Paragon of success

Rooted in Gujarat, yet focussed on the globe. With its plasma protein initiative, Intas Biopharmaceuticals displays a savvy business sense by entering a less attractive but potentially lucrative segment. Suja Nair traces their journey

"Celestial is the only player in India, which sources plasma from various blood banks in India, and obtains fractionated plasma proteins through a contractual arrangement" - Dr Urmish Chudgar Managing Director IBPL

Incorporated by Hasmukh Chudgar in 1976, Intas Biopharmaceuticals Limited (IBPL) has come a long way. From a small unit at Vatva, near Ahmedabad, IBPL entered mainstream pharma market, showing consistent growth over the years. Since the launch of biotechnology operations in May 2000, R&D and manufacturing of biopharmaceutical products, with a special focus on oncology, have been major thrust areas for the company. According to Dr Urmish Chudgar, Managing Director, IBPL, "Starting with bio-generics, IBPL has structured its progression to the development of proprietary and innovative recombinant biopharmaceuticals. IBPL derives its competitive edge from successful and strategic moves it has made in the areas of R&D, manufacturing, marketing and global operations." The company has successfully launched bio-similar products like Neukine (rHu G-CSF), Erykine and Epofit (rHu EPO), Intalfa (rHu IFN Alfa-2b), and Neupeg (Pegylated rHu G-CSF). According to Mani Iyer, Executive Director, IBPL, "Our bottom line sales have been strong throughout past fiscal. With the launch of Neupeg (Peg Filgrastim), we have gained monopoly in the domestic market in terms of being sole manufacturers of Peg Filgrastim in India. With an array of oncology products and new sales strategy in place for current fiscal, we are looking to grab major market share in the oncology segment."

Highlights

"Its potent combination of pioneering vision, entrepreneurial spirit, sound infrastructure and ability to adapt to changing times have helped shape Gujarat as a pharma hub" - Mani Iyer Executive Director IBPL

As per ORG IMS report of May 2007, IBPL is amongst the top 20 players in the Indian pharma industry. IBPL is present in South East-Asia and the African continent. Further, with its European venture, the company has also consolidated it’s position in international markets. Its manufacturing unit at Matoda, on the outskirts of Ahmedabad, is rated as one of the best in the Asia-Pacific region, for cytotoxic products with barrier isolation technology. The facility complies with strict international good manufacturing practice (GMP) regulations and has also received the European Union-Good Manufacturing Practice (EU-GMP) and conforms to guidelines laid down by World Health Organization (WHO).

The company has a oncology product basket catering to solid tumours, haematological malignancies and supportive therapies. On the R&D front, IBPL has significant presence in North America with an agreement and MoU with two technology companies. In January 2007, the company committed Rs 13 crore towards conducting clinical trials and producing Factor IX, used for treatment of haemophilia B, through novel transgenic platform. Thereafter, IBPL inked an MoU with Canada-based Viropro for co-development of a novel molecule.

Branching out

IBPL’s facility at Moraiya, 22 kms from Ahmedabad

IBPL has a number of subsidiaries through which it functions; one of them is Indus Biotherapeutics, which is a biopharmaceutical contract research organisation that solely concentrates on research and development of novel targets as well as bio-generics. Another subsidiary that is associated with the company is Celestial Biologicals, which focuses on manufacturing and marketing of plasma-derived products. The company has commenced marketing of plasma proteins—albumin and immunoglobulins (IVIG)—under the brand names of 'Albucel' and 'Globucel' respectively in the Indian market, and has plans to expand its product portfolio. Chudgar adds, "Celestial is the only player in India, which sources plasma from various blood banks in India, and obtains fractionated plasma proteins through a contractual arrangement. There are plans to invest heavily in South Asia's largest plasma fractionation facility, which is focused on being able to offer fractionation services to South Asian nations, apart from India."

Looking ahead

The company is set to tap emerging opportunities in active biologic ingredients (ABIs) and bio-generics market. The company has also entered several supply and marketing agreements with reputed international companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia and CIS, South and Central America and Africa. Currently, the company is executing contract research and manufacturing agreements (CRAMS) for a European client for development, scale-up and commercial supply of a novel bio-therapeutic protein. Iyer informs, "We are planning to generate clones for commercial production of protein using state-of-the-art technologies to improve yields, quality, as well as adopting novel expression systems (including transgenics) with an objective to build intellectual property (IP) over the long run. IBPL, in a planned and phase-wise manner, will screen technologies/new molecules and identify the most promising ones, prioritising them on the basis of their business potential and compatibility." On the same lines, he says that this area has strong potential for generating IP in terms of patents and publications and could provide a novel platform for delivery of many protein therapeutics.

Listing Gujarat’s achievement over the past century, Iyer says "Gujarat was the first to manufacture APIs and finished dosage form in India, manufacture pharmaceutical machinery, lead the way with clinical research organisations and become the first to undertake pre-clinical safety and toxicology studies in the country. Strong linkages between SME players, industrial bodies and medical and financial institutions have created a proper ecosystem for growth of pharma/biotech industry in the state. Its potent combination of pioneering vision, entrepreneurial spirit, sound infrastructure and ability to adapt to changing times have helped shape Gujarat as a pharma hub." He further said that in future, Gujarat has potential to capitalise on SEZ-led exports, as well as the fast growing CRAMS and R&D biogeneric segments.

On Government initiatives, Iyers avers that central Government bodies including Department of Science and Technology (DST) and Department of Biotechnology (DBT) have played a major role in extending benefits to biotechnology companies by means of fiscal incentives, special grants and other tax-friendly measures. He also mentions that the Government has made an important contribution towards strengthening regulatory framework and Intellectual Property Rights (IPR) issues. They have significantly helped in development of skilled resources in terms of academic institutes and educational base as well as increased allocation of funds with an emphasis on R&D. However, he adds that the Government can certainly take more steps to improve. For instance, the SME and middle size pharma/biotech companies should have access to more financing opportunities from Government in the form of venture capital which will encourage entrepreneurs. Further he concludes, "The state's approach to biotech development is reflected from the fact that the new Biotechnology Policy has major focus on promoting biotech research and extending support in the form of incentives, concessions and benefits to new players."

suja.nair@expressindia.com