Wockhardt is preparing for what its leadership calls a defining decade in antibiotic innovation, with an ambitious pipeline designed to address the growing challenge of drug-resistant infections. Chairman Dr Habil Khorakiwala has outlined plans to launch 5-6 new antibiotics over the next 4-5 years, with additional candidates in early development stages.

Strategic Focus on Antibiotic Innovation

The pharmaceutical company has adopted what Khorakiwala describes as a "white-space strategy" in anti-infectives, capitalizing on the market opportunity created as global players have retreated from antibiotics due to low commercial returns. This strategic positioning allows Wockhardt to address both medical need and market opportunity in an area where resistance levels are rising sharply.

"We will have every two years, three years, a new drug coming out for the next 10 to 15 years. I have another two or three drugs which we have not even announced, which are in early stages," Khorakiwala stated during a recent industry event in Mumbai.

The company plans to remain exclusively focused on antibiotics for the next 10-20 years, leveraging its existing expertise and market position in this specialized therapeutic area.

Pipeline Overview and Key Candidates

Wockhardt's antibiotic pipeline concentrates heavily on multi-drug resistant (MDR) infections, featuring several novel agents at various development stages:

Additional early-stage candidates include WCK 771 and WCK 2349, all targeting critical unmet needs for severe bacterial infections.

Zaynich Regulatory Progress

The company's lead candidate Zaynich is currently undergoing a 6-8 month Fast Track USFDA review process, with approval expected by mid-2026. Khorakiwala expressed confidence in achieving a positive outcome for this drug designed to combat life-threatening multi-drug resistant infections.

The Fast Track designation reflects the urgent medical need for new treatment options against increasingly resistant bacterial strains, positioning Zaynich as a potentially significant addition to the limited arsenal of effective antibiotics.

Global Commercialization Strategy

Wockhardt is evaluating multiple approaches for global market entry, including building its own commercial infrastructure in key markets such as the United States. The company has appointed a merchant banker and is conducting discussions with potential partners, though leadership maintains they will pursue independent commercialization if partnership valuations don't reflect the scientific value created.

For the US market specifically, Khorakiwala noted that developing a commercial organization for injectable hospital antibiotics would require focused sales teams of 50-100 people targeting tertiary-care, high-end hospitals. He emphasized that building commercial capabilities is "far easier" than developing the underlying research engine.

Strategic National Asset Positioning

Khorakiwala has positioned Wockhardt's antibiotic research as a strategic national asset, suggesting India could become a global leader with appropriate government support through funding and regulatory reforms. The company advocates for streamlining Phase 3 approvals, which currently take nearly two years in India compared to 5-6 months in the US and Europe.

This regulatory efficiency gap represents a significant challenge for Indian pharmaceutical innovation, potentially delaying patient access to critical new treatments and affecting the country's competitive position in global drug development.

Source: https://www.moneycontrol.com/news/business/we-can-launch-a-new-drug-every-2-or-3-years-wockhardt-chairman-khorakiwala-13778531.html

Wockhardt shares gained nearly 4.00% on Wednesday following the company's announcement of filing a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) for its novel antibiotic WCK 5222 on January 5. This regulatory milestone represents a significant development in the pharmaceutical company's drug development pipeline and marks the first New Chemical Entity discovered and developed in India to be submitted for pan-European marketing authorisation.

Stock Performance and Market Response

Shares of Wockhardt are trading 3.20% higher at ₹1,514.00, reflecting positive investor sentiment following the regulatory filing announcement. The stock has gained 15.00% over the past month, demonstrating sustained momentum in the pharmaceutical company's market performance.

Regulatory Submission and Accelerated Assessment

The company filed the marketing application with the EMA, which serves as the regulatory authority for pharmaceutical products across 27 European Union member states and three European Economic Area countries. The EMA has informed Wockhardt that WCK 5222 is eligible for Accelerated Assessment, allowing for an abridged review timeline that reflects the unmet medical need addressed by the product.

Management Commentary and Market Potential

In an interaction with CNBC-TV18, Wockhardt's Habil Khorakiwala indicated that European approval for Zaynich is expected by July and August, with the market size in the continent estimated between $400.00 million to $500.00 million. Khorakiwala also stated that Zaynich's financial impact will begin reflecting in the balance sheet by financial year 2028.

About Zaynich® (WCK 5222)

Zaynich® is a novel, proprietary antibiotic combining Zidebactam and Cefepime to combat multi-drug resistant Gram-negative infections. The drug recently completed a global, pivotal Phase III clinical trial supporting its marketing authorization across international markets. The New Drug Application has been filed and accepted by the US FDA under fast-track review, while applications have also been submitted to Indian regulatory authorities.

Based on comprehensive clinical and regulatory data included in the application, Wockhardt expects WCK 5222 approval for treatment of resistant Gram-negative infections across all countries under EMA jurisdiction. The priority review status underscores the global urgency to make effective treatment options available for patients suffering from life-threatening multi-drug resistant infections.