By Lisa Seachrist
The Liposome Co.'s Evacet, which an FDA advisory panel rejected in September as a therapy for metastatic breast cancer, has found new life following a meeting with the agency last Wednesday.
On the advice of the agency, Princeton, N.J.-based Liposome will pull its new drug application (NDA) for Evacet - a liposomal formulation of doxorubicin - and resubmit the NDA later this year after addressing issues the agency had with the drug. The company reported the turn of events late Thursday evening.
"We had a meeting with [the FDA] on Wednesday and they strongly encouraged us to take this route," said Doug Farrell, director of investor relations for Liposome. "There are, of course, no guarantees. If we do get an approval, we may only get approval for a high-risk indication; but we view this as a very positive sign."
Farrell said the agency has requested that the company better document the comparison between Evacet and epirubicin, as well as map out the outcomes for high-risk patients. The company expects to submit a new NDA before year's end.
Doxorubicin is a derivative of an antibiotic that has anticancer activity and has been used as a treatment for metastatic breast cancer for 36 years. However, doxorubicin has serious side effects, the most notable being heart damage culminating in congestive heart failure.
Evacet is designed to lessen the cardiotoxicity of the drug by encapsulating it as a doxorubicin citrate complex in liposomes. As a result, the drug is much less likely to find its way into the heart muscle where it can do damage.
The Oncologic Drugs Advisory Committee (ODAC) concluded in September that Evacet was much safer than doxorubicin. The panel, however, had concerns over one study showing that the doxorubicin-treated group had a median survival 5.5 months longer than Evacet and a study comparing Evacet to the anthracycline epirubicin, marketed by Pharmacia & Upjohn, where the dosage of epirubicin appeared to be much lower than normal (See BioWorld Today, September 17, 1999, p.1.)
"If we can better document the epirubicin data, we might be able to get a [broad label] approval," Farrell said. "The good thing is that they didn't tell us to do additional studies."
Nevertheless, Alex Zisson, senior analyst and managing director at Hambrecht and Quist LLC in New York, considers it more likely that the FDA will approve the drug for a more specific indication.
"My guess is they will focus on one or two patient populations, such as patients suffering from heart damage as a result of pretreatment with doxorubicin," Zisson said. "The prospects for Evacet certainly look better than they did after the panel hearing."
Farrell told BioWorld Today the company is currently speaking with a number of pharmaceutical companies about serving as their European marketing partner. "We are talking with several big pharma companies about becoming our European marketing partner," Farrell said. "You can expect an announcement about that soon. Our European and Canadian regulatory filings are proceeding and we expect final word on them in June or July [of 2000]."
Liposome's stock (NASDAQ:LIPO) closed Friday at $7.625, up $0.625 a share.