Indian pharma sees traction in novel biologics

Forty-six-year-old Glenn Saldanha is steering Glenmark Pharmaceuticals towards becoming the second pharmaceutical company in India to launch a novel biological entity in the market. Saldanha, who had decided to pursue innovation rather than sticking to making copy-cat drugs, is yet to taste commercial success. But, he is now betting on its latest innovation — the GBR-830, a novel biologic for atorpic dermatitis, with an estimated market size of $8-9 billion.

Before Glenmark, Bengaluru-based Biocon was the first to develop and introduce two novel biologics in the Indian market. And only recently, Sun Pharmaceutical, too, has forayed into the segment, through a collaboration, but is eyeing the US and European markets for its psoriasis drug. 

Saldanha said, “Today, we have seven novel drugs and three specialty drugs in our research and development pipeline, and the company enjoys a strong position in IP (intellectual property) leadership and global footprint for rapid market penetration.” 
Glenmark’s GBR-830 completed Phase 2a trials recently, and is now looking for an out-licensing opportunity with a global partner. 

Sources indicated the company was looking at working out a partnering deal with a pharma player, who closely understands the auto-immune space, to make sure the timelines are met. The partner is likely to have the rights for the drug in the US, the EU, and Japan markets, and help with the approvals from the regulators in these countries. Typically, a royalty in the range of 10-15 per cent on sales is paid by the partner to the innovator.

Clinching the deal is crucial for Glenmark, as Saldanha himself has indicated the cash from out-licensing GBR-830 would be used for repayment of debt. It had signed seven out-licensing deals earlier. However, none reached the commercialisation stage. 

As for the US business — from which Glenmark draws around 60 per cent of its revenues — the company is having active discussions for out-licensing of four molecules (GBR-830, GSP-301, GBR-1342 and GBR-310) and expects to close at least one deal by end-FY18. 

Innovation-focussed Glenmark spends only 4-5 per cent of its research and development (R&D) budget on generics; the rest is used for speciality- and innovation-led products. Around $50-70 million is estimated to be spent on innovation products, and bulk of this is pumped into research for NBEs. 

So, while its R&D spending has grown from Rs 411.56 crore in FY13 to Rs 1,262.23 crore in FY17, its debt, too, has grown. As on March 31, 2017, Glenmark’s net debt was Rs 3,667 crore, up 118 per cent compared to Rs 1,682 crore in FY13. R&D spending as percentage of annual sales has grown from 8.21 per cent (FY13) to 13.74 per cent (FY17). 

The story of Indian pharma’s tryst with biologics dates almost a decade. Bengaluru-based Biocon had launched India’s first novel monoclonal antibody for head & neck cancer, Nimotuzumab in 2006. The firm, which had started out as an enzymes player, went public in 2004, and introduced India’s first indigenously-developed recombinant human insulin in the same year (using a proprietary fermentation technology). So far, Biocon has launched two novel biologics. 

The second novel molecule commercialised by Biocon is a novel biologic therapy for psoriasis — Itolizumab. It is marketed as Alzumab in India. Currently, Itolizumab is undergoing key clinical studies in Australia for evaluation in multiple indications.
Biocon, on average, invests about 12-15 per cent of its annual revenues in R&D, among the highest in India. Narendra Chirmule, senior vice-president & head R&D, Biocon said, “This covers our R&D efforts for novel biologics, biosimilars, complex generics.”  

Biocon’s next big project is the oral insulin molecule Tregopil — it is expected to usher in a paradigm shift in the way diabetes is treated globally. The company has announced positive clinical data for Insulin Tregopil (following Phase I studies in US) in 2016. 

It has collaborated with JDRF, global organisation supporting type 1 diabetes research, and is working on developing Insulin Tregopil in treating both type 1 and type 2 diabetes.

"We have also filed a Clinical Trial Application with the Indian drug regulator (DCGI) for a Phase 2 and 3 study with Insulin Tregopil in type 2 diabetes," Chirmule said.

In May this year, drug major Sun Pharmaceutical entered into a long term manufacturing agreement with South Korea's Samsung Biologics for a novel biological drug to treat psoriasis - Tildrakizumab. According to the deal valued at $55.5 million, Samsung Biologics, a leading contract manufacturing organisation, will make the drug for Sun. 

Sun Pharma had acquired rights for Tildrakizumab from US drug maker Merck in 2014. Merck was responsible for finishing the Phase 3 clinical trials and submit the biologics license application to the US drug regulator. Sun will look after all other regulatory activities, including pharmacovigilence, post approval studies, manufacturing and commercialisation of the approved product. 

The US Food and Drug Administration (USFDA)  as well the European Medicines Agency have already accepted the applications for Tildrakizumab for review. Sun has already signed a licensing agreement with Almirall SA for development and commercialisation of the molecule for the European market. 

The company is now hoping to launch the drug in the US market by FY19. An e-mail sent to Sun Pharma remained unanswered. 

As such the global biologics market is anticipated to touch $399.5 billion by 2025 (Grand View Research report). Barring the three mentioned here, analysts, however, do not see many Indian players joining the novel biologics play in the medium-term. 

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