298 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
makes the breast hard, tender, and unnatural in appearance. ese problems have prompted the
FD
A to reclassify current prostheses and move them from Class I to Class III Devices requirin
g
a st
ringent PMA (Premarket Approval) pathway.
Most authorities agree that capsular contraction can be effectively eliminated by “coating
”
th
e outer wall of the mammary implant with a suitable tissue ingrowth platform. No accepta
ble
ma
terial is currently available to manufacturers of breast prostheses that allows tissue ingrowt
h
wh
ile remaining biostable.
PolyMedica has pioneered the development of a proprietary medical textile that can be used
as
a tissue ingrowth platform. Its medical textile is based on a novel forty filament fiber which
is
melt extruded from a Chronoflex
TM
elastomer. Prototypes of this textile have been manufac-
tu
red by means of a sophisticated polar winding technique.
PolyMedica is currently negotiating an agreement with a major strategic partner for the
de
velopment, testing, manufacture, and distribution of a series of product(s) emanating f
rom
thi
s technology.
3. C
HRONOSPHERE
TM
MICROPARTICULATES
3.1 Description of Microparticulates
e concept of entrapping materials within a polymeric coating is commonly called
mi
croencapsulation. ese capsules all vary in size from less than one to as large as
2,
000microns. Historical examples of the use of the microencapsulation process in th
e
ph
armaceutical industry are the Spansules
R
of SmithKline, introduced in the 1950s for th
e
su
stained release of orally administered drugs. Estee Lauder introduced in the mid-1980s a
li
posome-based moisturizing cream which released hydrating agent overnight.
PolyMedica has developed a new technology which delivers ingredients by the process o
f
diffus
ion. e diffusion process involves the entrapment of active ingredients in an inactive
ca
rrier matrix, which releases the ingredients over a prolonged period of time.
Confidential PolyMedica Industries, Inc. 12
Writing a Winning Business Plan ◾ 299
3.2 Technical Background
In the pharmaceutical and personal care industries, microencapsulation of active
in
gredients can:
Sustain the effectiveness of such ingredients
Permit liquids to be handled as solids
Protect reactive components until time of use
Allow the safe handling of toxic materials
Extend the shelf life of delicate materials
Overcome product incompatibilities.
In topical products, which are generally liquids or creams, microcapsules have not been
us
ed. Current soluble or pressure sensitive microcapsules will release actives in storag
e
if
they are contained within a water-based lotion or cream or will release actives upo
n
br
eakage during processing. Insoluble microcapsules containing an active ingredient will
not
release their contents when it comes in contact with skin. PolyMedica has developed its
Ch
ronosphere
TM
technology to overcome these two problems.
3.3 Description of Chronospheres
Chronosphere
TM
polymer microparticulates represent an advanced technological system fo
r
th
e sustained and controlled delivery of cosmetic and pharmaceutical actives to the skin in a
tr
aditional liquid, semi-solid, or powder carrier.
Chronospheres are a matrix system in which the active ingredient is dissolved or
dis
persed into the liquid prepolymer. e solution occurs at a molecular level and insures
a
uniform concentration of active ingredient throughout the molecular particle. Since the
composit
ion of the polymer can be altered, its hydrophilic (water-loving) properties ca
n
be
adjusted. Chronospheres are completely insoluble in water and other common solvents
an
d can be incorporated into traditional liquid delivery vehicles (aerosol cans, sticks, pum
p
sp
rays, etc.).
Many pharmaceutical active ingredients are sensitive to chemical and environmenta
l
ex
posure, resulting in degradation. Chronospheres are produced without the use o
f
he
at, water or solvents, thereby protecting ingredients during processing. In addition
,
no
materialsother than pure prepolymer and copolymerizable additives are used during
Ch
ronosphere
TM
production so there is minimal leaching except for the desired active
ma
terial.
Confidential PolyMedica Industries, Inc.
300 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
3.4 Markets
Chronosphere
TM
microparticulates are intended for use in the following areas:
Over-the-Counter (OTC) Pharmaceuticals
e total OTC pharmaceuticals market in 1989 was estimated at $9.7 billion by Nielson, an
in
crease of 6.2% from the previous year. External remedies were at $1.6 billion, up 11.1%. Within
thi
s category, the following product formats could utilize Chronospheres to achieve super
ior
effi
cacy via sustained/controlled release:
OVER-THE-COUNTER PHARMACEUTICAL MARKETS: 1988
Estimated market size
($ millions)
Antiperspirants/deodorants $ 600
Acne
2
50
External analgesics 240
External antiseptics
1
89
Hydrocortisones
9
0
Burn remedies 35
Poison ivy
3
2
Jock itch 9
$
1,445
Skin Care
e total skin care category reached $2 billion in 1989, an increase of 8.5% over 1988.
Ch
ronosphere
TM
products may be able to address the following product segments:
Suntan lotions
Moisturizers
Hand and body lotions
Face creams
Lip balms
Astringents
Confidential PolyMedica Industries, Inc.
Writing a Winning Business Plan ◾ 301
Fragrances
e fragrance market is estimated at $4 billion annually. Chronosphere
TM
products m
ay
be a
ble to address the following areas of interest:
Dry scented products
Fragrance gels
Perfumes.
In
dustrial Applications
Chronosphere
TM
microparticulates offer sustained time-release and unique delivery
ch
aracteristics. eir manufacturing cost efficiency would be attractive to the following
in
dustrial market segments:
Pesticides/ insecticides
Catalysts
Oxidizers
Pigments/colorants
Flame retardants
Water treatment
Biocides.
With such a wide variety of applications for this technology, PolyMedica is discussing
th
e applications of its products in personal care markets with a well-positioned corporate
pa
rtner.
4.
0 CHRONOTHANE
TM
PHOTOPOLYMERS
4.1 Sustained-Delivery Technology
e past few years have brought a virtual revolution in delivery systems used by the
ph
armaceutical industry. Many of the common ointments and capsules have been replaced by
tran
sdermal patches. ese deliver an active ingredient through the skin of the patient directly
in
to the body. Future developments promise even more dramatic changes in drug delivery.
Confidential PolyMedica Industries, Inc.
302 ◾ The Guide to Entrepreneurship: How to Create Wealth for Your Company
e impetus for delivery changes is an effort to eliminate the limitations of existing
th
erapies. Sustained-delivery products improve drug performance by:
Increasing duration of action
Improving patient compliance
Eliminating side effects.
Secondly, the Price Competition and Patent Term Restoration Act of 1984 has
subs
tantially changed the competitive character of the pharmaceutical industry. Under thi
s
la
w, a new dosage that enhances the therapeutic efficacy of an existing drug may receive a
se
parate patent in its own right.
is, in essence, would grant an additional period of patent exclusivity to a drug company
th
at took one of its proprietary drugs, whose patent was expiring or had expired, and put it i
n
a
new delivery vehicle. us, a new generation of controlled/sustained delivery technologies
ha
s begun. Ciba-Geigy was one of the first companies to introduce transdermal patches into
th
e market.
e magnitude of the market has attracted companies such as Alza, Elan, Hereon,
Ci
ba-Geigy, Schering-Plough, and others. In each case, the companies have relied on
propr
ietary polymer based systems which formed the basis for their core deliver
y
tech
nology.
4.2 Chronothane
TM
Sustained Delivery Products
In October 1988, PolyMedica applied for a patent on a novel phatopolymer t
o
com
mercially exploit sustained-release products based on proprietary polymer technology.
e
products can be constructed to deliver in a topical, transdermal, transmucosal, or intraoral
sy
stem. Topical delivery involves local delivery of medications within a specific site of the
sk
in. In the transdermal mode, medications are delivered across intact skin. Transmucosal
refers to
the delivery of drugs through the lining of the cheek, and intraoral refers to delivery
of m
edications within the mouth.
e medications envisioned by PolyMedica for its unique drug delivery systems are:
(a
) OTC preparations and (b) prescription drugs (Such as antibiotics, antimicrobials, and
sy
stemic medications which require continuous dosing, such as AZT). ese incorporated
Confidential PolyMedica Industries, Inc.
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