Armed with clinical trial data, Indian stent makers prepare to challenge MNC domination

India-made cardiac stents which were often dismissed globally including by a section of our own doctors as inferior and not proven for safety and efficacy are finally breaking that mould.

India’s largest domestic stent maker SMT in September published the outcome of clinical trials conducted in Europe that established the company’s flagship drug-eluting stent (DES) Supraflex on par or 'non-inferior' to Abbott’s blockbuster stent Xience on safety and efficacy at 12 months.

Another Indian stent maker Translumina Therapeutics went a step ahead and published 10 years clinical data that found no significant differences between its stent Yukon Choice PC and Xience.

The research findings of a randomised control trial called ISAR-TEST 4 were presented early this month at the prestigious 2018 American Heart Association Scientific Sessions at Chicago, in the presence of leading cardiologists from all over the world.

“This is for the first time that a decade-long research data has been presented for the efficacy and safety of DES since its launch in 2001, as no other research has published data of more than 5 years,” said Gurmit Singh Chugh, Managing Director of Translumina.

A cardiac stent is a device used to unblock clogged arteries. DES are coated with medicines that help lower recurrence of an artery narrowing after corrective surgery. While SMT’s Supraflex is coated with immune suppressant drug called Sirolimus, Abbott’s Xience uses Everolimus.

Yukon Choice PC stents are manufactured at the Dehradun facility of Translumina Therapeutics, which holds around 15 percent share of the Rs 1,500 crore stents market in India.

Armed with positive clinical trial data, Translumina believes it has a fair chance to take on MNCs in their backyard and will also help it to gain market share in India.

Chugh said the company is in the process of partnering with a large US company by end of this year to do clinical trials and commercialise the Yukon Choice stent in that country. The company is also considering to aggressively participate in tender markets in Europe. Chugh said he is in the process of raising funds from PE investors for expansion.

Both the US and Europe are lucrative markets with annual stent consumption of one million each.

“We are very price competitive, but lack of clinical data used to be a hurdle to win contracts. Now with the data in hand, we have a higher probability to bag tenders,” said Ganesh Sabat, CEO of SMT.

NPPA boost

SMT was a major beneficiary of the Indian drug price regulator's - National Pharmaceutical Pricing Authority (NPPA) - effort to rein in distorted trade margin of cardiac stents through price controls.

NPPA in February last year has imposed pricing caps to lower prices of stents by as much as 85 percent to check unethical profiteering and exploitive pricing and to ensure fair, reasonable and affordable price for coronary stents.

The most commonly used DES stent is now capped at Rs 28,000 per unit, excluding taxes, from up to Rs 150,000 earlier.

NPPA found out that the trade margin enjoyed by distributors for sale to hospitals ranged between 13 percent and 196 percent, while the margin earned by hospitals was as high as 11 percent and 650 percent. It also imposed an 8 percent trade margin cap that would cover margins across the trade channels working from the level of manufacturers to the end user, even covering hospital-handling charges.

While the NPPA decision caused heartburn to medical device makers and private hospitals and shrunk the overall size of the pie, that policy intervention has helped SMT emerge as the second largest stent maker in the country with a market share of 22 percent, trailing narrowly behind market leader Abbott which has a 25 percent share.