425 1 a2065230z425.htm FORM 425 Prepared by MERRILL CORPORATION
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MedImmune Contacts:
Lori Weiman
Senior Director, Corporate Communications
301-527-4321

Will Roberts
Manager, Investor Relations
301-527-4358

On December 3, 2001, MedImmune announced that it has entered into a definitive merger agreement under which it will acquire Aviron through an exchange offer and merger transaction. Attached and incorporated herein by reference in its entirety as Exhibit 1 is a copy of a slide-show presentation given to investors by MedImmune to further explain the transaction.


Filed by MedImmune, Inc.
Pursuant to Rule 425 under the Securities Act of 1933
and deemed filed pursuant to Rule 14d-2 of the Securities Exchange Act of 1934
Subject Company: Aviron
Commission File No. 000-20815

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Aviron Acquisition
December 2001


This announcement may contain, in addition to historical information, certain forward-looking statements that involve risks and uncertainties. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's and Aviron's filings with the SEC. MedImmune and Aviron are developing products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success. There can be no assurance that the offer and merger will close or that Aviron will be integrated successfully or without unanticipated costs.

We urge the Aviron stockholders and other investors to read the registration statement on Form S-4, Schedule TO, preliminary prospectus, supplements, final prospectus and other exchange offer documents which will be filed by MedImmune with the Securities and Exchange Commission and the related solicitation/recommendation statement which will be filed by Aviron with the SEC. These documents will contain important information which should be read carefully before any decision is made with respect to the offer. When documents are filed with the SEC, they will be available for free at the SEC's website at www.sec.gov. Documents are available for free from the contact persons above.



Agenda

  Transaction Details


 

Strategic Rationale


 

FluMist™ Opportunity


 

Aviron Pipeline Overview


Transaction Details

$1.5B transaction value


$47.41 per AVIR share (28% premium) at 11/30/01


Stock-for-stock, tax free exchange offer


1.075 MEDI shares for each AVIR share


Equity ownership
  86% MEDI
  14% AVIR


Standard closing conditions


Anticipate closing 1Q '02


Strategic Rationale
Excellent Strategic Fit

Scientific and medical overlap
  Infectious disease
  Respiratory disease
  Vaccine technology
  Pediatrics


Leverages infrastructure and capabilities
  Product development
  Regulatory
  Manufacturing/QA/QC
  Marketing and sales


Strategic Rationale
Unique Ability to Assess and Execute

R&D   Jim Young, PhD


Clinical

 

Frank Top, MD
Ed Connor, MD


Regulatory

 

Peter Patriarca, MD


Mfg./QC/QA

 

Gail Wasserman, PhD
Ed Goley
Ben Machielse


Marketing

 

Jeff Hackman


Strategic Rationale
Excellent Financial Fit

Dilutive in 2002


Neutral to cash EPS in 2003


Double digit accretion thereafter


Accelerates '03-'06 growth targets
  25% annual revenue growth
  30% annual EPS growth


Strategic Rationale
Excellent Financial Fit

Financial Goals

 
  2002
  2003
  2006
Revenues   $900M   $1.1 - $1.25B   >$2.1B
Cash EPS   $0.65 - $0.70   $1.15 - $1.20   >$2.50

2006 Operating Metrics (Goals)

  77% to 80% gross margin
  15% to 17% R&D
  21% to 23% SG&A
  Over 40% EBITDA and pre-tax margins


Strategic Rationale
Create Premier Biotech Company

Two blockbuster products
  Synagis®
  FluMist™


Rich pipeline
  Antibodies and vaccines
  Four in Phase 3, five in Phase 2


Proven ability to deliver
  Product approvals
  Manufacturing scale-up
  Commercial success
  Financial results


The FluMist Opportunity



Influenza

Most common cause of medically attended acute respiratory illness


Acute febrile illness (up to 104°F)
  Chills, myalgia, cough, sore throat, nasal congestion, headache, malaise


High risk of mortality and other severe complications
  Pneumonia and influenza—6th leading cause of death in the US


Impact of Influenza

Every Year in the U.S.

 


25-50 Million People Infected

 


20,000-50,000 Deaths

 


70 Million Lost Work Days

 


38 Million Lost School Days

 


Costs Nearly $15 Billion

Source: MMWR 2001
Source: American Lung Association, 3/01



Influenza-related Morbidity and Mortality

LOGO

Glezen WP. Emerging Infections: pandemic influenza. Epidemiol Rev. 1996; 18(1),64-76.



Influenza

Vaccination is primary method for prevention
  Annual vaccination
  Inactivated vaccine


Three manufacturers
  Aventis Pasteur
  Medeva
  American Home Products


80 million doses sold annually in U.S.
  Growing at 10%
  Price doubled to approximately $5 recently
  Expected to reach $10 soon


Anticipate proprietary vaccine pricing for FluMistTM

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FluMist™

Live

 

Active viral replication

 

X

 

>20,000 vaccinated in ~20 studies

Attenuated

 

"Mild" illness

 

X

 

Positively viewed by pediatric community

Cold-adapted
Temperature-
sensitive

 

Replication restricted
mainly to nasopharynx

 

X

 

Anticipated by recommending bodies

Trivalent

 

A (H3N2, H1N1), B

 

X

 

Significant public health impact

Dose = 0.5 ml (~107 TCID50)
0.25 ml into each nostril

 

 

 

 


Efficacy

Endpoint

  % Efficacy
  95% CI
Culture Confirmed Flu   91.7   87.7, 94.4

Febrile Illness

 

93.6

 

89.7, 96.0

Otitis Media

 

96.2

 

87.6, 98.8
Lower Respiratory Illness   95.2   62.2, 99.4
Endpoint

  % Reduction
  P-Value
Missed daycare/preschool/school days        
  Any Illness   12.8   0.07 
  Culture Positive Illness   93.2   <0.001

Healthcare Provider Visits

 

 

 

 
  Any Illness   11.2   0.02 
  Culture Positive Illness   92.1   <0.001

Parental Lost Work

 

 

 

 
  Any Illness   12.6   0.17 
  Culture Positive Illness   93.0   <0.001


Frozen FluMist BLA
Under FDA Review

BLA Submission: October 31, 2000
  10 month PDUFA calendar


Pre-licensure inspections conducted 1H 2001
  Clinical sites
  Manufacturing sites


FDA advisory committee (VRBPAC): July 26-27, 2001


VRBPAC Efficacy Discussion

Question 1:   Are the data adequate to support the efficacy of FluMist?

 

 

Adults 18-64 years of age?
Yes 13-2

 

 

Children 1-17 years of age?
Yes 8-7

 

 

Children 2-17 years of age?
Yes 13-2


VRBPAC: Safety Discussion

Question 2:   Are the data adequate to support the safety of FluMist in the population in which an indication is being sought (i.e., 1-64 years)?

 

 

No 10-4

 

 

6 of 10 no votes were provisional pending final FDA data analysis

 

 

Issues
        Pneumonia    
        Asthma    
        Concurrent use    


Pediatric Pneumonia

 
  FluMist
  Placebo
Study

  N
  Cases
  Greater Than or Equal to 21d
  N
  Cases
  Greater Than or Equal to 21d
AV006-Y1   1070   8   6   532   2   1
AV006-Y2   917   2   1   441   0   0
AV007   400   1   1   100   0   0
AV0012-Y1   4298   2   1            
AV0012-Y2   5251   6   4            
AV0015   949   1   1            
AV0017   1175   3   3   0   0   0
AV0019   6495   14   10   6   10   6
Total   20,555   37   27   4,321   12   7
Percent       0.18%   0.13%       0.21%   0.16%


Asthma Episodes (All Doses)

Healthy Children AV019

Age
  Setting
  FluMist
n/N

  Placebo
n/N

  Rate per 1000
person-months
FluMist / Placebo

  Binomial
Relative Risk
(90% CI)

1 - 17   Combined   58 / 6473   30 / 3216   4.58 / 4.77   0.96
(0.66, 1.40)
P=.422

1 - 8

 

Combined

 

45 / 3769

 

21 / 1868

 

5.05 / 4.76

 

1.06
(0.69, 1.66)
P=.418

18 - 35 mos.

 

Combined

 

16 / 728

 

2 / 369

 

9.30 / 2.29

 

4.06
(1.29, 17.86)
P=.019

12 - 17 mos.

 

Combined

 

1 / 171

 

3 / 90

 

2.51 / 14.43

 

0.17
(0.01, 1.17)
P=.067


Safety Database
(approximate number of participants)

 
  Pre-Aviron
Data Set

  Included in
BLA

  Included in
Safety Update

Healthy Children   2,600   6,000   18,000
Healthy Adults   4,600   3,700   4,000
High Risk   900   700   2,000
Total   8,100   10,400   24,000


Complete Response Letter

  Complete response letter received 8/31/01


 

FDA requested additional information and clarification on clinical & manufacturing data


 

Response planned by December 31, 2001


 

FDA will re-establish review period


 

Optimistic that available data will satisfy FDA


Potential Label

Indication   Prevention of influenza in healthy persons age 18mo - 64yrs

ClinPharm

 

93% Efficacy in healthy children 37%[Arrow Down Symbol] Febrile otitis media Reduction in direct/indirect costs

Precautions/
Warnings

 

Do not administer to persons with prior Hx wheezing; do not administer with other vaccines

Side Effects

 

Mild URI Sx in 20-50%
Significant fever 2-5%

Dosage/Admin

 

0.5 cc intranasally (0.25 cc/nostril)
2 doses 30-60d apart for age <9yrs


Conclusions

X   Important medical advancement

X

 

New approach to immunization

X

 

Efficacy established

X

 

Draft clinical responses address major CR issues

X

 

Primary issues that may affect timing and labeling
    •  Concomitant immunization data
    •  Wheezing/asthma

X

 

Data support high likelihood of approval


FluMist™ Commercial Structure

AHP (Wyeth-Lederle Vaccines) alliance
  U.S. co-promotion
  AHP distributes Ex-U.S.
  AHP records end-user sales


Aviron manufactures frozen FluMist


Aviron/AHP share manufacturing of liquid FluMist


AHP pays (reimburses) sales and marketing expenses


Co-funding of clinical development costs


Aviron receives approximately 50% of worldwide end-user sales and operating profit


R&D Programs

FluMist Enhancements
  Liquid presentation
  sterile filtration for virus harvest
  Reduced NAF
  Plasmid rescue for development of MVS
  Cell culture production
  Mapping of mutations in MDV


Herpes Simplex Vaccine


Cytomegalovirus Vaccine


Parainfluenza Virus-3/bovine PIV-3 Vaccine Hybrid


RSV Vaccine/bovine PIV-3 Vaccine Hybrid


Aviron Acquisition

  Excellent strategic fit


 

Excellent financial fit


 

Creates premier biotech company

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QuickLinks

Agenda
Transaction Details
Strategic Rationale Excellent Strategic Fit
Strategic Rationale Unique Ability to Assess and Execute
Strategic Rationale Excellent Financial Fit
Strategic Rationale Excellent Financial Fit
Strategic Rationale Create Premier Biotech Company
The FluMist Opportunity
Influenza
Impact of Influenza
Influenza-related Morbidity and Mortality
Influenza
Efficacy
Frozen FluMist BLA Under FDA Review
VRBPAC Efficacy Discussion
VRBPAC: Safety Discussion
Pediatric Pneumonia
Asthma Episodes (All Doses)
Safety Database (approximate number of participants)
Complete Response Letter
Potential Label
Conclusions
FluMist™ Commercial Structure
R&D Programs
Aviron Acquisition