“We have invested about $31 million globally including India to enhance research facilities”

In an exclusive interview, Dr Anil Gulati, Chairman and CEO, Pharmazz Inc. answers our questions on the company’s current operations in India and globally, its R&D initiatives, key disease areas and long-term plans.

Pharmazz has been at the forefront of developing innovative therapies for critical conditions. Could you elaborate on your most recent product developments?

Pharmazz, Inc. is an innovative biopharmaceutical company with an approved product, a promising drug pipeline, and a seasoned management team. It is a Delaware Corporation based in Willowbrook, Illinois, USA, focused on discovering, acquiring, developing, and commercializing therapeutics that target critical care medicine. The company is developing novel first-in-class drug products across multiple critical care indications. Its first product, Centhaquine, is for Hypovolemic Shock, where a new therapeutic was greatly needed. Centhaquine for septic shock is being developed where mortality is very high, and there is an unmet need to save lives. Pharmazz’s second compound, Sovateltide, is for cerebral ischemic stroke, Alzheimer’s disease, Alzheimer’s disease (AD), Hypoxic ischemic encephalopathy, and spinal cord injury. 

How much investment has the company made in the last five years to establish manufacturing or research facilities in India? 

The company has invested about $31 million, of which the majority has been spent in India developing and enhancing research facilities. 

Company’ drug for hypovolemic shock has shown promise in clinical trials. What are the next steps for its regulatory approval and commercialization?

We have made significant strides in the clinical development and global expansion of Centhaquine, a novel therapeutic for hypovolemic shock, after achieving market authorization for Centhaquine in India in May 2020. Our recent partnership with Dr. Reddy’s Laboratories, one of India’s leading pharmaceutical companies, will support the sales and marketing of Centhaquine in India. This collaboration signals the company’s ambition to increase access to life-saving treatment in emerging markets.

The Pharmazz is planning to advance Centhaquine development globally with planned clinical trials in the United States, Europe, Australia, and other countries. The company’s efforts have expanded globally, with approval from the U.S. Food and Drug Administration (FDA) to begin a Phase 3 clinical trial for Centhaquine in hypovolemic shock in September 2021. The approval comes on the heels of the company’s successful development program in India and offers new hope for patients in the U.S. facing this potentially fatal condition. Pharmazz has also received USFDA approval for a phase II clinical trial for centhaquine in patients with acute respiratory distress syndrome (ARDS). A pilot study of centhaquine is approved by the Australian regulatory agency to assess the effect of centhaquine on hemodynamic and cardiovascular parameters in patients with vasodilatory shock. Pharmazz is planning to develop centhaquine to manage Septic shock in the future.  

“The company expects a compound annual growth rate (CAGR) of 56% in the coming years.”

Kindly share the details about your collaborations in India and how these partnerships shaped the company’s journey so far?

Pharmazz has licensed exclusive worldwide rights to several molecules indicated for critically ill patients from Midwestern University, Downers Grove, USA. The company has a strong patent position and a robust pipeline in different stages of clinical development. The company is developing novel first-in-class drug products across multiple critical care indications. Pharmazz has partnered with Sun Pharmaceutical Ltd to Sell and Market Sovateltide in India. Pharmazz’s recent partnership with Dr. Reddy’s Laboratories, one of India’s leading pharmaceutical companies, will support the sales and marketing of Centhaquine in India. 

The regulatory landscape for pharmaceuticals is constantly evolving. How does Pharmazz stay ahead of these changes, particularly in the context of FDA approvals?

Pharmazz has shown a strong commitment to ongoing collaboration with regulatory agencies across multiple regions. For example, its successful progression through the clinical trial phases in India—culminating in market authorization in 2020—was supported by close interaction with India’s Central Drugs Standard Control Organization (CDSCO). Similarly, the company sought and obtained approval from the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of Centhaquine in hypovolemic shock and Sovateltide in Acute cerebral Ischemic Stroke. This proactive engagement ensures that Pharmazz remains aligned with the latest regulatory requirements and standards, enabling smoother approvals for clinical trials and market entry.

The company has demonstrated the ability to quickly adapt to different regulatory environments, particularly as it expands globally. The process of obtaining market approval in India, followed by submitting an Investigational New Drug (IND) application to the FDA, indicates the company’s capacity to meet the distinct regulatory requirements of each region. By tailoring clinical trial designs and regulatory submissions to the specific needs of local agencies, Pharmazz can expedite approval processes while ensuring compliance with regional standards. The company has been able to pivot and modify its development strategy based on changing regulatory guidelines—such as those introduced in response to the pandemic—highlighting its adaptability.

What are the company’s expansion plans within India, aiming to scale up production capacity, extend R&D footprint, and enhance distribution network?

Pharmazz has obtained approval from the US FDA to conduct phase III clinical trials for both sovateltide and centhaquine. The manufacturing activity of centhaquine was already in a US FDA-approved facility in India. Now, the company is working on sovateltide, which will be manufactured in an additional facility in India that is US FDA-approved.

How has the company performed in terms of revenue during FY 2023-24 and expectations from FY 2024-25?

Pharmazz India Private Limited was profitable with earnings per share of Rs. 7.35 in 2023-2024, a jump from earnings per share of Rs. 3.67 in 2022-2023. The company expects a compound annual growth rate (CAGR) of 56% in the coming years.

What are your long-term goals for Pharmazz both in the Indian context and globally? How do you plan to continue driving innovation and growth in the coming years?

The company plans to expand the market size of existing drugs that our partners have launched. The company plans to expand its research activities further by developing new drugs and tapping markets worldwide. In addition, partnerships with major pharmaceutical companies in India.

*This interview was first featured in the January 2025 edition of BioVoice eMagazine.