MedImmune Announces Preliminary Data From CAIV-T Pivotal Phase Three Trial - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

OPERATOR: Good day, ladies and gentlemen, and welcome to the preliminary results of Phase III head-to-head influenza vaccine study conference call. My name is Gregory, and I will be your coordinator for today. At this time, all participants are in listen-only mode. We will be facilitating a question-and-answer session towards the end of today's conference. (OPERATOR INSTRUCTIONS). As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the call over to your host for today's call, Mr. Peter Vozzo, Director of Investor Relations. Please proceed, sir.

PETER VOZZO, IR DIRECTOR, MEDIMMUNE: Good morning and welcome to our conference call to discuss the preliminary results of our pivotal Phase III study comparing CAIV-T, the investigational refrigerator-stable formulation of FluMist to the injectable influenza vaccine. This call is being electronically recorded and is copyrighted by MedImmune. No reproductions, retransmissions or copies of this conference call can be made without the written permission of MedImmune.

In this call, members of our senior management will discuss this morning's press release describing the preliminary results of the Phase III trial and other recent progress with our influenza vaccine franchise.

Please note that any statements about the Company's prospects or future expectations are forward-looking statements. As you know, forward-looking statements involve substantial risks and uncertainties, and actual results may differ materially from expectations. Please refer to the press release issued earlier today that is related to this call and to our filings with the SEC for more information on the risks and uncertainties that could cause actual results to differ.

Today's press release describing our preliminary results of our Phase III, head-to-head influenza vaccine study may be found on our Web site at www.MedImmune.com in the box marked "news" or with the archived press releases on the Investor Relations page.

Now, I will have the call over to David Mott, MedImmune's President and Chief Executive Officer.

DAVID MOTT, PRESIDENT, CEO, MEDIMMUNE: Thank you very much, Peter. Good morning, everyone.

In addition to Peter, with me on the call today are Jim Young, our President of R&D, Ed Connor, our Executive Vice President and Chief Medical Officer, and Armando Anido, our Executive Vice President and head of Sales and Marketing.

We're all very pleased to discuss with you the preliminary results of our Phase III influenza vaccine study in children 6 months through 59 months of age, comparing CAIV-T, the next generation form of our intranasal flu vaccine, FluMist, to the injectable vaccine. As you know, our long-term plans for FluMist are to establish it as a better influenza vaccine preferred by pediatricians. To get there we needed to show that refrigerator-stable CAIV-T is biologically equivalent to the currently approved frozen formulation. To that end, we successfully demonstrated equivalent immunogenicity of CAIV-T and FluMist in our bridging study, and in September, we submitted a supplemental biologics license application with FDA for approval to use CAIV-T in preventing influenza in healthy individuals 5 through 49 years of age. If we obtain FDA approval, we can then eliminate the difficult storage conditions that currently hamper the handling of FluMist after it is shipped to customers.

In addition, in August, we submitted an application to the FDA for our new, state-of-the-art bulk vaccine manufacturing facility in the UK. This facility, which incorporates several improvements to the manufacturing process, will add a capacity of up to 15 million trivalent bulk doses per month, or approximately 90 million trivalent doses per influenza manufacturing season. Construction and validation were substantially completed in spring of 2005, and the FDA completed its site inspection of this new facility in October of 2005. We anticipate approval of this facility shortly.

Our blend/fill/finish vaccine production facility in Pennsylvania has also undergone improvements and modifications to increase finished product capacity to approximately 35 million trivalent doses per influenza season.

Next, we needed to expand the label to include children under the age of five and to compare CAIV-T to the injectable vaccine at helping to reduce influenza illness in young children. It's extremely gratifying to report that the trial met its primary and secondary endpoints and that the strong efficacy results confirm our belief about the potential opportunity for this product. The preliminary results indicate that CAIV-T was highly efficacious compared to the injectable flu vaccine, showing a statistically significant 55% relative reduction in influenza illness caused by both matched and mismatched strains of influenza.

To give more color on these results, I'd like to hand the call over now to Dr. Ed Connor, our Chief Medical Officer.

ED CONNOR, EVP, CHIEF MEDICAL OFFICER, MEDIMMUNE: Thank you, Dave. Good morning, everyone.

Dave has highlighted some of the topline results from the CP 111 trial and now I will give you a bit more detail.

First, let me briefly discuss the design of the study. This pivotal Phase III trial for CAIV-T was a randomized, double-blind, multinational study to assess the safety and relative efficacy of CAIV-T in the injectable and activated influenza vaccines during the 2004-2005 influenza season. A total of 8492 children aged 6 months through 59 months were enrolled at 249 sites in 16 countries in North America, Europe and Asia. Children were randomized one-to-one to receive either CAIV-T or the injectable influenza vaccine. A placebo nasal spray or placebo injection was also given to each child to preserve the double-blind design of the…