The Indian pharmaceutical industry has made giant strides in the highly regulated markets with investments in R&D activities. The R&D activities have helped them to secure more approvals from regulatory bodies in the US and Europe. Further, focus on R&D investment has assisted them to launch new affordable products and compete with international majors. Availability of talent pool, infrastructure facilities and government assistance have helped in fighting stiff competition. Globally, Indian companies were able to capture handsome market share in niche therapies.
During the year 2016, Indian companies secured approvals for 201 Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (US FDA) out of total approvals of 598 ANDAs and this worked out to 34 per cent of total final approvals during 2016 US FDA.
During the last decade, out of total 4,666 ANDAs approved by US FDA, Indian companies received final approval for 1,524 ANDAs from US FDA which worked out to almost 33 per cent. The R&D expenditure of leading 25 Indian pharma companies increased by 24 per cent to Rs 11,710 crore during 2015-16 from Rs 9,439 crore in the previous year and these companies established strong presence in highly regulated markets and the same trend is likely to continue in 2016-17.
Indian companies secured 33.6 per cent of total ANDAs approved by US FDA during 2016. In absolute terms Indian companies grabbed 201 final approval from US FDA during January-December 2016 out of total 598 ANDAs approved by US FDA and 79 tentative approvals out of 133 tentative approvals, which accounts for 59.4 per cent. Aurobindo, Glenmark Pharma and Sun Pharma remained as top three companies with higher ANDA approvals.
Aurobindo received highest number of approvals for 58 ANDAs during 2016 followed by Glenmark Pharma 18 ANDAs and Sun Pharma and Taro Pharma also secured 18 ANDA approvals, of which Sun Pharma received 10 ANDA approvals. Lupin grabbed 11 ANDAs. The R&D expenditure of Aurobindo Pharma went up by 23 per cent to Rs 443 crore during 2015-16 from Rs 360 crore in the previous year. Glenmark's R&D spend went up by over 36 per cent to Rs 818 crore from Rs 601 crore and that of Lupin went up by 55 per cent to Rs 1,732 crore. Sun Pharma's R&D expenditure moved up by 17.8 per cent to Rs 2,303 crore from Rs 1955 crore in the previous year. The R&D investment of these companies also increased in the first half of 2016-17.
Aurobindo Pharma grabs highest number of ANDA approvals
Aurobindo Pharma, the fourth largest pharma major in India with net sales of Rs 13,650 crore plus, grabbed the highest number of ANDA approvals from US FDA during 2016. The company received 54 final ANDA approvals and 19 tentative approvals from US FDA during January-November 2016. Its cumulative ANDA approvals as at the end of September 2016 reached at 284, including 41 tentative approvals. The company remained on top with highest number of approvals.
During the first half ended September 2016, Aurobindo filed 14 ANDAs with US FDA including nine in oral and five in injectable segment. So far, it had filed over 1,100 ARV dossiers for registration across the globe. Its new initiatives include gaining entry into complex R&D in new businesses and differentiated technology platforms such as oncology, hormones, enzymes, peptides, depot injections, inhalers, nasal and dermatology products. It is manufacturing peptides from short to long chain molecules supporting mg to kg scale.
In the oncology and hormones segment, Aurobindo's current product portfolio includes eight hormonal products and 54 oncology products. It exhibit batches for 13 oncology products & seven hormonal products are scheduled in current year. The company has setup a new R&D centre dedicated for generic research in he field of oncology and hormones at Hyderabad to develop anticancer drugs and hormonal products. The company has selected over 50 oncology products in its portfolio Further, it has set up a new block to manufacture oncology API for future requirement.
The company is also engaged in developing enzymes and vaccines. It develops biocatalysts with application in the pharma and chemical industry. It supplies AuroZymes Enzyme screening panels and supports any scale of manufacturing. The company has set a joint venture to develop pneumococal conjugate vaccine and planning to achieve commercial launch of branded conjugate vaccines products in 2018.
The company is investing in dermatology and inhaler products at its new facility at Raleigh, NC, USA. Researach and development work has started on 18 products.
It has established strong presence in international market with 88 per cent of sales in the global market spanning across more than 150 countries. The company has set up 24 API and formulation manufacturing units with 3 in US and 1 in Brazil. Currently, it employed over 16,000 persons.
Sun Pharma : Quality problems hit growth
Sun Pharma, a Rs 27,700 crore plus leading Indian pharma entity, has spent 7 per cent of its sales on R&D during the first half ended September 2016 to Rs 1,101 crore. This R&D expenditure includes investments on account of funding the clinical development of its specialty pipeline.
The company has a comprehensive product offering in the US market consisting of approved ANDAs for 423 products while filings for 11 ANDAs await US FDA approval, including 13 tentative approvals. The pipeline includes 37 approved NDAs while 4 NDAs await US FDA approval as at the end of first half ended September 2016. Its cumulative filings reached at 572 ANDAs at the end of March 2016 and it submitted total 1,013 patent applications. Further, it filed cumulative applications for 422 DMF/CEP.
The company is investing in R&D to build a strong and differentiated product pipeline. These R&D efforts include a pragmatic mix of initiatives directed towards generating short-term, medium-term and long-term cash flows. Besides present activities, it is targeting dermatology and ophthalmic areas. It invested heavily during 2015-16 in the development of Tildrakizumab, which it had in-licensed from Merck in 2014. It is taking steps towards filing the Biologics License Application for this product with the US FDA. Its R&D activities are carried out by over 2,000 research scientists.
Though the company is passing through difficult phase on account of US FDA warning letters regarding cGMP, the merger of Ranbaxy during 2014-15 may likely to benefit from substantial synergies that lie in its technologies, combined pipeline and R&D expertise, wider product portfolio and rationalisation of manufacturing footprint in new near future. In December 2016, The USFDA issued Form-483, citing 9 inspectional observations regarding its Halol facility in Gujarat
Sun Pharma entered into a tripartite research and option agreement with Israel-based Weizmann Institute of Science and Spain's Health Research Institute of Santiago de Compostela during 2015-16. This will help to develop breakthrough products for the treatment of neurological diseases like brain stroke; as well as glioblastoma, a lethal brain cancer.
Currently it has 49 manufacturing facilities across six continents and engaged in manufacturing generics, branded generics, specialty products, over-the-counter products and anti-retroviral (ARVs) and APIs.
Glenmark develops pipeline of molecules
Glenmark Pharmaceuticals, a research-driven, global company with net sales of Rs 7,500 crore plus, has set up six R&D centers along with 17 manufacturing facilities in four countries. It received approvals for 11 products from US FDA during the first six months ended September 2016 and now it is planning to file seven ANDA applications with the US FDA. It received approval for 24 ANDas, comprised of 19 final approvals and five tentative approvals upto the end of March 2016. Currently, it is marketing 110 generic products in the US market. It has 61 applications pending in various stages of the approval process with the US FDA. Its R&D team is consisting of over 800 members across six R&D facilities and focusing on dermatology, respiratory and oncology.
The company launched over ten new products in Europe during the first six months ended September 2016 through a mix of in-licensing and in house development. Its German subsidiary launched three new products; the UK subsidiary launched three products and the other European subsidiaries launched another six products cumulatively. The company in pipeline has eight molecules – two NCEs and six NBEs molecules in clinical trials or ready to enter clinical trials soon.
Its domestic sales during the first half increased by 11.9 per cent to Rs 1,210 crore from Rs 1,081 crore in the corresponding period of last year. Its US sales also increased by 26.7 per cent to Rs 1,469 crore and that in ROW moved up by 21.7 per cent to Rs 448.75 crore. Its European sales increased by 5.4 per cent to Rs 284.65 crore from Rs 270.20 crore. However, sales in Latin America declined by 24.7 per cent to Rs 289.41 crore from Rs 384.15 crore. Its API sales grew by 39 per cent to Rs 417.63 crore from Rs 300.44 crore in the first half of last year.
Glenmark has successfully out-licensed seven molecules upto March 2016 to five companies and have received a total of US4 217 million in up-front and milestone payments.
Glenmark Pharmaceuticals Inc., USA has launched ezetimibe, the first and only generic version of ZETIA (Merck) in the United States for the treatment of high cholesterol during December 2016. The availability of ezetimibe is the result of a licensing partnership with Par Pharmaceutical, an Endo International plc operating company, with whom Glenmark will share profits. Glenmark and its partner, Endo will be entitled to 180 days of generic drug exclusivity for ezetimibe.
Ezetimibe is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hyperlipidemia.
Glenmark Pharma has chalked out its plans to overcome challenges in global markets. The company has announced its “Strategic Blueprint to Transition into an innovation-led Global Pharmaceutical Organization over the next decade.” The revenue is likely to move up by 15 to 20 per cent every year upto 2025 and profit margins will maintain growth of over 25 per cent as focus will be on US operations. With the help of advance NME pipeline it will continue to look for partnering opportunities.
As against the present R&D investment of nine per cent of sales, it is planning to increase it over 11 per cent of its net sales to focus on three key therapeutic areas viz., oncology, respiratory and dermatology.
Lupin: Acquisition and higher R&D investments to boost revenues
Lupin’s revenue expenditure on R&D increased by 48.3 per cent during the first half ended September 2016 to Rs 755 crore from Rs 509 crore. It filed four ANDAs and received nine approvals from the US FDA during the second quarter. Cumulative ANDA filings with the US FDA stood at 338 as at the end of September 2016. It received total 196 approvals. It now has 45 First-to-File (FTF)filings including 25 exclusive FTF opportunities. It also filed 1 MAA with the European authority during the quarter ended September 2016. Cumulative filings stood at 64 and it received 54 approvals so far.
Lupin's biotechnology group has developed a robust pipeline of biosimilars addressing therapies like oncology, anti-inflammatory, anti-virals, rheumatoid arthritis, endocrinology, diabetes, ophthalmology and women's health. It successfully commercialized its first two oncology biosimilars in India – Lupifil and Lupifil-P in India. It is alsomaking significant investments to augment its Biotech manufacturing and R&D infrastructure. The company is setting up fill finish facility and likely to go on stream in FY2017. Its Bioresearch Center is located in Pune, India and conducting bioequivalence studies for its generic products and branded formulations. .
For the full year ended March 2016, Lupin's R&D expenditure increased almost by 55 per cent to Rs 1,732 crore from Rs 1119 crore in the previous year. The R&D expenditure worked out to 11.7 per cent of net sales. Currently, over 17,00 scientists spread across the company's Research hubs.. The company is building a pipeline in niche high-barrier segments such as inhalation, biosimilars and complex injectables.