PRODUCTS

GBL 310
The Company's first product offering, GBL 310, is being developed as a topical drug for the treatment of actinic keratosis. In a Phase II study, Grannus will investigate the therapeutic potential of 310 to stop the hyperproliferation of lesions prior to their malignant progression. Actinic Keratosis “AK” also known as solar keratoses or sun-induced keratoses are precancerous, superficial skin growths usually caused by overexposure to the sun. These benign tumors commonly present in multiple lesions although single lesions can occur. Studies have shown that 80% of individuals who have an actinic keratosis have multiple lesions. They present as rough, scaly patches of skin with some underlying redness on average 3-10mm in diameter, usually on the face and dorsa of the hands. They represent early epithelial transformations and approximately 20% of Actinic Keratoses may develop into invasive squamous cell Carcinoma (SCC) a malignant and deadly form of skin cancer. In fact, 60% of SCCs occur at the site of a previous AK lesions and up to 97% of invasive SCCs are associated with a contiguous solar keratosis located at the periphery or within the confines of the SCC. Associated conditions include senile skin, solar elastosis and other sun-induced skin changes.

Actinic Keratosis is a prevalent condition affecting more than 80% of the population over the age of 50. Individuals with a history of basal or squamous cell carcinomas, the incidence of which is 1.2 million per year in the US alone, are at the highest risk. Diagnosis is performed through biopsy with histological confirmation characterized by acanthosis and dyskeratosis. The keratinocytes vary in size and shape and display many mitotic figures. Unusually marked hyperkeratosis and areas of parakeratosis with a loss in granular layer are present. A dense inflammatory infiltrate may also be present. The market potential for an effective agent would be in the range of $500 million USD. Currently, there are few alternative methods to treat AK. Surgery remains the only truly effective means of eliminating lesions to prevent their progression to malignancy.

GBL 100
Grannus’ second product offering, TB4SO or GBL 100, is being developed as a topical agent for the treatment of inflammatory dermatologic indications in psoriasis and contact dermatitis. Psoriasis is a chronic, non-contagious debilitating disorder, characterized by scaling of the skin. Psoriasis affects 2% of the population or 80 million people world wide, can cost upwards of $10-30,000 per year in patient care. Many analysts believe that demand for psoriatic treatments may generate as much as $1.5 billion in revenues for products by the end of the decade. Current remedies include steroids, vitamin D analogues such as Dovonex, drugs such as methotrexate, and biologics such as Amevive and Raptiva. There is significant unmet clinical need from steroid resistance to rebound following biologic therapy. GBL100 will also be tested against contact dermatitis, a disorder that afflicts millions of people due to exposure to common chemicals such as detergent or metals such as nickel. Currently, steroids are used to manage the disease. Initial preclinical studies suggest that TB4SO may prove beneficial in ameliorating the symptoms of contact dermatitis. The Company estimates that GBL100 could reach the market place several years following the conclusion of successful Phase II testing in the US and Europe.

GBL 101
Grannus’ third product offering is a TB4SO derivative, GBL 101, developed for respiratory diseases such as emphysema. Chronic Obstructive Pulmonary Disease or COPD is the 4th leading cause of death worldwide. It is a particularly severe debilitating disorder characterized by progressive and irreversible constriction of the airflow obstruction caused by inflammation of the parenchyma. COPD's prevalence is related to smoking. Current treatments are mostly symptomatic and include the use of corticosteroids, anticholinergics, beta agonists and xanthines. There is a particularly significant unmet need since most treatments are palliative and prolonged steroid use has serious side effects. The global prescription drug market for the treatment of COPD is estimated between $2-3 billion dollars. The Company plans to complete the preclinical testing of the respiratory product late in 2006. If successful, Grannus will most likely target an indication in “steroid resistant” disease. In addition, Grannus will investigate whether GBL 101 might reduce the complications of neutrophil infiltration in Cystic Fibrosis.