Sun Pharma's new molecule in phase III

Sun Pharma Advanced Research Company (SPARC) will soon join the ranks of Dr Reddy's Laboratories with a new chemical entity (NCE), or new drug molecule, in the third phase of clinical trials.

The third phase, during which the drug is tested on a large number of human volunteers, is the the last stage before the product is produced commercially.

SPARC, which demerged a few months ago, is the NCE and new drug delivery business subsidiary of the Rs 2,132 crore Sun Pharmaceutical Industries.

The pharmaceutical industry is estimated to be developing about 60 NCEs in its quest to come out with India's first original chemical drug.

Of these, only Dr Reddy's has been able to progress into phase III stage with one drug so far.

SPARC's lead NCE, SUN 1334 H (an anti-allergy drug), will enter phase III trials in a few months, according to Dilip Shanghvi, chairman and managing director, Sun Pharma.

"Results for the second phase of development will be available soon and the phase III clinical trials will start within a few months," said Shanghvi, adding the drug had reported good results so far. "As far as possible, we will take the drug forward on our own and outlicense it at an appropriate time."

However, the company has not yet initiated discussions with pharmaceutical companies to outlicense the molecule.

Dr Reddy's balaglitazone, an oral anti-diabetic drug under development in association with Rheoscience of Denmark, entered the phase III stage in August 2007. Ranbaxy's lead molecule for malaria (RBx11160) is still at the phase II stage.

Similarly, Glenmark's asthma research molecule oglemilast (code name GRRC 3886), which entered the phase II trials two years ago, is yet to advance due to the additional data sought by the US Food and Drug Administration (FDA). Glenmark had outlicensed the drug to Forest Laboratories of the US for further development.

Lupin Laboratories has a product in the phase III stage, but it is a nasal spray herbal compound for migrane and cannot be classified as an NCE.

Similarly, biotech major Biocon also has three drugs in the phase III stage and has launched Biomab, a cancer drug, say industry experts.

SPARC has also developed two revolutionary new drug delivery platforms which the company is in the process of patenting in several countries.

SPARC has also developed an easy-to-use dry powder inhalation device for treating asthma, which ensures that the drug reaches the lungs uniformly.

Typically, with other inhalation devices less than 20 per cent of the drug reaches the lungs.