Delay in FDA review of Calgene Inc.'s Flavr Savr tomato willresult in a large financial loss to the company in 1994, Calgeneannounced Thursday. Agency representatives have told thecompany that they are still reviewing its food additive petitionfor the APH(3')II selectable marker gene and its request for anadvisory opinion on the safety of the Flavr Savr tomato itself.According to Calgene, FDA did not say when its review will becomplete. The company requested an advisory opinion fromFDA in 1990.
Calgene had been expecting to launch the product late in thefall of 1993, but is now anticipating a launch in the secondquarter of 1994. Ironically, Calgene said "significant quantities"of tomatoes, including the genetically altered Flavr Savr that isengineered to resist decay, may rot while awaiting FDAapproval. The company will also incur large losses associatedwith the expense of maintaining its large-scale productioninfrastructure without realizing sales from the Flavr Savr.Currently the company is selling MacGregor brand tomatoes,which are not genetically altered.
The APH(3')II (kanamycin-resistant) selectable marker gene isadded to the tomato to identify it as a genetically modifiedplant. An antisense gene, which causes slower softening of thefruit, is attached to the marker.
While the Davis, Calif., company did not place a figure on itslosses, it predicted that they would be larger than its $25.6million loss in 1993.
FDA's slow action will not affect Calgene's launch strategy, acompany spokesperson said. The company still plans tointroduce the Flavr Savr in small quantities in the midwestbefore full scale introduction of the tomato across the country.
Calgene's stock (NASDAQ:CGNE) closed at $12.63 per share onThursday, down 13 cents.
-- Karl A. Thiel Associate Editor
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