Thallion Pharmaceuticals and LFB biotechnologies sign definitive agreement to develop and commercialize treatment for E. Coli (STEC) infection
Les Ulis, France and Montréal, Quebec, February 16, 2010 - Thallion Pharmaceuticals Inc. (‘‘Thallion'') (TSX: TLN) and LFB Biotechnologies (‘‘LFB'') today announced the signing of a definitive development and commercialization agreement for Shigamabs®, Thallion's product candidate for the treatment of Shiga toxin-producing E. coli, or STEC, infections. Thallion has granted LFB, an affiliate of the Laboratoire français du Fractionnement et des Biotechnologies of Les Ulis, France, an exclusive license for the commercial rights to Shigamabs® in Europe, South America and other territories of strategic interest to LFB, including Russia, Turkey, China, South Korea and Northern African countries. Thallion retains commercial rights for the rest of world, including North America. The agreement follows the binding Letter of Intent signed in December 2009 between the two parties.
"This transaction transforms our company into a focused Shigamabs® play with a strong and stable balance sheet and a quality partner with extensive experience in both the development of monoclonal antibodies and the commercialization of hospital-based products that treat rare diseases," said Dr. Allan Mandelzys, Chief Executive Officer of Thallion. "The collaborative nature of this agreement establishes joint committees comprising members from both organizations that will oversee the development and commercialization of Shigamabs®. Together, we plan to put Shigamabs® back in the clinic and initiate a Phase II study in South America during the second half of this year."
"LFB shares Thallion's vision of developing new treatments for under-served markets," stated Christian Béchon, LFB's Chairman & CEO. "Shigamabs® is particularly well suited to broadening LFB's portfolio of monoclonal antibodies and, as an Orphan Drug, perfectly fits with our commitment in rare and severe diseases. We look forward to moving Shigamabs® into the Phase II clinical trial."
Pursuant to the agreement, Thallion is eligible to receive payments of up to €95 million (approximately C$150 million) from LFB, which includes an up-front licensing fee of €1.5 million (approximately C$2.3 million), funding for substantially all future clinical development costs, as well as milestone payments associated with the development, approval and commercial sales of Shigamabs®. In addition, Thallion is eligible to receive tiered, double digit royalties based on product sales in all the LFB territories. Thallion will retain primary responsibility for the conduct of the clinical program, whereas LFB will be responsible for the exclusive global manufacturing and supply of Shigamabs® for both clinical study and commercial sales.
Thallion and LFB anticipate promptly submitting an amended protocol to selected South American regulatory agencies, based on a clinical protocol that had been approved previously by both the Argentinean and Chilean authorities. The companies intend to immediately initiate activities preparing for the launch of a Phase II study in South America in the second half of 2010, coinciding with the start of the high incidence season for STEC infection in the Southern hemisphere.
Notice of Conference Call
Thallion will hold a conference call this morning, Tuesday, February 16, 2010, at 11:00 a.m. (ET) hosted by Dr. Allan Mandelzys, Chief Executive Officer, Mr. Lloyd Segal, Chairman of the Board of Directors and Mr. Michael Singer, Chief Financial Officer, to discuss the Shigamabs® agreement. To access the conference call by telephone, dial 1-888-231-8191 or 1-647-427-7450. A live audio webcast of the call will be available at www.thallion.com. The webcast will be archived for 90 days.
Shigamabs® consists of two monoclonal antibodies designed to bind specifically and exclusively to the Shigatoxin 1 and Shigatoxin 2 toxins secreted by Shiga-toxin E. coli (STEC) bacteria. STEC infections are primarily foodborne bacterial infections that cause serious health complications, particularly in young children and the elderly, and affect approximately 314,000 people annually in the industrialized world. There are no approved products available for the treatment of STEC infections. The Shigamabs® antibodies, administered as a single intravenous injection, bind to their respective toxin and neutralize them by forming a complex that is absorbed and destroyed by the liver and spleen. The dual antibody approach enables Shigamabs® to address STEC infections caused by E.coli secreting either Shigatoxin 1, Shigatoxin 2 or both Shigatoxins. Shigamabs® has obtained orphan drug designation both in the US and in Europe.
Thallion has completed multiple preclinical studies and four Phase I clinical trials evaluating the efficacy and safety of Shigamabs®. The clinical trials demonstrated that Shigamabs® are safe and well tolerated when administered both individually and in combination at various dose levels. No serious adverse events were experienced in any of the 50 healthy volunteers that have received the drug. In preclinical studies Shigamabs® demonstrated a significant protective effect at relatively low doses, and animal rescue was possible even when the drug was administered 72 hours post-infection.
LFB is part of the LFB group, a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, namely Hemostasis, Immunology and Intensive Care. LFB Group is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide and is also among the leading European companies for the development of monoclonal antibodies and new-generation proteins based on biotechnologies. With its strong focus on research, the LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. In 2008, LFB reported total turnover of 352,4 million euros, an increase of 9%, and invested 66,6 millions euros in product development. LFB markets its products in 20 countries around the world. For more information about LFB visit www.lfb.fr.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX: TLN) is a biotechnology company developing pharmaceutical products in the areas of infectious disease and oncology. The Company's clinical programs include Shigamabs® and TLN-4601, a novel anti-cancer therapy. Shigamabs® is a dual antibody product for the treatment of Shiga toxin producing E. coli bacterial infections which is anticipated to enter Phase II clinical testing in the second half of 2010. Additional information about Thallion can be obtained at www.thallion.com.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words "believe", "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect" and other similar expressions which constitute "forward-looking information" within the meaning of applicable Canadian securities laws. Forward-looking statements reflect Thallion's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, the satisfaction of conditions provided in the development and commercialization agreement with LFB, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in Thallion's ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Thallion undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.