Pharma major Lupin said it is in the process of setting up two new R&D centres in the US, focusing on research in inhalation and on complex formulations.
“In keeping with our global strategy of building a highly differentiated generic and speciality business, the company is in the process to setting up two dedicated Centres of Excellence for research in inhalation and complex injectables in Florida and Maryland in the US,” Lupin chairman Desh Bandhu Gupta said in its annual report.
The company had also increased research and development spending to Rs 958.28 crore in FY’14 as compared to Rs 770.85 crore in the FY’13.
“Lupin continues to invest heavily in its R&D programmes and in FY 2014, the company invested 8.6 per cent of its net sales in R&D and related spends, amounting to Rs 958.30 crore,” Gupta said.
It had invested 8.1 per cent of its net sales in R&D and related spends amounting to Rs 770.85 crore in FY’13.
Research is the backbone of our performance. In addition to a robust internal generics research programme, 2013-14 marked significant enhancement of our research capabilities, Lupin Managing Director Nilesh Gupta said.
“We are attracting some of the best talent from the industry. We continue to hit milestones in our novel Drug Discovery & Development program and our joint venture with Yoshindo Inc. gives us a clear line of sight now to commercialise biosimilars for Japan. All of these investments would emerge as significant growth-drivers for the future,” Gupta said.
The company said that in 2013-14, it had stepped up its filings made by the process and formulations research group.
FY 2014 also marked making progress in its Novel Drug Discovery and Development (NDDD) and Biotechnology research programmes.
Gupta said: “Our generics research programmes continue to fuel the company’s growth into higher orbits of leadership in advanced as well as emerging markets.
“Our Advanced Drug Delivery Systems (ADDS) programmes continue to focus on creating and leveraging technologies which are helping build a differentiated pipeline of branded products and out-licensing opportunities. The Biotechnology group has been steering its efforts towards the development of affordable, high quality biosimilars for emerging and advanced markets like Japan.”
Commenting on benefits derived as a result of the R&D, he said that FY 14 was a productive year for the pharma research group as efforts bore fruits in the form of 45 approvals in key advanced markets including 22 and one Supplemental NDA in the US, 10 in EU, 6 in Australia, 5 in Canada and 2 in Japan.
“The company also filed 19 ANDAs (of which, 4 are potentially first-to-file) with the US FDA, 4 MAAs with European regulatory authorities, 4 MAAs in Australia and 2 ANDS in Canada. The cumulative ANDA filings with the USFDA stood at 192 with 99 approvals. The company has 30 confirmed first-to-files including 15 exclusive ones,” he said.
The company’s ADDS programme received further project milestone payments aggregating USD 8.8 million for two products that are currently under joint development with Medicis Pharmaceutical Corporation, US.
Gupta said the company has identified future areas of growth and will prudently invest to move up the technology curve and tap new markets and global opportunities.
“FY 2014 saw the company acquire Nanomi BV in the Netherlands for its patented technology platforms that it plans to leverage to develop complex injectable products,” he added.
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