Novel Ready-to-Administer Chemotherapy Drug Launched by Sun Pharma
Sun Pharma, India’s largest drugmaker, said it has launched a ready-to-administer version of chemotherapy drug gemcitabine in Europe. Gemcitabine is indicated in the treatment of ovarian, lung, breast and pancreatic cancers. In a press release, Sun Pharma said its Gemcitabine InfuSMART has the approval of drug controllers in the Netherlands, the UK, Spain, Germany, Italy and France. InfuSMART is a technology in which oncology products are developed in a ready-to-administer (RTA) bag. Sun Pharma said Gemcitabine InfuSMART is the world’s first licensed RTA product, which was developed by its R&D team in India.
With sales totaling $4.3 billion for FY16, the drugmaker is pushing to build a global business of branded products, and has identified areas where it estimates considerable need gaps exist. Sun Pharma said InfuSMART is expected to play an increasingly important role due to its improved safety, convenience and time-saving benefits. It is part of strategy to build a “meaningful and differentiating presence in the global oncology therapy market”, it said.
Hellen de Kloet, Sun Pharma’s business head of Western Europe and ANZ, said that over time, about 60-80 per cent of the market may have the potential to
switch to the ready-to-administer version of drugs, but added that market size and competitive elements will have a role to play in analysing the exact business opportunity. Kloet said Sun is eyeing a presence in five-six such products over a two-to three-year timeframe.A launch in the US may also be examined, Kloet said. As per industry estimates, the annual requirement of such products in Europe could be 13-15 million units for the top 35 products that are delivered as intravenous fluids. The opportunity for Sun Pharma in Europe will also depend on the local healthcare services. The drugmaker said that while it is open to commercial partnerships, it will begin by selling the product on its own. According to Kloet, in the UK the company may evaluate participating in the tender business, as a large part of the procurement process for cancer drugs happens through that route.
Sun Pharma said it received regulatory approval to manufacture the drug at eight key stock-keeping units. The concept involves ‘dose banding’, whereby through agreement between prescribers and pharmacists, standardised doses of intravenous cytotoxic drugs are used for ranges of doses calculated for individual patients.
While traditionally such medicines are compounded at hospitals or outsourced to compounding pharmacies, taking a longer time to process, Kloet said InfuSMART will provide a differentiating solution.
The UK National Health Service has been encouraging development of licensed RTA products and has issued guidelines for procuring such products. Large drug makers like Mylan, Fresenius, Hospira and Baxter are among the companies that have indicated interest in RTA products. According to Surajit Pal, analyst at Prabhudas Lilladher, the launch of the drug will need a dedicated sales team.
“The success in the EU market will be back-ended, given the company’s miniscule presence, lack of experience in branded drugs and highly institutionalised market,” he wrote in a note. According to WHO data, as many as 14 million new cases of cancer was detected in 2012 while 8.2 million died that year. Cancer cases are expected to rise by about 70 per cent over the next two decades.
