Here’s how this Indian company’s antibiotic became the first to receive US FDA

Wockhardt’s antibiotic Zaynich has become the first drug discovered and developed entirely in-house by an Indian company to receive US FDA approval. The achievement comes after 25 years of research and an investment of approximately $800 million across six novel antibiotic molecules. Dr Habil Khorakiwala, Founder and Chairman of the Wockhardt Group, spoke to Business Today about what this milestone means for Indian pharma, how Wockhardt plans to bring Zaynich to patients in India and the US, and why the company believes it can build a sustainable business around antibiotic innovation at a time when most large pharmaceutical companies have stepped back from the field. Edited excerpts from the interview:

BT: Why is Zaynich’s FDA approval such a landmark achievement for both Wockhardt and the Indian pharmaceutical industry?

HK: We have been involved in a drug discovery programme for the last 25 years, and finding a new drug is a very complex activity in a highly competitive global environment. We compete not only in the marketplace for our products but also in the research space. From that perspective, Zaynich is the first drug from the Indian pharmaceutical industry to receive US FDA approval after being discovered and developed in-house. It meets all the scientific rigour required to discover a new drug. It is a significant step forward for Indian pharma towards becoming truly innovative. Our industry is known not only for generic and biosimilar products, but ultimately the pinnacle is to discover a new drug. As far as anti-infectives are concerned, India alone loses a very large number of people every year to multidrug resistance, and that number continues to increase. This achievement therefore has enormous value in terms of saving lives and addressing a major unmet medical need in India, the US, and across the world.

BT: Why has it taken so long for an Indian company to discover, develop and secure FDA approval for a novel antibiotic entirely in-house?

HK: Establishing a drug discovery programme takes considerable time. It takes about ten years just to build such a programme across approximately 15 different scientific disciplines, and a further seven to ten years is a normal timeline for any pharmaceutical company to bring a new drug to approval. Zaynich is only the first of the drugs we are discussing. We have six such molecules in total. The US FDA has granted Fast Track and QIDP status to several of them, and over the next three to five years we expect to see many more entering the US market. In India, we have already introduced two of these drugs.

BT: At a time when many global pharmaceutical companies have scaled back antibiotic R&D because of weak economics, what convinced Wockhardt to stay committed to this area?

HK: That was precisely the reason we entered this space. It became clear that large pharmaceutical companies were stepping away from antibiotic research, yet new antibiotics are still urgently needed because bacteria continue to develop resistance. That reality created a significant opportunity for us to focus on antibiotic research. Our scientific team has done a tremendous job in discovering several new molecules, and Zaynich in particular represents an important breakthrough.

BT: How much has Wockhardt invested in developing Zaynich and building its antibiotic innovation platform?

HK: For the antibiotics programme, we have invested approximately $800 million. That may sound substantial on its own, but we have six drugs to show for it. Developing a single drug at a major pharmaceutical company can cost approximately $2.3 billion. Our approach has been one of frugal innovation at a fraction of that cost. Developing six drugs at a large multinational company could cost between $15 billion and $17 billion. We have accomplished it for approximately $800 million.

BT: What gives you the confidence that Zaynich can become a meaningful global product rather than just a niche antibiotic?

HK: Zaynich belongs to a new class of antibiotics, and a new antibiotic class emerges only once in approximately 20 years. It has a very different mechanism of action. Technically, zidebactam’s PBP2-binding mechanism contributes to the strong antibacterial activity of the cefepime-zidebactam combination. It kills bacteria rapidly and comprehensively. We are establishing an organisation in the US and have built a strong team there. One reason is that many pharmaceutical companies have moved away from the antibiotic space, which has enabled us to attract highly experienced talent. There is also strong awareness of Zaynich within the US industry. We have more than 200 scientific publications worldwide relating to our antibiotic programme.

BT: Now that Zaynich has secured approvals in India and the US, how do you plan to commercialise the product? Will Wockhardt market it independently in key markets, or are you evaluating partnerships, licensing arrangements or strategic collaborations?

HK: In India, we would be doing it ourselves. We already have a field force for anti-infectives, so that is where we would operate, and we should be able to have the product in the market within six months. India is a very important market, not only from a need point of view, but from a business point of view as well.

BT: When do you expect Zaynich to become available to patients in India, and how are you approaching pricing and access given the growing burden of antimicrobial resistance in the country?

HK: Around December or January. The price will be discounted by roughly 80%. In the US, a seven to ten-day treatment would vary between $10,000 and $15,000, so India will be priced at an 80% discount to that.

BT: What preparations is Wockhardt making for launches in the US, India and Europe, and what timelines should stakeholders expect? Will your existing manufacturing network be sufficient to meet global demand, or will additional capacity be required?

HK: In the US, we are doing it ourselves. The top management team is already in place, and Zahabiya Khorakiwala, who handles the hospital segment, will take additional responsibility to lead the US team. They are working on the detailed plan to operationalise the activity. We are also partnering with a company for capital-intensive areas, while keeping the intellectual work and leadership in-house, and simplifying the organisation so that routine work is handled by those who can do it better. The product should be available in the US around the first quarter of 2027. For manufacturing, we are supplying the US and European markets through third-party manufacturing in Europe, where there is more than sufficient capacity. The same is true in India, where we manufacture ourselves. There is no capacity constraint in either market.

BT: What is the commercial opportunity for Zaynich in the US market, and what kind of revenue contribution do you expect over the next few years?

HK: Antimicrobial resistance is growing, and Zaynich represents a $1.5 billion to $2 billion opportunity globally, out of a total addressable market of approximately $9 billion. We expect to achieve a market share of around 15% to 20% globally over time, and approximately 40% to 45% of this market is in the United States.

BT: Do you think Zaynich could eventually become a blockbuster product, and what milestones would need to be achieved for that to happen?

HK: Zaynich has the potential to become a very successful product for two reasons. First, there is a clear unmet need. There is no drug equivalent to Zaynich anywhere in the world today, including in the United States. Competing products exist, but they typically address one or two organisms, whereas Zaynich covers the entire Gram-negative space. Second, it will become a larger-value product over time. It may not be used as a first-line treatment initially because older drugs tend to be used first, but given its breadth of coverage, its clinical and commercial value will continue to grow.

BT: Many global pharmaceutical companies have exited antibiotic research because the returns have often failed to justify the investment. What gives you confidence that Wockhardt can create a sustainable business model around antibiotic innovation?

HK: The very reason we entered this space was that we anticipated multinationals would exit after 20 to 25 years, and that is now becoming a reality. The cost advantage we have is significant. Where large companies would invest $15 billion to $20 billion for six drugs, we have done it for around a billion dollars. The molecules they pursue need to generate $1.5 billion to $2 billion in opportunity, which is inadequate for their level of investment and return expectations. For them it is not viable. For us it very much is. We will remain committed to antibiotic research and this is not a one-product story. A number of products are already in the pipeline globally, and our investment in antibiotic research will continue. We see clear white space globally because the large players are no longer active in this space. We are building a comprehensive business organisation over the next two to three years.

BT: Where does India stand in pharmaceutical innovation today, and how do you see the industry evolving over the next ten years?

HK: Around the 1990s, approximately half a dozen Indian companies entered the new drug discovery space. Almost none of them persisted over the years, which reflects just how challenging this path is. It requires sustained long-term investment, and one must recognise that the competition is global. Innovation is a race. If we are developing a new drug, others are also working on new molecules. This achievement can encourage more companies to commit to research and new drug discovery.

BT: After achieving this milestone, what does the future hold for Wockhardt, and what does the pipeline mean for patients in India and around the world?

HK: We are actively transforming ourselves into a more research-based company. The other drugs in our pipeline are expected to reach global markets within the next three to five years, with additional candidates following thereafter. We are also building a major global commercial organisation to support these products. In the antibiotic space, we already have drugs in development that are expected to address many of the major multidrug-resistant organisms over the next five years. Our ongoing research programme is designed to ensure that as new resistance patterns emerge, we will have new drugs ready to counter them. We intend to place India firmly on the global map for new antibiotic discovery and help meet the immense need created by the growing burden of multidrug resistance.