About Caleco
Pharma Corp.
Our business plan is to develop our
proprietary technology designed to treat
moderate to severe liver maladies, such as
elevated liver enzymes and the Hepatitis C
viral infection, (the "Liver Health
Formula") as an over-the-counter product and
as a United
States Food and Drug Administration ("FDA")
approved pharmaceutical. To date, our
intellectual property covering the Liver
Health Formula comprises of patent
applications in the United States, Europe
and Canada and four European Drug Master
File applications, as well as a document
issued by the European Health Authorities
allowing the sale of the product
“Lamirodosin” OTC, under the number Pl
1400/1 Lamiridosin, name which will be used
in Europe and other areas.
Caleco has filed U.S. provisional patent
applications No. 60/901,602 filed February
13, 2007 and No. 61/000,550 filed October
26, 2007. Additionally, it filed World
Intellectual Property Organization
Application W0 2008/100547 A2 on February
13, 2008 and 4 EDMFs (European Drug Master
Files) approved through Exxentia Puleva
Biotech (its manufacturer and European
Marketing Partner, (www.exxentia.com)
and (http://www.pulevabiotech.com/pb/en/home.jsp)
The Importance of Hepatitis C Virus (HCV)
•
Primary cause of liver cancer and
liver transplant
•
HIV and Hepatitis C
–
#1 cause of death and
hospitalizations in people living with HIV
–
Up to 1/3 of those living with HIV
also have
–
HIV infection may promote HCV disease
progression
–
Anti-HIV medications may cause
hepatitis
–
HIV may impact HCV transmission
(sex/perinatal)
•
Other Liver problems, elevated
enzymes et al
–
All Statin Users (Lipitor, Crestor,
etc.) at risk
–
Many Rx medications warn for liver
impact
–
Lifestyle risks, e.g. heavy drinking,
stress, etc.
•
Cost of Hep-C and Liver related
issues in the billions
Proprietary Caleco Pharma OTC formulations
containing Lamium and Agrimonia exhibited
favorable effects on liver health in 14
persons with Hepatitis C. See charts below:


Excerpts from Prof. Fong’s White Paper dated
August 20, 2008 on the development of
HP-201(Caleco’s product)
·
Based on research conducted in our
laboratories, the anti-hepatitis/liver
cirrhosis mitigation effects observed in the
clinical study of LHF are most likely
mediated by a direct anti-viral mechanism.
·
Structurally, HP-201, possessing four
hydroxyl and one carbonyl groups, is an
ideal lead compound for structural
modification to produce more active
candidates for drug development.
·
Seven of [13] congeners showed
significant inhibition against the HCVpp
infection
·
With the anti-HCV activity profiles having
been demonstrated in two bioassay systems,
and considering the observed clinical
effects of the parent herbal formulation,
I believe that there is a strong potential
for the development of HP-201 and/or its
congeners and derivatives into one or more
anti-HCV therapeutic agents.
·
USA patent application* has been filed, and
action has also been taken in filing for
European patent(s) on these molecules. *USA
patent application* has been filed, and
action has also been taken in filing for
European patent(s) on these molecules
Additional supportive scientific medical
opinion:
Plutarco Restituyo, M.D. Gastroenterologist
Center of Gastrodiagnosis and Specialties -
Santo Domingo, Dominican Republic
Doctor Restituyo supervised first clinical
study on HP-201
Conclusions from his Clinical Study with the
product
-
We can consider the clinical response as
EXCELLENT
-
The Biochemical response as VERY GOOD
-
The virological response as VERY
ACCEPTABLE
-
“We still have a lot to learn from the
treatments with this product, we don’t
know if it is an immune regulator or an
antiviral or both at the same time, in
any case everything indicates, that if
the results obtained in this limited
number of patients would result to be
similar in a number of patients equal or
higher than a 100, we could confirm that
this product would be in percentage
terms very much above the actual
existing therapies for Hepatitis C.”
Current Hep-C Therapies
Drug Based
•
Current Standard of Care: combination
therapy for 24-48 weeks
–
Interferon (injected 3x week): an
immune booster
–
Pegylated Interferon (injected 1x
week): interferon w/ protein
–
Ribavirin (pill several times a day):
an antiviral
•
Very Expensive, $25-$50,000
•
Limited Effectiveness, about 50% on
average
•
Severe side-effects, similar to
chemo, severe impact on QOL
OTC Based
•
As adjunctive/complimentary therapy
only
•
Limited if any effectiveness—no
clinical evidence of efficacy
•
Little awareness and self-limiting
marketing
Corporate Officers, Key Contributors and
Advisors
John Boschert
President, CEO, CFO, Director and Officer of
Caleco Pharma Corp.
Mr. Boschert has been our Secretary and
Treasurer since April 19, 2006 and our Chief
Executive Officer, Chief Financial Officer,
President and Director since August 20,
2008. Mr. Boschert received his diploma in
business administration from Langara College
in 1989. He has been the owner/operator of
several successful private ventures as well
as an independent consultant having
participated in raising venture capital for
various private/public companies. Over the
past ten years, Mr. Boschert has also served
as an officer or director of several
publicly traded companies. This experience
being primarily with seeking and evaluating
business opportunities along with the
financing, development and commercialization
of various proprietary technologies, and the
day to day management of public companies.
Javier Benedi
Director of Caleco Pharma Corp.
Mr. Javier Benedi has been a Director since
January 27, 2009 and has over thirty-five
years of experience in the fields of
banking, Investment, real estate, and
biotechnology. Mr. Benedi obtained a degree
of commerce from the Salamanca School of
Commerce located in Salamanca, Spain. After
completing his degree in commerce and until
the 1980s, he worked in the banking and
finance industry with a number of firms,
including EXCO.
In the 1980s and early 1990s, Mr. Benedi
gained considerable experience in the fields
of real estate development and Investment
operations. During this period, Mr. Benedi
worked with LRC Technologies, LLC, Global
Remediation, Inc., and Casino de Madrid (a
privately owned club in Madrid). In 1994, he
founded Societe de Participations et de
Valeurs (SPV) in Luxembourg, a holding
company engaged in Property Development,
Metal trading, Leisure Industry and Finance
activities. Mr. Benedi was the president and
sole shareholder of SPV until 2000, when the
assets of the company were sold. Since then,
he has focused on the development,
management and financing of various
ventures.
James Sandino
Director of Caleco Pharma Corp.
James Sandino has been a Director since
October 16, 2008. Mr. Sandino has over
twenty five years of marketing experience,
including significant expertise marketing in
the healthcare industry. In 1970, Mr.
Sandino obtained a Bachelor of Arts from St.
John’s University in Collegeville Minnesota.
His professional experience in marketing
began on the client side with Coca Cola. He
began his agency experience with clients
like American Express, The U.S. Olympic
Committee, Time, Sports Illustrated, and
AT&T.
In healthcare, Mr. Sandino‘s credits include
the re-launch of Rogaine, the launch of
Lamisil, and numerous other successful
efforts across every major therapeutic
category for nearly every major Pharma
company. From 1996 to 2001, Mr. Sandino was
the President and CEO of Lowe Consumer
Healthcare World Wide, a consumer focused
healthcare marketing agency. Since 2001, Mr.
Sandino has been the President and CEO of
the Sandino Group, LLC, an independent
marketing and business development
consultancy which specializes in healthcare,
direct marketing and strategic planning.
From 2005 to 2008, Mr. Sandino also was the
Chief Marketing Strategist for Integrated
Marketing Solutions, Inc. and assisted
clients in establishing brand recognition.
Harry H.S. Fong, Ph.D.
C.V.
Harry H.S. Fong
Advisor for Product and Intellectual
Property Development
Professor Emeritus of Pharmacognosy Dept. of
Medicinal Chemistry and Pharmacognosy
University of Illinois at Chicago
2008 Recipient of the Prestigious Burton
Kallman Scientific Award
The major research interests of Prof. Fong
are in the search for antitumor, cancer
chemopreventive, anti-malarial, anti-HIV and
anti-TB agents from plants and herbal
medicine. He currently serves as project
leader or co-project leader in projects on
drug discovery from higher plants. In herbal
medicine research, Prof. Fong is supported
on program project and center grants funded
by NIH. Much of his work focuses on quality
assurance and quality control, safety and
clinical efficacy of natural products and
herbal medicine, including his work with the
American Botanical Council Ginseng
Evaluation Program.
Prof. Fong is also involved with issues
concerning the standardization of botanical
dietary supplements and traditional herbal
medicines; of monographing medicinal plants;
and of evidence-based traditional herbal
medicine. Prof. Fong is the author and
co-author of more than 255 original research
papers, several book chapters and review
articles and is co-editor of a book series
on Chinese medicine as well as a contributor
to World Health Organization monographs and
guidelines on medicinal plants. He has
served as a consultant to a number of herbal
medicine and dietary supplements companies
and is founder and president of NatProPharm
Services, Ltd, a natural products
pharmaceuticals research and development and
consulting services company.
Jim Metropoulos, MD
Advisor for Product Development and
Marketing
Dr. Metropoulos is a physician with a unique
experience and perspective on the role of
healthcare communications in clinical
medicine. Healthcare communications is a
rapidly growing business that represents one
of the largest revenue drivers for global
communications holding companies such as WPP
Group, Omnicom and Publicis. Over the next
several years, drug sponsors, regulatory
agencies, and human subject protection
programs will require increased training and
oversight of physicians in an effort to
bring foreign based investigators into
compliance with Good Clinical Practice (GCP)
guidelines.
Dr. Metropoulos has been a senior executive
in healthcare communications for the past 15
years. Over this time he has advanced
progressively to positions of increasing
responsibility. Early in his career he was
Chief Strategic Officer, North America, for
Lowe McAdams Healthcare where he established
a highly successful Strategic Planning
practice modeled after Account Planning at
consumer agencies. This resulted in his
being promoted to Chief Strategic Officer
for Lowe McAdams Healthcare Worldwide, a
position focused on global network strategic
planning and acquisitions. In 2002 Dr.
Metropoulos was appointed Chief Strategic
Officer at Sudler & Hennessey (a division of
Young and Rubicam) where he was charged with
managing business development and a
strategic planning practice.
From 2003 to 2006, Dr. Metropoulos was
Co-President of Sudler & Hennessey. In this
role he helped increase revenues from $45
million to $97 million per year while
increasing the client base from 12 to 35. In
addition, he established publication
planning and managed care practices, managed
a second network agency (Sentrix NJ),
established joint ventures with a contract
research organization, Tablet PC firm, and
managed care specialty firm and participated
in the acquisition of a sales training and
medical education company. From 2006 to
2007, Dr. Metropoulos was President and CEO
of Euro RSCG Life Worldwide, the global
healthcare communications network of Euro
RSCG Worldwide and Havas, Inc.
In 2007, Dr. Metropoulos became a co-founder
of Rearden Health Partners, a full-service
marketing communications firm dedicated to
the design, development and licensing of
proprietary health education, marketing and
communications products and services.
Bob Adler
Advisor for Product Development and
Marketing
With over 25 years in the US and
International healthcare industry, Bob Adler
is an accomplished business leader who has
met the unique challenges of startup,
turnaround and high growth companies and
brands. With a degree in microbiology and
biochemistry, Mr. Adler brings broad based
scientific knowledge combined with
exceptional strategic marketing and
outstanding business development
accomplishments in pharmaceutical,
biomedical, and healthcare fields from both
industry and service agency perspectives.
Including HIV, hepatitis, cardiovascular and
hospital product experience, Mr. Adler has
been actively engaged throughout many
pharmaceutical and biotechnology sectors,
with mature as well as developing
organizations across myriad therapeutic,
medical device and diagnostics categories.
From market and competitive intelligence
research, to clinical assessments, advisory
boards and war gaming; and from branding to
comprehensive patient, professional and
business to business communications and
relationship development activities, Mr.
Adler brings strategic insights as well as
managed market experience to help clients at
all levels innovate and successfully exceed
expectations.
From spearheading product and program
development activities, to partnering,
executing and leading launch teams, Mr.
Adler is sought after for his leadership to
assist organizations and teams throughout
all phases of business, product development
and commercialization activities. In
addition, he has valuable experiences
in-licensing valuations, as well as
co-promotion and co-marketing activities.
Entrepreneurial by nature, Mr. Adler has
lead cross-functional internal and client
teams in integrated business development
tasks across a range of product, franchise,
and company-wide initiatives.
Fernando Chávarri
General Manager International Division
Fernando
Chávarri holds a law degree
from the Universidad Complutense de Madrid,
is a practicing lawyer by the Ilustre
Colegio de Madrid (Chartered 25,191), and
Master in Community Law from the Complutense
University of Madrid. Since 1986, he has
been a member of the National Graphical
Association of Press and TV (No.1062). Mr.
Chávarri has performed
duties of Deputy Director in the Regional
Central Bank of Europe (Madrid) and three
years working as Financial Advisor-Sales at
Barclays Bank (Madrid). Since 1998, he has
had multiple roles as an Attorney Advisor
and Personal Assistant in business companies
owned by Mr. Benedi’s holding companies
(Property Development, Leisure Industry,
Finance activities, etc.).
Ricardo Xalma
Technical Director International Division
Ricardo Xalma holds a degree in Graphic
Design and Advertising from the School of
Arts and Crafts in San Telmo (Málaga). He
has developed his professional experience as
a graphic designer and multimedia in various
Spanish and foreign companies: Mediafusion
(Madrid), Iber Explorer, SA (Barcelona),
Iber Explorer - France Telecom SA (France),
Virtual Net, Inc. (Malaga), Eworldmedia
Entertainment (Los Angeles-USA), etc. In
1995 he worked as head of the Graphic Design
Department of the shopping center El Corte
English (Málaga). Mr. Xalma specializes in
web-media developments in various
programming languages.
Recent Key Press Releases
Monday, October 5, 2009 – Caleco Pharma
Corp. Announces Engagement of Cosmetic
Project Management -
BELLINGHAM, WASHINGTON - (MARKET WIRE) -
Caleco Pharma Corp. (the
"Company") (OTCBB: CAEH)(FRANKFURT:
T3R)(WKN: AON9YO) (www.calecopharmacorp.com)
is pleased to announce that it has developed
or in the process of developing its Natural
Hair Care Products (LamiriShampoo,
LamiriHair Conditioner, LamiriHair Tonic)
and Natural Skin Care Products (LamiriGel
and LamiriCreme). The formulations of these
products are derived from the Company's
proprietary technology that it refers to as
the "Liver Health Formula". In connection
with the development of these products, the
Company has engaged Cosmetic Project
Management, a Spanish corporation engaged in
the business of the formulation, development
and commercialization of cosmetic products,
to assist it in formulating, developing and
commercializing its Natural Hair Care
Products and Natural Skin Care Products. In
particular, Cosmetic Project Management has
agreed to do the following:
(a) Produce samples for each of the
Company's Natural Hair Care Products and
Natural Skin Care Products.
(b) Provide the Company with a feasibility
study on the Company's Natural Hair Care
Products and Natural Skin Care Products.
(c) Design product packaging and develop an
advertising plan for the Company's Natural
Hair Care Products and Natural Skin Care
Products.
(d) Assist the Company in selecting a
manufacturer in order to ensure good
manufacturing practice guidelines are met.
(e) Assist the Company in preparing and
filing a product dossier for each of the
Company's Natural Hair Care Products and
Natural Skin Care Products.
In consideration for these services, the
Company has agreed to pay EUR 20,100 to
Cosmetic Project Management, of which EUR
10,050 has already been paid as a deposit.
The balance of the payment is to be paid
immediately prior to the production of the
samples.
The Company anticipates that it will use the
samples of its Natural Hair Care Products
and Natural Skin Care Products for clinical
studies purposes. These clinical studies
will assist the Company in determining
whether there are any dermatological health
benefits for hair and skin through the use
of its Natural Hair Care Products and
Natural Skin Care Products.
Thursday, October 1, 2009 – Caleco Pharma
Corp. Announces Signing of Letter of Intent
with Caleco Pharma Europe S.L. -
Caleco Pharma Corp. is pleased to announce
that on September 30, 2009 the Company
signed a letter of intent (the "Letter of
Intent") with Caleco Pharma Europe S.L.
("SL"), a Spanish
Corporation. The Letter of Intent sets out
the proposed terms of a License agreement
whereby SL has agreed to acquire an
exclusive license in Continental Europe to
market and exploit certain products the
Company has developed or is developing. The
term of the proposed license is for a period
of twenty (20) years. The products under the
proposed license include the Company's
Natural Hair Care Products (LamiriShampoo,
LamiriHair Conditioner and LarimiHair
Tonic), Natural Skin Products (LamiriGel and
LamiriCreme), Energy Drinks (KTKin) and
Chewing Gum (KTK Chewing Gum and KTKids
Children Chewing Gum) (the "Products"). The
formulations of these products are derived
from the Company's proprietary technology
that it refers to as the "Liver Health
Formula".
Under the terms of the proposed license
agreement, SL will be required to do the
following:
(a) deliver to the Company of 10% of the
shares of SL which will be delivered no
later than 30 days from the execution of the
proposed license agreement;
(b) pay a royalty of five percent (5%) of
its gross sales of the Products to Caleco;
and
(c) achieve annual gross revenues of: (i)
$3,000,000 from the sale of the Company's
product during the period of July 31, 2012
to July 30, 2013; (ii) $5,000,000 from the
sale of the Company's product during the
period of July 31, 2013 to July 30, 2014;
and (iii) $12,000,000 from the sale of the
Company's product during the period of July
31, 2014 to July 30, 2015. If SL is unable
to achieve these revenues, the Company will
have the right to terminate the proposed
license agreement.
Under the proposed license agreement,
subject to the approval of the Company, SL
will have the right to sub-license the
Products in continental Europe. The Company
or SL will also have the right to assign its
entire interest in the proposed license
agreement subject to the following:
(a) the assignment is subject to the mutual
agreement of both the Company and SL on the
conditions of the proposed assignment; and
(b) any refusal of approval by the Company
will not be considered reasonable if the
transaction that is the subject of the
refusal is in accordance with
internationally accepted standards for the
licensing of products.
The terms of the Letter of Intent are
non-binding and will expire unless a formal
agreement is entered into by November 29,
2009. The above is subject to the conclusion
of a formal agreement. There is no assurance
that a formal agreement will be concluded or
that the terms will not change from those
described above.
Wednesday, September 30, 2009 – Caleco
Pharma Corp. – Corporate Update -Caleco
Pharma Corp. is pleased to announce a
corporate update with respect to its
business activities. Over the course of the
past 60 days, several meetings and
presentations have occurred between the
Company's management and various
corporations, private and public, to further
the development of our proprietary
technology known as our "Liver Health
Formula" and the expansion of our marketing
and commercialization efforts of our Liver
Health Formula.
As a result of these meetings, we have
identified several business opportunities.
As previously announced, we signed a letter
of intent (the "Letter of Intent") with Puleva
Biotech S.A. ("Biotech"), a publicly
listed Spanish Corporation engaged in the
business of research, development and
commercialization of health related
products. The Letter of Intent sets out the
terms of a proposed license agreement
whereby we have agreed to acquire an
exclusive license to market and
exploit Biotech's patented probiotic
bacteria product known as Hereditum in the
United States, Canada and Mexico. We have
also submitted proposals to form alliances
in order to provide for the development and
distribution of products derived from our
Liver Health Formula.
We plan to provide further corporate updates
to our shareholders and the investment
community upon our forming additional
relationships and completing additional
letters of understanding. We will continue
to explore adding industry professionals and
experts who have experience in the areas of
clinical research, product development,
marketing and distribution to our Board of
Directors and will continue to seek out
strategic relationships with these
individuals. We plan on continuing the
development of our proprietary technology as
naturally sourced health supplements and for
dermatological applications.
Thursday, September 10, 2009 – Caleco Pharma
Corp. Announces Signing of Letter of Intent
with Puleva Biotech S.A. -
Caleco Pharma Corp. is pleased to announce
that it has signed a letter of intent (the
"Letter of Intent") with Puleva Biotech
S.A. ("Biotech"), a publicly listed Spanish
Corporation engaged in the business of
research, development and commercialization
of health related products. The Letter of
Intent sets out the proposed terms of the
license agreement whereby the Company will
acquire an exclusive license to market and
exploit Biotech's patented probiotic
bacteria product known as Hereditum in the
United States, Canada and Mexico.
Under the terms of the proposed license
agreement, the Company will be required to
do the following:
(a) pay 1,000,000 Euros (the "Cash Purchase
Price") to Biotech on the later of 120 days
from execution of the proposed license
agreement or five business days following
delivery to the Company of a Generally
Recognized as Safe ("GRAS") authorization
from the U.S. Food and Drug
Administration (the "FDA");
(b) pay a royalty of 5% of the Company's
gross sales of Hereditum to Biotech;
(c) conduct a clinical trial, at the
Company's expense, on the effectiveness of
Hereditum in preventing Mastitis. If the
clinical trial fails to establish a
substantial difference between Hereditum and
a placebo, the Company may terminate the
proposed license agreement and be entitled
to a payment of 1,000,000 Euros from
Biotech;
(d) achieve sales of Hereditum at reasonable
commercial levels within three years
following payment of the Cash Purchase
Price. If the Company is unable to obtain
sales at reasonable commercial levels, the
license will become a non-exclusive license
and Biotech may grant other licenses within
the United States, Canada and Mexico; and
(e) achieve gross revenues of $40,000,000
from the sale of Hereditum within five years
following payment of the Cash Purchase
Price. If the Company is unable to achieve
these revenues, Biotech will have the right
to terminate the proposed license agreement.
Under the proposed license agreement,
subject to the approval of Biotech, the
Company will have the right to sub-license
Hereditum in the United States, Canada and
Mexico. The Company will also have the right
to assign its entire interest in the
proposed license agreement subject to the
following:
(a) if the assignment is for a combination
of a cash payment and royalties, the Company
will be entitled to retain the cash payment
and 50% of the royalty. If the royalty is
less than 5%, Biotech will be entitled to a
minimum royalty of 2.5% and the Company will
be entitled to the balance of the royalty;
and
(b) if the assignment is for cash
consideration only, the Company will be
entitled to retain 70% of the cash payment
and Biotech will be entitled to 30% of the
cash payment.
The terms of the Letter of Intent are
non-binding and will expire unless a formal
agreement is entered into by October 30,
2009. The above is subject to the conclusion
of a formal agreement. There is no assurance
that a formal agreement will be concluded or
that the terms will not change from those
described above.
Company Contact:
Caleco Pharma Corp.
John Boschert
President
(360) 306-1133
www.calecopharmacorp.com