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MedImmune Expects Initial Data From Head-To-Head Numax/Synagis Trial Before Nov. 23

This article was originally published in The Pink Sheet Daily

Executive Summary

While the firm anticipates a superiority finding, the study comparing its RSV therapies is powered for both superiority and non-inferiority, MedImmune execs say during Q3 call.

MedImmune expects to release top-line data for its Synagis follow-on Numax by Thanksgiving, President-R&D James Young said during a third quarter earnings call Oct. 26.

The pivotal Phase III trial pitting Synagis (palivizumab), MedImmune's top selling product, against its follow-on respiratory syncytial virus therapy Numax (motavizumab) is powered for both "robust" non-inferiority and superiority, Young said.

"We think that we have a very good chance of showing superiority [and] certainly think that non-inferiority should not be a question - we're very confident with respect to that," Young said.

A finding of superiority makes it "virtually impossible" to do a clinical study comparing a new product to Numax, he said. "It really secures the franchise for us for the long haul."

"The cutoff point for launching the product would be where we don't see a clinical benefit, but as long as there is clinical benefit, as well as financial benefit to the organization, we'll launch the product," added VP-Marketing & Sales Peter Greenleaf.

Pending approval, the company plans to launch Numax "sometime during the 2008-2009 [RSV] season," CFO Loa Zoth said during the company's second-quarter call (1 (Also see "MedImmune To Release Phase III Data By Year-End For Synagis Follow-On" - Pink Sheet, 21 Jul, 2006.))

MedImmune is in "active dialogue" with FDA and expects to have final action by year-end on the refrigerator-stable formulation of its FluMist intranasal flu vaccine, CEO David Mott said. The Gaithersburg, Md.-based company received a "complete response" letter for its BLA for CAIV-T (cold adapted influenza vaccine, trivalent) in July and responded in August (2 (Also see "MedImmune Puts FluMist In FDA's Fridge" - Pink Sheet, 14 Aug, 2006.)). The application seeks labeling for use in children and adults ages 5-49 years.

Mott said the company also is trying to accelerate the May 28 PDUFA date on an sBLA that would expand the CAIV-T label to cover children 12-59 months of age with no history of wheezing or asthma.

"It does seem a little ironic that given the current shortage and delays in getting vaccine out to this very patient population that we don't have a priority review on that," Mott said. The sBLA was submitted in July (3 (Also see "Refrigerator-Stable FluMist Submitted For Young Children" - Pink Sheet, 31 Jul, 2006.)).

"We're trying to do everything we possibly can to work with the agency to accelerate that review," Mott said, adding that MedImmune plans to "work hard" with FDA, the Centers for Disease Control & Prevention's Advisory Committee on Immunization Practices and the American Academy of Pediatrics.

This quarter marked the first time MedImmune received royalty and milestone income ($7 mil.) from Merck for its license on "virus-like particle technology" used in the human papilloma virus vaccine Gardasil . Merck reported $70 mil. in income from the vaccine for the third quarter (4 (Also see "Merck’s Gardasil Records $70 Mil. In Sales In Q3" - Pink Sheet, 20 Oct, 2006.)).

Mott said the company anticipates that GlaxoSmithKline will submit its HPV vaccine, Cervarix , to FDA by year-end. In a same-day call, however, GSK said the filing would be delayed to April 2007 (5 (Also see "Cervarix Filing Delay Will Not Impact The HPV Vaccine’s Market Potential – GSK" - Pink Sheet, 26 Oct, 2006.)).

Mott said he anticipates a U.S. Supreme Court decision in MedImmune v. Genentech "no later than the first half of 2007." The case tests whether a firm can challenge the validity of a licensed patent when it has not breached the licensing agreement (6 (Also see "Declaratory Judgment Ruling From U.S. Supreme Court Could Impact Licensing Deals, ANDAs" - Pink Sheet, 10 Oct, 2006.)).

In its third quarter report, MedImmune notes a profit on the sale of its investment in Mountain View, Calif.-based Avidia to Amgen, which acquired the company and its therapeutic protein engineering platform in September (7 (Also see "Amgen Expands Inflammation Pipeline With Avidia Purchase" - Pink Sheet, 29 Sep, 2006.)).

Total MedImmune revenues for the quarter increased 15% over Q3 2005, driven by a 52% increase in sales of FluMist to $16 mil. and an 11% increase in worldwide sales of Synagis to $112 mil.

For the first nine months of 2006, MedImmune's total product sales of $716 mil. included $608 mil. from worldwide Synagis sales. For that same period in 2005, total sales were $739 mil., including $624 mil. in worldwide Synagis sales.

FluMist sales were $18 mil. in 2006 and $13 mil. in 2005 for the same period. This year 1.2 mil. doses of FluMist have been shipped, compared with only 800,000 in the third quarter of last year, Zoth said.

- Shirley Haley ([email protected])

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