The Mumbai based Sun Pharma Advanced Research (SPARC), the demerged company of Sun Pharmaceuticals, is developing a strong NCE and NDDS pipeline in the next two years. The company will invest between Rs 250 to 300 crore on NCE and NDDS programme. Currently, SPARC is working on four NCEs and certain products based on four NDDS.
A Company spokesperson told Pharmabiz, "After the demerger of the innovative projects, Sun Pharma will focus on generic product and process development for formulations and API. We have four NCE and four NDDS projects, and one of our pilot work is SUN-1334H, an antiallergic, is currently in the phase II trial in the US, but phase III for the same lead is likely to begin in 2008. But SUN 44, 09 and 461 are at preclinical stage, IND filing and phase I for these projects will begin in 2008".
The company's Dry Power Inhaler (DPI) for asthma and COPD deliver a uniform dose over a range of patients and can be used both with existing steroid and bronchodilator combinations, as well as NCE steroid molecules. A product based on this novel DPI is likely to be launched in semi-regulated markets by 2009, and an NDA will be filed for regulated markets by 2011. The Gastro Retentive Innovative Device (GRID) is designed to retain and release a drug over an eight-hour.
The company source said that there will be no technical collaboration or partnership has been immediately envisaged. The innovative company will evaluate whether it will continue on its own or seek partners for out licensing once the projects finish phase II clinical trials.
Baclofen GRS, a once-a-day formulation as compared to twice or thrice daily administration of the competing product, is being developed to treat muscle spasticity. For India, clinical trials have been completed successfully after which the product was approved. For the US, IND filing is likely in 2007.
Wrap matrix, a multi-layered matrix based tablet is designed to offer a controlled release of high dose and high solubility products. This design has an advantage over competing technologies, where it is difficult to reproduce bioavailability. Metoprolol XL with a once-a-day advantage has been launched in India. A few ANDAs using this technology have been filed with the US FDA.
Tobramycin + Dexa ophthalmic solution unlike the competing product which is a suspension causing gritty feeling in the eye, our product is being developed as a clear solution for use in the prophylaxis of infections after cataract surgery. A pre-IND meeting with the FDA has been completed, with likely IND filing for 2007.
Depot Technology that uses long-acting injectable micro-particles for slow/sustained drug release over a month to several months using biocompatible and biodegradable polymers. The company's product uses a conventional needle, unlike the competing product where tiny rods are implanted, thus reducing patient trauma and pain. A GnRH analogue is in preclinical trials, with clinical studies slated for 2008. A somatostatin analogue is in clinical studies in India.
Nanoemulsion based products that offer higher drug localization to the cancer cells and fewer side effects were discussed. Our product uses a unique encapsulation process to achieve more than 98 per cent encapsulation of bioactive substance, unlike competing products. Two cytotoxic products are being developed with this technology.