ProMetic Life Sciences Inc.
TSX : PLI

ProMetic Life Sciences Inc.

November 08, 2007 15:05 ET

ProMetic Announces an Agreement With Kedrion for the Development of Multiple Hyperimmunes

Targets a $300 M market opportunity Kedrion to implement ProMetic's yield improving and prion reduction technologies for new generation of hyperimmune products

LUCCA, ITALY, ROCKVILLE, MARYLAND, USA, AND MONTREAL, QUEBEC, CANADA--(Marketwire - Nov. 8, 2007) - Kedrion S.p.A. ("Kedrion") and ProMetic BioTherapeutics, Inc., ("BPT") a subsidiary of ProMetic Life Sciences Inc. ("ProMetic")(TSX:PLI) announced today that they have reached a preliminary agreement for multiple hyperimmunes. Under the terms of this agreement, Kedrion will in-license technologies from ProMetic to enable the manufacturing of hyperimmune products in Europe. The agreement, based on license fees, service fees, and royalties to be paid by Kedrion to ProMetic for the sales in Europe, will be closed shortly.

Kedrion will fund the product development program initiated this year, which also includes a clinical trial to demonstrate bioequivalence to their existing products. The clinical trial will be performed to meet European and U.S. regulatory requirements.

Full scale commercial manufacturing will take place within Kedrion's facility in Italy. ProMetic retains the commercial rights for the fully developed hyperimmune products for the North American market. ProMetic will in turn pay Kedrion royalties on its sales of the hyperimmune products in North America.

"This agreement leverages each company's expertise and is expected to build value while bringing a new generation of hyperimmune products to the market," explained Mr. Paolo Marcucci, President and CEO of Kedrion. "The companies will exploit ProMetic's yield improving manufacturing technology and ProMetic's prion reduction technology to provide the market with significantly improved products."

The integration of ProMetic's technologies into Kedrion's existing manufacturing infrastructure will increase Kedrion's manufacturing capacity and enable both companies to increase market share in Europe and in North America.

"Kedrion's proven track record in the development and marketing of hyperimmunes is strategic for ProMetic," commented Mr. Pierre Laurin, President and CEO of ProMetic. "This transaction is the first step towards providing ProMetic with the ability to market finished biopharmaceutical products into the North American market."

The first product being targeted will be Hepatitis B and could reach commercial stage by 2010/2011. The market for Hepatitis B Hyperimmune in Europe and in the U.S. is currently estimated at $200 M and is expected to double by 2015.

"This agreement provides us with the opportunity to expand our reach in Europe and in the U.S. markets," explained Mr. Marcucci.

More about Hepatitis B

HB, hepatitis B IVIG is primarily used in preventing reinfection with hepatitis B in HBV positive liver transplant patients. It is also used in the treatment of acute exposure to hepatitis B following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg positive persons, and household exposure of infants to persons with acute hepatitis B virus infection. The groups usually considered at risk are hepatitis B researchers and workers, and many health care professionals. This group is estimated to lead to a demand for 45,000 doses per year of hepatitis B immune globulin. Pricing varies, but a reasonable rule of thumb is $900 per treatment. The market hepatitis B immune globulin in the U.S. is estimated $42 M in 2005. This should grow at a 10% AAGR to $67.6 M by 2010. (The Blood Industry, Copyright(C) Business Communications Co., Inc., Norwalk, CT USA, Web: www.bccresearch.com)

More about Kedrion S.p.A.

Kedrion is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. In Italy, Kedrion is the main reference point for the National Health Service as regards the production of plasma-derived drugs. Moreover, its skills are also put to use in strategic partnerships with overseas health services. Kedrion is present in over 40 countries, and is in 6th place in the world for volume of fractionated plasma and 7th for sales. The quality of its products, its continuous commitment to research and development, its consistent industrial capacity and its consolidated presence on the national and international market are the company's main areas of competitiveness.

Kedrion is located in Castelvecchio Pascoli, in the province of Lucca, Tuscany, and has two production plants, Kedrion Bolognana, in the vicinity of Lucca, and Hardis S. Antimo, in the vicinity of Naples. Kedrion's operations cover three different areas of business: production and distribution of plasma-derived products, Contract Manufacturing and transfer of technological know how. The three principal types of plasmaderivates produced by Kedrion are: standard and hyperimmune immunoglobulin, albumin and coagulation factors (procoagulants and anticoagulants). Its Website is www.kedrion.com.

About ProMetic Life Sciences Inc.

ProMetic Life Sciences Inc. (www.prometic.com) is a biopharmaceutical company specialized in the research, development, manufacture and marketing of a variety of commercial applications derived from its proprietary Mimetic Ligand™ technology. This technology is used in large-scale purification of biologics and the elimination of pathogens. ProMetic is also active in therapeutic drug development with the mission to bring to market effective, innovative, lower cost, less toxic products for the treatment of hematology and cancer. Its drug discovery platform is focused on replacing complex, expensive proteins with synthetic "drug-like" protein mimetics. Headquartered in Montreal (Canada), ProMetic has R&D facilities in the UK, the USA and Canada, manufacturing facilities in the UK and business development activities in the USA, Europe, Asia and in the Middle-East.

Forward Looking Statements

This press release contains forward-looking statements about ProMetic's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, ProMetic's ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of ProMetic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations on page 21 of ProMetic's Annual Information Form for the year ended December 31, 2006, under the heading "Risk Factors". As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason.

Contact Information

  • Kedrion Communications Area
    Iria Cogliani
    Head
    Mob. +39-320-9191125
    or
    Kedrion Communications Area
    Lisa Nordio
    Press Officer
    Mob. +39-348-6559718
    or
    ProMetic Life Sciences Inc.
    Pierre Laurin
    President and CEO
    +1-514-341-2115
    p.laurin@prometic.com
    or
    ProMetic Life Sciences Inc.
    Anne Leduc
    Manager, Communications
    +1-514-341-2115 ext.2234
    a.leduc@prometic.com
    or
    Echoes Financial Network Inc.
    Dominic Sicotte
    +1-514-842-9551
    dsicotte@echoesfinancial.com
    or
    Lippert / Heilshorn & Associates
    Bruce Voss
    +1-310-691-7100
    BVoss@lhai.com
    or
    Lippert / Heilshorn & Associates
    Kim Golodetz
    +1-212-838-3777
    KGolodetz@lhai.com