MedImmune will hold off submitting a BLA for Numax , the follow-on to its respiratory syncytial virus therapy Synagis , so it can include data from a second Phase III study, Senior VP-Marketing and Sales Peter Greenleaf said during a Feb. 7 year-end earnings call.

"Our plan forward is to include additional data from our placebo-controlled Phase III study involving Native American children in our BLA package," Greenleaf said. The data should be available in late summer, he said.

The company said it anticipates filing the Numax BLA by year-end and expects FDA action in the second half of 2008. MedImmune has set a tight timeline for Numax; it has said it intends to launch the therapy during the 2008-2009 RSV season (¹ Also see "MedImmune Expects Initial Data From Head-To-Head Numax/Synagis Trial Before Nov. 23" - Pink Sheet, 26 October, 2006.).

The Gaithersburg, Md., company released top-line data from a pivotal Phase III study comparing Numax (motavizumab) and Synagis (palivizumab ) in November.

In that study, Numax met the noninferiority endpoint, reducing the incidence of RSV hospitalizations by 26 percent in approximately 6,600 infants at high risk for the disease compared to Synagis, MedImmune's top-selling product.

The newer therapy also met a secondary endpoint of reducing the incidence of RSV-specific medically attended outpatient lower respiratory infections by approximately 52 percent in the two-year, randomized, double-blind study. Final data from the study will be presented at the Pediatric Academic Society meeting in May, Greenleaf said.

Extending its RSV franchise beyond Numax, MedImmune already plans to file an IND during 2007 for a third-generation monoclonal antibody that has shown four times the halflife of Numax in preclinical testing, Greenleaf said.

During the call, Greenleaf also announced that MedImmune will cease development of its lead oncology candidate Abegrin in all indications, following disappointing 18-month survival data in a Phase II study with prostate cancer patients.

MedImmune's total revenues for 2006 were $1.3 billion, up 3 percent from $1.2 billion in 2005, CFO Lota Zoth reported. Revenues for the fourth quarter of 2006 were $529 million, compared to $492 million during the same period in 2005, a 7 percent increase.

In the fourth quarter, worldwide sales of Synagis were $457 million, up slightly from $453 million in the same quarter in 2005. Annual worldwide sales were $1.1 billion in both 2005 and 2006, Zoth said.

Sales of the intranasal influenza vaccine FluMist increased 71 percent to $18 million for the fourth quarter of 2006 and 128 percent for the full year to $36 million.

The company also earned $26 million from royalties and milestones related to human papillomavirus vaccines in 2006. MedImmune owns "virus-like particle technology" used in production of Merck's Gardasil and GlaxoSmithKline's vaccine candidate Cervarix .

A refrigerated formulation (cold-adapted influenza vaccine, trivalent) of FluMist was approved in January for healthy children and adults five years to 49 years of age. The company's sBLA to expand the refrigerator-stable formulation's label to include children 12 months to 59 months with no history of wheezing or asthma has a May user fee date (² Also see "MedImmune’s Refrigerated FluMist To Be Priced At Slight Discount To Old Formulation" - Pink Sheet, 8 January, 2007.)

- Shirley Haley (s.haley@elsevier.com)

MedImmune Delays Numax BLA Pending Additional RSV Trial Data

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