Adherex Technologies Inc. (AMEX: ADH) has announced that it has received an orphan drug designation for its ADH-1 from the FDA for the use of ADH-1 in conjunction with melphalan for the treatment of Stage IIB/C, III, and IV malignant melanoma.
Adherex is currently conducting a Phase IIb expansion trial in melanoma using systemic ADH-1 in combination with regional melphalan; and Adherex is also evaluating the synergy of systemic ADH-1 in combination with regionally-infused melphalan for the treatment of melanoma in a Phase I/IIb trial. Another Phase I trial is also nearing completion at US Oncology where systemic ADH-1 is being evaluated in combination with three different chemotherapies.
The FDA orphan drug designation could be substantial for this company. It "could" provide incentives such as funding for clinical studies, study assistance, a waiver of FDA user fees, potential tax credits, and up to seven years of market exclusivity upon marketing approval.
If you will recall the blow-up at Medarex (NASDAQ: MEDX) and the massive options speculation that was trading around the stock before the FDA review, the mere potentiality of this is huge. This is a very different company and the treatment here is a different treatment as this is malignant. But traders will likely tie the two at least in relation to each other. Melanoma is a very under-treated disease in the US and throughout the world with a mega-blockbuster drug potential. Metastatic melanoma is currently nothing short of a death sentence.
Jon C. Ogg
February 22, 2008