- Filing of certain prospectuses and communications in connection with business combination transactions (425)
September 07 2011 - 1:56PM
Edgar (US Regulatory)
Filed by Trimeris, Inc.
Pursuant to Rule 425 under the
Securities Act of 1933 (the Securities Act) and
deemed filed
pursuant to Rule 14a-12 under the
Securities Exchange Act of 1934 (the Exchange Act)
Securities Act File Number: 333-175512
Subject Company: Trimeris, Inc.
Exchange Act File Number: 000-23155
This filing relates to the proposed merger involving Trimeris, Inc. (
Trimeris
) and Synageva BioPharma Corp.
(
Synageva
), pursuant to the terms of an Agreement and Plan of Merger and Reorganization, dated as of June 13, 2011, by and among Trimeris, Tesla Merger Sub, Inc., a wholly owned subsidiary of Trimeris, and Synageva. Beginning on
September 7, 2011, the following PowerPoint slides are being used for presentations by Synagevas management to certain investors:
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©
Copyright 2011 Synageva BioPharma
Company Presentation
September 2011
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©
Copyright 2011 Synageva BioPharma
Forward-Looking Statements
These materials and oral statements made from time to time by Synageva
representatives in respect of the same subject matter may contain forward-looking
statements. These statements can be identified by introductory words such as
expects, plans, intends, believes, will,
estimates, forecasts, projects, or
words of similar meaning,
and by the fact that they do not relate strictly to historical or
current facts.
Forward-looking statements frequently are used in discussing potential
product applications,
potential collaborations, product development activities, clinical
studies, regulatory
submissions and approvals, and similar operating matters. Many
factors may cause actual results
to differ from forward-looking statements, including
inaccurate assumptions and a broad
variety of risks and uncertainties, some of which
are known and others of which are not.
No forward-looking statement is a guarantee of
future results or events, and one should
avoid placing undue reliance on such
statements. Synageva undertakes no obligation to update
publicly any forward-looking
statements, whether as a result of new information, future
events or otherwise. Synageva
cannot be sure when or if it will be permitted by regulatory
agencies to undertake
additional clinical trials or to commence any particular phase of clinical
trials or how
quickly patent enrollment in clinical trials will occur. Because of this,
statements
regarding the expected timing of clinical trials or ultimate regulatory approval
cannot be
regarded as actual predictions of when Synageva will obtain regulatory approval for
any
phase of clinical trials or when it will obtain ultimate regulatory approval by
a
particular regulatory agency.
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Synageva Strategy & Direction
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©
Copyright 2011 Synageva BioPharma
Vehicle
Focus
Count-Down
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Deal
Synageva and Trimeris merge in all-stock transaction
3:1 exchange ratio
Transaction has been unanimously approved by both boards
Rationale
Provides Synageva financial resources to aggressively pursue
corporate strategy
Gives Synageva access to public markets
Allows Synageva to maintain focus
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©
Copyright 2011 Synageva BioPharma
Synageva Transaction
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Synageva
Investment Highlights
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©
Copyright 2011 Synageva BioPharma
Team
Rare Disease
Lead Product
Status
Commercial
Manufacturing
Rare Disease Experience
Unmet Medical Need
ERT
for
LSD
Model is Predictive
Patient Dosing Commenced
Pull-through Expertise
Robust, Efficient and Scalable
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Chief
Executive Officer
Product Development
Chief Financial Officer
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©
Copyright 2011 Synageva BioPharma
Sanj K. Patel
Carsten Boess
Mark Goldberg
Eric Grinstead
Anthony Quinn
Tara OMeara
Joe DeCourcey
Commercial Operations
Chief Medical Officer
Clinical Operations
Manufacturing
Proven Management Team
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©
Copyright 2011 Synageva BioPharma
Program
SBC-102
(rhLAL)
SBC-103
(rhNAGLU)
SBC-104
SBC-105
SBC-106
Therapeutic
Recombinant
Lysosomal
Acid Lipase
Recombinant
-N-acetyl-
glucosaminidase
Extra Cellular
Protein
Enzyme
Replacement
Therapy
Enzyme
Replacement
Therapy
Disease
LAL
Deficiency
(LSD)
MPS IIIB/
Sanfilippo B
(LSD)
Severe
Genetic
Condition
Severe
Metabolic
Disorder
Severe
Genetic
Condition
Development
Status
Clinical
Preclinical
Preclinical
Preclinical
Preclinical
Regulatory
Opportunity
Orphan
Designation
Granted US
Granted EU
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Significant unmet medical need
Synageva Pipeline
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Lead
Program
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©
Copyright 2011 Synageva BioPharma
ERT for Lysosomal Acid Lipase Deficiency
(beselipase alfa)*
*Name under review by INN
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LDL
LDL receptors
coated
vesicle
Cholesterol
esters & TG
FFA
Free
Cholesterol
Free cholesterol and
fatty acids are key
regulators of lipid
synthesis
lysosome
ENDOCYTOSIS
Liver lipid content in model of
LAL Deficiency
Cholesteryl Ester
Triglyceride
©
Copyright 2011 Synageva BioPharma
LAL Deficient
LAL Deficient
Normal
Normal
LAL Deficient
Normal
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Shortened lifespan and morbidity
Prominent hepatic manifestations
Fatty liver
Elevated transaminases
Fibrosis
Liver failure
Other manifestations: splenomegaly,
type II hyperlipidemia
Rare disease in a common phenotype
Abdominal distention due to liver failure
Liver biopsy showing cirrhosis in CESD
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©
Copyright 2011 Synageva BioPharma
SBC-102
Late Onset LAL Deficiency (CESD)
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Prominent hepatic and GI
manifestations
Hepatomegaly and liver failure
Splenomegaly
Persistent vomiting
Abdominal distension
Profound growth failure
Adrenal calcification
Rapidly progressive and fatal
4.4
6.6
8.8
11
13.2
15.4
17.6
19.8
22.1
24.3
26.5
28.7
30.9
33.1
3rd
15th
50th
85th
97th
1
2
3
4
5
6
7
8
9
10
11
12
LAL Deficient
Age (months)
Weight-for-age percentiles:
Boys, birth to 12 months
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Copyright 2011 Synageva BioPharma
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SBC-102
Early Onset LAL Deficiency (Wolman)
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Terminal mannose/GlcNac and
mannose-6-phosphate (M6P)
for targeted delivery
Uptake into key cells, including
macrophages
Lysosomal localization
demonstrated
Corrects enzyme deficiency
Lysotracker red
Overlap images
Oregon green-
labeled SBC-102
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©
Copyright 2011 Synageva BioPharma
*
*
*
*Data in macrophages
0
1
2
3
4
5
6
0
0.16
0.5
1.6
5
SBC-102 (ug/ml)
Normal Human Fibroblasts
LD Fibroblasts
0
0.16
0.5
1.6
5.0
SBC-102
T
argeting and Activity
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Normal
4 weeks
8 weeks
Normalizes liver
Untreated
LAL
Deficient
©
Copyright 2011 Synageva BioPharma
SBC-102
Corrects Key Disease Related Abnormalities
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Normal
LAL Deficient
SBC-102 Treated, qw
©
Copyright 2011 Synageva BioPharma
SBC-102
Rapid Correction of Growth Failure in LAL Model
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Liver
Spleen
Marked Reduction In Liver Cholesteryl Ester Content
Across A Broad Range Of Doses
©
Copyright 2011 Synageva BioPharma
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SBC-102
Efficacy With Every Other Week Dosing
LAL Deficient
Normal
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Frequency
mg/kg
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Copyright 2011 Synageva BioPharma
Therapy
Pre-Clinical
Effective Dose
Approved Dose
Disease Model Key
Results
Aldurazyme
0.5-2mg/kg once weekly (canine)
QW
0.58
Lysosomal targeting
&
substrate reduction
Fabrazyme
0.3-3mg/kg twice monthly
(rodent)
QOW
1
Naglazyme
1-2mg/kg once weekly (feline)
QW
1
Myozyme
10-100mg/kg once weekly or
twice monthly (rodent)
QOW
20
SBC-102
0.35-3mg/kg once weekly or
twice monthly (rodent)
Under investigation
Lysosomal
targeting &
substrate reduction
Endpoints that translate
to humans
SBC-102
ERT Models Predict Efficacy and Dose
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Proof
of concept established in disease model
Small patient numbers accelerate
development timelines
(~5 years vs 5-10 years for common diseases)
Patient dosing initiated within 3 months of IND and CTA clearance
Conventional Development Programs
2020
2020
2011
2011
PIVOTAL
PHASE I/II
Late Onset
Early Onset
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©
Copyright 2011 Synageva BioPharma
SBC-102
Clinical Development
COMMERCIALIZATION
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Adult patients with liver dysfunction due
to LAL Deficiency
Open label dose escalation
4 week dosing
3 dose levels
Multicenter
N = 9
Patient dosing underway
Followed by extension protocol
Phase I/II Open-Label
Phase I/II Open-Label
Primary endpoint:
Safety
Secondary endpoint:
Pharmacokinetics
Trial Measurements:
Pharmacodynamic markers
Liver Function Tests
Endpoints:
Safety, Efficacy and
Pharmacokinetics
Patients with liver dysfunction due to
LAL Deficiency
Randomized, placebo-controlled study
6 months dosing
3 arm study
Multicenter
N = ~24
Randomized, Double-Blind,
Randomized, Double-Blind,
Placebo-controlled Trial
Placebo-controlled Trial
Late Onset Natural History Study On-going
©
Copyright 2011 Synageva BioPharma
SBC-102
Clinical Development Late Onset (CESD)
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Growth failure in children due to LAL
Deficiency
Open label dose escalation
4 month dosing
Multicenter
N= 8
Active
Phase I/II Open-Label
Phase I/II Open-Label
Secondary endpoints:
Efficacy (including growth,
weight gain)
Pharmacokinetics
Pharmacodynamics
Primary endpoint:
Long term efficacy and
safety (including survival)
Secondary endpoint:
Efficacy (including growth,
weight gain, organ function)
Pharmacokinetics
Patients from Phase I/II study
Continuation with dose regimen from
Phase I/II
Dosing for > 6 months
Multicenter
N= ~8
Open-Label Long-term Extension
Open-Label Long-term Extension
Early Onset Natural History Study On-going
©
Copyright 2011 Synageva BioPharma
SBC-102
Clinical Development Early Onset (Wolman)
Primary endpoint:
Safety and tolerability
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IND
filed on schedule and cleared within 30 days
EU CTAs filed 3 months ahead of
schedule
US & EU orphan drug designations granted 2010
Fast Track designation granted by the FDA
Clinical production for studies on schedule, internal manufacturing
Initiated multiple US and EU clinical trial sites
Patient dosing commenced
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©
Copyright 2011 Synageva BioPharma
SBC-102
Clinical and Regulatory Milestones
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An
infant with LAL Deficiency has received treatment with
SBC-102 on a
compassionate use basis
Presented with anemia, increasingly abnormal liver function tests, and growth
failure prior to treatment
Child has received weekly infusions since April 2011 with no complications and
is demonstrating substantial improvements in:
Growth rate
Liver function tests (reduction in serum transaminases)
Other disease-associated abnormalities consistent with Synagevas
preclinical data for SBC-102
Infant continues to receive treatment with SBC-102
©
Copyright 2011 Synageva BioPharma
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SBC-102
Compassionate Use: Patient Data
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©
Copyright 2011 Synageva BioPharma
ERT for MPS IIIB / Sanfilippo B
SBC-103 (rhNAGLU)
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Heparan sulfate accumulation in CNS, liver,
spleen, skin and joints
May affect as many as 8 lives per million
Progressive mental impairment with sleep
disturbances and behavioral manifestations
Severe phenotype -
wheelchair dependent and
death within first two decades
Attenuated phenotype
early onset intellectual
disability with delayed progression
Strategy
Builds on ERT experience with SBC-102
Slow CNS onset provides Rx window
Leverages progress in intrathecal delivery
©
Copyright 2011 Synageva BioPharma
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From curekirby.org
Age 9
Age 18
SBC-103
MPS IIIB / Sanfilippo B
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Historical attempts to produce
NAGLU ERT for MPS IIIB have
failed due to lack of cell uptake
©
Copyright 2011 Synageva BioPharma
Yogalingham G et al, 2000
NAG
(nmol/h per mg)
Normal fibroblasts
25.12
±
2.23
MPS-IIIB fibroblasts
0.101
±
0.025
MPS-IIIB fibroblasts + MPS-IIIB/LNCNAG
0.388
±
0.048
conditioned medium
Markedly increased cellular enzyme levels
Properties substantially better than cell culture produced
material in previous publications
SBC-103
NAGLU Production for ERT
Demonstrated good uptake into enzyme-deficient
human fibroblasts
Synageva
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Proprietary Vector System
Human Biopharmaceutical
Expression in Egg White
FDA-accepted Aseptic
Protein Harvest
GMP compliant facilities
Automated commercial scale
infrastructure
Finished Product
Consistent and
Reliable Scale-up
Purification
Established industry standard
IND approved process
Consistent
Scalable
Efficient
Clinically validated
Studies included over 250
patients, including 189 pt
Ph II GCSF trial
Multiple cleared INDs
4 INDs
Pipeline generator
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©
Copyright 2011 Synageva BioPharma
Stable commercial supply
Synageva Expression Platform
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Drug
SBC-102
Cerezyme
Fabrazyme
Myozyme
Soliris
SBC-103
Indication
LAL
Deficiency
Type I
Gaucher
Disease
Fabry
Disease
Pompe
Disease
PNH
MPS IIIB/
Sanfilippo B
Estimated
Prevalence
1 in 59,000
to 86,000
2
1 in 40,000
to 476,000
2
1 in 40,000
to 146,000
2
1 in
~77,000
3
1 in
125,000
4
to
211,000
5
1.
Muntoni, et al 2007. Prevalence of Cholesteryl Ester Storage Disease,
Arteriosclerosis, Thrombosis, and Vascular
Biology, 27, p.1866
2.
Genzyme, AMCP Dossier for Cerezyme
3.
Alexion, AMCP Formulary Dossier
4.
Héron B, et al. Incidence and natural history of mucopolysaccharidosis type
III in France and comparison with United
Kingdom and Greece. Am J Med Genet
A. 2011 Jan;155A(1):58-68.
5.
Meikle, P.J., Hopwood, J.J., Clague, A.E. & Carey, W.F., 1999. Prevalence of
lysosomal storage disorders. JAMA,
281(3), p.249.
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©
Copyright 2011 Synageva BioPharma
SBC-102
Commercial: Ultra-Orphan Opportunity
1 in 40,000
1
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~17,000
homozygotes with LAL mutation
Enzyme
DNA
1
1
Estimated distribution for US, EU and BR
Estimated distribution for US, EU and BR
©
Copyright 2011 Synageva BioPharma
27
Simple blood test
Enzyme Assay
DNA Sequencing
Lab Prototypes
1.
Baylor College of Medicine
2.
Willink Lab, St Marys Manchester, UK
Simple blood test
Enzyme Assay
DNA Sequencing
Lab Prototypes
1.
Baylor College of Medicine
2.
Willink Lab, St Marys Manchester, UK
Right
Right
Right Test
Geneticists
Suspected
Patients
Hepatologists
Liver
Lipidologists
Lipid
SBC-102
Commercial: Finding Patients
Practice
Patient
Phenotype
Phenotype
1
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30-60M Americans have
NAFLD
6-10M Americans have NASH
6K Americans are predicted to
have CESD
1
http://www.digestive.niddk.nih.gov/ddiseases/pubs/NASH/
2
Muntoni, et al; Prevalence of Cholesteryl Ester Storage Disease, Arteriosclerosis,
Thrombosis, and Vascular Biology, July 19,2010
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©
Copyright 2011 Synageva BioPharma
1
2
SBC-102
Commercial: Rare & Devastating Disease in a
1
Common Phenotype
..
CESD should more often be considered as a
differential
diagnosis
in
liver
diseases
unknown (nonalcoholic steatohepatitis or NASH)
or known (alcoholic steatohepatitis) origin and in
dyslipidemic
patients
with
combined
hyperlipidemia and low HDL-cholesterol (Familial
Combined Hyperlipidemia).
Muntoni
of
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Investing in the future
Valued as a clinical stage biotech
First-ever ERT for LAL in humans
Proof of Concept
Established
Human Data on
SBC-102
Pipeline
products
entering clinic
Filing and
Approval for
SBC-102
Commercial-stage biotech
company
Potential Five product
introductions expected
Valued on revenue and margin
development
Fast Revenue
Ramp
Attractive Margin
Profile
Stage 2
Stage 1
Multiple Value Drivers
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©
Copyright 2011 Synageva BioPharma
Synageva
Value Drivers in Two Distinct Stages
company
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Trimeris cash ending Q2 2011 was approx $52 million
Synageva cash ending Q2 2011 was approx $18 million
May 25th, 2011 Trimeris signed new agreement with Roche:
Trimeris received $4.9 million upfront fee
Trimeris to receive a 16% royalty on global sales of Fuzeon, an HIV drug
marketed globally by Roche (55 countries)
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©
Copyright 2011 Synageva BioPharma
Pro forma Synageva would have approximately
$70 million in cash ending Q2 2011
Financials
Cash balance will allow Synageva to reach multiple value creating events
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Summary
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Program
SBC-102
(rhLAL)
SBC-103
(rhNAGLU)
SBC-104
SBC-105
SBC-106
Therapeutic
Recombinant
Lysosomal
Acid
Lipase
Recombinant
-N-accetyl-
glucosaminidase
Extra
Cellular
Protein
Enzyme
Replacement
Therapy
Enzyme
Replacement
Therapy
Disease
LAL
Deficiency
(LSD)
MPS IIIB/
Sanfilippo
B
(LSD)
Severe
Genetic
Condition
Severe
Metabolic
Disorder
Severe
Genetic
Condition
Development
Status
Clinical
Preclinical
Preclinical
Preclinical
Preclinical
Regulatory
Opportunity
Orphan
Designation
Granted US
Granted EU
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
MULTIPLE VALUE DRIVING EVENTS
31
©
Copyright 2011 Synageva BioPharma
Synageva Pipeline of Opportunity
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©
Copyright 2011 Synageva BioPharma
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About Synageva BioPharma Corp.
Synageva is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic products for patients with life-threatening rare diseases and unmet
medical need. SBC-102 has been granted orphan designations by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and
fast track
designation by the FDA. Synageva has several protein
therapeutics in its pipeline, including two enzyme replacement therapies for lysosomal storage disorders and two programs for life-threatening genetic conditions for which there are currently no approved treatments. The Company has assembled a team
with a proven record of bringing orphan therapies to patients.
On June 13, 2011, Synageva announced that they had entered into a definitive
agreement under which Synageva will merge with Trimeris, Inc. (NASDAQ: TRMS) in an all-stock transaction. Upon closing, the combined company will be named Synageva BioPharma Corp., and will create a publicly-traded company focused on the development
of novel therapeutics for patients with rare diseases and unmet medical need.
Further information regarding Synageva BioPharma Corp. is
available at http://
www.synageva.com
.
About Trimeris, Inc.
Trimeris, Inc. (NASDAQ: TRMS) pioneered the development of a class of antiviral drug treatments called fusion inhibitors. Trimeris currently marketed product is FUZEON, an anti-HIV fusion inhibitor
which was developed by Trimeris in collaboration with Roche. Substantially all of Trimeris revenues are derived from its collaboration with Roche relating to FUZEON. For more information about Trimeris, please visit the companys website
at http://
www.trimeris.com
.
Important Merger Information and Additional Information and Where to Find It
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities of Trimeris or Synageva or the solicitation
of any vote or approval. In connection with the proposed merger, Trimeris filed a Registration Statement on Form S-4, filed with the SEC on July 13, 2011 and amended on August 23, 2011 (the Registration Statement), which includes a
preliminary joint proxy statement of Trimeris and Synageva and constitutes a preliminary prospectus of Trimeris. These materials are not yet final and will be further amended. The joint proxy statement/prospectus of Trimeris and Synageva will be
mailed to the stockholders of Trimeris and Synageva once it is final.
Investors are strongly urged to read the definitive joint proxy statement/prospectus when it becomes available and other documents filed with the SEC by Trimeris, because they
will contain important information about Trimeris, Synageva and the proposed merger.
Investors and security holders of Trimeris and
Synageva may obtain free copies of the joint proxy statement/prospectus for the proposed merger and other documents filed with the SEC by Trimeris through the website maintained by the SEC at www.sec.gov. In addition, investors and security holders
of Trimeris will be able to obtain free copies of the joint proxy statement/prospectus for the proposed merger by contacting Trimeris, Inc., Attn: James Thomas, Chief Financial Officer. Investors and security holders of Synageva will be able to
obtain free copies of the joint proxy statement/prospectus for the merger by contacting Synageva BioPharma Corp., Attn: Secretary, 128 Spring Street, Suite 520, Lexington, MA 02421.
Trimeris and Synageva, and their respective directors and certain of their executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated
by the agreement between Trimeris and Synageva. Information regarding Trimeris directors and executive officers is contained in Trimeris Annual Report on Form 10-K for the fiscal year ended December 31, 2010, which was filed with the SEC
on March 14, 2011, and in its proxy statement prepared in connection with its 2010 Annual Meeting of Stockholders, which was filed with the SEC on March 16, 2010. Information regarding Synagevas directors and officers and a more complete
description of the interests of Trimeris and Synagevas respective directors and officers in the proposed transaction is available in the Registration Statement.
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