Companies

Wockhardt gets DCGI nod for two novel antibiotic drugs

Rutam Vora Ahmedabad | Updated on January 16, 2020 Published on January 16, 2020

Eyes Rs 100 crore business from the two products over 18-24 months

Drug maker, Wockhardt Limited on Thursday informed that the company has become the first Indian player to receive Drug Controller General of India (DCGI) nod to market two new antibiotics targeting infections from superbug like Methicillin resistant Staphylococcus aureus (MRSA).

The patented drugs, EMROK (IV) and EMROK-O (Oral tablet), will be made available in Indian market during this year, while the company eyes Rs 100 crore business opportunity from the two drugs over the next 18-24 months.

"Our two molecules - one an IV and other an Oral products are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. We will be launching this products in India in next few months. As we are in the new discovery stage and these being new products, but we believe (the two) to become (combined) Rs 100-crore products over the next 18-24 months in Indian market," said Dr. Murtaza Khorakiwala, Managing Director, Wockhardt Ltd during a conference call making an announcement.

Indian antibiotic market is estimated at about Rs 16,000 crore at generic pricing with annual growth of about 7%.

Foreign market

After the India launch, Wockhardt will also look to export the two products to potential emerging markets including China, Latin America, Africa and parts of Europe. "The discussions are on to explore suitable partners to sell these products to outside India...At some emerging markets we can use the same data as we have in India. So these markets can be available to us within a year-and-a-half. Other markets, where additional clinical developments and trials will be required, may take 2.5-3 years," added Dr Khorakiwala.

Apart from India, UK, US, Europe and Emerging markets are seen as important pillars for the company's growth.

The studies have revealed that superbugs like MRSA are a leading cause of rising antimicrobial resistance (AMR). India carries one of the largest burdens of drug-resistant pathogens worldwide. Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India due to AMR by the year 2050.

Existing anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, which limits the use for a longer period and compromise the safety of critically ill patients in the ICU.

Dr Mahesh Patel, Chief Scientific Officer, Wockhardt said, "The new drugs are setting a new benchmark in patient safety. Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs."

Future plans

After the latest launch of these two products, there are three more in the pipeline. "We will initiate the development of the third molecule soon. The clinical work for Indian market will be done sometime in the following year. The other two molecules are lifesaving Gram Negative antibiotic to be used in hospital section. That we are taking up for global clinical development this year," added Dr Khorakiwala.

Published on January 16, 2020
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