- Filing of certain prospectuses and communications in connection with business combination transactions (425)
July 20 2011 - 3:23PM
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 Synageva BioPharma Corp. (
Synageva
) and Trimeris, Inc.
(
Trimeris
), 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 July 20, 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
Company Presentation
July 2011
July 2011
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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.
2
©
Copyright 2011 Synageva BioPharma
Forward-Looking
Statements
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Vehicle
Vehicle
Focus
Focus
Synageva Strategy & Direction
3
©
Copyright 2011 Synageva BioPharma
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
4
©
Copyright 2011 Synageva BioPharma
Synageva Transaction
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Synageva
Investment Highlights
5
©
Copyright 2011 Synageva BioPharma
Team
Rare Disease Experience
Rare Disease Experience
Rare
Disease
Unmet Medical Need
Unmet Medical Need
Lead
Product
ERT
for
LSD
Model
is
Predictive
ERT
for
LSD
Model
is
Predictive
Status
Patient Dosing Commenced
Patient Dosing Commenced
Commercial
Pull-through Expertise
Pull-through Expertise
Manufacturing
Robust, Efficient and Scalable
Robust, Efficient and Scalable
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Chief
Executive Officer
Sanj K. Patel
Sanj K. Patel
Chief Medical Officer
Anthony Quinn
Anthony Quinn
Commercial Operations
Eric Grinstead
Eric Grinstead
Manufacturing
Joe DeCourcey
Joe DeCourcey
Program Management
Christine Maurer
Christine Maurer
Chief Financial Officer
Carsten Boess
Carsten Boess
6
Clinical Operations
Tara OMeara
Tara OMeara
©
Copyright 2011 Synageva BioPharma
Proven Management Team
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7
©
Copyright 2011 Synageva BioPharma
Program
SBC-102
(rhLAL)
SBC-103
(rhNAGLU)
SBC-104
SBC-105
SBC-106
Therapeutic
Recombinant
Lysosomal
Acid Lipase
Recombinant
a
-
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
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Liver
lipid content in model of
LAL Deficiency
SBC-102
Lysosomal
Acid Lipase (LAL) Biology
Cholesterol
esters & TG
FFA
Free
Cholesterol
Free cholesterol and
fatty acids are key
regulators of lipid
synthesis
LDL
LDL receptors
lysosome
coated
vesicle
ENDOCYTOSIS
9
©
Copyright 2011 Synageva
BioPharma
LAL Deficient
Normal
Cholesteryl
Ester
Triglyceride
LAL Deficient
LAL Deficient
Normal
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
©
Copyright 2011 Synageva BioPharma
11
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
0
0.16
0.5
1.6
5.0
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©
Copyright 2011 Synageva BioPharma
*
*
*
SBC-102
Targeting and Activity
SBC-102 (ug/ml)
Normal Human Fibroblasts
LD Fibroblasts
0
1
2
3
4
5
6
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13
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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14
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
15
LAL Deficient
Normal
SBC-102
Efficacy With Every Other Week Dosing
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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
Frequency
mg/kg
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©
Copyright 2011 Synageva BioPharma
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
2020
2020
2011
2011
PIVOTAL
PHASE I/II
Late Onset
Early Onset
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©
Copyright 2011 Synageva BioPharma
COMMERCIALIZATION
Conventional Development Programs
SBC-102
Clinical Development
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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
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)
Patients with liver dysfunction due to LAL
Deficiency
Endpoints: Safety, Efficacy and Pharmacokinetics
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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
Primary endpoint:
Safety and tolerability
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
©
Copyright 2011 Synageva BioPharma
SBC-102
Clinical Development Early Onset (Wolman)
Early Onset Natural History Study On-going
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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
Proof of concept data presented at key meetings
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 13+ infusions 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
Synageva
Demonstrated good uptake into enzyme-deficient human
Markedly increased cellular enzyme levels
Properties substantially better than cell culture produced
SBC-103
NAGLU Production for ERT
fibroblasts
material in previous publications
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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
Stable commercial supply
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
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 40,000
1 in 59,000
to 86,000
1 in 40,000
to 476,000
1 in 40,000
to 146,000
1 in
~77,000
1 in
125,000 to
211,000
Reported 2010
Revenue ($M)
Significant
Unmet
Need
$719.6
$188.2
$411.8
$540.9
Significant
Unmet
Need
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.
6.
www.medtrack.com, 2010 revenues
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Copyright 2011 Synageva BioPharma
2
1
2
2
3
4
5
6
6
6
6
SBC-102
Commercial: Ultra-Orphan Opportunity
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~17,000
homozygotes with LAL mutation
~17,000 homozygotes with LAL mutation
1
1
Estimated distribution for US, EU and BR
Estimated distribution for US, EU and BR
©
Copyright 2011 Synageva BioPharma
27
Enzyme
DNA
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
Practice
Right
Patient
Right Test
Geneticists
Suspected
Patients
Hepatologists
Lipidologists
Liver
Phenotype
Lipid
Phenotype
SBC-102
Commercial: Finding Patients
1
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30-60M Americans have
NAFLD
1
6-10M
Americans
have
NASH
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
Commercial: Rare & Devastating Disease in a
1
6K Americans are predicted to
have CESD
2
SBC-102
Common Phenotype
Muntoni
.
CESD should more often be considered as a
differential diagnosis
liver diseases
of
unknown (nonalcoholic
steatohepatitis or
NASH) or known (alcoholic steatohepatitis)
origin and in
dyslipidemic patients
with
combined hyperlipidemia and low HDL-
cholesterol (Familial Combined
Hyperlipidemia).
in
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Multiple Value Drivers
Stage
1
Investing in the future
Valued as a clinical stage biotech
First-ever ERT for LAL in humans
Stage
2
Commercial-stage
biotech
Potential
Five
product
Valued
on
revenue
and
margin
Synageva
Value Drivers in Two Distinct Stages
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©
Copyright 2011 Synageva BioPharma
Proof of Concept
Established
Human Data on
SBC-102
Pipeline
products
entering clinic
Filing and
Approval for
SBC-102
Fast Revenue
Ramp
Attractive Margin
Profile
company
company
introductions
expected
development
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Financials
Pro forma Synageva would have approximately
$70 million in cash ending Q1 2011
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
Cash balance will allow Synageva to reach multiple value creating events
Trimeris cash ending Q1 2011 was approx $47 million
Synageva cash ending Q1 2011 was approx $23 million
May 25th, 2011 Trimeris signed new agreement with Roche:
Summary
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MULTIPLE VALUE DRIVING EVENTS
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©
Copyright 2011 Synageva BioPharma
Synageva Pipeline of Opportunity
Program
Therapeutic
Disease
Development
Status
Regulatory
Opportunity
SBC-102
(rhLAL)
Recombinant
Lysosomal Acid
Lipase
LAL
Deficiency
(LSD)
Clinical
Orphan
Designation
Granted US
Granted EU
Fast Track
Designation
SBC-103
(rhNAGLU)
Recombinant
-N-acetyl-
glucosaminidase
MPS IIIB/
Sanfilippo B
(LSD)
Preclinical
Potential for
Orphan &
Fast Track
Designation
SBC-104
Extra
Cellular
Protein
Severe
Genetic
Condition
Preclinical
Potential for
Orphan &
Fast Track
Designation
SBC-105
SBC-106
Enzyme
Replacement
Therapy
Enzyme
Replacement
Therapy
Severe
Metabolic
Disorder
Severe
Genetic
Condition
Preclinical
Preclinical
Potential for
Orphan &
Fast Track
Designation
Potential for
Orphan &
Fast Track
Designation
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©
Copyright 2011 Synageva BioPharma
Every Second Counts!
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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 U.S. Securities and Exchange Commission (the
SEC
) on July 13, 2011 (the
Registration Statement
), which includes a preliminary joint proxy statement of Synageva and Trimeris and constitutes a preliminary prospectus of Trimeris. These materials are not yet final and will be further amended. The joint
proxy statement/prospectus of Synageva and Trimeris will be mailed to the respective stockholders of Synageva and Trimeris 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 Synageva, Trimeris and the proposed merger.
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. Investors and security holders of Trimeris 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, 2530 Meridian Parkway, 2nd Floor, Durham, NC 27713.
Synageva and Trimeris, 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 Synageva and Trimeris. Information regarding Synagevas directors and officers and a
more complete description of the interests of Synagevas and Trimeris respective directors and officers in the proposed transaction is available in the Registration Statement. 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.
Cautionary Note Regarding Forward-Looking Statements
Statements in this communication regarding the development of Synagevas product candidates, including SBC-102 and SBC-103, preclinical and clinical
results from trials involving Synagevas product candidates, the predictability of enzyme replacement therapy models, regulatory review and the likelihood and timing of approval of any product candidate, the impact of obtaining fast track
designation from the FDA, the potential for SBC-102 to treat LAL Deficiency, the size of the commercial opportunity for any of Synagevas product candidates, the proposed merger between Synageva and Trimeris, including the timing, conditions to
and anticipated completion of the proposed merger, the expected ownership of the combined company and the combined companys board of directors, the anticipated cash balance of the combined company, and any other statements about
Synagevas future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact
(including statements containing the words believes, plans, could, anticipates, expects, estimates, plans, should, target, will,
would and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such
forward-looking statements, including: the risk that Synageva cannot demonstrate safety and/or efficacy of its product candidates in clinical trials; the risks involved with development and commercialization of product candidates; the potential
inability of Synageva to obtain, maintain and enforce patent and other intellectual property protection for its products, discoveries and drug candidates; the risk that Synageva and Trimeris may not be able to complete the proposed merger as
anticipated or at all; and other risks and uncertainties that are more fully described in the Registration Statement. Investors and stockholders are urged to read the risk factors set forth in the Registration Statement.
In addition, the statements in this communication reflect our expectations and beliefs as of the date of this communication. We anticipate that
subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so,
whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this communication.
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