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Bioresorbable Nonwoven and Growth Factor
N
growth factor
Background
Biopharm GmbH and Freudenberg New Technologies KG
offering
Joint product development for innovative product concepts in
regenerative medicine
Employing bioresorbable nowovens and growth factors
Providing an industrialized production site as contract manufacturer
Offering exclusive licenses for innovative products
Looking for partners for approval and marketing
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Content
Company Profiles Biopharm and Freudenberg
Combined Drug Device Technology
Key Facts
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Biopharm GmbH in Heidelberg
Founded in 1986, independently owned,
35 Employees
Sites in
Heidelberg (550 m2)
HD-Eppelheim (1.500 m2)
Areas of activity
BIOPHARM: Development of biopharmaceuticals
SYMBIOSIS: Analytical services for classical
pharmaceuticals and biopharmaceuticals
License agreements
BIOPHARM and ATRM (part of Johnson & Johnson),
clinical phase Ia/IIb
BIOPHARM and Cil Technology GmbH (part of
Medtronic), clinical phase III
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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The Freudenberg Group
Family company
160 years old
16 Business Groups
34.000 Employees
Operating in 59 countries
5,481 million EUR in 2010
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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The Freudenberg Group: Business Areas
Parent Company Freudenberg & Co.
Business Area
Seals & Vibration Control
Business Area
Nonwovens
Business Area
Household Products
Business Area Specialties
and Others
Business Groups
Business Groups
Business Groups
Business Groups
Freudenberg Seals and
Vibration Control Technology
Europe
Freudenberg
Nonwovens
Freudenberg
Household Products
Freudenberg Chemical Specialities
Freudenberg-NOK General
Partnership
Freudenberg
Filtration
Technologies
NOK-Freudenberg Group
China
Freudenberg Politex
Nonwovens
Vibracoustic (Europe)
Burgmann Industries
Freudenberg NOK Mechatronics
Freudenberg IT
Freudenberg New Technologies
Division
Freudenberg Service Support
Freudenberg Real Estate Management
Dichtomatik
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
growth factor
Content
Company Profiles Biopharm and Freudenberg
Combined Drug Device Technology
Key Facts
7
© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Combined Drug Device Technology
Growth Factor Technology by Biopharm
Platform Technology offers new
opportunities using tailor made drug
design with significant advantages over
existing growth factors
Bioresorbable Nonwoven Technology by Freudenberg
Platform Technology allows transforming
sensitive biopolymers into a bioresorbable
nowoven and incorporation of active
pharmaceuticals into the fibers
Bioresorbable scaffolds
bearing growth factors for
regenerative medicine
Combination of both Platform
Technologies offers new
opportunities for active wound care,
cartilage and bone repair.
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Wound treatment: Accelerated Wound Healing with rhGDF-5
Model: Wound healing
Porcine split-thickness wound healing model (5x5 cm wounds)
Treatment with 3 µg rhGDF-5 daily over 9 days
Photo documentation and H&E histology staining
Untreated
wound
defect
Epidermal layer is thin and not homogenous
Formation of a granulation tissue appears poorly
Red surface of the wound, healing is still in progress
5x
Neo-epithelium is thicker and smoother, organized in
well defined layers
Completely closed, no signs of inflammation
Good organization of the granulation tissue, smoother
Results are very close to healthy tissue on day 9 p.o.!
Wound
treated with
rhGDF-5
5x
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Combination: growth factor rhGDF-5 / bioresorbable nonwoven
Expected advantages of the drug device combination
in wound healing:
Local release of dermal derived growth factor GDF-5
Bioresorbable nonwoven as non-adherent wound contact layer
Avoid irritation to the regenerating tissue by change of dressings
3D scaffold for cellular growth and tissue regeneration
Suitable for epithelial regeneration and dermis replacement
ECM components as matrix polymers, enhancing wound healing
Easy to adapt to rough or irregular surfaces, wet stable
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Bone Fraction: BB-1 as a novel bone inducer for fracture healing
Model: Fracture healing in critical size defect (rabbit)
15-mm segmental defect in the middle of the diaphysis of
rabbit radius was created
Collagen sponges, loaded with buffer, BMP-2, GDF-5 and
BB-1, were placed into the gap
Micro-CT scans were made 4, 8 and 12 weeks post surgery
4 weeks
control
BMP-2
GDF-5
8 weeks
12 weeks
BB-1 mediated early long bone formation
with a reconnected medullar cavity.
BB-1 treated defects were bridged 100%
(9/9) 4 weeks post surgery, while only 33%
(3/9) of BMP-2 treated defects were bridged
with mineralized tissue.
BB-1
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Combination: growth factor BB-1 / bioresorbable nonwoven
Expected advantages of the drug device combination
in healing of long bone fraction:
Incorporation and stabilization of sensitive growth factor BB1
Local therapy by diffusion from and degradation of the fibers
Release of active ingredients in line with clinical requirements (long term)
Additionally osteoinductive matrix polymers and additives possible
Easy to adapt to rough or irregular surfaces
Secure positioning and fixation, wet stable
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Osteoarthritis: Cartilage repair by tailor made growth factor
Expected advantages of the drug device combination
in cartilage repair:
Defect
Incorporation and stabilization of sensitive growth factor
Tailor made growth factor (under development) based on
growth factor platform technology
Local therapy by diffusion from and degradation of the fibers
Selected matrix polymers to support cartilage cell differentiation
Secure positioning and fixation, wet stable
For use in microinvasive (arthroscopic) surgery
Repair
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
growth factor
Content
Company Profiles Biopharm and Freudenberg
Combined Drug Device Technology
Key Facts
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Key facts: growth factor / bioresorbable nonwoven
Growth Factors (Biopharm)
unique platform technology and many years of expertise
comprehensive positive safety data derived from clinical trial
mode of action well known
proof of efficacy (animal model)
comprehensive worldwide patent protection
Bioresorbable Nonwovens (FNT)
unique platform technology and industrialized production
bioresorbable and wet stable application system
controlled and flexible drug release adaptable to specific indication
gentle production method preserves integrity of bio-molecules
comprehensive worldwide patent protection
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
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Key facts: Cooperation
Cooperation model
Create partnership as licenser and contract
manufacturer
Looking for a medical company for clinical approval and
marketing & sales
No direct market approach by Freudenberg and
Biopharm
Customer benefits
Significantly reduced development cost
Opimized benefit / risk ratio
Increased probability of successful commercialization
Products for regenerative medicine with unique selling proposition
Innovative Products in worldwide multi-billion markets
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© 2010-2011: Freudenberg New Technologies KG | Confidential Sheet | Any copies need to be authorized by FNT KG – BIOPHARM GmbH
Danke für Ihre Aufmerksamkeit!