As a pre-cursor to the hiving off of Sun Pharma Advanced Research Company Ltd (SPARC Ltd), the innovative research company to be demerged from the Sun Pharma, the director board has disclosed its proprietary pipeline on development of New Chemical Entity (NCE) and New Drug Delivery System (NDDS) molecules.

In its NCE pipeline, the company is estimated to complete IND filing for three molecules for indications of asthma and COPD, for seizures and CNS related disorders and muscle spasticity by the year 2008, an IND filing for its anti allergic molecule is to be completed by 2007.

According to the announcement, the company is estimated to file its first New Drug Application (NDA) by 2011, on its dry powder inhaler (DPI) product, which is a combination of steroid and bronchodilator. The NDDS pipeline of the company includes gastro retentive innovative device (GRID), Wrap Matrix System, Nanoemulsion, and Biodegradable implants or injectables.

"As we have declared earlier, we are disclosing some of our innovative research activities around 30 to 40 days prior to the launching of the research based company. We have reasonable clarity on the Intellectual Property Protection on these products," Dilip Shanghvi, chairman, Sun Pharmaceutical Industries Ltd said.

According to him, the Sun Pharma is estimated to invest around USD 60 to 75 million for the initiative in the next three years. In this, USD 45 mn cash flow will be carried in the process of hiving off the new company. The company will gather its funding for investment from licensing products once the de-merger is finished.

The company is expected to finish the ongoing phase two trials, chronic toxicity studies of its anti allergic oral product in US, by the end of 2007. The current global market size for the product is USD 5.5 bn. The phase one human clinical trials on its anti-inflammatory product will commence by the beginning of 2008. Another NCE, a pro drug of Gabapentin, currently in pre clinical studies, is estimated to commence phase one studies and would be ready for IND filing by the second quarter of 2008.

The DPI product, which can be modified for systematic deliver of drugs to lungs, is planned to introduce first in semi regulated market by 2009, following its entry into the regulated markets and NDA filing by 2011.

Baclofen GRS capsule is already approved in Indian market and is estimated to go for IND filing within a few months as the phase three studies has been completed.

The company has also filed a few ANDAs for its controlled release drug delivery system wrap matrix system, for hypertension and asthma. Research works on new products under the nanoemulsion technology, biodegradable injectables and a new ophthalmic solution are also under progress, according to the company announcement.