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Caleco Pharma Corp. (CAEH)

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
 

 


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