If filing of DMFs and ANDAs are of any indication, most of the leading pharmaceutical companies in Maharashtra are entering aggressively into the highly regulated market through their own research and development activities. These companies are filing higher number of DMFs and ANDAs in USA, Europe and other emerging markets. The companies are awaiting approval for a good number of new products. By launching several cost effective products, leading companies are giving tough time for international giants.
India has largest US FDA approved facilities after USA in the world and most of these US FDA approved facilities are situated in Maharashtra. Major companies like Lupin, Wockhardt, Glenmark Pharmaceutical, Ipca Laboratories, etc, filed several ANDAs and DMFs during 2006-07 and focusing more on the regulated markets. Further, a few medium scale pharma companies are also taking steps to tap highly profitable markets like US, Europe, Brazil, Russia, CIS and Middle East.
Launching of new products in the regulated market is very expensive and time consuming. Further, it requires special groundwork and investments in R&D base. With adoption of patent laws in the country from January 2005, there is no alternative for the Indian companies for survival except investment in R&D. The R&D investment of the Lupin, Wockhardt, Glenmark Pharmaceuticals, Ipca and Sun pharmaceutical has increased up to 7.2 per cent from 6.0 per cent to Rs 481 crore from 326.95 crore, earlier. Cipla, the third largest company in India with registered office in Mumbai, is spending over 4 per cent of its total sales on R&D.
Sun Pharmaceutical, which demerged its R&D activities into a separate company, has incurred R&D expenditure of Rs 154 crore during 2006-07 as compared to Rs 113 crore in the previous year, a significant growth of 35.4 per cent. Lupin, Nicholas Pirmal and Wockhardt also stepped up investments in R&D to Rs 136 crore, Rs 88 crore and Rs 128 crore, respectively during 2006-0, reflecting a growth of 32 per cent, 38 per cent and 58 per cent, respectively. The Inoco Remedies' investment in R&D during 2006-07 went up to Rs 24.70 crore from Rs 4.57 crore in the previous year. Thus, this shows that the Maharashtra-based companies are focusing on R&D to file DMFs and ANDAs in regulated markets.
As per the calendar year of 2007, Lupin has become the first rank holder with the seven US FDA approvals. Wockhardt has given stiff competition to the Lupin, with six US FDA approvals. While Glenmark Pharmaceutical holds two approvals, Ipca Lab holds only one US FDA approval in its basket.
Recently, Indoco Remedies has commissioned its new R&D centre at Navi Mumbai at a cost of Rs 225 million, in order to fully concentrate on CRAMS space. The research activities at the facility include synthesis of APIs, process improvement and development of non-infringing processes for APIs and intermediates, formulations development, analytical studies and regulatory affairs.
Aditi Kare Panandikar, director business development, said, "Indoco aims to transform itself into a completely integrated player in CRAMS space". India has emerged as a secure territory for research and manufacturing of patented products and the company would leverage this opportunity. The facility would work for firms from the European countries and US.
"Unique feature of the R&D centre is the Kilolab, which is versatile to perform a wide variety of reactions and complete multistage intermediate and API processes for pre clinical phase I to III studies. It will, in turn, amplify Indoco's contract development and manufacturing services to the rest of the world", Aditi said.
Indoco views its R&D capabilities as a vital component of its business strategy that will provide the company long-term competitive advantage. The company intends to take up NDDS research and expects to commercialise the first NDDS product in 2008. The company is in the process of setting up a separate R&D team for the same.
The company has applied for two Indian patents and two more are in pipeline. Recently, company's first shipment has gone to US and the second shipment is expected to happen by the end of 2007.
The Mumbai-based Sun Pharma Advanced Research (SPARC), the demerged company of Sun Pharmaceuticals, is engaged in the development of a strong NCE and NDDS pipeline. The company is expected to come out with the results within the next two years. The company will invest between Rs 250 and 300 crore on NCE and NDDS programme. Currently, SPARC is working on four NCEs and certain products based on four NDDS.
Wockhardt Ltd has signed a memorandum of understanding (MoU) with Maharashtra Industrial Development Corporation to establish a special economic zone (SEZ). This SEZ will provide the base for a new thrust in international markets that will drive Wockhardt's growth in the coming years. The company is expected to turn Aurangabad as a major hub for pharmaceutical and biotechnology industries. It will take 3 to 5 years for the completion of SEZ.
Lupin's research and development expenditure reached at Rs 135.90 crore during 2006-07 and worked out to 6.7 per cent of its gross revenue. The company filed 15 ANDAs, 14 DMFs, 24 EDMFs/COS, 11MAA (EU) and seven dossiers (TGA) during 2006-07.
Speaking to Pharmabiz, Dr.Kamal K Sharma, MD said, "We have over 50 ANDA's filed and have received approval for about 20. We plan to file about 15-20 ANDA's every year. The company has an alliance with Baxter and Henry Schein for Ceftriaxone injectables. The company would look for alliance on a product or in a market, if more value can be built by synergistic application. Recently, we have launched five new products in the US market, namely Meloxicam, Ceftriaxone 10g, Lisinopril HCTZ, Sertraline and Quinapril."
The leading pharmaceutical company Nicholas Piramal India (NPIL) has strengthened its performance during the year ended March 2007 on the back of acquisition and integration of Pfizer's manufacturing facility at Morpeth, UK and Avecia Pharmaceutical. On the research and development front, NPIL continued to invest and build its program. R&D expenditure during the year was up 63 per cent. Its discovery research pipeline has expanded to thirteen new chemical entities. Of these, three molecules are in human phase I/II trials.
Glenmark has introduced a number of new molecules and combination products along with line extensions to its top selling brands to complete its therapy basket. Glenmark's lead molecules, oglemilast (Development Partners Forest Laboratories Inc., and Teijin Pharma Ltd.,) and GRC 8200 (Development Partner Merck KGaA) continue to progress well in their phase II clinical trials.
One of Glenmark's four molecules in pre-clinical trials, GRC 6211, has progressed to phase I in late Q3 FY07. GRC 6211 is a vanniloid receptor [VR1] antagonist compound for a range of pain indications like osteoarthritis, dental pain, neuropathic pain and urinary incontinence. The study is in progress with Kendle, a leading global CRO.
Glenmark hopes to complete Phase 1 by Q1 FY08 and the dental pain study by Q4 FY08. The Company targets launching the molecule in 2011 and aims to be an early launcher in this class. Glenmark is also in discussions with potential licensing partners for this compound.