Allergan Inc
Filed by Allergan, Inc.
Pursuant to Rule 425 under the
Securities Act of 1933, as amended
Subject Company: Inamed Corporation
Commission File No.: 1-09741
Dermal Filler Fact Sheet
There is a large, growing demand among American consumers for minimally invasive cosmetic
procedures. Recent statistics released by the American Society for Aesthetic Plastic Surgery
(ASAPS)1 show enormous consumer demand that created a dermal filler market that is
estimated to be worth $80 million.2
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Of the 11.8 million cosmetic procedures performed in the United States in 2004, 9.7 million or 82 percent were
non-surgical in nature1 |
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The 35- to 50-year old age group is the fastest-growing demographic in the developed world and accounted for 45
percent of the 11.8 million cosmetic procedures performed in the U.S. in 20042 |
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More than 1.8 million dermal filler treatments were administered in 20043 |
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In 2004, collagen injections were the sixth most common aesthetic procedure in the U.S. with more than 785,000
treatments 31.5 percent used bovine-derived collagen products and 68.5 percent used human-derived collagen
products1 |
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With the introduction of the hyaluronic acid-based products into the U.S., the market is projected to grow to
about $175 million by 20074 |
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Hyaluronic acid-based fillers, such as Inameds Captique® and Hylaform®, surpassed
collagen to become the fifth most common aesthetic procedure in the U.S. with 880,000 treatments last
year1 |
BOTOX® Cosmetic (botulinum toxin type A) and Dermal Fillers
Allergans BOTOX® Cosmetic, which is considered by the American Society for Dermatologic
Surgery (ASDS) as the gold standard for treating glabellar lines (the dynamic vertical frown
lines between the brows), is often used in combination with dermal fillers. BOTOX®
Cosmetic works to relax the facial muscles that cause glabellar lines by blocking nerve impulses
that trigger wrinkle-causing muscle contractions, creating a smoothed and improved appearance
between the brows.
Dermal fillers replace tissue volume below the surface of the skin to alleviate the appearance of
facial lines at rest. Unlike glabellar lines, these lines usually appear in the lower portion of
the face.
Dermal Fillers Overview
Over time, collagen and hyaluronic acid in the skin diminish causing the skin to lose structure and
volume, so wrinkles appear. Increasingly, physicians are using collagen and hyaluronic acid-based
dermal fillers in combination to temporarily replace this loss, smoothing away unwanted lines and
wrinkles.5
Dermal fillers are made from a variety of natural, man-made or synthetic materials that have been
developed for injection into the skin. Fillers come in different thicknesses, and in general, the
thicker the product, the deeper it is injected into the dermal layer of the skin to add volume and
smooth lines and wrinkles. Dermal fillers are not new. Doctors as early as the 1890s could take
fat from patients arms and inject it below the surface of the skin as filler. By the mid 1900s,
doctors were using paraffin and then silicone, until the 1980s when American scientists discovered
a type of collagen that occurs naturally in cows skin and was safe in humans. In 1981, collagen
a protein that provides skin with structural support was the first filler approved by the
U.S. Food and Drug Administration (FDA) for soft-tissue filling by injection.6
Today, there are human-derived collagen products on the market that are more commonly used as
dermal fillers, such as those made from a highly purified form of hyaluronic acid. Hyaluronic acid
is a natural sugar found in living cells that attracts and binds water, hydrating the skin and
giving it volume. Most treatments do not require a skin test, can be carried out when wanted and
show immediate results. Treatment and recovery time is typically less than one hour.7
Aesthetic Use
Dermal fillers are most often used to enhance appearance. They have been administered for years to
increase the size and volume of womens lips, and this remains the most popular use. Treatments
are effective in both men and women to fill out lines around the lips, the lines from the nose to
the corners of the mouth (nasolabial lines), smile lines, crows feet and forehead wrinkles.
Thicker fillers also can be used to add volume to sunken cheeks and weak chins, reshape the tip of
the nose, fill out deeper scars or even treat more significant non-facial skin defects.
Therapeutic Use
Although more commonly used for aesthetic purposes, dermal fillers also are administered
therapeutically. Hyaluronic acid has been used in cataract operations and for injection into
arthritic joints to aid movement. Areas in which hyaluronic acid and dermal fillers are used
include:
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Drug delivery |
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Ophthalmology |
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Orthopedics |
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Rheumatology |
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Urology |
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General wound healing |
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Human vocal cord paralysis |
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Adhesion prevention |
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Inadequate or damaged tissue caused by surgery, injury, or disease |
Key Inamed Dermal Filler Products
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Captique® |
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Approved by the FDA in December 2004 for the correction of moderate to severe facial
wrinkles, Captique is the newest non-animal stabilized hyaluronic acid dermal filler. |
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Hylaform®, Hylaform Plus® and Hylaform Fineline® |
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Approved by FDA in April 2004 for the correction of moderate to severe facial lines and
wrinkles, Hylaform replenishes the skins lost hyaluronic acid, restoring skin volume.
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Juvederm® Dermal Filler Product Line |
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The Juvederm® dermal filler product line is a range of products based on non-animal, crossed linked,
homogenous gel hyaluronic acid-based products. Juvederm® is available in several
ex-U.S. markets, including the EU where the product is marketed by LEA Derm under the brand
name Hydrafill®. Juvederm® is currently under clinical development in
the U.S. |
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CosmoDerm® and CosmoPlast® |
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Approved by the FDA in March 2003, these are the first FDA-approved fillers that do not
require a skin test before treatment and the only ones on the U.S. market with anesthetic
and the ability to deliver immediate results. CosmoDerm® and
CosmoPlast® replenish skins lost collagen. |
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Zyderm® and Zyplast® |
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Introduced 18 years ago, Zyderm® and Zyplast® injectable collagen
implants have set the standard in filler materials for smoothing facial lines, wrinkles and
scars and in providing lip border definition. Today, more than one million people worldwide
have been treated with Zyderm® or Zyplast® collagen implants. |
Forward-Looking Statements
This communication contains forward-looking statements, including, among other statements,
statements regarding the proposed business combination between Allergan and Inamed, and the
anticipated consequences and benefits of such transaction. Statements made in the future
tense are intended to identify forward looking statements. These statements are based on
current expectations, but are subject to certain risks and uncertainties, many of which are
difficult to predict and are beyond the control of Allergan. Relevant risks and
uncertainties include those referenced in Allergans filings with the SEC (which can be
obtained as described in Additional
2
Information below). Risks and uncertainties relating to the proposed transaction include:
that required regulatory approvals will not be obtained in a timely manner, if at all; that
the anticipated benefits and synergies of the transaction will not be realized; that the
integration of Inameds operations with Allergan will be materially delayed or will be more
costly or difficult than expected; and that the proposed transaction will not be
consummated. These risks and uncertainties could cause actual results to differ materially
from those expressed in or implied by the forward-looking statements, and therefore should
be carefully considered.
Additional Information
Allergan intends to file a Registration Statement on Form S-4 and may file other documents
with the SEC in connection with the proposed acquisition of Inamed. Inamed stockholders
should read those filings, and any other filings made by Allergan with the SEC in connection
with the proposed acquisition, as they will contain important information. These SEC
filings, as well as Allergans other public SEC filings, can be obtained without charge at
the SECs website at www.sec.gov, and at Allergans website at www.Allergan.com.
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1 |
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American Society for Aesthetic Plastic Surgery.
Cosmetic Surgery National Data Bank Statistics. Available at:
http://www.surgery.org/download/2004-stats.pdf
Accessed on October 28, 2005. |
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JP Morgan. |
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American Society for Aesthetic Plastic Surgery.
Quick Facts 2004. Cosmetic Surgery National Data Bank Statistics. Available
at: http://www.surgery.org/press/procedurefacts-asqf.php
Accessed on October 28, 2005. |
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Medtech Insight LLC. |
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Inamed Corporation. Facial Aesthetics US
Patients: Product Information. Available at:
http://www.inamed.com/products/facial/us/patient/patient.html. Accessed
October 28, 2005. |
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ConsultingRoom.com.
http://consultingroom.com/Aesthetics/Treatment/Treatment_Details.asp?Treatment=21 |
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Inamed Corporation. Facial Aesthetics US
Patients: Product Information. Available at:
http://www.inamed.com/products/facial/us/patient/patient.html. Accessed
October 28, 2005. |
3
Breast Aesthetics Product Fact Sheet
According to the American Society of Plastic Surgeons (ASPS), more than 325,000 breast implant
procedures were completed in 2004 20 percent for reconstructive surgery following mastectomy and
80 percent for breast augmentation. In fact, breast augmentation was the second most commonly
performed cosmetic surgical procedure after liposuction last year.1
Saline and Silicone Breast Implants Overview
A breast implant is a prosthesis used in cosmetic surgery to reconstruct or enhance the size and
shape of a womans breasts.2
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For breast reconstruction, Inamed Corporations reconstruction
implants are designed with tissue expanders and matching
saline-filled or silicone gel-filled implants to provide patients
with the choices necessary to attain an aesthetic breast shape. Many
of the reconstructive products have a unique textured surface
(BIOCELL® and BIOSPAN®) designed to reduce the
chance of capsular contracture (hardening of the scar tissue around
the implant) and promote tissue adherence, which may help to hold the
implant in place. These implants are available in six
styles.3 |
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For breast augmentation, Inamed has five styles of implants also
designed with tissue expanders and matching saline-filled implants to
provide patients with the choices necessary to attain an aesthetic
breast shape, including the uniquely textured BIOCELL®
surface.4 |
Implants for Breast Reconstruction
According to ASPS, reconstruction of a breast that has been removed due to cancer or other diseases
is one of the most rewarding surgical procedures available today. New medical techniques and
devices have made it possible for surgeons to create a breast that can come close in form and
appearance to matching a natural breast.5
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Frequently, reconstruction is possible immediately following
mastectomy, so the patient wakes up from surgery with a breast mound
already in place. |
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Overall, there has been a 40 percent increase in reconstructive
procedures since 1992. For breast reconstruction alone, there were
twice as many procedures conducted in 2004 than in 1992.6 |
Implants for Breast Augmentation
Breast implants are most often used to enhance appearance. Advances in breast implant technology
and surgical technique are making breast augmentation a popular option among women of all ages.
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In 2004, more than 264,000 breast augmentation procedures were performed.1 |
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From 2000 to 2004, patients choosing breast augmentation increased 24 percent.7 |
Safety and Efficacy
The new generations of saline and silicone implants have undergone rigorous safety testing, and are
subject to strict U.S. Food and Drug Administration (FDA) regulatory standards. Years of
experience with this operation has demonstrated highly satisfactory results for most patients
considered suitable candidates for the surgery.
Forward-Looking Statements
This communication contains forward-looking statements, including, among other statements,
statements regarding the proposed business combination between Allergan and Inamed, and the
anticipated consequences and benefits of such transaction. Statements made in the future
tense are intended to identify forward looking statements. These statements are based on current
expectations, but are subject to certain risks and uncertainties, many of which are difficult to
predict and are beyond the control of Allergan. Relevant risks and uncertainties include those
referenced in Allergans filings with the SEC (which can be obtained as described in Additional
Information below). Risks and uncertainties relating to the proposed transaction include: that
required regulatory approvals will not be obtained in a timely manner, if at all; that the
anticipated benefits and synergies of the transaction will not be realized; that the integration of
Inameds operations with Allergan will be materially delayed or will be more costly or difficult
than expected; and that the proposed transaction will not be consummated. These risks and
uncertainties could cause actual results to differ materially from those expressed in or implied by
the forward-looking statements, and therefore should be carefully considered.
Additional Information
Allergan intends to file a Registration Statement on Form S-4 and may file other documents with the
SEC in connection with the proposed acquisition of Inamed. Inamed stockholders should read those
filings, and any other filings made by Allergan with the SEC in connection with the proposed
acquisition, as they will contain important information. These SEC filings, as well as Allergans
other public SEC filings, can be obtained without charge at the SECs website at www.sec.gov, and
at Allergans website at www.Allergan.com.
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American Society of Plastic Surgeons.
2000/2002/2003/2004 National Plastic Surgery Statistics Cosmetic and
Reconstructive Procedure Trends. Available at:
http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=16158. Accessed October 28, 2005. |
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Wikipedia Dictionary. Definitions of breast
implant on the Web. Available at:
http://en.wikipedia.org/wiki/Breast_implant. Accessed October 28, 2005. |
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Inamed Corporation. Breast Reconstruction US
Patients: Saline-Filled Implants Product Information.
http://www.inamed.com/products/recon/us/patient/saline/prodinfo.html.
Accessed October 28, 2005. |
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Inamed Corporation. Breast Augmentation US
Patients: Saline-Filled Implants Product Information. Available at:
http://www.inamed.com/products/aug/us/patient/saline/prodinfo.html.
Accessed October 28, 2005. |
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American Society of Plastic Surgeons. Home:
Learn About Procedures: Procedures. Available at:
http://www.plasticsurgery.org/public_education/procedures/BreastReconstruction.cfm. Accessed October 28, 2005. |
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American Society of Plastic Surgeons. 2004
Quick Facts. Cosmetic and Reconstructive Plastic Surgery Trends. Available at:
http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=16154. Accessed October 28, 2005. |
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American Society of Plastic Surgeons. 2004
Quick Facts. Cosmetic and Reconstructive Plastic Surgery Trends. Available at:
http://www.plasticsurgery.org/public_education/loader.cfm?url=/commonspot/security/getfile.cfm&PageID=16144. Accessed October 28, 2005. |
2
Obesity Intervention Fact Sheet
In the United States, an estimated 97 million adults are overweight or obese that is 55 percent
of the American adult population. Despite growing obesity awareness, obesity is the second leading
preventable cause of death and is today considered the most prevalent epidemic in the U.S. and a
public health crisis throughout the world.1 About 120,000 bariatric (obesity)
operations were performed last year, triple the number performed just two years ago, or a 500
percent increase in number of bariatric surgeries performed annually since 1992. Industry
estimates are that there will be more than 200,000 bariatric surgeries performed in the U.S. by
2005.2
BioEnterics® LAP-BAND® System Overview
Approved by the Food and Drug Administration (FDA) in June 2001, Inamed Corporations
BioEnterics® LAP-BAND® System (LAP-BAND®) is a market-leading,
minimally invasive surgical approach to reduce the health risks of obesity.3
LAP-BAND® (laparoscopic adjustable gastric band) is the second-most-common bariatric
procedure in the U.S., and the leading bariatric procedure worldwide, having been implanted in more
than 100,000 patients. LAP-BAND® is less invasive than other obesity surgeries, such as
gastric bypass or stomach stapling, and does not disrupt the way the body absorbs nutrients. It
also is the only adjustable and reversible bariatric procedure, and is more cost-effective than
gastric bypass or laparoscopic bypass surgery.4 In fact, gastric bypass is nearly twice
the average cost of a LAP-BAND® procedure.5
The LAP-BAND® System, used primarily by surgeons specialized in obesity and other GI
related disorders, would anchor the portfolio alongside the planned development of Allergans
BOTOX® (botulinum toxin type A) as a potentially minimally invasive treatment for
gastroparesis and Allergans proton pump inhibitor pro-drug for the potential treatment of
gastrointestinal heartburn.
How the LAP-BAND® System Works 3
The LAP-BAND® System is a unique and comprehensive quality system approach that
works by inducing weight loss by reducing the capacity of the stomach, which restricts the amount
of food that a person can consume.
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During the procedure, surgeons usually use laparoscopic techniques
(using small incisions and long-shafted instruments rather than a
large incision), to implant an inflatable silicone band into the
patients abdomen. |
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The band is fastened around the upper stomach to create a new, tiny
stomach pouch that limits and controls the amount of food one can
eat. It also creates a small outlet that slows the emptying process
into the stomach and the intestines. |
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As a result, patients experience an earlier sensation of fullness and
are satisfied with smaller amounts of food. This, in turn, results
in weight loss. |
LAP-BAND® System Safety and Efficacy3
The LAP-BAND® System procedure is considered the least traumatic of all weight loss
surgeries since there is no cutting, stapling or stomach rerouting involved. The laparoscopic
approach to the surgery also offers the advantages of reduced post-operative pain, a shortened
hospital stay and quicker recovery. If for any reason the LAP-BAND® System needs to be
removed, the stomach generally returns to its original form.
The BioEnterics® Intragastric Balloon (BIB®) System6
Inameds BioEnterics® Intragastric Balloon (BIB®) System is a non-surgical,
non-pharmaceutical alternative for the treatment of obesity. The BIB® System is
designed to provide short-term weight loss therapy to reduce health risks related to obesity or
risks prior to vital surgery, or as part of a supervised weight loss program.
Endoscopically placed and inflated with saline, the BIB® System balloon (made of
durable, elastic, high-quality silicone) partially fills the stomach to induce the feeling of
fullness and support patients in reducing food intake and adopting new dietary habits. It is used
in conjunction with a supervised diet and behavior modification program to help maintain weight
loss over time after removal of the device, which can also be done endoscopically.
The BIB® System is available in several European countries; it is not currently
available in the U.S.
Forward-Looking Statements
This communication contains forward-looking statements, including, among other statements,
statements regarding the proposed business combination between Allergan and Inamed, and the
anticipated consequences and benefits of such transaction. Statements made in the future tense are
intended to identify forward looking statements. These statements are based on current
expectations, but are subject to certain risks and uncertainties, many of which are difficult to
predict and are beyond the control of Allergan. Relevant risks and uncertainties include those
referenced in Allergans filings with the SEC (which can be obtained as described in Additional
Information below). Risks and uncertainties relating to the proposed transaction include: that
required regulatory approvals will not be obtained in a timely manner, if at all; that the
anticipated benefits and synergies of the transaction will not be realized; that the integration of
Inameds operations with Allergan will be materially delayed or will be more costly or difficult
than expected; and that the proposed transaction will not be consummated. These risks and
uncertainties could cause actual results to differ materially from those expressed in or implied by
the forward-looking statements, and therefore should be carefully considered.
Additional Information
Allergan intends to file a Registration Statement on Form S-4 and may file other documents with the
SEC in connection with the proposed acquisition of Inamed. Inamed stockholders should read those
filings, and any other filings made by Allergan with the SEC in connection with the proposed
acquisition, as they will contain important information. These SEC filings, as well as Allergans
other public SEC filings, can be obtained without charge at the SECs website at www.sec.gov, and
at Allergans website at www.Allergan.com.
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1 |
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Inamed Corporation. Obesity solutions US
Patients. Available at:
http://www.inamed.com/products/obesity/us/patient/patient.html.
Accessed October 28, 2005. |
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The BBI Newsletter, July 1, 2004. |
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Inamed Corporation. Obesity solutions US
Patients. Available at:
http://www.inamed.com/products/obesity/us/patient/lapband/prodinfo.html.
Accessed October 28, 2005. |
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Inamed Corporation. Obesity solutions US
Patients. Available at:
http://www.inamed.com/products/obesity/us/patient/patient.html#lapband.
Accessed October 28, 2005. |
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Morgan Stanley report, 10/21/05. |
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Inamed Corporation. Obesity solutions UK
Patients. Available at:
http://www.inamed.com/products/obesity/uk/patient/patient.html#lapband.
Accessed October 28, 2005. |