Filed by Endorex Corporation pursuant to Rule 425 of the Securities Act of 1933,
as amended, and deemed to be filed pursuant to Rule 14a-12 of the Securities
Exchange act of 1934, as amended.
Subject: Corporate Technology Development, Inc.
Commission File No. 1-14778
ON September 5, 2001, ENDOREX CORPORATION, A DELAWARE CORPORATION GAVE THE
FOLLOWING PRESENTATION:
ORAL DELIVERY OF DRUGS
WELCOME TO A BRAVE NEW WORLD OF NO MORE NEEDLES
[Photographic image depicting a hand holding a syringe.]
Michael Rosen
President & CEO
Endorex Corporation
(AMEX: DOR)
Wells Fargo Van Kasper
"The Class of 2001"
Conference
September 5, 2001
FORWARD-LOOKING STATEMENTS:
SECURITIES LAW LEGENDS
This presentation contains forward-looking statements, within the meaning of
Section 21E of the Securities Exchange Act of 1934, as amended, that involve a
number of known and unknown risks and uncertainties. These statements are only
predictions and actual events or results in future periods may differ materially
from what is currently anticipated. In particular, Endorex cannot assure you
that it will be able to successfully develop or commercialize products based on
Endorex's technology, particularly in light of the significant uncertainty
inherent in developing drug delivery products, conducting clinical trials and
obtaining regulatory approvals, that Endorex's technologies will prove to be
safe and effective, that Endorex's cash expenditures will be at projected
levels, that Endorex will be able to obtain future financing or funds, that
Endorex or its joint ventures or its collaborations with other companies in the
U.S. and abroad will successfully develop products or become profitable, that
Endorex's joint ventures or its collaborations with other companies will
continue, that Endorex's business strategy will be successful or that Endorex
will be able to carry out our plans for 2001 and beyond. This presentation also
contains forward-looking statements regarding Endorex's, Corporate Technology
Development, Inc.'s, or CTD, and the combined companies' plans, expectations,
intentions and strategies. These statements include forward-looking statements
about Endorex's, CTD's and the combined companies' products, product development
and product pipeline. These statements are not guarantees of future performance
or results and actual results could differ materially from current expectations.
Factors that could cause or contribute to such differences include, but are not
limited to, product integration risk, the possibility that the operations and
management of Endorex and CTD will not be successfully integrated, the
possibility that the merger might not be consummated, the effects of the public
announcement on the progress of certain drug development projects and that
benefits sought to be achieved by the transaction will not be achieved.
Furthermore, Endorex, CTD, and the combined companies cannot assure you that
they will be able to successfully develop or commercialize products based on
their technology, particularly in light of the significant uncertainty inherent
in developing drug and drug delivery products, conducting clinical trials and
obtaining regulatory approvals, that their technologies will prove to be safe
and effective, that their cash expenditures will be at projected levels, that
product development and commercialization efforts will not be reduced or
discontinued due to difficulties or delays in clinical trials or due to lack of
progress or positive results from research and development efforts, that they
will be able to successfully patent, register or protect their technology,
trademarks and products, or that the business strategies of Endorex, CTD, or the
combined companies will be successful. In addition to the matters described in
this presentation, risk factors as described from time to time in Endorex's
filings with the Securities and Exchange Commission, including, but not limited
to, our most recent reports on Form 10-QSB, Form 10-KSB, as amended, and our
Registration Statement on Form S-3, as amended, may affect our financial
results. We assume no obligation to update the information in this release.
FORWARD-LOOKING STATEMENTS:
SECURITIES LAW LEGENDS
Additional Information and Where to Find It: It is expected that Endorex will
file a Registration Statement on SEC Form S-4 and Endorex and CTD wil file a
Joint Proxy Statement/Prospectus with the SEC in connection with the
transaction, and that Endorex and CTD will mail a Joint Proxy
statement/Prospectus to stockholders of Endorex and CTD containing information
about the transaction. Investors and security holders are urged to read the
Registration Statement and the Joint Proxy Statement/Prospectus carefully when
they are available. The Registration Statement and the Joint Proxy
Statement/Prospectus will contain important information about Endorex, CTD, the
transaction, the persons soliciting proxies relating to the transaction, their
interests in the transaction and related matters. Investors and security holders
will be able to obtain free copies of these documents through the website
maintained by the SEC at http://www.sec.gov. Free copies of the Joint Proxy
Statement/Prospectus and these other documents may also be obtained from Endorex
by directing a request by mail to Endorex at 28101 Ballard Drive, Suite F, Lake
Forest, IL 60045-4544, telephone (847) 573-8990, or from CTD by directing a
request by mail to CTD at 1680 Michigan Avenue, Suite 700, Miami, Florida 33139,
telephone 305-777-2258.
In addition to the Registration Statement and the Joint Proxy
Statement/Prospectus, Endorex files annual, quarterly and special reports, proxy
statements and other information with the SEC. You may read and copy any
reports, statements or other information filed by Endorex at the SEC public
reference rooms at 450 Fifth Street, N.W., Washington, D.C. 20549 or at any of
the SEC's other public reference rooms in New York, New York and Chicago,
Illinois. Please call the SEC at 1-800-SEC-0330 for further information on the
public reference rooms.
Endorex's filings with the SEC are also available to the public from commercial
document-retrieval services and at the website maintained by the SEC at
http://www.sec.gov.
Endorex, CTD, directors and certain executive officers of Endorex and CTD,
Paramount Capital, Inc. and certain affiliates and employees of Paramount
Capital, Inc., may be considered participants in the solicitation of proxies in
connection with the merger. Certain directors and executive officers may have
direct or indirect interests in the merger due to securities holdings of Endorex
and CTD and rights to bonus payments following the merger. Paramount Capital,
Inc. and certain affiliates and employees of Paramount Capital, Inc. may be paid
to solicit proxies in connection with the merger and may have direct or indirect
interests in the merger due to their securities holdings of Endorex and CTD. In
addition, certain directors and officers, after the merger, will be indemnified
by Endorex and will benefit from insurance coverage for liabilities that may
arise from their service as directors and officers of CTD prior to the merger.
Additional information regarding the participants in the solicitation will be
contained in the Joint Proxy Statement/Prospectus to be filed by Endorex and CTD
with the SEC.
ENDOREX PROFILE
- Oral drug delivery technology addresses significant markets:
- Biotech injectable products - $18.5 billion
- Other drugs with delivery issues
- Business strategy for extending patent and commercial life of existing
drugs via new delivery systems
- Strong intellectual property portfolio: 50+ issued patents
- New company acquisition strengthens drug pipeline, balance sheet and
management team
THE ADVANTAGE OF ORAL DELIVERY
- For the Patient:
- improved quality of life
- convenience
- compliance
THE PAIN OF INJECTIONS
- 4 million U.S. children receive up to 21 vaccine inoculations every 2
years
- 1 million U.S. insulin-dependent diabetics get 2-3 shots daily for life
CDC/American Diabetes Association data
[Photograph image depicting a mother comforting a crying child receiving an
injection via syringe.]
NEEDLE-PHOBIA AND THE IMPACT ON COMPLIANCE!
- 50 million Americans get annual "flu" shots
- 66% of patients receiving the Hepatitis B vaccine don't complete 3-shot
regimen
Frost & Sullivan/CDC data
[Photographic image depicting an elderly woman receiving an injection via
syringe.]
THE ADVANTAGE OF ORAL DELIVERY
- For the Patient:
- improved quality of life
- convenience
- compliance
- For the Healthcare System:
- reduced costs
THE COST OF ADMINISTERING INJECTIONS!
-------------------------------------
THE COST OF ADMINISTERING
INJECTIONS*
-------------------------------------
MEDICAL PERSONNEL 65%
-------------------------------------
TRAINING 8%
-------------------------------------
VACCINE 10%
-------------------------------------
REFRIGERATION 10%
-------------------------------------
SYRINGE 7%
-------------------------------------
CDC Data
- Medical Personnel
- Training
- Vaccine
- Refrigeration
- Syringe
THE ADVANTAGE OF ORAL DELIVERY
- For the Patient:
- improved quality of life
- convenience
- compliance
- For the Healthcare System:
- reduced costs
- For Administering Drugs into the Body:
- molecular size/weight
- solubility in water
- "fragility" in the gastrointestinal tract
PROTEIN/PEPTIDE DRUG DELIVERY
MOLECULAR WEIGHT DRUGS
VERY HIGH Vaccines (50 - 1000 KD)
>50 KD Monoclonal antibodies (150 KD)
HIGH Human Growth Hormone (22 KD)
21- 50 KD Erythropoietin (30 KD)
MEDIUM Insulin (6 KD)
6 - 20 KD Heparins (6-30 KD)
Interferons (20 KD)
Colony Stimulating Factors (19 KD)
LOW LHRH (1 KD)
.5 - 5 KD Calcitonin (3- 4 KD)
Other Peptides
BIOTECH INJECTABLE PRODUCTS MARKET
(PROTEINS/PEPTIDES)
$18.5 BILLION
(2001E - S. G. COWEN)
[Graphic of a circular chart sectioned into different categories setting forth
the different product markets making up the overall estimated injectable
products market for the year 2001, consisting of: (a) growth factors, (b)
hormones (c) vaccines, (d) cytokines (e) gene theraby and (f) others.]
LEADING BIOTECH INJECTABLE PRODUCTS
Product: Worldwide 2001 E Sales ($B)
------- ---------------------------
1. Insulin $3.6
2. Erythropoietin $3.1
3. Vaccines $3.0
4. Interferons $1.8
5. Monoclonal antibodies $1.7
6. Colony stimulating factors $1.4
7. Heparins $1.0
8. Growth Hormones $0.9
9. LHRH Analogues $0.9
10. Interleukins $0.3
11. Other (gene therapy, antisense, blood
factors,etc) $0.9
----
$18.5
S.G. Cowen data
ENDOREX ORAL DELIVERY TECHNOLOGIES
LIPID-BASED SYSTEMS
[Image of a microscopic photograph depicting polymerized liposomes.]
- Initial technology developed by DR. ROBERT LANGER at Massachusetts
Institute of Technology
- Platform capability for DRUGS and VACCINES
- Suitable for ORAL and NASAL delivery
- Capable of delivering range of "drug payloads"
- Protects "payload" through the gastrointestinal tract without altering
drug structure
- Scaleable
THE ORASOME(TM) ORAL DELIVERY SYSTEM
[Graphic depicting the Orasome(TM) oral delivery system consisting of a drawing
of a water soluble drug encapsulated by a lipid bilayer.]
ORAL DELIVERY PROCESS
POTENTIAL ADVANTAGES OF ENDOREX ORAL
DRUG DELIVERY TECHNOLOGY
- Patient
- easier delivery format (liquid/pill)
- Physician
- patient compliance with therapy
- Pharmaceutical Company/Partner
- differentiated product form
- extended product patent life
- suitable for water soluble and insoluble drugs
PRODUCTS UNDER DEVELOPMENT
Injectable
ORAL PRODUCT CANDIDATES Market*
- Human growth hormone $1.7 billion
- Insulin $3.6 billion
- Influenza vaccine $1.0 billion
- Tetanus vaccine $50 million
- Other protein/peptide drugs $1.3 billion
- Other water insoluble drugs $1.6 billion
*Frost & Sullivan
S.G. Cowen
ENDOREX BUSINESS STRATEGY
[Graphical image of a flow chart setting forth the business strategy of Endorex
with the following steps: (a) pharma companies to (b) new or approved injectable
drug/vaccine to (c) Endorex oral delivery systems to (e) new oral product &
patent.]
Revenue Stream:
--------------
- License and development fees
- Milestone fees
- Royalties
COMPETITIVE ARENA
* CDC DATA
COMPETITIVE ARENA
PROTEIN & PEPTIDE DELIVERY
IMPLANTS
Alkermes
Alza
Atrix
PULMONARY
Aerogen
Aradigm
Elan/Dura
Inhale Therapeutics
TRANSDERMAL
Bioject
Powerderject
NASAL
Aviron
ID Biomedical
West Pharm.
ORAL
Emisphere
Endorex
Generex
Nobex
Unigene
ISSUES FOR ENDOREX GROWTH
- Expanding drug delivery technology focus to include small molecules:
- macromolecular delivery challenges
- Creating a drug pipeline spanning clinical and preclinical development
- Having a product closer to market (phase 3)
- Obtaining additional financial resources to take product to market
STRATEGIC RATIONALE FOR CTD ACQUISITION
Products
1 - Phase 3
1 - Phase 1-2
STRATEGIC RATIONALE FOR CTD ACQUISITION
Intellectual
Products Property
1 - Phase 3 8 Patents
1 - Phase 1-2 10 Pending
Orphan drug
STRATEGIC RATIONALE FOR CTD ACQUISITION
Financial
$5M
No debt
Intellectual
Products Property
1 - Phase 3 8 Patents
1 - Phase 1-2 10 Pending
Orphan drug
STRATEGIC RATIONALE FOR CTD ACQUISITION
Financial Management
$5M Board
No debt Chairman/CEO
Products Intellectual
Property
1 - Phase 3 8 Patents
1 - Phase 1-2 10 Pending
Orphan drug
CORPORATE TECHNOLOGY DEVELOPMENT, INC
Profile:
- Founded in 1998
- HQ in Miami
- Privately-held specialty pharmaceutical company
- Key Investors:
- TVM Techno Venture Management
- Nomura Bank
- Paul Capital Partners
CORPORATE TECHNOLOGY DEVELOPMENT, INC.
KEY PRODUCTS
orBec(R)(beclomethasone diproprionate): corticosteroid
Current(Glaxo/Beconase) CTD
---------------------- ---
Formulation: Pulmonary/nasal Oral tablets (dual release)
(Beconase(R)/Glaxo)
Therapeutic Indication: Asthma Treatment of Intestinal
Graft vs. Host Disease;
other gastro disorders
Development Status: Marketed Phase 3 multicenter trials;
Orphan drug/FDA
"fast-track designation"
Market: $500 M/year 2500-5100 patients/year
(15-30% of allogeneic bone
marrow transplant patients)
CORPORATE TECHNOLOGY DEVELOPMENT, INC
KEY PRODUCTS
Oraprine(R) (azathioprine): immunosuppressant
Current(Faro/Imuran(R) CTD
---------------------- ---
Formulation: I.V./Tablet Oral (liquid)
Therapeutic Indication: Treatment of: Same
- transplant rejection Oral GVHD
- rheumatoid arthritis
Development Status: Marketed Phase 1
bioequivalency trial
Phase 1/2 trial for
chronic oral autoimmune
diseases completed;
Orphan drug
ENDOREX/CTD PRODUCT PIPELINE
[Graphical image of a chart depicting product candidates of Endorex and CTD with
arrows indicating the different stages of development for the following product
candidates:
orBec(TM)
- I GVHD [arrow indicates initial Phase 3 development stage]
- Other GI Disorders [arrow indicates development stage between Phase 1 and
Phase 2]
Oraprine(R)
- Oral autoimmune disorders [arrow indicates development stage between Phase 1
and Phase 2]
- Rheumatoid arthritis/transplant [arrow indicates Initial Phase 1 development
stage]
Oral Delivery
- Insulin [arrow indicates development stage between research and preclinical]
- Human Growth Hormone [arrow indicates development stage between research and
preclinical]
- Tetanus Vax [arrow indicates development stage between research and
preclinical]
- Infuenza Vax [arrow indicates development stage between research and
preclinical]
- Other Drugs [arrow indicates research development stage]
ACQUISITION OF CTD
- Endorex to acquire CTD for 10 million shares:
- 9.4 million common shares
- .6 million warrants/options
- Endorex to integrate CTD management/board:
- 3 members to join Endorex board
- Chairman Colin Bier, Ph.D., to assume position of Endorex Chairman/CEO
ENDOREX CAPITAL STRUCTURE
POST ACQUISITION
Shares - Millions
Outstanding Fully-Diluted
----------- -------------
Endorex 12.7 19.8
Endorex + CTD 22.1 29.8
CTD ownership of Endorex 44% 33%
SYNERGY OF COMPANIES
Oral/Mucosal Delivery
ENDOREX
MACROMOLECULES
PRECLINICAL
hGH
Insulin
Vaccines
Other
Management
Public
$9.5M cash
CTD
SMALL MOLECULES
CLINICAL
orBec(TM)
phase 3
Oraprine(R)
phase 1-2
Management
Private
$5.0M cash
ENDOREX
ORAL/MUCOSAL DELIVERY
Endorex
CTD
- Clinical/preclinical pipeline
- Expanded patent portfolio
- Enhanced management
- Strengthened balance sheet
ENDOREX HIGHLIGHTS
- Oral drug delivery technology addresses significant market:
- Biotech injectable products - $18.5 billion
- Other drugs with delivery issues
- Business strategy for extending patent and commercial life of existing
drugs via new delivery systems
- Strong intellectual property portfolio: 50+ issued patents
- New company acquisition strengthens drug pipeline, balance sheet and
management team
THANK YOU
WELCOME TO A BRAVE NEW WORLD OF NO MORE NEEDLES
[Photographic image depicting a hand holding a syringe.]