September 06, 2006

India Approves Glaucoma Drug


Sabinsa’s eye care product, Ocufors, gets nod from regulators in a first for a plant-based drug.

Sabinsa received approval Wednesday for a plant-derived glaucoma drug, Ocufors, from Indian regulatory agencies.

While it’s the first pharmaceutical product derived from a plant to be approved in India, it is also the first such eye care product worldwide.

Ocufors is made from Forskolin, an extract prepared from the herb Coleus forskohlii, a member of the mint family of plants that grows wild in some parts of India.

Sami Labs, the Bangalore, India, research and manufacturing arm of Piscataway, New Jersey-based Sabinsa, has the U.S. patent for preparing the extract from the herb.

Glaucoma is a progressively degenerative disease of the optic nerve and is the second-leading cause of blindness in the world affecting 67 million people globally.

“This is the first time in the world that the molecule Forskolin has been formulated as an ophthalmic solution to be used as a drug for treating glaucoma,” says Dr. Muhammed Majeed, chief executive of Sabinsa.

Ocufors has been found to be 30 percent more effective that existing and popular glaucoma drugs. The drug has undergone all the mandatory studies and clinical research at six different locations in India.

ests continued the research and studies done by the pharma giant Hoechst in the eighties. Hoechst had identified the efficacy of Forskolin in treating glaucoma but could not make an effective formulation and subsequently dropped the studies midway.

Sami Labs took up the research and succeeded in making Forskolin a water-soluble substance.

The company has domesticated and popularized the plant and is now cultivating it on more than 10,000 acres of land in the Indian states of Tamil Nadu, Andhra Pradesh, and Maharashtra.

Research Turns to Plants
New molecules for prescription drugs have been proving elusive for the pharmaceutical industry. The search has extended from laboratory chemistry to plant sources.

For a long time the pharmaceutical industry has relied on synthetic molecules discovered and designed in laboratories. But of late, the increasing cost and time to market have created a crisis of sorts, and most companies have seen declines in their new chemical entity pipeline.

“Add to this the issues of long-term toxicity, particularly in drugs for chronic diseases,” said Rajan Srinivasan of Indus Biotech, a Pune-based company that has some U.S. patents for plant-derived molecules. “This is increasingly coming to the fore as some drug companies have been forced to recall blockbuster drugs.”

He believes Ocufors’s regulatory approval may be the beginning of a trend. “It’s a prophecy of things to come,” said Mr. Srinivasan. “We are on the cusp of a major change in drug discovery paradigm, and many more drugs of botanical origin will enter the market in the next few years.”

More than 200 Investigational New Drug applications have been filed and accepted by the U.S. Food and Drug Administration for drugs originating from plants.

Since many of the plants studied for pharmaceutical purposes today are part of the human food chain in one form or another, safety issues become easier to handle.

Sami Labs is launching two more large human studies in India to explore new delivery systems for Ocufors.

“Glaucoma is a 24/7 disease and any eye drop lasts only six to eight hours,” said Dr. Majeed.

“We are looking at delivery systems that can keep the drug in the body for 24 hours.”

Sami Labs also has a plant-based drug for psoriasis in Phase III clinical trials.

Sabinsa will launch the glaucoma drug by the end of the year in India. It has an estimated market of $22 million. The company is seeking partners in the United States and the European Union to help it through the complicated regulatory approval process.