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Wockhardt's 20-Year Journey Pays Off with FDA Approval of Novel Antibiotic Zaynich

After more than two decades of investment in drug discovery, the founder-chairman of Wockhardt, Habil Khorakiwala, has seen a significant milestone achieved with the approval of Zaynich, a novel antibiotic aimed at tackling drug-resistant infections. The US Food and Drug Administration approved the drug on May 29, marking a major breakthrough for the pharmaceutical company.

In global Phase 3 trials, Zaynich showed an impressive 89 percent cure rate, including both improvement in patient symptoms and elimination of the bacteria. This is a significant improvement over the current standard of care, meropenem, which has a cure rate of 68.4 percent.

The journey to approval was not without its challenges, with financial strain and personal conviction playing a crucial role in the development of Zaynich. Khorakiwala has been instrumental in the project, attending internal scientific meetings, global KOL discussions, and reviewing progress regularly. The company also built partnerships with 20-30 companies for specialized work and hired young, talented scientists from top universities to invest in their development.

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DrugCure Rate
Zaynich89%
Meropenem (Current Standard of Care)68.4%

Wockhardt's end-to-end R&D model, which involved developing the drug internally and building a global team of experts, has paid off. The company's decision to focus on a white space in the antibiotic market, where large pharma companies were vacating, has also proven to be a wise move.

The commercialization phase is now underway, with the US launch expected to take around six to eight months and the Indian launch around five to six months. Revenue is expected to start contributing to Wockhardt's bottom line in FY28, with FY29 being the "zoom year" for the company.

The pricing strategy for Zaynich will be competitive, with prices in the US ranging from $10,000 to $15,000 per treatment for a seven to 10 day course. In India, prices will be around 75-80 percent lower, considering affordability.

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The commercial potential of Zaynich is significant, with an opportunity of around $1.5 billion to $2 billion globally per year. Wockhardt is well-positioned to take a share of this market and create a new opportunity for the company.

Khorakiwala's decision to build a research organization in-house, rather than licensing the drug to a global partner, will allow the company to create a business organization that can serve future drugs as well. This move will also enable Wockhardt to retain full value from its investment in Zaynich.

The approval of Zaynich is a significant milestone for Wockhardt and marks a major transformation for the company. With a strong pipeline of future drugs, including WCK 6777, a beta-lactam enhancer, the company is well-positioned for long-term growth and success.

Investor Takeaway

Investors should consider the potential of Wockhardt's Zaynich in tackling drug-resistant infections.

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