West Coast Editor
A bit of you know what at the end of the tunnel came for Miravant Medical Technologies Inc. in the form of an approvable letter for its light-activated drug to treat age-related macular degeneration, although the FDA is asking for another confirmatory trial.
Miravant's stock (OTC BB:MRVT) closed Friday at $1.67, up 11 cents.
A phone call to the company yielded a recorded message from Tom Herrick, manager of investor relations for Santa Barbara, Calif.-based Miravant.
"Until we've had an opportunity to consult with the FDA, the company will have no further information on this matter," Herrick said, adding that the company looks forward to working with the agency, and referred questions to Miravant's press release and the SEC filing that contains the release.
The drug, SnET2 (tin ethyl etiopurpurin), missed its primary endpoint in a Phase III study disclosed at the first part of 2002, causing Miravant's stock to plunge by about 75 percent, ending that day at $2.44. (See BioWorld Today, Jan. 15, 2002.)
However, seven months later the company said further analysis of the data showed certain subsets of patients demonstrated stabilized or improved visual acuity at two years, and by January 2003 Miravant was making known its plan to file a new drug application based on the trial.
In August, at the American Society of Retinal Specialists meeting in San Diego, Miravant detailed how SnET2 provided a visual acuity benefit in AMD patients with occult lesions. Those with mixed lesions (classic and occult) and pure occult lesions came up with a positive treatment response compared to placebo, and Miravant said the benefit was statistically significant for patients with both predominantly occult and pure occult lesions. SnET2 uses Miravant's PhotoPoint technology, which involves light-activated drugs that selectively target diseased cells and blood vessels.
Already on the market for predominantly classic AMD (a subset that comprises about 25 percent of all cases) is Visudyne (verteporfin), from Vancouver, British Columbia-based QLT Inc. and Novartis AG, of Basel, Switzerland. Visudyne's global sales for the first two quarters ended June 30 totaled $210 million.
Coming up fast is Macugen (pegaptanib sodium), a pegylated anti-VEGF aptamer for neovascular AMD that inhibits the activity of vascular endothelial growth factor, from Eyetech Pharmaceuticals Inc. and Pfizer Inc., both of New York. The FDA is reviewing a new drug application for Macugen.
Miravant had a cumulative net loss of about $206.2 million as of June 30. Also, its independent auditors, Ernst & Young LLP, indicated in their report accompanying the company's Dec. 31 consolidated financial statements that, based on generally accepted auditing standards, Miravant's "viability as a going concern is in question," Miravant said in its filing.