Thallion Pharmaceuticals has granted LFB Biotechnologies 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 covering this Shiga toxin-producing E. coli (STEC) infection treatment for the rest of world.
Thallion is eligible to receive up to €95 million (approximately $129.78 million), including a €1.5 million (about $2.05 million) up-front licensing fee, 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 earn tiered, double-digit royalties based on product sales in all LFB territories.
Thallion will retain primary responsibility for conducting clinical trials. LFB will be responsible for the exclusive global manufacturing and supply of Shigamabs for both clinical study and commercial sales.
“The collaborative nature of this agreement establishes joint committees comprising members from both organizations that will oversee the development and commercialization of Shigamabs,” says Allan Mandelzys, Ph.D., Thallion CEO. “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.”
Thallion and LFB anticipate 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 anticipate starting a Phase II study in South America in the second half of 2010, coinciding with the initiation of a high-incidence season for STEC infection in the Southern hemisphere.
Shigamabs consists of two mAbs designed to bind specifically and exclusively to the Shigatoxin 1 and Shigatoxin 2 toxins secreted by STEC bacteria. 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, Thallion explains.
“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,” Dr. Mandelzys adds.