Miravant Shares Soar 29% on FDA Ruling

Shares of Miravant Medical Technologies Inc. leaped 29% Tuesday after its new treatment for blindness won fast-track status from the Food and Drug Administration.

Miravant shares soared $6.13 to close at $27.13 in Nasdaq trading after the announcement that the FDA granted fast-track status to Purlytin, which is used to treat age-related macular degeneration, the leading cause of blindness in adults over 50.

Fast-track status is given to drugs and devices that treat serious or life-threatening conditions. It means a drug’s maker may submit data during the clinical trial process, and the FDA can expedite its regulatory review.

The treatment has the potential to generate billions of dollars in revenue for the Santa Barbara-based company once it wins regulatory approval, Chairman and Chief Executive Gary Kledzik said.

“The market size here is considerable since there is no effective treatment for these patients,” he said.

Kledzik said the expedited FDA review could help push forward the date when Miravant may turn its first profit.

“Some analysts have projected profitability for the company by the year 2000, and we don’t disagree on those numbers,” he said, adding that clinical trials on the procedure should be finished by the end of next year.

Purlytin is used in a procedure developed by Miravant called PhotoPoint. Its partner in the project is Kalamazoo, Mich.-based drug maker Pharmacia & Upjohn.

More than 165,000 new cases of age-related macular degeneration are reported each year in the U.S. More than 2 million people suffer from the vision-threatening condition, with the number expected to top 6 million by 2030.

Miravant’s stock has been on a roller-coaster ride for the last year. It rose as high as $72 but has recently been trading just above its 52-week low of $18.63.

Forbes magazine panned the company in May, writing, “There are plenty of near-miracles in medicine, but Miravant looks more like a penny-stock promotion than a magic bullet.”

Kledzik said the article was untrue in many respects. He said allegations that the stock was promoted so that insiders could sell were false, that Pharmacia has renewed funding contracts and that the FDA’s fast-track approval proves the regulatory body is taking the technology seriously.

Miravant is also using its technology to develop treatment for other conditions, including a variety of cancers.