MONTREAL, QUEBEC--(Marketwire - December 18, 2009) - Thallion Pharmaceuticals Inc. (TSX: TLN) today announced that it has signed a binding Letter of Intent ("LOI") with LFB Biotechnologies, of Les Ulis, France, an affiliate of the Laboratoire francais du Fractionnement et des Biotechnologies ("LFB"), for the development of Shigamabs®, Thallion's product candidate for the treatment of Shiga toxin-producing bacterial, or STEC, infection. The partnership is subject to the execution of definitive agreements which Thallion anticipates in the first quarter of 2010. The LOI provides for immediate funding by LFB Biotechnologies of costs associated with re-initiating the Shigamabs® program.
"We have always believed in the potential of Shigamabs® to treat STEC infection, a serious condition for which no approved therapy currently exists. LFB Biotechnologies is an ideal partner for this program as they bring their extensive experience in the development of monoclonal antibodies and next-generation protein therapies as well as their considerable commercial and financial support that is necessary to successfully develop Shigamabs®," said Dr. Allan Mandelzys, EVP of Licensing & Corporate Development of Thallion Pharmaceuticals Inc.
Under the terms of a definitive agreement, LFB Biotechnologies will receive commercial rights to Shigamabs® for Europe and South America, while Thallion retains the rights for North America and the rest of world. Thallion can receive payments of up to _95 million (approximately C$150 million), 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 will receive tiered, double digit royalties based on product sales. Thallion will retain primary responsibility for the conduct of the clinical program, whereas LFB Biotechnologies will be responsible for the manufacture and supply of Shigamabs® for both clinical study and commercial sale.
A Joint Development Committee to be comprised of members from both Thallion and LFB Biotechnologies will be established to oversee the clinical development of Shigamabs®. Based on a Thallion clinical protocol that had been approved previously by both the Argentinean and Chilean regulatory agencies, the companies intend to promptly initiate activities for the launch of a Phase II study in South America.
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 a foodborne bacterial infections that cause serious health complications, particularly in young children and the elderly, and affects 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 any cases where one and/or the other Shigatoxin is present and also overcomes the inability of existing diagnostic technology to distinguish between cases caused by only one of the two toxins. 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 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: http://www.lfb.fr.
About Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals Inc. (TSX: TLN) is a biotechnology company developing pharmaceutical products in the areas of oncology and infectious disease. 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 ready to begin a Phase II clinical program upon the completion of a development partnership. 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 obtaining of court and other regulatory approvals and consents, the satisfaction of closing conditions, 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.