Caleco Pharma Corp.
OTC Bulletin Board : CAEH

Caleco Pharma Corp.

June 09, 2010 16:26 ET

Caleco Pharma Announces Lead Products for the $4 Billion Hepatitis C Marketplace

Company Provides Update on Two-Tiered Development Strategy

LONG VALLEY, NEW JERSEY--(Marketwire - June 9, 2010) - (OTCBB:CAEH)(FRANKFURT:T3R)(WKN:A0N9Y0) ( Caleco Pharma Corp. (the "Company" or "Caleco"), is a company engaged in the development of biopharmaceutical and consumer health products. The Company, which identifies and develops products derived from natural sources including plant extracts, functional oils and probiotics, is pleased to provide an update on the development of its products that target the global Hepatitis "C" prescription market - an estimated $4 Billion market – and the liver health maintenance market via a nutritional supplement formulation. Over 200 million persons are infected with chronic hepatitis C and less than 5% are treated with prescription medications today.

"International pharmaceutical research firm, GlobalData, has issued their current research report on the hepatitis C marketplace, which seems to confirm that the Company is strategically positioned to pursue the development of its proprietary, patent applied formulations," said Caleco's CEO, John Boschert.

"GlobalData's analysis suggests that the global hepatitis C market was worth $4.4 billion in 2009. It is forecast to grow at a Compound Annual Growth Rate (CAGR) of 9.8% for the next seven years to reach $8.5 billion by 2016. Increasing prevalence of the disease and the availability of new first-in-class therapies with better safety and efficacy profiles are expected to drive the growth of the hepatitis C market. The market has a huge potential for molecules with better safety and efficacy profiles.

The global hepatitis C market is attractive, with high levels of unmet need. The market is poorly served due to the moderate effectiveness and low tolerability of current treatment options. The adverse effects of the drugs include pregnancy, mental health problems, blood related disorders and autoimmune disorders. Patients using the standard interferon combination therapy to treat hepatitis C soon develop resistance against these drugs and must wait for novel therapies to enter the market. There is huge untapped potential in the current hepatitis C market which could be captured by novel molecules, targeted to fulfill the current void left by the existing treatment options. Thus the hepatitis C market has high potential for further research and development (R&D) activities." (Source: GlobalData, "Hepatitis C – Drug Pipeline Analysis and Market Forecasts to 2016", May 12, 2010)

Pre-clinical research conducted by Caleco's Advisory Board member, Prof. Harry Fong, a world authority in pharmacognosy, confirms that Caleco Pharma's 'Liver Health Formulation' exhibits strong anti-viral activity in vitro. "Our plan is to continue pre-clinical work with compounds CPC.12115HP201 and CPC.12115HP202 in 2010, which will involve focusing on developing and testing semi-synthetic derivatives (of CPC.12115HP201) in preparation for entering phase 1 clinical trials in 2011 as well as further compound isolation work on a second isolate of the parent mixture (CPC.12115HP202). With the anti-viral activity profiles having been demonstrated in two bioassay systems, and considering the observed clinical effects of the parent herbal formulation, the Company believes continued preclinical development work is warranted," continued Mr. Boschert.

Consistent with its dual commercialization pathway model the Company is actively engaged in development projects to bring the parent mixture ("Liver Health Formulation") to worldwide markets as a food supplement for the promotion of liver health following additional clinical trials expected to start later this year. In addition, derivatives of the parent herbal formulation's primary active ingredient Lamiridosin are being considered for oral supplement development targeted at immune system enhancement and as dermatologic products for use in common chronic skin conditions.
Collectively these products are known as our Lamiridosin Franchise and include:

(1) Oral food supplement – Liver Health Formulation
(2) Oral food supplement – Immune system enhancement
(3) Dermatologic formulations for psoriasis, acne, dermatitis and other chronic skin conditions
(4) Hair and scalp health products

"The proprietary Lamiridosin-based plant extracts exhibit anti-viral and anti-inflammatory properties making them ideal candidates for multiple formulations targeting chronic conditions," concluded Mr. Boschert.

To date, the Company's intellectual property covering the "Liver Health Formulation" is comprised of patent applications in the United States, Europe and Canada and four European Drug Master File applications.

Additional information is available on the Company's website at:

About Caleco Pharma Corp.

Caleco Pharma is focused on the ongoing research and development of its pipeline of over-the-counter and prescription medications including its proprietary antiviral and "Liver Health" OTC formulations. In addition Caleco Pharma is developing Dermatological Products based on the active ingredients found in its proprietary formulation. To date, Caleco Pharma's intellectual property covering the Liver Health formulations and derivatives consists of patent applications in the United States, Europe and Canada and four European Drug Master File applications.
Caleco Pharma's shares are traded in the United States on the OTC Bulletin Board (OTCBB:CAEH) and in Germany on the Frankfurt Stock Exchange (FRANKFURT:T3R)(WKN:A0N9Y0).

This press release may contain, in addition to historic information, forward-looking statements. These statements may involve known and unknown risks and uncertainties and other factors that may cause the actual results to be materially different from the results implied herein. In particular, there are no assurances that: (i) Caleco will be granted a patent in connection with its current patent applications in the United States, Europe and Canada; (ii) Caleco Pharma will be able to manufacture and produce its products or that its products will be effective; (iii) Caleco will be able to carry out any pre-clinical or clinical trials of its products; (iv) Caleco will be able to obtain additional financing in order to meet the costs of the clinical studies of the "Liver Health" formulation; and (v) Caleco will be able to control the costs of the clinical studies of the "Liver Health" formulation. Readers are cautioned not to place undue reliance on the forward-looking statements made in this press release.

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