Cadila Healthcare Ltd and Bharat Serums and Vaccines Ltd (BSV), both among the top 10 biotech companies in India, will set-up a a 50:50 joint venture company to develop, manufacture and market a novel non-infringing and proprietary drug delivery system (NDDS) for an approved anti-cancer product for global markets.
The company says that with evidence of promising safety and anti-tumour activity in a variety of cancer models in animals, this NDDS product has demonstrated competitive advantages that could differentiate it from the currently available dosage form. The product has been approved by the drug controller general of India for commercialisation in India.
Both companies will undertake a core development programme and are initiating clinical trials for product registration in leading pharmaceutical markets for potential treatment of multiple types of cancer. The annual global sales of currently available dosage form is likely to reach $500 million in 2005. The two companies have also developed a global development programme to maximise the commercial potential of the product.
Announcing the signing of the JV agreement, Pankaj R Patel, chairman and managing director, Cadila Healthcare, said, "We believe that the future of the oncology market will be driven by novel drug delivery systems offering improved efficacy, better safety and an improved tolerability profile resulting in optimal therapy for patients. The NDDS product has demonstrated scientific evidence to deliver these differentiated features for commercial success in global pharmaceutical markets. This collaboration with BSV complements our strategic focus on developing innovative injectable oncology products and highlights our commitment to global oncology markets."
Zydus Cadila files IND for new molecule ZY1-1
In an unrelated development, Cadila has announced the filing of its second investigational new drug (IND) application with the drug controller general of India for the new molecular entity ZYI-1, which the company says is a novel agent for the treatment of inflammatory disorders. The drug molecule has been designed and developed by the Zydus Research Centre.
ZYI-1 has shown a good pre-clinical profile and has a unique mechanism of action. This anti-inflammatory compound has the potential to correct various pain related conditions and be a safe, potent pain reliever.
The company estimates that between one and two per cent of the global population world-wide is afflicted by various kinds of inflammatory disorders and in India lone there are over 100 million patients in India alone who suffer from various arthritic disorders like rheumatoid arthritis, osteoarthritis or other related conditions.
The pre-clinical studies on ZYI-1, says Cadila, have indicated that this may be the molecule of choice for pain management. Earlier this year the research centre had filed its first IND-ZY-H1 to treat dyslipidemia, for which the Phase 1 clinical trials are currently on.