended March 2024. Sales rose 6.14% to Rs 743.00 crore in the quarter ended March 2025 as against Rs 700.00 crore during the previous quarter ended March 2024. For the full year,net loss reported to Rs 47.00 crore in the year ended March 2025 as against net loss of Rs 463.00 crore during the previous year ended March 2024. Sales rose 7.65% to Rs 3012.00 crore in the year ended March 2025 as against Rs 2798.00 crore during the previous year ended March 2024. Particulars Quarter Ended Year Ended Mar. 2025 Mar. 2024 % Var. Mar. 2025 Mar. 2024 % Var. Sales 743.00700.00 6 3012.002798.00 8 OPM % 8.61-8.43 - 13.053.25 - PBDT 31.00-78.00 LP 201.00-131.00 LP PBT -22.00-136.00 84 -16.00-354.00 95 NP -25.00-169.00 85 -47.00-463.00 90
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Business Standard
29-05-2025
- Business
- Business Standard
Wockhardt Q4 results: Drug maker's net loss shrinks to Rs 45 crore
Drug firm Wockhardt on Thursday reported a consolidated net loss of Rs 45 crore in the fourth quarter ended March 31, 2025. The drug maker had reported a net loss of Rs 177 crore in the January-March quarter of FY24. Revenue from operations rose to Rs 743 crore in the fourth quarter as compared to Rs 700 crore in the year-ago period, Wockhardt said in a regulatory filing. For FY25, the company said its net loss stood at Rs 57 crore as compared to Rs 472 crore in the year-ago period. Revenue increased to Rs 3,012 crore as compared to Rs 2,798 crore in 2023-24 fiscal. Shares of the company closed at Rs 1,347.75 apiece, 0.63 per cent higher from previous close, on the BSE.
