Magene Life Sciences Private Ltd is taking up bio-therapeutic development activity for a US company, which has its subsidiary in Hyderabad. The company will be delivering the recombinant therapeutic protein starting from cloning through all the stages upto pre-clinical validation in animals.
The company intends to develop a formulation, which will be non-infringing in global markets. Magene and its US collaborator plan to target bio-generics markets of US and the Europe. The name of the US company was not disclosed. TR Bhoopathy, managing director and CEO of Magene Life Sciences told Pharmabiz that the final regulatory guidelines for introduction of biogeneric equivalents are yet awaited. The European Union, however, has recently opened its market for biogenerics, and US is soon expected to take a decision in this direction. More companies will now be targeting EU markets.
Once Magene and its US partner develop a product, the collaboration will extend towards developing many more new products in future. Magene is to pick up equity stake in the US company, as part of the agreement. The collaboration with the US company will allow Magene to have an access to US markets. Magene may become a manufacturing partner with the US company for production of biotherapeutic products. Intellectual property right (IPR) of developing the protein will lie with Magene. The collaboration between the partners is proving as a win-win deal, Bhoopathy added.
Magene in addition, has a joint venture with a US based doctor / scientist for developing anti cancer products. Magene has already filed three patents jointly with this scientist. Magene has extended support in terms of funds, management, and manpower to conduct pre-clinical and clinical studies in India that fit DCGI regulations and also meet the requirements of the US and European regulatory authorities.
Magene is working on a naturally occurring fatty acid that is found to be effective in the area of brain cancer and is also working on multiple solid tumours along with the US-based doctor / scientist, he informed.
Magene has complete commercial rights over the products, to be developed through the joint venture. The products has been successfully tested in patients and the current pre-clinical and clinical initiative is to revalidate the findings to meet the international regulatory requirements for ultimately marketing the anti cancer products worldwide. Magene will initiate phase III trials and is awaiting ICMR / DCGI approval, and expects to obtain the approval within next three months.
For multiple tumours, Magene is working on a combination of fatty acids with other compounds. The company has the patent for this compound and the unique formulation. The pre-clinical and clinical studies may take anywhere between 24-36 months for completion. Animal studies are to be initiated soon, he added.
Magene has about 40 acres of land in Medchal near Hyderabad, where it operates the R&D facility. Bhoopathy revealed venture capital companies have shown interest in funding Magene's initiatives. The VC companies are keen to support drug discovery activity. Magene is in talks with various investors and prospective partners for strategic value addition, giving access to global networks.
Magene is uniquely placed with its distinctive biological services including in-vitro screening of new chemical entities (NCEs). The company also has the distinction of being the first biological contract research company in India to receive a financial commitment of Rs 35 million from the Technology Development Board. TDB provides soft loans to companies involved in unique technology for the purpose of development and commercialization.
Magene is also in the process of finalizing its restructuring plan, as part of which drug discovery and contract research activity may be treated as separate business units. The company has kept a target of achieving revenues up to Rs 150 million by next financial year, he added.