Wockhardt Limited , a global pharmaceutical company, has achieved a significant milestone in the field of antibiotic development. The company's pivotal Phase 3 clinical study on its novel antibiotic, Miqnaf (Nafithromycin), has been published in THE LANCET Regional Health Southeast Asia journal, marking the first publication in a LANCET journal for a novel drug discovered and developed in India.

Breakthrough in Antibiotic Development

Miqnaf represents the first new macrolide antibiotic in over three decades, designed to treat community-acquired bacterial pneumonia (CABP). The drug offers a convenient once-daily, three-day oral treatment regimen, which could potentially improve patient compliance and reduce hospitalization rates.

Robust Clinical Evidence

The Phase 3 study, involving nearly 500 patients, demonstrated Miqnaf's non-inferior efficacy compared to moxifloxacin, a gold-standard CABP drug. Key findings include:

• Clinical improvement observed in over 90% of patients within 3-4 days
• Efficacy against multi-drug resistant CABP
• Potential to address the growing challenge of macrolide resistance, which has reached nearly 75% in India according to the 2023 ICMR report

Global Recognition and Impact

Miqnaf has received Qualified Infectious Disease Product designation from the US FDA, highlighting its potential global impact. The publication in THE LANCET Regional Health Southeast Asia provides a scientifically robust resource for clinicians worldwide, emphasizing Miqnaf's potential to:

• Reduce CABP-related hospitalization burden
• Address antimicrobial resistance (AMR) through a dual mechanism of action
• Enable shorter, more effective treatment courses

Wockhardt's Commitment to Antibiotic Innovation

This achievement underscores Wockhardt's dedication to antibiotic innovation:

• Miqnaf is the third novel antibiotic from Wockhardt's discovery program
• The company has been at the forefront of antibiotic innovation for over 27 years
• Wockhardt's pipeline includes six antibiotics at various stages of clinical development and commercialization, all with QIDP designation from the US FDA

Global Presence and Impact

Wockhardt's global footprint includes:

• Operations in the UK, Ireland, Switzerland, France, Mexico, Russia, and other countries
• A workforce of approximately 2,900 employees across 27 nationalities
• Manufacturing and research facilities in India and the UK, with an additional manufacturing facility in Ireland
• International businesses generating about 77% of the company's global revenues

The publication of Miqnaf's Phase 3 study in THE LANCET Regional Health Southeast Asia not only validates Wockhardt's research efforts but also highlights India's growing contribution to global antimicrobial innovation. As antibiotic resistance continues to pose a significant global health challenge, developments like Miqnaf offer hope in the ongoing fight against multi-drug resistant infections.

Wockhardt , a prominent pharmaceutical and biotechnology company, has made significant strides in its novel antibiotics program while reporting its financial results for the first quarter. The company has also submitted its monitoring agency report for the quarter ended June 30, regarding the utilization of funds from its Qualified Institutions Placement (QIP).

Progress in Novel Antibiotics Program

Wockhardt has successfully completed two pre-New Drug Application (NDA) meetings with the U.S. Food and Drug Administration (FDA) for its novel antibiotic ZAYNICH® (Zidebactam/Cefepime, WCK 5222). The company is targeting to file the NDA dossier in September, marking a crucial step towards bringing this innovative treatment to market.

ZAYNICH® has demonstrated promising results in clinical trials, including:

1. A global, pivotal, registration-enabling Phase III study in hospitalized patients with complicated urinary tract infections (cUTI).
2. A trial in patients with meropenem-resistant infections in India.

The antibiotic has also shown life-saving potential under compassionate use, with successful treatments reported in medical journals for severe pan-drug resistant infections.

Q1 Financial Highlights

For the quarter ended June 30, Wockhardt reported:

The company's financial performance reflects its continued focus on profitability while balancing investments in its innovative portfolio of novel antibiotics and diabetes biosimilars.

Business Segment Performance

Strategic Realignment and US Operations

Wockhardt has decided to exit the US generic pharmaceutical segment. The company has filed for voluntary liquidation under Chapter 7 of the US Bankruptcy Code for its US step-down subsidiaries, Morton Grove Pharmaceuticals Inc. and Wockhardt USA LLC. This strategic move aims to eliminate recurring losses and sharpen focus on innovation-led growth.

As a result of this decision, the company has impaired goodwill of ₹97.00 crore in its books of account as of June 30, which has been disclosed as an exceptional item.

QIP Fund Utilization

Wockhardt Limited submitted its monitoring agency report for the quarter ended June 30, confirming no deviation from stated objectives in utilizing proceeds from its Qualified Institutions Placement of approximately ₹1,000 crore. The report, issued by CRISIL Ratings Limited, shows:

• Total utilization: ₹583.08 crore out of net proceeds of ₹977.79 crore
• Unutilized amount: ₹394.71 crore

Fund allocation and utilization:

1. Debt repayment: ₹500 crore allocated, ₹416.31 crore utilized
2. Capital expenditure and R&D: ₹250 crore allocated, ₹32.77 crore utilized
3. General corporate purposes: ₹227.79 crore allocated, ₹134 crore utilized

Unutilized proceeds of ₹394.71 crore are invested in various mutual funds, earning ₹13.20 crore in returns. The QIP was conducted from November 6-11, with net proceeds revised upward by ₹3.82 crore due to lower actual issue expenses than estimated.

Other Developments

• MIQNAF® (Nafithromycin): Approved and launched in India on May 27, with encouraging initial response from clinicians.
• Intellectual Property: 5 patents filed and 5 patents granted during the quarter, bringing the total to 3,278 filings and 853 granted patents.

Wockhardt continues to progress in its mission to develop innovative pharmaceutical solutions, with a particular focus on addressing the global challenge of antimicrobial resistance through its novel antibiotics program.