Bangalore-based Sami Labs has received approval from the Drugs Control General of India for marketing a herbal formulation to treat psoriasis first time in the country.
The drug will be launched in the next six weeks, Dr Muhammed Majeed, managing director, Sami Labs Limited told Pharmabiz.
Scientists at Sami Labs developed a patent pending combination treatment for psoriasis. The regimen entails internal administration of a phytonutrient-mineral composition along with the application of a topical cream containing selected phytonutrients.
Preliminary laboratory data was encouraging. Multi centric trials on at least 100 psoriasis patients formed part of the protocol. The study has been conducted at centers in various climatic zones in the country, to enable determining the efficacy of the formulation in subjects exposed to diverse atmospheric temperature and humidity parameters, according to the company.
Meanwhile, Sabinsa Corporation which is conducting the international operations of Sami Labs, has received a patent from the Republic of South Africa for its natural proprietary composition with clinically proven efficacy and safety in the treatment of psoriasis.
"For several years now, we have been on a quest to find a remedy for psoriasis with a natural formulation. We are proud to have finally achieved this," stated Dr Majeed. Of the many of the drugs available for psoriasis, our product did not show any untoward side effects in any of our clinical trials, he added.
Psoriasis is a non-contagious, lifelong skin disease which causes red, scaly patches on any area of the skin. According to the National Institutes of Health, as many as 7.5 million Americans suffer from psoriasis. Psoriasis affects nearly three per cent of the world's population. It can develop in males or females of any race or age. It often appears between the ages of 15 and 35, although it can strike at any age, including infants and the elderly. The skin disease can range from mild or moderate to very severe and disabling. According to the National Psoriasis Foundation, about 56 million hours of work are lost each year by people who suffer from psoriasis, and between $1.6 billion and $3.2 billion is spent per year to treat psoriasis.
With regards to Sami Labs much-awaited glaucoma drug developed from Forskolin with a brand name Ocufors has been tweaked to make it a once-a day formulation from the earlier thrice a day regime. The company hopes to be ready with the new version in a year, stated Dr Majeed. The reason for a re-development of Ocufors came about to make the formulation more functional, Dr Majeed added.
A third novel formulation from the Sami Labs research lab is a drug for asthma for which an investigational new drug (IND) has been filed. The next phase is the clinical trials.
On the infrastructure front, Sami Labs has invested Rs 30 crore to set up a herbal active ingredient facility at Hassan. The company was sanctioned the land by Karnataka Industrial Area Development Board. The constriction has commissioned and it was take two years for commissioning, informed Dr Majeed.
Ending March 2008, Sami Labs registered a turnover of 200 crore.