Sun Pharma Discloses NCE and NDDS Pipeline

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Sun Pharma, the no. 1 pharmaceutical company in India in speciality therapy areas and with brands in 26 markets worldwide, shares details of its NCE (New Chemical Entity) and NDDS (New Drug Delivery System) programs that the team of scientists at its research center, SPARC, have been working on.

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In a detailed presentation yesterday, management of Sun Pharmaceutical Industries Ltd. shared details of its NCE (New Chemical Entity) and NDDS (New Drug Delivery System) programs that the team of scientists at its research center, SPARC, have been working on. 4 NCEs and products based on 4 NDDS platform technologies were discussed.

New Chemical Entity Research

Sun Pharma shared information on its therapeutic analogue based programs in the allergy/ inflammation area. Modification of poorly absorbed molecules is another focus area.

SUN 1334 H, a selective histamine receptor antagonist, is currently in Phase II clinical trials in the US. This is an anti-allergic used for seasonal and allergic rhinitis, urticaria, etc. In preclinical studies, Sun 1334H was found to have high specificity for H1 receptors, and this indicates a low side effect profile. Sun 1334H was found to have a clean profile with fast onset of action, was non sedating and offered efficacy similar to cetirizine. Phase I trials in Europe indicated that the molecule was well tolerated, effective and appropriate for once-a-day dosing. Phase III for this lead is estimated to begin in 2008.

SUN 461, an anti-inflammatory for asthma and COPD, is being developed as an inhalation drug. This soft corticosteroid is a glucocorticoid receptor agonist, with similar activity but significantly lower side effects whe compared to other marketed steroids.

SUN 44, a prodrug of gabapentin for the treatment of neuropathy and seizures, uses molecular modifications in the structure for better absorption. In preliminary animal studies, this molecule was found to be far better absorbed and safer than existing products. Its profile indicates higher blood availability, a once-a-day formulation and higher safety.

SUN 09 is a prodrug of a currently marketed drug used as a skeletal muscle relaxant for spasm related disorders. This molecule's physicochemical and structural features have been modified for better absorption, and it seems to be easy to formulate as an injectable and once-a-day dosage form. Preclinical and acute toxicity studies on this molecule are ongoing.

SUN 44, 09 and 461 are at preclinical stages. IND filing and Phase I for these projects will begin in 2008.

Delivery system based projects: Four delivery system based platforms and the projects based on these were highlighted.

Dry Power Inhaler (DPI): The novel DPI for asthma and COPD delivers a uniform dose over a range of patient effort and can be used both with existing steroid and bronchodilator combinations, as well as NCE steroid molecules. It can also be modified for systemic delivery of drugs to lungs. This easy to operate inhaler-- just 3 steps of open, inhale and close - will comply with US FDA and European regulatory requirements. Our DPI is designed to deliver uniform dose irrespective of patient inhalation effort, eliminate double dosing or dose wastages and ease use by children, adults as well as elderly thus addressing shortcomings of other devices. 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.

Controlled-release drug delivery systems

The Gastro Retentive Innovative Device (GRID) is designed to retain and release a drug over an eight hour span, ideal for an once- a - day system. The release profile can be tailored to give a combination of instant and sustained release profiles.

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: This 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 USFDA.

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. Our 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 an unique encapsulation process to achieve more than 98% encapsulation of bioactive substance, unlike competing products. Two cytotoxic products are being developed with this technology.

About Sun Pharma

Established in 1983, listed since 1994 and headquartered in India, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. The company is pursuing NCE and NDDS programs with the aim to bring products based on proprietary technology to market. More information about the company can be found at http://www.sunpharma.com.

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