Eleven entitled to receive $22.5 million milestone payment for IND effectiveness
CAMBRIDGE, MA, USA I July 7, 2016 I Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that the company’s Investigational New Drug (IND) application for EBI-031, a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling, for treatment of ocular diseases, has become effective. As a result of the achievement of this milestone, Eleven is entitled to receive a $22.5 million payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) pursuant to the terms of its license agreement with Roche.
On June 13, 2016, Eleven announced that it had entered into an exclusive license agreement with Roche for the further development and commercialization of EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Under the terms of the agreement, Eleven could receive up to $262.5 million upon the achievement of certain regulatory, development and commercialization milestones, including this $22.5 million payment upon the effectiveness of the IND for EBI-031. In addition, Eleven could be entitled to receive royalties for net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds. Effectiveness of the license agreement, including Roche’s obligation to make the $22.5 million milestone payment, is subject to approval of the license by holders of at least a majority of the outstanding shares of Eleven’s common stock.
“We look forward to Roche advancing EBI-031 into the clinic to explore its potential use for ocular diseases, such as diabetic macular edema, in an effort to bring this potential treatment to patients,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics.
About EBI-031
Eleven Biotherapeutics’ most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven’s AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016 for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the Company’s understanding of the structural biology of cytokines and the Company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. For more information please refer to the Company’s website www.elevenbio.com.
SOURCE: Eleven Biotherapeutics
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Eleven entitled to receive $22.5 million milestone payment for IND effectiveness
CAMBRIDGE, MA, USA I July 7, 2016 I Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a biopharmaceutical company discovering and developing protein therapeutics to treat diseases of the eye, today announced that the company’s Investigational New Drug (IND) application for EBI-031, a humanized monoclonal antibody that potently binds interleukin-6 (IL-6) and inhibits all known forms of IL-6 cytokine signaling, for treatment of ocular diseases, has become effective. As a result of the achievement of this milestone, Eleven is entitled to receive a $22.5 million payment from F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (Roche) pursuant to the terms of its license agreement with Roche.
On June 13, 2016, Eleven announced that it had entered into an exclusive license agreement with Roche for the further development and commercialization of EBI-031 and all other IL-6 antagonist antibody technology owned by Eleven. Under the terms of the agreement, Eleven could receive up to $262.5 million upon the achievement of certain regulatory, development and commercialization milestones, including this $22.5 million payment upon the effectiveness of the IND for EBI-031. In addition, Eleven could be entitled to receive royalties for net sales of potential future products containing EBI-031 or any other potential future products containing other Eleven IL-6 compounds. Effectiveness of the license agreement, including Roche’s obligation to make the $22.5 million milestone payment, is subject to approval of the license by holders of at least a majority of the outstanding shares of Eleven’s common stock.
“We look forward to Roche advancing EBI-031 into the clinic to explore its potential use for ocular diseases, such as diabetic macular edema, in an effort to bring this potential treatment to patients,” said Abbie Celniker, Ph.D., President and Chief Executive Officer of Eleven Biotherapeutics.
About EBI-031
Eleven Biotherapeutics’ most advanced preclinical product candidate is EBI-031 for treatment of diabetic macular edema, or DME, and uveitis. EBI-031 was designed and engineered for intravitreal delivery using Eleven’s AMP-Rx platform. EBI-031 is a potent blocker of both free IL-6 and IL-6 complexed to the soluble IL-6 receptor (IL-6R). Eleven filed an IND with the FDA in June 2016 for the purpose of conducting clinical trials of EBI-031 in DME and uveitis.
About Eleven Biotherapeutics
Eleven Biotherapeutics, Inc. is a preclinical-stage biopharmaceutical company with a proprietary protein engineering platform, called AMP-Rx, that it applies to the discovery and development of protein therapeutics to treat diseases of the eye. Eleven’s therapeutic approach is based on the role of cytokines in diseases of the eye, the Company’s understanding of the structural biology of cytokines and the Company’s ability to rationally design and engineer proteins to modulate the effects of cytokines. Cytokines are cell signaling molecules found in the body that can have important inflammatory effects. For more information please refer to the Company’s website www.elevenbio.com.
SOURCE: Eleven Biotherapeutics
Post Views: 135
