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United News of India
12-07-2025
- Business
- United News of India
Wockhardt announces exit from generics drugs Business in US
Mumbai, July 12 (UNI) Pharma company Wockhardt stated in a regulatory filing that it will exit from the US generic drugs market. The move has come after years of sustained losses in the segment, with the company's generics business posting a loss of approximately $8 million in FY25. Wockhardt stated in a regulatory filing on Friday that it has initiated voluntary liquidation proceedings for its two US subsidiaries, namely Morton Grove Pharmaceuticals Inc and Wockhardt USA LLC, under Chapter 7 of the US Bankruptcy Code. Both the companies incorporated in Delaware, United States, are wholly owned by Wockhardt Bio AG. Wockhardt's statement emphasised that the exit from the US generics sector will enhance its ability to deliver sustainable profitability through innovation and scientific leadership. The company reiterated its commitment to pharmaceutical operations in India, the UK, Ireland, and other international markets, where its businesses continue to perform profitably. The decision is part of Wockhardt's broader plan to streamline operations and concentrate on its high-value, innovation-driven product lines. By exiting the US generics market, the company aims to redirect capital and executive focus toward two key growth areas of novel antibiotics and its biologicals portfolio, particularly in insulin-based therapies. Earlier, Wockhardt's founder chairman Habil Khorakiwala had hinted about the move, saying that the company would move away from commoditised generics in the US and concentrate on launching innovative drugs developed in Europe at FDA-approved facilities. This approach aligns with Wockhardt's long-term goal of transforming into a research-led pharmaceutical firm with a global footprint, he had stated. UNI XC BM
Time of India
11-07-2025
- Business
- Time of India
Wockhardt exits US generics biz to focus on drug discovery
Mumbai: Wockhardt will exit its loss-making generics business in the US as part of its strategy to enhance focus on innovation with new antibiotic drug discovery and biologics portfolio in insulin. ET was the first to report on July 1 the Mumbai-based drug maker's shift in strategy to become an innovation-driven company and its plans to exit the US generics segment. At the time, chairman Habil Khorakiwala said Wockhardt does not see itself as a generics company. "In fact, in the US, we are exiting will be focused on the biological area and NCE ( new chemical entities ) and strictly on antibiotics," he told ET. "We have revisited what are the strengths and what are the opportunities-one obviously is our new drug discovery-in India and worldwide," said Khorakiwala. He also stressed on the company's focus on biologics portfolio in insulin and GLP1 as another key growth driver. "As part of this transition, the company has taken the decision to exit the US generic pharmaceutical segment, paving the way for deeper focus and investment in its advanced product portfolio," the company said in a regulatory filing on Friday. Wockhardt's US generics business has been incurring losses for the past several years. In FY25, the generics business incurred a loss of nearly $8 million. Wockhardt has filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its US step down subsidiaries, Morton Grove Pharmaceuticals and Wockhardt USA, incorporated in Delaware and wholly-owned subsidiaries of Wockhardt Bio. The decision, effective July 11, enables clean and structured exit from a legacy segment and unlocks management bandwidth and capital for high-impact areas, according to the company. "Continuing in this segment would detract from its broader innovation agenda," it said. Going forward, Wockhardt will focus its efforts on new antibiotic drug discovery where it has established a leadership position globally, with a strong pipeline of differentiated assets while also bolstering its biologicals portfolio in insulin. "By stepping away from the commoditised generics space, Wockhardt is positioning itself to create long-term value through innovation, scientific excellence, and sustainable profitability. The company remains committed to its pharmaceutical operations in India, the UK, Ireland, and other geographies where its businesses continue to deliver strong performance," the company noted. ET had reported that Wockhardt is working on ambitious plans for its "miracle drug" Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments.
Mint
11-07-2025
- Business
- Mint
Wockhardt exits its US generics business
Wockhardt Ltd is exiting its loss-making US generics business, as it focuses on its new antibiotics drug discovery and insulin portfolios. The drugmaker said on Friday that it has made a Chapter 7 filing for voluntary liquidation of its US subsidiaries Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC. The business has been incurring losses over the past several years, clocking nearly $8 million losses in FY25. In an interview with Mint in April, Wockhardt chairman Habil Khorakiwala had said the company is planning to exit the US generics segment, in a move to 'derisk the organization fundamentally'. The company will continue to run its pharmaceutical operations in India, the UK, Ireland, and other geographies. The US market has become 'very uncertain', Khorakiwala had said in the interview, adding the company's focus would be on developing its antibiotics pipeline for the global market, while its generics pharma business will focus on the rest of its existing markets. Exiting the US generics market 'will improve profits because we are losing money in the US," he said. Wockhardt is increasing focus on its new drug discovery programme, with a pipeline of novel antibiotics for drug resistant bacterial infections, and new biosimilar drugs to treat diabetes. It has a pipeline of six novel antibiotics targeting bacterial drug resistance. Two of these, Emrok and Miqnaf, have already been launched in India. Its third drug candidate, Zaynich, has completed global phase 3 trials with promising results. Wockhardt has filed for approval with the Indian drug regulator, and is expecting approval in the second half of FY26. It plans to file with the US FDA in Q2 FY26, with a potential launch in FY27, it said in an investor meeting in June. Zaynich could potentially change the company's fortunes, with an addressable patient pool of two million. The addressable market potential for Zaynich is $7 billion in the US and Europe, the company said. Wockhardt is also looking at building its insulin business more robustly for India and emerging markets. The company is doubling its capacity in the next three years to tap the growing demand in the space.
Economic Times
01-07-2025
- Business
- Economic Times
Wockhardt activates Zaynich push, eyes global licensing deals
Habil Khorakiwala Mumbai: Wockhardt is working on ambitious plans for Zaynich, a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of '26. In the US, it plans to file for regulatory clearance in August.'We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,' Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for.'We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,' Khorakiwala said. 'One option is licensing out, the other is in some markets like in India we are doing ourselves,' he said. 'The US is another market where we are thinking of the possibility (of marketing on its own); you don't need too much marketing cost and you have talent available.'Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part.'For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,' said Khorakiwala. 'Zaynich — we are manufacturing everything in Europe.' It will adopt the same strategy to outsource most of the manufacturing for all its other new company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. 'That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,' he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. 'We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,' said also stressed on the company's focus on biologics as another key growth driver.'Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,' he does not see itself as a generic company, he said. 'In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,' he chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said.
Time of India
30-06-2025
- Business
- Time of India
Wockhardt activates Zaynich push, eyes global licensing deals
Mumbai: Wockhardt is working on ambitious plans for Zaynich , a combination of zidebactam and cefepime that was found to be effective during clinical trials to fight superbugs or bacterial infections that show resistance to a range of existing antibiotic treatments. The drug maker has hired merchant bankers to identify possible out-licensing deals for the novel product, chairman Habil Khorakiwala told ET in an exclusive interview. Wockhardt in March sought regulatory approval for Zaynich in India and expects its commercial launch in the first half of '26. In the US, it plans to file for regulatory clearance in August.'We will get into the US market by the end of FY26 or latest by the second half of 2026 and Europe will be a year later,' Khorakiwala said. Zaynich is seen as a game-changing drug against drug-resistant gram-negative pathogens. Play Video Pause Skip Backward Skip Forward Unmute Current Time 0:00 / Duration 0:00 Loaded : 0% 0:00 Stream Type LIVE Seek to live, currently behind live LIVE Remaining Time - 0:00 1x Playback Rate Chapters Chapters Descriptions descriptions off , selected Captions captions settings , opens captions settings dialog captions off , selected Audio Track default , selected Picture-in-Picture Fullscreen This is a modal window. Beginning of dialog window. Escape will cancel and close the window. Text Color White Black Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Text Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Opaque Semi-Transparent Transparent Caption Area Background Color Black White Red Green Blue Yellow Magenta Cyan Opacity Transparent Semi-Transparent Opaque Font Size 50% 75% 100% 125% 150% 175% 200% 300% 400% Text Edge Style None Raised Depressed Uniform Drop shadow Font Family Proportional Sans-Serif Monospace Sans-Serif Proportional Serif Monospace Serif Casual Script Small Caps Reset restore all settings to the default values Done Close Modal Dialog End of dialog window. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like 2025년 가장 여유 넘치는 농장 게임. 설치 없음 Taonga: 아일랜드 팜 플레이하기 Undo These pathogens are difficult to kill. Zaynich is estimated to have a market opportunity of about $9 billion. Around a million people die due to multidrug resistance in India every year, while worldwide, the number is 5 million, Khorakiwala said. Currently there are very few effective treatments available for these infections. Mumbai-based Wockhardt completed the Phase-3 clinical trials for Zaynich earlier this year. In January it announced that the drug demonstrated more than 97% clinical efficacy in treating serious infections of bacteria resistant to carbapenem antibiotics, which are often used as a last resort to treat severe infections. Live Events The company is prepared to go solo to market Zaynich in India, the US and other markets if the licensing proposals do not meet its expectations on valuation, Khorakiwala said without revealing the valuation he is looking for. 'We will evaluate how to go about and take an appropriate call, so we are keeping two options fully alive,' Khorakiwala said. 'One option is licensing out, the other is in some markets like in India we are doing ourselves,' he said. 'The US is another market where we are thinking of the possibility (of marketing on its own); you don't need too much marketing cost and you have talent available.' Wockhardt also plans to fully outsource manufacturing for the Western markets to eliminate issues related to the US Food and Drug Administration, and channel its focus on the clinical and research part. 'For manufacturing, plenty of options are available in Europe and the US, so I am not getting into FDA-related manufacturing problems,' said Khorakiwala. 'Zaynich — we are manufacturing everything in Europe.' It will adopt the same strategy to outsource most of the manufacturing for all its other new products. The company had in the past faced some issues with the US FDA over alleged violations of good manufacturing practices. 'That (FDA-elated manufacturing problems) was our weakness, and I am eliminating that completely from my western markets to only focus on the clinical and research part,' he said. COMPANY TURNAROUND Wockhardt has seen a remarkable turnaround in its stock price in the past year and a half with renewed confidence from investors, with developments on Zaynich being among the key drivers. Its stock price more than doubled in the last 12 months and increased over three-and-a-half times since January 2024. The shares closed at `1,713.20, up 4.5%, on BSE Monday. 'We have revisited what are the strengths and what are the opportunities — one obviously is our new drug discovery — in India and worldwide,' said Khorakiwala. He also stressed on the company's focus on biologics as another key growth driver. 'Within biologics we will stay in insulin and GLP1; we are not going to touch the rest of the biologics like monoclonal antibodies and others. Because we feel it is important to be focused,' he said. Wockhardt does not see itself as a generic company, he said. 'In fact, in the US we are exiting generics … we will be focused on the biological area and NCE (new chemical entities) and strictly on antibiotics,' he said. The chairman said his research pipeline has a range of antibiotics under development, including early-stage work on an oral version of Zaynich. PRICING STRATEGY Khorakiwala said the treatment cost with most new products including antimicrobials launched in the last 10 years in the US has been in the range of $10,000-15,000 per treatment. Zaynich will also hover in that range in the US but in India, the price will be significantly lower, he said.
