Orchid Pharma antibiotic product for treating UTI coming to India: MD

Company says it's returning to profit after takeover by Dhanuka Laboratories under insolvency resolution

Orchid Pharma, which was taken over by Dhanuka Laboratories under insolvency resolution in March 2020, is making a turn-around in revenue and profit as it commercialises a molecule developed in-house, said its senior executive.

Manish Dhanuka, managing director of Chennai-based Orchid Pharma, told Business Standard the new chemical entity (NCE) is known as Enmetazobactam. The molecule is a BLI (Beta-lactamase Inhibitor) used in combination with beta-lactam antibiotic cefepime.

“The drug product which has completed global clinical trials is a combination of Enmetazobactam with Cefepime. This is an injectable product, which is highly effective in treating complicated Urinary Tract Infections (cUTI),” Dhanuka said in an interview.

The global antibiotics market is projected to grow to $60.99 billion by 2030. The market size was estimated to be $38.08 billion, according to Fortune Business Insights. The market is roughly clocking a 2.5-3.5 percent compounded annual growth rate.

India’s market for anti-infectives--medicines to prevent or treat infections--is roughly worth Rs 22,011 crore as of October 2022, according to AWACS data. The market is largely constituted by antibiotics, with anti-virals and anti-fungals forming a part.

“It took us seven years to develop this molecule in an R&D (facility) that was set up with an investment of Rs 100 crore. Enmetazobactam is one of the first invented-in-India anti-infective molecules to have completed phase-3 trials and is in the New Drug Application phase,” Dhanuka said.

The company was debt ridden for some years before Gurgaon-based Dhauka Group stepped in. “Developing a molecule from the Pre-Clinical Stage to completing Phase-3 Trials and then launching the drug commercially worldwide is a lengthy process and requires huge investment. The molecule was out-licensed in 2013 to a European company Allecra Therapeutics, which has been able to complete the development with Ph-3 Clinical Trials in 2020,” Dhauka said.

As per the out-licensing agreement, Orchid Pharma is entitled to a 6 to 8 percent royalty on worldwide sales of the product. Allecra is now further out-licensing this product worldwide.

“They have already out-licensed it to Advanz Pharma in Europe and Shanghai Haini in China. Orchid, which retains the rights for the Indian market, will commercialize the product in India, after conducting necessary trials on the Indian population,” he said.

Enmetazobactam, in combination with cefepime, addresses the need to tackle bacteria developing resistance against antibiotics. According to a recent study published in The Lancet, antibiotic-resistant bacteria killed nearly 1.3 million people worldwide in 2019.

According to a 2022 special report by USA’s Centers for Disease Control and Prevention, resistant hospital-onset infections and deaths both increased at least 15 percent overall during the first year of the pandemic.

Orchid Pharma’s revenues have increased since its takeover by Dhanuka Group. In 2021-22, it achieved a turnover and operating income of Rs 559.56 crore on a consolidated basis, marking a 24 per cent year-on-year jump. Comprehensive loss for FY22 stood at Rs 0.53 crore, compared to a loss of Rs 115.87 crore in the previous year.

In a Nutshell

•  Orchid Pharma has developed a new chemical entity (NCE) known as Enmetazobactam
•  It is used in combination with beta-lactam Antibiotic cefepime 
•  It is an injectable product for complicated Urinary Tract Infections (cUTI)
•  Orchid Pharma out-licensed the molecule to Allecra Therapeutics in 2013
•  Orchid Pharma is entitled to a 6 to 8 % royalty on worldwide sales of this product\
•  Allecra already out-licensed it to Advanz Pharma in Europe and Shanghai Haini in China\
•  Orchid owns India rights; plans to bring it in India
•  Enmetazobactam in combination with cefepime addresses the unmet need in tackling AMR (Antimicrobial Resistance) as lot of bacteria are developing resistance against existing antibiotics