Isis Files First Antisense NDA; Triggers $5M CIBA Milestone
By Lisa Seachrist
WASHINGTON — The first antisense drug to reach Phase III clinical trials, fomivirsen for cytomegalovirus (CMV), is now the first antisense drug to be put before the FDA, as Isis Pharmaceuticals Inc. filed a new drug application (NDA) for the compound Thursday.
While a development benchmark for the Carlsbad, Calif.-based company, the filing also triggered a $5 million milestone payment from marketing partner CIBA Vision Corp., of Atlanta. The two companies made a joint NDA submission.
"Obviously, it is a very exciting moment for the company, especially for the clinical development team," said Jane Green, senior director of investor relations for Isis. "There is a significant and growing body of evidence for antisense technology as a therapeutic product."
Isis is seeking approval of fomivirsen to treat patients with newly diagnosed CMV retinitis as well as those with more advanced disease. CMV retinitis is a serious and debilitating complication of AIDS. Fomivirsen is an antisense DNA product that prevents CMV from replicating. The drug is injected directly into the eye.
Earlier this week, the company released data from a Phase III study of patients with an advanced form of the disease, establishing that fomivirsen delays progression of CMV retinitis. (See BioWorld Today, April 7, 1998, p. 2.)
The study also showed that a dosing regimen of injections at day 1, day 15 and then monthly doses of 330 micrograms of fomivirsen was just as efficacious as, and safer than, a dosing regimen calling for 330 micrograms once a week for three weeks followed by doses every other week.
Those data, along with a study of fomivirsen in newly diagnosed patients, serve as the cornerstone of the companies' application. Studies involving fomivirsen with gancyclovir and some European results will serve as supportive data for the NDA.
"We haven't specifically requested expedited review or fast-track status," Green said. "However, we have some indications from FDA that they intend to move quickly on the application. So, we have reason to be hopeful."
Last summer, Isis signed a $20 million marketing deal for fomivirsen with CIBA Vision, a subsidiary or Novartis AG, of Basel, Switzerland. (See BioWorld Today, July 16, 1997, p. 1.)
That deal grants CIBA Vision worldwide marketing rights for fomivirsen. Isis will provide the drug to CIBA.
Isis also has antisense drugs in clinical trials to treat Crohn's disease, cancer, transplant rejection, rheumatoid arthritis and ulcerative colitis.
The company expects to file for regulatory approval of fomivirsen in the European Union shortly.
Isis' stock (NASDAQ: ISIP) closed Thursday at $15.437, up $0.125. *