The Food and Drug Administration has postponed two highly anticipated advisory panel meetings next week that were slated to review rival drugs from
. Both drugs are being developed to treat Fabry disease, a rare genetic disorder.
A statement released Friday by Transkaryotic said the FDA decided to put off the Sept. 26-27 advisory panel meetings "due to administrative reasons until later this year." No further details were provided.
The last-minute postponement just adds more drama to the heated competition between Genzyme and Transkaryotic that dates back to 2000, when each company submitted applications for their respective Fabry disease drugs. The FDA is supposed to render a final decision under rules defined by the Orphan Drug Act, which means that only one drug gets approved and is given seven years of market exclusivity in the U.S.
Fabry disease is rare -- only about 2,000 patients suffer from it in the U.S., but treatment is expected to cost upwards of $165,000 per year, which makes this a $330 million market opportunity for both companies.
As the advisory panel dates neared, speculation was rising as to how the FDA would make its decision. Some observers believe the regulatory agency would use loopholes to approve both drugs, while others believed a sole winner would be picked.
There's more than money riding on the FDA decision. Genzyme badly needs some positive news after falling on its face this year with round after round of sales and earnings
warnings tied to its Renagel drug. Transkaryotic, on the other hand, is a much smaller firm -- still unprofitable -- that is trying to get its first drug approvd in the U.S.
Transkaryotic's Replagal and Genzyme's Fabrazyme were both approved for sale in Europe in August 2001. Replagal has
won about 60% of the market, because its drug is easier to administer and has demonstrated clearer clinical benefit to patients, according to published studies.
Shares of Transkaryotic were hit relatively harder Friday on news of the delayed panel meetings, falling $2.61, or 7.9%, to $30.38 in recent trading. Shares of Genzyme are down 26 cents, or 1.2%, to $21.50.