Actis Biologics Pvt Ltd (ABPL), the Indian arm of the California based Actis Biologics Inc, is expected to launch its first technology product - Vascular Fusion Factor 2 (VFF2) - in India within a year along with plans to introduce a total of two or three products in the country within next 24 months.
The VFF2, the yeast-mammalian cell culture technology currently under development stage, is expected to increase the production of protein eight times from the normal rate by increasing body mass of the particular cell and thus enable the biotech drug companies to bring down the cost of dosage production, according to ABPL sources. The technology can be used in production of a wide range of biotech drugs including interferon and erythropoietin (EPO) and currently some of the clones are prepared in the company's Mumbai based lab.
"While the biotech products like EPO, VEGEF and GCSF products are high in price and are not affordable to the majority of population, the VFF2 technology will help the companies to dramatically cut down the cost and make these drugs affordable to the public. The technology is not only applicable to produce the off patented drugs, but also for drug development of new biotech drugs, which shows it that it has a very high potential of market," said Sanjeev Saxena, chief executive officer, Actis. The market of biosimilars itself is currently at US $29 bn and is slated to go up by US $60 bn in 2010.
The company is planning a stage-wise global launching, starting from Asia and later introducing the technology to US and Europe. The company is working with some potential partners for the technology development of VFF2, and has received a grant of US $1 mn from ICICI venture.
Angiozyme, another novel platform based on nucleic acid technology developed by the company's Ribozyme platform division, is expected to enter into the phase III studies soon and the company expects to launch the technology within next 18 to 24 months. The product is currently going through regulatory filings both with the office of Drug Controller General of India (DCGI) and the US Food and Drug Administration (FDA) to commence the Phase 3 studies with an expected number of 300 patients.
The technology primarily targets colorectal cancer and later on lung and prostrate cancer and would also studied for its effect on age-related macular degeneration (AMD), glioblastoma and for obesity. Actis Biologics has a worldwide licence for Angizyme, an anti-cancer drug from Sirna and Chiron which has a current market potential of USD 15 bn.
With the launch of angiozyme, the company will have two to three products in India within next two years, informed Saxena. Meanwhile, the company's Malaysia subsidiary, Telesto Diagnostics will launch CAD based diagnostics for various abnormalities within one year and another subsidiary, Cogenesis will have its novel respiratory technology product in market within 12 to 18 months from now.
Actis's gene therapy candidate MSP36, developed with the support of Department of Biotechnology (DBT), is also expected to reach animal trial stage in next six to eight months. The particular protein from the gene has shown promising results with three different mechanisms of action simultaneously in the preliminary studies, added Saxena. The company's preclinical compounds, IL21 for melanoma, lymphoma, renal cell carcinoma and mutated IgFBP3 for treatment of prostate and lung cancers are the other two promising products.
The company is also finalising an agreement with Santiago based cancer institute for research and development of biomarkers for certain cancer drug. The agreement is expected to be finalised within a month. ABPL, which has a Rs 15 crore research centre in Mumbai, is planning for an expansion with its Rs 100 crore funds to set up a bigger research centre in the metro within a year.