RLS is pursuing the P2P model, where the drugs that you develop and make will be marketed by a domestic or an MNC with a larger marketing network. How important is this model for you
RLS, with its core strength in R&D and technology intends to leverage on the larger sales workforce of its P2P partners to enhance reach of its products. These partnerships are in the nature of principal-to-principal marketing arrangements in the domestic market and risk-sharing clinical development and marketing partnerships in overseas markets.
What are some of the P2P partnerships the company has at the moment
RLS has P2P partnerships for biosimilars and pharmaceutical formulations with several domestic and multi-national companies operating in the country. The major ones are TPA (tissue plasminogen activator) with Abbott, FSH (follicle stimulating hormone) with Abbott, Lupin and Sun Pharma, hCG (chorionic gonadotrophin hormone) with Abbott and Sun Pharma, Erythropoietin with Lupin and Capecitabine with Aureate. At present, the company is in active discussions with multiple domestic and global companies for strategic partnerships.
What would be the strengths that RLS would expect from a strategic partner
In a partnership, RLS expects the strategic partner to take responsibilities for clinical development, regulatory approvals and marketing of products. RLS would be responsible for product development, pre-clinical development and manufacturing.
What is the status of development of novel drugs, their launch and commercialisation
The development of novel drugs is a long process and it is difficult to ascertain timelines for launch and commercialisation. However, we can say that RLS has generated promising data in in-vitro and small animal models for several molecules in anti-cancer and anti-viral applications of siRNA molecules, monoclonal antibodies and fusion proteins.
Some of the unique work you do is in the area of unmet medical needs. Could you provide an update on that
RLS has several drugs and therapies addressing unmet medical needs cord blood stem cell transplants for beta thalassemia, leukemia, melanocytes for pigmentation disorders, limbal and conjunctival stem cell therapies for ocular (eye) surface damage. It is also developing novel molecules for dengue and cancer treatment.
India has recently drafted guidelines for biosimilars. Is the pathway now clear for development and commercialisation of biosimilars
The Indian Biosimilars Guidelines drafted by Department of Biotechnology and Central Drugs Standard Control Organization are comprehensive in nature and address pre and post-market regulatory requirements for biosimilars. The guidelines factor the Indian context of affordability and accessibility while ensuring product safety, quality and efficacy. The guidelines have provided the regulatory pathway for approval of a biosimilar. Now the companies with stakes in biosimilar business have to gear up to follow these guidelines. This would lead to a greater need to invest in people, analytics and clinical trials.
Is RLS open to a stake sale to a strategic investor, which can also contribute to taking your products globally
At present, RLS is not contemplating any stake sale to a strategic or financial investor.
Which areas does the company see major growth coming from
RLS envisages future growth coming from new products, new overseas markets for biosimilars and new business models.