Liposome Co.'s Evacet will take a major step closer to the market ,,,
WASHINGTON (Dow Jones)--Liposome Co.'s (LIPO) anti-cancer drug Evacet will take a major step closer to the market if it gets a positive recommendation from a federal panel Sept. 16.
The drug is a different formulation of the popular chemotherapy doxirubicin. In Evacet, the doxirubicin is placed into a fat bubble called liposome, which is designed to protect the body's healthy cells. The drug is released when it reaches the tumor.
Liposome said this method allows patients to use more of the potent drug without its serious side effects, which include heart failure.
The company will ask the panel to support Evacet as a treatment for metastatic, or spreading breast cancer. The Food and Drug Administration will make the final decision on the drug; however, it usually heeds the advice of its expert panels.
In one study of 297 women with metastatic breast cancer, Evacet was compared to conventional doxirubicin. The company said the study showed patients on both drugs had similar response rate and survival time. Five of the doxirubicin patients had congestive heart failure, while none of the Evacet patients developed the ailment. Cardiac toxicity was seen in 22% of patients on doxirubicin and in 6% of those on Evacet.
Another study of 160 women with metastatic breast cancer showed about the same percentage of patients responded to the treatments. However, in this study, the company said the drug worked for a significantly longer time in Evacet patients compared to those on doxirubicin. No heart toxicity was seen in either group of patients.
Corey Davis, a pharmaceutical analyst at Hambrecht & Quist, said getting a positive vote from the panel and then getting Evacet on the market is "absolutely critical for the next phase" of growth for Liposome.
"For them to get to the next level Evacet has to be successful," Davis said. "From the data I've seen there is a very high likelihood of success with the panel and the FDA."
Davis projects that if Evacet is approved for sale in the U.S., next year it will have sales of $18 million and sales of $100 million in 2002.
"Ultimately what will determine sales is pricing, because doxirubicin is a fairly inexpensive drug because it is a generic," he said. Of the 60,000 new metastatic breast cancer patients diagnosed each year, Davis expects Evacet to capture 20% of the market and be sold for about $6,000 per patient per year.
About 25% of the drug's sales, if approved, will be for off-label uses. Once the FDA approves a drug for any use, doctors can prescribe it as they see fit. However, companies can only market it for the approved use.
Davis expects to see Evacet used to treat ovarian cancer and other types of breast cancer. Another liposomal form of doxirubicin, Alza Corp.'s (AZA) Doxil, won expanded FDA approval in June to treat
advanced ovarian cancer. Doxil has been on the market in the U.S. since 1995, when it was approved to treat an AIDS-related cancer. Last year, Doxil's U.S. sales were $42.2 million.
-Otesa Middleton; 202-862-6654 |
