The Pune-based Serum Institute of India Limited (SIIL), one of the largest vaccine manufacturing companies in India, is on an endeavour to add more vaccines and recombinant products in its product portfolio. During the past few years, the company's operations were revolving around US and European Union markets.
Serum Institute of India commenced its operations in 1966 to win the immuno-biologicals market through indigenous technology, when the country was importing the products at high prices due to acute shortage of vaccines and recombinants. Research was the primary and basic mantra of the company, which led the company to the highs of vaccine business in the country.
The company, with an emphasis on immunisation for preventing and controlling diseases, has lined up research on products, including meningococcal A conjugate vaccine, meningitis A, Y, C, W-135 quadrivalent vaccine, bladder cancer vaccine and pneumococcal polysaccharide and conjugate vaccine. The research pipeline for recombinant products include recombinant granulocyte colony stimulating factor, interferon alpha and recombinant erythropoietin.
The conjugate meningococcal vaccine against meningitis A is expected to reach in India by the middle of 2008, if the phase 3 trial for the drug is successful. The volumes in manufacturing expected for the products are from 40 to 50 million doses a year, according to Dr S S Jadhav, Executive Director, SIIL. The meningococcus conjugate vaccine is being developed under the Meningitis Vaccine Project (MVP) - a partnership between World Health Organization (WHO) and the Seattle-based non-profit Program for Appropriate Technology in Health (PATH).
Further, products like quadrivalent vaccine for meningitis A, Y and C and vaccine for bladder cancer may also hit the market soon, as the drugs are in various stages of research and clinical trials, according to the company sources.
The R&D effort of the company has recently hit one of the milestones, as it developed haemophilus influenzae type B (HIB) vaccine indigenously. The company is expected to launch this vaccine by mid 2007. The HIB vaccine, under the brand name Hibpro is expected to be produced 100 million doses per year, it is learnt.
"Serum Institute is the only indigenous manufacturers of HIB vaccine in India today. Unlike other vaccine manufacturers who import HIB vaccine in bulk, the company manufactures HIB vaccine in India. The institute has invested significantly in R&D and these efforts are yielding results," said Dr Cyrus Poonalwala, Chairman, Serum Institute of India.
The company's endeavors in combination vaccines, which recorded continuous success in market, have helped SIIL to become number one vaccine producer in the country. For instance, the Q-Vac, a sterile, opaque, uniform suspension of diphtheria toxoid, tetanus toxoid, killed bordetella pertussis bacilli and hepatitis B surface antigen adsorbed on aluminum gel, has recorded sales of Rs 1 lakh doses during its first seven days of the launch.
The company has also earned name as the first Indian company to get into the qualification rounds for combination vaccine from World Health Organisation to supply to the United Nations (UN) Agencies, in 2006.
As part of the company's efforts to woo overseas market through drug development and distribution projects, it has tied up with Akorn Inc, for developing oncology and other injectable drug products for United States and Canada. Akorn is a manufacturer and marketer of sterile specialty pharmaceuticals with its manufacturing facilities in Decatur, Illinois and Somerset, New Jersey.
Earlier, in 2006, the company had entered into a definitive development and exclusive distribution agreement with Akron for rabies monoclonal antibody. The market size in North, Central and South America and Europe for rabies Mabs is approximately $100 million, reports Akorn. Serum granted Akorn the option to obtain exclusive marketing rights in North, Central, and South America for a second Mab product, anti-D human Mab.
As per the agreement, Akorn will receive 40 per cent of the revenues from product sales in North America and 50 per cent of the revenues from product sales in Central and South America. The term of the agreement is 10 years following the first commercial sale of products. Last year, the company also purchased one million Akorn shares at a price of US $3.56 per one share. Akorn is expected to start filing products with the US Food and Drug Administration (FDA) sometime this year.
Apart, the company has picked up 14 per cent stake in the UK-based Lipoxen, a biopharmaceutical company specializing in the development of differentiated biologicals, vaccines and oncology drugs, in the last financial year. The company has also entered into a development and manufacturing agreement (DMA) with Lipoxen in August 2006. The strength of SIIL, which has developed a complete process of fermentation, purification and manufacture of polysialic acid (PSA) and DMA, is the key factor that attracted Lipoxen to forge collaboration with Serum.
The company's moves comes as part of its efforts to establish itself as a major player in New Drug Delivery Systems (NDDS). The company is also conducting NDDS research projects on measles vaccine through the aerosol route in collaboration with the WHO for the last couple of years.
Apart from its focus on vaccine research, manufacturing and marketing, the company has initiated India's first biotech special economic zone (SEZ) - the Serum Bio Pharma Park, in March 2006. The park is set up adjacent to its existing manufacturing unit, with an estimated investment of Rs 1200 crore.
According to official sources, Serum will have 5 to 6 units in the SEZ, which is expected to be completed by 2010. The SEZ, which has been allocated 55 acres of notified land, will be gradually expanded to 250 acres. The Zone will be utilised to prepare vaccines for pneumonia, rotavirus and combination vaccines for the entire range of meningitis and influenza.
SIIL, the largest exporter of vaccines in the country, is currently exporting its vaccines and anti-cancer products along with anti venom serums to over 145 countries across Asia, Africa, Europe and Central and South America. The company is planning for Initial Public Offer to accumulate around Rs 500 crore. This sum would be invested for phase I of biotech park. The revenues of the company surged by 37 per cent to Rs 951 crore in the year ended March 31, 2007, from Rs 703 crore in last financial year.