West Coast Editor
MedImmune Inc. has given the FDA the information it sought in a complete response letter regarding the nasal influenza vaccine FluMist, but analysts don't expect the federal agency to cough up its review quickly - and that may put a chill on prospects for launch by the upcoming flu season, at least in the view of some.
"When I talked to the company this morning, they said they were still in the game or still in the running to make the season this year," Philip Nadeau, analyst with SG Cowen in New York, said Tuesday. "But it would take basically everything going MedImmune's way in the next two months for that to happen."
Company representatives did not return calls seeking comment.
The biologics license application for FluMist was submitted almost two years ago by Aviron Inc., of Mountain View, Calif., which MedImmune has since acquired in a $1.5 billion merger. Since the BLA has been in the hands of regulators, Aviron - and now MedImmune - has been going back and forth with the FDA, plodding toward the goal of getting FluMist on the market by the 2002-03 season. (See BioWorld Today, Dec. 4, 2001.)
One year ago, a government panel said efficacy data for FluMist in children and adults were adequate, but safety data were not solid enough to win recommendation for approval, and more recently MedImmune said it was working "feverishly" to answer 68 questions in the latest FDA letter: 24 related to manufacturing and 44 related to clinical information. (See BioWorld Today, July 30, 2001, and July 12, 2002.)
The company has done that, and at issue next is whether the FDA will identify the matter as Class I, which requires a response from the agency within two months, or Class II, which requires a response within six months.
"Nothing [MedImmune has] disclosed to us about the FDA's questions would preclude the Class I designation, but nothing would guarantee it, either," Nadeau told BioWorld Today. "We'll have to wait and see."
MedImmune has three products on the market, including Synagis (palivizumab) for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk for the disease, which Nadeau called "one of the most successful drugs ever developed by the biotechnology industry," estimating it will sell more than $650 million this year.
Later this fall, data are expected from Phase III trials of Synagis in congenital heart disease and cystic fibrosis, Nadeau said.
"Based on the prospects for continued growth of Synagis and the potential of FluMist, MedImmune has some of the strongest fundamentals among its large-cap biotech peers," he wrote in a research note.
The other marketed drugs are Ethyol (amifostine), a selective cytoprotective agent used to reduce some toxicities associated with cancer chemotherapy and radiotherapy; and CytoGam, an intravenous immune globulin indicated for prophylaxis against cytomegalovirus disease associated with the transplantation of a kidney, lung, liver, pancreas or heart. Eleven more products are in the pipeline, undergoing various stages of clinical testing.
MedImmune's stock (NASDAQ:MEDI) closed Tuesday at $26.88, down $1.68.